An implantable intracardiac blood pressure temperature telemetry device

Abstract

The application provides an implantable intracardiac blood pressure temperature telemetering device, belonging to the field of in-vivo implantation devices, comprising an integrated chip, a recess is formed in the integrated chip, a pressure sensor is fixed in the recess, a first pressure-sensitive film is fixed on the surface of the recess, the pressure sensor is left with a gap from the inner wall of the recess, and a flexible support member for assisting the first pressure-sensitive film is attached to the inner wall of the recess. The device is flexibly deformed in the direction of the pressure sensor by the first pressure-sensitive film under the pressure of the external environment, the flexible support member is located at the edge of the recess, thereby playing an auxiliary supporting role on the connecting edge of the first pressure-sensitive film, simultaneously playing a role of connecting the edge of the recess, increasing the contact range of the flexible support member and the first pressure-sensitive film, and making the flexible support member deform with the first pressure-sensitive film and assist the deformation, so that the deformation amount of each region of the first pressure-sensitive film is more balanced, and the service life of the whole first pressure-sensitive film is indirectly improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of implantable devices in vivo, in particular to an implantable device for measuring blood pressure and temperature in heart. BACKGROUND

[0002] The implantable device for measuring blood pressure in heart is an advanced medical equipment for monitoring and treating heart and blood pressure related diseases. The device is mainly used for monitoring the pressure changes in heart, such as left ventricular pressure, right ventricular pressure, etc. It has important significance for the diagnosis and treatment of heart failure, cardiomyopathy and other heart diseases.

[0003] US20070118038A1 discloses an implantable device for measuring blood pressure and temperature in heart, which comprises an antenna, an integrated chip including a first substantially rigid substrate, at least one pressure sensor arranged in the substrate to generate a signal indicative of a sensed pressure. The pressure sensor is located in a recess, the surface of the recess has a flexible membrane, and the pressure is transmitted to the pressure sensor by extrusion of the flexible membrane by external pressure. Since the weight of the integrated chip is less than about 1 gram, the surface area on one side is less than or equal to about 10 mm 2 The integrity of the flexible membrane determines the service life and detection accuracy of the overall implantable device.

[0004] Under the long-term pressure, the flexible membrane will be stretched and worn out at the fixed edge, which will affect the service life of the implantable device. SUMMARY

[0005] According to the present application, an implantable device for measuring blood pressure and temperature in heart is provided, which comprises an integrated chip, a recess is formed in the integrated chip, a pressure sensor is fixed in the recess, a first pressure-sensitive membrane is fixed on the surface of the recess, the pressure sensor has a gap with the inner wall of the recess, and a flexible support member is attached to the inner wall of the recess to assist the first pressure-sensitive membrane. Through the above technical features, the first pressure-sensitive membrane is deformed in the direction of the pressure sensor under the pressure of the external environment, the flexible support member is located at the edge of the recess, thereby assisting the support of the connecting edge of the first pressure-sensitive membrane, and playing a role of connecting the edge of the recess, increasing the contact range of the flexible support member and the first pressure-sensitive membrane, and making the flexible support member deform with the first pressure-sensitive membrane and assist the deformation, so that the deformation amount of each region of the first pressure-sensitive membrane is more balanced, and the service life of the first pressure-sensitive membrane is indirectly improved.

[0006] In some embodiments, the recess is a circular recess, and the pressure sensor is fixed at the center region of the bottom wall of the recess. In this way, when the first pressure-sensitive membrane is flexibly deformed, the tension on each region of the first pressure-sensitive membrane is more balanced, which on the one hand reduces the uneven physical performance of the first pressure-sensitive membrane caused by excessive local tension, and on the other hand improves the service life of the first pressure-sensitive membrane and the measurement accuracy of the pressure sensor.

[0007] In some embodiments, an annular auxiliary support arm is arranged in the gap between the recess and the pressure sensor, and the flexible support member is located in the annular region between the auxiliary support arm and the inner wall of the recess. In this way, the arrangement of the auxiliary support arm controls the deformation space of the flexible support member at the top region of the flexible support member, which reduces the deformation amount of the flexible member in the height direction when the first pressure-sensitive membrane is deformed, thereby ensuring the auxiliary support of the flexible support member to the fixed edge of the first pressure-sensitive membrane in the recess.

