Implantable cardiac monitor

Abstract

The present invention discloses an implantable cardiac monitor, which includes a housing composed of a first metal member, a second metal member, and a signal window member disposed between the first metal member and the second metal member; a circuit component is disposed in the housing, and an antenna for wireless communication is disposed at a position corresponding to the signal window member. The above solution simplifies the antenna structure and reduces the length of the implantable cardiac detector.

Description

Technical Field

[0001] The present invention belongs to the field of implantable medical devices, and particularly relates to an improvement in the structure of implantable medical devices. Background Art

[0002] An implant cardiac monitor (ICM for short) has an elongated main body metal housing structure. Sensing electrodes are respectively provided at both ends thereof, and the sensing electrodes are connected to a hybrid circuit inside the ICM. The hybrid circuit includes a sensing unit, an execution unit, etc. for analyzing the electrocardiogram signal of a patient and diagnosing whether a cardiac event occurs.

[0003] The implant cardiac monitor is connected to a programmer outside the human body or a handheld device through a wireless communication signal. The programmer can display the human body data detected by the implantable medical device, the diagnosis made, the cardiac events that have occurred, etc. And the programmer can set the parameters of the implant cardiac monitor, control logic, etc. through wireless communication.

[0004] Since the main housing of the implant cardiac monitor is made of a metal material (such as stainless steel or titanium, etc.), in order to prevent the wireless signal from being shielded and weakened by the metal housing, the antenna for communication must be provided outside the housing, and a material that allows electromagnetic signals to pass through freely is used to cover the communication antenna.

[0005] For example, the patent with the publication number CN104768611B discloses an ICM head end. The head end is provided at one end of the ICM and connected to the metal housing. An antenna and a sensing electrode are provided inside the head end and embedded in the head end material by injection molding. The head end is then assembled with the housing through an attachment plate to form a complete ICM structure. The head end plays a role in transmitting and receiving communication signals on the one hand, and plays a role in sensing the electrocardiogram signal through the sensing electrode on the other hand.

[0006] Generally, this antenna structure provided at one end has the following several problems: 1. In order for the antenna to receive signals, the antenna must extend outside the titanium shell, so that the overall structure of the ICM is lengthened due to the antenna. 2. In the head end, there are a sensing electrode and an antenna, etc., and there is a possibility that the antenna communication signal interferes with the sensing electrode signal. 3. The antenna component, the sensing electrode, etc. need to be supplied and fixed in the head end more complicatedly. Summary of the Invention

[0007] The present invention provides an implant cardiac monitor, and a signal window for passing antenna signals is provided at the middle position of the cardiac monitor, and an antenna is built in the signal window component.

[0008] The implant cardiac monitor is characterized by comprising:

[0009] A housing composed of a first metal component, a second metal component, and a signal window component disposed between the first metal component and the second metal component;

[0010] A circuit component is disposed in the housing, and an antenna for wireless communication is disposed at a position corresponding to the signal window component.

[0011] In a preferred embodiment, the signal window component includes a first connection end and a second connection end respectively connected to the first metal component and the second metal component, and the first connection end and the second connection end are inserted into the inner cavities of the first metal component and the second metal component.

[0012] In a preferred embodiment, the signal window component has a hollow structure, the circuit component passes through the hollow inner cavity, and both ends of the circuit component not received in the hollow structure of the signal window are received in the first metal component and the second metal component.

[0013] In a preferred embodiment, the circuit component includes a contact component electrically connected to the first metal component and the second metal component, and the contact component is connected to a sensing module in the circuit component.

[0014] In a preferred embodiment, both ends of the surfaces of the first metal component and the second metal component are sensing electrodes, and the regions other than the sensing electrodes of the first metal component and the second metal component are insulating regions.

[0015] In a preferred embodiment, an insulating layer covers the surface of the insulating region.

[0016] In a preferred embodiment, as described in the claims, the signal window is made of a material through which electromagnetic signals can pass.

[0017] In a preferred embodiment, the signal window is made of a material through which optical signals can pass.

[0018] In a preferred embodiment, the circuit component includes an optical sensor, and the optical sensor is connected to an optical detection module of the circuit component.

[0019] In a preferred embodiment, the materials composing the signal window component include: quartz, glass, sapphire, diamond, silicon carbide, polyurethane, silicone rubber, polyvinyl chloride, polyethylene, polypropylene, silicone rubber, polylactic acid, bioglass ceramics, hydroxyapatite ceramics, carbon, alumina, zirconia, β-tricalcium phosphate.

