CN111262011A

CN111262011A - Antenna and implanted medical device

Info

Publication number: CN111262011A
Application number: CN202010191977.1A
Authority: CN
Inventors: 丁皓; 刘威
Original assignee: Suzhou Wushuang Medical Equipment Co ltd
Current assignee: Suzhou Wushuang Medical Equipment Co ltd
Priority date: 2020-03-18
Filing date: 2020-03-18
Publication date: 2020-06-09

Abstract

The invention discloses an antenna and an implanted medical device for wireless communication by means of the antenna, wherein the medical device comprises a device shell, a hybrid circuit, the antenna and a feed-through assembly, the antenna is designed into a three-dimensional shape, the radiation aperture of the antenna is increased to the maximum extent, the two-dimensional area of the antenna is reduced, a conductive shell is changed into a partial radiation part through coupling, and the energy transmission efficiency and the data transmission distance are improved.

Description

Antenna and implanted medical device

Technical Field

The invention relates to an antenna which can be packaged in an implanted medical device, is connected with a hybrid circuit of the implanted medical device through a feed-through assembly, realizes far-field communication between the implanted medical device and external remote equipment, and is suitable for the medical instrument and clinical fields.

Background

Implantable medical devices (implants) are ubiquitous to provide diagnostic or therapeutic capabilities. Three types of active implant products, such as an Implantable Cardiac Defibrillator (ICD), an Implantable Cardiac Monitor (ICM), an implantable Cardiac Pacemaker (cardioc Pacemaker), a leadless implantable Cardiac Pacemaker, a Subcutaneous Implantable Cardiac Defibrillator (SICD), various tissue, organ and nerve stimulators or sensors, generally require doctors or professionals to realize wireless communication between an external program controller and an implant stimulator to complete possible functions of data transmission, implant software upgrading, emergency stop and the like. The invention aims to solve the problems of wireless communication efficiency and communication quality, improve wireless transmission efficiency and avoid unsmooth or failed communication.

The traditional communication mode carries out wireless communication at a distance of a few centimeters in an inductive near-field coupling mode, and the traditional communication mode has the following defects: the communication distance is too close, the use mode is limited and the data rate is low, and the data rate is generally thousands or tens of thousands of bits.

With the advance of technology, the remote communication between the implant circuit and the external program controller and other remote control devices becomes possible, and the application in the aspects of device control, data transmission, real-time monitoring and the like is more and more common, and the implant and the external device can communicate at a distance of several meters. As one of hardware bases of communication, the implanted antenna is placed in the connector outside the shell, so that the energy radiated by the antenna can be ensured not to be absorbed by the metal shell and conducted out to the maximum extent.

With the increasing integration and miniaturization of circuits and structures, the physical space of antennas is limited. Generally, the communication distance is related to the radiation efficiency/gain of the antenna, the transmission power of the transmitting antenna, and the sensitivity of the receiving antenna. The efficiency/gain of the antenna is positively correlated to the size of the antenna. In order to increase the antenna efficiency and the maximum transmission distance to the maximum, designers have proposed various schemes. For example, the communication frequency and the decoding mode are modified, so that the system has better sensitivity to signals under the same hardware condition; or try to design a more directional antenna in anticipation of achieving better efficiency in a certain direction; or a matching network is added to achieve smaller return loss and better radiation efficiency, and longer transmission distances can be achieved at specific frequencies. These methods are generally undesirable because they either deviate from the frequency band of communication allowed by the implant in practice, or require additional requirements during the procedure, or are difficult to maintain communication stability in changing environments and add to the devices required.

Generally, to achieve a desired antenna efficiency, the total length of the antenna needs to be at least one-quarter to one-half wavelength. A reduction in antenna length reduces the radiation impedance of the antenna, making it more difficult to match the antenna to the source and couple to the air impedance, thereby significantly reducing antenna efficiency. This example presents a solution to increase the effective radiation efficiency of an antenna that obtains better radiation capability by bending multiple times in three dimensions and coupling with the housing.

