METHOD FOR MANUFACTURING A COMPONENT FOR A PATIENT VENTILATION SYSTEM

Description

[0001] The invention relates to a method for producing an assembly for a patient ventilation system.

[0002] Components for a patient ventilation system are known from US 2017 / 0 197 055 A1, WO 2007 / 051 230 A1, DE 10 2019 216 489 A1, US 9,903,371 B2, and US 2019 / 0 290 866 A1. A patient ventilation system called "VentStar Helix" is also known on the market. DE 10 2018 218 629 A1 discloses a method for manufacturing an angled connector.

[0003] US 2016 / 199612 A1 describes a connection arrangement for a respiratory therapy system, comprising: an outlet assembly, the outlet assembly comprising an outlet housing and a rotary disc arranged on the outlet housing, the outlet housing and the rotary disc at least partially defining a recess; an outlet connector arranged at one end of a tube section, the outlet connector comprising an electrical connector;and a cable having a first end for connecting to the electrical connector and a second end for connecting to at least one electrical component of the respiratory therapy system, the cable having a slack portion, the outlet connector and the rotary disc being rotatable together between a first position and a second position, and the slack portion of the cable extending from the recess and wrapping around the rotary disc when the rotary disc is rotated from the first position to the second position;

[0004] It is an object of the present invention to further develop a manufacturing method for an assembly of such a patient ventilation system in such a way that it is suitable for mass production.

[0005] The object is achieved according to the invention by a method having the features specified in claim 1.

[0006] According to the invention, it was recognized that it is possible to produce the assembly using a manufacturing sequence that includes two overmolding steps. A first overmolding step serves to fix a prepared cable connection, via which, in particular, an electrical connection can be established between sheathed wires of the breathing air hose section and the electronic component. The contact pins of the component receptacle can be designed as end sections of a respective conductor carrier of the cable connection. The conductor carrier housing sleeve of the connector, as a result of the first overmolding step, has at least one sleeve section for guiding the breathing air. In the subsequent, further overmolding step, a component receptacle for the electronic component is then formed together with an outer connector housing. The electronic component can then optionally be accommodated in the component receptacle, or a blind cover can be inserted there.The electronic component can be a sensor device. In addition to respiratory air parameters (temperature, humidity, respiratory pressure, respiratory air composition), the sensor device, which has at least one such sensor, can also measure other parameters, namely patient parameters, ventilation technology parameters, and / or environmental parameters.

[0007] The temperature sensor, in particular, enables temperature threshold detection. This can be used for medical purposes, but also for other purposes, such as fire protection. The accuracy of the temperature sensor can be better than 0.5 K and can be, for example, 0.2 K, 0.1 K, or even 0.05 K. This accuracy can be guaranteed within a range between -10°C and 80°C. A narrower temperature range in which accuracy is guaranteed is also possible, for example, between 0°C and 50°C or between 10°C and 50°C.

[0008] If a temperature sensor is used as an electronic component, it can be used, for example, to detect temperature threshold values.

[0009] The additional component of the patient ventilation system that carries the ventilation air and to which the connector of the assembly connects can be a patient interface. Alternatively, this additional component could be, for example, a humidifier.

[0010] A preform according to claim 1 has proven particularly suitable for mass production applications. The 2D conductor structure from which the conductor connection is provided can be a leadframe with a plurality of correspondingly prefabricated conductor components. The 2D conductor structure can be a leadframe.

[0011] The 2D conductor structure can be made of metal, especially copper. Alternatively, the 2D conductor structure can also be a thermoset conductor carrier, such as a PCB, and / or a printed circuit board.

[0012] The 2D conductor structure can have a frame support component that supports the respective line connection components. Components that are not used for a selected line connection can then be part of the frame support component. Such components not used for electrical transmission can also initially remain with the provided line connection as holding components and can be removed later, possibly even after electrical contact has been made.