[0020] The present invention provides an implantable cardiac monitor, which includes a separated first metal housing and a second metal housing, as well as a signal window component connecting the first metal housing and the second metal housing. The signal window component is arranged above the circuit board of the ICM and coincides with the circuit board in the length direction, so that the overall length of the cardiac monitor can be saved. On the other hand, sensing electrodes are respectively arranged at both ends of the first metal housing and the second metal housing, and the sensing electrodes are far away from the antenna, so the interference of the antenna signal to the sensing electrodes is small. The antenna can be formed on the circuit board during the manufacture of the circuit board, and is assembled together after the circuit, the signal window component, the first metal housing and the second metal housing are manufactured, so as to simplify the manufacturing process and avoid different materials from participating in the injection molding process. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Schematic diagram of the implantation of the implantable cardiac monitor.

[0022] Figure 2 Schematic diagram of the overall structure of the implantable cardiac monitor.

[0023] Figure 3 Schematic diagram of the perspective structure of the implantable cardiac monitor.

[0024] Figure 4 Schematic diagram of the exploded structure of the implantable cardiac monitor.

[0025] Figure 5 Schematic diagram of the circuit module structure of the implantable cardiac monitor. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0026] Referring to Figure 1 the implantable cardiac monitor 100 shown, which is implanted in the human body 101. The cardiac monitor 100 is configured to have an outer shape suitable for subcutaneous implantation in the human body 101. It can be used to monitor one or more physiological parameters of a patient. For example, it can be used to sense and store the electrocardiogram signal of the human body, and can detect arrhythmia events according to the electrocardiogram signal, such as abnormal heart rhythm events such as ventricular tachycardia, ventricular fibrillation, atrial tachycardia, and atrial fibrillation.

[0027] In the implantable cardiac monitor, there are electrodes for sensing electrocardiogram signals, and circuit components electrically connected to the electrodes. The electrodes are arranged at both ends of the housing of the ICM 100. At the same time, it may also include a photoelectric sensor and a biochemical signal sensor to obtain the blood oxygen, blood sugar and other physiological parameter markers of the patient.

[0028] In Figure 1 the cardiac monitor 100 is implanted in the left chest area of the patient and close to the heart, so that the implantable cardiac monitor 100 can sense the electrocardiogram signal. Obviously, the implantation position of the cardiac monitor can be adjusted according to the specific situation of the patient.

[0029] It also includes an external device 102 that communicates with the implantable cardiac monitor. The external device 102 includes a handheld computer device, a programming device for use by doctors, technicians, and patients. The programmer can be used to manage patient information and can also receive the electrocardiogram signal data detected by the implantable cardiac monitor 100. The programmer includes interfaces for interacting with the user. These interfaces include interfaces for setting parameters. The programmer includes a display, and a graphical user interface for interacting with the user can be displayed on the display. Figure 1

[0030] The programmer and the cardiac monitor can communicate through any wireless communication scheme, including RF radio frequency communication, NFC near field radio frequency communication, ultrasonic communication, Bluetooth communication, etc.

[0031] Referring to Figure 2 and Figure 3 , the housing of the implantable cardiac monitor is composed of three main parts, namely a first metal member 202, a second metal member 204, and a signal window member 206 that connects the first metal member 202 and the second metal member 204. In Figure 2 , the first metal member 202 and the second metal member 204 are of the same size and are symmetric about the signal window member 206. In some embodiments, the sizes of the metal members 202 and 206 can be different. The ends 208 and 210 of the first metal member 202 and the second metal member 206 are arc-shaped structures, which can reduce the discomfort after being implanted into the patient's body. The first metal member 202 and the second metal member 204 include hollow cavities 302 and 304, and the signal window 206 member is connected to the first metal member 202 and the second metal member 204 through the openings of these cavities.

[0032] Referring to Figure 4, a circuit component 400 is disposed inside the housing, and an antenna 402 for wireless communication is disposed at a position corresponding to the signal window member 206. The circuit component 400 includes a substrate 404 and circuit devices disposed on the substrate 404. On the substrate, there are a first circuit module 406, a second circuit module 408, and a power module 410 disposed on the substrate 404 opposite to the first circuit module 406 and the second circuit module 408. The first circuit module 406 and the second circuit module 408 include one or more functional circuits, and these functional circuits include: a sensing module 502 for sensing an electrocardiogram signal, a wireless communication module 512, a power management module 506 for controlling power charging and discharging, a photochemical detection module 508 for performing photochemical signal detection, and an execution unit 510 for executing analysis detection and controlling the operation logic of the implanted electrocardiogram monitor. The first functional circuit module 406 and the second functional circuit module 408 may also not be the two-piece structure shown in the figure. They may be set as an integral single-piece structure or more piece structures.

