Electrosurgical devices are used in many surgical procedures which may include removing, shrinking, or sealing tissues as part of the therapeutic process. In some examples, electrosurgical devices may apply electrical energy directly to tissue in order to effect the surgical treatment. Alternatively, electrosurgical devices may use the electrical energy as a source of power for other modes of surgical treatment, for example to generate ultrasonic energy which may then be applied to the tissues. An electrosurgical device may comprise an instrument having a distally-mounted end effector comprising components designed to introduce the therapeutic energy into the tissue being treated. Such end effectors may consist of two or more jaws in which at least one of the jaws is moveable from a position spaced apart from the opposing jaw for receiving tissues to a position in which the space between the jaws is less than that of the first position. Movement of the moveable jaw may compress the tissue held between. The therapeutic energy delivered by components of the end effector, in combination with the compression achieved by the jaw movement, may form hemostatic seals within the tissue and/or between tissues and thus may be particularly useful for sealing blood vessels, for example. The end effector of an electrosurgical device may also comprise a cutting member that is movable relative to the tissue and the jaws to transect the tissue.
In some electrosurgical devices, electrical energy may be transmitted to the instrument by a generator and applied directly by the electrosurgical device to the tissue under treatment. In some examples, the electrical energy may be in the form of radio frequency (“RF”) energy. The electrical energy may be in the form of radio frequency (“RF”) energy that may be in a frequency range described in EN 60601-2-2:2009+A11:20. In some applications, the applied energy may have a frequency restricted to less than 5 MHz. Typically, frequencies above 5 MHz are not used in order to minimize the problems associated with high frequency leakage currents. It is generally recognized that 10 mA is a lower threshold of thermal effects on tissue. RF energy may be supplied by a power source and introduced into tissue compressed between the two or more jaws. Such RF energy may cause ionic agitation in the tissue, in effect producing resistive heating, and thereby increasing the temperature of the tissue. Increased temperature of the tissue may lead to tissue cauterization. In some surgical procedures, RF energy may be useful for removing, shrinking, or sculpting soft tissue while simultaneously sealing blood vessels.
Other electrosurgical devices may use the electrical energy as a source of power for other modes of surgical treatment, for example to generate ultrasonic energy which may then be applied to the tissues. Ultrasonic surgical instruments can be used for the safe and effective treatment of many medical conditions. Generally, ultrasonic surgical instruments can be used to cut and/or coagulate organic tissue, for example, using energy in the form of ultrasonic vibrations, i.e., mechanical vibrations transmitted to a surgical end-effector at ultrasonic frequencies. These ultrasonic vibrations, when transmitted to organic tissue at suitable energy levels and using a suitable end-effector, may be used to cut and/or coagulate the tissue. Such instruments may be used for open procedures or minimally invasive procedures, such as endoscopic or laparoscopic procedures, for example, in which the end-effector of the medical device is passed through a trocar to reach a surgical site.
It may be recognized that proper control of the electrical energy supplied to an electrosurgical device is critical for safe and effective operation of the device. It is therefore desirable for a medical device energy source to supply an appropriate amount of electrical energy to an electrosurgical device to promote a safe and effective therapeutic outcome. For example, an appropriate amount of electrical energy may be dependent on the type of electrosurgical device and its usage history.
In one aspect, a medical device energy source may be composed of an energy source, an energy source power interface configured to deliver electrical energy from the energy source, and an energy source computing device. The energy source computing device may further be composed of an energy source processor unit, an energy source memory storage component in operative communication with the energy source processor unit, an energy source network communication interface in operative communication with the energy source processor unit, and an energy source data interface in operative communication with the energy source processor unit. The energy source computing device may be configured to control a function of the energy source. Further, the energy source memory storage component may include instructions that, when executed by the energy source processor unit, may cause the energy source computing device to receive an identifier code via the energy source data interface, receive a plurality of medical device identity codes via the energy source network communication interface, compare the identifier code with each of the plurality of medical device identity codes, and control the function of the energy source based on the comparison of the identifier code with each of the plurality of medical device identity codes.
In one aspect of the medical device energy source, the identifier code may be composed of two identifier strings, each of which may include a string of processor readable characters.
In one aspect of the medical device energy source, the instructions that cause the energy source computing device to compare the identifier code with each of the plurality of medical device identity codes may include instructions that cause the energy source computing device to compare each of two identifier strings with each of two identity strings comprising each of the medical device identity codes.
In one aspect of the medical device energy source, the energy source memory storage component may include instructions that, when executed by the energy source processor unit, further cause the energy source computing device to receive, via the energy source network communication interface, a plurality of medical device status indicators, in which each medical device status indicator corresponds to each of the plurality of medical device identity codes.
In one aspect of the medical device energy source, the instructions that cause the energy source computing device to control the function of the energy source further comprise instructions that cause the energy source computing device to control the function of the energy source base on the medical device status indicators corresponding to a medical device identity code equal to the identifier code.
In one aspect of the medical device energy source, the energy source memory storage component may include instructions that, when executed by the energy source processor unit, further cause the energy source computing device to retain, in the energy source memory storage component, an energizer value corresponding to an amount of energy supplied by the energy source, an energizer time value corresponding to a length of time during which the energy source supplies an amount of energy, an energizer number corresponding to a number of times the energy source supplies an amount of energy, or combinations thereof.
In one aspect, the medical device energy source may further include a user display in operative communication with the energy source processor unit.
In one aspect, a medical device system may be composed of a medical device, a medical device energy source, and a medical device network server. The medical device may be composed of a device memory storage component configured to store an identifier code; a device data interface in operative connection with the memory storage component; and a device power interface configured to receive electric power from an energy source. The medical device energy source may be composed of the energy source, an energy source power interface in operative communication with the device power interface and configured to deliver electrical energy from the energy source to the medical device, and an energy source computing device. The energy source computing device may further be composed of an energy source processor unit, an energy source memory storage component in operative communication with the energy source processor unit, an energy source network communication interface in operative communication with the energy source processor unit and configured to transmit data to and receive data from a communication network, and an energy source data interface in operative connection with the device data interface, in which the energy source computing device may be configured to control a function of the energy source. The medical device network server may be composed of a network server processor unit, a network server memory storage component in operative communication with the network server processor unit and configured to store a medical device database comprising a plurality of medical device identity codes and corresponding medical device status indicators, and a network server communication interface in operative communication with the network server processor unit and configured to transmit data to and receive data from at least one medical device power source via the communication network. In this aspect, the energy source memory storage component may include instructions that, when executed by the energy source processor unit, cause the energy source computing device to receive, from the device memory storage component, the identifier code, receive, from the network server memory storage component, the plurality of medical device identity codes from the medical device database, compare the identifier code with each of the plurality of medical device identity codes, and control the function of the energy source based on the comparison of the at least one identifier code with the plurality of medical device identity codes.
In one aspect of the medical device system, the identifier code may be composed of two identifier strings, each of which may include a string of processor readable characters. In this aspect, the instructions that cause the energy source computing device to compare the identifier code with each of the plurality of medical device identity codes includes instructions that cause the energy source computing device to compare each of the two identifier strings with each of two identity strings comprising each of the medical device identity codes.
