Implantable intracardiac blood pressure and temperature telemetering device

Abstract

The invention provides an implantable intracardiac blood pressure and temperature telemetering device, which belongs to the field of in-vivo implantation devices and comprises an integrated chip, a groove is formed in the integrated chip, a pressure sensor is fixed in the groove, a first pressure-sensitive film is fixed on the surface of the groove, and a gap is reserved between the pressure sensor and the inner wall of the groove. And a flexible supporting piece for assisting in supporting the first pressure-sensitive film is attached to the inner wall of the groove. According to the device, the first pressure-sensitive film is subjected to pressure of an external environment and flexibly deforms in the direction of the pressure sensor, and the flexible supporting piece is located at the edge of the groove, so that the connecting edge of the first pressure-sensitive film is supported in an auxiliary manner, and meanwhile, the edge of the groove has a connection transition effect; the contact range of the flexible supporting piece and the first pressure-sensitive film is enlarged, the flexible supporting piece deforms along with the first pressure-sensitive film and assists in supporting, the deformation quantity of all areas of the first pressure-sensitive film is more balanced, and the overall service life of the first pressure-sensitive film is indirectly prolonged.

Description

Technical Field

[0001] The present invention generally relates to the field of in vivo implantable devices, and in particular to an implantable intracardiac blood pressure and temperature telemetry device. Background Art

[0002] Implantable heart blood pressure monitoring device is an advanced medical device used to monitor and treat heart and blood pressure related diseases. This device is mainly used to monitor the pressure changes inside the heart, such as left ventricular pressure, right ventricular pressure, etc. It is of great significance for the diagnosis and treatment of heart diseases such as heart failure and cardiomyopathy.

[0003] The US patent with publication number US20070118038A1 for an implantable device for intracardiac blood pressure and temperature telemetry discloses: an antenna; an integrated chip, which includes a first substantially rigid substrate, and at least one pressure sensor disposed in the substrate to generate a signal indicating the sensed pressure. The pressure sensor is located in a groove, and the surface of the groove has a flexible membrane. The pressure is transmitted to the pressure sensor by squeezing the flexible membrane by external pressure. Since the integrated chip weighs less than about 1 gram and has a thickness of less than or equal to about 10 mm on one side, the pressure sensor is located in a groove, and the surface of the groove has a flexible membrane. The pressure sensor is located in a groove, and the surface of the groove has a flexible membrane. The pressure sensor is transmitted to the pressure sensor by squeezing the flexible membrane by external pressure. 2 The flexible membrane has a surface area of ​​less than about 1 mm and a thickness of less than about 1 mm, so the integrity of the flexible membrane determines the service life and detection accuracy of the entire implant device.

[0004] Under long-term pressure, the flexible membrane will be stretched and worn at the fixed edge, causing loss, thereby affecting the service life of the implantable device. Summary of the invention

[0005] According to the present invention, in view of the problems existing in the above-mentioned prior art, an implantable intracardiac blood pressure and temperature telemetry device is provided, including an integrated chip, a groove is provided on the integrated chip, a pressure sensor is fixed in the groove, a first pressure-sensitive film is fixed on the surface of the groove, a gap is left between the pressure sensor and the inner wall of the groove, and a flexible support member for auxiliary support of the first pressure-sensitive film is attached to the inner wall of the groove. By having the above-mentioned technical features, the first pressure-sensitive film is flexibly deformed in the direction of the pressure sensor under the pressure of the external environment, and the flexible support member is located at the edge of the groove, thereby playing an auxiliary supporting role for the connecting edge of the first pressure-sensitive film, and at the same time plays a role of transition at the edge of the groove, increasing the contact range between 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 in supporting, so that the deformation amount of each area of ​​the first pressure-sensitive film is more balanced, indirectly improving the overall service life of the first pressure-sensitive film.

