Pharmaceutical connection device for a hose line
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- BAUSCH STROEBEL MASCHINENFABRIK ILSHOFEN GMBH CO KG
- Filing Date
- 2024-07-10
- Publication Date
- 2026-05-27
AI Technical Summary
Conventional pharmaceutical connection devices for flexible hose lines, particularly those made of PTFE, face issues with deformation during cleaning and sterilization, leading to leaks and maintenance challenges, as they require dismantling for effective CIP/SIP processes.
A connection device with a structurally simple design featuring a base body, clamping body, and fixing device that applies radial clamping force to the hose line, ensuring a secure seal without the need for a connection nipple, allowing for tool-free assembly and disassembly, and maintaining integrity during high-temperature sterilization.
The solution provides a reliable, easy-to-handle connection that maintains tightness and seal integrity even after multiple sterilization cycles, preventing leaks and reducing maintenance, while enabling CIP/SIP processes without dismantling.
Smart Images
Figure EP2024069569_23012025_PF_FP_ABST
Abstract
Description
[0001] PHARMATECHNICAL CONNECTING DEVICE FOR A HOSE LINE
[0002] The present invention relates to a pharmaceutical connecting device for a flexible hose line, comprising a base body in which a channel is formed that is in fluid communication with the hose line. The connecting device can, for example, comprise a pharmaceutical filling needle for filling a container, wherein the filling needle can be encompassed or formed by the base body.
[0003] Such a connecting device is used, for example, in a system for processing pharmaceutical containers. The containers can be vials, syringes, cartridges, or ampoules. One possible use of the connecting device is to connect the flexible hose in a filling station to a filling needle. The product to be filled into the container, for example, a liquid, flows through the hose and the filling needle into the container.
[0004] However, the present invention is not limited to this. It is conceivable to use the connecting device to connect the hose line to an object other than a filling needle.
[0005] It is known to use hose lines made of PTFE (polytetrafluoroethylene), which are designed for pharmaceutical use. However, it is necessary to clean the hose lines after production cycles. This can be achieved, for example, by dismantling the connecting devices and cleaning the hose lines externally. However, cleaning within the system (in-line) is desirable, without having to dismantle the connecting device. Such a process is known, for example, as CIP / SIP (CIP, Cleaning in Place / SIP, Sterilization in Place). During in-line sterilization, the hose line is flowed through with superheated steam, which has a temperature of, for example, approximately 135 °C and a pressure of approximately 2 bar or more. PTFE hose lines can deform in the process, which can impair the tightness of the connection in the connecting device.
[0006] Connecting devices are known in which the hose line must be slipped over a connection nipple of the base body. This is complex in terms of maintenance. With repeated cleaning or sterilization, deformation of the hose line at the end section slipped over the base body can also lead to leaks. The object of the present invention is to provide a connecting device for a flexible hose line, wherein the connecting device has a structurally simple design and is preferably easy to handle.
[0007] This object is achieved by a pharmaceutical connecting device for a flexible hose line, comprising: a base body in which an insertion region for the hose line and a channel are formed, wherein the insertion region opens into the channel and a contact region for the hose line is arranged on the inlet side of the channel; a clamping body through which the hose line is guided and which comprises or forms a clamping region facing the base body; a clamping receptacle which has a particularly conical taper in the direction of the contact region; and a fixing device for fixing the clamping body relative to the base body in a use state of the connecting device;wherein the clamping body, in the state of use, engages with the clamping area in the tapered clamping receptacle and the clamping area applies a clamping force to the hose line radially from the outside, and wherein the hose line runs with an end section through the insertion area and rests on the front side against the contact area forming a sealing seat;
[0008] With the connecting device according to the invention, a flow connection from the hose line to the channel can be achieved in that the hose line rests on its end face against the contact area on the inlet side of the channel. The contact area forms a corresponding sealing seat for the end face of the hose line. The hose line runs with an end section through the insertion area in the base body, which opens into the channel. In this case, it is provided in particular that a cross-sectional area of the insertion area, in which the end section of the hose line is arranged, is larger than the cross-sectional area of the channel. A clamping body is provided which, when the connecting device is used as intended, is arranged in the clamping receptacle of the connecting device. The hose line is guided, for example, through a through-opening of the clamping body.A force is applied radially from the outside to the hose assembly via the clamping body, allowing it to be clamped. The fixing device enables the clamping body to be fixed relative to the base body during use. This ensures that the hose assembly is held immovably relative to the base body, ensuring a sufficient seal at the sealing seat. This seal is preferably suitable for cleaning and / or sterilization without disassembling the connecting device, especially for CIP / SIP applications. In practice, the connecting device has been shown to be easy to handle. Preferably, manual and, in particular, tool-free assembly and / or disassembly of the connecting device is conceivable.