In one aspect of the medical device system, the energy source memory storage component may include instructions that, when executed by the energy source processor unit, further cause the energy source computing device to receive, via the energy source network communication interface, a plurality of medical device status indicators, in which each of the plurality of medical device status indicators corresponds to each of the plurality of medical device identity codes. Further, the instructions that cause the energy source computing device to control the function of the energy source further include instructions that cause the energy source computing device to control the function of the energy source base on a medical device status indicator corresponding to a medical device identity code equal to the identifier code.
In one aspect of the medical device system, the energy source memory storage component may further include instructions that, when executed by the energy source processor unit, cause the energy source computing device to transmit, to the medical device network server, data to update a medical device status indicator corresponding to a medical device identity code equal to the identifier code.
In one aspect of the medical device system, the network server memory storage component may include instructions that, when executed by the network servicer processor unit, cause the network server processor unit to receive, from the medical device energy source, data to update a medical device status indicator corresponding to the medical device identity code equal to the identifier code and to update the status indicator in the data base corresponding to the medical device identity code equal to the identifier code.
In one aspect of the medical device system, the medical device data base may further include one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base.
In one aspect of the medical device system, the energy source memory storage component may further include instructions that, when executed by the energy source processor unit, cause the energy source computing device to store in the energy source memory storage component an indicator of total medical device uses and a total amount of power supplied by the medical device energy source to the medical device over the total number of medical device uses. The energy source memory storage component may further include instructions that, when executed by the energy source processor unit, cause the energy source computing device to store in the energy source memory storage component an indicator, for each use of the total medical device uses, of an amount of power supplied by the medical device energy source to the medical device, and a length of time during which the medical device energy source supplies the amount of energy to the medical device.
In one aspect of the medical device system, the energy source memory storage component may further include instructions that, when executed by the energy source processor unit, cause the energy source computing device to receive, from the medical device network server, values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base and control the function of the energy source based on the value of the one or more of the additional indicators corresponding to the medical device identity code equal to the identifier code.
In one aspect of the medical device system, he network server memory storage component may include instructions that, when executed by the network servicer processor unit, cause the network server processor unit to receive, from the medical device energy source, values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base, and update the values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device database.
In one aspect, a method of controlling a medical device may include receiving, by a medical device energy source via an energy source data interface in operative communication with an energy source processor unit, an identifier code from a medical device, storing, by the medical device energy source in an energy source memory storage component in operative communication with the energy source processor unit, the identifier code, receiving, by the medical device energy source via an energy source network communication interface in operative communication with the energy source processor unit, a plurality of medical device identity codes from a medical device network server, comparing, by the energy source processor unit, the identifier code with each of the plurality of medical device identity codes, controlling, by the energy source processor unit, an amount of energy delivered by the energy source via an energy source power interface to the medical device, based on the comparison between the identifier code and the plurality of medical device identity codes, and displaying, on a user display operatively controlled by an energy source computing device comprising the energy source processor unit, information corresponding to the amount of energy delivered by the energy source to the medical device.
In one aspect, the method may further include transmitting, by the medical device energy source to the medical device, control data to control at least one function of the medical device.
In one aspect, the method may further include receiving, by the medical device energy source via the energy source network communication interface, a plurality of medical device status indicators, wherein each of the plurality of medical device status indicators corresponds to each of the plurality of medical device identity codes.
In one aspect, the method may further include controlling, by the energy source processor unit, an amount of energy delivered by the energy source via the energy source power interface to the medical device, based on the medical device status indicator corresponding to a medical device identity code that is equal to the identifier code.
In one aspect, the method may further include transmitting, by the medical device energy source to the medical device, control data to control at least one function of the medical device based on the medical device status indicators corresponding to the medical device identity code that is equal to the identifier code.
The features of the various aspects are set forth with particularity in the appended claims. The various aspects, however, both as to organization and methods of operation, together with advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings as follows:
Reference will now be made in detail to several aspects, including example implementations of electrosurgical medical instruments for cutting and coagulating tissue. Wherever practicable similar or like reference numbers may be used in the figures and may indicate similar or like functionality. The figures depict examples of the disclosed surgical instruments and/or methods of use for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative examples of the structures and methods illustrated herein may be employed without departing from the principles described herein.
Various aspects of surgical instruments that utilize therapeutic and/or sub-therapeutic electrical energy to treat tissue or provide feedback to the generators (e.g., electrosurgical instruments). The various aspects are adapted for use in a manual or hand operated manner, although electrosurgical instruments may be utilized in robotic applications as well.
With reference to
In other forms, the electrical outputs of the ultrasonic generator module 1008 and the electrosurgery/RF generator module 1010 may be combined into a single electrical signal capable of driving the multifunction device 1202 simultaneously with electrosurgical RF and ultrasonic energies. The multifunction device 1202 comprises an ultrasonic transducer 1014 coupled to an ultrasonic blade and one or more electrodes in the end effector 1032 to receive electrosurgical RF energy. In such implementations, the combined RF/ultrasonic signal is coupled to the multifunction device 1202. The multifunction device 1202 comprises signal processing components to split the combined RF/ultrasonic signal such that the RF signal can be delivered to the electrodes in the end effector 1032 and the ultrasonic signal can be delivered to the ultrasonic transducer 1014.
In accordance with the described forms, the ultrasonic generator module 1008 may produce a drive signal or signals of particular voltages, currents, and frequencies, e.g., 55,500 cycles per second (Hz). The drive signal or signals may be provided to the ultrasonic device 1004, and specifically to the transducer 1014, which may operate, for example, as described above. The transducer 1014 and a waveguide extending through the shaft (waveguide not shown in
The generator 1002 may be activated to provide the drive signal to the transducer 1014 in any suitable manner. For example, the generator 1002 may comprise a foot switch 1020 coupled to the generator 1002 via a footswitch cable 1022. A clinician may activate the transducer 1014 by depressing the foot switch 1020. In addition, or instead of the foot switch 1020 some forms of the ultrasonic device 1004 may utilize one or more switches positioned on the hand piece that, when activated, may cause the generator 1002 to activate the transducer 1014. In one form, for example, the one or more switches may comprise a pair of toggle buttons 1036a, 1036b (
Additionally or alternatively, the one or more switches may comprise a toggle button 1036c that, when depressed, causes the generator 1002 to provide a pulsed output. The pulses may be provided at any suitable frequency and grouping, for example. In certain forms, the power level of the pulses may be the power levels associated with toggle buttons 1036a, 1036b (maximum, less than maximum), for example.
It will be appreciated that a device 1004 may comprise any combination of the toggle buttons 1036a, 1036b, 1036c. For example, the device 1004 could be configured to have only two toggle buttons: a toggle button 1036a for producing maximum ultrasonic energy output and a toggle button 1036c for producing a pulsed output at either the maximum or less than maximum power level. In this way, the drive signal output configuration of the generator 1002 could be 5 continuous signals and 5 or 4 or 3 or 2 or 1 pulsed signals. In certain forms, the specific drive signal configuration may be controlled based upon, for example, EEPROM settings in the generator 1002 and/or user power level selection(s).
