Sensor head device for minimally invasive ventricular assist device and method for producing the sensor head device

Abstract

The present invention relates to a sensor head device (105) for a ventricular assist device, the sensor head device (105) having at least one sensor carrying element (205). The sensor carrying element (205) has at least one sensor cavity (155, 210) for accommodating at least one sensor (215, 220) and / or at least one signal transmitter cavity (225, 230) for accommodating at least one signal transmitter (235).

Description

[0001] describe

[0002] The invention derives from an apparatus or a method according to the independent claim categories. A subject of the invention is also a computer program.

[0003] A cardiac support system, such as an implanted left ventricular support system, may have multiple sensors for detecting body parameters.

[0004] Starting from this, the present invention is based on improving the sensor head arrangement in the sense of optimizing the integration and packaging of the sensor or signal transmitter and specifying a corresponding advantageous production method.

[0005] In this context, in the manner presented herein, a sensor head device for a minimally invasive heart support system, a method for producing a sensor head device for a heart support system, and a device using the method, and finally a corresponding computer program are provided according to the main claim. Advantageous developments and improvements of the device specified in the independent claim can be achieved by means of the measures listed in the dependent claims.

[0006] The method presented here for a sensor head device for a heart support system relates to improving the integration and packaging of sensor technology in a minimally invasive left ventricular heart support system, for example in the location of the aortic valve. In this case, the sensor head device is designed, for example, as a plug-like sensor package, which can be arranged, for example, at the distal end of a supply cannula of a heart support system and has at least one cavity for at least one electronic sensor and / or at least one signal transmitter, for example an ultrasonic element.

[0007] A sensor head device for a minimally invasive heart support system insertable into a patient's body is provided, wherein the sensor head device has at least the following features:

[0008] A sensor carrier element having at least one sensor cavity for accommodating at least one sensor and / or at least one signal transmitter cavity for accommodating at least one signal transmitter.

[0009] The sensor head device can be a structural element of a heart support system, which is used to integrate or accommodate sensor components, such as temperature sensors and / or pressure sensors and / or ultrasonic elements. A heart support system, also called an artificial heart or VAD (ventricular assist device), can be understood to mean a pumping device for increasing the pump performance of the heart. For example, the heart support system can be inserted into a heart chamber or aorta by means of a catheter. The heart support system can be a (percutaneous) left ventricular support system in particular. The sensor-carrying element can be a carrying component, such as a housing, a bracket and / or a frame, on which can be or arrange at least one sensor and / or at least one signal transmitter, wherein the sensor and / or the signal transmitter are mechanically protected and firmly supported by the sensor-carrying element. The sensor cavity can be understood to mean a cavity (e.g., formed squarely or cubically, or in the form of at least partially circumferential grooves), which is formed, for example, in a sensor-carrying element of a sensor head device and is used to accommodate and encapsulate a sensor. For example, a sensor can be a technical component that can detect a specific physical variable (e.g., temperature and pressure as measured variables, qualitatively or quantitatively). In this case, these variables can be detected by physical effects and, for example, converted into further processable electrical signals. A signal transmitter cavity can be understood to mean a cavity (for example, formed in a square or cylindrical shape) which is formed, for example, in a sensor carrier element of a sensor head device and is used to accommodate and encapsulate a signal transmitter. For example, the signal transmitter can be an ultrasonic element as an ultrasonic transmitter and / or receiver.

[0010] The advantages of the method for a sensor head device for a cardiac support system (e.g., a cardiac support system that can be minimally invasively inserted into a patient's body) presented here are particularly that it creates the possibility of optimally integrating and packaging at least one pressure sensor and / or temperature sensor in the end of the cardiac support system. There is currently no system on the market that inserts active electronic components and sensor technology in the head area of ​​the cardiac support system. In this case, for example, the body temperature of a person suffering from heart disease can be advantageously measured by an integrated temperature sensor. Since sepsis is a common complication in patients with implanted cardiac support systems, febrile infections can be detected in a timely manner and treated or prevented early, for example, by means of trend analysis of blood temperature. For example, the ventricular pressure of a patient with heart disease can be detected by the integration and packaging of an improved (preferably barometric) pressure sensor. The integration in this case is designed, for example, so that the pressure measurement is not tampered with by a slight negative pressure in the guide cannula of the cardiac support system. For example, the ventricular pressure of the patient can be measured using determined pressure data, and a pump can be adjusted based on the ventricular pressure to, for example, protect the ventricle from collapse. The pressure data determined in this way can also be used to determine, for example, the pressure difference across the pump, ie aortic pressure minus ventricular pressure, and thereby monitor the pump, the pump performance or the pump function.

