Medical and / or pharmaceutical fluid connector
Patent Information
- Application Number
- EP2023798905
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-26
- Filing Date
- 2023-10-26
- Publication Date
- 2025-09-03
AI Technical Summary
Existing medical and pharmaceutical fluid connectors are not operationally reliable and cost-effective for mass production, particularly in clinical and pharmaceutical filling applications, due to complex designs and multiple parts.
A medical and pharmaceutical fluid connector is developed using a soft component molded onto a hard component in a 2K injection molding process, reducing parts and ensuring a captive seal, with TPE or silicone as soft components and ABS or other plastics as hard components, allowing for reliable sealing and simplified production.
The solution results in a cost-effective, operationally reliable fluid connector suitable for mass production, with reduced logistics complexity and enhanced sealing reliability, enabling efficient connection of multiple fluid lines in medical applications such as eye surgery.
Smart Images
Figure 1.1
Abstract
Description
[0001] Medical and / or pharmaceutical fluid connector
[0002] Description
[0003] The invention relates to a medical and / or pharmaceutical fluid connector for connecting at least two fluid lines.
[0004] A corresponding fluid connector is known from the market.
[0005] Applications for a corresponding fluid connector include, for example, clinical applications, laboratories, or pharmaceutical filling.
[0006] It is an object of the present invention to further develop a fluid connector of the type mentioned at the outset in such a way that it is reliable in operation while being manufactured cost-effectively and, in particular, is suitable for mass production.
[0007] This object is achieved according to the invention by a medical and / or pharmaceutical fluid connector having the features specified in claim 1.
[0008] According to the invention, it was recognized that instead of, for example, separate sealing O-rings, a soft component can be used as a sealing component, which is molded onto a hard component of a 2K injection-molded base body in a 2K injection-molded process.
[0009] This results in a reduction in the number of parts in the connector, which on the one hand simplifies production, especially its logistics, and also ensures that the seal is captive. The seal designed as a soft component is also particularly reliable in operation, since the only contact surface to be sealed is the soft component resting against a wall of the medical fluid line to be sealed and connected. A tight seal between the seal and the base body section of the base body is achieved anyway due to the 2-component manufacturing. The plug connection base body section on the one hand and the seal on the other hand can also be components of a multi-component injection-molded base body. The base body or even the entire fluid connector can be manufactured accordingly as injection-molded elements with more than two components.
[0010] In the context of this description, the term "fluid" can encompass both liquids and gases. The term can also include liquid-gas mixtures. The fluid can, for example, comprise or be air. For example, air can flow in or through the medical fluid connector according to the invention.
[0011] The fluid connector can be used, for example, in eye surgery, particularly in the correction of refractive cataracts. It can also be used in conjunction with other surgeries.
[0012] A TPE as a soft component plastic material according to claim 2 has proven itself in practice. Alternatively, silicone or polyurethane (PUR) can also be used as the plastic material for the soft component.
[0013] ABS has proven itself in practice as a hard component plastic material according to claim 3. Alternatively, polypropylene (PP), polyethylene (PE), polycarbonate (PC), polybutylene terephthalate (PBT), or polyetheretherketone (PEEK) can also be used for the hard component.
[0014] The fluid connector can have exactly one seal. At least two circumferential seals according to the invention, which are present in further embodiments, enable sealing of the base body of the fluid connector, in particular against coaxially extending inner walls of the fluid line to be connected. This enables, for example, a connection of two inlets and two outlets of medical fluid lines. The fluid connector can, for example, be inserted into a socket of a medical and / or pharmaceutical device with an axially lower end, at which the circumferential seals are arranged. The axially lower end of the fluid connector can be plug-shaped. It can be designed as a plug, in particular as a coaxial plug.One of the seals may be arranged at a lower collar portion of the axially lower end of the fluid connector and another of the seals may be arranged at an upper collar portion of the axially lower end of the fluid connector, wherein the upper collar portion has a larger diameter than the lower collar portion.
[0015] One design according to the invention is that at least one connecting fluid channel of the fluid connector opens radially from the plug-connector base body section between the circumferential seals. The plug-connector base body section of the 2K injection-molded base body can then be designed to be compact.
