ADAPTER PART FOR CONNECTING A MEDICAL HOLLOW BODY TO A TENSION/COMPRESSION MEASURING DEVICE, TEST ASSEMBLY, METHOD FOR TESTING A TIGHTNESS OF A MEDICAL HOLLOW BODY, AND USE OF A TENSION/COMPRESSION MEASURING DEVICE

Abstract

The invention relates to an adapter part (9) for connecting a medical hollow body (11) to a tension/compression measuring device (3), comprising a first connecting end (13), which is designed to connect the adapter part (9) to an interior (15) of a medical hollow body (11) in a fluid-tight manner, and comprising a second connecting end (17), which has a pressure chamber (19) and is designed to operatively connect the adapter part (9) to a tension/compression measuring device (3), so that a pressure in the pressure chamber (19) can be adjusted by means of the tension/compression measuring device (3), a hollow channel (21) passing through the adapter part (9) from the pressure chamber (19) to the first connecting end (13).

Claims

1. An adapter part (9) for connecting a medical hollow body (11) to a tension/compression measuring device (3), comprising a first connecting end (13), which is designed to connect the adapter part (9) to an interior (15) of a medical hollow body (11) in a fluid-tight manner, and comprising a second connecting end (17), which has a pressure chamber (19) and is designed to operatively connect the adapter part (9) to a tension/compression measuring device (3), so that a pressure in the pressure chamber (19) can be adjusted by means of the tension/compression measuring device (3), a hollow channel (21) passing through the adapter part (9) from the pressure chamber (19) to the first connecting end (13).

2. The adapter part (9) according to claim 1, characterized by a pressure measuring channel (23), which branches off from the hollow channel (21) or the pressure chamber (19) between the first connecting end (13) and the second connecting end (17), a) the compression measuring channel (23) preferably being designed for the arrangement of a pressure measuring device (33) on the pressure measuring channel (23), and/or b) a pressure measuring device (33) preferably being operatively connected to the pressure measuring channel (23) in order to measure a pressure in the pressure measuring channel (23).

3. The adapter part (9) according to claim 1, characterized in that a) a piston (35) is displaceably arranged in the pressure chamber (19), so that a volume of the pressure chamber (19) can be changed by displacing the piston (35), or in that b) the adapter part (9) has a piston (35), which is designed to be displaceably arranged in the pressure chamber (19).

4. The adapter part (9) according to claim 1, characterized in that the piston (35) a) has a piston disk (37) or is designed as a piston disk (37), and/or b) has a coupling part (39), which is designed to be mechanically coupled to a working end (7) of a tension/compression measuring device (3).

5. The adapter part (9) according to claim 1, characterized in that the pressure chamber (19) and/or the piston (35) is assigned a scale (41) from which an instantaneous pressure in the pressure chamber (19) can be read depending on an instantaneous position of the piston (35) in the pressure chamber (19).

6. A test assembly (1), comprising a tension/compression measuring device (3), which has a standing body (5) and a working end (7), which can be axially displaced relative to the standing body (5), and comprising an adapter part (9) according to claim 1, the second connecting end (17) of the adapter part (9) being operatively connected to the working end (7) in such a way that a pressure in the pressure chamber (19) can be adjusted by axially displacing the working end (7) relative to the pressure chamber (19).

7. The test assembly (1) according to claim 6, characterized in that the standing body (5) has a fastening part (43) for fixing the adapter part (9) relative to the standing body (5).

8. The test assembly (1) according to claim 6, characterized in that the working end (7) is a) connected to a piston disk (37) of the adapter part (9) in a tension- and/or pressure-transmitting manner, or b) mechanically coupled to a coupling part (39) of the piston (35), or c) arranged displaceably as a piston in the pressure chamber (19).

9. The test assembly (1) according to claim 6, characterized in that the tension/compression measuring device (3) has a control device (53), which is designed to be operatively connected to a pressure measuring device (33) and to record and preferably evaluate a pressure in the hollow channel (21).

10. The test assembly (1) according to claim 6, characterized in that the control device (53) is designed to carry out a tightness test of a medical hollow body (11) in an automated manner.

