TRANSCUTANEOUS ENERGY TRANSFER

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND
Field

The disclosure relates to a device for the transcutaneous transfer of energy into a human body and method for transferring energy into a human body.

Description of the Related Art

Current heart support systems, or ventricular assist devices (VAD), consist of intracorporeal components, for example a pump, and extracorporeal elements, a control unit, and batteries. The intracorporeal and extracorporeal components may be connected by a cable through the skin, the so-called driveline so that energy may be transferred to the intracorporeal components.

SUMMARY

This application concerns a device for transcutaneous transfer of energy into a human body, and a method for transferring energy into a human body to power a VAD. However, the systems and embodiments described herein can be used to power any intracorporeal medical device. The disclosure provides an improved human-machine interface for medical devices with transcutaneous energy transfer (TET), such as a VAD or an implanted cardiac support system. The device is ergonomic and easy to use. Use of the device can reduce the risk of operating errors and damage to the patient. It may also accelerate the healing process and make other processes, both in everyday patient life and in hospitals, more efficient. Further, in time-critical surgery situations the device can save valuable seconds.

A device for transcutaneous transmission of energy into a human body is described herein. The device may comprise an extracorporeally arranged or arrangeable transmission device with induction charging coil and a sensor device. The induction charging coil is adapted to provide a magnetic field for transferring energy to an induction coil arranged intracorporeally, and the sensor means is adapted to determine a relative position between the induction charging coil and the induction coil. The device may be used to power medical devices. For example, the device may be used in patients with heart failure who use a VAD, such as a heart pump. In such cases, the extracorporeal induction charging coil and the magnetic field wirelessly generate a current in the intracorporeal induction coil, which in turn powers the cardiac support system. In some embodiments, transcutaneous energy transfer may be employed to charge an intracorporeal battery. Advantageously, there is no need for partially rigid cable connections, reducing the risk of infection or injury and increasing the patient's everyday ease-of-use of the cardiac support system.

For optimal transcutaneous energy transfer, alignment of the extracorporeal induction charging coil and the intracorporeal induction coil is important. To establish a current flow, the induction charging coil may be placed on the body and positioned as congruently as possible over the intracorporeal coil. The device may include a sensor configured to detect the relative position between the induction charging coil and the induction coil. During the inductive transmission of electrical energy, the sensor allows the device to determine the relative alignment between the transmitting and receiving inductions coils without using mechanical guides or extensive measuring. Thus, the device can ensure optimal alignment of intra- and extracorporeal induction coils with each other. The device may also be configured to assist a patient or medical staff in the alignment of the induction charging coil.

According to some embodiments, the sensor may include at least one Hall sensor for detecting the position of the extracorporeal induction coil relative to the intracorporeal induction coil. For example, a linear Hall sensor can be placed in the center of the extracorporeal induction charging coil. The Hall sensor may be comprised of a ground connection, supply voltage, and an output. The Hall sensor may be connected to a microcontroller with AC/DC conversion. The supply voltage may be connected to the operating voltage of the microcontroller. The output may be connected to a pin with AC/DC conversion. A small permanent magnet may also be inserted in the center of the intracorporeal induction coil. When the extracorporeal induction charging coil approaches the intracorporeal induction coil, the Hall sensor may be brought into the magnetic field of the permanent magnet. As a result, the voltage at the output of the Hall sensor may increase or decrease, depending on the polarity of the magnetic field. A zero value can be determined during a calibration process where the Hall sensor output is averaged over a short period of time when no magnet is near the device. The maximum deviation from zero value, or maximum output, can be determined by placing the Hall sensor in direct contract with the permanent magnet. Using the output of the Hall sensor, a precise distance between the extracorporeal induction coil and the intracorporeal induction coil can be determined.

According to some embodiments, the sensor may have three Hall sensors. The three Hall sensors may be arranged in a triangle relative to one another in the middle of the extracorporeal induction charging coil. The three sensors may be configured to determine the exact direction of the spatial deviation between the device and the induction coil. For example, if the device approaches the induction coil from one side, the deviation from the zero value for a first Hall sensor may change at a faster rate than the remaining sensors. On the other hand, if the device is approached from above, the measured values of all three sensors may change evenly. Thus, it can be determined whether the permanent magnet of the intracorporeal induction coil is correctly positioned left-to-right and whether the distance between the components is correct. By using more than one Hall sensor, the offset voltage caused by environmental factors can be suppressed, e.g. via spatial spinning current operation.

Additionally, a fourth Hall sensor may be used to determine the exact position of the device relative to the induction coil, specifically whether the device is oriented or rotated in the correctly. This fourth Hall sensor may be placed centrally between the other three Hall sensors. A bar magnet may also be inserted in the center of the intracorporeal induction coil. Because the bar magnet has a north and a south pole, the relative orientation of the device and the induction coil can be determined. The Hall sensors closer to the North Pole may output a value less than Vcc/2, i.e. less than half the supply voltage of the sensors. The fourth Hall sensor can be used to detect the center of the induction coil by placing the Hall sensor in the center of the bar magnet, causing the fourth Hall sensor to output exactly Vcc/2. Accordingly, the device can be ideally aligned over the induction coil if the fourth Hall sensor measures Vcc/2; at least one of the other Hall sensors measures a value less than Vcc/2; and at least one other Hall sensor measures a value greater than Vcc/2. Since the intracorporeal induction coil should not rotate in the body, the sensor may accurately determine the position of the relative position of the intra- and extracorporeal components regardless of the position that the patient is placed in.

According to some embodiments, a software calibration procedure may be performed. During the calibration procedure, the patient or a physician may be instructed or prompted to move the extracorporeal device first exactly downwards, then exactly right, move it exactly up and exactly to the left. Measurements of each of the Hall sensors may be recorded during each movement. This data can be used, for example, as a reference for future displays of the alignment direction.

According to another design, the sensor device can have a gyroscopic sensor for sensing a spatial position of the device. The gyroscopic sensor may provide a spatial signal representing the spatial position of the components of the device. For example, the sensor device may have three Hall sensors arranged in a triangle, and the gyroscopic sensor may be disposed in the center of the triangle. In some embodiments, the device may be positioned while the patient is upright, e.g., in a sitting or standing position. During the positioning process, the gyroscopic sensor can be calibrated by identifying the direction of gravity, i.e. measuring an acceleration of about 9.81 m/s{circumflex over ( )}2. Thus, the position of the device in space and the corresponding alignment of the induction charging coil relative to the induction coil can be indirectly detected.

In addition, the apparatus may also include control apparatus, which may also be referred to as a control unit, for controlling an operation of the induction charging coil using the position signal. The control apparatus may include a non-transitory memory and a processor to execute the functions of the control unit. The position signal may, for example, be used to control a position of the extracorporeal induction charging coil using several sensors of the sensor device represents the relative position detected between the device and the intracorporeal induction coil. As discussed below, the control apparatus may comprise a variety of components that may be positioned intra- or extracorporeally. The control apparatus may be disposed extracorporeally or intracorporeally. Some embodiments may include more than one control unit. For example, an extracorporeal electronic control unit (eECU) may be configured to establish communication with an intracorporeal control unit, which may also be referred to as an intracorporeal electronic controller (iECU), from outside the body. In some embodiments, the device may include the eECU and/or the iECU. The functions of the eECU and control unit are described below. However, the iECU may also be configured to perform the same functions, individually or with the eECU.

The eECU may be configured to control the power supply of the intracorporeal system by means of inductive charging. The power supply may be comprised of one or more rechargeable batteries, also known as extracorporeal batteries (eBAT), which may be connected to the control apparatus and the induction charging coil. Using the position signal, an eECU may initiate or control the charging process for charging an intracorporal energy storage device of a cardiac support system. In addition, the eECU may collect and process technical data of the cardiac support system like positional or system data as well as the patient's vitals. In some embodiments, sensors may be disposed within components of the intracorporeal cardiac support system, for example a flowrate sensor may be arranged in or near a heart pump. The sensors may be designed to record technical data, such as energy consumption and the speed of the pump, and to transmit the collected data to the eECU.

According to some embodiments, the eECU may be configured to provide the collected data to a remote computing environment, such as a cloud network. The eECU may be connected to the remote computer environment via a network such as a wireless network, personal area network, mobile network, or the like. The eECU may also be configured as an interface between different components of the device. For example, the eECU may manage internal components of the device, e.g., a VAD system, as well as external components, such as one or more sensors, a battery, or one or more positioning devices, as well as any communication between components.

In addition, the control apparatus may provide a user with direct feedback for alarms or information about the cardiac support system. According to another design, the device may include a display means for displaying information. The display means may display position information based on the position signal and/or in response to the spatial signal. According to some embodiments, the display device may be adapted to display vital signs of the patient and technical data of the cardiac support system. The display device may also provide a clear presentation of system information such as battery status, pump status, connection status, alarm history and active alarms. Advantageously, a display device may quickly provide a patient or medical personnel with an easy-to-read overview of relevant data relating to the cardiac support system and the patient's health.

According to some embodiments, the display device may show a graphical display of the positional information, system information, or patient vitals. The graphical display may include a battery level indicator, an alarm indicator to indicate an alarm and/or an alarm history. The graphical display may also include a connection indicator to indicate connected devices, components, and/or connection possibilities. Further, the graphical display may include a system indicator to display system information. According to some embodiments, the control unit may receive corresponding signals regarding technical data of the cardiac support system or vital parameters of the patient from an intracorporeally arranged sensor system and generate the graphical display to be displayed by the display unit. A large amount of information may be included in the graphical display. For example, the graphical display may include information, such as body temperature, measured flow of a heart pump or blood pressure, which may be presented to a patient in an understandable manner.

In some instances, the device may include a light unit to visually display the position information. The light unit is configured to facilitate the handling of the device by providing a patient with quick, easily understandable feedback on the cardiac support system and device. In some embodiments, the light unit may be a component of the display device or the control unit. The light unit may be a polychromatic LED light that changes color depending on the relative position. For example, the LED light may shine red light, indicating that the extracorporeal induction coil is located at a distance or angle that is unfavorable for energy transfer. A green light may indicate an optimal positioning of the induction coils. In some embodiments, the light unit may be monochrome. In some embodiments, the light unit may only be activated when the device has reached a predefined minimum distance from the intracorporeal induction coil. According to some embodiments, the light unit may include an alarm function. For example, the light may be activated in case of a device malfunction or low battery.