In certain forms, a two-position switch may be provided as an alternative to a toggle button 1036c. For example, a device 1004 may include a toggle button 1036a for producing a continuous output at a maximum power level and a two-position toggle button 1036b. In a first detented position, toggle button 1036b may produce a continuous output at a less than maximum power level, and in a second detented position the toggle button 1036b may produce a pulsed output (e.g., at either a maximum or less than maximum power level, depending upon the EEPROM settings).
In accordance with the described forms, the electrosurgery/RF generator module 1010 may generate a drive signal or signals with output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgery applications, the drive signal may be provided, for example, to electrodes of the electrosurgical device 1006, for example. Accordingly, the generator 1002 may be configured for therapeutic purposes by applying electrical energy to the tissue sufficient for treating the tissue (e.g., coagulation, cauterization, tissue welding).
The generator 1002 may comprise an input device 1045 (
The generator 1002 may also comprise an output device 1047 (
Although certain modules and/or blocks of the generator 1002 may be described by way of example, it can be appreciated that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the forms. Further, although various forms may be described in terms of modules and/or blocks to facilitate description, such modules and/or blocks may be implemented by one or more hardware components, e.g., processors, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Application Specific Integrated Circuits (ASICs), circuits, registers and/or software components, e.g., programs, subroutines, logic and/or combinations of hardware and software components. Also, in some forms, the various modules described herein may be implemented utilizing similar hardware positioned within the instruments 1004, 1006, 1202 (i.e., the generator 1002 may be omitted).
In one form, the ultrasonic generator drive module 1008 and electrosurgery/RF drive module 1010 may comprise one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules 1008, 1010 may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and so forth. The firmware may be stored in nonvolatile memory (NVM), such as in bit-masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may preserve flash memory. The NVM may comprise other types of memory including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery backed random-access memory (RAM) such as dynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).
In one form, the modules 1008, 1010 comprise a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1004, 1006, 1202 and generating a corresponding output control signals for operating the devices 1004, 1006, 1202. In forms in which the generator 1002 is used in conjunction with the device 1004, the output control signal may drive the ultrasonic transducer 1014 in cutting and/or coagulation operating modes. Electrical characteristics of the device 1004 and/or tissue may be measured and used to control operational aspects of the generator 1002 and/or provided as feedback to the user. In forms in which the generator 1002 is used in conjunction with the device 1006, the output control signal may supply electrical energy (e.g., RF energy) to the end effector 1032 in cutting, coagulation and/or desiccation modes. Electrical characteristics of the device 1006 and/or tissue may be measured and used to control operational aspects of the generator 1002 and/or provide feedback to the user. In various forms, as previously discussed, the hardware component may be implemented as a DSP, PLD, ASIC, circuits, and/or registers. In one form, the processor may be configured to store and execute computer software program instructions to generate the step function output signals for driving various components of the devices 1004, 1006, 1202, such as the ultrasonic transducer 1014 and the end effectors 1026, 1032.
The energy source power interface 226 may be configured to source electrical energy to the device power interface 217. In some non-limiting examples, the electrical energy may be transmitted from the medical device energy source 220 to the medical device 210 by means of a power cable 244. Further, the energy source data interface 224 may be configured to receive data from or transmit data to the device data interface 218. Such data may be used by the medical device 210 to control one or more medical device functions. Alternatively, data from the medical device 210 may be transmitted from the device data interface 218 to the energy source data interface 224. The data from the medical device 210 may be stored by the energy source 220 or may be used by the energy source 220 to control one or more energy source functions. In some non-limiting examples, the data transmitted from the medical device energy source 220 to the medical device 210, or by the medical device 210 to the energy source 220, may be accomplished by means of a data cable 242.
In some non-limiting examples, the medical device data interface 218 and the energy source data interface 224 may include wireless interfaces. Such wireless interfaces may not require a data cable 242 for exchanging data between the energy source 220 and the medical device 210.
In some non-limiting examples, the medical device data interface 218 and the medical device power interface 217 may be merged into a single medical device interface. Similarly, the energy source power interface 226 and the energy source data interface 224 may be merged into a single energy source interface. In such examples, a single power/data cable may be capable of transmitting both electrical energy and data.
The medical device system 200 may also include a medical device network server 230 having a network server communication interface 232. The medical device network server 230 may store one or more databases of information related to the medical device 210, the energy source 220, and their respective functions. The medical device network server 230 may be in data communication with the energy source 220 via a network server communication interface 232 and an energy source network communication interface 228. Data communication 246 between the medical device network server 230 and the energy source 220 may be accomplished through any standard data exchange method. Thus, the data communication 246 may include parallel communications methods, serial communications methods, optical communications methods, internet communications methods, wireless communication methods, and cellular communication methods. Although the medical device network server 230 is depicted in
In general, the medical device 210a, 201b may comprise various physical or logical elements implemented as hardware, software, or any combination thereof, as desired for a given set of design parameters or performance constraints. In various aspects, the physical or logical elements may be connected by one or more communications media. For example, communication media may comprise wired communication media (including one or more communication busses), wireless communication media, or a combination of both, as desired for a given implementation.
The medical device 210a, 201b further comprises a device processor unit 310 and one or more device memory storage components 312. The device processor unit 310 and the one or more memory storage components 312 may be in data communication via a device data bus 330. The device data interface 218 may also be in data communication with the processor unit 310 and the one or more memory storage components 312 via the device data bus 330. The device processor unit 310 may also be in communication with the device energy controller 316 over an energy control bus 332. Alternatively, the device energy controller 316 may be in communication with the device processor unit 310 via the device data bus 330.
The device data interface 218 may include any data communication interface that may be in data communication with the medical device energy source 220. Such an interface may be a wired interface or a wireless interface. Wired communication modes include any mode of communication between points that utilizes wired technology including various protocols and combinations of protocols associated with wired transmission, data, and devices. Wireless communication modes include any mode of communication between points that utilizes, at least in part, wireless technology including various protocols and combinations of protocols associated with wireless transmission, data, and devices. Non-limiting examples of wired communication interfaces may include a serial interface, a parallel interface, an ethernet interface, and an optical cable interface. Non-limiting examples of a wireless interface may include a wireless local area network (WLAN) interface, a wireless wide area network (WWAN) interface, and a wireless personal area network (PAN) interface.
The device processor unit 310 may also control one or more electromechanical components 318 via one or more additional control lines 334. The one or more electromechanical components 318 may include relays, motors, or other components configured to convert electrical energy into mechanical actuation. The mechanical actuation of the electromechanical components 318 may be transmitted via mechanical linkages 340 to other mechanical components of the medical device 210a, 210b such as jaw actuators and cutting actuators at the end effector (1032, 1026 in
The device processor unit 310 may also be in communication with one or more input and/or output interfaces of the medical device 210a, 201b. Input interfaces may include, without limitation, push buttons, slide buttons, pressure sensors, heat sensors, magnetic sensors, light sensors, or other inputs associated with the medical device 210a, 201b which may provide data regarding device use. Output interfaces may be used to activate, without limitation, LEDs, LED displays, LCD displays, audio indicators, haptic indicators, or other indicators to notify the user of the status of the medical device 210a, 201b.