11. A method for testing the tightness of a medical hollow body (11), comprising the following steps: connecting a medical hollow body (11) to a tension/compression measuring device (3) via an adapter part (9) according to claim 1; setting a specific pressure in an interior (15) of the medical hollow body (11) by displacing a working end (7) of the tension/compression measuring device (3) and recording an instantaneous pressure in the interior (15) over a specific test time.

12. The method according to claim 11, characterized in that the working end (7) is kept still after the specific pressure has been set and during the specific test time.

13. The method according to claim 11, characterized in that the method is carried out automatically by the tension/compression measuring device (3).

14. The method according to claim 11, characterized in that the medical hollow body (11) is checked before a medical stopper is arranged in the medical hollow body (11).

15. A method for using a tension/compression measuring device (3) to test the tightness of a medical hollow body (11).

Description

[0057] The invention is explained in greater detail below with reference to the drawing. In the drawing:

[0058] FIG. 1 is a schematic representation of a first embodiment of a test assembly with an embodiment of an adapter part;

[0059] FIG. 2 is a schematic sectional view of the test assembly according to FIG. 1, and

[0060] FIG. 3 is a schematic representation of a second embodiment of a test assembly.

[0061] FIG. 1 is a representation of a first embodiment of a test assembly 1, which has a tension/compression measuring device 3. The tension/compression measuring device 3, for its part, has a standing body 5 and a working end 7 that can be axially displaced relative to the standing body 5, i.e. in the vertical direction with reference to FIG. 1. Furthermore, the test assembly 1 has an adapter part 9, which is designed to connect a medical hollow body 11 to the tension/compression measuring device 3. The adapter part 9 has a first connecting end 13, shown in FIG. 2, which is designed to connect the adapter part 9 in a fluid-tight manner to an interior 15 of the medical hollow body 11, also shown in FIG. 2. The adapter part 9 also has a second connecting end 17. The second connecting end 17 has a pressure chamber 19 and is designed to operatively connect the adapter part 9 to the tension/compression measuring device 3, so that a pressure in the pressure chamber 19 can be adjusted by means of the tension/compression measuring device 3.

[0062] The adapter part 9 also has a hollow channel 21, which passes through said adapter part from the pressure chamber 9 to the first connecting end 13.

[0063] In addition, the embodiment of the adapter part 9 shown here has a pressure measuring channel 23, which branches off from the hollow channel 21 or the pressure chamber 19, in this case from the hollow channel 21, between the first connecting end 13 and the second connecting end 17.

[0064] The second connecting end 17 is operatively connected to the working end 7 of the tension/compression measuring device 3 in such a way that a pressure in the pressure chamber 19 can be adjusted by axially displacing the working end 7 relative to the pressure chamber 19.

[0065] In this way, a precise pressure setting in the pressure chamber 19 and thus ultimately also in the interior 15 of the medical hollow body 11 can be carried out in a simple manner by means of the tension/compression measuring device 3, which can be used for a tightness test of the medical hollow body 11. It is thus ultimately possible to use a device for this tightness test that is already used to test medical hollow bodies 11, namely the tension/compression measuring device 3, which is used regularly, for example, to measure breakaway forces or displacement forces of stoppers in medical hollow bodies 11.

[0066] The standing body 5 preferably has a measuring tower 25 on which the working end 7 can be displaced. For this purpose, the tension/compression measuring device 3 preferably has a drive 27, which is designed to displace the working end 7 in the axial direction, in particular on the measuring tower 25.

[0067] The working end 7 is preferably designed as a measuring element or has a measuring element. However, it is also possible for the working end 7 to be designed purely as a mechanical component or mechanical adapter, in particular as a mechanical connecting part for attaching further parts, in particular measuring arrangements, for example load cells, to the tension/compression measuring device 3.

[0068] The first connecting end 13 is preferably assigned a sealing device 29 that is designed to seal the fluidic connection between the hollow channel 21 and the interior 15 of the medical hollow body 11. For this purpose, the sealing device 29 preferably has at least one sealing element, in this case specifically two sealing rings 31, 31′, which are arranged on the first connecting end 13, in particular encompassing the first connecting end 13 in the circumferential direction.

