CN111375130A

CN111375130A - Method for binding a patient control device with an active implant device and medical control device

Info

Publication number: CN111375130A
Application number: CN201811647583.1A
Authority: CN
Inventors: 朱建亮; 何庆; 夏俊伟; 龚嘉骏
Original assignee: Shanghai Shenyi Medical Technology Co ltd
Current assignee: Shanghai Shenyi Medical Technology Co ltd
Priority date: 2018-12-29
Filing date: 2018-12-29
Publication date: 2020-07-07

Abstract

The invention provides a method for binding patient control equipment and active implanted equipment, medical control equipment, a computer readable storage medium and an implanted medical system, wherein in the binding method, the patient control equipment and the active implantable equipment are configured through the medical control equipment, so that the unique binding relationship between the patient control equipment and the active implanted equipment is realized, the problem of binding the patient control equipment and other activated active implanted equipment is avoided, and the binding process is safe and reliable; moreover, the patient control equipment does not have high-level control authority in the whole binding process and is always controlled by the medical control equipment, so that the condition that a patient operates an option to be controlled by a doctor due to misoperation is avoided, medical accidents are avoided, and the use process of the active implantation equipment is safer.

Description

Method for binding a patient control device with an active implant device and medical control device

Technical Field

The invention relates to the technical field of active implantable medical systems, in particular to a method for binding patient control equipment and active implantable equipment, medical control equipment, a computer storage medium and an implantable medical system.

Background

With the development of medical technology, active implantable medical devices are increasingly being used to address patient conditions. Such as: the artificial cochlea enables a patient with severe deafness to generate certain sound perception; a deep brain electrical stimulator for treating parkinson; cardiac pacemakers are used to treat cardiac dysfunction caused by certain arrhythmias. The active implantable medical device mainly comprises an active implantable device in a body, a medical control device and a patient control device. The medical control device and the patient control device acquire or set parameters of the active implant device through far-field or near-field communication to control operating parameters of the in-vivo implant device. Medical control devices are used by attending physicians or nurses who are trained in the use of the device, and therefore there is no serious risk problem in the use of the device. However, since patients are different, they lack experience in use and have various use environments, and various situations can occur, safe and reliable control between a patient control device and an active implanted device in the body of the patient is an especially important place in the development of active implantable medical devices.

However, there is a certain safety risk in binding the patient control device and the intracorporeal implantable medical device currently on the market, for example, a DBS (deep brain stimulator, also called a brain pacemaker or neurostimulator) system manufactured by Medtronic has a medical control device, a patient control device (also called a patient programmer) and an active implantable device, and the system allows communication between any two devices among the three devices, but when the patient control device of the DBS system manufactured by Medtronic is bound with the active implantable device, there is a problem that the patient control device which is just shipped from factory can be directly bound with the active implantable device which is activated, and this may cause a situation that the device which is just shipped from factory is used to perform malicious binding, thereby generating a control risk. For another example, the DBS system available from Boston Scientific also has a medical control device, a patient control device and an active implantable device, and the system can only allow communication between the medical control device and the patient control device and between the patient control device and the active implantable device, but when the patient control device of the DBS system available from Boston Scientific is connected with the active implantable device, the patient control device needs to be switched to a doctor control mode by combining keys, because of the advanced operating rights in this mode, this results in that there may be false triggers during use of the patient to enter the doctor control mode, so that the patient controls the part which should be controlled by the doctor, thus generating a use risk.

Disclosure of Invention

The invention aims to provide a method for binding patient control equipment and active implanted equipment, medical control equipment, a computer storage medium and an implanted medical system, which can solve the potential safety hazards of mistaken binding, mistaken triggering and the like existing in the binding process of the patient control equipment and the active implanted equipment in an implanted medical device.

To achieve the above object, the present invention provides a method of binding a patient control device with an active implant device, comprising:

a medical control device establishes communication connection with an active implant device and a patient control device respectively, and sets the active implant device and the patient control device to enter a binding mode respectively; and the number of the first and second groups,

after both the active implant device and the patient control device successfully enter a binding mode, a communication interaction is established between the patient control device and the active implant device, and when the communication interaction is established successfully, the patient control device is successfully bound with the active implant device.

Optionally, the step of the medical control device setting the active implant device and the patient control device to enter the binding mode respectively includes:

the medical control equipment respectively acquires the information required by the active implant equipment and the patient control equipment for completing the binding, and the information required by the active implant equipment for completing the binding comprises the unique identification address of the active implant equipment; the information of the patient control device required for completing the binding comprises a unique identification address of the patient control device; and the number of the first and second groups,

and the medical control equipment respectively sets the active implantation equipment and the patient control equipment to enter a binding mode according to the information required for completing the binding.

Optionally, the information of the active implant device required for completing the binding further includes a current binding state of the active implant device; the information of the patient control device required for completing the binding further comprises a current binding state of the patient control device; and when the active implant device and/or the patient control device are currently bound, the medical control device unbinds the active implant device and/or the patient control device before setting the active implant device and the patient control device to enter a binding mode, respectively.

Optionally, the medical control device acquires information of the active implant device required for completing the binding, acquires information of the patient control device required for completing the binding, and adaptively configures part or all of the information of the active implant device including the unique identification address required for completing the binding into the patient control device.

Optionally, the method further comprises: after the medical control equipment respectively sets the active implantation equipment and the patient control equipment to enter the binding mode, the medical control equipment respectively acquires information whether the active implantation equipment and the patient control equipment successfully enter the binding mode.

Optionally, the active implant device and/or the patient control device performs at least one of the following processes upon successful entry into a binding mode: and feeding back a signal of successfully entering a binding mode to the medical control equipment, sending a prompt of waiting for executing a binding command and processing the binding command, wherein the binding command is communication interaction aiming at binding the active implant equipment and the patient control equipment together.

Optionally, the method further comprises: setting a binding time limit on at least one of the medical control device, the patient control device and the active implant device, starting timing after the patient control device and/or the active implant device enters the corresponding binding mode, and when the result of timing exceeds the binding time limit and the binding of the patient control device and the active implant device is not successful, the patient control device and/or the active implant device automatically exits the binding mode.

