Method and apparatus for manufacturing a cardiac assist system - Patents.com

Abstract

A system and method for manufacturing and assembling a cardiac assist system. The method may include providing a sensor device and an inlet tube. The inlet tube may be adapted to aspirate a patient's bodily fluid and may include a drive unit for operating the cardiac assist system. The method may further include connecting the sensor device to a first end of the inlet tube and connecting the drive unit to a second end of the inlet tube.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 261,552, filed September 23, 2021, entitled “METHOD AND APPARATUS FOR MANUFACTURING A CARDIAC ASSIST SYSTEM,” the entire contents of which are incorporated by reference herein and made a part hereof for all purposes. [Background technology]

[0002] Disclosed herein are methods and apparatus for manufacturing cardiac assist systems, as well as corresponding computer programs. Cardiac assist systems are used in medicine, for example, to alleviate a patient's cardiac weakness. These systems may be heart pumps or mechanical circulatory assist devices, and may be configured to assist or improve a patient's cardiac function. These systems may assist cardiac function via the coronary arteries. Summary of the Invention

[0003] The approaches presented herein relate to improved methods for manufacturing cardiac assist systems, improved cardiac assist systems, apparatus using the methods, and corresponding computer programs.

[0004] The approach presented herein advantageously allows for a reduction in the required production space of the cardiac assist system by providing a manufacturing and / or assembly sequence for the individual components of the cardiac assist system, while at the same time ensuring functionality of the cardiac assist system.

[0005] A method for manufacturing a cardiac assist system is provided, the method may include a providing step and / or a connecting step. The providing step may include providing and / or manufacturing a sensor device, an inlet tube having a first end and a second end opposite the first end, the inlet tube configured to aspirate a body fluid of a patient, and a drive unit for operating the cardiac assist system. In the connecting step, the sensor device may be connected to the first end of the inlet tube and the drive unit may be connected to the second end of the inlet tube to produce at least a portion of the cardiac assist system.

[0006] The approaches described herein may be advantageously used to create biocompatible and long-term stability options, for example, for integrating sensor cables into cardiac assist systems. The sensor device may be advantageously configured to measure bodily fluid (e.g., blood) flow rate and / or volumetric flow, and / or properties of the bodily fluid, such as pressure, viscosity, and / or temperature.

[0007] According to one embodiment, the sensor device and the inlet tube may be connected in a connecting step to create a connecting device. Advantageously, the sensor device may be located at a distal tip of the connecting device to acquire data in operation without interrupting the pumping action of the cardiac assist system. In this configuration, erroneous readings may be advantageously reduced. The connecting device may be connected to a drive unit in a connecting step to create at least a portion of the cardiac assist system. Hence, the cardiac assist system may advantageously be manufactured in a modular manner.

[0008] According to one embodiment, a housing element for the cardiac assist system may be provided in the providing step. In the connecting step, the drive unit may be connected to the housing element. The housing element may be shaped, for example, to protect electrical components of the cardiac assist system from external influences. Furthermore, the housing element may be shaped to protect a blood vessel into which the cardiac assist system is inserted, for example, from pump elements of the cardiac assist system.

[0009] According to an embodiment, the manufacturing method may include a step of prepositioning and fixing the sensor device, the inlet tube, and / or the drive unit. The sensor device, the inlet tube, and / or the drive unit may be bonded, siliconized, and / or conductively bonded together in a fixing step. At least some of the prepositioning and fixing steps may be repeated as desired. It may be advantageous to connect subcomponents in a modular sequence to form a result component, for example by material bonding and / or electrical connection. In other words, two subcomponents may be modularly combined to form a result component, which may then be combined with at least one further subcomponent to form a further result component. This advantageous procedure may be implemented in software, hardware, and / or mixed forms of software and hardware, such as an automatic control unit. The presented approach allows the manufacture of devices that may be configured to perform, control, or implement alternative steps of the processes presented herein in suitable facilities. For this purpose, the device may have at least one computing unit for processing signals or data, at least one memory 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 a data or control signal to an actuator, and / or at least one communication interface for reading or outputting data, which may be embedded in a communication protocol. The at least one computing unit may for example be a signal processor, a microcontroller, etc., whereby the memory unit may be a flash memory, an EEPROM, or a magnetic memory unit. The at least one communication interface may be configured to read data wirelessly and / or wired, whereby the at least one communication interface capable of reading or outputting wired data may for example read this data electrically or optically from a corresponding data transmission path.Or it may output it to a corresponding data transmission path. In this case, the device may be understood as an electrical device that processes the sensor signals and outputs control and / or data signals accordingly. The device may have at least one interface, which may have hardware and / or software functions. In the case of hardware, the at least one interface may be part of a so-called system ASIC, which may include various functions of the device. The at least one interface may include an integrated circuit or may at least partially include separate components. In the case of software-based training, the at least one interface may be a software module that may be installed together with other software modules that may be available on the microcontroller.

