CN100386728C - On-line software updating method of implantation medical equipment - Google Patents
On-line software updating method of implantation medical equipment Download PDFInfo
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- CN100386728C CN100386728C CNB2006100115528A CN200610011552A CN100386728C CN 100386728 C CN100386728 C CN 100386728C CN B2006100115528 A CNB2006100115528 A CN B2006100115528A CN 200610011552 A CN200610011552 A CN 200610011552A CN 100386728 C CN100386728 C CN 100386728C
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- 238000002513 implantation Methods 0.000 title claims abstract description 62
- 238000000034 method Methods 0.000 title claims abstract description 44
- 230000006854 communication Effects 0.000 claims abstract description 27
- 238000004891 communication Methods 0.000 claims abstract description 24
- 230000006870 function Effects 0.000 claims description 15
- 230000008569 process Effects 0.000 claims description 14
- 230000008859 change Effects 0.000 claims description 10
- 238000012795 verification Methods 0.000 claims description 7
- 230000005055 memory storage Effects 0.000 claims description 5
- 238000007689 inspection Methods 0.000 claims description 2
- 230000008901 benefit Effects 0.000 abstract description 3
- 230000002457 bidirectional effect Effects 0.000 abstract 1
- 238000010586 diagram Methods 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 229910052719 titanium Inorganic materials 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- 108010022579 ATP dependent 26S protease Proteins 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000009432 framing Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000003950 pathogenic mechanism Effects 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
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- 238000011269 treatment regimen Methods 0.000 description 1
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Abstract
The present invention belongs to the technical field of implantation medical instruments, which is characterized in that a self-programming FLASH memory of an implantation instrument has a terminal execution program, and software update is not affected; bidirectional wireless communication is established between a program control system (comprises palm computer and program control device) and the implantation instrument, and the program control system obtains new edition software from an exterior memory; data information is interchanged by instruction data frames and answer frames; the new version software is written into the idle space of the FLASH memory; the address of the program entry address is updated after right checkout, so that backup on-line upgrade of software is completed after the replacement and restart of the implantation instrument. The on-line upgrade method of software of the present invention has the advantages of universality, security, high reliability and easy use, and is suitable for various implantation medical instruments.
Description
Technical field
The present invention relates to the method for the on-line software updating of implantation medical equipment, belong to the implantation medical equipment technical field.
Background technology
The implantation medical equipment kind is a lot, as implantable cardiac pacemaker and defibrillator, brain pacemaker, nerve stimulator, muscle stimulator, electrocardiorecorder etc., for preventing that body fluid from infiltrating, generally circuit is placed in the titanium shell, carry out hermetically sealed with method for laser welding.The circuit of implantation medical equipment generally is core with the microprocessor, with the measurement or the pacing stimulation function of software control entire circuit, and by two-way wireless communication and external remote measurement/stored program controlled swap data.The software of above-mentioned microprocessor, when implantation medical equipment dispatches from the factory, be solidificated in the program storage, can't change after implanting in patient's body, software upgrading or run into the situation that the storer individual elements lost efficacy if desired can only be performed the operation and be changed whole implantation medical equipment.
For implantation medical equipment, the framework of circuit hardware passes through years of development comparative maturity in the world, present progress mainly is the develop rapidly of medical science, people are constantly progressive to the understanding of pathogenic mechanism, new signal processing algorithm and treatment pattern constantly occur, promoted the more and more faster update of implantation medical equipment, and such function renewal is regenerated, and can realize by software upgrading fully.In addition, implantation medical equipment is not in use got rid of the storer individual elements and was lost efficacy, and causes the possibility of running software fault, and the situation that the pacemaker of multiple model is forced to recall because of out of memory once appearred in the U.S..
The longevity of implantation medical equipment is in battery capacity, and generally at 5-8, and price is very expensive, and operation is changed not only to the patient and brought wound on the health, and follows huge economic pressures.Along with the continuous progress of battery performance, and wireless fast development through the skin charging technique, the life-span of the implantation medical equipment of newly developing constantly prolongs, so the online upgrading of software is with a wide range of applications.After in implantation medical equipment is implanted patient's body, using, only need by doctor or professional's control, set up two-way wireless communication with external remote measurement/stored program controlled and implantation medical equipment, the software of redaction is write program storage, can realize the treatment function that some are new, thereby avoided operation to change the trouble that instrument brings, also saved expense simultaneously greatly.