In addition, the device may include at least one speaker unit for acoustically transmitting the position information. For example, the speaker may be included as part of the control unit. The speaker unit may be configured to emit an acoustic signal as soon as the device has reached the optimal position for power transmission. The acoustic signal may be a simple sound such as a beeping that increases in frequency as the induction coils become more aligned. In some embodiments, the signal may be verbal instructions detailing how the extracorporeal induction coil should be moved to bring it into alignment with the intracorporeal induction coil. The speaker unit may also be configured to generate an acoustic warning signal if an alarm is present, for example, if an unfavorable position change of an induction coil occurs during a charging process. The acoustic signal may allow an alarm to be perceived even when the patient is not actively monitoring the device or becomes distracted. For example, the acoustic signal can be perceived if the device is not positioned directly on the body, e.g., in a pocket, and the alert would not be perceptible visually or haptically.

In some instances, the device may include one vibration unit for haptic display of the position information. According to some embodiments, the vibration unit may be a component of the display device or otherwise disposed against the patient's body. For example, the control apparatus may include a vibration motor, which is mounted on a side of the control apparatus so that a vibration performed by the vibration unit can be transmitted to the human body. The vibration motor may also be placed on a transport or carrying system for the device. In some embodiments, the vibration motor may be placed on the skin or in clothing. The vibration unit may be positioned so that haptic signals can be perceived directly by the patient such that alarms and instructions that are not perceptible by others. The vibration unit may be configured to emit a haptic signal based on the positioning of the device. For example, the vibration unit may emit a haptic signal when the device is placed in an optimal position or when an undesired change in position occurs. The haptic signals generated by the vibration unit may be different based on the positioning of the device. For example, a first haptic signal may be generated in response to the device being placed in the optimal position, and a second haptic signal may be generated if an undesired change in position occurs. Continuing the example, the first signal may be a short, repetitive haptic signal, and the second signal may be a long vibration that continues until the device returns to the optimal position.

The device may further comprise an alarm button configured to trigger an emergency call. The alarm button may be a hardware button or a graphical menu item in the graphical display of the display unit and may be configured to call an emergency contact or emergency services. According to some embodiments, the device may comprise a microphone and a speaker to allow for communication between the patient and the call recipient. The control unit may be connected or connectable to a mobile phone network. Upon pressing the alarm button, the control unit may call a family member stored in the control unit's system and/or call the emergency services. In some embodiments, the alarm button may connect to an emergency center for the VAD system, which can forward the call for help. It is also possible that the control apparatus can be trained to notify the emergency services independently. For example, if an alarm condition of high priority exists for a period of time, the control unit may connect to the stored emergency contact, emergency services, and/or the emergency center for the VAD system and generate a recorded voice message or a text transmission describing the alarm. In some embodiments, the device may be equipped with a GNSS sensor, and the control unit may be further configured to transmit location of the patient.

The control apparatus may be detachably connected to the induction charging coil. For example, the connection can be made by a cable, and after the end of the desired use, e.g. after the end of a charging process, the two components can be separated. In such embodiments, the control apparatus may can be manufactured, stored, or replaced independently of the rest of the cardiac support system. In addition, a control apparatus that can be used externally may provide easy access to the control apparatus.

The control apparatus may be integrated into the extracorporeal transfer device. For example, one or more buttons can be arranged directly on the induction charging coil, whereby the handling of the transmission equipment can be simplified. The extracorporeal transfer device can be designed to be easily accessible so that one or more buttons or a graphical user interface can be used to control the connected components. For example, the one or more buttons may be used to mute alarms. Further, in an emergency, the patient may be found by someone who is not familiar with VAD systems. Outputs from the integrated control apparatus can help the person find the induction charging coil and place it appropriately.

The control apparatus may be arranged in a waterproof and/or dustproof housing. For example, the housing can be designed according to the IP protection class IP55 dustproof and jet-proof. In some embodiments, the housing maybe designed according to IP57 dust protected and protected against temporary immersion. The housing may be manufactured by casting the housing with an epoxy resin or by using a sealant and suitable switches and plug boxes. In some instances, the control apparatus can be protected, especially in case of contact with sweat or water.

The cardiac support system may further comprise a positioning apparatus configured for positioning an extracorporeal induction coil of a cardiac support system on a body. In some embodiments, the positioning apparatus may also retain extracorporeal components of the cardiac support system. The positioning apparatus may include a receiving element for receiving the induction coil, a connecting line for connecting the receiving element and/or the induction coil to at least one extracorporeal component of the cardiac support system, and/or a carrying device and/or a supporting device for carrying the extracorporeal component of the cardiac support system. The receiving element may be detachably connectable to the body and/or a supporting device. The support device, in some instances, may comprise at least one connecting element for releasably connecting the component to the support device.

A correct alignment between the intra- and extracorporeal coils with a displacement of max. 20 mm is important to supply the intracorporal system with sufficient current. In some embodiments, the extracorporeal induction coil may be fastened to the receiving element, which may also be referred to as a mounting element, of the positioning device. The receiving element may be positioned at the optimal position on the body for an energy transfer or charging process. The ergonomic and reliable fastening of the receiving element may provide for increased safety and only slight slipping even when the patient moves, which makes the cardiac support system more efficient and able to transmit greater power. The mounting element may be glued directly onto the patient's skin or connected to the positioning apparatus. The supporting element may include a textile layer such as a vest or a belt system. By means of the textile layer, the receiving element and the induction coil located therein can be connected to other extracorporeal components of the cardiac support system.

The extracorporeal components may include a control apparatus or an energy source, such as a battery. The extracorporeal components may be electrically connected to the receiving element. This connection may be facilitated by such as an electrical conduit or guiding fabric channel in the textile layer that guides wiring between components, for example. In some embodiments, the textile layer may include wiring to connect to the components. During the charging process, the connecting line can allow all the required extracorporeal components to be positioned close to the extracorporeal induction coil while allowing the patient extensive freedom of movement. The components of the positioning apparatus may be connected a supporting element and/or holder. For example, the supporting element may be a holster or vest configured to receive the extracorporeal components of the VAD such as a control unit or the battery. The extracorporeal components may be attached to the supporting element with removable clips, Hook-and-loop fasteners, and associated cable management system.

The receiving element may be releasably connected to the induction coil. According to some embodiments, the receiving element can be formed as a ring and may be comprised of a relatively strong, semi-flexible material. The receiving element may include a raised bead in its surface configured to grip the induction coil a corresponding an undercut in the induction coil when the coil is inserted into the receiving element. According to some embodiments, the receiving element may be comprised of a snap-fit assembly. The snap-fit assembly may be comprised of two members. A first member may be mounted to the patient and optimally positioned relative to an intracorporeal induction coil. The second member may be configured to receive the extracorporeal induction coil. For example, the extracorporeal induction coil may snap into the second member of the snap-fit assembly. According to some embodiments, the snap-fit assembly may be an annular snap-fit assembly. The first member may be ring-shaped and configured to receive the second member concentrically inside of the first member.

The snap-fit assembly allows the induction coil to be easily separated from the receiving element, whereby no residues, for example of an adhesive, remain on the induction coil. Both the induction coil and the receiving element can thus be replaced independently of each other, saving costs and material. In addition, the receiving element can remain on the carrying device, for example, while the induction coil is exchanged or removed. For example, this may advantageously help to protect the coil from water during showering. In such embodiments, the receiving element can remain on the body to avoid skin irritation. In some instances, once the optimal position of the extracorporeal induction coil on the body has been determined, the coil can then be placed in the receiving element quickly and precisely.

According to some embodiments, the receiving element may be comprised of a hook-and-loop fastener, another snap-fit design, or a magnetic clasp. For example, the supporting element can be designed as a vest or shirt, which can, for example, enclose the patient's chest and back. The inside of the supporting element may be comprised of a soft, hook-and-loop material disposed in four defined areas. Accordingly, the receiving element can have hook-and-loop material on a side facing away from the induction coil. The receiving element can then be positioned on one of the hook-and-loop clad areas of the support device and fixed by means of a hook-and-loop fastener. Other means, such as the snap-fit assembly or the magnetic clasp may be similarly utilized.

The receiving element may be designed as part of a positioning patch. For example, the positioning patch can be positioned on the body by means of an adhesive. In some instances, the positioning patch may include a multi-layer structure. For example, the receiving element can be arranged on a carrier layer via a connecting film, such as an adhesive film. The carrier layer can be designed to adapt to different positions and body curvatures. In some embodiments, the carrier layer may be comprised of be made of a very soft and flexible material, which enables it to compensate for different curvatures between the carrier layer and the receiving element. An adhesive may be applied to one side of the carrier layer for adhesion to the patient's skin. The positioning patch may be produced as a low-cost disposable article due to its low-complexity form. The positioning patch may also be configured to be disposable or sterilizable.

The positioning patch, in some instances, may also include an at least partially folded protective film to protect the adhesive. The protective film may be comprised of a thin, smooth, and flexible material and may be formed in one part or in two parts (e.g., double-folded). The folded protective film may prevent the adhesive from drying out and allow the positioning patch to be moved on the body. In some instances, the positioning patch may be allowed to be continuously placed until the optimal charging position for the extracorporeal induction coil is located. After the induction coil has been optimally positioned, the protective film may be removed from the adhesive. For example, the protective film may be pulled away from the adhesive by two tabs. After the protective foil has been pulled off, the adhesive of the positioning patch can be adhered to the body, and the extracorporeal induction coil can be fixed in the optimal charging position.

The supporting element may be comprised of a textile layer. The cable connecting the extracorporeal induction coil to the cardiac support system may be guided or guided along the textile layer. For example, the textile layer may enclose the entire upper body of the patient in the form of a vest, whereby easy dressing and undressing can be realized, for example, by means of a zipper at the front or buttons. In some instances, the positioning apparatus may be designed as a belt system that can be flexibly positioned on the patient's upper body. The cable connecting the extracorporeal induction coil and the cardiac support system may be routed along a surface of the carrying device or be integrated into the structure of the textile layer. The connecting cable may be a fixed shape such that more freedom of movement can be achieved by the patient while wearing the positioning apparatus, increasing patient comfort and protecting the VAD system components.

The positioning apparatus may further comprise a connecting element configured to join the components of the positioning apparatus and/or the extracorporeal components of the cardiac support system. In some embodiments, the connecting element may comprise a groove for inserting a retaining element. For example, the connecting element, which may contain the control apparatus, can be attached onto another component, such as a battery, or the supporting element via a vertical tongue and groove construction. A mechanical spring mechanism may be attached to the tongue and can first be pushed back by the insertion of the tongue into the groove and then return to lock the tongue in a final position in the groove. To unhook the components, an outwardly accessible release button may be pressed. The components may be connected vertically or laterally, and the connection may be secured by additional features, such as a magnet. For example, a horizontal tongue and groove construction can be used, which can have an open profile at defined points in order to insert the fastener. The connecting element can be pushed laterally up to a stop and held in place by a magnet. The magnetic force may be configured to prevent accidental pushing back while allowing people to release the components with relatively little force.