[0008] In some embodiments, the height of the auxiliary support arm is lower than the depth of the recess, and the depth of the recess is higher than three-quarters of the depth of the recess. In this way, when the first pressure-sensitive membrane is deformed towards the pressure sensor, it will drive the flexible support member to deform and support. Since the height of the auxiliary support arm is lower than the edge of the recess, the deformation direction of the flexible support member is limited, which ensures the stability of the force on each region of the first pressure-sensitive membrane.

[0009] In some embodiments, the flexible support member includes a second pressure-sensitive membrane and a flowable body injected into the second pressure-sensitive membrane. In this way, the second pressure-sensitive membrane plays a role in supporting and limiting the flowable body, and the force applied by the first pressure-sensitive membrane will drive the flowable body to flow in the second pressure-sensitive membrane, and the flow effect is due to the flexible material of the solid state.

[0010] In some embodiments, the integrated chip is fixed on one side of a rigid substrate, a rigid cover is attached to one side of the integrated chip, and a through hole is formed in the region of the pressure sensor. In this way, the rigid cover mainly plays a shielding and protecting role for the integrated chip, and also ensures that the pressure sensor is exposed to the measured region, which ensures the normal and accurate measurement of blood pressure.

[0011] In some embodiments, the through hole is filled with a flexible body, and the edge of the through hole is fixed by a flexible film. In this way, the overall structure of the flexible body and the flexible film does not affect the pressure measurement of the pressure sensor on the measured region, while the overall structure of the integrated chip is closed, which improves the integration of the integrated chip.

[0012] In some embodiments, the rigid substrate and the rigid cover are further surrounded by a rigid limiting body which limits the dislocation of the rigid substrate and the rigid cover. Thus, under the impact of the blood flowing in the human body, the rigid substrate and the rigid cover tend to dislocate, affecting the flow of the flexible body and the accuracy of the pressure sensor measurement, so the rigid limiting body wraps the rigid substrate and the rigid cover, protecting the overall structure and limiting the stress of the lateral dislocation of the rigid substrate and the rigid cover, indirectly improving the accuracy of the pressure sensor measurement.

[0013] In some embodiments, the rigid substrate, the rigid cover and the rigid limiting body are entirely wrapped in a biocompatible sheath. Thus, since the integrated chip needs to be anchored in the human body for a long time, in order to reduce the rejection of the human body to foreign objects, the biocompatible sheath protects the internal structure, avoids the entry of blood, ensures the normal transmission of pressure, and reduces the rejection of the human body to the device.

[0014] It should be understood that the content described in the summary is not intended to limit or important features of the embodiments of the present disclosure, nor is it intended to limit the scope of the present disclosure. Other features of the present disclosure will become apparent through the following description. BRIEF DESCRIPTION OF DRAWINGS

[0015] Figure 1 The overall structure of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0016] Figure 2 The structure of an integrated chip in a monitoring body of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0017] Figure 3 The local structure of a pressure sensor in an integrated chip of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0018] Figure 4 The local structure of a pressure sensor in an integrated chip of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0019] Figure 5 The deformation process of a pressure sensor in an integrated chip of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0020] Figure 6 The cross-sectional view of a flexible support of an implantable intracardiac blood pressure and temperature telemetry device is shown.

[0021] Figure 7 An exploded view of a fixing structure of an integrated chip of an implantable intracardiac blood pressure and temperature telemetry device is shown according to an embodiment of the present application;

[0022] Figure 8 A perspective view of a monitoring body of an implantable intracardiac blood pressure and temperature telemetry device is shown according to an embodiment of the present application.

[0023] Symbol explanation

[0024] 1, monitoring body; 11, integrated chip; 111, pressure sensing area; 1111, pressure sensor; 112, temperature sensing area; 113, groove; 2, antenna; 3, external reader; 4, coil; 51, first pressure sensitive membrane; 52, auxiliary support arm; 53, flexible support; 531, second pressure sensitive membrane; 532, flowable body; 61, rigid substrate; 62, rigid cover; 621, through hole; 63, flexible membrane; 64, rigid limiting body; 65, flexible body; 7, biocompatible sheath. DETAILED DESCRIPTION

[0025] The preferred embodiments (or implementation manners) of the present application will be described in detail below with reference to the accompanying drawings.

