CN113223695A - Medical device with safety confirmation and safety confirmation method thereof - Google Patents
Medical device with safety confirmation and safety confirmation method thereof Download PDFInfo
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- CN113223695A CN113223695A CN202010071264.1A CN202010071264A CN113223695A CN 113223695 A CN113223695 A CN 113223695A CN 202010071264 A CN202010071264 A CN 202010071264A CN 113223695 A CN113223695 A CN 113223695A
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
- G06F21/31—User authentication
- G06F21/32—User authentication using biometric data, e.g. fingerprints, iris scans or voiceprints
Abstract
The invention discloses a medical device for setting safety confirmation, which comprises: the remote device and the functional device, the functional device can receive some function instruction sent by the remote device, the function instruction includes drug infusion instruction or non-drug infusion instruction; and the safety confirmation module is arranged in the functional equipment, and after the safety confirmation module receives a confirmation instruction matched with the functional instruction, the functional equipment can execute the functional instruction, wherein the confirmation instruction comprises the limb action of the user. Before the medical device executes each function, safety confirmation is required, and the safety performance of the medical device is improved.
Description
Technical Field
The invention mainly relates to the field of medical instruments, in particular to a medical device with safety confirmation and a safety confirmation method thereof.
Background
Diabetes is mainly metabolic diseases caused by abnormal functions of pancreas of human bodies, diabetes is a lifelong disease, diabetes cannot be radically treated by the existing medical technology, and the occurrence and development of diabetes and complications thereof can be controlled only by stabilizing blood sugar. The normal human pancreas can automatically monitor the change of the blood glucose content of the human body and automatically secrete the required insulin. Currently, the working mode of a medical device for stabilizing blood glucose is: the blood sugar change of a human body is dynamically monitored in real time through a glucose sensor implanted into subcutaneous tissues of the human body; and insulin can be accurately infused into the subcutaneous tissue of the human body for 24 hours continuously through the hose implanted into the subcutaneous tissue of the human body.
With the development of internet and software technology, patients can remotely control drug infusion through software. However, remote devices connected to the internet are easily interfered or attacked, tampered and the like, and great potential safety hazards exist. Prior art devices require security certification prior to drug infusion. The device will perform the drug infusion function if the security certificate matches the infusion instruction. However, in addition to the infusion function, the non-infusion function is also important, but the prior art does not provide safety for these non-infusion functions.
Accordingly, there is a need in the art for a medical device that provides safety confirmation for both infusion and non-infusion functions.
Disclosure of Invention
The embodiment of the invention discloses a medical device with safety confirmation and a safety confirmation method thereof.
The invention discloses a medical device for setting safety confirmation, which comprises: the remote device and the functional device, the functional device can receive some function instruction sent by the remote device, the function instruction includes drug infusion instruction or non-drug infusion instruction; and the safety confirmation module is arranged in the functional equipment, and after the safety confirmation module receives a confirmation instruction matched with the functional instruction, the functional equipment can execute the functional instruction, wherein the confirmation instruction comprises the limb action of the user.
According to one aspect of the invention, the security validation module comprises a linear acceleration sensor or a gyroscope sensor.
According to one aspect of the invention, the linear acceleration sensor is a three-axis linear acceleration sensor.
According to one aspect of the invention, the medication comprises insulin and the medication infusion instruction comprises an insulin basal infusion instruction or an insulin bolus infusion instruction.
According to one aspect of the invention, the non-drug infusion instructions comprise one or more combinations of start/stop instructions, function switch instructions, function select instructions, data recording/display instructions, failure detection instructions, recovery connect/disconnect instructions, or matching instructions of the remote device and the functional device of the functional device.
According to one aspect of the invention, the limb movement comprises one or more of jumping, squatting, leg movement, arm movement, flapping to the functional device, bending, body twisting, special walking patterns, and the confirmation instructions matching different functional instructions are not identical.
The invention also discloses a safety confirmation method of the medical device, which comprises the following steps: providing remote equipment, functional equipment and a safety confirmation module, wherein the safety confirmation module is arranged in the functional equipment; the user operates the remote equipment to wirelessly send a certain function instruction to the function equipment, wherein the function instruction comprises a drug infusion instruction or a non-drug infusion instruction; the user sends a confirmation instruction matched with the functional instruction to the safety confirmation module, wherein the confirmation instruction comprises the limb action of the user; the safety confirmation module receives a confirmation instruction; and the functional device executes the functional instructions.