[0011] According to one embodiment, the sensor carrier element can have a channel extending in the longitudinal extension direction of the sensor head device, and / or at least one sensor cavity can be open in a different direction than at least one signal transmitter cavity. This embodiment of the method presented here provides the advantage that such a channel allows the guide wire to be guided centrally through the sensor carrier provided with the sensor cavity. This ensures optimal mechanical protection and a secure mounting. It is also possible to achieve a very precise measurement of body parameters due to the different opening directions of the cavities.

[0012] According to one embodiment, the sensor-carrying element may have a circular cap at one outer end. In cross section, the rotationally symmetrical sensor-carrying element may alternatively or additionally have an outer wall (e.g., a cylindrical outer wall) arranged in the shape of a U and / or E, and / or have an inner wall (e.g., a cylindrical inner wall) arranged in the shape of a U and / or E at at least one inner end, wherein at least one signal transmitter cavity or sensor cavity is particularly formed between the outer walls and / or between the outer wall and the inner wall. This embodiment of the method presented here provides the following advantages: for example, when the cardiac support system is advanced during implantation of the system, the outer end with the circular cap or the outer end of the sensor head device designed in the shape of a mushroom head is advantageously formed to introduce the cardiac support system into the patient's body so as not to cause any damage in a heart patient or to ensure good sliding properties. In this case, the outer end designed in the shape of a mushroom head, as well as the outer end designed, for example, in the shape of a pot, continue to provide mechanical protection and a secure encapsulation for the integrated sensor.

[0013] This embodiment of the method presented herein provides the advantage that the embodiment of the sensor head device as a type of plug at the end of the guide cannula of the heart support system allows for simple production of the sensor head device, wherein the manufacturing process saves time and money.

[0014] According to one embodiment, the sensor carrying element may have an opening in its center, wherein the opening in particular has a cylindrical tube. For example, the tube may be inserted into the opening and / or formed in the opening over the entire length of the sensor carrying part. This embodiment of the method presented here provides the following advantages: For example, a guide wire can be inserted into the opening and / or into the cylindrical tube. When the heart support system is implanted in the left heart chamber or the aorta of a heart patient, the guide wire can first be placed in the patient's ventricle. Then, the heart support system can be pushed onto the guide wire and advanced along the guide wire to an end position. In this way, very precise positioning of the heart support system can be achieved.

[0015] According to one embodiment, the sensor head device can have at least one sensor, in particular a sensor designed as a temperature sensor and / or a pressure sensor, and / or at least one signal transmitter, in particular a signal transmitter designed as an ultrasonic element or an ultrasonic transducer for emitting and / or receiving ultrasonic waves. Alternatively or additionally, at least one sensor and / or at least one signal transmitter can be arranged on the conductive element. The ultrasonic element can also, for example, have its own housing, wherein the outer wall surrounding the ultrasonic element can be omitted. In this case, the wall can be used both for mechanical stabilization and for packaging of the ultrasonic element for biocompatibility purposes. This embodiment of the method presented here provides the following advantage: Integrating at least one ultrasonic element into the sensor head device of a cardiac support system allows volume flow measurement of the blood of a heart patient.

[0016] According to one embodiment, the signal transmitter cavity can be at least partially covered by a lens element, wherein the lens element is specifically designed as an ultrasound lens and / or is made of silicone material. This embodiment of the method presented here provides the following advantages: the ultrasound lens is used for the sound formation of the ultrasound energy, the ultrasound lens further firmly encapsulates the ultrasound element, and the ultrasound lens can conduct the blood flow of the heart patient entering through multiple inlet ports.

[0017] According to one embodiment, the sensor-carrying element can be formed from a thermoplastic and / or manufactured in a mechanical manufacturing process and / or as an injection molded part. This embodiment of the method presented herein provides the following advantages: For example, high-quality and resilient medical products can be manufactured by an injection molding process. The flushing production from raw raw materials to the finished injection molded parts makes the injection molding process a fast and cost-effective process, which can be used, for example, to manufacture precision parts. Especially very small individual parts, such as parts for the manufacture of minimally invasive heart support systems, benefit from precise production. Typically, no further post-processing of the finished parts is required so that production can be completed quickly.

[0018] According to one embodiment, the sensor cavity can be filled with a casting compound, wherein the casting compound in particular contains solid or gel-like silicone or silicone oil. This embodiment of the method presented here provides the following advantages: Filling the sensor cavity with a casting compound can protect the sensor from, for example, blood and mechanical damage. In this case, the casting compound should be able to transmit the patient's heart pressure determined by the pressure sensor in order to continue to achieve accurate pressure measurements. The casting compound can be, for example, solid and / or gel-like silicone, or even silicone oil, wherein such a casting compound requires additional packaging of the sensor.