The device processor unit 310 may be implemented as a general purpose processor, a chip multiprocessor (CMP), a dedicated processor, an embedded processor, a digital signal processor (DSP), a microprocessor such as a complex instruction set computer (CISC) microprocessor, a reduced instruction set computing (RISC) microprocessor, and/or a very long instruction word (VLIW) microprocessor, or other processing device. The device processor unit 310 also may be implemented by a controller, a microcontroller, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a programmable logic device (PLD), and so forth. In various aspects, the device processor unit 310 may be arranged to run an operating system (OS) and various mobile applications. Examples of an OS include, for example, operating systems generally known under the trade name of Microsoft Windows OS, and any other proprietary or open source OS.
In various aspects, the one or more device memory storage components 312 may comprise any machine-readable or computer-readable media capable of storing data, including both volatile and non-volatile memory. For example, memory may include read-only memory (ROM), random-access memory (RAM), dynamic RAM (DRAM), Double-Data-Rate DRAM (DDR-RAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory (e.g., NOR or NAND flash memory), content addressable memory (CAM), polymer memory (e.g., ferroelectric polymer memory), phase-change memory (e.g., ovonic memory), ferroelectric memory, silicon-oxide-nitride-oxide-silicon (SONOS) memory, or any other type of media suitable for storing information.
The device data bus 330 and the energy control bus 332 may be composed of any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, Industrial Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), Universal Serial Bus (USB), Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer Systems Interface (SCSI) or other proprietary bus.
The one or more device memory storage components 312 may be used to store instructions that may be executed by the device processor unit 310. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like. The instruction or a set of instructions may include those that, if executed by the device processor unit 310, may cause the device processor unit 310 to perform a method and/or operations in accordance with the embodiments. The instructions may be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language, such as C, C++, Java, BASIC, Perl, Matlab, Pascal, Visual BASIC, assembly language, machine code, and so forth.
Instructions stored in the one or more device memory storage components 312 may include instructions to control an amount of energy delivered by the device energy controller 316 to the end effector 212. Other instructions may control operations of the one or more electromechanical components 318. Additional instructions may cause the device processor unit 310 to store information associated with the use of the medical device 210a, 201b. Use information may include, without limitation, a number of times energy is delivered by the end effector 212 to a single piece of tissue or to multiple pieces of tissue, data related to an amount of energy delivered to a tissue by the end effector 212 for each application of energy to the tissue, and a length of time during with the amount of energy is delivered to the tissue. Additional use information may be stored, including, without limitation, temperature of a tissue receiving energy and an impedance measurement of the tissue.
The one or more device memory storage components 312 may also store data associated with the medical device 210a, 201b and its use. As disclosed above, data associated with device use may include, without limitation, a number of times energy is delivered by the end effector 212 to a single piece of tissue or to multiple pieces of tissue, data related to an amount of energy delivered to a tissue by the end effector 212 for each application of energy to the tissue, and a length of time during with the amount of energy is delivered to the tissue. Additional use information may be stored, including, without limitation, temperature of a tissue receiving energy and an impedance measurement of the tissue.
The one or more device memory storage components 312 may also store information characterizing the medical device 210a, 201b. Such characterizing information may include, without limitation, a device name, a device model number, a device lot or serial number, a device use limitation number, a device power limitation number, a device expiration date, and a device identifier code. The device identifier code may include one or more machine readable characters, or one or more strings of such machine readable characters. The device identifier code may be composed of a single string of machine readable characters. Alternatively, the device identifier code may be compose of a plurality of strings of machine readable characters, such as, as non-limiting examples, two strings of machine readable characters or three strings of machine readable characters. In one non-limiting example, the device identifier code may comprise a string of machine readable characters related to the device characterizing information. In another non-limiting example, the device identifier code may comprise one or more strings of randomly generated machine readable characters. The device identifier code may be composed of one or more strings of any number of machine readable characters. Non-limiting examples of the number of machine readable characters in each of the one or more strings of the device identifier code may include 32 characters, 64 characters, 128 characters, 256 characters, 512 characters, or any number of characters therebetween including endpoints.
It should be understood that a corded medical device 210a that accepts electrical energy via a power cable 244 may also include a battery for electrical power storage. Such additional power storage capability may be used as a separate power source for electrical and/or electromechanical components of the medical device 210a. Such a battery may be used to electrically isolate the electrical or electronic components from noise on the device power bus 320 during the operation of the device. Alternatively, such a battery may serve as a back-up power supply to the electronic components in the event of a power failure of the medical device energy source 220.
As depicted in
The energy source 435 may be controlled by an energy source computing device 450. The energy source computing device 450 may be composed of an energy source processor unit 410, one or more energy source memory storage components 412, one or more energy source input interfaces 424, one or more energy source output interfaces 422, and an energy source data bus 430 It may be understood that the energy source data bus 430 may be configured to place the one or more of the energy source memory storage components 412, one or more energy source input interfaces 424, and one or more energy source output interfaces 422 in operative communication with the energy source processor unit 410.
The one or more energy source memory storage components 412 may be used to store instructions that may be executed by the energy source processor unit 410. Some non-limiting examples of such instructions may include: instructions to receive data from the one or more energy source input interfaces 424; instructions related to a display of information on display devices that may be in operative communication with the energy source output interfaces 422; instructions to control the operation of the energy source 435; instructions to transmit data to the medical device via the energy source data interface 224; instructions to receive data from the medical device via the energy source data interface 224; instructions to determine that the medical device 210 is in functional communication with the medical device energy source 220; instructions that the energy source power interface 226a,b in operative communication with the device power interface 217a,b; and instructions to determine that the energy source data interface 224 is in operative communication with the device data interface 218. Additional instructions may cause the energy source 435 not to deliver an effective amount of electrical energy via the energy source power interface 226a,b to the medical device 210a,b when the medical device is not in functional communication with the medical device energy source. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like. The instruction or a set of instructions may include those that, if executed by the energy source processor unit 410, may cause the energy source processor unit 410 to perform a method and/or operations in accordance with the embodiments. The instructions may be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language, such as C, C++, Java, BASIC, Perl, Matlab, Pascal, Visual BASIC, assembly language, machine code, and so forth.
The energy source input interfaces 424 may comprise any interface configured to provide input from a user to the energy source computing device 450 via energy source data bus 430. Non-limiting examples of such an input interface 424 may include a serial interface, a parallel interface, an audio (microphone) interface, a wireless interface including an RF interface, and an optical interface. Such an energy source input interface 424 may be in data communication with any number of user actuators including, without limitation, push buttons, slide buttons, keyboards, knobs, touch screens, and computer mice. A user may employ the actuators to direct the operation of the medical device energy source 220a, for example setting a maximum amount of electrical energy to be supplied by the energy source 435, or a number of times the energy source 435 may supply electrical energy to the medical device 210a.