With regard to memory technology, present up-to-date non-volatile mass storage FLASH, not only have characteristics such as read or write speed is fast, simple in structure, low-power consumption, and great majority all support ISP and IAP technology, for the online upgrading of implantation medical equipment software provides guarantee.
Existing method for updating embedded system software all needs to make the flush bonding processor can active detecting and obtain software upgrading data (for example by dialing, network, perhaps removable memory).This is worthless for the implantation medical equipment that is in round-the-clock treatment duty.Simultaneously, implantation medical equipment also has higher requirement to the reliability of software.
Summary of the invention
At the deficiencies in the prior art, the objective of the invention is to be implantation medical equipment, a kind of safe and reliable on-line software updating method is provided, thereby under the situation that need not to perform the operation, give implantation medical equipment stronger function, realize not having wound, model change cheaply.
Described implantation medical equipment comprises two parts of implantation medical equipment in external stored program controlled and the body; Wherein, described stored program controlled is by two-way interconnected program controller, PDA and external memory storage are formed successively, implantation medical equipment in the described body contains microcontroller, produces circuit with the two-way interconnected RAM storer of this microcontroller, FLASH storer, communication interface, stimulus signal respectively, and and this stimulus signal produce the two-way interconnected electrode of circuit, the program controller in the described stored program controlled is with the communication interface two-way communication in the implantation medical equipment in communication and the body; Described method contains following steps successively:
Step 2.1: the user starts the software upgrade procedure of this PDA, checks whether described external memory storage has legal refresh routine, then points out the user that microcontroller is carried out reset operation if having;
Step 2.2: if legal refresh routine is arranged, then PDA sends update request to described microcontroller, starts the terminal server in the implantation medical equipment in the described body;
Step 2.3:PDA sends password and login instruction, to obtain read-write operation power;
Step 2.4:PDA checks the program version information of the implantation medical equipment in the body, whether need to confirm the software upgrade operation, if confirm to need upgrading, then changes next step over to;
Step 2.5:PDA sends the instruction of wiping FLASH storer specified section, for software upgrading is prepared;
Step 2.6: if wipe end, then PDA sends the instruction that writes this FLASH storer, write the program that to upgrade, upgrade medical functions program entry address, perhaps send the instruction that writes the FLASH storer, revise login password, perhaps again the program that has just write is read, whether correctly complete with check;
Step 2.7:PDA sends the program after the warm start instruction makes the interior implantation medical equipment execution renewal of this body;
After the implantation medical equipment in this body entered the process of software upgrading, microcontroller was wherein carried out following steps successively:
Step I: check to receive among the buffer memory RAM whether receive frame head,, then change next step over to if receive;
Step II: check whether the byte of receiving subsequently is the instruction of agreement, the instruction of described agreement is meant writes the instruction of FLASH frame, or wipes the instruction of FLASH frame, if instruction is correct, then changes next step over to; Otherwise, return step I;
Step II I: whether total long value of the reception data content that the repetition that inspection is received subsequently is twice is consistent, if unanimity then changes next step over to; If different, perhaps do not receive, then return step I;
Step IV: the total long value of data content that receives according to Step II I is from the communication interface reading of data and carry out CRC check, if correct, then execution command is returned execution result with the acknowledgement frame of setting, and as if incorrect, then returns corresponding error information.
The on-line software updating method of described implantation medical equipment, it is characterized in that, this method is a backup formula upgrade method, promptly write the software of redaction in the FLASH of free time storage space, after verification is correct, revise the medical functions program entry address in the described FLASH storer, after described microcontroller resets and restarts, realize software upgrading.
The on-line software updating method of described implantation medical equipment, it is characterized in that, the reset operation process of described microcontroller is, at first controlling magnet is placed external position near the implantation medical equipment in the body, this PDA controls that the electromagnetic wave of described program controller emission setpoint frequency realizes simultaneously.
Compared with prior art, the present invention has following beneficial effect: multiple implantation medical equipments such as (1) support implantable cardiac pacemaker and defibrillator, brain pacemaker, nerve stimulator, muscle stimulator, electrocardiorecorder, by wireless two-way communication online upgrading software; (2) security of software upgrade process and reliability height are easy to use, and escalation process can interrupt at any time, can also proceed upgrading from interruptions; (3) implantation medical equipment of costliness is upgraded, enhancement function prolongs Acceptable life, and the present invention has high economic benefit and social benefit.