Optionally, the method further comprises: when the binding of the patient control device and the active implant device fails and/or succeeds, a prompt of the binding failure and/or the binding success is made on the medical control device and/or the patient control device.

Optionally, the patient control device initiates a communication interaction procedure including multiple steps to the active implant device, or the medical control device controls the patient control device to initiate a communication interaction procedure including multiple steps to the active implant device, so that communication interaction is established between the patient control device and the active implant device, where when all steps in the communication interaction procedure are completed in sequence, the patient control device and the active implant device are successfully bound, and otherwise, when any step in the communication interaction procedure is failed, the patient control device and the active implant device are failed to bind.

Optionally, the communication interaction process includes: an activation step of the active implant device, a confirmation step of the reliability of the communication between the patient control device and the active implant device, and a step of data communication between the patient control device and the active implant device.

Optionally, the step of activating the active implant device comprises hardware activation and/or software wake-up; the step of confirming the reliability of the communication between the patient control device and the active implant device comprises a communication handshake process, a status inquiry process, a parameter setting confirmation process, and a data saving process.

Optionally, the step of communicating data between the patient control device and the active implant device includes encrypting and verifying data by an encryption algorithm and a verification algorithm.

Based on the same inventive concept, the present invention also provides a computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the method for binding a patient control device to an active implant device according to the present invention.

Based on the same inventive concept, the invention also provides a medical control device, comprising:

a communication module configured to establish communicative interaction with an active implant device and a patient control device, respectively;

a pseudo-binding module configured to set the active implant device and the patient control device into a binding mode, respectively.

Optionally, the medical control apparatus further includes:

a true binding module configured to control establishment of a communicative interaction between the patient control device and the active implant device to achieve binding of the patient control device with the active implant device upon successful entry of both the active implant device and the patient control device into a binding mode.

Optionally, the pseudo-binding module is further configured to: respectively acquiring information required by the active implant equipment and the patient control equipment for completing binding, and respectively setting the active implant equipment and the patient control equipment to enter a binding mode according to the information required by the active implant equipment and the patient control equipment for completing binding; and the information of the active implant device required for completing the binding comprises a unique identification address of the active implant device; the information of the patient control device required for completing the binding comprises a unique identification address of the patient control device.

Optionally, the information of the active implant device required for completing the binding further includes a current binding state of the active implant device; the information of the patient control device required for completing the binding further comprises a current binding state of the patient control device; the pseudo-binding module is further configured to: unbinding the active implant device and/or the patient control device and setting the active implant device and the patient control device, respectively, to enter a bind mode when the active implant device and/or the patient control device is currently bound.

Optionally, the pseudo-binding module is further configured to: the information of the active implant device required for completing the binding is acquired first, then the information of the patient control device required for completing the binding is acquired, and part or all of the information of the active implant device including the unique identification address required for completing the binding is adaptively configured into the patient control device.

Optionally, the medical control apparatus further includes: a recovery module configured to: setting a binding time limit, starting timing after the patient control device and/or the active implant device enters the corresponding binding mode, and enabling the patient control device and/or the active implant device to exit the binding mode when the timing exceeds the binding time limit and the patient control device and the active implant device are not successfully bound.

Optionally, the medical control apparatus further comprises a prompt module configured to: when the binding of the patient control equipment and the active implant equipment fails and/or is successful, prompting the binding failure and/or the binding success on the medical control equipment; and/or a login module configured to: and receiving and verifying login information of a user so that the user logs in the medical control equipment, and further binding the patient control equipment and the active implant equipment through the medical control equipment.

Optionally, the true binding module is further configured to: presetting a communication interaction flow comprising a plurality of steps, and after the patient control device and the active implant device both enter the corresponding binding mode, controlling the patient control device to initiate the communication interaction flow to the active implant device so as to establish communication interaction between the patient control device and the active implant device, wherein when all steps in the communication interaction flow are completed in sequence, the patient control device and the active implant device are successfully bound, otherwise, when any step in the communication interaction flow fails to be executed, the patient control device and the active implant device are failed to be bound.

Optionally, the medical control device further has a display screen and a controller for directly controlling and adjusting the active implant device.

Based on the same inventive concept, the invention also provides an implantable medical system, which comprises the medical control device, at least one patient control device and at least one active implant device, wherein the medical control device is used for enabling the patient control device and the corresponding active implant device to enter a binding mode so as to complete mutual binding.

Optionally, the active implant device and/or the patient control device is configured to: upon successful entry into the binding mode, at least one of the following processes can be performed: feedback of success or failure to enter a bind mode, issue a prompt to wait for execution of a bind command, and process a bind command, the bind command being a communication interaction aimed at binding the active implant device and the patient control device together.

Optionally, the patient control device and/or the active implant device is configured to: setting a binding time limit, starting timing after entering the corresponding binding mode, and automatically exiting the binding mode when the timing exceeds the binding time limit and the patient control device and the active implant device are not successfully bound.

Compared with the prior art, the technical scheme of the invention has the following beneficial effects:

1. according to the binding method and the computer-readable storage medium, the medical control equipment is used for configuring the patient control equipment and the active implantable equipment, so that the unique binding relationship between the patient control equipment and the active implantable equipment can be realized, the problem that the patient control equipment is bound with other activated active implantable equipment is solved, and the binding process is safe and reliable; moreover, the patient control equipment does not have high-level control authority in the whole binding process and is always controlled by the medical control equipment, so that the patient is prevented from operating options which are controlled by a doctor due to misoperation, medical accidents are avoided, and the using process of the patient control equipment is safer.

2. The medical control equipment and the implanted medical system can enable the patient control equipment and the active implanted equipment to be uniquely bound under the control of a doctor, avoid the problem that the patient control equipment is bound with other activated active implanted equipment and the problem that the patient control equipment triggers a doctor control mode by mistake, have safe and reliable binding process and improve the use safety of the active implanted equipment.