Disclosure of Invention

The invention provides an antenna, which comprises four parts, wherein the first part is a bent section, the bent section comprises an L-shaped section (123), an arc section (34) and a plane section (45), the L-shaped section is connected with the plane section through the arc section, and the plane of the L-shaped section is vertical to the plane of the arc section; the second part is a plane section (567) which is positioned in the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, the narrower two ends of the plane section are positioned on different sides of the plane section, and the plane of the plane section is vertical to the plane of the L-shaped section (123) in the first part and the plane of the bending section (34); the third part is a circular arc section (78); the fourth part is a bent section (89), the bent sections (89) are located in the same plane, and the antenna is connected according to the sequence of the first part, the second part, the third part and the fourth part.

The antenna is used for MICS microwave communication, and the working frequency is MICS402MHz to 405 MHz.

The antenna is a monopole antenna, has no dual structure and is a single feed point structure.

The bending section of the antenna comprises a vertical Z shape, a plurality of continuous vertical Z shapes, a horizontal Z shape, a plurality of continuous horizontal Z shapes, a horizontal trapezoid, a plurality of continuous horizontal trapezoids, a vertical trapezoid, a plurality of continuous vertical trapezoids, a horizontal W shape, a plurality of continuous horizontal W shapes, a vertical W shape and a plurality of continuous vertical W shapes.

The plane of the bent section (78) of the antenna is parallel to the plane of the first part L-shaped section (123), and the plane of the circular arc section (34) of the first part of the antenna is parallel to the plane of the fourth part bent section (89).

The tail end of the antenna bending section is connected with the main body equipment through an integral structure formed by connecting an arc section and a plane section.

The invention provides an implantable medical device, which consists of four parts, namely a device shell, a hybrid circuit, an antenna and a feed-through assembly, wherein the antenna is characterized by comprising four parts, the first part is a bent section, the bent section comprises an L-shaped section (123), an arc section (34) and a plane section (45), the L-shaped section and the plane section are connected through the arc section, and the plane of the L-shaped section is vertical to the plane of the arc section; the second part is a plane section (567) which is positioned in the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, the narrower two ends of the plane section are positioned on different sides of the plane section, and the plane of the plane section is vertical to the plane of the L-shaped section (123) in the first part and the plane of the bending section (34); the third part is a circular arc section (78); the fourth part is a bent section (89), the bent sections (89) are located in the same plane, and the antenna is connected according to the sequence of the first part, the second part, the third part and the fourth part.

The antenna of the medical device is connected to the medical device body through a feedthrough assembly and is encapsulated within the feedthrough assembly.

The radiation part of the implanted medical device is composed of an antenna body and an implant shell.

The implanted medical device comprises a hybrid circuit module, wherein the hybrid circuit module comprises a radio frequency antenna, a radio frequency chip and a corresponding software configuration, and the radio frequency part of the implant body comprises an antenna debugging chip.

The antenna of the medical device is connected with the main body of the medical device through an integral structure formed by connecting an arc section and a plane section.

The edge line of the medical device is parallel to the mid-plane segment edge of the second portion of the antenna.

The antenna of the medical device is folded for the last time below the antenna parallel to the shell.

The invention discloses an implantable medical device capable of realizing signal transmission between an external remote device and an external remote device through an antenna. In some examples, the implantable medical device is capable of automatically completing triggering of sensing of cardiac electrical signal parameters internal to the heart, e.g., without a triggering input initiated from an external source, e.g., based on a request initiated from the patient or initiated by a physician from an external device, and transmitting the sensed physiological parameters to the exogenous far-field device based at least in part on one or more physiological parameters of the patient.

Drawings

Fig. 1 is a schematic diagram of the external structure of an implanted medical device and the relative positions of various components in the heart when the medical device is implanted inside the heart.

Fig. 2 is a schematic perspective view of an antenna.

Fig. 3 is a schematic diagram of the relative position of the antenna shown in fig. 2 mounted to an implantable medical device ICD.

Fig. 4 is a schematic view of the position of the antenna mounted to the implantable medical device ICD, as seen in the direction of arrow T in fig. 3.