[0013] The pre-forming of the 3D line connection according to claim 2 is carried out in such a way that the resulting line connection does not extend flatly, but has an extension in all three spatial dimensions that goes beyond the line cross-section of line components of the line connection.

[0014] Overmolding in a multi-cavity injection molding tool according to claim 1 increases the production throughput of the manufacturing process. The individual inner conductor carrier housing sleeves resulting from this multi-cavity overmolding can then be further processed individually and, in particular, individually overmolded to form the outer connector housing.

[0015] Ultrasonic welding according to claim 3 has proven to be particularly suitable for electrical connection.

[0016] An embodiment of the invention is explained in more detail below with reference to the drawing, in which: Figure 1 shows a perspective view of an assembly for a patient ventilation system with a breathing air hose section, a connector connected thereto for connecting the breathing air hose section to a patient interface, and a sensor receptacle into which a temperature sensor device is inserted; Figure 2 shows a side view of the assembly according to Figure 1, again with the temperature sensor device inserted; Figure 3 again shows a perspective view of the assembly in an intermediate stage of its production, wherein a pre-formed 3D line connection is each integrally overmolded with contact pins of the sensor receptacle and sheathed wires of the breathing air hose section to form an inner line carrier housing sleeve of the connector; Figure 4 partially schematically shows processing steps in a method for producing the assembly, including the production of several inner line carrier housing sleeves by overmolding and subsequent mechanical separation of initially interconnected 3D line connections, which were still connected to each other during the overmolding step within a multiple cavity; Figure 5 shows further processing steps of the manufacturing process up to the production of the finished assembly and a subsequent quality control; Figure 6 in a Figure 3similar representation, which shows a core of an ultrasonic welding tool, a further embodiment of the assembly in the intermediate stage of its production, wherein a prepared cable connection, designed as a 2D cable connection with the contact pins of the sensor holder and the sheath wires of the breathing air hose section is overmolded to form the inner cable carrier housing sleeve of the connector; Figure 7 a plan view of the completely manufactured assembly, starting from the intermediate stage after Figure 6 , the assembly being shown without the temperature sensor device installed.

[0017] A patient ventilation system, which includes an assembly 1, which is provided with a plugged-in temperature sensor device 2 in the Figure 1The device shown in perspective is used for ventilating a patient in a clinical, other inpatient, or home care setting. Such a patient ventilation system is known from WO 2007 / 051 230 A1 and DE 10 2019 216 489 A1. A corresponding patient ventilation system is known from the market under the product "VentStar Helix."

[0018] The essential air-conducting components of the ventilation system 1 are made of plastic.

[0019] The assembly 1 has a breathing air hose section 3 for guiding ventilation air from a breathing air source (not shown) to a patient.

[0020] Electrically conductive sheath wires 5, 6 and 7 (cf. Figure 3). This routing is helical around an inner air guide lumen of the breathing air hose section 3. For this purpose, the sheathed wires 5 to 7 are helically overmolded with material from the breathing air hose section. Two of these sheathed wires, namely sheathed wires 5 and 6, represent heating wires for the breathing air hose section 3, which can be supplied with heating current via a supply device (not shown). The third sheathed wire 7 represents a signal line for the temperature sensor device 2.

[0021] A connector 8 of assembly 1 is connected to the breathing air hose section 3 by overmolding the breathing air hose section 3. The connector 8 serves to connect the breathing air hose section 3 to a patient interface of the patient ventilation system (not shown in the drawing). This connection is such that an inner air guide connector component 9 of the connector 8 forms an integral part with the breathing air hose section 3, at least in certain sections.

[0022] The connector 8 has an inner cable carrier housing sleeve 10 and an outer connector housing 11. Those sections of the air guide connector component 9 that are molded onto the breathing air hose section 3 and thus form an integral part therewith are sections of the outer connector housing 11 of the connector 8.

[0023] Formed into the inner conductor carrier housing sleeve 10 are conductor components 12, 13 of a three-dimensionally extending 3D conductor connection of the assembly 1. This 3D conductor connection will be explained below.