Description of drawings
Fig. 1 is an inner structure block diagram of supporting the implantation medical equipment of online software upgrade.
Fig. 2 is the allocation of space synoptic diagram of FLASH storer.
Fig. 3 is the program flow diagram of PDA.
Fig. 4 is the program flow diagram that the implantation medical equipment in the body receives the processing instruction Frame.
Fig. 5 is the structural representation of instruction Frame and acknowledgement frame: a is a command frame, and b is for wiping the FLASH frame, and c is for writing the FLASH frame, and d is an acknowledgement frame.
Embodiment
Make a detailed description below in conjunction with the preferred implementation of accompanying drawing the on-line software updating method of implantation medical equipment of the present invention.
As shown in Figure 1, implantation medical equipment mainly comprises implantation medical equipment (being called for short " implanting apparatus ") and the vitro program controlled system in the body, and stored program controlled comprises program controller and palm PC PDA two parts again.The implanting apparatus operation is implanted in the patient body, carries out predetermined specific medical function, partly is made up of the microcontroller of being furnished with serial communication module (UART) (MCU), communication interface, RAM storer, FLASH storer and medical functions execution module etc.Stored program controlled is by doctor and related personnel operation, and the management software on the operation PDA is set up double-direction radio data communication based on the electromagnetic coupled mode by program controller and implanting apparatus, controls software upgrading and other course of work of implanting apparatus.Wherein, wireless data communication system can realize 4cm left and right sides communication distance, the above traffic rate of 600bps through the skin two-way wireless communication, satisfy the requirement of implantation medical equipment software upgrading.
As shown in Figure 2, the FLASH storer of implanting apparatus is divided into a plurality of program storage areas and an information storage area.Startup and TX are being deposited in the system program memory block, and data such as frame head mark, instruction character, and this part can not be changed in software upgrade process.Other program storage areas are being deposited the program of controlling implanting apparatus work.Generally speaking, the external relatively Medical Instruments of implanting apparatus, the function of realization is simpler, the code size of program is also less, is example with the embedded nerve stimulator, generally in the 2k byte, FLASH storer with a 60kB is an example, the program that can store 30 versions.Therefore, for the purpose of implanting apparatus safety, use backup formula upgrade method, promptly in the program memory space of free time, write the program of redaction, after verification was correct, the data of revising in the information storage area were come the refresh routine entry address, after microprocessor resets and restarts, promptly realized the online upgrading of software.
The user is by stored program controlled (PDA and program controller) and controlling magnet control whole software escalation process, and typically the PDA operating process is as shown in Figure 3:
1. whether legal renewable software document is arranged in the detection external memory storage.
2. after confirming to have available software, the prompting user carries out reset operation, makes implanting apparatus enter the software upgrading mode of operation;
3. send password and login instruction, to obtain read-write operation power;
4. the scrutiny program version information whether need to confirm the software upgrade operation, if confirm to need upgrading, then changes next step over to;
5. send and wipe memory instructions, for software upgrading is prepared;
6. send the write store instruction, new software is write;
7. send the write store instruction, medical functions program entry address is upgraded;
8. when needing, can send the write store instruction, revise login password;
9. when needing, can read the program that has just write again, whether correctly complete with check;
10. send the warm start instruction, system will enter new program execution after a while.
When reset operation, at first controlling magnet is placed the position of external corresponding implanting apparatus, the program controller of PDA control simultaneously continues the electromagnetic wave of emission characteristic frequency, under the acting in conjunction of above-mentioned two conditions, implanting apparatus enters reset mode, and restarts when any one condition does not satisfy.After implanting apparatus restarted, microcontroller and peripheral circuit were initialised, and the microcontroller start-up routine continues to read the serial ports buffer zone subsequently, detected to start the terminal program instruction.If in 5 seconds, detect instruction, then start TX.Implanting apparatus at first carries out erase operation according to the instruction that receives to the specified section of FLASH storer, receives the director data frame then one by one, deposits data in RAM earlier, writes the FLASH storer after verification is correct, writes end until the whole procedure file.