Drawings

FIG. 1 is a flow chart of a method of binding a patient control device to an active implant device in accordance with an embodiment of the present invention;

FIG. 2 is a schematic diagram of the connection between the medical control device, the patient control device and the active implant device in the binding method shown in FIG. 1;

FIG. 3 is a schematic diagram of a communication interaction flow of an embodiment of the present invention;

fig. 4 is a schematic structural diagram of a medical control apparatus according to an embodiment of the present invention.

Detailed Description

The present invention will be described in detail with reference to the accompanying drawings in order to make the objects and features of the present invention more comprehensible, however, the present invention may be realized in various forms and should not be limited to the embodiments described above. Furthermore, it should be noted that the techniques disclosed herein may be implemented in hardware and/or in software (including firmware, microcode, etc.). Further, the term "and/or" herein refers to either or both.

An embodiment of the invention provides a method for binding patient control equipment and active implant equipment, which is characterized in that the patient control equipment and the active implant equipment are bound by medical control equipment, and the medical control equipment, the patient control equipment and the active implant equipment have the highest security level and control authority and are only used by a doctor for logging in. Referring to fig. 1 and 2, the method for binding a patient control device and an active implant device provided in this embodiment includes the following steps:

s1, a medical control device 10 establishes communication with an active implant device 30 and a patient control device 20, respectively, and sets the active implant device 30 and the patient control device 20 into a binding mode, respectively; and the number of the first and second groups,

s2, after both the active implant device 30 and the patient control device 20 successfully enter the binding mode, a communication interaction is established between the patient control device 20 and the active implant device 30, and when the communication interaction is established successfully, the patient control device 20 is successfully bound with the active implant device 30.

In step S1, the medical control device 10 establishes communication connections with the patient control device 20 and the active implant device 30 by far-field communication (e.g., wifi communication, cellular mobile communication) or near-field communication (e.g., NFC communication, ZigBee communication, bluetooth communication), respectively, and acquires information of the patient control device 20 and the active implant device 30 required for completing the binding, and then sets the active implant device 30 and the patient control device 20 to enter the binding mode, respectively, according to the acquired information. As an example, the medical control device 10 first establishes a communication connection with the active implant device 30 through far-field or near-field communication (as shown in "1" between the medical control device 10 and the active implant device 30 in fig. 2 and 4), further acquires information required by the active implant device 30 for completing the binding, sets the active implant device 30 to enter a binding mode according to the acquired information, then establishes a communication connection with the patient control device 20 through far-field communication or near-field communication (as shown in "2" between the medical control device 10 and the patient control device 20 in fig. 2 and 4), further acquires information required by the patient control device 20 for completing the binding, configures binding parameters of the patient control device 20, and sets the patient control device 20 to enter the binding mode, thereby implementing time-sharing communication between the medical control device 10 and the active implant device 30 and the patient control device 20 And in turn, causes patient control device 20 and active implant device 30 to communicate with and bind together (as indicated by the "3" between patient control device 20 and active implant device 30 in fig. 2 and 4). The specific process of configuring the binding parameters of the patient control device 20 includes: the medical control device 10 sets the acquired information required for completing the binding of the active implantable device 10 including the unique identification address, partially or completely, into the patient control device 20 by far field or near field communication. In other embodiments of the present invention, the medical control device 10 may also establish a communication connection with the patient control device 20 and make the patient control device 20 enter the binding mode, and then establish a communication connection with the active implant device 30 and make the active implant device 30 enter the binding mode; the medical control device 10 may also establish a communication connection with both the patient control device 20 and the active implant device 30 simultaneously, so that both the patient control device 20 and the active implant device 30 enter the binding mode simultaneously. In both cases, the user may input in advance the information required for completing the binding of some or all of the designated active implantable device 10 and the designated patient control device 20, including the unique identification address, on the medical control device 10, and after the medical control device 10 establishes a communication connection with the patient control device 20 and the active implantable device 30, the information obtained from the patient control device 20 and the active implantable device 30 may be used for comparison with the information input in advance by the user to verify the validity of the connected patient control device 20 and the active implantable device 30. The information of the active implant device 30 required for completing the binding includes: (1) a unique identification address of said active implant device 30, which address is used to distinguish different active implant devices; (2) the current binding state of the active implant device 30, i.e. whether the active implant device 30 is currently bound or not, if the active implant device 30 is currently bound, the previous binding needs to be released; (3) information of whether the active implant device 30 successfully enters the binding mode, and the like, that is, after the medical control device 10 sets that the active implant device 30 enters the binding mode, the medical control device 10 can further acquire information of whether the active implant device 30 successfully enters the binding mode, so that when the active implant device 30 does not enter the binding mode, the active implant device 30 is set to enter the binding mode again. The binding mode of the active implant device 30 refers to: the active implant device 30 is used in a special operation mode for processing binding commands, and in this mode, the active implant device can only process binding commands, so as to improve the security of the binding process. The binding command is communication interaction information for binding the designated patient control device and the designated active implant device, and specifically may be a command issued by the medical control device 10 or initiated by the patient control device 20 to perform binding-related communication interaction between the designated patient control device 20 and the designated active implant device 30.

The information of the patient control device 20 required for completing the binding is similar to the information of the active implant device 30 required for completing the binding, including: (1) a unique identification address of the patient control device 20, which address is used to distinguish between different patient control devices; (2) the current binding status of the patient control device 20, i.e. whether the patient control device 20 is currently bound or not, if the patient control device is currently bound, the previous binding needs to be released first; (3) whether the patient control device 20 successfully enters the binding mode, etc., i.e., after the medical control device 10 sets the patient control device 20 to enter the binding mode, the medical control device 10 can further obtain information whether the patient control device 20 successfully enters the binding mode, so as to set the patient control device 20 to enter the binding mode again when the patient control device 20 does not enter the binding mode. The binding mode of the patient control device 20 refers to: the patient control device 20 currently allows a mode of binding with the active implant device 30 for prompting the user to perform the binding operation. If the user does not make the binding operation, or the user cancels the binding operation, the binding process ends, otherwise, step S2 is performed.