[0024] The line component 12 is electrically connected to the two heating sheath wires 5, 6 via a contact pad 15 and represents a short-circuit bridge for a heating circuit of the breathing air hose section 3. The line component 13 is electrically connected to the signal sheath wire 7 via a contact pad 16. To make contact with the contact pads 15, 16, the sheath wires 5 to 7 are exposed from the helical overmolding. Away from the contact pads 15, 16, the line components 12, 13 terminate in contact pins that protrude beyond an insulating connecting plate 17 of the inner line carrier housing sleeve 10. When the temperature sensor device 2 is plugged in, the contact pins of the line components 12, 13 are electrically connected to corresponding contact sockets of the temperature sensor device 2.

[0025] The two projecting contact pins of the line components 12, 13 serve to electrically connect the sheathed wires 5 to 7 with the temperature sensor device 2.

[0026] Together with a receiving body 18 (see the second to last figure of the Figure 5 ), which is a component of the outer connector housing 11, the connecting plate 17 represents a sensor receptacle 19 for inserting the temperature sensor device 2 into the connector 8 and, in particular, for inserting a temperature sensor 20 of the temperature sensor device 2 into the air guide connector component 9, i.e., into its air guide lumen. The sensor receptacle 19 is integrally formed into the outer connector housing 11 of the connector 8. The temperature sensor 20 serves to measure a temperature of the ventilation air flowing through the air guide connector component 9.

[0027] The temperature sensor device 2 is an example of an electronic component that can be inserted into the receptacle 19. The sensor receptacle 19 is therefore more generally a component receptacle. Instead of a temperature sensor, the electronic component can also use a sensor device for detecting another parameter, in particular a breathing air parameter.

[0028] The sensor device can be a sensor for measuring humidity or a chemical or spectroscopic sensor. Another electronic component can also be inserted into the component receptacle 19, for example, a monitoring unit for determining a service life or a service load of the assembly 1.

[0029] The sensor receptacle 19 has a passage 21 for passing the temperature sensor 20 of the temperature sensor device 2 into the air guide lumen of the air guide connector component 9. This passage 21 is designed as an opening in the connecting plate 17, which opens into the air guide lumen of the air guide connector component 9.

[0030] In addition, the sensor receptacle 19 has a sensor guide component 22, which serves, among other things, to guide the insertion movement of the temperature sensor 20 into the air guide lumen of the air guide connector component 9. The sensor guide component 22 also provides flow and / or contact protection for the temperature sensor 20.

[0031] The sensor guide component 22 can have at least one window through which the air guide lumen is accessible from the temperature sensor 20 for measuring the temperature of the ventilation air guided in the air guide lumen. The sensor guide component 22 can contain thermally conductive components for thermally connecting the temperature sensor 20 to the air guide lumen.

[0032] The sensor receptacle 19 is designed for plug-in insertion of the temperature sensor device 2. For this purpose, the temperature sensor device 2 has a support body 23, over which the temperature sensor 20 inserted into the sensor receptacle 19 projects downward into the air guide lumen of the air guide connector component 9. A locking section 24 (cf. Figure 1 ) for locking with a counter-locking section 25 of the sensor holder 19. The counter-locking section 25, in turn, is a molded-on component of the sensor holder 19.

[0033] In the support body 23, contact pins of the temperature sensor device are provided for connection to the contact pins of the line components 12, 13.

[0034] Also formed on the support body 23 is a grip portion 26 of the temperature sensor device 2 for detecting a portion of the support body 23 facing away from the temperature sensor 20.

[0035] A method for manufacturing assembly 1 is described below using the Figures 4 and 5 explained in more detail.

[0036] To manufacture assembly 1, a three-dimensionally extending conductor connection 27 is first preformed starting from a 2D conductor structure 28 designed as a leadframe. The conductor components of the 2D conductor structure 28 can have cross-sections that are smaller than 0.5 mm and can range between 50 µm and 200 µm.