The connecting element may be shaped as an eyelet for hooking the retaining element. For example, an eyelet can be attached to a carrying device designed as a vest or holster. The carrying device may be made of a tear-resistant and flexible textile. The components of the positioning apparatus and the extracorporeal components of the cardiac support system, such as a battery or a control unit, may include a ladder buckle with a hook, which can be hooked into the eyelet. In some instances, a component may be placed in a bag or pocket configured to attach to the eyelet. The component may be detachable from the rest of the positioning system. For example, the patient may use a familiar and easy-to-use buckle system.

The connecting element may include at least one electrical contact element for establishing an electrical contact between the component and the connecting line. For example, the connecting line can be electrically conductive and electrically connected to the component by means of the contact element. The electrical contacts may be spring-activated to compensate for tolerances and ensure constant pressure and contact with the opposite side. The contact element and connecting cable may be configured to allow current and signals to flow between the component, for example a control unit or battery and the receiving element, in which the induction coil for charging the cardiac support system can be located.

The positioning apparatus may further comprise a holding element for detachable connection of the component to the support device. The holding element can be located, for example, on a pocket for holding the component or on the component itself. This allows an extracorporeal component to be connected to or disconnected from the carrying device as needed, increasing the comfort of the positioning device for a patient.

The positioning apparatus may comprise a cable holder configured to guide a cable. The cable holder may be used to fix the connecting cable that leads from the component to the mounting element in the ready-for-operation state, i.e. the optimal position for charging. The cable holder may be configured to safely store cables used during a charging or energy transfer process, thus providing the patient with the greatest possible freedom of movement is made possible.

The positioning apparatus may include at least one strap to fix the carrying device to the body and additionally or alternatively at least one pocket to hold extracorporeal components. For example, the carrying device can be designed as a shirt and include two adjustable rubber straps. The rubber straps may be stretched over the patient's shoulders and cross over the patient's back. From the patient's back, the rubber straps can be led back to the front and fastened at the bottom of the positioning apparatus, for example, with hook-and-loop fasteners. The straps can be used to secure the carrying device and prevent the unwanted movement of the positioning apparatus, external components of the cardiac support system, or the extracorporeal induction coil. The positioning apparatus can be adapted to different body shapes. The carrying device may be expanded by means of pockets integrated into the carrying device for stowing the extracorporeal components. The pockets may be configured so that they are accessible from the outside or inside, for example.

A method for transferring energy into a human body using any one of the apparatuses described herein. The method may comprise providing a magnetic field for transferring the energy to an induction coil; and providing a position signal representing a relative position between the induction charging coil and the induction coil. This procedure can be implemented in software or hardware, for example, or in a mixture of software and hardware in an ECU, for example.

A method of operating any one of the positioning devices described herein may comprise a step of conducting energy from an energy storage device to the receiving element and/or the induction coil. This procedure can be implemented utilizing software, hardware, or in a mixture of software and hardware in an ECU. This procedure may use a computer program containing program code. The computer program may be stored on a machine-readable medium or storage medium (e.g., a semiconductor memory, a hard disk memory, and/or an optical memory). In some instances, the computer program may be used to perform, implement, and/or drive the steps of the procedure according to one of the above-described methods.

BRIEF DESCRIPTION OF THE DRAWINGS

Examples of the approach presented here are shown in the drawings and explained in more detail in the following description.

FIG. 1 shows a schematic representation of an execution example of a heart support system in a human body.

FIG. 2 shows a schematic representation of an execution example of a device with a control device.

FIG. 3 shows a schematic top view of an execution example of one device.

FIG. 4 shows a schematic top view of an example of a fixture.

FIG. 5 shows a perspective view of an example of a fixture design.

FIG. 6 shows a schematic top view of an execution example of a transmission device.

FIG. 7 shows a schematic top view of an example of a fixture.

FIG. 8 shows a perspective view of an execution example of a fixture.

FIG. 9 shows a schematic plan view of an example of a transmission device with a fourth Hall sensor.

FIG. 10 shows a schematic plan view of an example of an intracorporeal transfer device with a permanent bar magnet.

FIG. 11 shows a schematic plan view of an example of a transmission device with a gyro sensor.

FIG. 12 shows a perspective view of an example of an extracorporeal transfer device with integrated control unit.

FIG. 13 shows a cross-sectional view of an execution example of an extracorporeal transfer device with integrated control unit.

FIG. 14 shows an example of a display for displaying position information.

FIG. 15 shows an example of a display for displaying position information.

FIG. 16 shows an example of a display for displaying position information with a position bar.

FIG. 17 shows an example of a display for displaying position information with a position bar.

FIG. 18 shows an example of a start display of a display device.

FIG. 19 shows an example of a start display of a display device.

FIG. 20 shows an example of a menu display of a display device.

FIG. 21 shows an example of a menu display of a display device.

FIG. 22 shows an example of a system display device.

FIG. 23 shows an example of an alarm display unit.

FIG. 24 shows an example of an alarm display unit.

FIG. 25 shows an example of an alarm display unit.

FIG. 26 shows an execution example of a procedure to transfer energy into a human body.

FIG. 27 shows a schematic representation of an example of a positioning device.

FIG. 28 shows a schematic front view of an example of a carrying device.

FIG. 29 shows a schematic front view of an example of a carrying device.

FIG. 30 shows a schematic front view of an example of a carrying device.

FIG. 31 shows a schematic rear view of an example of a carrying device.

FIG. 32 shows a schematic rear view of an example of a carrying device.

FIG. 33 shows a schematic rear view of an example of a carrying device.

FIG. 34 shows a schematic front view of an example of a carrying device.

FIG. 35 shows a diagonal side view of an example of a carrying device.

FIG. 36 shows a cross-sectional representation of an example of an acquisition element.

FIG. 37 shows a cross-sectional representation of an example of a locating element as part of a positioning patch.

FIG. 38 shows a perspective top view of an example of a positioning patch.

FIG. 39 shows a perspective top view of an example of one or more recording elements.

FIG. 40 shows a schematic representation of an example of one or more pick-up element.

FIG. 41 shows a schematic representation of an example of a connecting element with a retaining element.

FIG. 42 shows a schematic representation of an example of a connecting element with a retaining element.

FIG. 43 shows a schematic representation of an example of a connecting element with a retaining element.

FIG. 44 shows a schematic representation of an example of a fastener with a retaining element.

FIG. 45 shows a schematic representation of an example of a connecting element with a retaining element.

FIG. 46 shows a schematic representation of an example of a connection unit.

FIG. 47 shows a schematic representation of an example of a connection unit.

FIG. 48 shows a schematic representation of an example of a connection unit.

FIG. 49 shows a schematic representation of an example of a retaining element with a mating contact element.

FIG. 50 shows a schematic representation of an example of a retaining element.

FIG. 51 shows a schematic representation of an example of a retaining element.

FIG. 52 shows an illustration of an access pathway from the femoral artery to the left ventricle.

FIG. 53 shows a cross sectional rendering of an example Mechanical Circulatory Support (MCS) device mounted on a catheter and positioned across an aortic valve via a femoral artery access.

FIG. 54 is a side elevational view of a mechanical circulatory support system.

DETAILED DESCRIPTION

In the following description, examples are given. In the figures, reappearing elements use identical signs, whereby a repeated description of these elements is omitted. However, the present disclosure should not be limited to any single embodiment described herein. The limitations described are interchangeable. The device may be practiced using any combination of the limitations described herein.

FIG. 1 shows a schematic representation of an exemplary embodiment of a Heart Support System 100 in a human body 105. The Heart Support System 100, which may also be referred to as a Cardiac Support System or Mechanical Circulatory Support system, may be a ventricular assist device (VAD). In this illustration, the human body 105 is shown with partially visible internal organs to show intracorporeal components. The Heart Support System 100 may include an intracorporeal components arranged inside the heart 110 between the left ventricle and the aorta. The Heart Support System 100 may be a ventricular assist device comprising a pump and an intracorporal control device 120. The Cardiac Support System 100 may support the heart rhythm and restart it, if necessary. The energy used to power the Cardiac Support System 100 may be transmitted transcutaneously by means of the device described in more detail in FIG. 2. In some embodiments, the Cardiac Support system 100 may comprise an intracorporeal energy storage unit 125, e.g. a battery, configured store energy. For transcutaneous transfer of energy into the body 105, the Cardiac Support System 100 may also include a first induction coil 130 and a second induction coil 135. Both the induction coil 130 and the second induction coil 135 may be configured to transmit a magnetic field to inductively transmit energy to the other components of the Cardiac Support System 100, such as the other induction coil.

FIG. 2 shows a schematic representation of an exemplary embodiment of a transcutaneous energy transfer (TET) device 200 comprising a control device 205. The control device 205, which can also be called a control unit, may be connected to an extracorporeal energy storage device 210, e.g. a battery with an adapter. The control unit 205 may be configured to direct energy from to the extracorporeal energy storage device 210 to the transmission device 215. The energy transmission device 215 may comprise an induction charging coil 220 (see FIG. 3) configured to generate a magnetic field to transfer the energy provided by the control device 205 to an intracorporeally located induction coil 130. To achieve energy transfer, the induction charging coil 220 may be positioned on the outside of the body 105 above the intracorporeal induction coil 130. In some instances, the induction charging coil 220 and intracorporeal induction coil 130 may be disposed concentrically. The transmission device 215 may comprise a device connected to the induction charging coil 220. The induction charging coil 220 may be directly connected to the control unit 205.

The Cardiac Support System 100 or the transcutaneous energy transfer (TET) device 200 may, in some embodiments, include a position sensor device 230 configured to detect a relative position between the induction charging coil 220 and the induction coil 130 and to provide a position signal 235 representing the relative position to the control device 205. In some embodiments, the control device 205 may include a display device 240. Using the position signal 235, the display unit 240 may display positional information or instructions related to how to improve relative position visually using symbols (e.g., representing the coils or a direction or quantity to move the transmission device) and/or using words, statements, sounds, or haptic feedback. The display unit 240 may also be configured to display patient information or information about the Cardiac Support System 100. The display unit 240 may be configured to generate a graphical display to convey the information to a patient or other user. The display unit can also be configured to output information via light symbols, beeps, haptic feedback by means of one or more vibration units, arrows, changes in color grading in the display output, coloring of the display edges, and/or a visual percentage indication for the alignment.