Preferably, the active implant device 30 and/or the patient control device 20 are capable of performing at least one of the following processes upon successful entry into the binding mode: and feeding back a signal whether the medical control device 10 successfully enters the binding mode, sending a prompt of waiting for executing the binding operation and processing a binding command. The binding command is a command of communication interaction for the purpose of binding the designated patient control device and the designated active implant device, and specifically may be a command issued by the medical control device 10 or initiated by the patient control device 20 to perform binding-related communication interaction between the designated patient control device 20 and the designated active implant device 30.

Step S1 completes the pseudo-binding relationship between the patient control device 20 and the active implant device 30, i.e. in step S1, the patient control device 20 and the active implant device 30 have the ability to process commands with each other through the configuration of the patient control device 20 and the active implant device 30 by the medical control device 10, but the commands processed between the patient control device 20 and the active implant device 30 are only commands required for the binding process, thereby allowing the patient control device 20 to have only minimal communication rights to complete the binding with the active implant device 30. The minimum communication authority can ensure the communication security during the binding process and avoid the misoperation of the patient, so as to improve the safety and reliability of the use of the active implant device 30.

In step S2, the medical control device 10 controls the patient control device 20 to initiate a communication interaction procedure comprising a plurality of steps to the active implant device 30, so that the patient control device 20 establishes communication interaction with the active implant device 30, wherein when all steps in the communication interaction procedure are completed in sequence, the patient control device 20 is successfully bound with the active implant device 30, and vice versa, when any step in the communication interaction procedure is failed, the patient control device 20 is failed to bind with the active implant device 30. Wherein the communication interaction process comprises: an activation step S21 of the active implant device 30, a confirmation step S22 of the reliability of the communication between the patient control device 20 and the active implant device 30, and a step S23 of the data communication between the patient control device 20 and the active implant device 30.

The communication interaction flow in this embodiment is shown in fig. 3. Specifically, in general, the active implant device 30 needs to enter a low power consumption mode in the non-operating state, the low power consumption mode is generally divided into two power consumption reduction modes of hardware and software, which can exist separately or simultaneously, and therefore, in step S21, the process of activating the active implant device 30 is to wake up the active implant device 30 in the low power consumption mode through hardware activation and/or software wake-up to process the related binding command.

The purpose of the communication reliability confirmation in step S22 is to confirm whether the patient control device 20 and the active implant device 30 satisfy the condition for mutual communication, and whether the communication data therebetween is erroneous. In this embodiment, the step S22 includes a communication handshake process, a status query process, a parameter setting confirmation process, and a data saving process, where the communication handshake process is to enable both the patient control device 20 and the active implant device 30 to negotiate a communication mode and tell the other party that data is ready to be sent and received, and a successful handshake indicates that a communication link is established and data transmission is possible. The state query process is mainly used for the patient control device 20 or the medical control device 10 to obtain the control parameters and the operating state of the active implant device 30, the parameter setting process is to modify some parameters in the data obtained by the state query by the patient control device 20 or the medical control device 10, and rewrite the modification result into the active implant device 30, and the parameter setting confirmation process is to confirm the parameters rewritten into the active implant device 30 by the active implant device 30, the patient control device 20, or the medical control device 10, and store the set parameter data after the confirmation is successful. The data saving process means that the binding information is saved when the patient control device 20 and the active implant device 30 are bound, and when the binding between the patient control device 20 and the active implant device 30 needs to be released, the information saved in the binding process can be directly emptied, thereby simplifying the unbinding process.

The data communication process in step S23 means that the patient control device 20 and the active implant device 30 can directly perform data transmission without the control of the medical control device 10, and the process mainly relates to the actual working data of the active implant device 30, which needs to be kept secret from the outside, so that the data transmitted from the active implant device 30 to the patient control device 20 is preferably encrypted with high security level by using the related encryption algorithm (e.g. aes algorithm, hash algorithm) and verification algorithm (e.g. crc algorithm, md5 algorithm) to ensure the security and reliability of data transmission.

In the binding method of the present embodiment, a binding time limit may be set on at least one of the medical control device 10, the patient control device 20, and the active implant device 30, and a timer may be started after the patient control device 20 and/or the active implant device 30 successfully enters the corresponding binding mode, and when the result of the timer exceeds the binding time limit and the patient control device 20 and the active implant device 30 are not successfully bound, the patient control device 20 and/or the active implant device 30 automatically exits the binding mode. Preferably, the method further comprises: when the binding of the patient control device 20 and the active implant device 30 fails and/or succeeds, a prompt of the binding failure and/or the binding success is made on the medical control device 10 and/or the patient control device 20, so that a user can know the binding result in time.

According to the binding method, the medical control equipment configures the patient control equipment and the active implant equipment, so that a safe and reliable binding process is realized, illegal binding is not allowed, the patient control equipment does not have high-level control authority in the whole binding process, the operation risk of the patient controller can be reduced, and a patient can feel safer and relieved when using the patient control equipment to control the active implant equipment. Compared with the existing Medtronic system, the binding method can acquire the unique identification address information of the patient control equipment and the active implant equipment through the medical control equipment, and enables the patient control equipment and the active implant equipment to be in communication connection only at the last stage, so that the problem that the patient control equipment which just leaves a factory can be directly bound with the activated active implant equipment in the Medtronic system is solved; compared with the Boston scientific system, the binding method has the advantages that the patient control device is always in the patient control mode in the whole binding process, and the patient control device does not have high-level control authority in the whole binding process, so that the patient does not operate options to be controlled by a doctor due to misoperation when the patient controls the active implanted device through the patient control device, medical accidents are avoided, and the process that the patient controls the active implanted device through the patient control device is safer.