According to one aspect of the invention, the security validation module comprises a linear acceleration sensor or a gyroscope sensor.
According to one aspect of the invention, the linear acceleration sensor is a three-axis linear acceleration sensor.
According to one aspect of the invention, the medication comprises insulin and the medication infusion instruction comprises an insulin basal or bolus infusion instruction.
According to one aspect of the invention, the non-drug infusion instructions comprise one or more combinations of start/stop instructions, function switch instructions, function select instructions, data recording/display instructions, failure detection instructions, recovery connect/disconnect instructions, or matching instructions of the remote device and the functional device of the functional device.
According to one aspect of the invention, the limb movement comprises one or more of jumping, squatting, leg movement, arm movement, flapping to the functional device, bending, body twisting, special walking patterns, and the confirmation instructions matching different functional instructions are not identical.
Compared with the prior art, the technical scheme of the invention has the following advantages:
in the medical device with the safety confirmation function, the functional equipment can receive a certain functional instruction sent by the remote equipment, the functional instruction comprises a medicine infusion instruction or a non-medicine infusion instruction, and the functional equipment can execute the functional instruction after the safety confirmation module receives the confirmation instruction matched with the functional instruction. The functional equipment needs to perform safety confirmation before executing the drug infusion or non-drug infusion function, and an intermediate confirmation link is added, so that the equipment can be prevented from being attacked, tampered and damaged by hackers, the phenomena of infusion disorder, physiological information leakage, equipment parameter tampering, sudden equipment stop working and the like are avoided, and the safety performance of the medical device is improved. Second, the confirmation instruction includes a limb movement of the user. It is easier for the user to perform a limb action. And the user can complete the confirmation action without carrying other confirmation components, thereby enhancing the user experience.
Further, the linear acceleration sensor is a three-axis linear acceleration sensor. The three-axis linear acceleration sensor can sense the spatial motion of a user more easily, and the sensitivity of the device to motion detection is improved.
Accordingly, in the safety confirmation method for the medical device provided by the invention, the user operates the remote equipment to wirelessly transmit a certain function instruction to the function equipment, wherein the function instruction comprises a drug infusion instruction or a non-drug infusion instruction. The functional equipment needs to perform safety confirmation before executing the drug infusion or non-drug infusion function, an intermediate confirmation link is added, the equipment is prevented from being attacked, tampered and damaged by hackers, the phenomena of infusion disorder, physiological information leakage, equipment parameter tampering, sudden equipment stop working and the like are avoided, and the safety performance of the medical device is improved. Second, the confirmation instruction includes a limb movement of the user. It is easier for the user to perform a limb action. And the user can complete the confirmation action without carrying other confirmation components, thereby enhancing the user experience.
Further, the linear acceleration sensor is a three-axis linear acceleration sensor. The three-axis linear acceleration sensor can sense the space action of a user more easily, and the sensitivity of equipment action detection is improved.
Drawings
FIG. 1 is a schematic workflow diagram of a medical device executing functional instructions according to one embodiment of the present invention;
fig. 2 is a schematic structural view of a medical device according to an embodiment of the present invention.
Detailed Description
As previously mentioned, prior art medical devices do not have security certification for non-drug infusion function instructions.
It has been found that the reason for the above problems is that the drug infusion function is closely related to the physiological state, and the non-infusion function is mostly an auxiliary function of the medical device. Such medical devices are prone to other safety issues during use.
In order to solve the problem, the invention provides the medical device with the safety confirmation function, and the safety confirmation function and the non-infusion function are carried out simultaneously, so that the potential safety hazards caused by data leakage, parameter tampering, infusion disorder and the like due to equipment attack and tampering are eliminated, and the safety performance of the medical device is improved.
Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement of parts and steps, numerical expressions, and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise.
Further, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to scale, for example, the thickness, width, length or distance of some elements may be exaggerated relative to other structures for ease of illustration.
The following description of the exemplary embodiment(s) is merely illustrative and is not intended to limit the invention, its application, or uses in any way. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail herein, but are intended to be part of the specification as applicable.
It should be noted that like reference numerals and letters refer to like items in the following figures, and thus, once an item is defined or illustrated in one figure, further discussion thereof will not be required in the subsequent figure description.