[0006] In some embodiments, the groove is a circular groove, and the pressure sensor is fixed in the central area of ​​the bottom wall of the groove. Therefore, when the first pressure-sensitive film is flexibly deformed, the tension in each area thereof will be more balanced, which, on the one hand, reduces the uneven physical properties of each area of ​​the first pressure-sensitive film due to excessive local tension; on the other hand, it increases the service life of the first pressure-sensitive film and improves the measurement accuracy of the pressure sensor.

[0007] In some embodiments, an annular auxiliary support arm is provided in the gap between the groove 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 groove. Thus, the setting of the auxiliary support arm controls the deformation space of the flexible support member in the top region of the flexible support member, and when the first pressure-sensitive film is deformed, the deformation amount of the flexible member in the height direction is reduced, thereby ensuring the role of the flexible support member in auxiliary support of the first pressure-sensitive film at the fixed edge of the groove.

[0008] In some embodiments, the height of the auxiliary support arm is lower than the depth of the groove and higher than three quarters of the depth of the groove. Therefore, when the first pressure-sensitive film is deformed toward the pressure sensor, the flexible support member is deformed and supported. Since the height of the auxiliary support arm is lower than the edge of the groove, the deformation direction of the flexible support member is limited, thereby ensuring the stability of the force applied to each area of ​​the first pressure-sensitive film.

[0009] In some embodiments, the flexible support member includes a second pressure-sensitive film and a fluid injected into the second pressure-sensitive film. Thus, the second pressure-sensitive film plays a role of limiting support for the fluid, and the force exerted by the first pressure-sensitive film drives the fluid to flow in the second pressure-sensitive film, and the flow effect is due to the solid flexible material.

[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 rigid substrate located on the integrated chip, and a through hole is opened in the area of ​​the rigid cover located on the pressure sensor. Thus, the rigid cover mainly shields and protects the integrated chip, and also ensures that the pressure sensor is exposed to the external test area, thereby ensuring 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 blocked and fixed by a flexible film. Thus, the overall structure of the flexible body and the flexible film does not affect the pressure measurement of the pressure sensor on the measured area, and at the same time, the overall structure of the integrated chip is sealed, thereby improving the integrity of the integrated chip.

[0012] In some embodiments, the rigid substrate and the rigid cover are surrounded by a rigid stopper to limit the displacement of the rigid substrate and the rigid cover. Therefore, under the impact of blood flowing inside the human body, the rigid substrate and the rigid cover will tend to be dislocated, affecting the flow of the flexible body, thereby affecting the accuracy of the pressure sensor measurement. Therefore, the rigid stopper wraps the rigid substrate and the rigid cover, while protecting the overall structure, it also limits the stress of the lateral displacement of the rigid substrate and the rigid cover, indirectly improving the accuracy of the pressure sensor in measuring pressure.

[0013] In some embodiments, the rigid substrate, the rigid cover and the rigid limiter are integrally covered in a biocompatible sheath. Therefore, since the integrated chip needs to be anchored inside the human body for a long time, in order to reduce the human body's rejection of foreign bodies, the compatible sheath is used to protect the internal structure, prevent blood from entering, ensure the normal transmission of pressure, and reduce the human body's rejection of the device.

[0014] It should be understood that the contents described in the summary of the invention are not intended to limit the key or important features of the embodiments of the present disclosure, nor are they intended to limit the scope of the present disclosure. Other features of the present disclosure will become easily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 The overall structure diagram of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention is shown; Figure 2 A schematic diagram showing the structure of an integrated chip in a monitoring body of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention is shown; Figure 3 A partial structural schematic diagram of a pressure sensor in an implantable intracardiac blood pressure and temperature telemetry device integrated chip provided by an embodiment of the present invention is shown; Figure 4 A partial structural schematic diagram of a pressure sensor in an implantable intracardiac blood pressure and temperature telemetry device integrated chip provided by an embodiment of the present invention is shown; Figure 5 A schematic diagram showing the deformation process of a pressure sensor in an implantable intracardiac blood pressure and temperature telemetry device integrated chip provided by an embodiment of the present invention is shown; Figure 6 A cross-sectional view of a flexible support member of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention is shown; Figure 7 An exploded view of an integrated chip fixing structure of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention is shown; Figure 8 An overall perspective schematic diagram of an implantable intracardiac blood pressure and temperature telemetry device monitoring body provided by an embodiment of the present invention is shown.

