Portable system for transporting and calibrating cardiac implant before implantation

Abstract

A system (11) includes a portable compartment (55) configured to contain an implant (24) intended to be implanted in an organ, the implant configured to produce an ambient pressure measurement indicative of ambient pressure in a vicinity thereof; a wireless antenna (44) configured to supply electrical power to the implant, and receive the ambient pressure measurement from the implant while the implant is in the compartment; and a control assembly (99) disposed in the compartment, including a temperature module configured to produce a compartment-temperature signal indicative of an interior temperature of the compartment and heat the interior of the compartment, and a processor (77) configured to control the temperature module to retain the interior at a specified temperature based on the compartment-temperature signal, and to read the ambient pressure measurement from the implant, using the wireless antenna, while the implant is retained at the specified temperature.

Description

[0001] PORTABLE SYSTEM FOR TRANSPORTING AND CALIBRATING CARDIAC IMPLANT BEFORE IMPLANTATION CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application 63 / 756,291, filed February 10, 2025, whose disclosure is incorporated herein by reference.

[0002] FIELD OF THE INVENTION

[0003] The present invention relates generally to medical devices, and particularly to methods and systems for transporting and calibrating an implant for measuring blood pressure before implantation.

[0004] BACKGROUND OF THE INVENTION

[0005] Medical devices, such as implants for measuring blood pressure in a patient's heart, are transported (e.g., from a factory or a warehouse) to hospitals to carry out the implantation. The transportation poses a challenge to maintaining the implant in proper temperature and pressure conditions and may compromise the quality of the pressure measurements carried out by the implant.

[0006] SUMMARY OF THE INVENTION

[0007] An embodiment of the present invention that is described herein provides a system including (a) a compartment, which is portable and configured to contain an implant intended to be implanted in an organ, the implant configured to produce an ambient pressure measurement indicative of an ambient pressure in a vicinity thereof, (b) a wireless antenna, which is configured to (i) supply electrical power to the implant, and (ii) receive the ambient pressure measurement from the implant, while the implant is in the compartment, (c) a control assembly, which is disposed in the compartment and includes a temperature module configured to (i) produce a compartment-temperature signal indicative of a temperature of an interior of the compartment, and (ii) heat the interior of the compartment, and a processor, which is configured to (i) control the temperature module to retain the interior of the compartment at a specified temperature based on the compartment-temperature signal, and (ii) read the ambient pressure measurement from the implant, using the wireless antenna, while the implant is retained at the specified temperature.

[0008] In some embodiments, the processor is configured to: receive, at least in a time interval, (i) the ambient pressure measurement from the implant, and (ii) an additional pressure measurement, which is obtained by a pressure sensor located externally to the implant, andcompare between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor. In other embodiments, based on a comparison between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor, the processor is configured to calibrate the pressure measurement of the implant. In yet other embodiments, the processor is configured to (i) determine an offset between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor, and (ii) perform one or more additional comparisons between the ambient pressure measurement and the additional pressure measurement based on a magnitude of the offset.

[0009] In some embodiments, the system further includes a pressure pump, which (i) controlled by the processor based on the additional pressure measurement received from the pressure sensor, and (ii) configured to apply to the interior of the compartment a compartment-pressure determined by the processor. In other embodiments, the processor is configured to control the pressure pump to apply the compartment-pressure (i) higher than 1 atmosphere, and (ii) lower than 1 atmosphere. In yet other embodiments, the processor is configured to (i) control the pressure pump to apply a plurality of different compartment-pressures to the interior of the compartment, (ii) receive a plurality of ambient pressure measurements from the implant corresponding to the plurality of different compartment-pressures, and (iii) calibrate the ambient pressure measurement of the implant based on an average of comparisons between the plurality of ambient pressure measurements and corresponding additional pressure measurements from the pressure sensor.

[0010] In some embodiments, the processor is configured to retain the specified temperature of the implant by controlling a level of the electrical power supplied from the wireless antenna to the implant. In other embodiments, the implant includes an electronic device configured to (i) receive at least part of the electrical power from the wireless antenna, (ii) provide the ambient pressure measurement via the wireless antenna and (iii) provide via the wireless antenna a device-temperature measurement indicative of a temperature of the electronic device, and „ the processor is configured to control the level of the electrical power supplied to the implant based on the device-temperature measurement. In yet other embodiments, the processor is configured to activate the electronic device according to a pressure-measurement activation sequence that is shorter than an operational activation sequence of the electronic device, the pressuremeasurement activation sequence being configured to reduce self-heating of the electronic device during receipt of the device-temperature measurement, thereby reducing impact of selfheating of the electronic device on the device-temperature measurement.In some embodiments, the wireless antenna includes a circuit board (CB) and one or more coils and capacitors mounted on the CB, and the system further includes a power connector configured to provide the wireless antenna with the electrical power supplied by an electrical power source external to the compartment. In other embodiments, the system further including one or more plates fitted in the compartment and having cavities shaped to contain at least the wireless antenna and the control assembly, and the plates are made from material configured to pass (i) the electrical power from the wireless antenna to the implant, and (ii) the ambient pressure measurement from the implant to the processor via the wireless antenna. In yet other embodiments, the control assembly includes: (a) a thermal pad of the temperature module, which is configured to (i) receive additional electrical power from an electrical power source external to the compartment, and (ii) heat the interior of the compartment, and an electronic assembly including (i) the processor, (ii) a temperature sensor of the temperature module, which is configured to produce the compartment-temperature signal, and (ii) the pressure sensor.

[0011] In some embodiments, the one or more plates include (i) a first plate having a first cavity shaped to contain the wireless antenna, and (ii) a second plate having a second cavity shaped to contain the thermal pad, and a third cavity shaped to contain the electronic assembly, and the implant is disposed between the first and second plates. In other embodiments, the implant is disposed between the first and second plates in a package. In yet other embodiments, the implant includes a temperature sensor configured to produce an implant-temperature signal indicative of a temperature of the implant, and the processor is configured to control the temperature module based on the implant-temperature signal received from the implant via the wireless antenna.

[0012] In some embodiments, the processor is configured to (i) control the temperature module to heat the interior of the compartment to a temperature above a target temperature range, (ii) monitor a temperature of the implant via the wireless antenna while the interior of the compartment cools, and (iii) read the ambient pressure measurement from the implant when the temperature of the implant reaches the target temperature range. In other embodiments, the temperature module includes a cooling element configured to actively cool the interior of the compartment based on the compartment-temperature signal. In yet other embodiments, the processor is configured to (i) control the temperature module to cool the interior of the compartment to a temperature below a target temperature range, (ii) monitor the compartmenttemperature signal while the interior of the compartment warms toward the target temperature range without active heating, and (iii) read the ambient pressure measurement from the implant when the temperature of the interior of the compartment reaches the target temperature range.There is additionally provided, in accordance with an embodiment that is described herein, a method, including inserting, into a compartment that is portable, an implant intended to be implanted in an organ, the implant configured to produce an ambient pressure measurement indicative of an ambient pressure in a vicinity of the implant. An interior of the compartment is controlled to be at a specified temperature by (i) producing a compartmenttemperature signal indicative of a temperature of the interior of the compartment, and (ii) heating the interior of the compartment based on the compartment-temperature signal. Electrical power is supplied to the implant and receiving the ambient pressure measurement from the implant, using a wireless antenna while the implant is retained at the specified temperature. The ambient pressure measurement is read from the implant.