Fig. 1 is a schematic diagram of a workflow of a medical device executing functional instructions according to an embodiment of the present invention, and fig. 2 is a schematic diagram of structures of various parts of the medical device according to an embodiment of the present invention.
The method comprises the following steps: the user operates the remote device 100 to issue a function instruction.
In the embodiment of the present invention, the remote device 100 and the function device 110 perform information interaction by way of wireless propagation. The user may control the function device 110 to perform various functions through the remote device 100. The function device 110 feeds back the executed or acquired information to the remote device 100.
The functional device 110 is used to perform functions directly related to medical purposes. In an embodiment of the present invention, the functional device 110 is affixed to the skin surface of the user by means of an adhesive plaster 120. The functional device 110 comprises a drug infusion device, a physiological state detection device, or an integrated device that combines detection with infusion. Specifically, in the embodiment of the present invention, the function device 110 is a drug infusion apparatus, and the function device 110 infuses the drug into the body of the user through the infusion needle 121. In another embodiment of the present invention, the functional device 110 is an integrated device that combines detection with infusion. In this case, the structure 121 has both drug infusion and detection functions.
The drugs in the function device 110 include insulin, glucagon, antibiotics, nutrient solution, analgesics, morphine, anticoagulants, gene therapy drugs, cardiovascular drugs, or chemotherapy drugs, etc., and are not particularly limited herein. Specifically, in the embodiment of the present invention, the medicine in the function device 110 is insulin. In other embodiments of the present invention, the functional device 110 may store a plurality of drugs as described above.
The functional device 110 is capable of performing a variety of functions, such as the most basic drug infusion function. The user may send medication infusion instructions to the function device 110 via the remote device 100. Specifically, in one embodiment of the present invention, the medication infusion instruction comprises an insulin basal infusion instruction or an insulin bolus infusion instruction. As in an open loop system or a semi-closed loop system, the user operates the remote device 100 to issue basal volume infusion instructions based on the basal volume of insulin required by the body for different periods of time. Depending on the meal, the user may operate the remote device 100 to send bolus infusion instructions.
In addition, the remote device 100 of the present embodiment is also capable of sending non-drug infusion commands to enable the functional device 110 to perform other functions, as will be described in detail below.
In operation, a user sends various function instructions to function device 110 via remote device 100. Such as when the functional device 110 is installed, the remote device 100 may send an instruction to activate or initiate the functional device 110. Meanwhile, the remote device 100 needs to be matched with the function device 110 to interact with each other. Thus, in one embodiment of the invention, upon activation of the functional device 110, the remote device 100 is also capable of issuing an instruction containing device model information to match the functional device 110.
During use, remote device 100 may send instructions to functional device 110 to cause functional device 110 to switch between different functions. As in one embodiment of the present invention, the functional apparatus 110 is a medical device that detects infusion in one and is used in the diabetes care field. And functional device 110 is a closed-loop artificial pancreas, remote device 100 can send instructions to control functional device 110 to switch between an open-loop system and a closed-loop system.
The function device 110 can also receive instructions from the remote device 100 for intelligent selection. As in one embodiment of the present invention, a user issues an instruction via remote device 100 instructing functional device 110 to intelligently select a detection or infusion function, or to intelligently select an infusion amount of a medication.
The function device 110 also has a function of feeding back information to the remote device 100 as needed. Such as a record of physiological status information, a record of drug infusion data, or device status information that the functional device 110 may feed back detected, etc. Therefore, the remote device 100 may transmit a function instruction to acquire the above data information to the function device 110 according to a user's demand, thereby intuitively reflecting the information to the user.
The medical device may malfunction during use, such as a pause in drug infusion, loss of data, cessation of testing, loss of communication between the functional apparatus 110 and other devices, and the like. The user can send a detection instruction for the above-mentioned failure to the function device 110 through the remote device 100, so that the medical apparatus can be restored to normal operation.
In one embodiment of the present invention, remote device 100 may be used as an aid. When the device enters normal operation, the remote device 100 may issue a command to the functional device 110 to disconnect from the functional device 110. Remote device 100 may also issue functional instructions and resume connection with functional device 110, if desired.
Step two: the function device 110 receives a function instruction.