[0037] The respective 3D line connection 27 extends between the respective contact pads 15, 16 and the contact pins of the line components 12, 13. In the 2D conductor structure 28, a plurality of contact pads 15 and 16 are connected to one another via corresponding conductor tracks, which are bent relative to one another, in particular by 90°, to form the 3D line connection 27 during a preforming step 29.

[0038] The result of the preforming step 29 is a plurality of 3D line connections 27, in the present example, 3 such 3D line connections 27, which are assigned to a corresponding plurality of inner line carrier housing sleeves 10 of a respective connector 8 to be formed later. After the preforming step 29, these multiple 3D line connections 27 are initially mechanically connected to one another via predetermined breaking points 30.

[0039] After the preforming 29 of the 3D line connections 27, the still mechanically connected 3D line connections 27 are inserted into an injection molding tool in the form of an injection molding multi-cavity 31, which takes place in an insertion step 32. Following this, the 3D line connections 27 are overmolded in an overmolding step 33 to form the inner line carrier housing sleeves 10 of the respective connector 8. During the overmolding step 33, the majority of the still mechanically connected 3D line connections 27 are simultaneously overmolded to form the corresponding plurality of inner line carrier housing sleeves 10 in the injection molding multi-cavity 31.

[0040] The result of the overmolding step 33 is in particular the formation of the inner conductor carrier housing sleeve 10 with at least one sleeve section which serves to guide the breathing air.

[0041] After the overmolding step 33, a mechanical separation of the interconnected 3D cable connections 27 at the predetermined breaking points 30 takes place in a separation step 34 and thus a separation of the inner cable carrier housing sleeves 10.

[0042] Subsequently, a connection sleeve 35 of the separated inner cable carrier housing sleeve 10 is inserted into a facing end section of the breathing air hose section 3 in an insertion step 36.

[0043] Figure 5 shows at the top left an inner cable carrier housing sleeve 10 which is inserted into the breathing air hose section 3. During the insertion step 36, the contact pads 15, 16 of the cable components 12, 13 are positioned and aligned towards the exposed end sections of the sheathed wires 5 to 7.

[0044] In a subsequent connection step 37, the line components 12, 13 of the line connection 14 and 27, respectively, are electrically contacted with the end sections of the sheathed wires 5 to 7. This is done by ultrasonic welding with a corresponding ultrasonic welding device 38.

[0045] Subsequently, in an insertion step 39, the prefabricated raw assembly with the inner cable carrier housing sleeve 10 and the breathing air hose section 3 mechanically and electrically connected thereto is inserted into another injection molding tool. In a subsequent further overmolding step 40, the inner cable carrier housing sleeve 10 and an adjacent end region of the breathing air hose section 3 are then overmolded to form the outer connector housing 11. The sensor receptacle 19 in the outer connector housing is also formed during this process. The overmolding in the further overmolding step 40 results in the integration of the air guide connector component 9 with the breathing air hose section 3, so that the air guide connector component 9 of the manufactured connector 8 forms an integral part with the breathing air hose section.

[0046] The electronic component that can be accommodated in the component or sensor receptacle 19 can generally be a sensor device, for example the temperature sensor device 2.

[0047] After the further overmolding step 40, an optical quality control 42 and an electrical quality control 43 are carried out in a control step 41, whereby the assembly 1 can be subjected to a visual inspection and a check by appropriate optical and / or electrical / electronic measuring units.

[0048] Based on the Figures 6 and 7 A further embodiment 45 of the assembly for the patient ventilation system is described below, which can be used instead of the assembly described above with reference to the Figures 1 to 5 Components and functions corresponding to those described above with reference to the Figures 1 to 5already explained, have the same reference numbers and will not be discussed in detail again.

[0049] In the assembly 45, a cable connection 46, which otherwise corresponds to the 3D cable connection 27 of the design according to the Figures 1 to 5 corresponds to, is designed two-dimensionally. The contact pins 12, 13 of this line connection as well as the contact pads 15, 16 lie in a common arrangement plane of the 2D line connection 46.