[0026] Reference Figures 1-8 is made to an implantable intracardiac blood pressure and temperature telemetry device according to the present application.

[0027] Figure 1 A schematic view of the overall structure of an implantable intracardiac blood pressure and temperature telemetry device is shown according to an embodiment of the present application. Reference Figure 1 is made to the schematic view, the implantable intracardiac blood pressure and temperature telemetry device according to the present embodiment includes a monitoring body 1 for being fixed in the atrium of the heart or a blood vessel, an antenna 2 connected to the monitoring body 1 and fixed under the skin of the human body, an external reader 3 fixed outside the body, and a coil 4 connected to the external reader 3 and fixed around the antenna 2. The external reader 3 generates a radio frequency field in a manner known in the art and transmits energy to the antenna 2 to indirectly power the monitoring body 1, and the monitored physical parameters of the monitoring body 1 are also transmitted to the coil 4 through the antenna 2 and received by the external reader 3. The external reader 3 can obtain data from the monitoring body 1 in a continuous or intermittent manner to meet different requirements for adjustment.

[0028] Figure 2 A schematic view of the structure of an integrated chip 11 in a monitoring body 1 of an implantable intracardiac blood pressure and temperature telemetry device is shown according to an embodiment of the present application. Reference Figure 2As shown, the monitoring body 1 comprises an integrated chip 11 including a pressure sensing area 111 and a temperature sensing area 112. The pressure sensing area 111 is composed of a plurality of pressure sensors 1111, while the temperature sensing area 112 is composed of a plurality of temperature sensors. The monitoring body 1 can be composed of an application specific integrated circuit (ASIC) having a power regulation circuit, a sensing circuit, an analog circuit and a data processing circuit. The power regulation circuit detects when sufficient power is delivered and turns on the sensing circuit, the analog circuit and the data processing circuit. The data processing circuit sends the data monitored by the pressure sensors 1111 and the temperature sensors to an ASIC transmitter, which is connected to the antenna 2 and wirelessly transmits the data to the coil 4 and is finally received by the external reader 3. The external reader 3 can provide reception and storage of the pressure and temperature values, compare the pressure readings of the monitoring body 1 with the ambient pressure via internal sensors in the external reader 3, and transmit the electrocardiographic data to other devices, such as computers, handheld terminals, etc. via standard protocols.

[0029] In the present embodiment, the integrated chip 11 is a small-sized and light-weight chip to avoid exerting independent stress on the heart and / or generating turbulence in the heart chamber. The integrated chip 11 can be a millimeter-sized plate body, which is usually a rectangular plate body, and can also be a square plate body, depending on the specific application or position in the cardiovascular system where sensing will occur and depending on the delivery method.

[0030] Figure 3 A partial structural schematic diagram of the pressure sensor 1111 in the integrated chip 11 of the implantable intracardiac blood pressure and temperature telemetry device provided by the embodiment of the present application is shown; Figure 4 A partial structural schematic diagram of the pressure sensor 1111 in the integrated chip 11 of the implantable intracardiac blood pressure and temperature telemetry device provided by the embodiment of the present application is shown. Referring to Figure 3 and Figure 4 As shown, the integrated chip 11 has a plurality of recesses 113 formed on one side surface thereof. In some embodiments, the recesses 113 can be circular grooves, and the pressure sensors 1111 are fixed at the center area of the bottom wall of the recesses 113. The surface of each recess 113 is covered with a first pressure-sensitive film 51, which is fixed at the edge of the recess 113. Since the first pressure-sensitive film 51 is a pressure sensing member, its own physical properties affect the accuracy of the monitored pressure and the service life of the monitoring body 1. The first pressure-sensitive film 51 is deformed in a concave manner towards the pressure sensor 1111 under the influence of the ambient pressure, so that the first pressure-sensitive film 51 reciprocally deforms and wears with the edge of the recess 113. In order to reduce the reduction of service life caused by the wear of the first pressure-sensitive film 51, the structure inside the recess 113 is improved.