At present, most of the remote devices 100 can be connected to the internet, and the remote devices 100 and the functional devices 110 are interconnected through bluetooth, so that the remote devices 100 and the functional devices 110 are likely to be hacked, tampered, damaged, maliciously invaded and the like, or the remote devices 100 are mistakenly used by others, so that a potential safety hazard exists, and even a life risk is brought. For example, when the communication is invaded maliciously, the infusion of the medicine is controlled by others, and the life health of the user is endangered. Or the remote device 100 is inadvertently touched by a child, the medication is overdosed or the volume of infusion is reduced, presenting a safety hazard. For another example, when the interconnection between the remote device 100 and the function device 110 is attacked, other people can easily acquire the physiological status information of the user, resulting in data leakage. For another example, the parameters of the device and the interconnections between the devices may also be easily damaged or tampered, the device cannot work normally, a potential safety hazard exists, and the cost of the user is increased invisibly. Therefore, in the embodiment of the present invention, after the functional device 110 receives the functional instruction, the functional device 110 can execute the corresponding function only after security confirmation.
Step three: the user sends a confirmation instruction to a security confirmation module in the functional device.
Specifically, in the embodiment of the present invention, the function device 110 is provided with a security confirmation module 111, and when the security confirmation module 111 receives a confirmation instruction from a user, the function device 110 starts to execute a corresponding function. Obviously, since there are many functional instructions, the confirmation instruction also needs to have many types to be correspondingly matched with the functional instructions.
In an embodiment of the present invention, the security confirmation module 111 includes a linear acceleration sensor or a gyro sensor. A linear acceleration sensor or a gyroscope sensor is used as the safety confirmation module 111, and the user can complete confirmation only by performing simple limb actions. If the user does not need to carry other parts, even the confirmation can be completed without contacting the equipment, the convenience of the safety confirmation operation is improved, and the user experience is enhanced. Specifically, in the embodiment of the present invention, the linear acceleration sensor is a three-axis linear acceleration sensor. The three-axis linear acceleration sensor can detect the change of acceleration in three directions of the X, Y, Z axis, has the advantage of quickly detecting the movement of limbs, and improves the sensitivity of movement detection. In another embodiment of the present invention, the security validation module 111 is a gyroscope sensor. The gyroscope sensor can accurately detect the body actions such as rotation of a user, such as a special walking mode or a circle turning. In another embodiment of the present invention, the safety confirmation module 111 uses a combination of linear acceleration sensor or gyroscope sensor, and the function device 110 will detect the limb movement of the user more quickly and accurately.
In embodiments of the present invention, user limb movements include, but are not limited to, jumping, squatting, leg movements, arm movements, tapping the functional device 110, bending down, body twisting, special walking patterns. It should be noted here that the beating of the functional device 110 includes not only directly contacting the functional device 110, but also indirectly contacting or not contacting, for example, the user may beat the functional device 110 via clothes. Leg movements include, but are not limited to, raising the leg, trembling the leg. Arm actions include, but are not limited to, shaking arms, swinging arms, and swinging arms. The special walking modes include, but are not limited to, forward and backward, revolving and walking, zigzag walking and forward.
In the embodiment of the present invention, the confirmation command includes one or a combination of a plurality of body movements, and does not limit the frequency of a certain body movement. Preferably, in the embodiment of the present invention, a certain confirmation instruction is to tap the functional device 110 three times. The beating is carried out three times instead of one time, two times or more than three times, so that the interference caused by accidental actions is avoided, the beating mode is more convenient than the beating mode with more than three times, and the user experience is enhanced. In another embodiment of the present invention, the confirmation instruction for insulin basal infusion is that the user bends over first and then twists the body twice. In yet another embodiment of the present invention, the confirmation command of the activation function device 110 walks forward in a zigzag fashion.
As mentioned above, there are many functional commands, so there are many confirmation commands matching with the functional commands, and the body motions of different confirmation commands may be different or the same, but the body motions are not completely the same. Preferably, in the embodiment of the present invention, the confirmation command of starting and stopping the function device 110 is the same, or the confirmation command of disconnecting or resuming the connection is the same. The action of partial confirmation instructions is the same, so that the types of the action are reduced, the design cost is reduced, and the user can remember the actions conveniently.
It should be noted that, in other embodiments of the present invention, more acknowledgement commands may have the same action, and are not limited in particular here.
Step four: the user sends a confirmation instruction to a security confirmation module in the functional device.
When the security confirmation module 111 receives the corresponding confirmation instruction, the function device 110 starts to execute the function instruction. It should be apparent that in embodiments of the present invention, functional apparatus 110 does not execute a command if the confirmation instruction and the functional instruction do not match. This way the safety of the device is improved.