Embodiments of the present invention also provide a computer-readable storage medium having stored thereon a computer program, which may include code or computer-executable instructions, which when executed by a processor, implement the method of binding a patient control device and an active implant device shown in fig. 2 and any variations thereof. The computer-readable storage medium can be any medium that can contain, store, communicate, propagate, or transport the instructions. For example, the computer readable storage medium may include, but is not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. Specific examples of the computer-readable storage medium include: magnetic storage devices such as magnetic tape or hard disk (HDD, SSD); optical storage devices, such as compact disks (CD-ROMs); a memory, such as a Random Access Memory (RAM) or a flash memory; and/or wired/wireless communication links. The computer readable storage medium may be used for upgrading existing medical control devices, and even for upgrading entire implantable medical systems including medical control devices, patient control devices, and active implant devices.

In order to implement the above method, the present invention requires improvements to existing medical control devices to limit the authority of the respective patient control device and to limit the process of binding the patient control device and the active implant device. Therefore, referring to fig. 4, an embodiment of the present invention further provides a medical control device 10 for implementing the method of binding a patient control device and an active implant device of the present invention, including: a communication module 101, a pseudo binding module 102, and a true binding module 103. Wherein the communication module 101 is configured to establish communication interaction with an active implant device 30 and a patient control device 20, respectively; the pseudo-binding module 102 is configured to set the active implant device 30 and the patient control device 20 into a binding mode, respectively; the true binding module 103 is configured to control the establishment of a communication interaction between the patient control device 20 and the active implant device 30 after both the active implant device 30 and the patient control device 20 have successfully entered a binding mode, to enable binding of the patient control device 20 with the active implant device 30 when the communication interaction is established successfully.

The communication module 101 has a function of selecting a communication object, i.e., can select the active implant device 30 and the patient control device 20 that need to establish a communication interaction, and can establish a communication interaction with the selected active implant device 30 and the patient control device 20 through far-field communication or near-field communication.

The pseudo-binding module 102 is further configured to: and respectively acquiring the information required by the active implant equipment and the patient control equipment for completing the binding, and respectively setting the active implant equipment and the patient control equipment to enter a binding mode according to the information required for completing the binding. Wherein, the information of the active implant device 30 required for completing the binding includes: the unique identification address of the active implant device 30 (for distinguishing between different active implant devices), the current binding status of the active implant device 30 and whether the active implant device 30 has successfully entered the binding mode, and when the active implant device 30 has currently been bound, the previous binding of the active implant device 30 can be released by means of the medical control device 10 or directly by the patient control device 20. The binding mode of the active implant device 30 is: the active implant device 30 is used in a special operation mode for processing binding commands, and in this mode, the active implant device 30 can only process binding commands, so as to improve the security of the binding process. The information of the patient control device 20 required for completing the binding includes: a unique identification address of the patient control device 20 (for distinguishing between different patient control devices), a current binding status of the patient control device 20, and whether the patient control device 20 successfully entered the binding mode. When the patient control device is currently already bound, the previous binding of the patient control device 20 may be first released by means of the medical control device 10 or directly by the patient control device 20; the binding mode of the patient control device 20 is: the patient control device 20 currently allows a mode of binding with the active implant device 30 for prompting the user to perform the binding operation. The binding command is a communication interaction command for binding the designated patient control device and the designated active implant device, and specifically may be a command issued by the pseudo-binding module 102 or initiated by the patient control device 20 to perform a binding-related communication interaction between the designated patient control device 20 and the designated active implant device 30.

In this embodiment, the communication module 101 is configured to establish a communication connection with the active implant device 30 first (as indicated by "1" between the communication module 101 and the active implant device 30 in fig. 4) and then with the patient control device 20 (as indicated by "2" between the communication module 101 and the patient control device 20 in fig. 4), such that the pseudo-binding module 102 is configured to: acquiring information of the active implant device 30 required for completing the binding and bringing the active implant device 30 into a binding mode, acquiring information of the patient control device 20 required for completing the binding, and adaptively configuring part or all of the information of the active implant device 30 including the unique identification address required for completing the binding into the patient control device 20 so as to bring the patient control device 20 into the binding mode. Thereby, a time-sharing communication between the medical control device 10 and the active implant device 30 and the patient control device 20 can be achieved, which in turn enables the patient control device 20 and the active implant device 30 to communicate with each other and be bound together (as indicated by "3" between the patient control device 20 and the active implant device 30 in fig. 4). In other embodiments of the present invention, the communication module 101 may also establish a communication connection with the patient control device 20 first, and then establish a communication connection with the active implant device 30, so that the pseudo-binding module 102 controls the patient control device 20 to enter the binding mode first, and controls the active implant device 30 to enter the binding mode; the communication module 101 may also establish communication connections with both the patient control device 20 and the active implant device 30 such that the pseudo-binding module 102 simultaneously controls both the patient control device 20 and the active implant device 30 to enter a binding mode. In both cases, the user may input in advance the information required for binding, including the unique identification address, of the designated active implantable device 10 and the designated patient control device 20 on the pseudo-binding module 102, and after the medical control device 10 establishes a communication connection with the patient control device 20 and the active implantable device 30, the information obtained from the patient control device 20 and the active implantable device 30 may be used for comparison with the information input in advance by the user to verify the validity of the connected patient control device 20 and the active implantable device 30.

The pseudo-binding module 102 is capable of establishing a pseudo-binding relationship between the patient control device 20 and the active implant device 30, that is, the pseudo-binding module 102 configures the patient control device 20 and the active implant device 30 (the configuration command and the data such as the configuration parameters are transmitted through the communication module 101), so that the patient control device 20 and the active implant device 30 have the capability of mutually processing commands, but the commands processed between the patient control device 20 and the active implant device 30 are only commands required by the binding process, so that the patient control device 20 has only minimum communication rights to complete the binding with the active implant device 30. The minimum communication authority can secure the communication of the binding process to improve the security and reliability of the patient control device 20 and the active implant device 30.