Fig. 5 is a schematic view of the position of the antenna mounted to the implantable medical device ICD, as seen in the direction of arrow P in fig. 3.

In fig. 2 and 3, the dashed lines represent the planes where the dashed frames are located, every four dashed lines enclose a dashed frame, one dashed frame is located on one plane, three dashed frames in the figures represent three planes where three dashed frames are located respectively, and the three planes are two by two perpendicular to each other. And the planes (plane i, plane ii and plane iii) in fig. 2 and 3 are respectively parallel.

Detailed Description

The antenna is a monopole antenna, has no dual structure and is a single feed point structure. The monopole antenna has the greatest characteristic of providing satisfactory radiation characteristics over a wide frequency band, and has the advantages of simple structure, light weight, simple feed structure, convenience in analysis, good omnidirectional characteristics and the like. The raw material of the antenna can be copper plate or tin-plated steel plate. The working principle of the antenna is MICS microwave communication, and the working frequency of the antenna is from MICS402MHz to MICS405 MHz. The effective radiation efficiency of the antenna is increased through high frequency, and better radiation capability is obtained through multiple bending in three-dimensional space. The antenna can be packaged in implantable cardiac defibrillators, implantable cardiac monitors, implantable cardiac pacemakers, leadless implantable cardiac pacemakers, subcutaneous implantable cardiac defibrillators, and implantable medical devices such as various tissues, organs, and neurostimulators or sensors, wherein the relative positions of the antennas mounted to the implantable cardiac defibrillator ICD are schematically shown in fig. 3 and 4.

Fig. 1 is a schematic diagram of the external structure of an ICD100 and the relative positions of various components in the heart when the ICD is implanted inside the heart. The ICD is made up of four parts, a device housing 105, a hybrid circuit in the device housing, an antenna, and a feedthrough assembly. The antenna is encapsulated within a feedthrough assembly of the ICD header structure 107 that encapsulates not only the antenna feedthrough, but also the lead feedthrough inside. Lead feedthrough see ICD head structure in fig. 5, lead feedthrough is connected to lead 115, and the ICD main body circuit board is connected to the heart via antenna for sensing cardiac signal parameters or treatment by clicking. The device shell interior usually comprises a power supply, a capacitor and a hybrid circuit, and the hybrid circuit is usually realized by a chip through a program coding mode. The exertion of ICD function can be realized through two kinds of modes, one kind is the inside automatic formula regulation and control of ICD organism, does not need artificial manual trigger and control, can realize automatically. Another implementation is by the external programming device 190 sending the communication signal 185, typically a programmer, patient assistant, or other device capable of commanding it or sensing its internal signals. The communication mode between the ICD and the external programmable device 190 may be one or more of wired communication, bluetooth, WIFI, LTE, CDMA, and other wireless communication networks. ICD lead 115 shown in FIG. 1 is a single lead, and may be a double lead, a triple lead, or a quadruple lead during clinical use, with the basic lead structure being similar to lead 115. Lead 115 is formed from coil 118 electrode 120A and electrode 120B, coil 118 being connected to the ICD subject via connector 107, the coil functioning as: the sensing or treatment purpose is achieved through electric discharge. The signal parameters of the cardiac event are sensed by

electrodes

120A and 120B, also called helical heads, which contain helical coils inside of electrode 120B. The electrode spiral 120A on the lead is screwed in the insulating material on the periphery of the lead before use, and can be screwed out from the other end of the lead before being implanted into the heart of a human body, so that the electrode end 120A of the lead is fixed with myocardial tissue in the heart. The electrode lead needs to be coated by insulating materials such as silica gel, polyurethane or epoxy resin.