[0013] The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which:

[0014] BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Fig. 1 is a schematic, pictorial illustration of a system for combined assessment of body fluid retention and Left-Atrial (LA) blood pressure (LAP), in accordance with an embodiment of the present invention;

[0016] Figs. 2-3 are schematic, pictorial illustrations of a system fortransporting and calibrating an implant of the system of Fig. 1 before implantation in the patient's heart, in accordance with embodiments of the present invention;

[0017] and

[0018] Fig. 4 is a flow chart that schematically illustrates a method for transporting and calibrating the implant of the system of Fig. 1 before implantation in the patient's heart, in accordance with an embodiment of the present invention.

[0019] DETAILED DESCRIPTION OF EMBODIMENTS

[0020] OVERVIEW

[0021] Embodiments of the present invention that are described hereinbelow provide methods and system for (i) transporting (e.g., between sites) an implant configured to measure blood pressure in the Left Atrium (LA) of a patient's heart, and (ii) calibrating the implant's pressure measurements in the field. In the context of the present disclosure, the term "field" refers to any location between the fabrication factory of the implant and the operating room before implanting the implant in the patient's heart.In some embodiments, a system for (i) transporting the implant between sites in controlled conditions (described below), and (ii) calibrating the implant's pressure measurements comprises a portable (e.g., hand-carried) compartment, which is configured to contain an implant intended to be implanted in an organ, such as in a patient's heart. The compartment is configured to contain (i) the implant, or (ii) the implant and a delivery system used for delivering and implanting the implant in the patient's heart. The compartment has a container, and a cover configured to seal the container. The implant is configured to produce an ambient pressure measurement indicative of an ambient pressure of a fluid in the vicinity of the implant. In the present example, the implant comprises a microelectromechanical (MEMS)-based pressure sensor configured to measure the ambient pressure in the blood pool of the LA of the heart.

[0022] In some embodiments, the system fortransporting and calibrating the implant comprises a wireless antenna, which is configured to (i) supply electrical power to the implant, (ii) send commands to the implant (e.g., to perform ambient pressure measurements and switch between several measurement channels), and (iii) receive the ambient pressure measurement from the implant while the implant is in the compartment. It is noted that in the compartment the ambient typically comprises any suitable fluid, such as but not limited to air or another gas held in a controlled temperature, and optionally, in a controlled pressure as will be described below. As such, the wireless antenna receives from the implant the ambient pressure of the air surrounding the implant in the interior of the compartment. The configuration and operation of the antenna are described in detail in Figs 2 and 3 below.

[0023] In some embodiments, the system comprises a control assembly, which is disposed in the compartment. The control assembly comprises a temperature module, a pressure module, and a processor. The temperature module comprises (i) a temperature sensor configured to produce a compartment-temperature signal indicative of the temperature of the fluid (e.g., air) in the interior of the compartment, and (ii) a thermal pad configured receive electrical power so as to heat the interior of the compartment, as will be described in detail in Figs. 2 and 3 below. The pressure module comprises (i) a pressure sensor configured to produce a compartmentpressure signal indicative of the air pressure in the interior of the compartment, and (ii) a pressure pump configured to apply the compartment-pressure that can be higher or lower than 1 atmosphere as will be described herein. It is noted that because the LA receives blood full of oxygen from the lungs and then empties the blood into the left ventricle, the compartmentpressure can be (i) lower than 1 atmosphere to draw the oxygenated blood into the left atrium, and (ii) higher than 1 atmosphere to transfer the oxygenated blood from the left atrium to theleft ventricle. It is noted that the specified and controlled ranges of temperature and pressure in the interior of the compartment are determined based on the operational range of temperature and pressure of the heart. The structure of the pressure module is described in more detail in Figs. 2 and 3 below.

[0024] In some embodiments, the processor is configured to control the temperature and pressure modules to retain the interior of the compartment at a specified temperature (e.g., between about 34°C and 40°C or between about 36°C and 37°C or using any other suitable range of temperatures) and a specified pressure (e.g., between about 0.5 to 1.5 atm) based on the respective compartment-temperature and compartment-pressure signals. Moreover, the processor is configured to (i) read the ambient pressure measurement, which is received from the implant via the wireless antenna while the implant is retained at the specified temperature and pressure, and (ii) calibrate the ambient pressure measurement of the implant by comparing between the ambient pressure measurement from the implant and the air pressure received from the pressure sensor at the interior of the compartment. It is noted that while reading the ambient pressure measurements, the processor receives the compartment-temperature signal from the temperature sensor described above.

[0025] In the context of the present disclosure and in the claims, the terms "one-point calibration" (OPC) and "one-point inspection" (OPI) are used interchangeably to refer to a field calibration process in which the implant's pressure measurement is compared to a reference pressure sensor at one or more pressure points to determine and correct any offset. This calibration process may be performed in the compartment before implantation to verify and adjust the accuracy of the implant's pressure measurements.

[0026] In other embodiments, the pressure pump may be removed from the system configuration and the air in the compartment may be held in atmospheric pressure (or in any other environmental pressure), yet the temperature is controlled within the aforementioned normal operating temperature range, e.g. between about 34°C and 40°C. In such embodiments, the processor is configured to compare between the ambient pressure measurement received from the implant and any suitable data indicative of the compartment pressure to calibrate the ambient pressure measurement produced by the implant in the controlled temperature. For example, when opening the compartment in the operating room, the processor may receive a signal indicative of the environmental pressure (e.g., about 1 atm), and compare between the ambient pressure measurement produced by the implant and the environmental pressure of the operating room to calibrate the ambient pressure measurements carried out by the implant.In some embodiments, the wireless antenna and the implant are configured to exchange the electrical power and ambient pressure measurement wirelessly, typically over radiofrequency (RF) signals. In an embodiment, the system comprises upper and lower sheets or plates fitted in the compartment's cover and container, respectively. In some embodiments, the upper and lower sheets are made from materials, such as polyethylene (PE) sheets or other suitable materials that do not absorb (or negligibly absorb) RF radiation. The system further comprises an electronic assembly, which is external to the implant and comprises the processor and the temperature and pressure sensors described above. In some embodiments, the upper PE sheet has a cavity for containing the antenna, the lower PE sheet has two cavities to contain the thermal pad and the electronic assembly, respectively, and the implant is disposed between the upper and lower PE sheets. This arrangement prevents undesired movement of the aforementioned components while transporting the compartment, for example, in flights, cars or while walking.

[0027] In some embodiments, the implant comprises an electronic device, in the present example an application-specific integrated circuit (ASIC), which is configured to (i) receive at least part of the electrical power from the wireless antenna, (ii) provide the ambient pressure measurement (carried out by the pressure sensor of the implant) via the wireless antenna, and (iii) provide, via the wireless antenna, a device-temperature measurement (also referred to herein as an ASIC -temperature measurement) indicative of the temperature of the ASIC. In the present example, a temperature sensor is integrated in the design of the ASIC and configured to produce a signal indicative of the ASIC temperature. It is noted that the ASIC produces heat during its operation. When implanted in the heart, the blood flow dissipates the heat produced by the ASIC, but this cooling mechanism does not exist in the compartment described above. Moreover, the proximity between the wireless antenna and the ASIC in the compartment may cause generation of additional heat. In some embodiments, the processor is configured to control the level of the electrical power supplied to the implant based on the measured temperature of the ASIC. In other words, the processor is configured to provide the ASIC with the minimal electrical power required to exchange the RF signals without having the ASIC overheated.

[0028] The disclosed techniques provide users of the system with a portable jig configured to control the implant in specified temperature and pressure environments, and to calibrate the implant in the field.SYSTEM DESCRIPTION

[0029] Fig. 1 is a schematic, pictorial illustration of a system 10 for combined assessment of body fluid retention and Left- Atrial (LA) blood pressure, in accordance with an embodiment of the present invention. System 10 comprises an implanted device, also referred to herein as an implant 24, which is implanted at a desired location in a heart 28 of a patient 30 and is used for measuring the ambient blood pressure in its vicinity. In an example embodiment, implant 24 is implanted across an interatrial septum 80 of heart 28, and is configured to measure the blood pressure in the Left Atrium (LA).