The true binding module 103 is further configured to: presetting a communication interaction flow comprising a plurality of steps, and after the patient control device 20 and the active implant device 30 both enter the corresponding binding mode, controlling the patient control device 20 to initiate the communication interaction flow to the active implant device 30 so as to establish communication interaction between the patient control device 20 and the active implant device 30, wherein when all steps in the communication interaction flow are sequentially completed, the patient control device 20 and the active implant device 30 are successfully bound, and vice versa, when any step in the communication interaction flow fails to be executed, the patient control device 20 and the active implant device 30 are failed to be bound. In this embodiment, as shown in fig. 3, the communication interaction flow includes: an activation step S21 of the active implant device, a confirmation step S22 of the reliability of the communication between the patient control device and the active implant device, and a step S23 of the data communication between the patient control device and the active implant device. The specific process of the communication interaction flow may refer to the corresponding content in the above binding method, which is not described herein again. In other embodiments of the present invention, the medical control device 10 may not include the true binding module 103, and the patient control device 20 initiates a communication interaction procedure with the active implant device 30 and binds with the active implant device 30.

In an embodiment of the present invention, the medical control apparatus 10 further includes a login module (not shown) configured to: login information of a user (i.e., a doctor) is received and verified to enable the user to log in the medical control device 10, thereby performing binding of the patient control device 20 and the active implant device 30 through the medical control device 10. The login information may be an account and a password input by the user, or may be acquired information including at least one of an iris, a fingerprint, a face, a gesture, and a voice of the user.

In an embodiment of the present invention, the medical control device 10 further comprises a recovery module (not shown) configured to: setting a binding time limit and starting timing after said patient control device 20 and/or said active implant device 30 enters said respective binding mode, and controlling said patient control device 20 and/or said active implant device 30 to automatically exit said binding mode when the result of said timing exceeds said binding time limit and said patient control device 20 and said active implant device 30 are not bound successfully. In another embodiment of the present invention, the medical control device 10 may omit the recovery module, and in this case, the patient control device 20 and the active implant device 30 have their own functions of automatically exiting the binding mode, that is, a binding time limit is set on each of the patient control device 20 and the active implant device 30, and a timer is started after entering the corresponding binding mode, and when the timer exceeds the binding time limit and the patient control device 20 and the active implant device 30 are not bound successfully, the patient control device 20 and the active implant device 30 can automatically exit their respective binding modes.

In an embodiment of the present invention, the medical control device 10 further includes a prompt module (not shown) configured to: when the binding of the patient control device 20 and the active implant device 30 fails and/or is successful, a prompt of the binding failure and/or the binding success is made on the medical control device 10, so that a user can know the binding result, and the user can also bind the patient control device 20 and the active implant device 30 through the medical control device 10 or the patient control device 20 again.

In an embodiment of the present invention, the medical control apparatus 10 may be a new generation of conventional medical control apparatus, which generally integrates functional modules such as a medical examination module for examining the body of a patient, a controller for controlling and adjusting an active implant apparatus according to the examination result of the medical examination module, and a display screen for displaying various examination results and adjustment results, thereby realizing the production of the new generation of conventional medical control apparatus. In other embodiments of the present invention, the medical control apparatus 10 is only a functional device having a binding function between a patient control apparatus and an active implant apparatus, and it can be used as an auxiliary device of the conventional medical control apparatus, for example, the medical control apparatus 10 of the present invention can be used as a functional module, and can be embedded in a conventional medical control apparatus, which has a medical examination module for detecting the body of a patient, a controller for controlling and adjusting the active implant apparatus according to the examination result of the medical examination module, and a display screen for displaying various examination results and adjustment results integrated therein, or can be used as a stand-alone apparatus, which is independent of a conventional medical control apparatus, and can be communicatively connected with the conventional medical control apparatus by wireless, interface, or wire, hereby, it may be achieved that an existing conventional medical control device binds the patient control device and the active implant device according to the binding method of the invention.

It is understood that the communication module 101, the pseudo binding module 102, the true binding module 103, the login module, the prompt module, and the recovery module of the medical control device 10 of the present invention may be combined and implemented in one module, or any one of them may be divided into a plurality of sub-modules, or at least part of the functions of one or more of these modules may be combined with at least part of the functions of the other modules and implemented in one module. According to an embodiment of the present invention, at least one of the communication module 101, the pseudo-binding module 102, the true binding module 103, the login module, the prompt module, and the recovery module may be implemented at least partially as a hardware circuit, such as a Field Programmable Gate Array (FPGA), a Programmable Logic Array (PLA), a system on a chip, a system on a substrate, a system on a package, an Application Specific Integrated Circuit (ASIC), or any other reasonable manner of integrating or packaging a circuit, as hardware or firmware, or as a suitable combination of three implementations of software, hardware, and firmware. Alternatively, at least one of the communication module 101, the pseudo binding module 102, the true binding module 103, the login module, the prompt module, and the recovery module may be at least partially implemented as a computer program module that, when executed by a computer, may perform the functions of the respective modules.

Referring to fig. 4, the present invention further provides an implantable medical system, including a medical control device 10, at least one patient control device 20, and at least one active implant device 30 according to an embodiment of the present invention, where the medical control device 10 is configured to enable a designated patient control device 20 and a designated active implant device 30 to enter a binding mode to complete mutual binding. The implantable medical system can be an implantable nerve electrical stimulation system (including deep brain electrical stimulation (DBS), implantable cerebral cortex stimulation (CNS), implantable spinal cord electrical stimulation (SCS), implantable sacral nerve electrical stimulation (SNS), implantable vagus nerve electrical stimulation (VNS) and the like), an implantable heart electrical stimulation system (commonly called a cardiac pacemaker), an implantable drug infusion system (IDDS) and the like. Wherein the active implant device 30 and/or the patient control device 10 are configured to: upon successful entry into the binding mode, at least one of the following processes can be performed: a signal to feedback the success or failure to enter a binding mode, a prompt to wait for a binding command to be executed, and a process binding command, which is a communication interaction aimed at binding the active implant device 30 and the patient control device 20 together.