[0010] A computer program product or computer program having program code stored on a machine-readable medium or storage medium, such as a semiconductor memory, hard disk storage, or optical memory, and which can be used to execute, transform, and / or control the steps of the procedures described above, may be used, particularly when the program product or program is executed on a computer or device.

[0011] Also provided is a cardiac assist system including a sensor device, an inlet tube including a first end connected to the sensor device and a second end opposite the first end, the inlet tube configured to aspirate a patient's body fluid, and a drive unit for operating the cardiac assist system, the drive unit connected to the second end of the inlet tube.

[0012] The sensor device may, for example, be configured to obtain measurements that are as accurate and unaltered as possible. The inlet tube may advantageously be configured to conduct a bodily fluid, for example blood. A first end of the inlet tube may be connected to the sensor device.

[0013] According to one embodiment, the inlet tube may have at least one inlet opening at or near a first end, which may be configured to allow at least one bodily fluid to flow into the inlet tube. The at least one inlet opening may be configured as an interface between the sensor device and the inlet tube. Advantageously, the interface may be configured as an inlet grill that may form the at least one inlet opening. Advantageously, the at least one inlet opening may include at least two inlet openings (e.g., two, three, four, five, six).

[0014] According to one embodiment, the inlet tube may have at least one outlet opening at a second end, which may be configured to allow at least one bodily fluid to exit the inlet tube. Advantageously, the at least one bodily fluid may be conducted into a blood vessel in a regulated manner, thereby supporting, for example, cardiac function.

[0015] According to one embodiment, the cardiac assist system may have a deployable anchor structure, a driver (e.g., a motor), a pump element, and / or a connection interface. The deployable anchor structure may be configured, for example, to advantageously secure the cardiac assist system in place. In one implementation, the deployable anchor structure may have a grid-like structure that may advantageously be connected to a patient's tissue (e.g., to promote tissue ingrowth). The driver may be configured, for example, to drive the pump element. The pump element may be implemented, for example, as an impeller or pump wheel. The connection interface may be configured, for example, to connect electrical conductors.

[0016] The sensor device may have multiple sensor components, including at least one sensor, a layer substrate, a carrier element, and / or an ultrasonic transducer. Advantageously, the multiple sensor components may be modularly connected to each other.

[0017] According to one embodiment, at least two of the plurality of sensor components may be electrically connected to each other. Advantageously, for example, a signal or voltage may be transmitted via a connection to a corresponding sensor component. [Brief description of the drawings]

[0018] The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims taken in conjunction with the accompanying drawings. The present disclosure will be described with further specificity and detail through the use of the accompanying drawings, with the understanding that these drawings illustrate only some embodiments according to the present disclosure and should not be considered as limiting its scope. In the following detailed description, reference is made to the accompanying drawings, which form a part of this specification. In the drawings, similar symbols typically identify similar components unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that aspects of the present disclosure, as generally described herein and illustrated in the drawings, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are expressly contemplated and made a part of this disclosure. Examples of implementations of the approach presented herein are illustrated in the drawings and described in more detail in the following description. This shows the following: [Figure 1] FIG. 1 is a schematic diagram of a cardiac assist system according to one embodiment. [Diagram 2] FIG. 2 is a schematic diagram of a cardiac assist system according to one embodiment in an implanted state. [Diagram 3] FIG. 3 is a flow chart of a manufacturing process for producing a cardiac assist system according to one embodiment. [Figure 4] FIG. 4 is a block diagram of an apparatus according to one embodiment. [Diagram 5] FIG. 5 is a production sequence for manufacturing a sensor device having multiple sensor components, according to one embodiment. [Figure 6] FIG. 6 is an assembly sequence for manufacturing a connection device according to one embodiment. [Figure 7] FIG. 7 is a further assembly sequence for connecting the connecting device to the drive unit according to one embodiment. [Figure 8] FIG. 8 is a cabling sequence for wiring a cardiac assist system according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] In the following description, in the embodiments of the present invention, elements which appear in different figures and have similar effect will use the same or similar reference numerals, and these elements will not be described repeatedly.