[0019] According to one embodiment, the sensor cavity can be coated and / or covered with a membrane and / or a diffusion barrier, wherein the membrane is particularly designed as a thin film and / or layer separated from the gas or gas phase, and / or the diffusion barrier comprises a polyparaxylene material. When silicone oil is used to fill the sensor cavity, the surface of the sensor cavity is closed with a membrane made, for example, of a polymer or a metal (e.g. titanium). When solid and / or gel-like silicones are used, no surface treatment of the sensor cavity is required. However, since water may diffuse into the silicone, the silicone may swell and thus, for example, cause tension on the pressure sensor membrane of the pressure sensor, which in turn may lead to errors in the pressure sensor. Therefore, the solid and / or gel-like silicone can, for example, be coated with a water barrier and / or a diffusion barrier based on polyparaxylene.

[0020] The method presented herein also results in a heart support system with a sensor head device, wherein the sensor head device is arranged at one end of a guide cannula, wherein the sensor head device is electrically connected or electrically connectable with an electrically conductive element of the guide cannula, in particular by means of a connecting element. The particular advantages of the method presented herein can also be easily and cost-effectively achieved by this embodiment.

[0021] A method of producing a sensor head device for a cardiac support system is provided, wherein the method comprises at least the following steps:

[0022] A sensor carrier element is formed which has at least one sensor cavity for accommodating at least one sensor and / or at least one signal transmitter cavity for accommodating at least one signal transmitter in order to produce a sensor head device for a heart support system.

[0023] According to one embodiment, the method may comprise the step of inserting at least one sensor into a sensor cavity of a shaped sensor carrying element and / or at least one signal transmitter into at least one signal transmitter cavity of a shaped sensor carrying element.

[0024] The method presented here for producing a sensor head device for a cardiac support system can be implemented, for example, in software or hardware, or in a hybrid form of software and hardware, for example in a control device.

[0025] The method presented herein also creates a device designed to execute, control or implement the steps of the variant of the method presented herein for producing a sensor head device for a cardiac support system in a corresponding device. The underlying object of the invention can also be achieved quickly and efficiently in the form of a device with this design variant of the invention.

[0026] To this end, the device may have at least one computing unit for processing signals or data, at least one storage unit for storing signals or data, at least one interface to a sensor or actuator for reading a sensor signal from a sensor or outputting data or a control signal to an actuator and / or at least one communication interface for reading or outputting data embedded in a communication protocol. The computing unit may be, for example, a signal processor, a microcontroller or the like, whereby the memory unit may be a flash memory, an EEPROM or a magnetic memory unit. The communication interface may be designed to read or output data wirelessly and / or in a wire-bonded manner, wherein the communication interface that can read or output wire-bonded data may, for example, read the data electrically or optically from a corresponding data transmission line or output the data electrically or optically into a corresponding data transmission line.

[0027] In the present case, a device can be understood to mean an electrical device which processes sensor signals and outputs control signals and / or data signals as its function. The device can have an interface, which can be designed by hardware and / or software. In a design with the aid of hardware, the interface can, for example, be part of a so-called system ASIC which includes the various functions of the device. However, the interface can also be a separate integrated circuit or at least partially consist of discrete structural elements. In a design with the aid of software, the interface can be a software module which, in addition to, for example, other software modules, is also present on a microcontroller.

[0028] A computer program product or a computer program with a program code is also advantageous, in particular if the program product or the program is executed on a computer or a device, wherein the program code can be stored on a machine-readable carrier or storage medium, such as a semiconductor memory, a hard drive memory or an optical memory, and is used to execute, implement and / or control the steps of a method according to one of the above-described embodiments.

[0029] Exemplary embodiments of the method presented here are schematically shown in the drawings and are explained in more detail in the following description. The drawings show:

[0030] Figure 1 is a schematic diagram of a cardiac support system according to an exemplary embodiment;

[0031] Figure 2 is a schematic diagram of a first design variant of a sensor head device for a cardiac support system according to an exemplary embodiment;

[0032] Figure 3a is a schematic diagram of a second design variant of a sensor head device for a cardiac support system according to an exemplary embodiment;

[0033] Figure 3bis a schematic diagram of another design variation of a sensor head device for a cardiac support system according to an exemplary embodiment;

[0034] Figure 3c is a schematic diagram of another design variation of a sensor head device for a cardiac support system according to an exemplary embodiment;

[0035] Figure 4 is a schematic diagram of a sensor carrying component of a sensor head device according to an exemplary embodiment;

[0036] Figure 5 is a schematic diagram of a cylindrical ultrasonic element of a sensor head apparatus according to an exemplary embodiment;

[0037] Figure 6 is a flow chart of an exemplary embodiment of a method of producing a sensor head assembly for a cardiac support system according to an exemplary embodiment; and

[0038] Figure 7 is a block diagram of an apparatus for producing a sensor head apparatus for a cardiac support system according to an exemplary embodiment.