In a safety confirmation method for a medical device, only drug infusion needs to be confirmed, and other functions do not need to be confirmed, and the safety performance of the medical device is still low. And other parts are required to be used for contact or indirect induction confirmation, so that the action is complex and the user experience is poor. The medical device safety confirmation method provided by the embodiment of the invention not only can confirm the drug infusion function, but also can confirm other non-drug infusion functions, and is simple, higher in safety and better in user experience.
In summary, the present invention discloses a method for confirming safety of a medical device, wherein after a remote device issues a functional instruction of drug infusion or non-drug infusion, a safety confirmation is performed again, and the functional device executes a corresponding function, so as to improve the safety performance of the medical device and enhance the user experience.
With continued reference to fig. 1 and fig. 2, the present invention further provides a medical apparatus for setting security confirmation, which includes a remote device 100 and a function device 110. The function device 110 is provided with a security confirmation module 111.
In the embodiment of the present invention, the remote device 100 and the function device 110 perform information interaction by way of wireless propagation. The user may control the function device 110 to perform various functions through the remote device 100. The function device 110 feeds back the executed or acquired information to the remote device 100.
The functional device 110 is used to perform functions directly related to medical purposes. In an embodiment of the present invention, the functional device 110 is affixed to the skin surface of the user by means of an adhesive plaster 120. The functional device 110 comprises a drug infusion device, a physiological state detection device, or an integrated device that combines detection with infusion. Specifically, in the embodiment of the present invention, the function device 110 is a drug infusion apparatus, and the function device 110 infuses the drug into the body of the user through the infusion needle 121. In another embodiment of the present invention, the functional device 110 is an integrated device that combines detection with infusion. In this case, the structure 121 has both drug infusion and detection functions.
The drugs in the function device 110 include insulin, glucagon, antibiotics, nutrient solution, analgesics, morphine, anticoagulants, gene therapy drugs, cardiovascular drugs, or chemotherapy drugs, etc., and are not particularly limited herein. Specifically, in the embodiment of the present invention, the medicine in the function device 110 is insulin. In other embodiments of the present invention, the functional device 110 may store a plurality of drugs as described above.
The functional device 110 is capable of performing a variety of functions, such as the most basic drug infusion function. The user may send medication infusion instructions to the function device 110 via the remote device 100. Specifically, in one embodiment of the present invention, the medication infusion instruction comprises an insulin basal infusion instruction or an insulin bolus infusion instruction. As in an open loop system or a semi-closed loop system, the user operates the remote device 100 to issue basal volume infusion instructions based on the basal volume of insulin required by the body for different periods of time. Depending on the meal, the user may operate the remote device 100 to send bolus infusion instructions.
In addition, the remote device 100 of the present embodiment is also capable of sending non-drug infusion commands to enable the functional device 110 to perform other functions, as will be described in detail below.
In operation, a user sends various function instructions to function device 110 via remote device 100. Such as when the functional device 110 is installed, the remote device 100 may send an instruction to activate or initiate the functional device 110. Meanwhile, the remote device 100 needs to be matched with the function device 110 to interact with each other. Thus, in one embodiment of the invention, upon activation of the functional device 110, the remote device 100 is also capable of issuing an instruction containing device model information to match the functional device 110.
During use, remote device 100 may send instructions to functional device 110 to cause functional device 110 to switch between different functions. As in one embodiment of the present invention, the functional apparatus 110 is a medical device that detects infusion in one and is used in the diabetes care field. And functional device 110 is a closed-loop artificial pancreas, remote device 100 can send instructions to control functional device 110 to switch between an open-loop system and a closed-loop system.
The function device 110 can also receive instructions from the remote device 100 for intelligent selection. As in one embodiment of the present invention, a user issues an instruction via remote device 100 instructing functional device 110 to intelligently select a detection or infusion function, or to intelligently select an infusion amount of a medication.
The function device 110 also has a function of feeding back information to the remote device 100 as needed. Such as a record of physiological status information, a record of drug infusion data, or device status information that the functional device 110 may feed back detected, etc. Therefore, the remote device 100 may transmit a function instruction to acquire the above data information to the function device 110 according to a user's demand, thereby intuitively reflecting the information to the user.
The medical device may malfunction during use, such as a pause in drug infusion, loss of data, cessation of testing, loss of communication between the functional apparatus 110 and other devices, and the like. The user can send a detection instruction for the above-mentioned failure to the function device 110 through the remote device 100, so that the medical apparatus can be restored to normal operation.