[0031] The edge of the pressure sensor 1111 is spaced apart from the edge of the inner wall of the groove 113, and an annular auxiliary support arm 52 is arranged on the circumferential side of the pressure sensor 1111 in the annular groove, the auxiliary support arm 52 is coaxially arranged with the groove 113, and a gap is left between the auxiliary support arm 52 and the inner wall of the groove 113. A flexible support 53 is arranged in the gap between the auxiliary support arm 52 and the inner wall of the groove 113, the top of the flexible support 53 is in contact with the lower surface of the first pressure-sensitive film 51, and during the pressure deformation of the first pressure-sensitive film 51, the top of the flexible support 53 is extruded and deformed, thereby assisting the edge of the first pressure-sensitive film 51, on the one hand, the deformation of the first pressure-sensitive film 51 is more uniform, and on the other hand, the contact area between the first pressure-sensitive film 51 and the flexible support 53 is increased, and the stress is more balanced.

[0032] Figure 5 A schematic diagram of the deformation process of the pressure sensor 1111 in the implantable intracardiac blood pressure temperature telemetry device integrated chip 11 is shown. In some embodiments, the height of the auxiliary support arm 52 is lower than the height of the edge of the groove 113, and higher than three-quarters of the overall depth of the groove 113, so that during the pressure deformation of the flexible support 53, the inner circumferential side lacks the support of the auxiliary support arm 52, thereby assisting the first pressure-sensitive film 51 in the central area of the groove 113 during the deformation of the first pressure-sensitive film 51, thereby increasing the support range of the auxiliary support without affecting the deformation of the first pressure-sensitive film 51, so that the deformation of the first pressure-sensitive film 51 is more flexible and uniform.

[0033] Figure 6 A cross-sectional view of the flexible support 53 of the implantable intracardiac blood pressure temperature telemetry device is shown. Figure 6 As shown, in order to reduce the influence of the flexible support 53 on the reverse force of the first pressure-sensitive film 51, the flexible support 53 includes an annular cavity composed of a second pressure-sensitive film 531, and a flow body 532 located in the annular cavity, which is limited in the annular area abutting the inner wall of the groove 113 under the limitation of the auxiliary support arm 52. The flow body 532 can be a gel material or a non-conductive liquid, and after the first pressure-sensitive film 51 is deformed under pressure, the flow body 532 will flow towards the middle of the groove 113, reducing the local stress on the edge of the first pressure-sensitive film 51.

[0034] Figure 7 An exploded view of the fixing structure of the implantable intracardiac blood pressure temperature telemetry device integrated chip 11 is shown. Figure 7As shown, the integrated chip 11 is provided with a rigid substrate 61 on one side, and is embedded on one side surface of the rigid substrate 61, and the other side of the integrated chip 11 is provided with a rigid cover 62 which is the same size as the rigid substrate 61, and the integrated chip 11 is covered and protected by the mutual fixation of the rigid substrate 61 and the rigid cover 62, and the rigid cover 62 is provided with a through hole 621 which exposes the pressure sensor 1111 in the area of the pressure sensor 1111, so as to facilitate the pressure sensor 1111 to perceive the pressure change of the external environment.

[0035] In order to package the integrated chip 11, the through hole 621 is also filled with a flexible body 65, and a flexible film 63 is fixed at the port of the through hole 621. The flexible body 65 can be a gel material, and the pressure change of the external environment drives the flexible body 65 to press the first pressure film and transmit the pressure; and the flexible film 63 can be a pressure-sensitive film, so as to press the flexible body 65 through the external pressure change, and realize normal transmission of pressure.

[0036] Since the monitoring body 1 is located in the heart or in the blood vessel, the pressure of the blood flow will increase the local stress of the side wall of the rigid substrate 61 and the rigid cover 62, which is easy to cause the lateral displacement between the rigid substrate 61 and the rigid cover 62, thereby affecting the packaging area of the flexible body 65, causing the instability of the first pressure-sensitive film 51 under pressure, and affecting the accuracy of the final pressure sensor 1111 detection. Therefore, the periphery of the rigid substrate 61 and the rigid cover 62 is also fixed with a rigid limiting body 64 which wraps the rigid substrate 61 and the rigid cover 62.