[0030] In some embodiments, system 10 comprises an external unit 32, which is configured to communicate with implant 24 and to provide electrical power to the implant’s circuitry. In the present example, external unit 32 is fitted on a belt that is worn by the patient. The belt also comprises an antenna coil 13 of the external unit that surrounds the patient’s thorax. In the present example the belt is worn diagonally over the neck and one shoulder of the patient. Alternatively, however, any other suitable configuration can be used.

[0031] Implant 24 typically does not comprise an internal power source. The internal circuitry of the implant is powered by energy that is provided by external unit 32 using inductive coupling. Typically, external unit 32 generates an Alternating Current (AC) magnetic field via antenna coil 13. This magnetic field induces an AC voltage across an antenna of the implant, and this voltage is then rectified and used for powering the implant circuitry. At the same time, implant 24 sends data (e.g., measurement results of ambient blood pressure) by modulating the load impedance of its antenna, modulation that is sensed by the external unit 32.

[0032] Reference is now made to an inset 21 showing the mechanical structure of implant 24. In this example embodiment, implant 24 comprises an elongated tube 34 (also referred to herein as an implant tube 34) that comprises the electronic circuitry of the implant. Tube 34 is inserted into the interatrial septum 80 having a wall 81 of the left atrium and a wall 82 of the right atrium. A septum gripper also referred to herein as an anchor 40, comprising a collapsible and extensible mesh of a shape-memory alloy (SMA) such as nitinol (made from an alloy of nickel and titanium), is used for fixating tube 34 to the septum 80. In the present example, anchor 40 comprises meshes 39 and 41 placed in contact with walls 81 and 82, respectively.

[0033] In some embodiments, implant 24 comprises an electronic device, such as an application-specific integrated circuit (ASIC) 89 disposed in tube 34 in close proximity to a pressure sensor 38 located within a pressure cup 37, and an antenna coil 36 located within tube 34. In some embodiments, ASIC 89 and pressure sensor 38 are electrically connected with oneanother so as to exchange signals between one another. Implant 24 is implanted such that pressure sensor 38 and ASIC 89 are positioned in the left atrium. ASIC 89 is configured to receive from pressure sensor 38, ambient pressure measurements indicative of the ambient pressure of the blood in the LA of heart 28, and to transmit, via antenna 36, signals to external unit 32, as described above. In the present example, pressure sensor 38 comprises a microelectromechanical (MEMS) device configured to measure the ambient pressure in the blood pool of the LA. In some embodiments, ASIC 89 has an integrated temperature sensor configured to produce a signal indicative of the temperature of ASIC 89. It is noted that the temperature affects the accuracy of the pressure measurements, so that ASIC 89 is configured to determine the ambient pressure based on (i) the temperature measurement received from the aforementioned integrated temperature sensor, and (ii) the ambient pressure measurements received from sensor 38.

[0034] Implants of this sort are addressed in greater detail in U.S. Patent Application Publication 2018 / 0110468, entitled “Heart Implant with Septum Gripper” and in U.S. Patent Application Publication 2018 / 0098772, entitled “Deploying and Fixating an Implant Across an Organ Wall,” which are assigned to the assignee of the present patent application and whose disclosures are incorporated herein by reference.

[0035] Further aspects of blood pressure measurement using such implants, and of interaction between implants and external units using magnetic-field inductive coupling, are addressed, for example, in U.S. Patent Application Publication 2015 / 0282720, entitled “Drift Compensation for Implanted Capacitance-Based Pressure,” in U.S. Patent 10,105,103, entitled “Remotely Powered Sensory Implant,” in U.S. Patent Application Publication 2019 / 0008401, entitled “Power-Efficient Pressure-Sensor Implant,” and in U.S. Patent 10,205,488, entitled “Low-Power High- Accuracy Clock Harvesting in Inductive Coupling Systems.” All these patents and patent applications are assigned to the assignee of the present patent application, and their disclosures are incorporated herein by reference.

[0036] In some embodiments, external unit 32 comprises a wireless communication device configured to transmit signals comprising raw data indicative of the blood pressure measurements. System 10 comprises a cloud gateway device 18 configured to exchange signals with the wireless communication device of external unit 32. In the present example, the signals are exchanged using Bluetooth (BT) or using any other suitable communication protocol and devices. Cloud gateway device 18 is configured to transmit the signals to a cloud computingsystem, referred to herein as a cloud 15, which is configured to analyze the signals, and to display analyzed data described in detail below.

[0037] Additionally, or alternatively, gateway device 18 is configured to transmit the signals to a computer 12 of system 10 used by healthcare provider (not shown). In other embodiments, cloud gateway device 18 may be integrated into computer 12 or in any other suitable device or computing system.

[0038] In the present example, the analyzed data is transmitted from cloud 15 to computer 12, and at least a portion of the analyzed data is transmitted to a patient self-management web-based application installed on a mobile device 17 (e.g., a smartphone) of patient 30. In some embodiments, mobile device 17 may be used for exchanging the signals with cloud 15, instead of or in addition to gateway device 18. Additionally, or alternatively, external unit 32 may comprise a communication device (not shown), such as but not limited to a cellular modem configured to exchange the signals directly with cloud 15.

[0039] In some embodiments, in addition to external unit 32 and antenna coil 13 the belt is electrically connected to a power source (not shown), such as a rechargeable battery. The belt may be worn by patient 30 out of the hospital (e.g., at home) or at the hospital when patient 30 is hospitalized. It is noted that the (i) blood pressure measurements, and (ii) the communication between external unit 32 and implant 24, are carried out during one or more daily time intervals (e.g., each time interval has a duration between about one minutes and one hour), and the battery is being charged by the electrical grid not during these time intervals in order to prevent noise from the electrical grid to interfere with the blood pressure measurements.

[0040] In some embodiments, computer 12 comprises a processor 22, in the context of the present disclosure and in the claims, the term “processor” refers to one or more of the following devices: (i) any suitable type of a central processing unit (CPU) such as but not limited to a general -purpose processor, (ii) a graphical processing unit (GPU), (iii) a tensor processing unit (TPU), (iv) a digital signal processor (DSP), and (v) any other suitable type of an applicationspecific integrated circuit (ASIC). At least one of, and typically all the above types of processing units may have suitable front end and interface circuits configured for interfacing and exchanging signals with (a) several modules and stations of system 11, and (b) entities external to system 11.

[0041] Additionally, or alternatively, computer 12 comprises an interface 20, which is configured to exchange data between processor 22 and other entities of system 10 and / or external to system 10, such as cloud 15.In some embodiments, processor 22 and the electronic circuitry of the implant may be programmed in software to carry out the functions that are used by system 10, and store data for the software in a memory (not shown). The software may be downloaded to processor 22 and to the electronic circuitry of the implant in electronic form, over a network, for example, or it may be provided on non-transitory tangible media, such as optical, magnetic, or electronic memory media.

[0042] In some embodiments, computer 12 comprises a display device, referred to herein as a display 14, which is configured to display to the healthcare provider (e.g., a cardiologist, not shown) an image 19, such as a graph and / or data of the analyzed blood pressure measurements received from (i) processor 22, and / or (ii) cloud 15.

[0043] Figs. 2 and 3 are schematic, pictorial illustrations of a system 11 fortransporting implant 24 in controlled conditions between sites and calibrating pressure sensor 38 before being implanted in heart 28, in accordance with embodiments of the present invention.