The energy source output interface 422 may comprise any interface configured to provide information to a user to the energy source computing device 450 via energy source data bus 430. The user display may thus be in operative communication with the energy source processor unit 410 by means of the energy source output interface 422 and the energy source bus 430. Non-limiting examples of such an output interface 422 may include a serial interface, a parallel interface, a video interface, an audio (speaker) interface, a wireless interface including an RF interface, and an optical interface. Such energy source output interfaces 422 may be in data communication with any number of display or communication devices including, without limitation, LEDs, LED displays, LCD displays, plasma displays, audio annunciators, and speakers. The display or communication devices may be configured to provide information to a user regarding the use of the medical device energy source 220a including an amount of electrical energy sourced by the energy source 435 during a medical procedure, an indication of a fault condition of the energy source 435, or an indication that the medical device 210 is not an appropriate device to receive electrical energy from the energy source 435.
The energy source data bus 430 may be configured to transfer data and/or information among the components of the energy source computing device 450. The energy source data bus 430 may be configured to direct instructions to the energy source 435 to cause the energy source 435 to regulate the amount of electrical energy sourced therefrom. The energy source data bus 430 may also be configured to transmit data to and receive data from the energy source data interface 224, thereby permitting exchange of data with the medical device 210a. The energy source data interface 224 may thus be in operative communication with the energy source processor unit 410 by means of the energy source data bus 430. The energy source data bus 430 may further be configured to transmit data to and receive data from the energy source network communication interface 228, thereby permitting exchange of data with a medical device network server 230. The energy source network communication interface 228 may thus be in operative communication with the energy source processor unit 410 by means of the energy source data bus 430.
It may be recognized that the energy source processor unit 410 may include similar devices as those disclosed above with respect to the medical device processor unit 310. Additionally, the one or more energy source memory storage components 412 may include similar devices as those disclosed above with respect to the medical device memory storage components 312. Further, the energy source data bus 430 may include similar devices as those disclosed above with respect to the device data bus 330. It may also be recognized that the energy source data interface 224 may include complementary components to those disclosed above with respect to the device data interface 218. In some non-limiting examples, the energy source data interface 224 may comprise one or more of a serial data interface, a parallel data interface, a wireless interface, and an optical interface
The energy source network communication interface 228 may comprise any interface configured to permit information exchange 246 with one or more networked server devices, such as medical device network server 230. The medical device network server 230 may be logically connected to the medical device energy source 220a through the energy source network communication interface 228. The energy source network communication interface 228 may encompass any known interface including, without limitation, a wired internet interface, a wireless internet interface, a WiFi interface, a BlueTooth interface, a LAN interface, a WAN interface, a telephonic interface, a cellular interface, and an optical interface. The communication interface may permit communication among networks such as local-area networks (LAN) and wide area networks (WAN). Non-limiting examples of LAN technologies may include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. Non-limiting examples of WAN technologies may include, but are not limited to, point-to-point links, circuit switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).
The energy source network communication interface 228 may further comprise wireless or cellular communications interfaces. Examples of wireless protocols may include various wireless local area network (WLAN) protocols, including the Institute of Electrical and Electronics Engineers (IEEE) 802.xx series of protocols, such as IEEE 802.11a/b/g/n, IEEE 802.16, IEEE 802.20, and so forth. Other examples of wireless protocols may include various wireless wide area network (WWAN) protocols, such as GSM cellular radiotelephone system protocols with GPRS, CDMA cellular radiotelephone communication systems with 1×RTT, EDGE systems, EV-DO systems, EV-DV systems, HSDPA systems, and so forth. Further examples of wireless protocols may include wireless personal area network (PAN) protocols, such as an Infrared protocol, a protocol from the Bluetooth Special Interest Group (SIG) series of protocols, including Bluetooth Specification versions v1.0, v1.1, v1.2, v2.0, v2.0 with Enhanced Data Rate (EDR), as well as one or more Bluetooth Profiles, and so forth. Yet another example of wireless protocols may include near-field communication techniques and protocols, such as electro-magnetic induction (EMI) techniques. An example of EMI techniques may include passive or active radio-frequency identification (RFID) protocols and devices. Other suitable protocols may include Ultra Wide Band (UWB), Digital Office (DO), Digital Home, Trusted Platform Module (TPM), ZigBee, and so forth.
Examples of cellular communication systems may include CDMA cellular radiotelephone communication systems, GSM cellular radiotelephone systems, North American Digital Cellular (NADC) cellular radiotelephone systems, Time Division Multiple Access (TDMA) cellular radiotelephone systems, Extended-TDMA (E-TDMA) cellular radiotelephone systems, Narrowband Advanced Mobile Phone Service (NAMPS) cellular radiotelephone systems, third generation (3G) systems such as WCDMA, CDMA-2000, UMTS cellular radiotelephone systems compliant with the Third-Generation Partnership Project (3GPP), and so forth.
As disclosed above,
It may be recognized that the medical device network server processor unit 510 may include similar devices as those disclosed above with respect to the medical device processor unit 310. Additionally, the one or more medical device network server memory storage components 512 may include similar devices as those disclosed above with respect to the medical device memory storage components 312. Further, the medical device network server data bus 530 may include similar devices as those disclosed above with respect to the device data bus 330. It may also be recognized that the medical device network server input interfaces 524 and one or more medical device network server output interfaces 522 may include similar devices and data exchange protocols as those disclose above with respect to the energy source input interface 424 and energy source output interface 422, respectively.
The one or more medical device network server memory storage components 512 may be used to store instructions that may be executed by the medical device network server processor unit 510. The instructions may include any suitable type of code, such as source code, compiled code, interpreted code, executable code, static code, dynamic code, and the like. The instruction or a set of instructions may include those that, if executed by the medical device network server processor unit 510, may cause the medical device network server processor unit 510 to perform a method and/or operations in accordance with the embodiments. The instructions may be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language, such as C, C++, Java, BASIC, Perl, Matlab, Pascal, Visual BASIC, assembly language, machine code, and so forth.
A medical device network server input interface 524 may be in data communication with any number of user actuators including, without limitation, push buttons, slide buttons, keyboards, knobs, touch screens, and computer mice. A user may employ the actuators to direct the operation of the medical device network server 230, for example to input or modify a database that may be stored in the medical device network server memory storage components 512.
The medical device network server output interface 522 may comprise an interface configured to provide information to a user of the medical device network server 230 via medical device network server data bus 530. Non-limiting examples of such an output interface 522 may include a serial interface, a parallel interface, a video interface, an audio (speaker) interface, a wireless interface including an RF interface, and an optical interface. Such medical device network server output interfaces 522 may be in data communication with any number of display or communication devices including, without limitation, LEDs, LED displays, LCD displays, plasma displays, audio annunciators, and speakers. The display or communication devices may be configured to provide information to a user regarding the status of the medical device network server 230 or information relevant to the database stored in the medical device network server memory storage components 512.