[0009] For example, it may be intended that the clamping body be elastically deformable, at least in sections. This will be discussed further below.
[0010] The clamping body can be made of a plastic material, for example, PEEK (polyetheretherketone).
[0011] The base body and / or a fixing body of the fixing device can be made, for example, of a plastic material or of a metal material.
[0012] Preferably, the hose line is free from engagement by the base body. In the present case, this can be understood, for example, to mean that the hose line is not slipped over the base body. Unlike a conventional connecting device, the preferred embodiment of the connecting device according to the invention eliminates the need for the base body to engage the hose line with a connection nipple or the like. Rather, it is advantageously sufficient for the hose line to rest only on the contact area at its end face, and it can be gripped radially on the outside by the base body.
[0013] In a preferred embodiment of the invention, the base body forms the clamping receptacle, so that the clamping area is held in a clamp seat on the base body in use to apply the clamping force to the hose line. In structural terms, the clamping receptacle with the taper is arranged, for example, on the insertion area of the base body or is formed by it. The clamping body engages in the base body with the clamping area and is held there via the clamp seat to apply the clamping force to the hose line. Such an embodiment has, in particular, a structurally simple design. The fixing device of the last-mentioned advantageous embodiment comprises, for example, cooperating fixing elements on the clamping body and on the base body, wherein the clamping body is connected directly to the base body.This enables a structurally simple design, whereby the fixing device can be formed by the clamping body and the base body without the use of a separate fixing body.
[0014] The fixing elements can be or include, for example, screw elements, clamping elements, and / or locking elements. The use of screw elements can be advantageous. In this case, the depth of the screw connection between the clamping body and the base body can preferably influence the clamping force exerted on the hose line across the clamping area and / or the force on the hose line at the sealing seat.
[0015] The clamping body preferably engages the base body, with an external thread of the clamping body being screwed to an internal thread of the base body. Alternatively, for example, the clamping body can overlap the base body at least in sections, with an internal thread of the clamping body being screwed to an external thread of the base body.
[0016] In a preferred embodiment of the invention, the fixing device can comprise a fixing body formed separately from the clamping body, which is connected to the base body via fixing elements, wherein the clamping body is directly or indirectly supported on the fixing body with a side facing away from the base body. The clamping body can be subjected to a force directed toward the base body via the fixing body. This allows for reliable fixing of the clamping body.
[0017] The fixing elements can be or include screw elements, clamping elements, and / or locking elements, as described above. For the reasons already explained, screw elements can be advantageous. It can be provided, in particular, that the fixing body engages over the base body and an internal thread of the fixing body is screwed to an external thread of the base body.
[0018] The fixing body can be constructed in a simple manner, for example, in the form of a union nut that engages over the clamping body and at least partially over the base body and is connected to it. In the advantageous embodiments of the invention described above, the clamping receptacle is formed by the base body. Other embodiments may provide that the clamping receptacle is not formed by the base body, but by a separate receiving body.
[0019] For example, it may be advantageous if the connecting device comprises a receiving body which is formed separately from the base body and which forms the clamping receptacle, wherein the receiving body and the base body preferably abut one another via mutually facing end faces when the connecting device is in use. In this embodiment, the receiving body forms the clamping receptacle into which the clamping body engages. The clamping body can be fixed in place in use via the fixing device, which can be operatively connected to the receiving body and / or to the clamping body, in order to fix the hose line. The end section of the hose line is arranged partially outside the base body, for example in the clamping area, and can engage in the insertion area on the base body.
[0020] It is particularly advantageous if the receiving body and the clamping body are connected to each other.
[0021] From a structural point of view, the receiving body can be designed, for example, as a sleeve that surrounds the clamping body at least in part. For example, the clamping body extends through the sleeve or engages into it. The clamping body itself can be designed, for example, in the shape of a sleeve.
[0022] The connection between the receiving body and the clamping body can be achieved, for example, by screwing, clamping, and / or locking. A screw connection, for example, can be advantageous. This allows, for example, the clamping force exerted on the hose line and / or the force exerted on the front of the hose line to be adjusted.
[0023] It is conceivable that an internal thread of the receiving body is screwed to an external thread of the clamping body.
[0024] It can be provided that the receiving body forms a fixing body, so that the fixing device does not comprise a further, separate fixing body.
[0025] In another advantageous embodiment, the fixing device comprises a fixing body formed separately from the receiving body and / or the clamping body, which is connected to the base body via fixing elements, wherein the receiving body and / or the clamping body is preferably supported directly or indirectly on the fixing body with a side facing away from the base body. The receiving body and / or the clamping body can be fixed in use via the fixing body. Conveniently, the receiving body and / or the clamping body is supported directly or indirectly on the fixing body. When the receiving body and clamping body are connected, it may be sufficient if one of these two bodies is supported directly or indirectly on the fixing body.