[0020] 1 shows a schematic diagram of a cardiac assist system 100 according to one embodiment. The cardiac assist system 100 may be implemented, for example, as a cardiac pump and may be configured to support a cardiac function of a patient. The cardiac assist system 100 may include a sensor device 105 that may be configured, for example, to measure a flow rate and / or a volumetric flow of a bodily fluid, and / or properties of the bodily fluid, such as pressure, viscosity, and / or temperature.

[0021] The cardiac assist system 100 may include an inlet tube 110 having a first end 115 and a second end 120 opposite the first end 115, the inlet tube 110 being connected to the sensor device 105. The inlet tube 110 may be configured to aspirate a patient's bodily fluid, such as blood. According to one embodiment, the first end 115 may be connected to the sensor device 105. Furthermore, the cardiac assist system 100 may include a drive unit 125 for operating the cardiac assist system 100. The drive unit 125 may be connected to the second end 120 of the inlet tube 110. According to one embodiment, a component 165 (not shown) may be positioned between the second end 120 of the inlet tube and the drive unit 125. The component 165 (not shown) may be configured as an interface between the inlet tube 110 and the drive unit 125. In one embodiment, the component 165 may be implemented as an impeller housing. In one embodiment, the component 165 (not shown) may include at least one outlet opening. The inlet tube 110 may be bent, or at least curved, between the first end 115 and the second end 120, for example in a region closer to the first end 115. The bend or curve may be a rounded corner.

[0022] According to an embodiment, the sensor device 105 may have multiple sensor components. The multiple sensor components may be formed of at least one sensor, layer substrate, carrier element, and / or ultrasonic transducer, which may be electrically connected to each other. According to an embodiment, the inlet tube 110 may have at least one inlet opening 130 at the first end 115. The at least one inlet opening 130 may be configured, for example, to allow at least one body fluid to flow into the inlet tube 110. The at least one inlet opening 130 may be configured, for example, as an inlet grille and may be configured as an interface between the sensor device 105 and the inlet tube 110. According to an embodiment of the inlet tube 110, the at least one inlet opening 130 may include multiple inlet openings (e.g., at least three similarly shaped openings), which may be oval, rectangular, square, circular, or diamond shaped. At the second end 120, the inlet tube 110 may include at least one outlet opening 135. According to an embodiment, the at least one outlet opening 135 may be configured to allow the exit of at least one body fluid from the inlet tube 110. The at least one exit opening 135, as well as the at least one inlet opening 130, may be oval, rectangular, square, circular, or diamond shaped. The inlet tube 110 may be configured according to the embodiment with at least one exit opening 135, including at least three exit openings, which may be configured as an exit grille, for example, as well as the at least one inlet opening 130.

[0023] According to an embodiment, the cardiac assist system 100 may include a deployable anchor structure 140, a drive unit 125, a pump element 150, and / or a connection interface 155. The deployable anchor structure 140 may be configured, for example, to anchor the cardiac assist system 100 in a blood vessel. The drive unit 125 may be implemented, for example, as a motor or as a motor element that may be configured, for example, to power the sensor device 105 and / or the pump element 150. The pump element 150 may be implemented, for example, as an impeller or as a pump wheel. According to an embodiment, the deployable anchor structure 140 may be connected to the drive unit 125 by a web 160. This allows the cardiac assist system 100 to allow the greatest possible protection of cables, avoid electrical connections along the surface of the cardiac assist system 100, improve the functional integrity of the transmitted components, for example, the inlet tube, and ensure that the pump can be manufactured and assembled.

[0024] The cardiac assist system 100 may include several individual components as described. During production, the appropriate manufacturing and assembly sequence of the individual components, also known as, for example, sensor components, may be determined. The manufacturing and assembly sequence may advantageously follow, for example, the required time sequence of surface treatment steps and at the same time define the interface between the manufacturing partners. Furthermore, the described approach ensures biocompatibility and long-term stable integration of the sensor cable, which may be used as a connection interface of the pump assembly. The connection interface may occupy a minimum installation space without reducing the pump diameter and therefore does not impair the efficiency of the pump element 150.