The TX of implanting apparatus is responsible for receiving and the execution command Frame, comprises the steps (as shown in Figure 4):
1. check and receive in the buffer memory whether receive the frame head byte, then change step 2 after receiving over to;
2. check whether the byte of receiving subsequently is the instruction of agreement, correctly then enters step 3, otherwise returns step 1;
3. check whether the 2 byte data length overalls receive subsequently are identical, if identical then access step 4, if two byte data differences would not perhaps receive data and then forward step 1 to;
4. according to the data of the data length overall that receives, change step 5 subsequently over to from reception buffer memory reception some.If do not receive the data of sufficient amount then change step 1 over to;
5. take out last 2 bytes receive data, other part carried out CRC generate computing, and with 2 bytes of taking out relatively, if verification is correctly then change step 6 over to, otherwise change step 1 over to;
6. take out information such as order code, operation address, data length, carry out relevant operation;
7. operating result or error message are sent to stored program controlled;
8. forward step 1 to, prepare to receive and carry out the next frame director data.
As shown in Figure 5, the method for interchanging data that transmits is frame by frame adopted in software upgrading of the present invention, frame is divided into two classes, be stored program controlled send to implanting apparatus the director data frame (with all kinds of instructions and data encapsulation framing thereof, be called " director data frame "), and implanting apparatus returns to the acknowledgement frame of stored program controlled.During communication, vitro program controlled system at first sends the director data frame, and implanting apparatus is received back execution associative operation, and acknowledgement frame is sent it back stored program controlled.Before the important operations such as wiping, write in execution, need input password login system, to obtain corresponding authority.
The director data frame is made up of 7 parts: frame head, instruction, content length overall, operation address, data length, data, check code mainly comprise and write the FLASH frame and wipe the FLASH frame, being described as follows of each several part:
1. frame head shows the classification of instruction, as being operating as 80H for software upgrading;
2. instruction shows the operation of stored program controlled requirement, as to write FLASH be 26H, and wiping FLASH is 25H;
3. the content length overall is meant the total bytes of operation address, data length, data, check code, with 1 byte representation, sends twice during communication to carry out verification;
4. operation address is the start address that the FLASH storer is operated;
5. for writing the FLASH frame, data length is meant the data word joint number that will write FLASH, is the data that write subsequently, and variable-length is generally 16 bytes; For wiping the FLASH frame, because the requirement of wiping of FLASH storer is carried out (for example every section 512 byte) by section, thus only need provide above-mentioned operation address, and need not to provide the long and data of data;
6. check code calculates for adopting the CRC-16 method of calibration.
Acknowledgement frame is that returns replied after implanting apparatus received the director data sign indicating number of vitro program controlled system.Its composition is fairly simple, comprises frame head and execution result.Frame head shows the classification of instruction, as being operating as 80H for software upgrading; Execution result divides to be operated successfully and two kinds of operation failures.
The on-line software updating method of implantation medical equipment, outstanding feature are the high requirements to security, and solution is as follows:
1. implanting apparatus is generally the titanium body seal, has capability of electromagnetic shielding preferably, and its communication and on-line software updating require program controller apart from about skin 3-4 centimetre, and extraneous electromagnetic interference (EMI) can't reach the intensity of interfere with communications and software upgrading;
2. the software upgrading function of implanting apparatus, when its operate as normal, can not call, have only with program controller and magnet acting in conjunction, it is resetted and restart after 5 second time in, use PDA to send specific instruction and start TX, and, could start on-line software updating with PDA and program controller operation special software;
3.PDA in the time of before software upgrading, can confirm its version information authenticity by checking means such as electronic signature, also can check implanting apparatus user profile simultaneously, confirm whether this software is suitable for this user.Wipe or during write operation, the implanting apparatus end needs verification 32 byte software upgrading passwords by TX, could begin on-line software updating after all correct;
4. the communication process of software upgrading has complete handshake mechanism, and request instruction can't be set up with the response message mistake and communicate by letter;
5. the communication process of software upgrading, CRC check is all carried out in the transmission of each director data frame, find that communication process is interfered and after causing data transmission fails, interrupt software updating operation at any time, implanting apparatus still can normally start and move TX;
6. in the software upgrade process, the redaction program that implanting apparatus receives does not cover the legacy version program, but writes on the new zone of FLASH storer, have only whole redaction programs write correct after, just enable the redaction program.
7. the TX in the implanting apparatus only is responsible for data transmit-receive and storer associative operation, and its 26S Proteasome Structure and Function of simplifying has guaranteed the reliability of software to the full extent.The sequence of operations of software upgrading is by the software control on the PDA.