[0044] Reference is now made to Fig. 2. In some embodiments, system 11 comprises a portable compartment 55, in the present example a hand-carried compartment, configured to contain implant 24 typically in a package 25, but implant 24 could also be placed in compartment 55 without package 25. In some embodiments, compartment 55 is configured to contain implant 24 and a delivery system 27 coupled to implant 24 and configured for delivering and implanting implant 24 in heart 28 of patient 30. In alternative embodiments, implant 24 may be disposed in compartment 55 without delivery system 27.

[0045] In some embodiments, compartment 55 is made from a thermoplastic polymer such as polypropylene and comprises components of a suitcase, such as handles and rollers (not shown) for carrying compartment 55 between sites, for example from a warehouse to a hospital. As described above, pressure sensor 38 (shown in Fig. 1 above) is configured to produce the ambient pressure measurement, which is indicative of the ambient pressure of a fluid in the vicinity of implant 24. For example, when implanted in heart 28, the ambient pressure measurement is indicative of the ambient pressure of the blood in the blood pool of the LA of heart 28, and when placed in the compartment 55, the ambient pressure measurement is indicative of the ambient pressure of the air or any other gas in the interior of compartment 55.

[0046] In some embodiments, some features of external unit 32 and antenna coil 13 (both described in Fig. 1 above) are implemented in an electronic assembly 33 and a coil-based wireless antenna 44, which are described in detail below. System 11 comprises a connector 47 configured to connect between electronic assembly 33 and antenna 44. During the operation of system 11, electronic assembly 33 is positioned outside compartment 55 and coupled toconnector 47. In such embodiments, electronic assembly 33 is typically configured to fulfill the functions of external unit 32 described in Fig. 1 above, but in some embodiments, the configuration of electronic assembly 33 may not be necessarily similar to that of external unit 32 (e.g., may comprise different types of sensors and / or a different type of processor or controller). While implant 24 is in compartment 55, antenna 44 is configured to exchange signals wirelessly with implant 24. More specifically, antenna 44 is configured to supply electrical power to implant 24, and to receive from implant 24 the ambient pressure measurement of the air surrounding implant 24 in the interior of compartment 55. In some embodiments, antenna 44 comprises a printed circuit board (PCB) also referred to herein as a circuit board (CB) having electronic components, such as coils and capacitors, mounted on a board (in case the PCB refers to a board) or on a flexible substrate known as flexible printed circuit or flex PCB.

[0047] In some embodiments, system 11 comprises a control assembly 99, which is disposed in compartment 55 and comprises electronic assembly 33, a silicon-based thermal pad 52, and optionally, a pressure pump 66. System 11 further comprises a pressure sensor 67 that could be integrated with pressure pump 66, or alternatively, may be separated from pressure pump 66 and coupled, for example, to an internal wall of compartment 55. Moreover, system 11 comprises a temperature sensor 68 disposed in the interior of compartment 55, e.g., coupled to an internal wall of compartment 55. In such embodiments, (i) pressure sensor 67 is configured to produce a compartment-pressure signal indicative of the pressure of (the fluid within) the interior of compartment 55, and (ii) temperature sensor 68 is configured to produce a compartment-temperature signal indicative of the temperature of the interior of compartment 55.

[0048] In some embodiments, electronic assembly 33 comprises a temperature sensor 45, a pressure sensor 46, and a processor 77 mounted on a PCB (also referred to herein as a CB, not shown). In other embodiments, at least one of temperature sensor 45, pressure sensor 46, and processor 77 may be disposed outside electronic assembly 33. The functionalities of electronic assembly 33 are described herein. In some embodiments, when electronic assembly 33 is connected to connector 47 (outside compartment 55) temperature sensor 45 is configured to produce a temperature signal indicative of the temperature of the air (and in some cases other gas) surrounding compartment 55. Alternatively, when positioned within compartment 55, temperature sensor 45 is configured to produce a compartment-temperature signal indicative of the temperature of the fluid (e.g., air) in the interior of compartment 55. Moreover, thermal pad 52 is controlled by processor 77 and configured to receive electrical power from the aforementioned external power source to heat the interior of compartment 55, the combinationof (i) temperature sensor 68 and / or 45 and (ii) thermal pad 52 are also referred to herein as a thermal module. In the context of the present disclosure and in the claims, the combination of thermal pad 52 and temperature sensors 45 and 68 is also referred to herein as a temperature module controlled by processor 77 and configured to control the specified temperature in the interior of compartment 55.

[0049] In some embodiments, the electrical power from an external source may be supplied to system 11 via any power connector, such as through one or more of (i) connector 47, (ii) a power connector disposed in the port of pressure pump 66 and / or pressure sensor 67, (iii) a power connector disposed in the port of temperature sensor 68, or through any other suitable power connector and / or from a battery (not shown) coupled to or disposed in compartment 55 of system 11.

[0050] In some embodiments, when electronic assembly 33 is coupled to connector 47 (i.e., outside compartment 55) pressure sensor 46 is configured to produce an environmental-pressure signal indicative of the air pressure outside compartment 55, and pressure sensor 67 is configured to produce a compartment-pressure signal indicative of the pressure of the fluid (e.g., air) in the interior of compartment 55. When system 11 operates under environmental pressure (i.e., the pressure surrounding compartment 55) processor 77 is configured to use pressure readings received from pressure sensor 46, and temperature measurements received from temperature sensor 68 and / or 45 for calibrating pressure sensor 38 of implant 24. When system 11 operates under controlled pressure that is different from the environmental pressure, compartment 55 is configured to be sealed to maintain the pressure applied to the interior of compartment 55, processor 77 is configured to control pressure pump 66 to apply the compartment-pressure in response to the (i) compartment-pressure signal received from pressure sensor 67, and (ii) compartment-temperature signal received from temperature sensor 68. As described above, compartment 55 is configured to be sealed for maintaining the pressure applied by pressure pump 66. It is noted that when implant 24 is disposed in the interior of compartment 55, processor 77 is configured to be used for calibrating the ambient pressure measurement carried out by pressure sensor 38 of implant 24. As such, pressure pump 66 is configured to apply to the air in compartment 55, suitable levels of pressure that could be lower and higher than atmospheric pressure (e.g., between about 0.5 atmospheres and 1.5 atmospheres or any other suitable pressure), because when implanted in heart 28, less than 1 atmosphere is required when the LA draws blood from the lungs, and more than 1 atmosphere is required when LA pumps out the blood into the left ventricle of heart 28. Pressure sensors 46 and 67 and pressure pump 66 are also referred to herein as a pressure module.In some embodiments, the OPC can be performed at multiple pressures within the pressure range of implant 24 to verify calibration across, at least part of, or the entire range of pressures. In such embodiments, a processor of system 10 that is remote from compartment 55 (for example, a processor of cloud 15) is configured to improve offset cancellation accuracy by averaging the calibration results across multiple pressure points rather than relying on a single pressure measurement. Additionally, or alternatively, processor 77 is configured to control the temperature and / or pressure in compartment 55 during the OPC procedure, to receive from implant 24 (via antenna 44) raw data indicative of the pressure measurements performed by implant 24, and to transmit, via a communication link, the raw data and corresponding reference pressure measurements (e.g., from pressure sensor 67) to the remote processor for performing the offset cancellation.

[0051] In some embodiments, multiple measurements can be performed at a single pressure and temperature point, and processor 77 is configured to reduce measurement error and improve calibration accuracy, for example, by calculating an average of these measurements. This approach may provide more reliable calibration results by reducing the effect of random measurement variations.