[0025] The cardiac assist system 100 may include a sensor head, described herein as a sensor device 105, an inlet grill having at least one inlet opening 130, an inlet tube 110, an outlet grill, a pump element 150, at least one outlet opening 135, a deployable anchor structure 140 which may include, for example, a bar coupled to a drive unit 125, and a connection interface 155 which may be configured to merge electrical connection lines and a supply cable.

[0026] Fig. 2 shows a schematic diagram of a cardiac assist system 100 according to an embodiment in an implanted state. The cardiac assist system 100 corresponds to or is at least similar to the cardiac assist system 100 described in Fig. 1 and according to one embodiment may be positioned in a heart 200, more precisely across the aortic valve 205 of the heart 200, so that fluid from the left ventricle 210 can be sucked in through at least one inlet opening and expelled through at least one outlet opening into the aorta 215. This increases the patient's cardiac output per minute, symbolized by arrow 220, and thus assists or replaces the physiological function of the heart 200.

[0027] FIG. 3 shows a flow chart of a manufacturing process 300 for manufacturing a cardiac assist system according to an embodiment. The manufacturing process 300 illustrates an exemplary manufacturing process of the cardiac assist system 100, for example, as described in FIG. 1 and / or FIG. 2. The manufacturing process 300 may include a preparation step 305, a joining step 310, and an optional prepositioning and fixing step 315. The preparation step 305 may include providing and / or manufacturing a sensor device, an inlet tube having a first end and a second end opposite the first end, and a drive unit for operating the cardiac assist system. The inlet tube may be configured to aspirate a patient's body fluid. In the joining step 310, the sensor device may be connected to the first end of the inlet tube and the drive unit may be connected to the second end of the inlet tube to generate a resultant component, which may be part of the cardiac assist system. According to an embodiment, the second end of the inlet tube may be connected to a component, which may be connected to the drive unit. According to an embodiment, the component may include at least one outlet opening. In an optional prepositioning and fastening step 315, the sensor device, inlet tube, and / or drive unit may be prepositioned and connected to one another. In particular, the sensor device, inlet tube, and / or drive unit may be bonded, siliconized, and / or conductively bonded together.

[0028] According to one embodiment, in a preparation step 305 of the manufacturing process 300, a housing element may be provided as an option for a cardiac assist system that may be connected to a drive unit in a joining step 310.

[0029] Additionally, according to one embodiment, the joining step 310 may connect the sensor device and the inlet tube to form a connection device. Optionally, the connection device may be connected to a drive unit to create a resultant component that may be part of a cardiac assist system.

[0030] FIG. 4 shows a block diagram of the device 400 according to an embodiment. The device 400 may be configured to perform or at least control a manufacturing process for manufacturing a cardiac assist system, for example as described in FIG. 3. The device 400 may include a supply unit 405, which may be configured by a supply signal 410, for example, to supply the sensor device, an inlet tube having a first end and a second end opposite the first end, the inlet tube configured to aspirate a body fluid of a patient, and a drive unit configured to operate the cardiac assist system. The device 400 may include a connection unit 415, which may be configured by a connection signal 420, for example, to connect the sensor device to the first end of the inlet tube and to connect the drive unit to the second end of the inlet tube. Optionally, the device 400 may include a fixation unit 425, which may be configured by a fixation signal 430, for example, to provide pre-positioning and fixation of the sensor device, the inlet tube, and / or the drive unit, which may be bonded, siliconized, and / or conductively bonded to each other in a fixation step.

[0031] FIG. 5 shows a production sequence 1100 for manufacturing a sensor device having multiple sensor components according to one embodiment. The production sequence 1100 represents at least a partial sequence of the manufacturing process 300 as described in FIG. 3. The production sequence 1100 may include a substep 1105 of manufacturing and / or providing a sensor and a substep 1110 of manufacturing and / or providing at least one conductive element, such as a thin film substrate. In a contacting substep 1115, the sensor and the at least one conductive element may be in electrical contact with each other. In a providing substep 1120, a carrier element, such as polyetheretherketone (PEEK), may be provided and then bonded and / or joined to the sensor-conductive element combination, or may be siliconized, for example, in a bonding substep 1125. According to one embodiment, an ultrasonic transducer may additionally be provided in a substep 1130, which may be connected to the resulting components from the bonding substep 1125, for example, in a conductive bonding substep 1135, to obtain a sensor device, for example, as described in FIG. 1 and / or FIG. 2.