[0026] The fixing elements can be, for example, screw elements, clamping elements, and / or locking elements. For the reasons already explained, screw fastening is advantageous.
[0027] The fixing body can, for example, overlap the receiving body and the base body at least in sections, wherein an internal thread of the fixing body is screwed to an external thread of the base body.
[0028] The fixing body can be designed in a simple manner, for example as a union nut.
[0029] It may prove advantageous if the connecting device comprises a prestressing element which acts between the receiving body and / or the clamping body on the one hand and the fixing body on the other, whereby the receiving body and / or the clamping body can be subjected to a force directed onto the base body, in particular onto the contact area. The prestressing force can act in particular on the clamping body, for example directly or indirectly, if the receiving body is connected to the clamping body as explained above. The prestressing force can improve the sealing of the hose line at the sealing seat. In particular, this embodiment can prove advantageous for a CIP / SIP application for cleaning and / or sterilizing the hose line in the assembled state.In practice, it has been shown that long-term tightness at the sealing seat can be achieved even if multiple hot steam sterilizations are carried out at a temperature of, for example, approximately 135°C and a pressure of approximately 2 bar and above (for example, approximately 2.2 bar).
[0030] The preload element is designed, for example, as a spring element, in particular as a helical spring. To achieve a structurally simple design, it is advantageous if the preload element is designed as a single piece (monolithic) with the receiving body or as a single piece (monolithic) with the clamping body.
[0031] For one-piece production, an additive manufacturing process is used. For example, the preload element is manufactured using 3D printing together with the receiving body or the clamping body.
[0032] A compact design can preferably be achieved in that the pre-tensioning element is arranged radially inward with respect to the fixing body and / or in that the pre-tensioning element surrounds the clamping body and / or the receiving body.
[0033] The clamping body can, for example, be designed as an elongated sleeve.
[0034] A possible design of the clamping area is discussed in more detail below.
[0035] The clamping body can advantageously comprise two or more preferably elastically deformable clamping elements in the clamping area, separated from one another by a respective intermediate space, which are held at a common connecting area. The clamping elements, which may be finger-like, for example, can protrude from the connecting area. The clamping elements are separated from one another and can preferably be deformed independently of one another, with a spring-loaded design being conceivable. In use, the clamping elements in the clamping area are subjected to the force directed onto the hose line, so that the force is distributed across several points on the circumference of the hose line.
[0036] For example, more than two clamping members and respective intermediate spaces may be provided.
[0037] In an advantageous embodiment of the invention, for example, four clamping members can be provided, each of which has an angular distance of 90° from one another in the circumferential direction of the hose line.
[0038] It is conceivable that two clamping elements are provided which are opposite each other.
[0039] Alternatively or additionally, two opposing gaps can be provided. The two or more clamping elements are advantageously designed identically.
[0040] An angular distance between adjacent clamping members is preferably identical.
[0041] It can prove advantageous if the clamping elements include radially inner projections, which are preferably serrated. In practice, this has been shown to exert an axial force on the hose assembly in the direction of the base body. This can result in improved sealing at the sealing seat.
[0042] The clamping elements have a sawtooth shape in cross-section facing the hose line, for example.
[0043] The base body can be tapered at least in sections at the insertion area, with the taper being particularly conical. This can apply, for example, in the case where the clamping receptacle is not formed by the base body.
[0044] The contact area can, for example, define a contact plane aligned perpendicular to the duct. For example, a shoulder is arranged on the inlet side of the duct, against which the end face of the hose line rests.
[0045] Deviating from the above design with a contact plane oriented perpendicular to the channel, in an advantageous embodiment, the contact area can be designed, for example, as a conical taper (e.g., a 45° taper) of the base body toward the channel. This offers the possibility of compressing the hose line to achieve a good seal at the sealing seat.
[0046] The contact area can be located at the end of the tapered clamping area. Alternatively, a cylindrical section of the insertion area can be formed on the base body. The cylindrical section, for example, encloses the hose line, particularly in a form-fitting manner.