[0016] The fluid connector according to the invention can ensure a short-circuit-free connection to a fluid line, in particular a coaxial one, since one of the circumferential seals seals the inner line of the fluid line against an outer line of the fluid line surrounding the inner line and the other seal of the circumferential seals seals the outer line of the fluid line to the outside.
[0017] The at least one connecting fluid channel can, in particular, open from the upper collar region and axially and radially above the lower collar region. The upper and lower collar regions can be substantially cylindrical.
[0018] A web between the two circumferential seals according to claim 7 facilitates the injection-molded production of the two circumferential seals from the plastic material of the soft component. An overflow section according to claim 10 facilitates the injection-molded production of the seals from the soft component and ensures that sufficient casting material is available for the circumferential seals of the soft component. Unwanted trapped air can escape in a controlled manner during the injection-molding process.
[0019] The at least two seals can be arranged concentrically on the fluid connector, in particular in a cross-sectional plane through the fluid connector. The at least two seals can have different circumferences. The at least two seals can be annular, in particular, wherein the radius of the seals either increases or decreases along a longitudinal axis of the fluid connector or a connection axis of the fluid connector to a fluid line. The radius of the seals can decrease or become smaller, in particular, in a plug-in direction of the plug-connection base body portion of the fluid connector.
[0020] A two-component injection-molded base body according to claim 15 allows fluid lines to be plugged onto the mating connector sections. This allows for a simple connection of the fluid connector to these fluid lines. The fluid connector can have exactly two such mating connector sections.
[0021] A design of the outer wall of the mating connector section according to claim 16 without an undercut facilitates demolding during injection molding.
[0022] An angle between the mating connector sections according to claim 17 facilitates the attachment of fluid lines to these mating connector sections, as the ends of the mating connector sections are further apart from one another and thus easier to access individually. If the two fluid lines to be attached have different functions, this also allows for intuitive individualization of the two mating connector sections, which prevents unwanted confusion of the mating connector sections. The angle can also ensure that the mating connector sections and the fluid lines in the fluid connector as a whole meet installation space requirements. The angle at which the two mating connector sections extend to one another can be greater than 15°. This angle is regularly less than 60°, less than 45°, and can be less than 30°. The angle can be in the range of 20°.
[0023] A 2K injection-molded base body according to claim 18 has, as an alternative to the at least one mating connector section, at least one mating socket section into which a fluid line can be inserted. Depending on the application, such a socket variant can offer advantages. An inner wall of the at least one mating socket section can in turn be designed without an undercut, which offers corresponding advantages, as explained above in connection with claim 7. If several mating socket sections, for example two mating socket sections, are used, they can extend at an angle to one another that corresponds to that already explained above with reference to claim 8.
[0024] In particular, the fluid connector can be a medical fluid connector.
[0025] Embodiments of the invention are explained in more detail below with reference to the drawings, in which:
[0026] Fig. 1 is a perspective view of an embodiment of a medical fluid connector for connecting at least two fluid lines, in the case of the embodiment shown for connecting a total of four medical fluid lines;
[0027] Fig. 2 shows the medical fluid connector according to Fig. 1, again in a perspective view from the opposite direction to Fig. 1;
[0028] Fig. 3 shows a longitudinal section through the medical fluid connector in a perspective view corresponding to Fig. 2, illustrating the course of two connecting fluid channels between the four medical fluid lines to be connected; Fig. 4 shows a further embodiment of a medical fluid connector for connecting at least two medical fluid lines, in the case of the illustrated embodiment for connecting a total of four medical fluid lines; and
[0029] Fig. 5 shows a longitudinal section through the embodiment according to Fig. 4 in a representation similar to Fig. 3.
[0030] A medical fluid connector 1 (see Fig. 1) serves to connect at least two medical fluid lines; in the illustrated embodiment, it serves to connect four medical fluid lines. These four medical fluid lines to be connected to the fluid connector 1 are indicated in Fig. 1 as fluid lines 2, 3, 4, and 5. Fluid lines 2 and 3 are medical hose lines, and fluid lines 4 and 5 are a medical coaxial line with an inner lumen (fluid line 4) and an annular lumen (fluid line 5).