[0032] Thus, sub-steps 1105, 1110, 1115, 1120, 1125, 1130, and 1135 describe the manufacture of the sensor device. In sub-step 1105, at least one sensor may be manufactured and / or provided in an electrically contactable form, for example on a substrate or submount. In sub-step 1110, at least one conductive element may be manufactured and / or provided, for example in the form of a cable or an electrical thin film substrate, to electrically connect the at least one sensor to the electrical connection interface of the distal tip. Contacting sub-step 1115 may include electrically contacting the at least one sensor to the at least one conductive element. In providing sub-step 1120, a carrier element, for example PEEK, may be manufactured and / or provided by milling or injection molding. In bonding sub-step 1125, the at least one conductive element with the at least one electrically connected sensor may be bonded to the carrier element by subsequent encapsulation of a sensor cavity in the carrier element with medical grade silicone. At least one conductive element may protrude from the sensor head, for example for subsequent further connection along a cardiac assist system. In sub-step 1130, an ultrasonic transducer, such as a piezoelectric disk, or a transducer layered structure including a backing layer and a matching layer may be manufactured and / or provided and encapsulated with a biocompatible material, such as medical grade silicone. In conductive bonding sub-step 1135, the ultrasonic transducer may be conductively bonded to the sensor package on the at least one conductive element, and an ultrasonic lens may be, for example, injection molded to form a sensor device.

[0033] Figure 6 illustrates an assembly sequence 1200 for manufacturing a connection device according to one embodiment. The assembly sequence 1200 represents at least a partial sequence of the manufacturing process 300 described in Figure 3. In sub-step 1205, an inlet tube may be provided and / or manufactured, which may be connected to a sensor device in sub-step 1210, for example as made in Figure 5. A corresponding sensor cable may be assembled according to an embodiment in sub-step 1215, where the sensor cable may be made and / or joined to the connection device.

[0034] According to an embodiment, in siliconization substep 1220, the assembled components may be siliconized, for example by a coater, to obtain the connection device described in FIG. 1. Using substeps 1205, 1210, 1215, and 1220, the connection device assembly sequence is described according to an embodiment. In substep 1205, for example, the inlet tube may be manufactured by laser cutting from a Nitinol tube or by braiding Nitinol wires. In substep 1210, for example, a previously manufactured sensor device may be coupled to the inlet grille of the inlet tube (also known as the inlet cage) by a press fit supported by a glued joint. In substep 1215, at least one conductive element may be positioned along the inlet tube. In some embodiments, at least one conductive element may be positioned within or aligned with the helical structure of the inlet tube and / or the fixation of the carrier element along the helical structure by a biocompatible adhesive. In some embodiments, perforations in the inlet tube may result in the inlet tube not being liquid-tight, but may be sealed in substep 1220.

[0035] Substep 1220 may include the closure of the perforation with a biocompatible polymer, for example a silicone coating, in which the at least one pre-fixed conductive element may be encapsulated between the inlet tube and the silicone coating and thus mechanically protected.

[0036] Fig. 7 shows a further assembly sequence 1300 for connecting the connection device to the drive unit according to one embodiment. The assembly sequence 1300 represents at least a partial sequence of the joining step 310 described in Fig. 3 and builds on the assembly sequence 1200 described in Fig. 6, for example following substep 1220. In a preparation substep 1305, the drive unit may be prepared (e.g. provided and / or manufactured) and then assembled with the connection device in a joining substep 1310. In a laying and fixing substep 1315, the joined components may be glued together to create a resulting component, for example, of a cardiac assist system.

[0037] In other words, according to one embodiment, sub-steps 1305, 1310 and 1315 describe a motor assembly that may include a drive unit. In sub-step 1305, the drive unit may be manufactured and / or provided in parallel to the production sequence 1100 and / or the assembly sequence 1200. In sub-step 1310, the drive unit from sub-step 1305 and the connection device with at least one conductive element from sub-step 1220 may be joined together, for example, by press-fitting with a supported joint (for example, gluing, laser welding and / or finishing). In sub-step 1315, the remaining excess length of the at least one conductive element protruding from the inlet tube may be guided along the drive unit to a connection interface and fixed to the surface of the cardiac assist system with a biocompatible adhesive. A surface protective coating of the cable may then be performed, for example, using a biocompatible epoxy resin.