[0047] The base body can comprise or form a pharmaceutical filling needle for filling pharmaceutical containers. Alternatively, the connecting device can comprise a filling needle connected or connectable to the base body. The following description of advantageous embodiments of the invention, in conjunction with the drawings, serves to explain the invention in more detail. They show:
[0048] Figure 1: a perspective view of the connecting device according to the invention in a preferred embodiment;
[0049] Figure 2: the connecting device from Figure 1 in a perspective exploded view (partial);
[0050] Figure 3: the connecting device from Figure 1 in a longitudinal section view (partial);
[0051] Figures 4 and 5: further preferred embodiments of the connecting device according to the invention in a sectional view corresponding to Figure 3 (partial view);
[0052] Figure 6: a perspective view of the connecting device according to the invention in a further preferred embodiment;
[0053] Figure 7: a perspective exploded view of the connecting device of Figure 6 (partial);
[0054] Figure 8: a longitudinal sectional view of the connecting device from Figure 6 (partial view);
[0055] Figure 9: a representation of detail A in Figure 8 in a further preferred embodiment;
[0056] Figure 10: a perspective view of the connecting device according to the invention in a further preferred embodiment;
[0057] Figure 11: a perspective exploded view of the connecting device of Figure 10 (partial);
[0058] Figure 12: a longitudinal sectional view (partial) of the connecting device from Figure 10; Figure 13: a perspective exploded view (partial) of another preferred embodiment of the connecting device according to the invention; and
[0059] Figure 14: a longitudinal sectional view of the connecting device of Figure 13 (partial).
[0060] Several advantageous embodiments of the connecting device according to the invention are described below with reference to the drawing, wherein firstly an advantageous embodiment of the connecting device designated by the reference numeral 100, which is shown in Figures 1 to 3, is discussed.
[0061] Identical reference numerals are used for identical or equivalent features and components of the various embodiments. After explaining the first embodiment 100, only the essential differences between the other embodiments will be described. The properties, advantages, and effects described in connection with the first embodiment apply accordingly to the other embodiments, even if this is not explained in detail.
[0062] Figure 1 shows the connecting device 100 in a perspective view, Figure 2 in a perspective exploded view. Figure 3 is a sectional view of the connecting device 100.
[0063] The connecting device 100 serves to connect a flexible hose line 102 to an object 104. In the present embodiment, the object 104 is a filling needle 106 used in a system for filling pharmaceutical containers. The system and the containers themselves are not shown in the drawing.
[0064] The connecting device 100, together with the filling needle 106, is accommodated in a filling station of the system. A product to be filled, in particular a liquid, is supplied via the hose line 102. The container is filled via the filling needle 106, which engages the container.
[0065] This application of the invention is exemplary and non-limiting. Instead of connecting the tubing 102 to the filling needle 106, a different type of connection can be made to an object 104 that differs from the filling needle 106. As mentioned, the tubing 102 is flexible and made of a pharmaceutical-grade material, for example, PTFE (polytetrafluoroethylene).
[0066] The connecting device 100 comprises a base body 108. In the present case, the base body 108 forms the filling needle 106, or the filling needle 106 is connected to the base body 108.
[0067] The base body 108 is essentially cylindrical in shape, comprising a first portion 110 and a second portion 112, which are coaxially aligned with respect to an axis 114 of the base body 108. The diameter of the second portion 112 is larger than that of the first portion 110. However, this is only an exemplary embodiment.
[0068] A channel 116 is formed in the base body 108, which has the axis 114 and comprises a contact area 118 on the inlet side, ie, in the inflow direction of the liquid. The channel 116 is in flow connection with the hose line 102.
[0069] The contact area 118 is formed by a shoulder 120, which defines a contact plane 122. The contact plane 122 is oriented transversely and, in this case, particularly perpendicularly to the axis 114.
[0070] Furthermore, the base body 108 comprises an insertion area 124, in which, in the present example, the hose line 102 runs with an end section 126. The insertion area 124 opens into the channel 116 and is arranged directly in front of the channel 116 in the direction of the inserted hose line 102.
[0071] The connecting device 100 comprises a clamping receptacle 128. In this case, the clamping receptacle 128 is formed by the base body 108 at the insertion area 124. The clamping receptacle 128 has a taper 130, which in the present example is particularly conical. Overall, the clamping receptacle 128 tapers toward the contact area 118.
[0072] On the inlet side of the base body 108, a receiving space 132 is formed, in this case on the second section 112. On the receiving space 132, the base body 108 has a fixing element 134, which is a component of a fixing device 136 of the connecting device 100. The fixing element 134 is designed in this case as a screw element 138 with an internal thread of the base body 108. The connecting device 100 comprises a clamping body 140. The clamping body 140 is designed in this case as an elongated sleeve 142. The clamping body 140 defines an axis 144, which coincides with the axis 114 in the intended use state of the connecting device 100. In the use state, the clamping body 140 is connected to the base body 108 for adapting the hose line 102.
[0073] In the present case, the hose line 102 passes through the clamping body 140 at a central through-opening.
[0074] On the side facing the contact area 118, the clamping body 140 comprises a clamping area 146. In the present case, the hose line 102 projects beyond the clamping area 146 and beyond the clamping body 140.
[0075] As a further fixing element 148 of the fixing device 136, a screw element 150, configured with an external thread, is provided on the clamping body 140. The fixing elements 148, 134 can cooperate to fix the clamping body 140 to the base body 108.