FIG. 3 shows a schematic top view of an example of a TET device 200. The TET device 200 may comprise an extracorporeal transmission device 215 and an intracorporal transmission device 300. According to some embodiments, the TET device 200 may comprise a sensor device 230. The sensor device may be a Hall sensor 302. The Hall sensor 302 may be disposed in the middle of the induction charging coil 220, which can also be called TET coil. The Hall sensor 302 may comprise a ground connection 305, a supply voltage 310, and output 315. The sensor device 230 may be connected to a microcontroller 320 with A/D conversion. In some instances, the microcontroller 320 may be a component of the control device 205. The ground connection 305 of the Hall sensor 302 may be connected to a ground 325 of the microcontroller. The supply voltage 310 may be connected to the operating voltage 330 of the microcontroller 320, and the output 315 may be connected to pin 335 with A/D conversion. The intracorporeal transmission device 300, which can also be described as an intracorporeal TET coil, may comprise an induction coil 130. A small permanent magnet 340 may be disposed in the center of the intracorporeal induction coil 130 to provide a magnetic field that can be detected by the sensor device 230. As the extracorporeal transmission device 215 and the intracorporeal transmission device 300 become concentrically aligned, the Hall sensor 302 is brought into the magnetic field of the permanent magnet 340. As illustrated in FIG. 3, the extracorporeal transmission device 215 can be offset from the intracorporeal transfer device 300, and as such, the magnetic field cannot be fully detected by the sensor 302.

FIG. 4 shows a schematic diagram of an embodiment of the TET device 200. As depicted in FIG. 4, the extracorporeal transmission device 215 is almost concentrically arranged relative to the intracorporeal transfer device 300. This arrangement can allow the magnetic field provided by the permanent magnet 340 to be detected by the Hall sensor 302. The alignment may change the voltage at output 315 of the Hall sensor 302. For example, the voltage at output 315 of the Hall sensor 302 may increase or decrease, depending on the polarity of the magnetic field. The Hall sensor 302 may be calibrated by averaging the output 315 over a short period of time when a magnet is not near the extracorporeal induction charging coil 220. This calibration may allow a zero value to be determined. A maximum deviation from the zero value may be determined by placing the Hall sensor 302 in direct contact with the permanent magnet 340. Using the zero value and maximum deviation, the relative distance between the extracorporeal charging coil 220 and the intracorporeal induction coil 130 can be determined based on the output 315.

FIG. 5 shows another perspective of the TET device 200 depicted in FIG. 4. As shown in FIG. 5, the extracorporeal transmission device 215 is almost concentrically arranged relative to the intracorporeal transfer device 300. The magnetic field provided by the permanent magnet 340 can be transmitted through the Hall effect and may be detected by the Hall sensor 302. Based on the output voltage of the Hall sensor 302, the relative distance 500 between the induction charging coil 220 and the induction coil 130 can be determined. In some embodiments, the control unit 205 may be configured to receive the output voltage from the Hall sensor 302 and determine the relative position of the induction coils 220 and 130.

FIG. 6 shows a schematic top view of an embodiment of an extracorporeal transmission device 215. The transfer device shown in FIG. 6 may be substantially similar to the those described in the previous FIGS. 2 to 5. As illustrated in FIG. 6, the sensor device 230 of the transmitter 215 may include at least three Hall sensors: a first Hall sensor 302, a second Hall sensor 600, and a third Hall sensor 605. The three Hall sensors 302, 600, 605 may be disposed in or toward the middle of the extracorporeal induction charging coil 220 and arranged in a triangle or any desired shape.

FIG. 7 shows a schematic top view of the TET device 200, which may be substantially similar to those in FIGS. 2 to 6. The TET device 200 can comprise an intracorporal transfer device 300, which is partially overlaid by the extracorporeal transmission device 215 as illustrated in the figure. The extracorporeal transmission device 215 may comprise a sensor device 230 that may include a first Hall sensor 302, a second Hall sensor 600, and a third Hall sensor 605. As shown in FIG. 7, the Hall sensors 302, 600, and 605 may be disposed in a middle section of the extracorporeal induction charging coil 220 and arranged in a triangle. The intracorporeal induction coil 130 of the intracorporeal transfer device 300 may include a centrally-arranged permanent magnet 340. The control unit 205 may be configured to determine the exact direction and quantification of the deviation of the induction charging coil 220 from the induction coil 130 using the output voltages of the Hall sensors 302, 600, and 605 via triangulation. For example, if the extracorporeal induction charging coil 220 approaches the intracorporeal induction coil 130 from the side, one of the Hall sensors will detect a greater deviation from the zero value than the other sensors. Specifically, as shown in the embodiment of FIG. 7, the measured value of the third Hall sensor 605 will deviate more from a zero value than that of the second Hall sensor 600 and the first Hall sensor 302, if the extracorporeal induction coil 220 approaches the intracorporeal induction coil 130 laterally from the left side of the figure. Based on the output of the three Hall sensors 302, 600, and 605, the control unit 205 may determine the position of the extracorporeal induction coil 220 relative to the intracorporeal induction coil 130. The control unit 205 may further determine the direction the extracorporeal induction coil 220 is moving or is required to move such that it becomes concentrically aligned with the intracorporeal induction coil 130. For example, as illustrated in FIG. 7, the control unit 205 may determine that the center of the Hall sensors 302, 600, and 605 is to the left of the permanent magnet 340 based on the output voltage of each Hall sensor. The control unit may determine that the induction charging coil 220 should be moved in the direction of the third Hall sensor 605 until the induction coils 130 and 220 are concentrically aligned.

FIG. 8 shows an isometric perspective of the TET device 200 shown in FIG. 7. In the figure, the induction charging coil 220 is concentrically disposed relative to the induction charging coil 130. In this position, the measured values of the Hall sensor 302, the second Hall sensor 600, and the third Hall sensor 605 can be the same or substantially the same. Thus, the control unit may determine that the permanent magnet 340 is located an equal distance or a substantially equal distance from each of the sensors.

FIG. 9 shows a top view of an embodiment of a transmission device 215 that is substantially similar to the transmission device described above in conjunction with FIG. 6. The transmission device can include at least three Hall sensors 302, 600, and 605. The transmission device can include a fourth Hall Sensor 900 configured to determine the position of the extracorporeal induction charging coil 220 relative to the intracorporal induction coil. The first Hall sensor 302, the second Hall sensor 600 and the third Hall sensor 605 may be arranged concentrically around a center of the extracorporeal induction coil 220, while the fourth Hall sensor 900 may be disposed in the center of the other Hall sensors 302, 600, and 605.

FIG. 10 shows a diagram of an intracorporeal transfer device 300 that comprises a permanent bar magnet 1000. The intracorporeal transfer device 300 depicted in FIG. 10 may be substantially similar to the intracorporeal transfer device 300 described above in any one of FIGS. 3-5, 7 and 8. In some instances, the center of the induction coil 130 may be fitted with a permanent rod magnet 1000. The permanent bar magnet 1000 can include a north pole 1005 and a south pole 1010. The position of the extracorporeal induction charging coil 220 (as shown in FIG. 9) may be determined relative induction coil 130 based on the output voltage of the four Hall sensors 302, 600, 605 and 900 based on the poles 1005, 1010 of the bar magnet 1000. The Hall sensors of the induction charging coil, which are closer to the north pole 1005, may indicate a value less than half the supply voltage (Vcc) of the sensors. The Hall sensors, which are closer to the south pole 1010, may show a value between Vcc/2 and Vcc. The fourth Hall sensor 900, described in FIG. 9, may be configured to find the center of the induction coil 130. If the fourth Hall sensor is disposed in the middle of the permanent magnet 1000, the output voltage of the fourth Hall sensor will be Vcc/2. For example, the control unit 205 may determine that the extracorporeal induction charging coil 220 is aligned concentrically over the intracorporeal induction coil 130 if the fourth Hall sensor measures Vcc/2, at least one of the other Hall sensors measures a value smaller than Vcc/2, and at least one other Hall sensor measures a value greater than Vcc/2.

FIG. 11 shows a schematic top view of an embodiment of a transmission device 215 that may be configured substantially similar to the transmission device 215 described above in conjunction with any one of FIGS. 2 through 10. The transmission device may comprise a gyro sensor 1100. The gyro sensor 1100 may be disposed in the center of the induction charging coil 220 and configured to compensate for positional inaccuracies that occur during use of the Cardiac Support System 100, such as twisting of the extracorporeal induction coil 220. The gyro sensor 1110 may be a gyroscope, a micro-electromechanical systems (MEMS) gyroscope, such as a gyrometer, a ring laser gyroscope, a fiber optic gyroscope, or the like. The extracorporeal induction charging coil 220 may comprise any suitable number of Hall sensors (e.g., as illustrated, a first Hall sensor 302, a second Hall sensor 600, and a third Hall sensor 605), which may be arranged concentrically around a center of the coil 220. The intracorporeal induction coil, in some instances, may also include a permanent magnet (1000) as described herein. In some embodiments, energy transfer can be performed while the patient is in an upright position, e.g. sitting upright or standing. Once the patient is upright, the transmission device 215 can be positioned. During the positioning process, the gyro sensor 1100 may measure an acceleration of gravity (9.81 m/s{circumflex over ( )}2) and transmit a baseline orientation signal 1105 to the control unit 205. The control unit 205 may be configured to position or generate instructions for positioning the extracorporeal induction coil 220 using the baseline orientation signal, which can also be referred to as a spatial or “room” signal. As the extracorporeal induction coil 220 is moved into place, the gyro sensor 1100 may generate an output signal in response to the movement and transmit the output signal to the control unit 205. The control unit 205 may be configured to update the relative position of the extracorporeal induction coil 220 or the positioning instructions based on the update output signal from the gyro sensor 1100.