[0031] The fluid connector 1 has a 2K injection-molded base body 6. This has a mating connector connection base body section 7 for plug-in connection with the fluid lines 2, 3 via mating connector sections 8, 9. The 2K injection-molded base body 6 also has a plug-in connection base body section 10 for plug-in connection with the two other fluid lines 4, 5, i.e., with the medical coaxial line. The plug-in connection base body section 10 has two externally circumferential seals 11, 12. The seal 11 serves to seal the plug-in connection base body section 10 against an inner wall of the fluid line 4 to be connected. The seal 12 serves to seal the plug-in connection base body section against an inner wall of the fluid line 5 to be connected, i.e., against the outer inner wall of the annular lumen of the medical coaxial line 4, 5.
[0032] The plug connection base body section 10 is designed as a hard plastic component, and the seals 11, 12 are designed as soft plastic components of the 2K injection-molded base body 6 of the medical fluid connector 1. A thermoplastic elastomer (TPE) is used as the plastic material for the soft component. Other examples of the soft component are silicone or polyurethane (PUR).
[0033] A thermoplastic polymer is also used as the plastic material for the hard component. An example material for the hard component is a thermoplastic terpolymer, in particular, an acrylonitrile butadiene styrene copolymer (ABS). Other examples of the hard component are polypropylene (PP), polyethylene (PE), polycarbonate (PC), polybutylene terephthalate (PBT), or polyetheretherketone (PEEK).
[0034] Depending on the design of the medical fluid connector 1, for example when it is used to connect two medical fluid lines, i.e. a fluid line on the side of the mating connector connection base body section 7 and a fluid line on the side of the plug connection base body section 10, it can also have exactly one seal instead of the two seals 11, 12, which is then designed as a soft component.
[0035] The two seals 11, 12 each have an overflow section 13 (see Fig. 1) in which excess soft component injection molding material arising during the injection molding production of the 2K injection molded base body 6 can collect.
[0036] The two circumferential seals 11, 12 are concentrically formed and arranged relative to one another. As shown in Figure 1, the seals 11, 12 are arranged one above the other along the longitudinal axis of the fluid connector. The radius of the upper seal 12 is larger than the radius of the lower seal 11. The seal 11 is located on a lower collar region 102 of the plug connection base body section 10 in the longitudinal direction of the fluid connector, which is designed to be arranged in the inner fluid line 4 when connected to a coaxial fluid line 4, 5, in particular to be pushed into the inner fluid line 4.The seal 12 is located on an upper collar region 104 of the plug-connector base body section 10, which is arranged above the lower collar region 102 in the longitudinal direction of the fluid connector and is designed to be arranged in the outer fluid line 5 when connected to a coaxial fluid line 4, 5, in particular to be inserted into the outer fluid line 5 (see Figure 3). The lower and upper collar regions 102, 104 form the lower end of the fluid connector and the plug-connector base body section 10, respectively.
[0037] For this purpose, the inlet or outlet of the fluid line 4 is set back with respect to the inlet or outlet of the fluid line 5.
[0038] The two circumferential seals 11, 12 are connected to each other via a web 14 (see Fig. 2) made of the soft component. The seal 12 is connected to a soft component injection port 16 of the 2K injection-molded base body 6 via a further web 15.
[0039] At the same axial height as the soft component injection port 16, a hard component injection port 17 of the 2K injection-molded base body 6 is arranged offset in the circumferential direction.
[0040] At the level of the two injection ports 16, 17, the 2K injection-molded base body 6 has a circumferential collar 18 made of the hard component. The collar 18 can serve as a stop for the medical coaxial line 4, 5. The collar 18 is designed as an area or section protruding from the 2K injection-molded base body. In a longitudinal section through the fluid connector (see, for example, Fig. 3), the collar 18 comprises two projections that protrude or protrude from the 2K injection-molded base body 6.
[0041] The two mating connector sections 8, 9 each have an outer wall without undercuts. Fixing of the mating connector sections 8, 9 with the attached fluid lines 2, 3 can be achieved by solvent bonding, i.e., adhesively. The two mating connector sections 8, 9 extend at an angle of 20° to each other. This angle is designated by a in Fig. 3. Depending on the design of the fluid connector 1, this angle between the longitudinal axes of the mating connector sections 8, 9 can also have a different absolute value of at least 10° or greater than 10°. This angle is usually less than 60°.