[0076] In this case, the clamping body 140 is dimensioned such that it engages positively with the base body 108. The screw elements 138, 150 are screwed together so that the clamping body 140 is reliably held on the base body 108 in the operating state.
[0077] The clamping area 146 engages the tapered clamping receptacle 128. As a result, the clamping area 146 is held in a clamping fit on the base body 108. This allows the hose line 102 to be subjected to a clamping force radially from the outside (in this case, relative to the axis 144, which coincides with the axis of the hose line 102). As a result, the hose line 102 is reliably held on the clamping body 140 and thus adapted to the filling needle 106 by means of the connecting device 100.
[0078] The end face 152 of the hose line 102 rests against the contact area 118 forming a sealing seat 154. The hose line 102 rests abutting against the shoulder 120. This is sufficient in this case to achieve a sufficient seal between the hose line 102 and the base body 108.
[0079] In particular, it is not necessary for the base body 108 to engage with the hose line 102, as is the case with conventional connecting devices. The connecting device 100 also proves to be structurally simple to manufacture and easy to handle. For example, manual and, in particular, tool-free assembly and / or disassembly is conceivable.
[0080] As can be seen particularly from Figures 2 and 3, the clamping body 140 comprises a plurality of clamping members 156 at the clamping area 146. The clamping members 156 protrude from a common connecting area 158 of the sleeve 142 in the direction of the contact area 118. In the clamping receptacle 128, the clamping members 156, in particular, interact with the base body 108.
[0081] The clamping members 156 are made of an elastically deformable material. For example, they could be made of a plastic material, such as PEEK. The clamping body 140 can be made entirely of the plastic material and, for example, be formed in one piece.
[0082] In the present case, four clamping members 156 are provided, the number of which is merely exemplary. A gap 160 is arranged between adjacent clamping members 156. Two clamping members 156 are located opposite each other. Similarly, two gaps 160 are located opposite each other.
[0083] The clamping members 156 each extend over the same angular range with respect to the axis 144 and have identical angular distances from one another.
[0084] In particular, the clamping members 156 are designed identically.
[0085] Radially facing the inside of the hose line 102, the clamping members 156 have projections 162, preferably a plurality of projections 162 each. The projections 162 are tooth-shaped and, in the present example, are designed such that the clamping member 156 has a sawtooth shape in the cross section facing the hose line 102 (Figure 3).
[0086] In use, the clamping members 156 are compressed by the clamping receptacle 128. The projections 162 engage with the hose line 102. This not only serves to reliably secure the hose line 102, but also ensures that the hose line 102 is subjected to an axial force during screwing, thereby achieving a reliable seal at the contact area 118. Depending on the depth of the screw connection of the clamping body 140 to the base body 108, the load applied to the hose line 102 can be influenced, and thus also the force between the hose line 102 and the contact area 118.
[0087] For cleaning purposes, particularly for sterilization purposes after a production cycle, the connecting device 100 can be easily disassembled. Even after repeated sterilization using superheated steam, the hose line 102 retains its shape so that repeated use and a fluid-tight connection using the connecting device 100 are possible.
[0088] Depending on the dimensions of the hose line 102, the connecting device according to the invention can have different dimensions. In practice, for example, the use of hoses with an inner diameter of approximately 0.9 mm up to approximately 7.5 mm is common, and in individual cases even higher. A wall of the hose line 102 is, for example, approximately 0.8 mm to 1.5 mm thick.
[0089] The connecting devices 164 and 166, partially shown in Figures 4 and 5, are functionally identical to the connecting device 100, but are adapted to hose lines 102 of different sizes. While the hose line 102 in the variant according to Figure 4 has a smaller diameter than the connecting device 100, the hose line 102 in the variant according to Figure 5 has a larger diameter. Otherwise, the above statements apply.
[0090] The reference numeral 170 denotes an advantageous embodiment of the connecting device shown in Figures 6 to 8.
[0091] In the connecting device 170, in particular the clamping body 140 and the fixing device 136 are designed differently from the connecting device 100.
[0092] In contrast to the connecting device 100, the base body 138 does not have a second section 112 with a receiving space 132. In the present example, a mounting section 172, for example, configured flange-like, is provided adjacent to the first section 110. Furthermore, a second section 112 is provided, which has an external thread as a fixing element 134. The clamping body 140 in the connecting device 170 is not intended for direct attachment to the base body 108. Instead, the fixing device 136 comprises a fixing body 174.
[0093] The clamping body 140 comprises, as the connecting region 158, an annular collar 176 from which the clamping members 156 protrude. The clamping members 156 are compressed by the clamping receptacle 128 as explained above, thereby securing the hose line 102. Furthermore, an axial load is applied to the contact area 118 for improved sealing.