FIG. 12 shows an embodiment of an extracorporeal transmission device 215 further comprising an integrated control unit. The transmission device 215 may be configured substantially similar to the transmission devices described above in conjunction with any one of FIGS. 2-9 and 11. In some instances, the transmission device 215 may arranged in a housing 1200. For example, the integrated control unit may be at least partially located within the housing 1200. The housing 1200 may be watertight, fluid impermeable, and/or dustproof. The housing 1200 may be attached to the interface 1202 and sealed to ensure water, fluid, and/or dust resistance. In an operational state, the transmission device 215 may rest directly on the body 105. The transmission device 215 may also comprise a ring-shaped light unit 1205 configured for the visual display of position information. For example, the ring light may light up only in a direction relative to the center of the transmission device to indicate the transmission device needs to be moved in that direction. For example, the ring light may or a portion of it may flash at a rate that is related to the distance of offset (e.g., the light may blink more quickly as it gets closer to the target). The ring-shaped light unit 1205 may be arranged on the side of the transmission device 215 opposite the body 105, i.e. the side or face of the transmission device 215 that is not in contact with the body 105. The transmission device 215 may comprise a mechanical button 1210 disposed in the center of the ring-shaped light unit 1205. The button 1210 may be designed as part of the control unit and be configured to control various components of the transmission unit 215 or the Cardiac Support System 100. For example, pressing the button 1210 may trigger a system function such as muting alarms. Further, the transmission device 215 may comprise a loudspeaker unit 1215 arranged between the button 1210 and the light unit 1205 for acoustic output of the position information, patient information, or other information related to the use of the Cardiac support system. As illustrated in the example shown in FIG. 12, the button 1210 can be a circle concentrically surrounded by the light unit 1205. A speaker unit 1215 can reside between the button 1210 and the light unit 1205. However, it will be understood by one having ordinary skill in the art that the button 1210, the speaker unit 1215, and the light unit 1205 are not limited to these shapes or orientations relative to one another. The button 1210, the speaker unit 1215, and the light unit 1205 may be a variety of shapes and may be oriented in any manner based on the shape and size of the transmission device 215.

FIG. 13 shows a cross-sectional view of an example of an extracorporeal transmission device 215 with an integrated control unit similar to the transmission device described in the previous FIG. 12. The housing 1200 of the transmission device 215 may be formed from a lower half of the housing 1302 and an upper half of the housing 1301. The transmission device 215 may comprise a ferrite component 1303. The ferrite component 1303 may be disposed inside the housing 1200 and be arranged as a core of the winding of the induction charging coil 220 and configured to shield the same. A circuit board 1305 may be disposed above the ferrite component 1303. Additional elements of the control unit may be arranged on the circuit board 1305. For example, a vibration unit 1310 for haptic display of the position information may be disposed on any side (e.g., the underside) of the circuit board 1305. The vibration unit 1310 can be in direct contact with the ferrite component 1303. In some embodiments, the ferrite component 1303 may include a recess 1312 to accommodate the vibration unit 1310, which may reduce the overall height of the transmission device 215. The vibration unit 1310 may be configured to and arranged such that vibrations can be transmitted from the vibration unit to the human body 105 via the housing 1200. For example, as illustrated in FIG. 13, the vibration unit may initiate a vibration which is transferred from the ferrite component 1303 to the housing 1200 to the body 105. In some embodiments, a button 1315 with a mechanical knob 1210 may be disposed on the side of the circuit board 1305 opposite the vibration unit 1310 (e.g., the side facing away from the body 105). A speaker unit 1215 may also be arranged beside the button 1210. The speaker unit 1215 may be arranged in a sealed chamber 1320 and configured to emit sound to the patient through a speaker opening 1325, which may be waterproofed for example by sealing the speaker opening with a flexible membrane. Around the button 1210 and the speaker unit 1215 may be a light unit 1205. The light unit 1205 may include an LED or array of LED's 1330 and a ring-shaped light guide 1335.

FIG. 14 shows an example of a display 1400 for displaying position information, patient information, or other information related to the use of the Cardiac Support System 100. The display 1400 may be a graphical display generated by a display unit 240 as described herein. The display unit 240 may be configured to generate the display 1400 or changes thereon. In some embodiments, the control unit 205 may be configured to generate the display 1400 on the display unit 240 and update the display 1400 based on data received by the control unit, e.g. positional data, patient data, or the like. The display 1400 may be configured to execute a user interface, such as a touch user interface. The display 1400 may be a 2.8″ display. The display may be adjusted to be displayed on smaller or larger displays and adapted to different aspect ratios, such as 4:3 or 16:9.

FIG. 14 is divided into three subfigures: 14A, 14B and 14C. In these subfigures, various display options are shown. Each of the display options is configured to convey information regarding the relative positioning of an extracorporeal induction charging coil over an intracorporeal induction coil. In the left-hand figure, 14A, a warning message 1402 with the information “TET not connected, position TET” is shown. Below the warning message 1402, the display includes two concentric circles, which represent a position point 1405 and a position circle 1410 arranged around the position point 1405. Based on any of the position signals described herein, the control device 205 (e.g., as described in connection with FIGS. 2, 12 and 13) may be configured to display position points 1405 of different sizes in the display device 240. For example, as the induction coils become increasing misaligned, the position point 1405 may become smaller. In FIG. 14B, position point 1405 is shaped with a larger diameter than in FIG. 14A, which indicates that the extracorporeal induction coil is approximately aligned with the intracorporeal induction coil. In some instances, the circle will grow as the induction coils come closer to concentric alignment. In the right-hand FIG. 14C, the two coils are generally concentrically aligned, and the display unit 240 may generate a check mark 1415 instead of the position point 1405. After the coils are aligned and the check 1415 appears, the control unit 205 may be configured to instruct the display unit 240 to display a home screen. In some embodiments, the display unit 240 may be configured to return to a home screen after a predetermined period of time. If the induction charging coil slips out of alignment, the display unit may display the positioning screen shown in FIGS. 14A and 14B again.

FIG. 15 shows another example of a display 1400 and includes three subfigures: 15A, 15B and 15C. In these subfigures, various display options for information regarding the positioning of an extracorporeal induction charging coil over an intracorporeal induction coil are shown in a display 1400 of the display unit 240. The position point 1405, shown in FIG. 15 as a filled, light-grey circle in the partial FIG. 15A, may be generated on the display 1400 and represent the position of the extracorporeal induction coil 220. The position circle 1410, shown as an unfilled black circle, may be positioned on a center line of the display 1400 and represent a position of the intracorporal induction coil 130. The position point 1405 may be generated on the display based on the position data of the extracorporeal induction coil relative to the intracorporeal induction coil. For example, in FIG. 15A the position point 1405 may be disposed to the left of the position circle 1410 based on position data, indicating that the extracorporeal induction coil 220 is to the left of the intracorporeal induction coil 130. In some embodiments, the display 1400 may comprise an arrow 1500 configured to indicate the direction in which the extracorporeal induction coil 230 should be moved in order to achieve alignment with the intracorporeal induction coil. FIG. 15B illustrates an example where the position point 1405 is shown laterally above the position circle 1410. In FIG. 15C, the induction coil and induction charging coil are optimally aligned, and a 1415 checkmark appears in the 1400 display. In some embodiments, the position circle 1410 may also be filled in grey when the induction coils are aligned (or provide some other visual indication that correct alignment is achieved, such as a green light).

FIG. 16 shows an example of a display 1400, which may include a position bar 1600. FIG. 16 is divided into two partial figures: 16A and 16B. The display 1400 variant shown here may be suitable for wide displays with low height or as a component of a display 1400 that includes other information, such as patient information or other information related to the Cardiac Support System 100. As shown in FIG. 16A, the display may comprise a position bar 1600 with any number of bar modules 1605 (e.g., seven as illustrated). The position bar 1600 may be disposed in the middle of the display 1400. A different coloring of the bar modules 1605 (dark grey and white) may represent the degree to which the extracorporeal induction charging coil is aligned with the intracorporeal induction coil. In FIG. 16A, only four exemplary bar modules 1605 are colored grey and three bar modules 1605 are colored white, which may indicate a moderate, but not optimal, alignment of the induction coils. As the alignment between the induction coils improves, more bar modules 1605 become white from left to right. For example, if alignment improved slightly from FIG. 16A, the fourth bar module 1605 may become white. In FIG. 16B, the induction coils may be optimally aligned, and all modules may become white. Once the induction coils are aligned, a check mark 1415 may be generated in the middle of the position bar 1600.

FIG. 17 shows an example of a display 1400 configured to display position information with a position bar 1600. FIG. 17 is divided into three subfigures: 17A, 17B and 17C. The display 1400 shown here is similar to the one in the previous FIG. 16, with the difference that an additional arrow 1500, which is similar to the arrow in FIG. 15, may be included and configured to indicate which direction the extracorporeal induction charging coil 220 should be moved to achieve alignment with the intracorporeal induction charging coil 130. For example, in FIG. 17A the arrow 1500 points diagonally downwards and in the FIG. 17B the arrow 1500 points to the right. The direction of the arrow 1500 in FIGS. 17A and 17B may be determined based on the current position of the extracorporeal induction coil 220 relative to the intracorporeal induction coil 130. The direction of the arrow 1500 may correspond to the direction the extracorporeal induction coil 220 needs to be moved to be in alignment with the intracorporeal induction coil 130. In FIG. 17C, the inductions coils may be optimally aligned to each other. Accordingly, all bar modules 1605 of position bar 1600 are white, and a check 1415 is displayed instead of the arrow 1500.

FIG. 18 shows an exemplary embodiment of a start display 1800 to be generated on any display unit 240 as described herein. FIG. 18 is divided into two partial figures: 18A and 18B. In the subfigures, different options for displaying information regarding a connected energy storage device are shown. The start display 1800, which may also be called home screen, may include information about connected batteries. For example, in FIG. 18A, the start display 1800 may include a battery symbol I, a battery symbol J, and a battery symbol K, which may correspond with three batteries attached to the Cardiac Support System 100. If a battery is not connected, such as battery K in the example shown here, only the outline of the battery symbol may be shown. In FIG. 18A, two batteries are connected (I and J), and the induction charging coil may be positioned so that energy is supplied to the intracorporal system is transferable. Accordingly, battery symbol I and battery symbol J are filled with colored bars 1805 and gray bars 1810. Each bar may represent 25% of a full charge. In some embodiments, each bar may represent 20%, 10%, 1%, or another portion of a full charge. The color of the bars may represent the following information:

Grey: part of the battery already discharged.

Green: remaining battery charge, total battery charge>50%.

Yellow: remaining battery charge, total battery charge<50%>25%

Red: remaining battery charge, total battery charge<25%.

As shown in FIG. 18B, all three batteries may be connected, and the battery symbol K is displayed filled in. The start display 1800 may also include a symbol A which represents the internal battery (iBAT), a symbol B which represents a first external battery (eBAT1), and a symbol C which represents a second external battery (eBAT2). Further, the start display 1800 may include a symbol D that symbolizes all of the batteries attached to the Cardiac Support System 100. The start display 1800 may also include a remaining charge time (marked as L in FIG. 18A), which indicates how long the iBAT and eBATs can power the Cardiac Support System 100 before charging is required.