[0042] Fig. 3 illustrates a course of connecting fluid channels 19, 20 in the 2K injection-molded base body 6. In Figure 3, in particular the longitudinal axis of the fluid connector is shown by the solid line Ax and the insertion direction of the fluid connector or the plug connection base body section 10 is shown by the arrow ER.
[0043] The connecting fluid channel 19 connects the fluid lines 2 and 4 to one another. In the plug-connector base body section 10, the connecting fluid channel 19 initially runs coaxially to a longitudinal axis of the 2K injection-molded base body section 10 in a first channel section 19a. Axially, approximately at the level of the collar 18, the connecting fluid channel 19 then bends and runs at an angle of 20° to the longitudinal axis along a channel section 19b and opens out of the base body 6 via the mating connector section 8. An inner diameter of the connecting fluid channel 19 is in the range between 1.5 mm and 4 mm, for example in the range between 2 mm and 2.5 mm.
[0044] The connecting fluid channel 20 connects the two fluid lines 3 and 5. The connecting fluid channel 20 runs parallel to the longitudinal axis of the base body 6. The connecting fluid channel 20 opens out of the plug connection base body section 10 radially between the two circumferential seals 11, 12 via an outlet section 20a. In the area of this outlet section 20a, an inner diameter of the connecting fluid channel 20 can be reduced compared to the other inner diameter, which is as large as the inner diameter of the connecting fluid channel 19.
[0045] As shown in Figure 3, the lower collar region 102, which forms the axially lower end of the base body 6 or the plug-connector base body section 10, has a circumferential recess or notch in which the seal 11 is arranged and fixed. The upper collar region 104, arranged axially above the lower collar region 102, also has a circumferential recess or notch in which the seal 12 is arranged and fixed. The upper collar region 104 is located axially between the lower collar region 102 and the collar or stop 18. In the longitudinal direction of the fluid connector, the plug-connector base body section 10 has a circumferential undercut or a recess / notch or groove 108 between the lower collar region 102 and the upper collar region 104.The circumferential groove 108 is shaped such that a step 106 is formed in the lower collar region 102, by which the lower collar region 102 is offset from the upper collar region 104. The outlet section 20a is arranged axially and radially above the step 106.
[0046] In other words, in the connected state of the fluid connector with a coaxial fluid line, the connecting fluid channel 20 and the outer line 5 of the fluid line as well as the connecting fluid channel 19 and the inner line 4 of the fluid line are connected to one another in a fluid-tight manner.
[0047] The fluid connector shown in Figure 3 further has at least one undercut 21. The undercut 21 can run around the base body 6. The undercut 21 can be designed as an indentation or recess in the base body 6. The at least one undercut 21 is arranged between the collar 18 and the seal closest to the collar 18, namely seal 12. The at least one undercut The at least one undercut 21 is formed and / or arranged on the base body 6 in such a way that a locking element, which can be arranged on the coaxial fluid line 4, 5, can lock or engage with the undercut 21 and thus secure the connection between the coaxial fluid line and the fluid connector. The locking element can be a spring element, for example.
[0048] Fig. 4 and 5 show another embodiment of a medical fluid connector
[0049] 25, which can be used instead of the medical fluid connector 1 according to Figures 1 to 3. Components and functions explained above in connection with the embodiment according to Figures 1 to 3 have the same reference numerals and will not be discussed again in detail.
[0050] Instead of a mating connector base body section with mating connector sections, the fluid connector 25 has a mating socket base body section 26 with mating socket sections 27, 28. The mating socket section 27 serves as a socket for the plug-in connection with the fluid line 2, thus having a function corresponding to that of the mating connector section 8. The mating socket section 28 serves as a socket for the plug-in connection with the fluid line 3, thus having a function corresponding to that of the mating connector section 9. In the fluid connector 25, the fluid lines 2, 3 are therefore not plugged onto corresponding plug sections, but rather plugged into corresponding socket sections, namely the mating socket sections 27, 28.