[0094] A cylindrical section 178 is formed in the base body 108 between the contact area 118 and the taper 130 of the clamping receptacle 128. This section is dimensioned such that the hose line 102 is enclosed in a form-fitting manner. The section 178 serves to stabilize and guide the hose line 102 at the end section 126.
[0095] To secure the clamping body 140 in the use state, the fixing body 174 of the fixing device 136 is provided with a fixing element 180. This is designed here as a screw element with an internal thread of the fixing body 174, which is cap-shaped, for example, as a union nut.
[0096] The hose line 102 passes through a through opening 182 on an upper section 184 of the fixing body 174, from which an edge 186 projects in the direction of the base body 108, which carries the internal thread.
[0097] In this way, the fixing body 174 overlaps the clamping body 140 and, in sections, the base body 108. The fixing elements 134 and 180 are screwed together.
[0098] The clamping body 140 is supported on the fixing body 174 with a side 188 facing away from the base body 108, in this case directly. In particular, the fixing body 174 and the clamping body 140 preferably lie flat against one another via corresponding contact elements (Figure 8).
[0099] Depending on how tightly the fixing body 174 and the base body 108 are screwed together, the hose line 102 is subjected to a greater or lesser degree of stress via the clamping area 146. The same applies to the force acting on the end face 152 at the sealing seat 154. Figure 9 shows a detail (A) of Figure 8 for a variant of the design of the contact area 118. Such a design can be used not only for the connecting device 170, but, deviating from the respective illustration, can be provided for all connecting devices described here.
[0100] In the variant according to Figure 9, the contact area 118 is shaped such that it is formed as a conical taper 190 of the base body 108 in the direction of the channel 116. The hose line 102, which is in abutting contact, is thereby compressed. This can be advantageous for a better seal at the sealing seat 154.
[0101] Further preferred embodiments, designated by reference numeral 200 in Figures 10 to 12 and by reference numeral 300 in Figures 13 and 14, will be discussed below. In terms of design and functionality, there are many similarities between the connecting devices 200 and 300, which can therefore initially be explained together. The differences will then be discussed.
[0102] In the connecting devices 100, 164, 166, and 170, the clamping receptacle 128 with the tapered portion 130 is formed by the base body 108. This differs from the connecting devices 200, 300, in which a receiving body 202 is used to form the clamping receptacle 128.
[0103] The base body 108 is essentially cylindrical and forms the channel 116 and the insertion area 124 located in front of it. In the present example, the section 178 is arranged at the insertion area for the form-fitting enclosure of the hose line 102. A tapered portion 204, albeit slight, is provided on the inlet side of the insertion area 124.
[0104] On the inlet side, the receiving space 132 is formed on the base body 108, which is enclosed by an edge 206 having the fixing element 134 in the form of the external thread.
[0105] To fix the clamping body 140 by means of the fixing device 136, the fixing body 174 is also provided in the connecting devices 200. This comprises the fixing element 180, designed as an internal thread, for interaction with the fixing element 134.
[0106] In the present case, the edge 186 is elongated, so that the fixing body 174 has an overall cylindrical shape with a longitudinal extension that significantly exceeds its diameter. However, this is only an exemplary embodiment. The through-opening 182 is also provided, with not only the hose line 102 but also the clamping body 140 extending through the through-opening 182.
[0107] The clamping body 140 has a shape that largely corresponds to the shape of the clamping body 140 in the connecting device 100. In the connecting devices 200, 300, the clamping body 140 is also designed as an elongated sleeve 142.
[0108] The clamping body 140 comprises the fixing element 148, designed as a screw element with an external thread, and the clamping area 146 with a plurality of clamping members 156.
[0109] The clamping receptacle 128 is formed by the receiving body 202. In the present case, the receiving body 202 is designed as a sleeve 208 that surrounds the clamping body 140. In the present example, the sleeve 208 has a smaller longitudinal extension (approximately half) compared to the sleeve 142, but this is only an example.
[0110] The sleeve 208 includes a through-opening 210 into which the clamping body 140 engages from the side facing away from the base body 108. The clamping receptacle 128 is formed with the tapered portion 130 on the sleeve 208 facing the base body 108.
[0111] The sleeve 208 further comprises a fixing element 212, in this case configured as an internal thread. The fixing element 212 is arranged on the side facing away from the base body 108.
[0112] The fixing elements 148 and 212 can cooperate to screw-connect the clamping body 140 to the receiving body 202. In this case, too, the depth of the screw connection can influence the force applied to the hose line 102 at the clamping area 146 and the force with which the end face 152 rests against the sealing seat 154.
[0113] In the connecting devices 200, 300, unlike the connecting device 170, the clamping body 140 is not subjected to a force directly by the fixing body 174. Instead, the force is applied indirectly.