The start display 1800 may include a symbol F configured to represent the strength of the connection to the mobile phone network. The start display 1800 may also include a symbol E that represents the functionality of the VAD. Both of the F and E symbols are designed as buttons on a touch-user interface and may be configured to access a corresponding information screen, which may display more specific information. The display unit 240 may be a touch screen configured to receive touch inputs. In some embodiments, the display unit 240 may include analog buttons to navigate the user interface generated on the display unit 240. For example, pressing the E symbol may generate a pump information display that includes pump speed, pump volume, or other pump related information. The start display 1800 may also include a Symbol G that represents the current time and a symbol H, which may be a touch-user interface button to enter the menu for the Cardiac Support System 100 in some embodiments.

FIG. 19 shows an example of a start display 1800 of a display unit 240 as described in any embodiment herein. The start display 1800 in FIG. 19 may be substantially similar to the start display described in FIG. 18. FIG. 19 is divided into three subfigures: 19A, 19B and 19C. Each of the subfigures shows different ways of displaying information regarding a connected energy storage device. In some embodiments, such as the embodiment shown in FIG. 19, the display unit 240 may be designed to display different alarm conditions. For example, the start display 1800 may include the header 1915, which is shown in FIGS. 19A, 19B, and 19C as the blue, yellow, and red bar at the top of the display 1800. The control unit 205 or the display unit 240 may be configured to generate the header 1915 when an alarm condition is present. The header may be colored based on the type or urgency of the alarm that is present. For example, the blue header in FIG. 19A is an example of a low priority alarm; the yellow header in FIG. 19B is a medium priority alarm; and the red header in FIG. 19C is a high priority alarm.

Additionally, the control unit 205 or the display unit 240 may be configured to generate an alarm symbol M between the Battery symbol J and the battery symbol K. The alarm signal M may indicate a variety of dangerous conditions. For example, the alarm symbol M may represent a slipping of the induction charging coil. The alarm symbol M may indicate that no battery is connected. In subfigure 19B, another alarm symbol N may be generated by the control unit 205 or the display unit 240. The alarm symbol N may be arranged next to the battery symbol I. As shown in FIG. 19B, the alarm symbol N may represent a low energy level of the intracorporeal energy storage device. In subfigure 19C, several alarms are active, and several alarm symbols accordingly appear at the corresponding locations on the display. As a part of the user interface described above, the display device 240 may be configured to display further information regarding the alarm message when the alarm symbols are pressed by the patient or another user.

FIG. 20 shows an example of a menu display 2000, which may be generated on a display unit as described above. The menu display 2000 may include a header 2005 that is substantially similar to the header 1915 described in FIG. 19 As shown in FIG. 20, the header 2005 may include a symbol S in the form of a house instead of a menu symbol (a hamburger menu icon) on the right of the header 2005. The symbol S may represent a button to get to the start display. The menu display 2000 may also include a Q symbol and an R symbol, which may be buttons in a touch-user interface in some embodiments. In this example, the Q symbol represents the strength of the connection to the mobile phone network, and the R symbol represents the functionality of the pump. In addition, an O symbol may be displayed and may be designed as a button to access the alarm history. A P symbol may also be displayed and configured as a button to get to the battery information.

FIG. 21 shows an example of a menu display 2000 of a display unit 240 that is substantially similar to the menu display 2000 described in any one of the previous FIG. 20 or FIG. 21 is divided into three subfigures: 21A, 21B and 21C. Similar to the embodiments described herein, the header 2005 may be colored differently based on the presence of an alarm and the urgency or severity of the alarm. Similar to FIG. 19, the header 2005 in subfigure 21A is colored blue and may indicate a low priority alarm. The header 2005 in the middle subfigure, FIG. 21B, is colored yellow and may indicate a medium priority alarm, and the header 2005 of the right sub-figure 21C is colored red and may indicated a high priority alarm. Depending on the alarm present, the header 2005 may be colored differently. The colors and associated alarm levels are not limited to those described herein. The display unit 240 may include a setting that allows patient or another user to set the colors for each alarm.

FIG. 22 shows an example of a system display 2200 which may be generated on a display unit as described in FIG. 2. FIG. 22 is divided into four subfigures: 22A, 22B, 22C, and 22D, which include displays for various system information. The system display 2200 and precise information on system data may be accessed in a third level of the interface (i.e. two-clicks or touches away from the start display 1800) so that patients are not overwhelmed with information. Using the system display 2200, the patient may access specific information as shown in the subfigures. Alternatively, if one of the parameters reach a critical value, the patient may be alerted via an alarm. For example, if the patient's heart rate rises or their blood pressure spikes, an alarm may be generated on the start display 1800 or the menu display 2000 as described above. Upon clicking the alarm symbol or the header, detailed information 2205 regarding the patient's vitals may be shown on the display unit 240, as shown in subfigure 22A. In another example shown in subfigure 22B, connectivity information 2210 regarding the intracorporeal VAD may be shown. For example, the connectivity information 2210 may indicate whether the components, such as the control units, of the cardiac support system 100 are connected to one another or whether the system is connected to the internet. As an example, in FIG. 22B, the iECU is connected to the system, and the system is connected to the internet. However, the eECU 2 is not connected. The display unit 240 may be configured to display progress curves or a connection history when the corresponding parameter is pressed. For example, a patient may select a component from the connectivity information 2210, and the progress curve or connection history may be shown.

In subfigure 22C, a battery information display 2215 may show detailed battery information based on the status of the available energy. The battery display 2215 may also include additional information such as the runtimes for the individual batteries. In addition, graphs showing the time course of the battery charge may be displayed. In some embodiments, the additional information about a particular battery may be shown after a user selects a battery in the battery information display 2215 using a touch-user interface as described above. In the right-hand FIG. 22D, an alarm history 2220 is shown. In this exemplary embodiment, two scroll buttons (T) may be shown in the alarm history 2220 and configured to allow a user to scroll through the alarms or an alarm history. In addition, the alarm history 2220 may include a time 2225 that the alarm occurred and a time when the alarm ended or was silenced by the user. As shown in FIG. 22, system information may be displayed in individual display. In each display, additional information or plots may be displayed after touching the individual parameters. In some embodiments, the system information shown in FIG. 22 may be included in a single display that a user may scroll through. Other information may also be included about the Cardiac Support System 100 such as pump speed, pump volume, or the like.

FIG. 23 shows an example of an alarm display 2300 to be generated on the display unit 240 as described in FIG. 2. FIG. 23 is divided into four subfigures: 23A, 23B, 23C, and 23D, which display different warning messages 1402. In the example embodiments shown in FIG. 23, the warning messages 1402 may be low priority and colored blue. For example, the warning message 1402 in FIG. 23A may indicate a connection error between the extracorporeal induction charging coil and the intracorporeal induction coil even though the induction coils are correctly positioned. As discussed above, the correct positioning of the induction coils may be indicated by a check 1415. FIG. 23B shows a warning message 1402 that may indicate a connection error between the extracorporeal induction charging coil and the intracorporeal induction coil due to incorrect positioning of the induction coils. As discussed above, when the induction coils are out of alignment, the position of the induction charging coil may be indicated by a position point 1405 in a position circle 1410. FIG. 23C depicts an example embodiment where the warning message 1402 indicates a connection error between the extracorporeal induction charging coil and an external energy storage device, or battery. In FIG. 23D, the warning message 1402 may indicate that one or more of the external batteries is empty.

FIG. 24 shows another example of an alarm display 2300. The alarm display 2300 of FIG. 24 may be substantially similar to the alarm display described in the previous FIG. 23, with the difference that the warning messages have a medium priority in the exemplary embodiment shown here. Accordingly, the warning messages 1402 may be colored yellow. FIG. 24 is divided into four subfigures: 24A, 24B, 24C and 24D. In the example embodiments shown in FIG. 24, the warning message 1402 in FIG. 24A may indicate a low energy level of an intracorporeal energy storage. In FIG. 24B, the warning message 1402 may indicate a low energy level of an intracorporeal energy storage device caused by an incorrectly positioned extracorporeal induction charging coil. As discussed above, the position of the induction charging coil may be indicated by a position point 1405 in a position circle 1410. In FIG. 24C, the warning message 1402 may indicate that a connection error between the induction charging coil and an external energy storage device. In FIG. 24D, the warning message 1402 may indicate that an energy storage device is empty.

FIG. 25 shows further example of an alarm display 2300 that may be substantially similar to the alarm display 2300 described in the previous FIGS. 23 and 24. However, the warning messages 1402 in the alarm display 2300 shown in FIG. 25 may have a high priority and be colored red. FIG. 25 is divided into three sub-figures 25A, 25B and 25C. In the example embodiment shown in subfigure 25A, the warning message 1402 may show a critical energy level of an intracorporeal energy storage device with an incorrectly positioned induction charging coil. The position of the induction charging coil is indicated by a position point 1405 in a position circle 1410. Somewhat similarly, in the example embodiment shown in subfigure 25B, the warning message 1402 may indicate a critical energy level of an intracorporeal energy storage device and a simultaneous connection error between the extracorporeal induction charging coil and an external energy storage device. The warning message 1402 in subfigure 25C may indicate a critical energy level of an intracorporeal energy storage device and may be displayed if the external energy storage is also empty.

FIGS. 23, 24, and 25 show different examples of alarm screens. The alarms, or warning messages 1402 may be colored according to priority, blue for low priority, yellow for medium priority, or red for high priority. The alarm display 2300 may also provide information about the alarm, e.g. the cause of the alarm, and how it can be resolved. The priority may change according to the urgency of the action as specified in the DIN EN ISO 60601-1-8 standard. A special case of the alarm screen is shown in the partial FIGS. 23A, 23B, 24B and 25A. This occurs when the extracorporeal induction coil is no longer positioned correctly over the intracorporeal induction coil, so that energy transfer is no longer possible. In this case, a graphical alignment aid described above in conjunction with FIG. 14 may appear.

FIG. 26 shows an execution example of a method 2600 for transcutaneous transfer of energy into a human body. The method 2600 may include a first step 2605 of generating a magnetic field by passing an electrical current through an extracorporeal induction coil to transfer the energy to an intracorporeal induction coil and a step 2610 of providing a position signal representing a relative position between the induction charging coil and the induction coil.

FIG. 27 shows a schematic representation of a positioning apparatus 2700, which may also be referred to as a carrying device or support system. Generally, the positioning apparatus 2700 may be used to transport or carry the extracorporeal components of the Cardiac Support System 100 and maintain alignment of the extracorporeal induction coil 230 with the intracorporeal induction coil 130. The positioning apparatus 2700 may take many forms and have different configurations. In this exemplary embodiment, the positioning device 2700 comprises a carrying device 2705, which may be shaped as a jacket to partially enclose a body 2710 of a patient 2715 as shown in the figure. The carrying device 2705 may comprise a receiving element 2725 disposed on a textile layer 2720 of the carrying device 2705, which corresponds to the inside of the jacket in this example.