In this embodiment, when the medical control device 10 has a prompting function for prompting a user (including a doctor or a patient) whether the binding is successful or not, that is, when the medical control device 10 includes a prompting module (not shown), when the binding of the patient control device 20 and the active implant device 30 fails and/or is successful, the prompting module can prompt the medical control device 10 that the binding fails and/or is successful, so that the user knows whether the specified active implant device 30 and the specified patient control device 20 are successfully or not. When the medical control device 10 does not have the above-mentioned prompting function, the patient control device 20 may be made to have the above-mentioned prompting function, that is, when the binding of the patient control device 20 with the active implant device 30 fails and/or is successful, a prompt of the binding failure and/or the binding success may be made on the patient control device 20, so that the user knows whether the binding of the specified active implant device 30 and the specified patient control device 20 is successful or not.

In this embodiment, when the medical control device 10 has a recovery function capable of causing the patient control device 20 and the active implant device 30 to exit the binding mode when the patient control device 20 and the active implant device 30 are not bound successfully, the patient control device 20 and the active implant device 30 can exit their respective binding modes according to the control of the medical control device 10, i.e. the medical control device 10 has a recovery module (not shown) configured to: a binding time limit is set and a timing is started after the patient control device 20 and/or the active implant device 30 enters the respective binding mode, and the patient control device 20 and/or the active implant device 30 is caused to exit the binding mode when the timing exceeds the binding time limit and the binding of the patient control device 20 and the active implant device 30 is not successful. When the medical control apparatus 10 does not have the above-described recovery function, the patient control apparatus 20 and the active implant apparatus 30 may be made to have the recovery function by themselves, and specifically, the patient control apparatus 20 and the active implant apparatus 30 are configured to: a binding time limit is set and a timing is started after entering the respective binding mode and the binding mode is automatically exited when the timing exceeds the binding time limit and the patient control device 20 and the active implant device 30 are not bound successfully.

In an embodiment of the present invention, when the medical control device 10 includes the true binding module 103, after both the active implant device 30 and the patient control device 20 successfully enter the binding mode, the true binding module 103 can control the patient control device 20 and the active implant device 30 to establish a communication interaction to achieve the binding of the patient control device 20 and the active implant device 30. Initiating, by the patient control device 20, a communication interaction procedure with the active implant device 30 and binding with the active implant device 30 when the medical control device 10 does not contain the true binding module 103.

In an embodiment of the present invention, the medical control device 10 may be a new generation of conventional medical control device, which generally integrates functional modules such as a medical examination module for detecting the body of a patient, a controller for controlling and adjusting an active implant device according to the examination result of the medical examination module, and a display screen for displaying various examination results and adjustment results, and can be used for not only binding the patient control device and the active implant device, but also medical examination, adjustment of the active implant device, and the like. In other embodiments of the present invention, the medical control device 10 is used as an auxiliary device of an existing conventional medical control device, and is only used for binding the patient control device 20 and the active implant device 30, that is, in this case, the implantable medical system further includes a conventional medical control device, and functional modules such as a medical examination module for detecting the body of the patient, a controller for controlling and adjusting the active implant device according to the examination result of the medical examination module, and a display screen for displaying various examination results and adjustment results are integrated in the conventional medical control device, and the medical control device 10 of the present invention as a functional module can be embedded in a conventional medical control device, or as an independent device, independent of a conventional medical control device, and can be wirelessly connected with the conventional medical control device, The interface mode or the wire mode and the like are in communication connection, so that the existing conventional medical control equipment can be bound with the patient control equipment and the active implant equipment according to the binding method of the invention.

Taking an implantable electrical nerve stimulation system (i.e., an implantable medical system) as an example, the active implantation device 30 includes a pulse generator implanted in the patient, an electrode, a lead and the like, the lead is connected to the electrode so as to transmit the pulse generated by the pulse generator to the electrode, and the pulse signal generated by the pulse generator is transmitted from the electrode to a specific nerve target point for electrical stimulation, so that the function of the human body is restored to a normal operation state. Conventional medical control devices are devices used by physicians to monitor and adjust the output parameters of their pulse generators in their bodies according to patient conditions, and generally one conventional medical control device can be used to control a plurality of pulse generators. The patient control device 20 can communicate with the pulse generator by means of a wireless communication mode, magnetic coils or other communication means, the patient control device 20 being a device provided for the patient to control switches or adjust the output parameters of the in-vivo pulse generator according to his own situation, the patient being normally only able to adjust himself within the adjustment range set by the physician via the medical control device 10. The medical control device 10 of the present invention may be the conventional medical control device or may be a means for merely assisting the conventional medical control device in binding the corresponding patient control device 20 and active implant device 30.

The medical control equipment and the implanted medical system can enable the patient control equipment and the active implanted equipment to be uniquely bound under the control of a doctor, avoid the problem that the patient control equipment is bound with other activated active implanted equipment and the problem that the patient control equipment triggers a doctor control mode by mistake, have safe and reliable binding process and improve the use safety of the active implanted equipment.

It will be apparent to those skilled in the art that various changes and modifications may be made in the invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims

1. A method of binding a patient control device with an active implant device, comprising:

2. The method of claim 1, wherein the step of the medical control device setting the active implant device and the patient control device into a binding mode, respectively, comprises:

3. The method of claim 2, wherein the information of the active implant device needed to complete the binding further includes a current binding state of the active implant device; the information of the patient control device required for completing the binding further comprises a current binding state of the patient control device; and when the active implant device and/or the patient control device are currently bound, the medical control device unbinds the active implant device and/or the patient control device before setting the active implant device and the patient control device to enter a binding mode, respectively.

4. The method of claim 2, wherein the medical control device first obtains the information of the active implant device required for binding completion, then obtains the information of the patient control device required for binding completion, and adaptively configures part or all of the information of the active implant device including the unique identification address required for binding completion into the patient control device.

5. The method of claim 1, further comprising: after the medical control equipment respectively sets the active implantation equipment and the patient control equipment to enter the binding mode, the medical control equipment respectively acquires information whether the active implantation equipment and the patient control equipment successfully enter the binding mode.

6. The method of claim 1, wherein the active implant device and/or the patient control device performs at least one of the following processes upon successfully entering a binding mode: and feeding back a signal of successfully entering a binding mode to the medical control equipment, sending a prompt of waiting for executing a binding command and processing the binding command, wherein the binding command is communication interaction aiming at binding the active implant equipment and the patient control equipment together.