[0033] An antenna 402 for wireless communication is disposed on the substrate between the first circuit module 406 and the second circuit module 408. The wireless communication antenna 402 is directly formed on the substrate 404. One end of the wireless communication antenna 402 is electrically connected to the first circuit module 406 or the second circuit module 408 such that the wireless communication module 402 is connected to the antenna 402 for transmitting and receiving communication signals. Figure 4 The antenna described above is a planar structure disposed on the circuit board. Those skilled in the art can also use a three-dimensional antenna structure such as the three-dimensional antenna structure shown in the patent with the patent application number CN104768611B. The antenna is fixed on the circuit board by fixing methods such as welding and is electrically connected to the first functional circuit module 406 or the second functional circuit module 408. Relatively speaking, the three-dimensional structure antenna formed in space can receive communication signals from all directions and has better signal reception ability. The position of the antenna on the substrate 404 corresponds to the position of the signal window member 206, that is, the antenna is housed inside the signal window member 206 such that the antenna signal can pass through the signal window and be received by the antenna.

[0034] Compared with the prior art, the antenna 402 is housed in the substrate 404 in the length direction, and there is no need to extend the antenna outside the substrate 404, which can reduce the length of the substrate 404. At the same time, directly printing or soldering the antenna on the substrate 404 also avoids the complex process of antenna injection molding. The antenna 404 can be manufactured together with the circuit board 404, and then the circuit board 404 is assembled with the housing, thereby optimizing the manufacturing process and simplifying the manufacturing process of the antenna.

[0035] The signal window member 206 is supported by a light-transmitting material, and the signal window 206 is made of a material that allows electromagnetic signals to pass through. These materials include, but are not limited to, glass, quartz, silicon dioxide, sapphire, silicon carbide, and diamond.

[0036] In a preferred embodiment, a photochemical sensor 420 is further provided on the substrate between the first circuit module 202 and the second circuit module 204. The photochemical sensor 420 includes a first optical signal emitting device 412, a second optical signal emitting device 416, and an optical signal receiving element. The photochemical sensor 420 emits a specific optical signal and senses the biochemical components through the optical signal analysis by the receiving element 414. The optical signal emitting device preferably includes an infrared LED, and the optical signal receiving sensor is preferably a CMOS semiconductor infrared sensor. The photochemical sensor 420 can detect various types of data. For example, blood glucose data, blood oxygen data, etc. can be detected by the photochemical sensor 420. Taking blood oxygen data as an example, the photochemical sensor 420 uses the optical signal emitting devices 412 and 416 to emit red light with a wavelength of 660 nm and near-infrared light with a wavelength of 940 nm as the incident light source and determines the blood oxygen concentration based on the light absorption rate of blood for different spectral lights.

[0037] Refer to Figure 3 and Figure 4 The photochemical sensor 420 is located inside the signal window member 206. The optical signal generated by the photochemical sensor 420 can pass through the signal window member 206, and the optical signal reflected by the human tissue can enter the optical signal sensor through the signal window member 206. In a preferred embodiment, an optical filter film can be formed on the surface of the optical member to reduce environmental light interference.

[0038] In a preferred embodiment, the signal window member 296 includes a first connection end 422 and a second connection end 424 that are respectively connected to the first metal member 202 and the second metal member 204. The first connection end 422 and the second connection end 424 are inserted into the inner cavities 302 of the first metal member 202 and the second metal member 204. The size of the window portion in the middle of the signal window member 206 is larger than that of the first connection end 422 and the second connection end 424 on both sides thereof. The connection ends of the middle portion of the window member with the first connection end 422 and the second connection end 424 form a stepped structure 426. This stepped structure 426 enables the surface 206 of the signal window member to be in the same plane as the surfaces of the first metal member 202 and the second metal member 204 after the signal window member 206 is connected to the first metal member 202 and the second metal member 204.