[0039] In the following description of advantageous exemplary embodiments of the present invention, identical or similar reference numerals are used for elements having similar effects shown in the individual figures, wherein a repeated description of these elements is omitted.

[0040] Figure 1 A schematic diagram of a cardiac support system 100 is shown according to an exemplary embodiment. For example, Figure 1 A left ventricular cardiac support system 100 is shown with an integrated sensor head device 105. By way of example, cardiac support system 100 has a cylindrical elongated structure with a substantially constant outer diameter and rounded tapered ends for easy positioning in a blood vessel, such as the left heart chamber or the aorta, by means of a catheter.

[0041] The heart support system 100, here as an example a left ventricle heart support system 100 for percutaneous implantation into the left ventricle, firstly has a sensor head device 105. The heart support system 100 also has an inlet cage 110 with a plurality of inlet openings 115 through which the blood of the cardiac patient enters the heart support system 100, a guide cannula 120, an impeller cage 125 with an impeller and a plurality of outlet openings 130, a coupling and motor housing 135, a rear end 140 with sensor technology, an optional sensor seat and an electrical connection field, and finally a connection cable 145 for connecting the heart support system 100 to an external energy source or an external evaluation or control device.

[0042] The sensor head device 105 of the heart support system 100 has, for example, a rounded outer end 150 facing away from the heart support system 100, and a sensor assembly arranged in at least one sensor cavity 155 of the sensor head device 105, which can also be designed as a circumferential groove and is used, for example, to measure the pressure and / or temperature of a cardiac patient. In this case, the sensor head device 105 is arranged at an inner end (not shown) on an inlet cage 110, wherein the inlet cage 110 can also be designed as an integral part of the guide cannula 120. In addition, the sensor head device 105 can be electrically connected to an electrically conductive element (not shown) of the guide cannula 120, for example by means of a connecting element (not shown) of the inlet cage 110.

[0043] Figure 2 A schematic diagram of a first design variant of a sensor head device 105 for a cardiac support system according to an exemplary embodiment is shown. The sensor head device 105 is arranged, for example, at the inner end on an inlet cage 110 or a guide sleeve 120, wherein the sensor head device 105 is electrically connected to an electrically conductive element (not shown) of the guide sleeve 120 by means of a connecting element (not shown) of the inlet cage 110.

[0044] The sensor head device 105 has a sensor carrier element 205 which, for example, forms a base body of the sensor head device 105. The sensor carrier element 205 is produced, for example, from a thermoplastic in an injection molding process, but can alternatively also be produced in a mechanical manufacturing process.

[0045] The sensor carrier element 205 shown here has, for example, a circumferential or at least partially circumferential sensor cavity (155 and 210) (however, it can also be designed as two separate sensor cavities 155 and 210) for accommodating, for example, two sensors 215 and 220. The sensor carrier element 205 also has, for example, a cylindrical signal transmitter cavity (225 and 230) for accommodating a cylindrical signal transmitter 235. The sensors 215 and / or 220 are, for example, temperature sensors and / or pressure sensors, but in particular absolute pressure sensors for measuring air pressure. The signal transmitter 235 is, for example, an ultrasonic element, on which, according to an exemplary embodiment, a lens element 245, for example an ultrasonic lens made of silicone, is positioned, wherein the lens element 245 at least partially covers the signal transmitter cavity 225.

[0046] According to an exemplary embodiment, the signal transmitter cavity 225 opens in a different direction from the sensor cavity 155, wherein the signal transmitter cavity 225 opens in a direction facing the heart support system so that the main beam direction of the signal transmitter points into the axis of the guide sleeve 120. At least one sensor cavity 155 is, for example, manufactured as an at least partially circumferential groove (for example, at an angle of 330° in the circumferential direction around the outer surface of the sensor head device 105) and is radially open. In a particularly advantageous manner, the wall of the groove as the sensor cavity 155 is designed so that the groove is wider toward the outside than at the base. Therefore, the expansion of the silicone introduced into the groove as a seal and into the sensor 215 arranged therein in the production step of the sensor carrier element 205 then leads to less tension of the MEMS element as the sensor 215.