Fig. 2 is a schematic perspective view of an antenna. For convenience of illustration and description, fig. 2 marks partial nodes of the antenna in the order of

arabic numerals

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 from one end to the other end of the antenna. The antenna comprises four parts: a first section, a second section, a third section, and a fourth section, and the antenna is connected in the order of the first, second, third, and fourth sections. The first part is a bending section and comprises numbers from 1 to 4, the bending section comprises an L-shaped section (123), an arc section (34) and a plane section (45), the L-shaped section and the plane section are connected through the arc section, and the plane where the L-shaped section is located is perpendicular to the plane where the arc section is located; the second part is a plane section (567) which is positioned on the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, the narrower two ends of the plane section are positioned on different sides of the plane section, the plane of the plane section is vertical to the plane of the L-shaped section (123) in the first part and the plane of the bending section (34), three holes in the wider section of the middle part of the plane section of the second part of the antenna are used for fixing the antenna, and the size, the shape and the number of the holes can be adjusted according to actual conditions; the third part is an arc section (78), the plane of the bent section (78) of the third part of the antenna is parallel to the plane of the L-shaped section (123) of the first part, and the plane of the arc section (34) of the first part of the antenna is parallel to the plane of the bent section (89) of the fourth part; the fourth part is a bending section (89), and the bending sections (89) are positioned in the same plane. Besides the shape of the vertical trapezoid shown in fig. 2, in an actual operation process, the fourth bending section of the antenna may be one or a combination of several of a vertical Z shape, a plurality of continuous vertical Z shapes, a horizontal Z shape, a plurality of continuous horizontal Z shapes, a horizontal trapezoid, a plurality of continuous horizontal trapezoids, a plurality of continuous vertical trapezoids, a horizontal W shape, a plurality of continuous horizontal W shapes, a vertical W shape, and a plurality of continuous vertical W shapes. But it is necessary to ensure that the various shapes of the bends are parallel to the plane.

Fig. 3 is a schematic diagram showing the relative positions of the antennas shown in fig. 2 mounted on the implantable medical device ICD, wherein three planes marked by dotted lines in fig. 3, namely plane i, plane ii and plane iii, are perpendicular to each other in pairs. The L-shaped section (123) of the first part of the antenna is parallel to the plane I, the plane where the circular arc section (34) of the first part is located is parallel to the plane II, and the plane section (45) of the first part is parallel to the plane III. The plane section of the second part and the plane (45) of the first part are positioned on the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, and the two narrower ends are positioned on different sides of the plane section; the third partial arc section (78) is parallel to the plane I. The plane of the fourth part bending section (89) is vertical to the plane of all the circular arc sections of the first part. The plane of the fourth partial bending section CD is parallel to the plane of the first partial circular arc section (34). The antenna is connected with the medical device main body through an integral structure formed by connecting an arc section and a plane section. 314 is the device housing of the medical device, and the inside of the device housing contains a hybrid circuit to complete the sensing and communication functions of the implanted device on the electrocardio parameters. A feedthrough assembly is encapsulated within the header of the ICD, the feedthrough assembly including an antenna feedthrough and a lead feedthrough. The antenna feedthrough is a component connecting the antenna and the device body. One end of the antenna 302 is connected with the circuit board inside the device body through the antenna feed channel part, and the interface is sealed through a round isolation sheet. 406 are wire coils, typically a medical device containing 1 to 6 wire coils, each separated by an insulator 404 to prevent communication between the wires from shorting the device. The coil of lead wire is spaced apart from the medical device body and may be wound at intervals around a fixed shaft located on the ICD head, the shaft being secured to the ICD head by a securing structure 308, the securing structure 308 being secured to the ICD head by a region 310. The medical device head has 1-6 coils 304 of wire, each two coils separated by a silicone insulator 312 to prevent short circuiting of the device by communication between the wires. The three holes 306 on the wider section of the middle part of the second part of the plane section of the antenna are used for fixing the antenna, and the size, shape and number of the holes can be adjusted according to actual conditions.