The receiving element 2725, which may also be referred to as a mounting element, may be configured to hold or mount an extracorporeal induction coil 2730. The mounting element 2725 may be ring-shaped and designed to detachably accommodate the induction coil 2730. The mounting element 2725 may also be detachably connected to the carrying device 2705 and/or the textile layer 2720 with a hook-and-loop fastener. In some embodiments the detachable connection may be achieved by means of magnets, snap fasteners or needles. The detachable connection of the receiving element 2725 allows the induction coil 2730 to be arranged in the receiving element 2725 and positioned as needed on the body 2710. For example, the position of the extracorporeal induction coil 2730 on the carrying device 2705 may correspond with the position of an intracorporeal induction coil 2735 in the body 2710 of the patient 2715, so that when the jacket is closed, the extracorporeal induction coil 2730 is aligned with the intracorporeal induction coil 2735. To provide power to the extracorporeal induction coil, the mounting element 2725 may be connected to the electrically conductive wiring 2740, which is in turn connected to an extracorporeal component 2745 of the cardiac support system, such as a battery or control unit. The extracorporeal component 2745 may also be connected to the support system 2705 via a connecting element 2750. The battery 2745 used in this exemplary embodiment powers the wiring 2740, which powers the receiving element 2725, which finally powers the induction coil 2730. In some embodiments, the battery 2745 may power the extracorporeal induction coil 2730 directly instead of the mounting element 2725. In an example embodiment, the battery 2745 may be used to charge an internal power storage component and may be detached from the positioning apparatus 2705 when the charging is complete.

FIG. 28 shows a schematic front view of a carrying device 2705 that may be substantially similar to the carrying device described in FIG. 27. The carrying device 2705 shown here may further comprise a strap 2800 and a second strap 2802 for fixing the carrying device 2705 to the body 2710. As shown in FIG. 28, the carrying device 2705 may also designed as a shirt or vest. The carrying device 2705 may be relatively short on the torso of the body 2710 and may only cover an area from the shoulders to just below the chest. For easy dressing and undressing, the carrying device 2705 may include a zipper 2805. In some embodiments, the straps 2800 and 2802 may pass over the shoulders and cross over one another on the back of the body. The straps 2800 and 2802 may be led to the front of the body 2710 again and fastened to the carrying device 2705 by means of a hook-and-loop or a hook-and-loop fastener counterpart 2810. In some embodiments, the straps 2800 and 2802 may be fastened using a mechanical fastener, such as a snap fastener or buckle, or other fastening means.

FIG. 29 shows a schematic front view of an example of a carrying device 2705. The carrying device 2705 may be substantially similar to the carrying devices described in previous figures. The carrying device 2705 shown here may further comprise a first fixing element 2900 for releasably fixing a receiving element 2725 comprising a second fixing element. The first fixing element 2900 may be arranged in a top right-hand corner of the supporting device 2705 and may comprise a hook-and-loop fastener material. In another design example, the first fixing element 2900 may be a magnet, a plurality of snap fasteners, an adhesive, or a sewn attachment. In this design example, a second fixing element 2905 is located in a top left corner and may be symmetrically positioned relative to the first fusing element 2900. In some embodiments, the entire inside of the carrying device 2705 may be designed to hold a mounting element 2725 in place. For example, large areas of hook-and-loop-compatible material may be disposed on the inside of the carrying device 2705.

FIG. 30 shows a schematic front view of another example of a carrying device 2705. The carrying device 2705 shown here corresponds or resembles the carrying device described in the previous figures, with the difference that the carrying device 2705 shown here is longer and extends from the shoulders to the hips of body 2710.

FIG. 31 shows a schematic rear view of another example of a carrying device 2705. The carrying device 2705 shown here corresponds or resembles the carrying device described in the previous figures. As shown in FIG. 31 and described above, the first strap 2800 and the second strap 2802 may pass over the shoulders, cross over each on the back of the body 2710, and be attached to the carrying device 2705 at the side of the body 2710.

FIG. 32 shows a schematic rear view of an example of a carrying device 2705. The carrying device 2705 shown here corresponds to or is similar to the carrying device described in the previous figures. In this embodiment, the first strap 2800 and the second strap 2802 may be attached to the carrying device 2705 the same side of body 2710 that they originate from unlike in FIG. 31. The straps 2800 and 2802 may pass over the shoulders, through a central eyelet 3200, and attach to the bottom of the carrying device 2705 as shown in FIG. 32.

FIG. 33 shows a schematic rear view of an embodiment of a carrying device 2705. The carrying device 2705 shown here may resemble the carrying device described in the previous figures. In this example, the first strap 2800 and the second strap 2802 may cross over four lateral eyelets 3300.

FIG. 34 shows a schematic front view of another example of a carrying device 2705. As shown in FIG. 34, an extracorporeal component 2745, a battery for example, may be arranged on the carrying device 2705. Another component 3400, such as a control unit, may also be attached to the carrying device 2705. As shown in FIG. 34, the extracorporeal components 2745 and 3400 may be arranged on the side of the body 2710. However, the components 2745 and 3400 may be disposed anywhere on the carrying device 2705. For example, the components 2745 and 3400 may be placed on the chest or back of the body 2710.

FIG. 35 shows an oblique side view of an example of a carrying device 2705. The carrying device 2705 shown here further comprises a pocket 3500 for holding an extracorporeal component. The pocket 3500 may be detachably connected to the carrying device 2705 via a connecting element 2750. The connecting element 2750 may be a mechanical fastener, a strap, hook-and-loop fasteners, a magnet, or other connecting means.

FIG. 36 shows a cross-sectional representation of an example of a receiving element 2725 configured to mount or hold an extracorporeal induction coil 2730. The mounting element 2725 shown here corresponds or resembles the mounting element described in FIG. 1. As shown in FIG. 36, the mounting element 2725 may be shaped like a ring and include a circumferential projection 3600. The projection 3600 may be configured to fit into a circumferential recess 3605 when the induction coil 2730 is placed into the holding element 2725. The holding element 2725, which can also be described as a holding ring, may be made of a relatively strong, semi-flexible material, such as a plastic. Further, the holding element 2725 may be mounted on a connecting foil 3610 comprised of a very soft and flexible material. In this example, the connecting foil 3610 may connect or pair the receiving element 2725 and a second fixing element 3615. The second fixing element 3615 may be configured to be attached to the carrying device 2705 or the body 2710. For example, the second fixing element 3615 may be an adhesive layer or a hook-and-loop material. By means of the second fixing element 3615, the mounting element 2725 can be fixed to a support device comprising a corresponding first fixing element as described in the previous figures. In some embodiments, the mounting element 2725 may be directly attached to the carrying apparatus 2705 without the second fixing element 3615.

FIG. 37 shows a cross-sectional view of an execution example of a receiving element 2725 that further comprises a positioning plaster 3700. The mounting element 2725 shown here may resemble the insertion element described in FIGS. 27 and 36. As shown in FIG. 37, the insertion element 2725 may further comprise a positioning patch 3700, which may be referred to in some places as a positioning plaster. The positioning patch 3700 may include a multilayer structure. The receiving element 2725 may be connected to a carrier layer 3705 via a connecting film 3610. The carrier layer 3705 may be made of flexible material and adapt to different positions and body curvatures. The connecting foil 3610 may compensate between different shapes of the carrier layer 3705 and the receiving element 2725 in some embodiments. On the side of the carrier layer 3705 opposite the receiving element 2725, an adhesive 3710 may be applied to adhere the carrier layer 3705 to the skin of a patient. The adhesive 3710 may be covered by a two-part and double-folded protective film 3715. In this example, the protective film 3715 is designed to protect the adhesive 3710 and allow the positioning patch 3700 to be moved on a patient's body until the extracorporeal induction coil 2730 is in the correct position for energy transfer.

FIG. 38 shows a top view of the positioning patch 3700. The positioning patch 3700 resembles the positioning plaster described in FIG. 37. As discussed above, the protective film 3715 may include tabs 3800 that may be removed laterally to expose the adhesive layer 3710.

FIG. 39 shows an oblique top view of a design example of a mounting element 2725 and a second mounting element 3900. The mounting element 2725 corresponds to or is similar to the receiving element described in FIGS. 27, 36 and 37. As discussed above, a hook-and-loop fastener can be fixed to a carrying device. In this illustration, the mounting element 3900 is another exemplary design of the receiving element 2725 and corresponds to it in shape and size, but it is designed to be glued directly to a body. The induction coil 2730 may fit in in the mounting element 2725 and the second mounting element 3900.

FIG. 40 shows a schematic representation of an example of the mounting element 2725 and the second mounting element 3900. In this example, the receiving element 2725 and the second receiving element 3900 may be glued directly onto a body 2710. The first mounting element 2725 may be disposed on an upper portion of body 2710 while the second mounting element 3900 may be disposed on a lower portion of body 2710. The positioning of the receiving element 2725 and/or the second receiving element 3900 depends on the position of an intracorporeal induction coil as described above in conjunction with FIG. 27.

FIG. 41 shows a schematic representation of an example of a fastener 2750 comprising a retaining element 4100. The fastener 2750 shown here corresponds to or is similar to the one described in the FIGS. 27 and 35. The connecting element 2750 may be formed as an eyelet and firmly connected to the carrying device 2705. In addition to the connecting element 2750, the supporting device 2705 may further comprise a connecting element 4105 that corresponds to the connecting element 2750. As shown in FIG. 41, the connecting element 2750 may be connected to the retaining element 4100, which may be hook-shaped. As shown in FIG. 41, the hook-shaped retaining element 4100 may be inserted through a corresponding loop-shape of the connecting element 4105 of the carrying device 2705. In another design example, the retaining element 4100 may be designed with hook-and-loop fasteners, press studs, magnets or sewn. The retaining element 4100 can also be designed as a buckle, clip, or another mechanical fastener. The retaining element 4100 and the second retaining element 4110 may be connected to a carrier plate 4125 via a length-adjustable belts 4115 and 4120, respectively. The carrier plate 4125 may also be referred to as an adapter and configured to receive different extracorporeal components of the cardiac support system 100. In some embodiments, a bag 3500 for holding an extracorporeal component can be attached to the support device 2705 via the support plate 4125. In this example, an additional belt 4130 may run from the support plate 4125 over the back of a patient (not shown here) and connected to a second carrier plate attached to the other side of the patient, so that the hardware fits more securely to the body and does not wobble. In some embodiments, the bag 3500 can be attached without the additional belt 4130.