[0039] Continue to refer to Figure 3, the signal window member 206 is a hollow structure, the circuit assembly 400 passes through the hollow inner cavity 302, and the antenna 402 and the optochemical sensor 420 on the circuit assembly 400 are arranged inside the signal window 206 so that the wireless communication signal and the optical signal in the signal window 206 can pass through the housing of the implantable electrocardiogram monitor 100. Both ends of the other part of the circuit assembly 100, that is, the part of the circuit not received by the signal window member 206, are received in the first metal member 202 and the second metal member 204. The first metal member 202 and the second metal member 204 are fixed to the circuit assembly 400 by common methods, and these fixing methods include but are not limited to fixing with fasteners, fixing with biocompatible glue, and any fixing techniques known to those skilled in the art such as snap connection, magnetic adsorption, welding, interference fit, etc.

[0040] Referring to Figure 2 and Figure 3 , the first metal member 202 and the second metal member 204 are hollow housing structures. The first metal member 202 is supported by any metal material suitable for implantation into the human body. The metal materials preferably include: stainless steel, titanium, cobalt, and titanium alloys, cobalt-based alloys, etc.

[0041] The first metal member 202 and the second metal member 204 play two roles. On the one hand, they serve as the housing of the implantable cardiac monitor 100 to protect the internal circuit assembly. On the other hand, the outer shells of the first metal member 202 and the second metal member 204 serve as sensing electrodes of the implantable cardiac monitor, and are connected to the sensing module in the circuit assembly to directly obtain electrocardiogram signals from human tissues.

[0042] To electrically connect the first metal member 202 and the second metal member 204 to the circuit assembly 400. The interiors of the first metal member 202 and the second metal member 204 are electrically connected to the circuit assembly 400. On the substrate of the circuit assembly 400, a first contact member 428 and a second contact member 430 for the first metal member 202 and the second metal member 204 are provided. These two contact members are arranged at both ends of the substrate 404 of the circuit assembly. The contact members are elastic and are respectively connected to the inner ends of the first metal member 202 and the second metal member 204. The first metal member 202 and the second metal member 204 are electrically connected to the contact members. The first contact member 428 and the second contact member 430 are in the sensing module of the circuit assembly, so that the first metal member 202 and the second metal member 204 form the sensing electrodes in the sensing module.

[0043] The two end portions 432 (or label 434) of the outer surfaces of the first metal member 202 and the second metal member 204 serve as contacts that directly contact human tissue. The regions 434 other than the two ends of the first metal member 202 and the second metal member 204 are subjected to insulation treatment, including Figure 4 the four main surfaces of the first metal member 202 and the second metal member 204 shown in Figure 4 The purpose of this is to provide a sufficient distance between the electrodes (labels 432 and 434) of the first metal member 202 and the second metal member 204 to obtain an electrocardiogram signal with sufficient strength. The insulation treatment includes forming an insulating coating ( Figure 4 dot-shaped filling part) on the surfaces of the first metal member 202 and the second metal member 204 to ensure non-conductivity between the first metal member 202 and the second metal member 204; a metal oxide layer (

[0044] dot-shaped filling part) can also be formed on the surfaces of the first metal member 202 and the second metal member 204, and the metal oxide layer serves as an insulating medium for the first metal member and the second metal member.

[0044] The insulating layer enables the two end portions of the implantable heart detector to serve as detection points for electrocardiogram signals. Without the insulating layer, the first metal member and the second metal member detect signals as a whole, resulting in an insufficient distance between the two electrocardiogram detection points and making it difficult to detect signals. Therefore, as Figure 4 shown, when the lengths occupied by the first metal member and the second metal member are more than half of the implantable heart detector and the first metal member and the metal member serve as detection electrodes, an insulating layer is formed on the surfaces of the first metal member and the second metal member, and this insulating layer functions to increase the distance between the detection electrodes.

[0045] At the same time, the use of the insulating layer makes it possible to fabricate most of the housing of the implantable heart detector using metal materials with high biocompatibility such as titanium and titanium alloys.

[0046] Referring to Figure 5 The circuit assembly 400 of the implantable heart monitor includes multiple functional modules, which include a sensing module 502, a photochemical sensor 514, an execution unit 510, a communication module 512, a power management module 506, and a storage module 516. The sensing module is connected to the electrodes at both ends of the ICM. The sensing module 502 is used to sense electrocardiogram signals and convert the electrocardiogram signals into digital signals that the execution unit 510 can process.