[0052] In the context of the present disclosure and in the claims, the term processor 77 refers to any suitable type of a central processing unit (CPU) or a controller. In some embodiments, processor 77 is configured to control the temperature module and the pressure modules to retain the interior of the fluid (e.g., air) in compartment 55 at a specified temperature and pressure corresponding to ranges temperatures and pressures in heart 28. For example, based on the temperature and pressure measurements received from sensors 68 and 67, respectively, processor 77 is configured to maintain in compartment 55 a temperature between about 34°C and 40°C or using any other suitable range of temperatures, and a pressure between about 0.5 and 1.5 atmosphere.

[0053] In some embodiments, the OPC or OPI can be performed at any temperature within the implant's 24 calibrated temperature range (e.g., between about 34°C and 40°C) rather than requiring a specific narrow temperature (e.g., 36.5°C ± 0.5°C). This approach may reduce the time required for temperature stabilization in compartment 55, thereby simplifying the calibration process in the field.

[0054] In some embodiments, the OPC can be performed at room temperature (e.g., between about 20°C and 25°C) if implant 24 was calibrated at room temperature during factory calibration. In such embodiments, the temperature module may not need to heat the interior ofcompartment 55, which may further simplify the system configuration and reduce the duration of the calibration. Additionally, or alternatively, the OPC can be performed at room ambient pressure (e.g., approximately atmospheric pressure), and in such embodiments the pressure pump (and any associated pressure or vacuum system) may be omitted from the configuration of system 11.

[0055] In some embodiments, the OPC can be performed at multiple temperatures within the calibrated temperature range to verify that implant 24 maintains accuracy across the entire temperature range. By performing calibration measurements at different temperatures, processor 77 is configured to improve the overall calibration accuracy and verify the implant's 24 thermal compensation capability.

[0056] In some embodiments, while implant 24 is held at the above-specified temperature and pressure, processor 77 is configured to receive from implant 24 (via antenna 44) the ambient pressure measurement performed by pressure sensor 38. Processor 77 is further configured to compare between (i) the ambient pressure measurement received from implant 24, and (ii) the compartment air pressure received from pressure sensor 67, and to calibrate pressure sensor 38 based on the comparison. It is noted that the temperature inside compartment 55 affects the accuracy of the pressure measurements performed by pressure sensors 67 and 38, and the temperature outside compartment 55 affects the accuracy of the pressure measurements performed by pressure sensor 46. In some embodiments, processor 67 is configured to calibrate the ambient pressure measurement performed by pressure sensor 38 based on (i) the temperatures measured by temperature sensors 45 and 68, and (ii) the pressures measured by pressure sensors 46 and 67. More specifically, when the operating conditions of system 11 require controlled specified temperature and pressure different from that of the environment surrounding compartment 55, processor 77 is configured to calibrate the ambient pressure measurement performed by pressure sensor 38 based on (i) the temperature measured by temperature sensor 68, and (ii) the pressure measured by pressure sensor 67.

[0057] In other embodiments, pressure pump may be removed from the configuration of system 11 and the air in compartment 55 may be held in the environmental pressure, such as approximately atmospheric pressure (depending on the location of the site). In such embodiments, processor 77 is configured to perform the calibration (a) based on the temperatures measured by temperature sensors 45 and 68, and (b) by comparing between (i) the ambient pressure measurement received from pressure sensor 38 of implant 55, and (ii) the environmental pressure received from pressure sensors 46 and / or 67 and / or any suitable source determined by a user of system 11.In some embodiments, ASIC 89 of implant 24 (shown in Fig. 1 above) is configured to exchange RF signals with antenna 44 for (i) receiving the electrical power, (ii) receiving commands from electronic assembly 33 to perform specific measurements at one or more measurement channels, and (ii) transmitting the ambient pressure measurement carried out by pressure sensor 38.

[0058] As described in Fig. 1 above, external unit 32 may comprise a communication device, such as a cellular modem configured to exchange the signals directly with cloud 15, e.g., without mobile device 17. In some embodiments, electronic assembly 33 may comprise a similar communication device (e.g., a cellular modem or any other suitable communication device, not shown) which is configured to exchange the signals, comprising raw data indicative of the temperature and pressure measurements described above, directly with cloud 15.

[0059] Reference is now made to Fig. 3. In some embodiments, system 11 comprises an upper sheet 51 and a lower sheet 53 (also referred to herein as upper and lower plates, respectively) made from materials that do not absorb RF radiation, such as foamed polyethylene (PE) sheets. PE sheets 51 and 53 are fitted in a container 56 and a cover 57 of compartment 55, respectively. Cover 57 is configured to close container 56 while transporting implant 24 between sites. In some embodiments, cover 57 is configured to seal container 56 so as to maintain the temperature and pressure in the interior of compartment 55.

[0060] In some embodiments, PE sheet 51 has a cavity 61 configured to contain and fit over antenna 44, and PE sheet 53 has cavities 62 and 63 configured to contain and fit over thermal pad 52 and electronic assembly 33 (shown in Fig. 2), respectively. It is noted that electronic assembly 33 is stored in cavity 63 while transporting system 11. During the operation of system 11, electronic assembly 33 is electrically connected to antenna 44 via connector 47 to carry out the operations described above.

[0061] Reference is now made back to Fig. 2 above. In some embodiments, implant 24 and delivery system 27 are disposed between PE sheets 51 and 53, so as to (i) exchange the RF signals with antenna 44 disposed over implant 24, and (ii) be in controlled temperature and pressure using thermal pad 52, pressure pump 66 and electronic assembly 33 for sensing and controlling the temperature and pressure of the air in the vicinity of implant 24.

[0062] Reference is now made back to Fig. 3. In some embodiments, the arrangement of antenna 44, thermal pad 52 and electronic assembly 33 in respective cavities 61, 62 and 63, prevents undesired movement of these components while moving compartment 55 of system 11 between sites, for example, in flights, cars or while walking.In some embodiments, the temperature sensor (e.g., a thermocouple implemented as temperature sensor 45 or 68) can be positioned as close as possible to implant 24, including within the package 25 of implant 24. The package 25 can be designed with improved thermal conductivity or with an aperture for inserting and positioning the thermocouple in close proximity to implant 24. This aperture can also be used for better positioning of antenna 44 relative to implant 24, which may reduce variability in the OPC measurement results.

[0063] Reference is now made back to Fig. 1. During the operation of implant 24, ASIC 89 receives power from external unit 32 and produces heat that is dissipated by the blood flowing through the left atrium. It is noted, however, that this cooling mechanism does not exist while implant is disposed in compartment 55 of system 11. With reference back to Fig. 2, the proximity between ASIC 89 of implant 24 and antenna 44 generates additional heat that increases the temperature of the air in the vicinity of implant 24.

[0064] In some embodiments, implant 24 comprises a temperature sensor integrated in ASIC 89 and configured to output a signal indicative of the temperature of ASIC 89. In some embodiments, processor 77 of system 11 is configured to control the level of the electrical power supplied to ASIC 89 of implant 24 based on the signal indicative of the temperature of ASIC 89. It is noted that ASIC 89 is disposed in close proximity to pressure sensor 38 (as shown in inset 21 of Fig. 1), thus, the measured temperature of ASIC 89 is approximately equal to the temperature of pressure sensor 38 of implant 24. In such embodiments, in the absence of the blood cooling mechanism and due to the proximity between ASIC 89 and antenna 44, processor 77 is configured to provide ASIC 89 with electrical power required to operate and exchange the RF signals with antenna 44, but the intensity of the supplied electrical power is limited to prevent overheating of ASIC 89. It is noted that overheating of ASIC 89 may be interpreted (e.g., by processor 77) as the temperature of implant 24 that is different than the ambient temperature. The difference in the measured temperature may result in an error in the pressure measurements carried out by pressure sensor 38 of implant 24.