Aforesaid way is the preferred embodiment of the present invention, for those skilled in the art, on the basis of implantation medical equipment on-line software updating method disclosed by the invention, be easy to expect being applied to various instrument systems, and be not limited only to the described system architecture of the specific embodiment of the invention, therefore previously described mode is just preferred, and does not have restrictive meaning.
Claims (3)
1. the on-line software updating method of implantation medical equipment is characterized in that described implantation medical equipment comprises two parts of implantation medical equipment in external stored program controlled and the body; Wherein, described stored program controlled is by two-way interconnected program controller, PDA and external memory storage are formed successively, implantation medical equipment in the described body contains microcontroller, produces circuit with the two-way interconnected RAM storer of this microcontroller, FLASH storer, communication interface, stimulus signal respectively, and and this stimulus signal produce the two-way interconnected electrode of circuit, the program controller in the described stored program controlled is with the communication interface two-way communication in the implantation medical equipment in communication and the body; Described method contains following steps successively:
Step 1. is stored in the terminal server of the implantation medical equipment in this body that comprises frame head mark, instruction word in this FLASH storer, and this terminal server remains former state in software upgrade process;
Step 2. user uses the method for interchanging data that transmits by command frame to control the software upgrade process of the implantation medical equipment in this body successively according to the following steps by this stored program controlled;
Step 2.1: the user starts the software upgrade procedure of this PDA, checks whether described external memory storage has legal refresh routine, then points out the user that microcontroller is carried out reset operation if having;
Step 2.2: if legal refresh routine is arranged, then PDA sends update request to described microcontroller, starts the terminal server in the implantation medical equipment in the described body;
Step 2.3:PDA sends password and login instruction, to obtain read-write operation power;
Step 2.4:PDA checks the program version information of the implantation medical equipment in the body, whether need to confirm the software upgrade operation, if confirm to need upgrading, then changes next step over to;
Step 2.5:PDA sends the instruction of wiping FLASH storer specified section, for software upgrading is prepared;
Step 2.6: if wipe end, then PDA sends the instruction that writes this FLASH storer, write the program that to upgrade, upgrade medical functions program entry address, perhaps send the instruction that writes the FLASH storer, revise login password, perhaps again the program that has just write is read, whether correctly complete with check;
Step 2.7:PDA sends the program after the warm start instruction makes the interior implantation medical equipment execution renewal of this body:
After the implantation medical equipment in this body entered the process of software upgrading, microcontroller was wherein carried out following steps successively:
Step I: check to receive among the buffer memory RAM whether receive frame head,, then change next step over to if receive;
Step II: check whether the byte of receiving subsequently is the instruction of agreement, the instruction of described agreement is meant writes the instruction of FLASH frame, or wipes the instruction of FLASH frame, if instruction is correct, then changes next step over to; Otherwise, return step I;
Step II I: whether total long value of the reception data content that the repetition that inspection is received subsequently is twice is consistent, if unanimity then changes next step over to; If different, perhaps do not receive, then return step I;
Step N: the total long value of data content that receives according to Step II I is from the communication interface reading of data and carry out CRC check, if correct, then execution command is returned execution result with the acknowledgement frame of setting, and as if incorrect, then returns corresponding error information.
2. the on-line software updating method of implantation medical equipment according to claim 1, it is characterized in that, this method is a backup formula upgrade method, promptly write the software of redaction in the FLASH of free time storage space, after verification is correct, revise the medical functions program entry address in the described FLASH storer, after described microcontroller resets and restarts, realize software upgrading.
3. the on-line software updating method of implantation medical equipment according to claim 1 and 2, it is characterized in that, the reset operation process of described microcontroller is, at first controlling magnet is placed external position near the implantation medical equipment in the body, this FDA controls that the electromagnetic wave of described program controller emission setpoint frequency realizes simultaneously.
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| CN102184113A (en) * | 2011-05-12 | 2011-09-14 | 深圳市锘特达科技发展有限公司 | Software upgrade method for implanted medical equipment |
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Effective date of registration: 20161008 Address after: 100084 N204, North building, Meng Meng science and technology building, Tsinghua University, Beijing, Haidian District Patentee after: Tsinghua University Patentee after: Beijing Pins Medical Co., Ltd. Address before: 100084 Beijing 100084-82 mailbox Patentee before: Tsinghua University |