Fig. 4 is a schematic view of the position of the antenna mounted to the implantable medical device ICD, as seen in the direction of arrow T in fig. 3. 402 is the device housing of the medical device, and the inside of the device housing contains a hybrid circuit to complete the sensing and communication functions of the implanted device on the electrocardiographic parameters. A feedthrough assembly is encapsulated within the header of the ICD, the feedthrough assembly including an antenna feedthrough and a lead feedthrough. The antenna feedthrough is a component connecting the antenna and the device body. One end of the antenna 410 is connected with the circuit board inside the device body through the antenna feed passage, and the interface is sealed through a circular isolation sheet 416. The holes 306 are used for fixing the antenna, and the size, shape and number of the holes can be adjusted according to actual conditions, and can also be fixed by adopting other fixing modes. Common fixing methods of the antenna include: the mechanical structure fixation, glue bonding, bolt connection, welding and riveting are carried out through punching, the shaft is in interference fit with the hole, the shaft is in transition fit with the hole in clearance fit, the shaft is in keyed connection and then is compressed by threads, and the like. Since the length of the antenna has a positive correlation with the sensitivity of the antenna to transmit and receive signals, the length of the antenna should be as long as possible to enhance the signal transmission sensitivity of the antenna. The width and thickness of the antenna can be adjusted according to the applicable implanted medical device, and the width and thickness of the antenna should be determined according to the fixing mode. 404 are wire coils, and typically a medical device contains 1 to 6 wire coils, each separated by an insulator 408 to prevent communication between the wires from shorting the device. The coil of lead wire is spaced apart from the medical device body and may be wound at intervals around a fixed shaft located on the ICD head, the shaft being secured to the ICD head by a securing structure 412, the securing structure 412 being secured to the ICD head at a location 414. Each of the wire coils 404 is connected one-to-one to the hybrid circuit inside the apparatus body 402 by a wire 418. Usually, the coil of the lead access hybrid circuit is designed to a fixed range area, which can save space, all leads are packaged together in the fixed space, and the interface of the lead and the main body equipment is sealed by a round spacer. The hybrid circuit is positioned in the head of the medical device main body, the coils of the hybrid circuit are separated by a silica gel insulator, and the silica gel insulator is designed between every two coils so as to prevent the short circuit of equipment caused by the communication between the leads. Reference numeral 420 denotes a ground line, which connects the circuit board inside the device to the ground to form a loop for transmitting wireless signals. The antenna is connected with an internal circuit board of the implanted medical device through an integral structure formed by connecting an arc section BC and a plane section AB, so that far-field communication between the implanted medical device and external remote equipment is realized. The ICD and the external program control instrument are respectively provided with a set of hardware configuration comprising a radio frequency antenna, a radio frequency chip and corresponding software configuration.

Fig. 5 is a schematic view of the position of the antenna mounted to the implantable medical device ICD, as seen in the direction of arrow P in fig. 3. The antenna 504 is fixed by three holes 508 on the antenna, except the three holes shown in the antenna in fig. 2, the antenna of the present invention can widen any section of the main body, and perforate the widened section, the number of the holes is 0 to 10, the size of the holes can be adjusted by combining the size of the specific medical device, and the holes of the antenna are used for fixing the antenna in the ICD head. The antenna of the invention can also be fixed by properly widening any one or more sections on the antenna main body structure and selecting a proper mode. Common fixing methods of the antenna include: the mechanical structure fixation, glue bonding, bolt connection, welding and riveting are carried out through punching, the shaft is in interference fit with the hole, the shaft is in transition fit with the hole in clearance fit, the shaft is in keyed connection and then is compressed by threads, and the like. The 506-bit antenna coil is separated from the antenna coil of the medical device by insulating silica gel. The antenna 504 is connected to the hybrid circuit inside the medical device and is sealed by a circular spacer 510.

Implantable medical devices (implants) are ubiquitous to provide diagnostic or therapeutic capabilities. Three types of active implant products, namely an implantable cardiac defibrillator, an implantable cardiac monitor, an implantable cardiac pacemaker, a leadless implantable cardiac pacemaker, a subcutaneous implantable cardiac defibrillator, various tissues, organs, nerve stimulators or sensors and the like, generally need doctors or professionals to realize wireless communication between an external program controller and an implant stimulator to complete possible functions of data transmission, implant software upgrading, emergency stop and the like. This embodiment takes an ICD as an example to illustrate the working scheme of the antenna in the implantable medical device.