As disclosed above, it may be recognized that proper control of the electrical energy supplied to an electrosurgical device may be critical for safe and effective operation of the device. It is therefore desirable for a medical device energy source to supply an appropriate amount of electrical energy to an electrosurgical device to promote a safe and effective therapeutic outcome. An example of a medical device system (200,
The second data field, comprising data 620a, 620b, . . . 620n, may be associated with a second characterizer of the medical device with which the database entry is associated. In one non-limiting example, the second data field may include an indicator of a medical device status. The indicator may include a text descriptor of the status or one or more processor readable characters that may encode the status. Examples of such status indicators may include, without limitation, “NEW,” “UNUSED,” “USED,” or “REFURBISHED.” Such status indicators may be used to identify the device as being new (for example, new out of the box), an unused device (previously attached to the energy source, but not used in any medical procedure), a device used in a medical procedure, and a device that had been used but was then refurbished (for example sterilized, cleaned, mechanically adjusted) for potential reuse. It may be understood that additional or alternative status indicators may also be included. Alternatively, a second data field may include alternative characterizations of the medical device including, without limitation, a device product number, a device serial number, a device lot number, an expiration date, or any other characterization of the medical device. Although database 600c is depicted as comprising two sets of data fields associated with each medical device, it may be recognized that the database 600c may include any number of sets of data fields associated with each medical device, including 3 sets, 4 sets, or any finite number of sets of data fields.
Data fields comprising sub-fields may be useful to retain historical data related to the use of a medical device. For example, a data field may include a total number of allowed uses of a device (630a), such as 5 total uses, and each subfield may include an individual use number, such as the number 1 in sub-field 630a1, the number 2 in sub-field 630a2, and so forth. Other types of data may include a total power permitted to be sourced to a medical device (for example, in data field 640a) as well as the amount of power sourced to the device for each use, for a first use in data field 640a1, for a second use in data field 640a2, and so forth. Other exemplary information that may be stored in such data fields comprising sub-fields may include a total time of medical device use, a maximum amount of time that the medical device may be used, and an amount of time for each use. It may be recognized that the examples of data stored in the data fields and sub-fields are not limiting, but may include any data related to the use of a given medical device.
Depending on the database structure (see, for example,
It may be noted that the medical device network server may be under the sole control of the manufacturer. In one non-limiting example, the database stored in the medical device network server may be accessible to only a limited number of employees of the manufacturer. In another non-limiting example, employees of a certified or licensed third party (for example, a third party contracted to refurbish or recertify a medical device) may also have access to the database. It may be understood that software instructions stored in the network server memory storage component may be used to limit or control access to the database by the manufacturer or third party employees according to protocols known in the art.
It may be understood, that additional data in the database may be updated, changed, or deleted as part of the maintenance procedure. For example, a status indicator associate with the medical device in the database may be set to indicate that the device has been refurbished or re-certified. Data that may be associated with the historical use of the device prior to the maintenance procedure (such as the prior number of actual uses, amount of time associated with the use of the device, and power supplied by the device) may be deleted from the database. Alternatively, the prior historical use data may be retained. Additional data related to the maintenance procedure may also be added to the database in one or more maintenance fields. Non-limiting examples of maintenance related data may include a date of maintenance, the number of times a maintenance procedure has been performed on the medical device, the name of the facility performing the maintenance, the name(s) of personnel recertifying the device, testing data associated with device re-certification, or combinations thereof.
A medical device may be contacted with a medical device energy source. Such contact may include affixing data cables and power cables between the two devices. Alternatively, such contact may include docking a cordless medical device with the medical device energy source, and causing a wireless data connection to be made between the two devices. The medical device energy source may be powered before the medical device is contacted with the medical device energy source, or may be powered after the medical device is contacted with the medical device energy source. Additionally, the medical device energy source, on being powered, may establish a communication link with a medical device network server over an appropriate communication channel (including one or more communication interfaces and one or more communication protocols).
After the medical device is contacted with the medical device energy source, the medical device energy source may read the device identifier code 740 from the medical device. In some non-limiting examples, the medical device may receive the device identifier code 740 via an energy source data interface. The device identifier code may be stored in a device memory storage component and may be received by the medical device energy source via an energy source data interface in operative communication with device data interface.
In one non-limiting alternative example, the medical device energy source may transmit the identifier code to the medical device network server 741. The medical device network server may compare the identifier code with one or more identity codes stored in the database. The medical device network server may respond by transmitting database information to the medical device energy source that is associated with a medical device having an identity code equal to the identifier code.
Alternatively, the medical device energy source may transmit a request to the medical device network server to receive data associated with the database. The medical device network server may respond to the request by transmitting all or a portion of the database information stored in the memory storage component of the medical device network server to the medical device energy source.
In either example, the medical device energy source may receive the database information from the server 742. The medical device energy source may include instructions that, when executed by the medical device processor, causes the medical device energy source to determine the energy level(s) to supply to the device 744 which may be based, in part, on a comparison of the device identifier code with a device identity code supplied by the medical device network server from the database.
The medical device energy source may set an appropriate power level for delivery to the medical device and/or set device options 746 of the medical device. The power level may be set by the energy source based on control instructions received from the medical device energy source computing device. As disclosed above, the energy level may comprise a therapeutic or non-therapeutic level of power. Non-limiting examples of a therapeutic amount of energy may include an amount of energy required to effect a therapy on a tissue, such as an amount of energy to cauterize a tissue, an amount of energy to shrink a tissue, or an amount of energy to cut a tissue according to the type of medical device receiving the electrical energy. Non-limiting examples of a non-therapeutic amount of energy may include an amount of energy that is not sufficient to effect a therapy on a tissue including an amount of energy to measure a tissue impedance or an amount of energy to power electronic components of the medical device. The electrical energy sourced by the energy source may be controlled with respect to a DC voltage, an AC voltage, an RMS voltage, a DC current, an AC current, an RMS current, a frequency, a pulse-width modulation, or any combination thereof.
While the medical device is being used, the medical device energy source may store some amount of medical device usage data 748 in the energy source memory storage component. Non-limiting examples of such usage data may include: a total number of times the medical device is energized with an amount of energy, the amount of energy supplied to the medical device for each energization step, the total amount of energy supplied to the medical device, the length of time the energy is supplied to the medical device for each energization step, and measurement data collected by the medical device before, during, or after each energization step. Non-limiting examples of such measurement data may include a tissue impedance value and a tissue temperature value.
The usage data obtained by the medical device energy source may be uploaded to the medical device network server 750. Such data may be uploaded during the medical procedure in which the medical device is being used or after the use of the medical device. Additional information may be uploaded to the medical device network server including, without limitation, a time stamp, a date stamp, a facility identifier (identifying the facility in which the medical device is used), and/or any other additional information related to the identity of the medical device being used, the circumstances under which the device is used, and the location in which the device is used. Additionally, the medical device energy source may upload data to the medical device network server to update the database for indicators including, but not limited to, the device status. In some examples, the medical device energy source may upload data to the medical device network server to update the device status to indicate that the device is unused or used.
It may be understood that one important feature of the a method related to the use of a medical device system as disclosed above is the step of determining the energy level(s) supplied by the medical device energy source to the medical device 744.