[0047] The sensor carrier element 205 has a channel 270 extending in the longitudinal extension direction of the sensor head device 105, wherein in the first design variant of the sensor carrier element 205 shown here, the channel 270 ends centrally, for example, in a round cap or mushroom head-shaped outer end 150 facing away from the heart support system. The mushroom head-shaped outer end 150 of the sensor head device 105 is rounded in order not to induce any damage in the heart patient and to ensure good sliding properties when the heart support system is advanced during implantation of the system.

[0048] By way of example, the sensor carrying part 205 has an opening 271 in its center. In this case, the opening 271 is used to accommodate a guide wire (not shown). When the cardiac support system is implanted in the left heart chamber or aorta of a heart patient, the guide wire is first placed in the patient's heart chamber. Then, the cardiac support system is pushed onto the guide wire and advanced along the guide wire to the end position.

[0049] In a first embodiment for guiding a guide wire in the region of the signal transmitter cavity, the sensor carrier 205 may include a tubular continuation 250 extending into the signal transmitter cavity so that the guide wire is guided to the contact surface between the ultrasound lens 245 and the blood in the region 110. In a second embodiment, a small tube 275 (e.g., a metal tube made of stainless steel, titanium or NiTiNol) is inserted into the channel 270 and extends through the sensor carrier 205 and beyond the sensor carrier into the signal transmitter cavity 225 to the contact surface between the ultrasound lens 245 and the blood in the region 110. The second embodiment has the advantage that the wall thickness can be significantly reduced, which results in a reduced width of the central opening in the signal transmitter, which is advantageous above all when the signal transmitter is designed as an ultrasonic transducer.

[0050] Towards the outside, the signal transmitter cavity is limited by a cylindrical jacket 265, which is, for example, part of the design of the sensor carrying part 205. The cylindrical signal transmitter 235 can therefore be designed with its central opening on the continuation 250 or on the small tube 275, depending on the design variant, and inserted into the signal transmitter cavity 225. The gaps between 250 and 235, or between 275 and 235 and between 235 and 265 can be filled, for example with epoxy or silicone, which also simultaneously serves as an adhesive fixation.

[0051] The mushroom-shaped outer end 150 represents an additional mechanical protection for the sensors 215, 220 arranged in at least one sensor cavity 155. In order to place the sensors 215 and 220 around the web 251 (cuboidal here, for example), the sensors 215 and 220 must be arranged on a flexible circuit board or a film substrate in the first design variant of the sensor head device 105 shown here. For example, the sensors 215, 220 are bonded to the film substrate. In the region of the sensors 215, 220, the film substrate should not bend, which is why it can be supported here with reinforcement elements, but most importantly, the substrate is not cylindrically rounded, but is designed as a cube with rounded corners. The rounded corners of the web 251 serve, for example, to maintain the bending radius of the film substrate (polyimide gold layer structure).

[0052] According to an exemplary embodiment, at least one sensor cavity 155 is filled with a casting compound to protect the sensors 215, 220 from blood and mechanical damage. In this case, the casting compound can be a solid and / or gel-like silicone, or even silicone oil. In this case, the casting compound should be able to transmit the patient's heart pressure so that accurate pressure measurement can continue to be achieved by the sensor 215 or 220.

[0053] Figure 3a A schematic diagram of a second design variant of a sensor head device 105 for a cardiac support system 100 according to an exemplary embodiment is shown. The sensor head device 105 is arranged, for example, at the inner end on a guide sleeve 120 or on an inlet cage 110, wherein the sensor head device 105 is electrically connected to an electrically conductive element (not shown) of the guide sleeve 120 by means of a connecting element (not shown here) of the inlet cage 110. In a narrower sense, the electrically conductive element is completely placed in one piece from the rear end 140 to the sensor head device 105, for example by being fixed to all components of the sensor head device 205.

[0054] The sensor head device 105 has a sensor carrier element 205 which, for example, forms a base body of the sensor head device 105. The sensor carrier element 205 is produced, for example, from a thermoplastic in an injection molding process, but can alternatively also be produced in a mechanical manufacturing process.

[0055] The sensor carrier element 205 shown here has, for example, two sensor cavities 155 and 210, or, as has already been described in detail above, at least a partially circumferential groove as a sensor cavity 155 for accommodating each sensor 215 or 220. The sensor carrier element 205 also has, for example, a signal transmitter cavity 225 for accommodating a signal transmitter 235. The sensors 215 and / or 220 are, for example, temperature sensors and / or pressure sensors, but in particular barometric absolute pressure sensors. The signal transmitter 235 is, for example, an ultrasonic element, on which, according to an exemplary embodiment, a lens element 245, for example an ultrasonic lens made of silicone, is positioned, wherein the lens element 245 at least partially covers the signal transmitter cavities 225 and 230.