[0016] Explanation of symbols 1. Monitoring body; 11. Integrated chip; 111. Pressure-sensitive area; 1111. Pressure sensor; 112. Temperature-sensitive area; 113. Groove; 2. Antenna; 3. External reader; 4. Coil; 51. First pressure-sensitive film; 52. Auxiliary support arm; 53. Flexible support member; 531. Second pressure-sensitive film; 532. Fluid; 61. Rigid substrate; 62. Rigid covering body; 621. Through hole; 63. Flexible film; 64. Rigid limiter; 65. Flexible body; 7. Biocompatible sheath. DETAILED DESCRIPTION

[0017] Hereinafter, preferred embodiments (or implementation modes) of the present invention will be described in detail with reference to the accompanying drawings.

[0018] refer to Figure 1-Figure 8 An implantable intracardiac blood pressure and temperature telemetry device of the present invention is described.

[0019] Figure 1 FIG. 1 is a schematic diagram showing the overall structure of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention. Figure 1 As shown, the implantable intracardiac blood pressure and temperature telemetry device provided in this embodiment includes a monitoring body 1 for fixing in the atrium or blood vessels of the heart, and an antenna 2 interconnected with the monitoring body 1 and fixed under the human skin, and also includes an external reader 3 fixed outside the body and a coil 4 interconnected with the external reader 3 and fixed to the peripheral area of ​​the antenna 2. The external reader 3 generates a radio frequency field in a manner known in the art, and transfers energy to the antenna 2 to indirectly power the monitoring body 1, and the vital sign parameters monitored by the monitoring body 1 through the hardware can also be 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, so as to be adjusted to meet different needs.

[0020] Figure 2 FIG. 1 is a schematic diagram showing the structure of an integrated chip 11 in a monitoring body 1 of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention. Figure 2As shown, the monitoring body 1 includes 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, and the temperature sensing area 112 is composed of a plurality of temperature sensors. The monitoring body 1 can be composed of a dedicated integrated circuit (ASIC), which has 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 sensor 1111 and the temperature sensor to the ASIC transmitter, the ASIC transmitter is connected to the antenna 2, and the data is wirelessly transmitted to the coil 4 and finally received by the external reader 3. The external reader 3 can provide reception and storage of pressure and temperature values, compare the pressure reading of the monitoring body 1 with the ambient pressure via the internal sensor in the external reader 3, and transmit the electrocardiogram data to other devices such as computers, handheld terminals, etc. via standard protocols.

[0021] In this embodiment, the integrated chip 11 is a small-sized, lightweight chip to avoid applying independent stress on the heart and / or generating turbulence in the heart chambers. The integrated chip 11 can be a millimeter-scale plate, depending on the specific application or location in the cardiovascular system where the sensing will occur and on the delivery method, and is generally a rectangular plate, but can also be a square plate.

[0022] Figure 3 A partial structural schematic diagram of a pressure sensor 1111 in an implantable intracardiac blood pressure and temperature telemetry device integrated chip 11 provided by an embodiment of the present invention is shown; Figure 4 FIG. 1 is a partial structural diagram of a pressure sensor 1111 in an implantable intracardiac blood pressure and temperature telemetry device integrated chip 11 provided by an embodiment of the present invention. Figure 3 and Figure 4 As shown, a plurality of grooves 113 are provided on one side surface of the integrated chip 11. In some embodiments, the groove 113 may be a circular groove body, and the pressure sensor 1111 is fixed in the central area of ​​the bottom wall of the groove 113. The surface of each groove 113 is covered with a first pressure-sensitive film 51, and the first pressure-sensitive film 51 is fixed at the edge of the groove 113. Since the first pressure-sensitive film 51 is a pressure-sensitive part, its own physical properties affect the accuracy and service life of the monitoring pressure of the monitoring body 1. The first pressure-sensitive film 51 is affected by the environmental pressure and is concavely deformed toward the direction of the pressure sensor 1111, thereby causing the first pressure-sensitive film 51 to reciprocate with the edge of the groove 113. In order to reduce the reduction in service life caused by the wear of the first pressure-sensitive film 51, the structure inside the groove 113 is improved.