In one embodiment of the present invention, remote device 100 may be used as an aid. When the device enters normal operation, the remote device 100 may issue a command to the functional device 110 to disconnect from the functional device 110. Remote device 100 may also issue functional instructions and resume connection with functional device 110, if desired.
At present, most of the remote devices 100 can be connected to the internet, and the remote devices 100 and the functional devices 110 are interconnected through bluetooth, so that the remote devices 100 and the functional devices 110 are likely to be hacked, tampered, damaged, maliciously invaded and the like, or the remote devices 100 are mistakenly used by others, so that a potential safety hazard exists, and even a life risk is brought. For example, when the communication is invaded maliciously, the infusion of the medicine is controlled by others, and the life health of the user is endangered. Or the remote device 100 is inadvertently touched by a child, the medication is overdosed or the volume of infusion is reduced, presenting a safety hazard. For another example, when the interconnection between the remote device 100 and the function device 110 is attacked, other people can easily acquire the physiological status information of the user, resulting in data leakage. For another example, the parameters of the device and the interconnections between the devices may also be easily damaged or tampered, the device cannot work normally, a potential safety hazard exists, and the cost of the user is increased invisibly. Therefore, in the embodiment of the present invention, after the functional device 110 receives the functional instruction, the functional device 110 can execute the corresponding function only after security confirmation.
Specifically, in the embodiment of the present invention, the function device 110 is provided with a security confirmation module 111, and when the security confirmation module 111 receives a confirmation instruction from a user, the function device 110 starts to execute a corresponding function. Obviously, since there are many functional instructions, the confirmation instruction also needs to have many types to be correspondingly matched with the functional instructions.
In an embodiment of the present invention, the security confirmation module 111 includes a linear acceleration sensor or a gyro sensor. A linear acceleration sensor or a gyroscope sensor is used as the safety confirmation module 111, and the user can complete confirmation only by performing simple limb actions. If the user does not need to carry other parts, even the confirmation can be completed without contacting the equipment, the convenience of the safety confirmation operation is improved, and the user experience is enhanced. Specifically, in the embodiment of the present invention, the linear acceleration sensor is a three-axis linear acceleration sensor. The three-axis linear acceleration sensor can detect the change of acceleration in three directions of the X, Y, Z axis, has the advantage of quickly detecting the movement of limbs, and improves the sensitivity of movement detection. In another embodiment of the present invention, the security validation module 111 is a gyroscope sensor. The gyroscope sensor can accurately detect the body actions such as rotation of a user, such as a special walking mode or a circle turning. In another embodiment of the present invention, the safety confirmation module 111 uses a combination of linear acceleration sensor or gyroscope sensor, and the function device 110 will detect the limb movement of the user more quickly and accurately.
In embodiments of the present invention, user limb movements include, but are not limited to, jumping, squatting, leg movements, arm movements, tapping the functional device 110, bending down, body twisting, special walking patterns. It should be noted here that the beating of the functional device 110 includes not only directly contacting the functional device 110, but also indirectly contacting or not contacting, for example, the user may beat the functional device 110 via clothes. Leg movements include, but are not limited to, raising the leg, trembling the leg. Arm actions include, but are not limited to, shaking arms, swinging arms, and swinging arms. The special walking modes include, but are not limited to, forward and backward, revolving and walking, zigzag walking and forward.
In the embodiment of the present invention, the confirmation command includes one or a combination of a plurality of body movements, and does not limit the frequency of a certain body movement. Preferably, in the embodiment of the present invention, a certain confirmation instruction is to tap the functional device 110 three times. The beating is carried out three times instead of one time, two times or more than three times, so that the interference caused by accidental actions is avoided, the beating mode is more convenient than the beating mode with more than three times, and the user experience is enhanced. In another embodiment of the present invention, the confirmation instruction for insulin basal infusion is that the user bends over first and then twists the body twice. In yet another embodiment of the present invention, the confirmation command of the activation function device 110 walks forward in a zigzag fashion.
As mentioned above, there are many functional commands, so there are many confirmation commands matching with the functional commands, and the body motions of different confirmation commands may be different or the same, but the body motions are not completely the same. Preferably, in the embodiment of the present invention, the confirmation command of starting and stopping the function device 110 is the same, or the confirmation command of disconnecting or resuming the connection is the same. The action of partial confirmation instructions is the same, so that the types of the action are reduced, the design cost is reduced, and the user can remember the actions conveniently.