[0056] According to an exemplary embodiment, if the sensor cavity 155 is not formed by an at least partially circumferential groove, the signal transmitter cavity 225 opens in a different direction than the sensor cavity 155 or the two sensor cavities 155 and 210, wherein the signal transmitter cavity 225 or the two signal transmitter cavities 225 or 230 opens in a direction facing the heart support system. As an example, the first sensor cavity 155 opens in a direction facing away from the heart support system, wherein the sensor cavity 155 thus opens in a direction offset by 90° relative to the signal transmitter cavity 225.

[0057] The sensor-carrying element 205 has a channel 270 extending in the longitudinal extension direction of the sensor head device 105, wherein the channel in the first design variant of the sensor head device 105 shown here extends through the web-shaped continuation 250 to the surface 252 of the sensor cavity or the surface of the signal transmitter 235 or the surface 246 of the optional ultrasound lens. In an embodiment not shown, the web-shaped continuation 250 can be formed by a small tube 275 (e.g., a small metal tube), so that the channel 270 can be designed to have thin walls. For example, the sensor cavity 155 located at the outer end 150 facing away from the heart support system can have an outer wall with a U-shaped cross section, or when the web-shaped continuation 250 is used, an E-shaped outer wall 310. According to an exemplary embodiment, the sensor cavity 155 or one sensor cavity 155, 210 for accommodating sensors 215, 220 is formed between each outer wall 310 and the web-shaped continuation 250 or the small tube 275. This design variant of the outer end 150 thus has, for example, a pot shape. The continuation of the channel 270 to the inner end 260 can also be performed by the web 250 or as a small tube 275. According to an exemplary embodiment, the signal transmitter cavity located here has walls with a U-shaped cross-section, or when the web 250 is used, has E-shaped walls, wherein a signal transmitter cavity 225 for accommodating a signal transmitter 235 is formed between each pair of the inner walls 265.

[0058] The design variant of the sensor head device 105 shown here has the advantage that the sensors 215 and 220 can be premounted, for example, on a round circuit board 320 , wherein in an alternative exemplary embodiment the signal transmitter 235 can also be premounted on the round circuit board.

[0059] According to an exemplary embodiment, the sensor cavity 155 or both sensor cavities 155, 210 are filled with a casting compound to protect the sensors 215, 220 from blood and mechanical damage. In this case, the casting compound can be a solid and / or gel-like silicone, or even silicone oil. In this case, the casting compound should be able to transmit the patient's heart pressure so that accurate pressure measurements can continue to be achieved by the sensors 155 and 210.

[0060] By way of example, the sensor-carrying element 205 has a channel 270 in its center, wherein a cylindrical tube 275 is positioned in the channel 270, for example. Over the entire length of the sensor head device 105, a tube 275 (which may also be referred to as a small tube) can be inserted into and / or formed in an opening 271. In this case, the opening 271 or the cylindrical tube 275 is used to accommodate a guide wire (not shown). When the cardiac support system is implanted in the left heart chamber or the aorta of a heart patient, the guide wire is first placed in the patient's ventricle. Then, the cardiac support system is pushed onto the guide wire and advanced along the guide wire to the end position.

[0061] Figure 3b FIG. 1 shows a schematic diagram of another design variant of a sensor head device 105 for a heart support system 100 according to an exemplary embodiment. Figure 3a In contrast to the design variant of the sensor head device 105 shown in FIG. Figure 3b In the design variant shown in , a small cylindrical tube 275 is provided which is inserted into the central part of the sensor carrier element 205 so as to form a channel 270 or an opening 271. In this case, the diameter of the small tube 275 is greater than the diameter of the opening of the sensor carrier element 205, so that after being inserted into the sensor carrier element 205, the small tube 275 can be retained in the sensor carrier element 205 by a press fit.

[0062] Figure 3c A schematic diagram shows a further design variant of a sensor head device for a heart support system according to an exemplary embodiment. Figure 3c The sensor carrier element 205 shown in FIG. 2 is shown here as a single piece or a one-piece component, for example in FIG. Figure 3a used in the illustration.