[0047] The electrocardiogram (ECG) signal sensing module 502 includes a signal input channel connected to the electrode 428 or 430. The ECG signal sensing module 502 further includes an amplification module, a filtering module, and an analog-to-digital conversion module ADC for processing signals. The ECG signal is finally converted into a digital signal that can be processed by the execution unit 510. This digital ECG signal serves as the basis for the execution unit 510 to process ECG data; the optochemical sensor.

[0048] The optochemical detection module 508 is used to convert the optical signal of the optochemical sensor 420 into a digital signal that can be processed by the execution unit. The optochemical detection module 508 includes an amplification module, a filtering module, and an analog-to-digital conversion module ADC.

[0049] The communication module 512 is connected to the execution unit 510. The execution unit 510 sends or receives data through this communication module. The communication module establishes a communication link with the programmer through wireless communication. This communication link is used to transmit the initialization parameters of the communication module during the implantation stage, or set parameters during user follow-up, or communicate with the patient's handheld device to issue timely reminders or warnings to the patient. The communication module preferably establishes a communication link through wireless communication methods such as WIFI, Bluetooth, RF, and ultrasonic waves.

[0050] The power management module 506 is connected to the battery 410. The power management module 410 is used to estimate the battery life, detect battery voltage, current and other parameters. The power management module 410 may further include power supply common functional circuits such as charging, boosting, and filtering. In terms of application form, the power management module 410 can be an integrated circuit, a discrete component combination circuit, or a hybrid use of an integrated circuit and discrete components. In short, any module that can achieve the same function can be used as the power module.

[0051] The execution unit 114 can be a functional circuit with data processing and control functions for the implantable cardiac detector 100, and it is preferably an MCU. The execution unit 114 can also be an ASIC (Application Specific Integrated Circuit). The execution unit 510 is connected to the communication module 512, the ECG signal sensing module 502, the power module 410, and the storage module 516, and is used to control the coordinated work between each module to ensure the normal function of the implantable medical device. In a preferred solution, the MCU is connected to each functional module through the system bus.

[0052] In a preferred solution, the storage module 516 stores the control program for controlling the implantable medical device. This control program includes parameter data (such as patient information, sensing parameters, diagnostic parameters, and treatment parameters). The power control program is pre-burned in the storage module.

Claims

1. An implantable cardiac monitor, characterized in that, Comprising: A housing composed of a first metal member, a second metal member, and a signal window member disposed between the first metal member and the second metal member; A circuit assembly is disposed within the housing, and an antenna for wireless communication is disposed at a position corresponding to the signal window member; The circuit assembly includes a substrate and circuit devices disposed on the substrate; The antenna is received on the substrate in the length direction; The circuit assembly includes a contact member electrically connected to the first metal member and the second metal member, and the contact member is electrically connected to a sensing module in the circuit assembly; Both ends of the surfaces of the first metal member and the second metal member are sensing electrodes, and the regions other than the sensing electrodes of the first metal member and the second metal member are insulating regions.

2. The implantable cardiac monitor according to claim 1, wherein, The signal window member includes a first connection end and a second connection end respectively connected to the first metal member and the second metal member, and the first connection end and the second connection end are inserted into the inner cavities of the first metal member and the second metal member.

3. The implantable cardiac monitor according to claim 2, characterized in that, The signal window member is of a hollow structure, the circuit assembly passes through the inner cavity of the hollow structure, and both ends of the circuit assembly not received in the hollow structure of the signal window are received in the inner cavities of the first metal member and the second metal member.

4. The implantable cardiac monitor according to claim 1, characterized in that, An insulating layer covers the surface of the insulating region.

5. The implantable cardiac monitor according to claim 1, wherein, The signal window member is made of a material through which electromagnetic signals can pass.

6. The implantable cardiac monitor according to claim 5, wherein The signal window member is made of a material through which optical signals can pass.

7. The implantable cardiac monitor according to claim 5 or 6, characterized in that, The circuit assembly includes an optical chemical sensor, and the optical chemical sensor is connected to a photochemical detection module of the circuit assembly.

8. The implantable cardiac monitor according to claim 5 or 6, characterized in that, The signal window member includes: quartz, glass, sapphire, diamond, silicon carbide, polyurethane, silicone rubber, polyvinyl chloride, polyethylene, polypropylene, silicone rubber, polylactic acid, bioglass ceramics, hydroxyapatite ceramics, carbon, alumina, zirconia, β-tricalcium phosphate.

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