[0038] FIG. 8 shows a cable wiring sequence 1400 for wiring a cardiac assist system according to an embodiment. According to this embodiment, the cable wiring sequence 1400 follows the further assembly sequence 1300 described in FIG. 7, for example following step 1315. In contact substep 1405, the sensor cable of the cardiac assist system may be electrically connected with the connection point of the connection interface. Then, in protecting substep 1410, the sensor located on or near the connection interface may be protected by a biocompatible protective cover such as silicone. The cable wiring sequence 1400 may include a sleeve assembly substep 1415, in which a sleeve may be assembled onto the sensor cable to obtain a hybrid cable. The hybrid cable may be electrically connected to the connection interface in a connection substep 1420. In substep 1425, a housing element may be provided and / or manufactured, which may be attached to the component from substep 1420 in an attachment substep 1430.

[0039] In other words, the components may be assembled together at the connection interface by sub-steps 1405, 1410, 1415, 1420, 1425, and 1430. In sub-step 1405, at least one conductive element may be electrically connected to a metal pin of the connection interface, for example by conductive bonding or soldering. In sub-step 1410, the sensor in the area of ​​the connection interface or the drive unit may be covered with a protective cover, for example encapsulated with silicone. In sub-step 1415, the sensor cable may be assembled, and a sleeve for contacting the cable strands to the pins of the connection interface may be connected to the cable. In sub-step 1420, the sensor cable may be electrically connected to the connection interface, for example, the pins of the connection interface, for example by welding, soldering, and / or conductive bonding. A protective housing and / or strain relief may be provided and / or manufactured in sub-step 1425, for example, from titanium sheet. In sub-step 1430, the electrical connection points in the connection interface may be bonded and coated, for example, with a biocompatible epoxy or silicone. After coating, the protective housing from sub-step 1425 may be assembled to cover the connection interface. Finally, a protective coating may be applied to the entire system, for example, with Parylene C.

[0040] Where an implementation example includes an "and / or" link between a first feature and a second feature, this should be interpreted as the implementation example including both the first feature and the second feature according to one implementation form, and including either only the first feature or only the second feature according to another implementation form.

[0041] Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the present disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein, but should be accorded the widest scope consistent with the claims, principles and novel features disclosed herein. The term "exemplary embodiment" is used herein only to mean "serving as an example, instance, or illustration." Any implementation described herein as an "exemplary embodiment" should not necessarily be construed as preferred or advantageous over other implementations, unless otherwise specified.

[0042] Certain features described herein in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination and may originally be claimed as such, one or more features from a claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination.

[0043] Similarly, although operations are illustrated in the figures in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown, or in any sequential order, or that all of the illustrated operations be performed, to achieve desirable results. Moreover, other implementations are within the scope of the following claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve desirable results.

[0044] In general, those of skill in the art will understand that the terms used herein are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," "having" should be interpreted as "having at least," "includes" should be interpreted as "including but not limited to," etc.). It will be further understood by those of skill in the art that where specific numerals of introduced claim recitations are intended, such intention will be expressly set forth in the claims, and in the absence of such recitation, no such intention exists. For example, as an aid to understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the claim recitations. However, the use of such phrases should not be interpreted as implying that the introduction of a claim recitation with the indefinite article "a" or "an" limits any particular claim that includes such an introduced claim recitation to embodiments that include only one such recitation, even if the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should typically be interpreted to mean "at least one" or "one or more"). The same applies to the use of definite articles used to introduce claim recitations. Moreover, even if specific numbers in an introduced claim recitation are explicitly recited, one of ordinary skill in the art will recognize that such recitations should typically be interpreted to mean at least the recited numbers (e.g., the mere recitation of "two recitations" without other modifiers typically means at least two recitations, or more than two recitations).Furthermore, when a convention similar to "at least one of A, B, and C, etc." is used, such an interpretation is generally intended in the sense that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). When a convention similar to "at least one of A, B, or C, etc." is used, such an interpretation is generally intended in the sense that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will be further understood by those skilled in the art that virtually any disjunction and / or phrase presenting two or more alternative terms in the description, claims, or drawings should be understood to contemplate the possibility of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B," or "A and B."