[0023] There is a gap between the edge of the pressure sensor 1111 and the edge of the inner wall of the groove 113. An annular auxiliary support arm 52 is provided in the annular groove on the circumferential side of the pressure sensor 1111. 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 member 53 is provided in the gap between the auxiliary support arm 52 and the inner wall of the groove 113. The top of the flexible support member 53 touches the lower surface of the first pressure-sensitive film 51. During the process of the first pressure-sensitive film 51 being compressed and deformed, the top of the flexible support member 53 is squeezed and driven to deform, 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 made more uniform, and on the other hand, the contact area between the first pressure-sensitive film 51 and the flexible support member 53 is increased, so that the force is more balanced.

[0024] Figure 5 The diagram shows the deformation process of the pressure sensor 1111 in the integrated chip 11 of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention. 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 deformation of the flexible support member 53 under pressure, its inner peripheral side lacks the support of the auxiliary support arm 52, so that during the deformation of the first pressure-sensitive film 51, the flexible support member 53 flows toward the center area of ​​the groove 113 to assist in supporting the first pressure-sensitive film 51, thereby increasing the support range of the auxiliary support member without affecting the deformation of the first pressure-sensitive film 51, so that the deformation transition of the first pressure-sensitive film 51 is more flexible and uniform.

[0025] Figure 6 FIG. 5 is a cross-sectional view of a flexible support member 53 of an implantable intracardiac blood pressure and temperature telemetry device provided by an embodiment of the present invention. Figure 6 As shown, in order to reduce the influence of the reverse force of the flexible support member 53 on the first pressure-sensitive membrane 51, the flexible support member 53 includes an annular cavity formed by the second pressure-sensitive membrane 531, and a fluid 532 located in the annular cavity. Under the limitation of the auxiliary support arm 52, the fluid 532 is limited as a whole in an annular area close to the inner wall of the groove 113. The fluid 532 can be a gel material or a non-conductive liquid. After the first pressure-sensitive membrane 51 is deformed under pressure, the fluid 532 will flow toward the middle of the groove 113, reducing the local stress on the edge of the first pressure-sensitive membrane 51.

[0026] Figure 7 FIG. 1 shows an exploded view of the fixed structure of an implantable intracardiac blood pressure and temperature telemetry device integrated chip 11 provided by an embodiment of the present invention. Figure 7As shown, a rigid substrate 61 is provided on one side of the integrated chip 11 and is embedded in one side surface of the rigid substrate 61, and a rigid covering body 62 of the same size as the rigid substrate 61 is provided on the other side of the integrated chip 11. The rigid substrate 61 and the rigid covering body 62 are fixed to each other to cover and protect the integrated chip 11, and the rigid covering body 62 is provided with a through hole 621 exposing the pressure sensor 1111 in the area of ​​the pressure sensor 1111, so that the pressure sensor 1111 can sense the pressure changes in the external environment.

[0027] 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 fixed at the end of the through hole 621. The flexible body 65 can be made of gel, and the pressure change of the external environment drives the flexible body 65 to squeeze the first pressure film and transmit the pressure; and the flexible film 63 can be a pressure-sensitive film, so that the flexible body 65 is squeezed by the external pressure change to achieve normal transmission of pressure.