[0051] The inner walls of the counter-socket sections 27, 28 are again designed without undercuts and are used for solvent bonding to fix the fluid lines 2, 3 in accordance with what was explained above in connection with the counter-plug sections 8, 9.
[0052] The angle between the two mating socket sections 27, 28 corresponds to the angle discussed above in connection with the mating plug sections 8, 9. In the illustrated embodiment, the angle between the mating socket sections 27, 28 is again 20°.
[0053] In the area of the mating socket sections 27, 28, an inner diameter of the connecting fluid channels 19, 20 for accommodating the fluid lines 2, 3 is enlarged compared to the other inner diameter. This other inner diameter can in turn be in the range from 1 mm to 5 mm, as already explained above in connection with the connecting fluid channels 19, 20 of the fluid connector 1. The seals 11, 12 ensure a process-reliable seal of the plug connection base body section 10 against the corresponding inner walls of the coaxial line 4, 5, which is designed as a coaxial socket. A circumferential undercut 21 interacts with a locking element of this coaxial line 4, 5 to axially secure the coaxial line 4, 5 to the plug connection base body section 10.
[0054] The 2K injection-molded base body 6 also has two actuating wings 22, 23, by means of which the base body 6 can be gripped when plugged into the coaxial cable 4, 5 and when pulled out of it. The actuating wings 22, 23 can be designed, for example, as ribs running essentially in the longitudinal direction of the base body 6. The actuating wings 22, 23, in particular the ribs, can be arranged in the circumferential direction of the base body 6. The ribs can have an inwardly bent or curved outer geometry with respect to the base body 6. The actuating wings 22, 23 can extend between the collar 18 and the mating plug 7, 8 or mating socket sections 27, 28.
[0055] This description also covers the following aspects:
[0056] 1. A medical fluid connector (1; 25) for connecting at least two medical fluid lines (2, 3, 4, 5), comprising a 2K injection-molded base body (6) made of plastic with at least one plug-connector base body section (10) for plug-in connection with at least one of the fluid lines (4, 5), wherein the plug-connector base body section (10) has at least one externally circumferential seal (11, 12) for sealing the plug-connector base body section (10) against an inner wall of the fluid line (4, 5) to be connected, wherein the plug-connector base body section (10) is designed as a hard component and the seal (11, 12) is designed as a soft component of the 2K injection-molded base body (6). 2. A medical fluid connector according to aspect 1, characterized in that a TPE is used as the plastic material for the soft component.
[0057] 3. Medical fluid connector according to aspect 1 or 2, characterized in that ABS is used as the plastic material for the hard component.
[0058] 4. Medical fluid connector according to one of aspects 1 to 3, characterized in that the plug connection base body section (10) has at least two circumferential seals (11, 12) for sealing the plug connection base body section (10) against coaxially extending inner walls of the fluid lines (4, 5) to be connected.
[0059] 5. Medical fluid connector according to aspect 4, characterized in that at least one connecting fluid channel (20) of the fluid connector (1; 25) opens out of the plug connection base body section (10) radially between the circumferential seals (11, 12).
[0060] 6. Medical fluid connector according to aspect 4 or 5, characterized in that the two circumferential seals (11, 12) are connected to one another via a web (14) made of the soft component.
[0061] 7. Medical fluid connector according to one of aspects 1 to 6, characterized in that the at least one outer circumferential seal (11, 12) has an overflow section (13) in which excess injection molding material can collect.
[0062] 8. A medical fluid connector according to one of aspects 1 to 7, characterized in that the 2K injection-molded base body (6) has a mating connector connection base body section (7) with at least one mating connector section (8, 9) for plugging into at least one further (2, 3) of the fluid lines (2 to 5). 9. A medical fluid connector according to aspect 8, characterized in that the at least one mating connector section (8, 9) has an outer wall without undercuts. 10. A medical fluid connector according to aspect 8 or 9, characterized by two mating connector sections (8, 9) for plugging into one of the further fluid lines, wherein the two mating connector sections (8, 9) extend at an angle (α) to one another that is greater than 10°. 11.Medical fluid connector according to one of aspects 1 to 7, characterized in that the 2K injection-molded base body (6) has a counter-socket connection base body section (26) with at least one counter-socket section (27, 28) for plug-in connection with at least one further (2, 3) of the fluid lines (2 to 5).