As depicted in
In one non-limiting example, the medical device energy source may receive data having a database structure depicted in
In another non-limiting example, the medical device energy source may receive data having a database structure depicted in
In yet another non-limiting example, the medical device energy source may receive data from a database structure depicted in
As one example, the medical device identifier code may be listed among the acceptable medical device identity codes, and the medical device may have a status of “NEW” or “UNUSED.” However, if an attempt is made to use the medical device after an expiration date (as determined from one of the additional fields in the database), the medical device energy source may not supply a therapeutic amount of energy to the medical device. In another example, a medical device energy source may receive additional data as part of a database from the medical device network server concerning the number of times a medical device may used or the amount of energy that may be sourced to the medical device for each use of the device or a total amount of energy that may be sourced to the medical device. During the use of the medical device, the medical device energy source may track the number of uses of the device, the amount of energy supplied during each use, and the amount of time during which the device is energized. Once a use limit has been reached—for example, the number of times the device is energized, an amount of time during which the device is energized, or the total amount of energy sourced to the device—the medical device energy source may be programmed to cease sourcing additional therapeutic energy to the device.
It will be appreciated that the terms “proximal” and “distal” are used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician. It will further be appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” or “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting or absolute.
Various aspects of surgical instruments and robotic surgical systems are described herein. It will be understood by those skilled in the art that the various aspects described herein may be used with the described surgical instruments and robotic surgical systems. The descriptions are provided for example only, and those skilled in the art will understand that the disclosed examples are not limited to only the devices disclosed herein, but may be used with any compatible surgical instrument or robotic surgical system.
Reference throughout the specification to “various aspects,” “some aspects,” “one example,” or “one aspect” means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one example. Thus, appearances of the phrases “in various aspects,” “in some aspects,” “in one example,” or “in one aspect” in places throughout the specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics illustrated or described in connection with one example may be combined, in whole or in part, with features, structures, or characteristics of one or more other aspects without limitation.
While various aspects herein have been illustrated by description of several aspects and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. For example, it is generally accepted that endoscopic procedures are more common than laparoscopic procedures. Accordingly, the present invention has been discussed in terms of endoscopic procedures and apparatus. However, use herein of terms such as “endoscopic”, should not be construed to limit the present invention to an instrument for use only in conjunction with an endoscopic tube (e.g., trocar). On the contrary, it is believed that the present invention may find use in any procedure where access is limited to a small incision, including but not limited to laparoscopic procedures, as well as open procedures.
It is to be understood that at least some of the figures and descriptions herein have been simplified to illustrate elements that are relevant for a clear understanding of the disclosure, while eliminating, for purposes of clarity, other elements. Those of ordinary skill in the art will recognize, however, that these and other elements may be desirable. However, because such elements are well known in the art, and because they do not facilitate a better understanding of the disclosure, a discussion of such elements is not provided herein.
While several aspects have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the disclosure. For example, according to various aspects, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope and spirit of the disclosure as defined by the appended claims.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
Various aspects of the subject matter described herein are set out in the following numbered clauses:
Clause 1. A medical device energy source, comprising:
an energy source;
an energy source power interface configured to deliver electrical energy from the energy source; and
an energy source computing device, comprising:
wherein the energy source computing device is configured to control a function of the energy source, and
wherein, the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to:
receive an identifier code via the energy source data interface;
receive a plurality of medical device identity codes via the energy source network communication interface;
compare the identifier code with each of the plurality of medical device identity codes; and
control the function of the energy source based on the comparison of the identifier code with each of the plurality of medical device identity codes.
Clause 2. The medical device energy source of clause 1, wherein the identifier code comprises two identifier strings, each of the two identifier strings comprising a string of processor readable characters.
Clause 3. The medical device energy source of clause 2, wherein the instructions that cause the energy source computing device to compare the identifier code with each of the plurality of medical device identity codes comprises instructions that cause the energy source computing device to compare each of the two identifier strings with each of two identity strings comprising each of the medical device identity codes.
Clause 4. The medical device energy source of any one of clauses 1-3, wherein the identifier code comprises at least one identifier string comprising a string of randomly generated processor readable characters.
Clause 5. The medical device energy source of any one of clauses 1-4, wherein, the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, further cause the energy source computing device to receive, via the energy source network communication interface, a plurality of medical device status indicators, each medical device status indicator corresponding to each of the plurality of medical device identity codes.
Clause 6. The medical device energy source of clause 5, wherein the instructions that cause the energy source computing device to control the function of the energy source further comprise instructions that cause the energy source computing device to control the function of the energy source base on the medical device status indicators corresponding to a medical device identity code equal to the identifier code.
Clause 7. The medical device energy source of any one of clauses 1-6, wherein the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, further cause the energy source computing device to retain, in the energy source memory storage component:
an energizer value corresponding to an amount of energy supplied by the energy source;
an energizer time value corresponding to a length of time during which the energy source supplies an amount of energy;
an energizer number corresponding to a number of times the energy source supplies an amount of energy;
or combinations thereof.
Clause 8. The medical device energy source of clause 7, wherein the instructions that cause the energy source computing device to control the function of the energy source, further comprise instructions that cause the energy source computing device to control the function of the energy source based on one or more of the energizer value, the energizer time value, and the energizer number.
Clause 9. The medical device energy source of any one of clauses 1-8, wherein the energy source power interface comprises a docking station.
Clause 10. The medical device energy source of any one of clauses 1-9, wherein the energy source data interface is configured to receive data from a medical device.
Clause 11. The medical device energy source of any one of clauses 1-10, wherein the energy source data interface is configured to transmit data to a medical device.
Clause 12. The medical device energy source of any one of clauses 1-11, further comprising a user display in operative communication with the energy source processor unit.
Clause 13. The medical device energy source of any one of clauses 1-12, wherein the energy source network communication interface comprises one or more of a wired internet interface, a wireless internet interface, a WiFi interface, a BlueTooth interface, a LAN interface, a WAN interface, a telephonic interface, a cellular interface, and an optical interface.
Clause 14. The medical device energy source of any one of clauses 1-13, wherein the energy source data interface comprises one or more of a serial data interface, a parallel data interface, a wireless interface, and an optical interface.
Clause 15. A medical device system, comprising:
a medical device, comprising:
a medical device energy source, comprising:
a medical device network server, comprising:
wherein, the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to:
Clause 16. The medical device system of clause 15, wherein the identifier code comprises two identifier strings, each of the two identifier strings comprising a string of processor readable characters.
Clause 17. The medical device system of clause 16, wherein the instructions that cause the energy source computing device to compare the identifier code with each of the plurality of medical device identity codes comprises instructions that cause the energy source computing device to compare each of the two identifier strings with each of two identity strings comprising each of the medical device identity codes.
Clause 18. The medical device system of any one of clauses 15-17, wherein the instructions that cause the energy source computing device to control the function of the energy source based on the comparison of the identifier code with each of the plurality of medical device identity codes comprises instructions to cause the energy source to deliver an effective amount of electrical energy via the energy source power interface to the medical device when the identifier code is equal to at least one of the plurality of medical device identity codes.
Clause 19. The medical device system of clause 18, wherein an effective amount of electrical energy comprises a therapeutic amount of energy, a non-therapeutic amount of energy, or both a therapeutic and a non-therapeutic amount of energy to the medical device.