[0065] In some embodiments, processor 77 is configured to manage heating of implant 24 during wireless communication with implant 24 so as to reduce self-heating effects and to improve accuracy of the OPC measurement. In such embodiments, processor 77 is configured to control at least one of: (i) a level of electrical power transferred from antenna 44 to implant 24, (ii) a duration of one or more wireless interrogation and measurement sequences, and (iii) a repetition rate (duty cycle) of the interrogation and measurement sequences. For example, when system 11 operates with a temperature-controlled interior of compartment 55, processor 77 is configured to execute an interrogation and measurement sequence that has a sufficiently lowpower, short duration, or a combination thereof, such that heat generated in ASIC 89 due to the wireless interrogation has a negligible effect on the temperature of ASIC 89 and on the resulting pressure measurement.

[0066] In other embodiments, system 11 is configured to be operated without controlling the temperature of the interior of compartment 55 to a target temperature range using thermal pad 52. In such embodiments, processor 77 is configured to intentionally heat implant 24 by executing a dedicated heating sequence in which antenna 44 supplies electrical power to implant 24 for a controlled duration, at a controlled power level, or a combination thereof, thereby causing ASIC 89 to dissipate power and raise the temperature of implant 24 toward a target temperature range for performing OPC. After completion of the heating sequence, processor 77 is configured to initiate the OPC process and to acquire one or more pressure measurements from implant 24, optionally using shortened interrogation sequences to reduce additional selfheating during the pressure measurement interval.

[0067] In yet other embodiments, system 11 combines coarse temperature control of the interior of compartment 55 with fine temperature control of implant 24. In such embodiments, thermal pad 52 is configured to provide coarse temperature control of the interior of compartment 55, and processor 77 is configured to provide fine temperature control of implant 24 by controlling at least one of the electrical power level and the duration of wireless power transfer from antenna 44 to implant 24. In this combined approach, processor 77 is configured to (i) bring the interior of compartment 55 and implant 24 into proximity of a desired temperature range using thermal pad 52, and (ii) compensate for residual temperature differences and / or temperature drift of implant 24 by applying controlled heating of implant 24 via antenna 44. This combined approach may reduce the time required for temperature stabilization and may improve repeatability of the OPC measurements.

[0068] In some embodiments, the heating control loop (also referred to as a temperature-control module and, in some implementations, part of control assembly 99) comprises (i) thermal pad 52 as the heating element, (ii) temperature sensors 45 and 68 for sensing temperature, and (iii) processor 77 for controlling the heating control loop. In other embodiments, the heating control loop is closed based on a temperature measurement received from implant 24 (for example, from a temperature sensor integrated in ASIC 89), rather than from an external thermocouple (for example, temperature sensor 68). In some embodiments, the heating control loop, which refers to the temperature module (which is part of control assembly 99), comprises (i) thermal pad 52 as the heating element, (ii) temperature sensors 45 and 68 for sensing temperature, wherein, in an embodiment, temperature sensor 68 is used as a primary sensor for controlling heating of theinterior of compartment 55, and temperature sensor 45 is used for redundancy and / or for measuring an environmental temperature outside compartment 55, and (iii) processor 77 for controlling the heating loop. In other embodiments, the heating control loop can be closed based on the temperature measurement received from the implant's 24 temperature sensor (e.g., the temperature sensor integrated in ASIC 89) rather than from an external thermocouple (e.g., temperature sensor 68). In such embodiments, the implant-temperature measurement may be calibrated and / or specified primarily over a limited temperature range (e.g., between about 34°C and 40°C), and temperature sensor 68 and / or 45 may be used to indicate temperature when the temperature in compartment 55 is outside the limited temperature range and / or to assist in calibrating the implant-temperature measurement. This approach may reduce the requirement to maintain thermal uniformity within compartment 55, for example when processor 77 controls the heating based on the actual temperature of implant 24 within a calibrated temperature range. This configuration may be particularly useful when multiple implants 24 are present within compartment 55 at different distances from the external thermocouple.

[0069] In some embodiments, an alternative approach may be used where no heating control loop is employed. In such embodiments, compartment 55 is heated to a temperature above the target temperature range (e.g., above 40°C), and then allowed to cool naturally while processor 77 monitors the implant temperature via wireless antenna 44. When the implant temperature reaches the desired temperature range (e.g., between about 34°C and 40°C), processor 77 is configured to initiate the OPC process. This approach may simplify the configuration of system 11 by eliminating the need for a closed-loop heating control.

[0070] In some embodiments, the temperature module is configured not only to heat, but also to actively cool the interior of compartment 55. For example, the temperature module may comprise a cooling element (not shown), such as a thermoelectric cooler (TEC) device, a refrigeration element, a cold plate thermally coupled to a heat sink, a forced-convection element (e.g., a fan), and / or any other suitable cooling apparatus configured to remove heat from the interior of compartment 55. In such embodiments, processor 77 is configured to control the cooling element based on the compartment-temperature signal (e.g., produced by temperature sensor 68 and / or temperature sensor 45) to retain the interior of compartment 55 within a target temperature range for performing OPC.

[0071] In some embodiments, system 11 is configured to use active cooling followed by passive heating (also referred to as warm-up) for bringing implant 24 to a desired temperature range prior to performing OPC. In such embodiments, processor 77 is configured to control the temperature module to cool the interior of compartment 55 to a temperature below a targettemperature range (for example, below about 34°C), and then to allow the interior of compartment 55 (and implant 24) to warm naturally toward the target temperature range without active heating. Notably, the passive warm up is limited to the ambient temperature (e.g., room temperature). While the interior of compartment 55 warms, processor 77 is configured to monitor the compartment-temperature signal (and / or an implant-temperature measurement received from implant 24 via antenna 44), and to initiate the OPC process when the monitored temperature reaches the target temperature range (for example, between about 34°C and 40°C or a lower temperature such as the room temperature). This approach may be useful, for example, when a cooling element can drive the temperature toward the target range more quickly than a heating element under certain ambient conditions, and / or when minimizing power consumption is desired by avoiding active heating during the warm-up period.

[0072] In some embodiments, to minimize self-heating of ASIC 89 during temperature measurement, a shortened measurement sequence can be used that activates ASIC 89 for a minimal duration (e.g., less than one second) to extract temperature readings. By reducing the activation time, the energy consumed by ASIC 89 is reduced, thereby minimizing the selfheating artifact that could otherwise affect the accuracy of the temperature measurement. In some embodiments, the shortened measurement sequence described above comprises a dedicated pressure-measurement activation sequence that is used, at least in some cases, for obtaining a device-temperature measurement from ASIC 89 in a manner that reduces selfheating. In the context of the present disclosure and in the claims, an “operational activation sequence” refers to an activation sequence of ASIC 89 that is used during normal operation of implant 24 for performing pressure monitoring and related processing functions (for example, when implant 24 is implanted in heart 28), and a “pressure-measurement activation sequence” refers to an activation sequence that is executed for obtaining one or more pressure measurements and / or a device-temperature measurement with reduced self-heating as compared to the operational activation sequence. In some embodiments, the pressure-measurement activation sequence is shorter than the operational activation sequence, for example by activating ASIC 89 for a reduced duration, and / or by terminating the sequence after completing one or more predefined checkpoints that are sufficient for acquiring the device-temperature measurement.