FIG. 42 shows a schematic representation of an example of a fastener 2750 and a retaining element 4100. The connecting element 2750 shown here may correspond with or resemble the connecting element described in the previous FIGS. 27, 35 and 41. As discussed above, the connecting element 2750 may be a mechanical fastener. For example, the connecting element 2750 may be a snap-fit fastener that comprises a receiving component and an insertion component, that may be interchangeably attached to the carrying device or an extracorporeal component of the cardiac support system 100. Further the carrying element 2750 may be configured to retain an extracorporeal component of the Cardiac Support System 100. In the example shown if FIG. 42, the connecting element 2750 is configured to retain a control unit 4200 and can be inserted into the retaining element 4100.

FIG. 43 shows a schematic representation of an example of a connecting element 2750 with a retaining element 4100. The connecting element 2750 and the retaining element 4100 shown here may correspond with or resemble those described in the previous FIGS. 27, 35, 41 and 42. In this design example, the connecting element 2750 can be pushed into the retaining element 4100 from above and be secured in a vertical groove 4300. The retaining element 4100 may include a mechanical spring mechanism 4305 that is designed to hold the connecting element 2750. The spring mechanism 4305 may be pushed back first and then snap into a final position so that the connecting element 2750 is held in place. In some embodiments, the connecting element may further comprise a recess or groove to receive the spring mechanism 4305. The retaining element may also include a release button 4310, which can be reached from the outside, to release the connecting element 2750 from retaining element 4100 when the appropriate pressure is applied.

FIG. 44 shows a schematic representation of an example of a connecting element 2750 with a retaining element 4100. The connecting element 2750 and the retaining element 4100 shown here may correspond or resemble those described in the previous FIGS. 27, 35, 41, 42 and 43. The retaining element 4100 in this design example also includes a horizontal groove 4400, which is formed at defined points with an open profile, to receive and secure the connecting element 2750 when it is inserted into the retaining element 4100.

FIG. 45 shows a schematic representation of a connecting element 2750 with a retaining element 4100. The connecting element 2750 and retaining element 4100 shown here may correspond with or resemble the connecting and retaining element described in the previous FIGS. 27, 35, 41, 42, 43 and 44. The retaining element 4100 in this design example includes a horizontal groove 4400 with two magnets 4500 to secure the lock. The retaining element 4100 may be designed to receive the connecting element 2750 laterally and hold the connecting element 2750 in place using magnetic force. The magnetic force may prevent slipping or accidental displacement. The magnetic connection may allow the connecting unit 2750 to be released with relatively little force. As discussed above, other locking variants may be used. For example, sliders, mechanical design variants with basic mechanical clips, snap fasteners, or hook-and-loop fasteners can be used. Other magnetic designs may also be used, e.g. using electromagnets or purely magnetic solutions.

FIG. 46 shows a schematic representation of an example of a retaining unit 4600 for connecting a connecting element 2750 to the retaining element 4600. As shown in FIG. 46, the connection unit 4600 may include a horizontal groove 4400 for lateral insertion of a connecting element 2750, which includes a corresponding tongue feature.

FIG. 47 shows a schematic representation of an embodiment of a retaining unit 4600. The retaining unit 4600 may be similar to the retaining unit described in FIG. 46, and further comprise an open profile.

FIG. 48 shows a schematic representation of another example of a retaining unit 4600. The retaining unit 4600 corresponds or is similar to the connector unit described in the previous FIGS. 46 and 47. As shown in FIG. 48, the retaining unit 4600 may also include an electrical contact element 4805. Accordingly, the connecting element 2750 may also include an electrical contact element 4800. The electrical contact element 4800 of the connecting element 2750 may be designed as a spring contact to compensate tolerances and ensure constant pressure and contact with the electrical contact 4805 of the retaining element 4600. The contact element 4805 may correspond in shape to the electrical contact element 4800. The electrical contact element 4805 may be arranged adjacent to the electrical contact element 4800 in the operational state. When the electrical contact devices 4800 and 4805 are connected, a current flow or transmission of electrical signals between the components of the Cardiac Support System 100 that are attached to the connecting element 2750 and the retaining element 4600 may be achieved. For example, a control unit 205 may be attached to the connecting element 2750. When the connecting element 2750 is attached to the retaining element 4600, an electrical connection may be established between the control unit 205 and other components of the Cardiac Support System 100, such as a display device 240 or an external battery.

FIG. 49 shows a schematic diagram of an example of a retaining element 4600 with the electrical contact element 4805. The retaining element 4600 may comprise the electrical contact element 4805 with three sub-contacts 4900, or contact points.

FIG. 50 shows a schematic representation of an exemplary embodiment of a retaining element 4100. The retaining element 4100 may be substantially similar to the retaining element described in the previous FIGS. 41 through 49. As shown in FIG. 50, the retaining element 4100 may further include a cable holder 5000 for guiding a cable 2740. The cable holder 5000 may be arranged on the side of the retaining element 4100 or in another location depending on the retaining element's shape. The cable holder 5000 may be mechanical fastener, hook-and-loop fastener, or the like.

FIG. 51 shows a schematic representation of another example of a retaining element 4100. In the illustration, the retaining element 4100 may be a ladder buckle with a hook that is hooked into a connecting element 2750, which may be a corresponding loop or eyelet. The retaining element 4100 may also include a strap 4115 for attaching a bag as shown in FIG. 35 and FIG. 41.

The Cardiac Support System 100 may also be referred to as Mechanical Circulatory Support (MCS) system. The MSC system includes a temporary (generally no more than about 6 hours) left ventricular support device for use during high-risk percutaneous coronary intervention (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and/or depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. It is placed across the aortic valve via a single femoral arterial access.

The system may include a low-profile axial rotary blood pump mounted on a catheter such as an 8 Fr catheter, referred to as an MCS pump or MCS device. When in place, the MCS pump can be driven by an MCS controller to provide up to about 4.0 liters/minute of partial left ventricular support, at about 60 mmHg. No system purging is needed due to improved bearing design and sealed motor, and the system is visualized fluoroscopically eliminating the need for placement using sensors.

The system may further include an expandable sheath, which allows 8-10 Fr initial access size for easy insertion and closing, expandable to allow introduction of 14 Fr and 18 Fr pump devices and return to a narrower diameter around the 8 Fr catheter once the pump has passed. This feature may allow passage of the heart pump through vasculature while minimizing shear force within the blood vessel, advantageously reducing risk of bleeding and healing complications. Distention or stretching of an arteriotomy may be done with radial stretching with minimal shear, which is less harmful to the vessel. Access may be accomplished via transfemoral, transaxillary, transaortal, or transapical approach.

FIG. 53 shows a rendering of the MCS device mounted on the tip of an 8 Fr catheter. An inlet tube portion of the device extends across the aortic valve. The impeller is located at the outflow section of the inlet tube drawing blood from the left ventricle and ejecting it into the ascending aorta. The motor is mounted directly proximal to the impeller in a sealed housing eliminating the need to flush the motor prior to or during use. This configuration provides hemodynamic support during high-risk PCI, time and safety for a complete revascularization via a minimally invasive approach (rather than an open surgical procedure).

The system has been designed to eliminate the need for motor flushing, provide increased flow performance up to 4.0 l/min at 60 mmHg with acceptably safe hemolysis due to a computational fluid dynamics (CFD) optimized impeller that minimizes shear stress.

The device actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation (shown in FIGS. 53 and 54). When in place, the MCS device can be driven by the complementary MCS Controller to provide between 0.4 l/min up to 4.0 l/min of partial left ventricular support.

In general, the overall MCS system includes a series of related subsystems and accessories, including the following:

The MCS Device including pump, shaft, proximal hub, insertion tool, proximal cable, infection shield and guidewire aid. The MCS Device is provided sterile.

The MCS shaft contains the electrical cables and a guidewire lumen for over-the-wire insertion.

The proximal hub contains guidewire outlet with a valve to maintain hemostasis and connects the MCS shaft to the proximal cable, that connects the MCS Device to the MCS Controller.

The proximal cable is 3.5 m (approx. 177 inch) in length and extends from the sterile field to the non-sterile field where the MCS Controller is located.

A MCS insertion tool as part of the MCS Device to facilitate the insertion of the pump into the Introducer Sheath and to protect the inlet tube and the valves from potential damage or interference when passing through the Introducer Sheath.

A peel-away guidewire aid pre-mounted on the MCS Device to facilitate the insertion of the 0.018″ placement guidewire into the pump and into the MCS shaft.

A 3 m 0.018″ placement guidewire, having a soft coiled pre-shaped tip for atraumatic wire placement into the left ventricle. The guidewire is provided sterile.

A 14 Fr Introducer Sheath with a usable length of 275 mm to maintain access into the femoral artery and provide hemostasis for the 0.035″ guidewire, the diagnostic catheters, the 0.018″ placement guidewire, and the insertion tool. The housing of the Introducer Sheath is designed to accommodate the MCS Insertion Tool. The Introducer Sheath is provided sterile.

An introducer dilator compatible with the Introducer Sheath to facilitate atraumatic insertion of the Introducer Sheath into the femoral artery. The introducer dilator is provided sterile.

An MCS Controller which drives and operates the MCS Device, observes its performance and condition as well as providing error and status information. The powered controller is designed to support at least about 12 hours of continuous operation and contains a basic interface to indicate and adjust the level of support provided to the patient. Moreover, the controller provides an optical and audible alarm notification in case the system detects an error during operation. The MCS Controller is provided non-sterile and is contained in an enclosure designed for cleaning and re-use outside of the sterile field. The controller enclosure contains a socket into which the extension cable is plugged.

Referring to FIG. 54, there is illustrated an overall MCS system 5500, subcomponents of which will be described in greater detail below. The system 5410 includes an introducer sheath 5412 having a proximal introducer hub 5414 with a central lumen for axially movably receiving an MCS shaft 5416. The MCS shaft 5416 extends between a proximal hub 5418 and a distal end 5420. The hub 5418 may be provided with an integrated Microcontroller or memory storage device for device identification and tracking of the running time, which could be used to prevent overuse to avoid excessive wear or other technical malfunction. The microcontroller or memory device could disable the device, for example to prevent using a used device. They could communicate with the controller, which could display information about the device or messages about its usage. An atraumatic cannula tip with radiopaque material allows the implantation/explanation to be visible under fluoroscopy.

A pump 5422 is carried by a distal region of the MCS shaft 5416. The system 5410 is provided with at least one central lumen for axially movably receiving a guide wire 5424. The proximal hub 5418 is additionally provided with an infection shield 5426. A proximal cable 5428 extends between the proximal hub 5418 and a connector 5430 for releasable connection to a control system typically outside of the sterile field, to drive the pump 5422.

TRANSCUTANEOUS ENERGY TRANSFER

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