The invention discloses a special-shaped antenna applicable to wireless communication of an implanted medical device, which is designed into a three-dimensional shape, the antenna of the medical device is folded for the last time below the antenna parallel to a shell, the parallel part can increase the capacitance between the antenna and the shell, and the shell can be changed into a partial radiation part through coupling, so that the radiation caliber of the antenna is increased to the maximum extent, the two-dimensional area of the antenna is reduced, the radiation efficiency is improved, and the energy transmission efficiency and the data transmission distance are improved.

Claims

1. An antenna is characterized by comprising four parts, wherein the first part is a bent section which comprises an L-shaped section (123), an arc section (34) and a plane section (45), the L-shaped section and the plane section are connected through the arc section, and the plane of the L-shaped section is perpendicular to the plane of the arc section; the second part is a plane section (567) which is positioned in the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, the narrower two ends of the plane section are positioned on different sides of the plane section, and the plane of the plane section is vertical to the plane of the L-shaped section (123) in the first part and the plane of the bending section (34); the third part is a circular arc section (78); the fourth part is a bent section (89), the bent sections (89) are located in the same plane, and the antenna is connected according to the sequence of the first part, the second part, the third part and the fourth part.

2. An antenna according to claim 1, wherein the antenna is for MICS microwave communication and has an operating frequency of MICS402MHz to 405 MHz.

3. An antenna as claimed in claim 2, wherein the antenna is a monopole antenna, having no dipole structure, and having a single feed point structure.

4. The antenna of claim 3, wherein the antenna meander comprises a vertical Z-shape, a plurality of consecutive vertical Z-shapes, a horizontal Z-shape, a plurality of consecutive horizontal Z-shapes, a horizontal trapezoid, a plurality of consecutive horizontal trapezoids, a vertical trapezoid, a plurality of consecutive vertical trapezoids, a horizontal W-shape, a plurality of consecutive horizontal W-shapes, a vertical W-shape, a plurality of consecutive vertical W-shapes.

5. An antenna according to claim 4, characterized in that the plane of the said bent section (78) of the antenna is parallel to the plane of the first L-shaped section (123), and the plane of the said arc section (34) of the first part of the antenna is parallel to the plane of the fourth bent section (89).

6. An antenna as claimed in claim 5, wherein the ends of the bent sections of the antenna are connected to the main device by an integral structure formed by connecting a circular section and a planar section.

7. An implantable medical device, characterized in that the medical device is composed of four parts, a device housing, a hybrid circuit, an antenna and a feed-through assembly, an antenna, characterized in that the antenna comprises four parts, the first part being a bent section comprising an L-shaped section (123), a circular arc section (34) and a plane section (45), wherein the L-shaped section and the plane section are connected by the circular arc section, the plane of the L-shaped section being perpendicular to the plane of the circular arc section; the second part is a plane section (567) which is positioned in the same plane, the middle of the plane section is wider, the two ends of the plane section are narrower, the narrower two ends of the plane section are positioned on different sides of the plane section, and the plane of the plane section is vertical to the plane of the L-shaped section (123) in the first part and the plane of the bending section (34); the third part is a circular arc section (78); the fourth part is a bent section (89), the bent sections (89) are located in the same plane, and the antenna is connected according to the sequence of the first part, the second part, the third part and the fourth part.

8. An implantable medical device according to claim 7, wherein the antenna of the medical device is connected to the medical device body by a feedthrough assembly and is encapsulated within the feedthrough assembly.

9. An implantable medical device according to claim 8, wherein the radiating portion of the implantable medical device is formed by the antenna body and the implant housing.

10. An implantable medical device according to claim 9, wherein the implantable medical device comprises a hybrid circuit module comprising a radio frequency antenna, a radio frequency chip and a corresponding software configuration, wherein the radio frequency part of the implant comprises an antenna commissioning chip.

11. An implantable medical device according to claim 7, wherein the antenna of the medical device is connected to the medical device body by a unitary structure formed by a circular arc segment and a planar segment.

12. An implantable medical device according to claim 11, wherein the edge line of the medical device is parallel to the edge of the planar section of the second part of the antenna.

13. An implantable medical device according to claim 12, wherein the antenna of the medical device is folded over a last time below parallel to the housing.