It should be noted that, in other embodiments of the present invention, more acknowledgement commands may have the same action, and are not limited in particular here.
When the security confirmation module 111 receives the corresponding confirmation instruction, the function device 110 starts to execute the function instruction. It should be apparent that in embodiments of the present invention, functional apparatus 110 does not execute a command if the confirmation instruction and the functional instruction do not match. This way the safety of the device is improved.
In a medical device provided with safety confirmation, the safety performance of the medical device is still low, only the drug infusion needs to be confirmed, and other functions do not need to be confirmed. And other parts are required to be used for contact or indirect induction confirmation, so that the action is complex and the user experience is poor. The medical device with the safety confirmation function provided by the embodiment of the invention not only has the safety confirmation function of medicine infusion, but also can confirm other non-medicine infusion functions, and has the advantages of simple method, higher safety and better user experience.
In summary, the present invention discloses a medical device with safety confirmation, after a remote device issues a functional instruction of drug infusion or non-drug infusion, the functional device needs to perform a corresponding function only after a safety confirmation, so as to improve the safety performance of the medical device and enhance the user experience.
Although some specific embodiments of the present invention have been described in detail by way of illustration, it should be understood by those skilled in the art that the above illustration is only for the purpose of illustration and is not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.
Claims (12)
1. A medical device configured for security validation, comprising:
the remote device and the function device can receive some function instruction sent by the remote device, wherein the function instruction comprises a drug infusion instruction or a non-drug infusion instruction; and
the safety confirmation module is arranged in the functional equipment, and after the safety confirmation module receives a confirmation instruction matched with the functional instruction, the functional equipment can execute the functional instruction, and the confirmation instruction comprises the limb action of a user.
2. The medical device of claim 1, wherein the safety confirmation module comprises a linear acceleration sensor or a gyroscope sensor.
3. The medical device of claim 2, wherein the linear acceleration sensor is a three-axis linear acceleration sensor.
4. The medical device of claim 1, wherein the medication comprises insulin and the medication infusion instruction comprises an insulin basal infusion instruction or an insulin bolus infusion instruction.
5. The medical apparatus of claim 4, wherein the non-drug infusion instructions include one or more of start/stop instructions, function switch instructions, function select instructions, data recording/display instructions, failure detection instructions, recovery connect/disconnect instructions, or matching instructions of the remote device and the functional device.
6. The medical device of claim 5, wherein the limb movement comprises one or more of jumping, squatting, leg movement, arm movement, flapping, bending, twisting, and walking a particular way of the functional apparatus, and the confirmation instructions matching different functional instructions are not identical.
7. A method of safety validation of a medical device, comprising:
providing a remote device, a functional device and a security confirmation module, wherein the security confirmation module is arranged in the functional device;
the user operates the remote equipment to wirelessly send some function instruction to the function equipment, wherein the function instruction comprises a drug infusion instruction or a non-drug infusion instruction;
the user sends a confirmation instruction matched with the functional instruction to the safety confirmation module, wherein the confirmation instruction comprises the limb action of the user;
the safety confirmation module receives the confirmation instruction; and
the function device executes the function instruction.
8. The medical device security validation method of claim 7, wherein the security validation module comprises a linear acceleration sensor or a gyroscope sensor.
9. The medical device safety validation method of claim 8, wherein the linear acceleration sensor is a three-axis linear acceleration sensor.
10. The medical device safety validation method of claim 7, wherein the medication comprises insulin and the medication infusion instruction comprises an insulin basal or bolus infusion instruction.
11. The medical device safety validation method of claim 10, wherein the non-drug infusion instruction comprises one or more of a start/stop instruction of the functional apparatus, a function switch instruction, a function select instruction, a data record/display instruction, a failure detection instruction, a recovery connect/disconnect instruction, or a matching instruction of the remote apparatus and the functional apparatus.
12. The method of claim 11, wherein the limb movement comprises one or more of jumping, squating, leg movement, arm movement, flapping, bending, twisting, and walking in a special way, and the confirmation commands matching different ones of the functional commands are not identical.
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| CN202010071264.1A CN113223695A (en) | 2020-01-21 | 2020-01-21 | Medical device with safety confirmation and safety confirmation method thereof |
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