[0028] Since the monitoring body 1 is located inside the heart or blood vessels, the pressure of blood flow will increase the local stress on the side walls of the rigid substrate 61 and the rigid cover 62, which may easily cause lateral misalignment between the rigid substrate 61 and the rigid cover 62, thereby affecting the packaging area of ​​the flexible body 65, causing the first pressure-sensitive film 51 to be unstable under pressure, and affecting the accuracy of the final pressure sensor 1111 detection. Therefore, a rigid limiter 64 is fixed to the peripheral side of the rigid substrate 61 and the rigid cover 62 to wrap the rigid substrate 61 and the rigid cover 62.

[0029] Figure 8 FIG. 1 is a perspective view of an implantable intracardiac blood pressure and temperature telemetry monitoring device 1 provided by an embodiment of the present invention. Figure 8 As shown, a biocompatible sheath 7 is provided outside the rigid substrate 61, the rigid cover 62, and the rigid stopper 64. The sheath is made of a flexible material and can transmit external pressure changes to the pressure sensor 1111 to perform pressure monitoring operations. Moreover, the port of the biocompatible sheath 7 is sealed with the connection line of the antenna 2 to reduce external blood from entering the biocompatible sheath 7. Moreover, due to its own material and characteristics, the rejection of the internal environment to the monitoring body 1 is also reduced.

[0030] In the description of this specification, the terms "connection", "installation", "fixation" and the like should be understood in a broad sense. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0031] The above are only preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An implantable intracardiac blood pressure and temperature telemetry device, comprising an integrated chip (11), a groove (113) being provided on the integrated chip (11), a pressure sensor (1111) being fixed in the groove (113), and a first pressure-sensitive film (51) being fixed on the surface of the groove (113), It is characterized in that A gap is left between the pressure sensor (1111) and the inner wall of the groove (113), and a flexible support member (53) for auxiliary supporting the first pressure-sensitive film (51) is attached to the inner wall of the groove (113).

2. An implantable intracardiac blood pressure and temperature telemetry device according to claim 1, It is characterized in that The groove (113) is a circular groove (113), and the pressure sensor (1111) is fixed in the central area of ​​the bottom wall of the groove (113).

3. An implantable intracardiac blood pressure and temperature telemetry device according to claim 2, It is characterized in that An annular auxiliary support arm (52) is provided in the gap between the groove (113) and the pressure sensor (1111), and the flexible support member (53) is located in the annular area between the auxiliary support arm (52) and the inner wall of the groove (113).

4. An implantable intracardiac blood pressure and temperature telemetry device according to claim 3, It is characterized in that The height of the auxiliary support arm (52) is lower than the depth of the groove (113) and is higher than three quarters of the depth of the groove (113).

5. An implantable intracardiac blood pressure and temperature telemetry device according to claim 4, It is characterized in that The flexible support member (53) includes a second pressure-sensitive film (531) and a fluid (532) injected into the second pressure-sensitive film (531).

6. An implantable intracardiac blood pressure and temperature telemetry device according to claim 5, It is characterized in that The integrated chip (11) is fixed on one side of a rigid substrate (61), a rigid covering body (62) is bonded to the rigid substrate (61) on one side of the integrated chip (11), and a through hole (621) is opened in the area of ​​the rigid covering body (62) located at the pressure sensor (1111).

7. An implantable intracardiac blood pressure and temperature telemetry device according to claim 6, It is characterized in that The through hole (621) is filled with a flexible body (65), and is shielded and fixed at the edge of the through hole (621) by a flexible film (63).

8. An implantable intracardiac blood pressure and temperature telemetry device according to claim 7, It is characterized in that The rigid substrate (61) and the rigid covering body (62) are also surrounded by rigid limiting bodies (64) for limiting the misalignment and deviation of the rigid substrate (61) and the rigid covering body (62).

9. An implantable intracardiac blood pressure and temperature telemetry device according to claim 8, It is characterized in that The rigid substrate (61), the rigid covering body (62) and the rigid limiting body (64) are integrally covered in a biocompatible sheath (7).

Images