7. The method of claim 1, further comprising: setting a binding time limit on at least one of the medical control device, the patient control device and the active implant device, starting timing after the patient control device and/or the active implant device enters the corresponding binding mode, and when the result of timing exceeds the binding time limit and the binding of the patient control device and the active implant device is not successful, the patient control device and/or the active implant device automatically exits the binding mode.

8. The method of claim 1, further comprising: when the binding of the patient control device and the active implant device fails and/or succeeds, a prompt of the binding failure and/or the binding success is made on the medical control device and/or the patient control device.

9. The method according to any one of claims 1 to 8, wherein the patient control device initiates a communication interaction procedure comprising a plurality of steps to the active implant device, or the medical control device controls the patient control device to initiate a communication interaction procedure comprising a plurality of steps to the active implant device, so that the communication interaction between the patient control device and the active implant device is established, wherein the binding of the patient control device to the active implant device is successful when all steps in the communication interaction procedure are completed in sequence, and vice versa, the binding of the patient control device to the active implant device is failed when any one step in the communication interaction procedure is failed.

10. The method of claim 9, wherein the communication interaction flow comprises: an activation step of the active implant device, a confirmation step of the reliability of the communication between the patient control device and the active implant device, and a step of data communication between the patient control device and the active implant device.

11. The method of claim 10, wherein the step of activating the active implant device comprises hardware activation and/or software wakeup; the step of confirming the reliability of the communication between the patient control device and the active implant device comprises a communication handshake process, a status inquiry process, a parameter setting confirmation process, and a data saving process.

12. The method of claim 10, wherein the step of communicating data between the patient control device and the active implant device includes encrypting and verifying data via an encryption algorithm and a verification algorithm.

13. A computer-readable storage medium having stored thereon a computer program, characterized in that: the computer program, when executed by a processor, implements a method of binding a patient control device to an active implant device according to any one of claims 1 to 12.

14. A medical control device, comprising:

15. The medical control device according to claim 14, further comprising:

16. The medical control device of claim 14 or 15, wherein the pseudo-binding module is further configured to: respectively acquiring information required by the active implant equipment and the patient control equipment for completing binding, and respectively setting the active implant equipment and the patient control equipment to enter a binding mode according to the information required by the active implant equipment and the patient control equipment for completing binding; and the information of the active implant device required for completing the binding comprises a unique identification address of the active implant device; the information of the patient control device required for completing the binding comprises a unique identification address of the patient control device.

17. The medical control device of claim 16, wherein the information of the active implant device needed to complete the binding further includes a current binding state of the active implant device; the information of the patient control device required for completing the binding further comprises a current binding state of the patient control device; the pseudo-binding module is further configured to: unbinding the active implant device and/or the patient control device and setting the active implant device and the patient control device, respectively, to enter a bind mode when the active implant device and/or the patient control device is currently bound.

18. The medical control device of claim 15, wherein the pseudo-binding module is further configured to: the information of the active implant device required for completing the binding is acquired first, then the information of the patient control device required for completing the binding is acquired, and part or all of the information of the active implant device including the unique identification address required for completing the binding is adaptively configured into the patient control device.

19. The medical control device according to claim 14 or 15, further comprising: a recovery module configured to: setting a binding time limit, starting timing after the patient control device and/or the active implant device enters the corresponding binding mode, and enabling the patient control device and/or the active implant device to exit the binding mode when the timing exceeds the binding time limit and the patient control device and the active implant device are not successfully bound.

20. The medical control device of claim 14 or 15, further comprising a prompting module configured to: when the binding of the patient control equipment and the active implant equipment fails and/or is successful, prompting the binding failure and/or the binding success on the medical control equipment; and/or a login module configured to: and receiving and verifying login information of a user so that the user logs in the medical control equipment, and further binding the patient control equipment and the active implant equipment through the medical control equipment.

21. The medical control device of claim 15, wherein the true binding module is further configured to: presetting a communication interaction flow comprising a plurality of steps, and after the patient control device and the active implant device both enter the corresponding binding mode, controlling the patient control device to initiate the communication interaction flow to the active implant device so as to establish communication interaction between the patient control device and the active implant device, wherein when all steps in the communication interaction flow are completed in sequence, the patient control device and the active implant device are successfully bound, otherwise, when any step in the communication interaction flow fails to be executed, the patient control device and the active implant device are failed to be bound.

22. The medical control device of claim 21, wherein the communication interaction procedure comprises: an activation step of the active implant device, a confirmation step of the reliability of the communication between the patient control device and the active implant device, and a step of data communication between the patient control device and the active implant device.

23. The medical control device according to claim 22, wherein the active implant device activation step comprises hardware activation and/or software wake-up; the step of confirming the reliability of the communication between the patient control device and the active implant device comprises a communication handshake process, a status inquiry process, a parameter setting confirmation process, and a data saving process.

24. The medical control device of claim 22, wherein the step of communicating data between the patient control device and the active implant device includes encrypting and verifying data via an encryption algorithm and a verification algorithm.

25. The medical control device of claim 14, further having a display screen and a controller for directly controlling and adjusting the active implant device.

26. An implantable medical system comprising a medical control device according to any one of claims 14 to 25, at least one patient control device and at least one active implant device, the medical control device being configured to bring the patient control device and the respective active implant device into a binding mode to accomplish mutual binding.

27. The implantable medical system of claim 26, wherein the active implant device and/or the patient control device is configured to: upon successful entry into the binding mode, at least one of the following processes can be performed: feedback of success or failure to enter a bind mode, issue a prompt to wait for execution of a bind command, and process a bind command, the bind command being a communication interaction aimed at binding the active implant device and the patient control device together.

28. The implantable medical system of claim 26, wherein the patient control device and/or the active implant device is configured to: setting a binding time limit, starting timing after entering the corresponding binding mode, and automatically exiting the binding mode when the timing exceeds the binding time limit and the patient control device and the active implant device are not successfully bound.