[0063] Figure 4 A schematic diagram of a sensor carrying part 205 of a sensor head device 105 according to an exemplary embodiment is shown. For example, the sensor carrying part 205 is implemented as several parts in the illustration shown herein. Therefore, a simple demoulding of the sensor carrying part 205 as an injection molded part made of a thermoplastic such as polyetheretherketone is possible. In this case, the injection molded part or sensor carrying element 205 only includes a mushroom cap-shaped outer end 150 with a web 251, wherein a cylindrical tube 275, for example made of a metal material, is inserted into a channel 270 formed in the center of the sensor carrying part 205. The tube 275 can be inserted into the channel 270, for example, over the entire length of the sensor carrying part 205, and is used, for example, to accommodate a guide wire (not shown). According to an exemplary embodiment, a sensor cavity 155 or a sensor cavity 155 and 210 are each formed on the side facing away from the mushroom cap above and below the web 251, wherein the sensor cavity 155 (or the sensor cavity 155 and 210 are each) is used to accommodate at least one sensor. As an example, the various parts of the sensor-carrying component 205 may be joined together by a biocompatible adhesive.

[0064] Figure 5A schematic diagram of a cylindrical ultrasonic element 235 pushed onto a sensor carrier element 205 of a sensor head device 105 according to an exemplary embodiment is shown. By way of example, the ultrasonic element 235 shown herein has an opening for pushing onto a tube 275. In this case, the tube 275 is inserted into the opening of the sensor carrier element in the region of the ultrasonic element 235 so as to ensure that the ultrasonic element 235 is also encapsulated from the inside. By way of example, the ultrasonic element 235 can be a piezoelectric element with the necessary backing and impedance adaptation layer and / or can be a gas-sealed element. The ultrasonic element 235 is, for example, arranged on a circular circuit board and in this case integrated into the sensor head device and encapsulated in the sensor head device so that the ultrasonic element 235 points in the direction of the guide cannula. Thus, the ultrasonic element 235 is optimally integrated into and securely encapsulated in the cylindrical shape of the guide cannula or the entire heart support system.

[0065] Figure 6 A flow chart illustrating an exemplary embodiment of a method 600 of producing a sensor head assembly for a cardiac support system in accordance with an exemplary embodiment.

[0066] In step 610 of method 600, a sensor carrying element is formed, the sensor carrying element having at least one sensor cavity for accommodating at least one sensor and / or at least one signal transmitter cavity for accommodating at least one signal transmitter, so as to produce a sensor head device for a cardiac support system. In step 620 of method 600, finally, at least one sensor is inserted into the sensor cavity and / or at least one signal transmitter is inserted into at least one signal transmitter cavity of the formed sensor carrying element.

[0067] Figure 7 A block diagram of an apparatus 700 for producing a sensor head device for a heart support system according to an exemplary embodiment is shown. In this case, the apparatus 700 is designed to execute and / or control the steps of a method for producing a sensor head device in corresponding units.

[0068] The device 700 thus has a forming unit 710 and an inserting unit 720. In this case, the forming unit 710 is designed to form a sensor carrying element having at least one sensor cavity for accommodating at least one sensor and / or at least one signal transmitter cavity for accommodating at least one signal transmitter in order to produce a sensor head device for a cardiac support system. The inserting unit 720 is finally designed to insert at least one sensor into at least one sensor cavity and / or at least one signal transmitter into at least one signal transmitter cavity of the formed sensor carrying element.

[0069] If an exemplary embodiment includes an “and / or” connection between a first feature and a second feature, this should be understood to mean that the exemplary embodiment according to one embodiment includes both the first feature and the second feature and according to another embodiment includes only the first feature or only the second feature.

Claims

1. A cardiac support system comprising: A pump configured to be delivered via a cannula to a left heart chamber to pump blood, the pump comprising: Guide cannula; one or more inlet openings in the side wall of the guide sleeve and located at a first end of the guide sleeve; one or more outlet openings located at the second end of the guide sleeve; and an impeller at least partially located in the guide cannula, wherein the impeller is configured to pump blood in through the one or more inlet openings and out of the one or more outlet openings; A sensor head device is located distally of the first end of the guide cannula and includes a sensor carrying element, the sensor carrying element including: at least one sensor cavity configured to receive at least one sensor; at least one signal transmitter cavity configured to accommodate at least one signal transmitter; and a conical cap at the outer end; Wherein the at least one sensor cavity and the at least one signal transmitter cavity are located distally from the inlet opening.

2. A cardiac support system as described in claim 1, wherein the at least one sensor cavity opens in a different direction from the at least one signal transmitter cavity.

3. A cardiac support system as described in claim 1, wherein the at least one sensor cavity is formed by a groove that is at least partially circumferential around the sensor carrying element.