Claims

1. A method (300) for manufacturing a cardiac assist system (100), comprising: providing (305) a sensor device (105), an inlet tube (110) having a first end (115) and a second end (120) opposite the first end (115), the inlet tube (110) configured to aspirate a patient's body fluid, and a drive unit (125) for operating the cardiac assist system (100); connecting (310) the sensor device (105) to the first end (115) of the inlet pipe (110) and connecting the drive unit (125) to the second end (120) of the inlet pipe (110); The method comprises: providing a sensor (1105); providing at least one conductive element (1110); electrically contacting the sensor and the at least one conductive element (1115); providing a carrier element (1120); From step 1115, joining the carrier element to the sensor and at least one conductive element in electrical contact (1125); providing an ultrasonic transducer (1130); and The method (300) further includes manufacturing the sensor device (105) by conductively bonding (1135) the ultrasonic transducer to a component resulting from the bonding step (1125).

2. The method (300) of claim 1, wherein connecting (310) the sensor device (105) with the first end (115) of the inlet pipe (110) forms a connecting device.

3. 3. The method of claim 2, wherein connecting the connecting device and the drive unit forms at least a portion of the cardiac assist system.

4. The method (300) of claim 1 further comprising providing a housing element (145) and connecting the drive unit (125) to the housing element (145).

5. 10. The method (300) of claim 1, further comprising pre-positioning and fixing (315) the sensor device (105), the inlet pipe (110), and the drive unit (125), wherein the sensor device (105), the inlet pipe (110), and the drive unit (125) are connected to each other.

6. providing (1205) said inlet pipe (110); and 3. The method (300) of claim 2, further comprising fabricating the connection device by connecting (1210) the inlet pipe (110) to the fabricated sensor device (105).

7. Assembling (1215) a corresponding sensor cable and / or joining said sensor cable to said connection device; The method (300) of claim 6, further comprising: siliconizing (1220) the assembled components.

8. providing (1305) said drive unit (125); coupling (1310) said drive unit (125) to said connection device; and 7. The method (300) of claim 6, further comprising assembling the drive unit (125) by laying and securing the joined drive unit and connection device (1315).

9. making electrical contact (1405) of a sensor cable of the cardiac assist system (100) with a connection point within a connection interface (155); 10. The method of claim 8, further comprising: protecting a sensor positioned on or near the connection interface with a biocompatible cover.

10. assembling (1415) a sleeve onto the sensor cable to obtain a hybrid cable; electrically connecting (1420) the hybrid cable to the connection interface (155); Providing (1425) a housing element (145); 10. The method (300) of claim 9, further comprising: attaching (1430) the housing element (145) to a component resulting from the electrically connecting step.

11. An apparatus (400) configured to perform and / or control the steps (305, 310, 315) of the method (300) according to claim 5 in corresponding units (405, 415, 425).

12. A computer program configured to perform and / or control the steps (305, 310, 315) of the method (300) of claim 5.

13. A machine-readable storage medium having stored thereon the computer program of claim 12.

14. A sensor device (105), providing a sensor (1105); providing at least one conductive element (1110); electrically contacting the sensor and the at least one conductive element (1115); providing a carrier element (1120); bonding the carrier element to the sensor and at least one conductive element in electrical contact (1125); providing an ultrasonic transducer (1130); and a sensor device (105) fabricated by conductively bonding (1135) the ultrasonic transducer to the resulting component from the bonding step (1125); an inlet tube (110) having a first end (115) coupled to the sensor device (105) and a second end (120) opposite the first end (115), the inlet tube (110) configured to aspirate a patient's bodily fluid; a drive unit (125) for operating the cardiac assist system (100), the drive unit (125) being connected to the second end (120) of the inlet tube (110).

15. The inlet pipe (110) includes at least one inlet opening (130) at the first end (115), the at least one inlet opening (130) comprising: allowing the body fluid to flow into the inlet tube (110); 15. The cardiac assist system (100) of claim 14, configured as an interface between the sensor device (105) and the inlet tube (110).

16. The inlet pipe (110) further comprises at least one outlet opening (135) at the second end (120), the at least one outlet opening (135) comprising: The cardiac assist system (100) of claim 14, configured to allow the body fluid to drain from the inlet tube (110).

17. 15. The cardiac assist system of claim 14, wherein the drive unit includes a deployable anchor structure, a housing element, a pump element, and a connection interface.

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