[0050] Figure 6 also shows a core 47 of an ultrasonic welding tool for ultrasonic welding of the line components 12, 13 of the line connection 14 or 27 with the end sections of the sheathed wires 5 to 7 of the assembly 45.

[0051] The manufacturing process of assembly 45 is basically the same as that described above with reference to Figures 4 and 5 has already been explained.

[0052] Instead of preforming a 3D line connection, the 2D line connection 46 is first provided during the manufacture of the assembly 45, starting from the 2D conductor structure 28 designed as a leadframe. This provision can only be achieved by separating the associated line components from surrounding support or line components of the leadframe 28.

[0053] The result of this provision of the 2D line connections 46 is a plurality of such 2D line connections 46, for example, three such 2D line connections 46, which are assigned to a corresponding plurality of the inner line carrier housing sleeves 10 of the respective connector 8 of the assembly 45 to be formed later. After the provision step, these multiple 2D line connections 46 are initially mechanically connected to one another via predetermined breaking points, as described above with reference to the 3D line connections 27 of the embodiment according to the Figures 1 to 4already explained.

[0054] During the manufacture of the assembly 45, the insertion 32, the overmolding, the separation 34, the insertion of the connection sleeve 35 including the positioning and alignment of the contact pads 15, 16 to the enclosed end sections of the sheathed wires 5 to 7, the electrical connection 37, the insertion 39, the further overmolding 40 and the inspection 41 then take place in accordance with what was described above in connection with the manufacture of the assembly 1 according to the Figures 1 to 5 has already been explained.

Claims

1. A method for the manufacture of an assembly (1; 45) for a patient ventilation system, - with a breathing air tube portion (3) for guiding breathing air from a breathing air source to a patient, wherein electrically conductive sheath wires (5 to 7) are guided along a tube sheath (4) of the breathing air tube portion (3), - with a connector (8) connected to the breathing air tube portion (3) for connecting the breathing air tube portion (3) to a further component of the patient ventilation system carrying the breathing air, wherein an air conduction connector component (9) of the connector (8) forms an integral component with the breathing air tube portion (3), - wherein the connector (8) comprises a component receptacle (19) for inserting at least one electronic component (2) into the connector (8), - wherein the component receptacle (19) comprises at least two contact pins (12, 13) for electrically connecting with the electronic component (2), comprising the following steps: - providing at least one conducting connection (27) between the contact pins (12, 13) of the component receptacle (19) and the sheath wires (5 to 7), - overmolding (33) of the conducting connection (27) to form an inner conduction carrier housing sleeve (10) of the connector (8), - electrically connecting (37) the conducting connection (27) to the sheath wires (5 to 7), - overmolding (40) of the inner conduction carrier housing sleeve (10) to form an outer connector housing (11) of the connector (8), in which housing the component receptacle (19) is implemented, wherein pre-shaping (29) of the conducting connection on the basis of a 2D conductor structure (28) takes place during the providing step, characterized in that after pre-shaping (29), a plurality of conducting connections (27), which are associated with a corresponding plurality of inner conduction carrier housing sleeves (10), initially remain mechanically connected to each other, - wherein during the overmolding (33) of the conducting connections (27), said plurality of conducting connections (27) are simultaneously overmolded to form the corresponding plurality of inner conduction carrier housing sleeves (10) in a corresponding plurality of cavities of an injection mold (31), - wherein after the overmolding (33) for shaping the inner conduction carrier housing sleeves (10), a mechanical separation of the interconnected conducting connections (27) and thus a separation of the inner conduction carrier housing sleeves (10) takes place.

2. The method according to claim 1, wherein during pre-shaping (29) a 3D conducting connection is formed on the basis of the 2D conductor structure (28).

3. The method according to claim 1, wherein the electrical connection (37) is performed by ultrasonic welding.