4. A cardiac support system as described in claim 1, wherein the sensor carrying element includes an outer wall arranged in a U-shape and / or E-shape, and / or includes an inner wall arranged in a U-shape and / or E-shape at at least one inner end of the sensor carrying element.

5. A cardiac support system as described in claim 4, wherein the at least one signal transmitter cavity or the at least one sensor cavity is formed between the outer walls and / or between the outer wall and the inner wall.

6. A cardiac support system as described in claim 1, wherein the sensor carrying element includes a channel in the center of the sensor carrying element.

7. A cardiac support system as described in claim 6, wherein the channel comprises a cylindrical tube.

8. The cardiac support system of claim 1, further comprising: at least one sensor including a temperature sensor and / or a pressure sensor; and / or at least one signal transmitter comprising an ultrasonic element, The at least one sensor and / or the at least one signal transmitter are arranged on the conductive element.

9. A cardiac support system as described in claim 1, wherein the signal transmitter cavity is at least partially covered by a lens element, wherein the lens element includes an ultrasound lens and / or a lens made of silicone material.

10. The cardiac support system of claim 1, wherein the sensor-carrying element is formed from a thermoplastic and / or the sensor-carrying element is manufactured by a mechanical manufacturing method and / or as an injection-molded component.

11. The cardiac support system of claim 1, wherein the at least one sensor cavity is filled with a casting compound comprising solid or gel-like silicone or silicone oil.

12. A cardiac support system as described in claim 1, wherein the at least one sensor cavity is coated and / or covered by a membrane and / or diffusion barrier, and the membrane comprises a thin film formed from polyparaxylene material.

13. The cardiac support system of claim 1, wherein the sensor head assembly is configured to be electrically connected to a rear end of the cardiac support system, the cardiac support system being located proximal to the second end of the guide sleeve.

14. A method for producing a sensor head assembly for a cardiac support system, comprising: A sensor carrying element is formed, the sensor carrying element being configured to be delivered to a heart via a cannula, the sensor carrying element comprising: at least one sensor cavity configured to receive at least one sensor; at least one signal transmitter cavity configured to accommodate at least one signal transmitter; and a conical cap at the outer end; and The sensor bearing element is mounted to the distal side of a pump, the pump being configured to be delivered to the left heart chamber via a cannula to pump blood, the pump comprising: Guide cannula; one or more inlet openings in the side wall of the guide sleeve and located at a first end of the guide sleeve; one or more outlet openings located at the second end of the guide sleeve; and an impeller at least partially located in the guide cannula, wherein the impeller is configured to pump blood in through the one or more inlet openings and out of the one or more outlet openings; Wherein the sensor head assembly is configured to be located distally of the first end of the guide cannula, and wherein the at least one sensor cavity and the at least one signal transmitter cavity are located distally of the one or more inlet openings.

15. The method of claim 14, further comprising inserting at least one sensor into the sensor cavity and / or inserting at least one signal transmitter into the at least one signal transmitter cavity of the formed sensor carrying element.

16. The method of claim 14, wherein the at least one sensor cavity opens in a different direction than the at least one signal transmitter cavity.

17. The method of claim 14, further comprising filling the at least one sensor cavity with a casting compound comprising solid or gel-like silicone or silicone oil.

18. The method of claim 14, further comprising coating and / or covering the at least one sensor cavity with a membrane and / or a diffusion barrier, the membrane comprising a thin film formed of a parylene material.

19. A non-transitory computer-readable storage medium comprising instructions thereon, which when executed, instruct a processor to perform a method comprising: A sensor carrying element is formed, the sensor carrying element being configured to be delivered to a heart via a cannula, the sensor carrying element comprising: at least one sensor cavity configured to receive at least one sensor; at least one signal transmitter cavity configured to accommodate at least one signal transmitter; and a conical cap at the outer end; and The sensor bearing element is mounted to the distal side of a pump, the pump being configured to be delivered to the left heart chamber via a cannula to pump blood, the pump comprising: Guide cannula; one or more inlet openings in the side wall of the guide sleeve and located at a first end of the guide sleeve; one or more outlet openings located at the second end of the guide sleeve; and an impeller at least partially located in the guide cannula, wherein the impeller is configured to pump blood in through the one or more inlet openings and out of the one or more outlet openings; Wherein the sensor head device is configured to be located distally of the first end of the guide cannula, and wherein the at least one sensor cavity and the at least one signal transmitter cavity are configured to be located distally of the one or more inlet openings.

20. The computer-readable storage medium of claim 19, wherein the method further comprises inserting at least one sensor into the sensor cavity and / or inserting at least one signal transmitter into the at least one signal transmitter cavity of the formed sensor-carrying element.

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