[0073] In some embodiments, additionally or alternatively, the pressure-measurement activation sequence reduces self-heating by using a reduced power level supplied to implant 24, by reducing an amount of computation performed by ASIC 89, by disabling or bypassing one or more functionalities that are executed during the operational activation sequence, by limitinga number of samples acquired, by reducing a sampling rate, and / or by limiting telemetry activity or other communication overhead. In such embodiments, processor 77 is configured to select between the operational activation sequence and the pressure-measurement activation sequence based on an operating mode of system 11, such as when system 11 is used in compartment 55 for OPC as opposed to when implant 24 is used for normal in-vivo monitoring. By using a pressure-measurement activation sequence that is shorter than (and / or otherwise configured to be less power intensive than) the operational activation sequence, system 11 reduces an impact of self-heating of ASIC 89 on the device-temperature measurement, and improves accuracy of temperature-based compensation and / or calibration of pressure measurements.

[0074] In some embodiments, system 11 does not need to be portable. System 11 can be configured as a stationary apparatus located at hospitals, warehouses, or other facilities for periodic calibration monitoring during storage and / or prior to implantation. Such a stationary system may be used to perform calibration checks at regular intervals (e.g., monthly) to monitor the calibration status of implant 24 over time.

[0075] This particular configuration of system 11 is shown by way of example, in order to illustrate certain problems, such as transporting and calibrating implant 24 before implantation in heart 28. These problems are addressed by embodiments of the present invention that demonstrate the application of these embodiments in enhancing the performance of such a system. Embodiments of the present invention, however, are by no means limited to this specific sort of example system, and the principles described herein may similarly be applied to other sorts of portable jigs that may be used for (i) transporting implant 24 or any other suitable medical device between sites, and / or (ii) calibrating such medical devices before being inserted into and / or implanted in an organ of a patient.

[0076] Fig. 4 is a flow chart that schematically illustrates a method for transporting implant 24 in controlled temperature and pressure, calibrating pressure sensor 38 before being implanted in heart 28, in accordance with an embodiment of the present invention.

[0077] In some embodiments, the number of OPC measurements can depend on the discrepancy between the pressure reading received from implant 24, and the reference pressure sensor (e.g., pressure sensor 67). If the offset is small (e.g., within an expected range based on storage conditions or product acceptance criteria, typically less than about 5 mmHg relative to the acceptance criteria, for example an offset between about -10 mmHg and 20 mm Hg), a single measurement may suffice. If the offset is larger than expected, processor 77 is configured to perform additional measurements to verify the offset before applying calibration correction. This adaptive approach may improve the reliability of the calibration process.In some embodiments, the OPC can be performed during various stages of the integration and manufacturing of implant 24 within the factory to identify which processes affect the accuracy of the readings received from implant 24. By performing OPC before and after specific integration steps (e.g., anchor assembly, sterilization), processor 77 is configured to detect integration steps that may affect calibration. This approach may enable process control and yield improvement by identifying and addressing manufacturing steps that could compromise the accuracy of the readings received from implant 24.

[0078] The method begins at an implant inserting step 100 with inserting implant 24 into the portable compartment 55, shown and described in detail in Figs. 2 and 3 above. Implant 24 is intended to be implanted in heart 28 and configured to produce ambient pressure measurement of a fluid in the vicinity thereof, as described in detail in Fig. 1 above.

[0079] At an interior environment controlling step 102, processor 77 is configured to control a specified temperature, and optionally a specified pressure of the air at the interior of compartment 55, by (i) receiving signals from temperature sensor 68 and pressure sensor 67, and (ii) controlling thermal pad 52 and pressure pump 66 based on the signals received from temperature sensor 68 and pressure sensor 67, as described in detail in Figs. 2 and 3 above.

[0080] At a wireless signal exchanging step 104, processor 77 is configured to control wireless transfer of electrical power from antenna 44 to implant 24, and to receive the ambient pressure measurement from implant 24 via wireless antenna 44, as described in detail in Figs. 2 and 3 above.

[0081] At an additional pressure receiving step 106, processor 77 is configured to receive, from a pressure sensor located externally to implant 24, in the present example pressure sensor 67 disposed in compartment 55, additional pressure measurement of the air at compartment 55, as described in detail in Figs. 2 and 3 above.

[0082] At a pressure calibration step 108 that concludes the method, processor 77 is configured to calibrate the ambient pressure measurement received from pressure sensor 38 of implant 24 by comparing between (i) the ambient pressure measurement from pressure sensor 38 of implant 24, and (ii) the additional pressure measurement from pressure sensor67, as described in detail in Figs. 2 and 3 above. It is noted that while operating in the environmental pressure, processor 77 is configured to (i) receive a signal indicative of the environmental pressure from pressure sensor 46 of electronic assembly 33, which is positioned outside compartment 55, and (ii) calibrate the ambient pressure measurement received from pressure sensor 38 of implant 24 based on the pressure readings received from pressure sensor 46.Although the embodiments described herein mainly address transporting and calibrating an implant configured to be implanted in a patient's heart and to produce ambient pressure measurement of blood flowing through the respective atrium of the heart, the methods and systems described herein can also be used in other applications, such as in (i) transportation of other types of sensing devices in controlled environment (e.g., temperature and / or pressure) and / or (ii) calibration of such sensing devices before being used in respective applications (medical or other). Such sensing devices may comprise, for example, altimeters, pressure sensors, temperature sensors, and barometer sensors.

[0083] It will thus be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in these incorporated documents in a manner that conflicts with the definitions made explicitly or implicitly in the present specification, only the definitions in the present specification should be considered.

Claims

CLAIMS1. A system, comprising:a compartment, which is portable and configured to contain an implant intended to be implanted in an organ, the implant configured to produce an ambient pressure measurement indicative of an ambient pressure in a vicinity thereof;a wireless antenna, which is configured to (i) supply electrical power to the implant, and (ii) receive the ambient pressure measurement from the implant, while the implant is in the compartment; anda control assembly, which is disposed in the compartment and comprises:a temperature module configured to (i) produce a compartment-temperature signal indicative of a temperature of an interior of the compartment, and (ii) heat the interior of the compartment; anda processor, which is configured to (i) control the temperature module to retain the interior of the compartment at a specified temperature based on the compartmenttemperature signal, and (ii) read the ambient pressure measurement from the implant, using the wireless antenna, while the implant is retained at the specified temperature.

2. The system according to claim 1, wherein the processor is configured to:receive, at least in a time interval, (i) the ambient pressure measurement from the implant, and (ii) an additional pressure measurement, which is obtained by a pressure sensor located externally to the implant, andcompare between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor.

3. The system according to claim 2, wherein, based on a comparison between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor, the processor is configured to calibrate the pressure measurement of the implant.

4. The system according to claim 3, wherein the processor is configured to (i) determine an offset between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor, and (ii) perform one or more additional comparisons between the ambient pressure measurement and the additional pressure measurement based on a magnitude of the offset.

5. The system according to claim 2, further comprising a pressure pump, which (i) controlled by the processor based on the additional pressure measurement received from the pressure sensor, and (ii) configured to apply to the interior of the compartment a compartmentpressure determined by the processor.

6. The system according to claim 5, wherein the processor is configured to control the pressure pump to apply the compartment-pressure (i) higher than 1 atmosphere, and (ii) lower than 1 atmosphere.

7. The system according to claim 5, wherein the processor is configured to (i) control the pressure pump to apply a plurality of different compartment-pressures to the interior of the compartment, (ii) receive a plurality of ambient pressure measurements from the implant corresponding to the plurality of different compartment-pressures, and (iii) calibrate the ambient pressure measurement of the implant based on an average of comparisons between the plurality of ambient pressure measurements and corresponding additional pressure measurements from the pressure sensor.

8. The system according to claim 1, wherein the processor is configured to retain the specified temperature of the implant by controlling a level of the electrical power supplied from the wireless antenna to the implant.

9. The system according to claim 8, wherein the implant comprises an electronic device configured to (i) receive at least part of the electrical power from the wireless antenna, (ii) provide the ambient pressure measurement via the wireless antenna and (iii) provide via the wireless antenna a device-temperature measurement indicative of a temperature of the electronic device, and wherein the processor is configured to control the level of the electrical power supplied to the implant based on the device-temperature measurement.