[0114] In the present example, a preload element 214 is provided, which acts between the fixing body 174 and the receiving body 202. The preload element 214 is designed as a spring element 216, in particular as a helical spring, which acts under pressure. The spring element 216 bears against the fixing body 174, in particular against the upper section 184, and can be supported thereon. The opposite end of the spring element 216 bears against the receiving body 202, in particular against its end section 218, which faces the upper section 184.
[0115] Since the clamping body 140 is connected to the receiving body 202, the clamping body is indirectly subjected to the preload force of the spring element 216. In the use state, the clamping body 140 is thus subjected to the force directed toward the base body 108 to secure the hose line 102.
[0116] The spring element 216 is arranged radially inward with respect to the fixing body 174 and is surrounded by its edge 206. With respect to the clamping body 140, the spring element 216 is arranged radially outward and surrounds it.
[0117] In the connecting device 200, the spring element 216 is a separate component that is formed separately from the receiving body 202 and separately from the clamping body 140.
[0118] In contrast, the prestressing element 214 in the connecting device 300 is formed integrally with the receiving body 202. Alternatively, a one-piece design with the clamping body 140 is conceivable, for example.
[0119] The one-piece (monolithic) production of the receiving body 202 and the preloading element 214 is advantageous from a manufacturing perspective. In particular, an additive process, such as 3D printing, is used here.
[0120] In particular, the connecting devices 200 and 300 are advantageously suited for cleaning and sterilizing the hose line without disassembly in a CIP / SIP process. In this process, the hose line 102 can be subjected to superheated steam, which, for example, has a temperature of approximately 135°C and a pressure of approximately 2 bar or more.
[0121] By means of the pre-tensioning element 214, it can be particularly reliably ensured that the hose line 102 does not lift off the sealing seat 154 and / or deform, even at high temperatures and high pressures, so that the advantageous sealing properties are maintained even during long-term use and repeated sterilization.
[0122] Connecting device Hose line Object Filling needle Main body First section Second section Axis Channel
[0123] Contact area Shoulder Contact level Insertion area End section Clamping receptacle Taper Receptacle space Fixing element Fixing device Screw element Clamping body Sleeve Axis
[0124] Clamping area Fixing element Screw element Front side Sealing seat Clamping element Connecting area Space Projection Connecting device Connecting device Connecting device Mounting section Fixing body Collar Cylindrical section Fixing element
[0125] Through opening upper section edge
[0126] Side conical taper connecting device receiving body taper
[0127] Edge Sleeve Through-hole Fixing element Preload element Spring element Section
[0128] Connecting device
Claims
PATENT CLAIMS 1. A pharmaceutical connecting device for a flexible hose line (102), comprising a base body (108) in which an insertion region (124) for the hose line (102) and a channel (116) are formed, wherein the insertion region (124) opens into the channel (116) and a contact region (118) for the hose line (102) is arranged on the inlet side of the channel (116); a clamping body (140) through which the hose line (102) is guided and which comprises or forms a clamping region (146) facing the base body (108); a clamping receptacle (128) which has a particularly conical taper (190) in the direction of the contact region (118); and a fixing device (136) for fixing the clamping body (140) relative to the base body (108) in a use state of the connecting device (100; 164; 166; 170; 200; 300);wherein the clamping body (140) engages in the tapered clamping receptacle (128) with the clamping region (146) in the use state and the clamping region (146) applies a clamping force to the hose line (102) radially from the outside, and wherein the hose line (102) extends with an end section (126) through the insertion region (124) and rests on the end face against the contact region (118) forming a sealing seat (154); 2. Connecting device according to claim 1, characterized in that the hose line (102) is free from engagement by the base body (108), in particular that the hose line (102) is not slipped over the base body (108).
3. Connecting device according to claim 1 or 2, characterized in that the base body (108) forms the clamping receptacle (128) so that the clamping area (146) is held in a clamping fit on the base body (108) in the use state for applying the clamping force to the hose line (102).
4. Connecting device according to claim 3, characterized in that that the fixing device (136) comprises cooperating fixing elements (134, 148) on the clamping body (140) and on the base body (108), wherein the clamping body (140) is directly connected to the base body (108).
5. Connecting device according to claim 4, characterized in that the fixing elements (134, 148) are or comprise screw elements, clamping elements and / or locking elements, wherein in particular the clamping body (140) engages in the base body (108) and an external thread of the clamping body (140) is screwed to an internal thread of the base body (108), or wherein the clamping body (140) engages over the base body (108) and an internal thread of the clamping body (140) is screwed to an external thread of the base body (108).