Clause 20. The medical device system of any one of clauses 15-19, wherein the instructions that cause the energy source computing device to control the function of the energy source based on the comparison of the identifier code with each of the plurality of medical device identity codes comprises instructions to cause the energy source computing device to cause the energy source not to deliver an effective amount of electrical energy via the energy source power interface to the medical device when the identifier code does not equal any of the plurality of medical device identity codes.
Clause 21. The medical device system of clause 20, wherein the instructions to cause the energy source computing device to cause the energy source not to deliver an effective amount of electrical energy via the energy source power interface to the medical device comprises instructions to cause the energy source computing device to cause the energy source to deliver a non-therapeutic amount of energy to the medical device.
Clause 22. The medical device system of any one of clauses 15-21, wherein the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, further cause the energy source computing device to determine that the medical device is in functional communication with the medical device energy source.
Clause 23. The medical device system of clause 22, wherein the instructions that cause the energy source computing device to determine that the medical device is in functional communication with the medical device energy source comprise instructions that cause the energy source computing device to determine that the energy source power interface is in operative communication with the device power interface and that the energy source data interface is in operative connection with the device data interface.
Clause 24. The medical device system of clause 22, wherein the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, further cause the energy source computing device to cause the energy source not to deliver an effective amount of electrical energy via the energy source power interface to the medical device when the medical device is not in functional communication with the medical device energy source.
Clause 25. The medical device system of any one of clauses 15-24, wherein, the energy source memory storage component comprises instructions that, when executed by the energy source processor unit, further cause the energy source computing device to receive, via the energy source network communication interface, a plurality of medical device status indicators, wherein each of the plurality of medical device status indicators corresponds to each of the plurality of medical device identity codes.
Clause 26. The medical device system of clause 25, wherein the instructions that cause the energy source computing device to control the function of the energy source further comprise instructions that cause the energy source computing device to control the function of the energy source base on a medical device status indicator corresponding to a medical device identity code equal to the identifier code.
Clause 27. The medical device system of clause 25, wherein each of the plurality of medical device status indicators is chosen from a group of: “new device”, “unused device”, “used device”, and “refurbished device”.
Clause 28. The medical device system of clause 27, wherein the energy source memory storage component further comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to cause the energy source to deliver an effective amount of electrical energy via the energy source power interface to the medical device when a value of a medical device status indicator corresponding to the medical device identity code equal to the identifier code is chosen from a group of: “new device”, “unused device”, and “refurbished device”.
Clause 29. The medical device system of clause 27, wherein the energy source memory storage component further comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to cause the energy source not to deliver an effective amount of electrical energy via the energy source power interface to the medical device when a value of a medical device status indicator corresponding to the medical device identity code equal to the identifier code is “used device”.
Clause 30. The medical device system of any one of clauses 15-29, wherein the energy source memory storage component further comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to transmit, to the medical device network server, data to update a medical device status indicator corresponding to a medical device identity code equal to the identifier code.
Clause 31. The medical device system of clause 30, wherein the medical device status indicator corresponding to a medical device identity code equal to the identifier code is chosen from a group of: “unused device” and “used device”.
Clause 32. The medical device system of clause 30, wherein the network server memory storage component comprises instructions that, when executed by the network servicer processor unit, cause the network server processor unit to:
receive, from the medical device energy source, data to update a medical device status indicator corresponding to the medical device identity code equal to the identifier code; and
update the status indicator in the data base corresponding to the medical device identity code equal to the identifier code.
Clause 33. The medical device system of any one of clauses 15-32, wherein the medical device data base further comprises one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base.
Clause 34. The medical device system of any one of clauses 15-33, wherein the energy source memory storage component further comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to store in the energy source memory storage component:
an indicator of total medical device uses;
an indicator, for each use of the total medical device uses, of:
a total amount of power supplied by the medical device energy source to the medical device over the total medical device uses;
or any combination thereof.
Clause 35. The medical device system of clause 34, wherein the one or more additional indicators comprises:
an indicator of total medical device uses;
an indicator, for each use of the total medical device uses, of:
a total amount of power supplied by the medical device energy source to the medical device over the total medical device uses;
a medical device product number;
a medical device serial number;
a medical device lot number;
a medical device manufacturing date; and
a medical device expiration date.
Clause 36. The medical device system of clause 34, wherein the energy source memory storage component further comprises instructions that, when executed by the energy source processor unit, cause the energy source computing device to:
receive, from the medical device network server, values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base; and
control the function of the energy source based on the value of the one or more of the additional indicators corresponding to the medical device identity code equal to the identifier code.
Clause 37. The medical device system of clause 34, wherein the network server memory storage component comprises instructions that, when executed by the network servicer processor unit, cause the network server processor unit to: receive, from the medical device energy source, values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base; and update the values of the one or more additional indicators corresponding to each of the medical device identity codes in the medical device data base.
Clause 38. The medical device system of any one of clauses 15-37, wherein the device memory storage component comprises one or more of a ROM component, a PROM component, an EPROM component, an EEPROM component, and an RFID component.
Clause 39. The medical device system of any one of clauses 15-38, wherein the communication network comprises one or more of a LAN, a WAN, a WiFi network, a BlueTooth network, an internet cloud network, and a cellular network.
Clause 40. A method of controlling a medical device, comprising:
receiving, by a medical device energy source via an energy source data interface in operative communication with an energy source processor unit, an identifier code from a medical device;
storing, by the medical device energy source in a memory source memory storage component in operative communication with the energy source processor unit, the identifier code;
receiving, by the medical device energy source via an energy source network communication interface in operative communication with the energy source processor unit, a plurality of medical device identity codes from a medical device network server;
comparing, by the energy source processor unit, the identifier code with each of the plurality of medical device identity codes;
controlling, by the energy source processor unit, an amount of energy delivered by the energy source via an energy source power interface to the medical device, based on the comparison between the identifier code and the plurality of medical device identity codes; and
displaying, on a user display operatively controlled by an energy source computing device comprising the energy source processor unit, information corresponding to the amount of energy delivered by the energy source to the medical device.
Clause 41. The method of clause 40, further comprising, receiving, by the medical device energy source via the energy source network communication interface, a plurality of medical device status indicators, wherein each of the plurality of medical device status indicators corresponds to each of the plurality of medical device identity codes.
Clause 42. The method of clause 41, further comprising controlling, by the energy source processor unit, an amount of energy delivered by the energy source via the energy source power interface to the medical device, based on the medical device status indicator corresponding to a medical device identity code that is equal to the identifier code.
Clause 43. The method of any one of clauses 40-42, further comprising transmitting, by the medical device energy source to the medical device, control data to control at least one function of the medical device.
Clause 44. The method of clause 43, wherein transmitting, by the medical device energy source, control data to control at least one function of the medical device comprises transmitting, by the medical device energy source, control data to control at least one function of the medical device when the identifier code does not equal any one of the plurality of medical device identity codes.
Clause 45. The method of clause 41, further comprising transmitting, by the medical device energy source to the medical device, control data to control at least one function of the medical device based on the medical device status indicators corresponding to the medical device identity code that is equal to the identifier code.