[0037] Figure 8 The overall perspective schematic diagram of the implantable intracardiac blood pressure temperature telemetry device monitoring body 1 provided by the embodiment of the application is shown. Referring to Figure 8 As shown, the rigid substrate 61, the rigid cover 62 and the rigid limiting body 64 are externally sleeved with a biocompatible sheath 7, which is a flexible material and can transmit the pressure change of the external environment to the pressure sensor 1111 for pressure monitoring. Moreover, the port of the biocompatible sheath 7 is sealed with the connecting line of the antenna 2, so as to reduce the entry of external blood into the biocompatible sheath 7. Moreover, due to the influence of its own material and characteristics, the rejection of the monitoring body 1 by the in-vivo environment is also reduced.

[0038] In the description of the present application, the terms "connection", "installation", "fixation" and the like should be understood in a broad sense, for example, "connection" can be fixed connection, or detachable connection, or integrally connected; can be directly connected, or indirectly connected through an intermediate medium. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0039] The above merely provides preferred embodiments of the present application, and is not used to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modifications, equivalent replacements, improvements, etc. made within the principles and technical scope of the present application shall fall into the scope of the present application.

Claims

1. An implantable intracardiac blood pressure temperature telemetry device, comprising an integrated chip (11), a recess (113) is formed on the integrated chip (11), a pressure sensor (1111) is fixed in the recess (113), and a first pressure-sensitive film (51) is fixed on the surface of the recess (113), characterized in that, The pressure sensor (1111) is spaced apart from the inner wall of the groove (113), and the inner wall of the groove (113) is attached with a flexible support (53) for assisting in supporting the first pressure-sensitive film (51); The groove (113) is a circular groove (113), and the pressure sensor (1111) is fixed at the center area of the bottom wall of the groove (113); The gap between the groove (113) and the pressure sensor (1111) is provided with an annular auxiliary support arm (52), and the flexible support (53) is located in the annular area between the auxiliary support arm (52) and the inner wall of the groove (113); The flexible support (53) comprises a second pressure-sensitive film (531) and a flowable body (532) filled in the second pressure-sensitive film (531); The height of the auxiliary support arm (52) is lower than the depth of the groove (113) and higher than three-quarters of the depth of the groove (113); In the initial state of the flexible support (53), the overall height of the flexible support (53) is equal to the depth of the groove (113), so that the top end of the flexible support (53) abuts against the lower surface of the first pressure-sensitive film (51); During the deformation of the first pressure-sensitive film (51) under pressure, the flowable body (532) in the top part of the flexible support (53) is laterally constrained and flows towards the center of the groove (113), and the top end of the flexible support (53) is limited in height by the auxiliary support arm (52), so that the flexible support (53) is supported on one side towards the center of the groove (113), and the top part of the flexible support (53) deforms towards one side of the center of the groove (113) following the deformation of the first pressure-sensitive film (51), and assists in supporting the deformation edge of the first pressure-sensitive film (51), so that the first pressure-sensitive film (51) is uniformly stressed.

2. An implantable intracardiac blood pressure temperature telemetering device according to claim 1, wherein, A rigid substrate (61) is arranged on one side of the integrated chip (11), and a rigid cover (62) is arranged on the other side of the integrated chip (11), and the rigid cover (62) is provided with a through hole (621) in the area of the pressure sensor (1111).

3. An implantable intracardiac blood pressure temperature telemetering device according to claim 2, wherein, The through hole (621) is filled with a flexible body (65), and the edge of the through hole (621) is blocked and fixed by a flexible film (63).

4. An implantable intracardiac blood pressure temperature telemetering device according to claim 3, wherein, The rigid substrate (61) and the rigid cover (62) are further surrounded by a rigid limiting body (64) for limiting the dislocation and deviation of the rigid substrate (61) and the rigid cover (62).

5. An implantable intracardiac blood pressure temperature telemetering device according to claim 4, wherein, The rigid substrate (61), the rigid cover (62) and the rigid limiting body (64) are integrally covered in a biocompatible sheath (7).

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