Claims
M26659.0 Patent claims 1. Medical and / or pharmaceutical fluid connector (1; 25) for connecting at least two medical fluid lines (2, 3, 4, 5), with a 2K injection-molded base body (6) made of plastic with at least one plug-connector base body section (10) for plug-in connection with at least one of the fluid lines (4, 5), wherein the plug-connector base body section (10) has at least one outer circumferential seal (11, 12) for sealing the plug-connector base body section (10) against an inner wall of the fluid line (4, 5) to be connected, wherein the plug-connector base body section (10) is designed as a hard component and the seal (11, 12) as a soft component of the 2K injection-molded base body (6), wherein the plug-connector base body section (10) has at least two circumferential seals (11, 12) for sealing the Plug connection base body section (10) against coaxially extending inner walls of the fluid lines to be connected (4,5) and at least one connecting fluid channel (20, 20a) of the fluid connector (1; 25) opens out of the plug connection base body section (10) radially between the circumferential seals (11, 12).
2. Fluid connector according to claim 1, wherein a TPE is used as the plastic material for the soft component.
3. Fluid connector according to claim 1 or 2, wherein ABS or PP is used as the plastic material for the hard component.
4. Fluid connector according to one of claims 1 to 3, wherein the two circumferential seals (11, 12) are connected to one another via a web (14) made of the soft component.
5. Fluid connector according to one of claims 1 to 4, wherein the circumferential seals (11, 12) are arranged at an axially lower end of the fluid connector.
6. The fluid connector of claim 5, wherein one of the seals is disposed at a lower collar portion (102) of the axially lower end of the fluid connector and another of the seals is disposed at an upper collar portion (104) of the axially lower end of the fluid connector, the upper collar portion (104) having a larger diameter than the lower collar portion (102).
7. Fluid connector according to claim 5 or 6, wherein the axially lower end of the fluid connector is designed as a plug, in particular as a coaxial plug.
8. Fluid connector according to claim 6 or 7, wherein the at least one connecting fluid channel (20, 20a) opens out of the upper collar region (104) and axially and radially above the lower collar region (102).
9. Fluid connector according to one of claims 6 to 8, wherein the lower and upper collar regions (102, 104) are substantially cylindrical.
10. Fluid connector according to one of claims 1 to 9, wherein the at least two outer circumferential seals (11, 12) have an overflow section (13) in which excess injection molding material can collect.
11. Fluid connector according to one of claims 1 to 10, wherein the at least two seals (11, 12) are arranged concentrically on the fluid connector to one another, in particular in a cross-sectional plane through the fluid connector.
12. Fluid connector according to one of claims 1 to 11, wherein the at least two seals (11, 12) have different circumferences from one another.
13. Fluid connector according to one of claims 1 to 12, wherein the at least two seals (11, 12) are annular, wherein the radius of the seals (11, 12) either increases or decreases along a longitudinal axis of the fluid connector or a connection axis of the fluid connector with a fluid line.
14. Fluid connector according to claim 13, wherein the radius of the seals (11, 12) decreases or becomes smaller in a plug-in direction (ER) of the plug-connector base body portion (10) of the fluid connector.
15. Fluid connector according to one of claims 1 to 14, wherein the 2K injection-molded base body (6) has a mating connector connection base body section (7) with at least one mating connector section (8, 9) for plug-in connection with at least one further (2, 3) of the fluid lines (2 to 5).
16. Fluid connector according to claim 15, wherein the at least one mating connector section (8, 9) has an outer wall without undercuts.
17. Fluid connector according to claim 15 or 16, wherein the fluid connector further comprises two mating connector sections (8, 9) for plugging into one of the further fluid lines, wherein the two mating connector sections (8, 9) extend at an angle (a) to one another which is greater than 10°.
18. Fluid connector according to one of claims 1 to 14, wherein the 2K injection-molded base body (6) has a counter-socket connection base body section (26) with at least one counter-socket section (27, 28) for plug-in connection with at least one further (2, 3) of the fluid lines (2 to 5).
19. The fluid connector of any one of claims 1 to 18, wherein the fluid connector is a medical fluid connector.