6. Connecting device according to claim 1 or 2, characterized in that the fixing device (136) comprises a fixing body (174) formed separately from the clamping body (140) and connected to the base body (108) via fixing elements (134, 180), wherein the clamping body (140) is supported directly or indirectly on the fixing body (174) with a side (188) facing away from the base body (108).
7. Connecting device according to claim 6, characterized in that the fixing elements (134, 180) are or comprise screw elements, clamping elements and / or locking elements, wherein in particular the fixing body (174) engages over the base body (108) and an internal thread of the fixing body (174) is screwed to an external thread of the base body (108).
8. Connecting device according to claim 1 or 2, characterized in that the connecting device (100; 164; 166; 170; 200; 300) comprises a receiving body (202) which is formed separately from the base body (108) and which forms the clamping receptacle (128), wherein preferably the receiving body (202) and the base body (108) in the use state of the connecting device (100; 164; 166; 170; 200; 300) abut one another via mutually facing end faces.
9. Connecting device according to claim 8, characterized in that that the receiving body (202) and the clamping body (140) are connected to one another, and / or that the receiving body (202) is designed as a sleeve (208) surrounding the clamping body (140) at least in sections.
10. Connecting device according to claim 9, characterized in that the receiving body (202) and the clamping body (140) are connected to one another by screwing, clamping and / or locking, wherein in particular an internal thread of the receiving body (202) is screwed to an external thread of the clamping body (140).
11. Connecting device according to one of claims 8 to 10, characterized in that the fixing device (136) comprises a fixing body (174) formed separately from the receiving body (202) and / or the clamping body (140), which is connected to the base body (108) via fixing elements (134, 180), wherein the receiving body (202) and / or the clamping body (140) is preferably supported directly or indirectly on the fixing body (174) with a side facing away from the base body (108).
12. Connecting device according to claim 11, characterized in that the fixing elements (134, 180) are or comprise screw elements, clamping elements and / or locking elements, wherein in particular the fixing body (174) engages over the receiving body (202) and the base body (108) and an internal thread of the fixing body (174) is screwed to an external thread of the base body (108).
13. Connecting device according to claim 11 or 12, characterized in that the connecting device (100; 164; 166; 170; 200; 300) comprises a prestressing element (214) which acts between the receiving body (202) and / or the clamping body (140) and the fixing body (174) and applies a force to the receiving body (202) and / or the clamping body (140) directed onto the base body (108), in particular onto the contact area (118).
14. Connecting device according to claim 13, characterized in that the prestressing element (214) is designed as a spring element (216), in particular as a helical spring.
15. Connecting device according to claim 13 or 14, characterized in that the prestressing element (214) is designed in one piece with the receiving body (202) or in one piece with the clamping body (140) and is manufactured in particular by an additive manufacturing process.
16. Connecting device according to one of claims 13 to 15, characterized in that the prestressing element (214) is arranged radially inwardly with respect to the fixing body (174) and / or that the prestressing element (214) surrounds the clamping body (140) and / or the receiving body (202).
17. Connecting device according to one of the preceding claims, characterized in that the clamping body (140) is designed as an elongated sleeve (142).
18. Connecting device according to one of the preceding claims, characterized in that the clamping body (140) comprises at the clamping region (146) two or more preferably elastically deformable clamping members (156) separated from one another by a respective intermediate space (160) which are held at a common connecting region (158).
19. Connecting device according to claim 18, characterized in that more than two clamping members (156) and respective intermediate spaces (160) are provided.
20. Connecting device according to claim 18 or 19, characterized in that two clamping members (156) are provided which are opposite one another and / or that two intermediate spaces (160) are provided which are opposite one another.
21. Connecting device according to one of claims 18 to 20, characterized in that the clamping members (156) comprise, on the radially inner side, preferably serrated projections (162), wherein the clamping members (156) facing the hose line (102) have, for example, a sawtooth shape in cross section.
22. Connecting device according to one of the preceding claims, characterized in that the base body (108) is tapered at least in sections at the insertion area (124), wherein the taper is in particular conical.
23. Connecting device according to one of the preceding claims, characterized in that the contact area (118) defines a contact plane (122) oriented perpendicular to the channel (116).
24. Connecting device according to one of claims 1 to 22, characterized in that the contact area (118) is designed as a conical taper (190) of the base body (108) in the direction of the channel (116).
25. Connecting device according to one of claims 1 to 22, characterized in that the contact area (118) is arranged at the end of the taper (130) of the clamping area (146) or that a cylindrical section (178) of the insertion area (124) is formed on the base body (108).
26. Connecting device according to one of the preceding claims, characterized in that the base body (108) comprises or forms a pharmaceutical filling needle (106) for filling pharmaceutical containers or that the connecting device (100; 164; 166; 170; 200; 300) comprises a filling needle (106) connected or connectable to the base body (108).