10. The system according to claim 9, wherein the processor is configured to activate the electronic device according to a pressure-measurement activation sequence that is shorter than an operational activation sequence of the electronic device, the pressure-measurement activation sequence being configured to reduce self-heating of the electronic device during receipt of the device-temperature measurement, thereby reducing impact of self-heating of the electronic device on the device-temperature measurement.

11. The system according to any of claims 2-10, wherein the wireless antenna comprises a circuit board (CB) and one or more coils and capacitors mounted on the CB, and comprising apower connector configured to provide the wireless antenna with the electrical power supplied by an electrical power source external to the compartment.

12. The system according to any of claims 2-10, further comprising one or more plates fitted in the compartment and having cavities shaped to contain at least the wireless antenna and the control assembly, and wherein the plates are made from material configured to pass (i) the electrical power from the wireless antenna to the implant, and (ii) the ambient pressure measurement from the implant to the processor via the wireless antenna.

13. The system according to claim 12, wherein the control assembly comprises:a thermal pad of the temperature module, which is configured to (i) receive additional electrical power from an electrical power source external to the compartment, and (ii) heat the interior of the compartment, andan electronic assembly comprising (i) the processor, (ii) a temperature sensor of the temperature module, which is configured to produce the compartment-temperature signal, and (ii) the pressure sensor.

14. The system according to claim 13, wherein the one or more plates comprise (i) a first plate having a first cavity shaped to contain the wireless antenna, and (ii) a second plate having a second cavity shaped to contain the thermal pad, and a third cavity shaped to contain the electronic assembly, and wherein the implant is disposed between the first and second plates.

15. The system according to claim 14, wherein the implant is disposed between the first and second plates in a package.

16. The system according to claim 1, wherein the implant comprises a temperature sensor configured to produce an implant-temperature signal indicative of a temperature of the implant, and wherein the processor is configured to control the temperature module based on the implanttemperature signal received from the implant via the wireless antenna.

17. The system according to claim 1, wherein the processor is configured to (i) control the temperature module to heat the interior of the compartment to a temperature above a target temperature range, (ii) monitor a temperature of the implant via the wireless antenna while the interior of the compartment cools, and (iii) read the ambient pressure measurement from the implant when the temperature of the implant reaches the target temperature range.

18. The system according to claim 1, wherein the temperature module comprises a cooling element configured to actively cool the interior of the compartment based on the compartmenttemperature signal.

19. The system according to claim 1, wherein the processor is configured to (i) control the temperature module to cool the interior of the compartment to a temperature below a target temperature range, (ii) monitor the compartment-temperature signal while the interior of the compartment warms toward the target temperature range without active heating, and (iii) read the ambient pressure measurement from the implant when the temperature of the interior of the compartment reaches the target temperature range.

20. A method, comprising:inserting, into a compartment that is portable, an implant intended to be implanted in an organ, the implant configured to produce an ambient pressure measurement indicative of an ambient pressure in a vicinity of the implant;controlling an interior of the compartment to be at a specified temperature by (i) producing a compartment-temperature signal indicative of a temperature of the interior of the compartment, and (ii) heating the interior of the compartment based on the compartmenttemperature signal;supplying electrical power to the implant and receiving the ambient pressure measurement from the implant, using a wireless antenna while the implant is retained at the specified temperature; andreading the ambient pressure measurement from the implant.

21. The method according to claim 20, further comprising: (a) receiving at least in a time interval (i) the ambient pressure measurement from the implant, and (ii) an additional pressure measurement, which is obtained by a pressure sensor located externally to the implant, and (b) comparing between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor.

22. The method according to claim 21, further comprising calibrating the ambient pressure measurement of the implant based on a comparison between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor.

23. The method according to claim 22, further comprising: (i) determining an offset between the ambient pressure measurement from the implant and the additional pressure measurement from the pressure sensor; and (ii) performing one or more additional comparisons between theambient pressure measurement and the additional pressure measurement based on a magnitude of the offset.

24. The method according to claim 23, further comprising: (i) controlling the pressure pump to apply a plurality of different compartment-pressures to the interior of the compartment; (ii) receiving a plurality of ambient pressure measurements from the implant corresponding to the plurality of different compartment-pressures; and (iii) calibrating the ambient pressure measurement of the implant based on an average of comparisons between the plurality of ambient pressure measurements and corresponding additional pressure measurements from the pressure sensor.

25. The method according to claim 21, further comprising controlling a pressure pump to apply to the interior of the compartment a compartment-pressure, which is predetermined and is based on the additional pressure measurement received from the pressure sensor.

26. The method according to claim 25, wherein controlling the pressure pump comprises controlling the pressure pump to apply the compartment-pressure (i) higher than 1 atmosphere, and (ii) lower than 1 atmosphere.

27. The method according to claim 20, further comprising retaining the specified temperature of the implant by controlling a level of the electrical power supplied from the wireless antenna to the implant.

28. The method according to claim 27, further comprising: (i) receiving at least part of the electrical power from the wireless antenna, (ii) providing the ambient pressure measurement via the wireless antenna and (iii) providing, via the wireless antenna, a device-temperature measurement indicative of a temperature of the electronic device, and controlling the level of the electrical power supplied to the implant based on the device-temperature measurement.

29. The method according to claim 28, wherein providing the device-temperature measurement comprises activating the electronic device according to a pressure-measurement activation sequence that is shorter than an operational activation sequence of the electronic device, the pressure-measurement activation sequence being configured to reduce self-heating of the electronic device during receipt of the device-temperature measurement, thereby reducing impact of self-heating of the electronic device on the device-temperature measurement.

30. The method according to any of claims 21-29, wherein the wireless antenna comprises a circuit board (CB) and one or more coils and capacitors mounted on the CB, and comprisingproviding the wireless antenna with the electrical power supplied by an electrical power source external to the compartment.

31. The method according to any of claims 21-29, further comprising one or more plates fitted in the compartment and having cavities shaped to contain at least the wireless antenna and a control assembly having at least a processor for controlling the interior of the compartment and reading the ambient pressure, and wherein the plates are made from material for passing at least (i) the electrical power from the wireless antenna to the implant, and (ii) the ambient pressure measurement from the implant to a processor via the wireless antenna.

32. The method according to claim 20, wherein controlling the interior of the compartment to be at the specified temperature comprises: (a) receiving the compartment-temperature signal, and (b) supplying additional electrical power to the compartment for heating the interior of the compartment based on the compartment-temperature signal.

33. The method according to claim 20, further comprising receiving, via the wireless antenna, an implant-temperature signal indicative of a temperature of the implant, and controlling the interior of the compartment to be at the specified temperature based on the implant-temperature signal.

34. The method according to claim 20, further comprising: (i) heating the interior of the compartment to a temperature above a target temperature range; (ii) monitoring a temperature of the implant via the wireless antenna while the interior of the compartment cools; and (iii) reading the ambient pressure measurement from the implant when the temperature of the implant reaches the target temperature range.

35. The method according to claim 20, wherein controlling the interior of the compartment to be at the specified temperature comprises actively cooling the interior of the compartment, using a cooling element, based on the compartment-temperature signal.

36. The method according to claim 20, wherein controlling the interior of the compartment to be at the specified temperature comprises: (i) cooling the interior of the compartment to a temperature below a target temperature range; (ii) monitoring the compartment-temperature signal while the interior of the compartment warms toward the target temperature range without active heating; and (iii) reading the ambient pressure measurement from the implant when the temperature of the interior of the compartment reaches the target temperature range.

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