[0069] The hollow channel 21 is open in particular at the first connecting end 13. In particular, said hollow channel opens into the first connecting end 13, or it opens into the interior 15 of the medical hollow body 11 in the region of the first connecting end 13 when the adapter part 9 is connected to the medical hollow body 11.

[0070] By means of the tension/compression measuring device 3 and the adapter part 9, both an overpressure and an underpressure can be set in the interior 15 of the medical hollow body 11, compared to an ambient pressure in the vicinity of the medical hollow body 11.

[0071] A pressure measuring device 33, which can in particular be designed as a manometer, is arranged on the pressure measuring channel 23. The pressure measuring channel 23 is preferably designed for connection to the pressure measuring device 33, for example by having a thread into which the pressure measuring device 33 can be screwed or to which the pressure measuring device 33 can be screwed.

[0072] The pressure measuring device 33 is operatively connected to the pressure measuring channel 23 in order to measure a pressure in the pressure measuring channel 23 and thus at the same time in the hollow channel 21, the pressure chamber 19 and the medical hollow body 11.

[0073] Alternatively, the pressure measuring device can also be connected to a distal end of the hollow body 11 in order to measure the pressure in the interior of the hollow body 11. In this case, an adapter part 9 can also be used that does not have a pressure measuring channel 23 or in which the pressure measuring channel 23 is closed, for example, with a blind stopper.

[0074] A distal end is understood here in particular to be an end of the hollow body 11 that, when the hollow body 11 is used, faces toward a patient and/or an injection site and preferably faces away from a user of the hollow body 11 as intended. The other end of the hollow body 11 is referred to as the proximal end.

[0075] A piston 35 is displaceably arranged in the pressure chamber 19, so that a volume of the pressure chamber 19 can be changed by displacing the piston 35. Alternatively, it is also possible for the adapter part 9 to have a piston, which is designed to be displaceably arranged in the pressure chamber 19. In particular, the piston 35 therefore does not have to be arranged permanently in the pressure chamber 19; in particular, there is no need for a captive, possibly inseparable, arrangement of the piston in the pressure chamber 19. However, it is possible for the piston 35 to be arranged permanently, in particular in a captive manner, in the pressure chamber 19.

[0076] The piston 35 preferably has a piston disk 37. Said piston disk is preferably arranged tightly in the pressure chamber 19, preferably by means of at least one sealing ring, which the piston disk 37 carries, in particular on the circumference thereof. According to one embodiment, it is possible for the piston 35 as a whole to be designed as a piston disk 37. In this case, the working end 7 preferably acts directly on the piston disk 37.

[0077] In the embodiment shown here, however, the piston 35 has a coupling part 39 that is designed to be mechanically coupled to the working end 7. The coupling part 39 is designed in particular as a coupling shaft. Said coupling shaft is preferably rigidly connected to the coupling disk 37, in particular so that it can be carried along. In particular, it is possible for the coupling part 39 and the coupling disk 37 to be formed in one piece, in particular from the same material, with one another and thus jointly form the piston 35 in one piece.

[0078] If the coupling part 39 is coupled to the working end 7, these can in particular be displaced together, so that the piston 35 as a whole is displaced together with the working end 7 when the latter is displaced. In this way, the volume in the pressure chamber 19 can be adjusted by moving the working end 7 and thus at the same time the piston 35. At the same time, this leads to an adjustment of the pressure in the hollow channel 21 and in the medical hollow body 11 when said medical hollow body is connected to the adapter part 9.

[0079] In the embodiment shown here, the pressure chamber 19 is assigned a scale 41 from which an instantaneous pressure in the pressure chamber 19 can be read depending on an instantaneous—axial—position of the piston 35 in the pressure chamber 19. In particular, the scale 41 is preferably arranged on an outer circumference of the pressure chamber 19, in particular glued or printed thereon, or attached in another suitable manner so that it can be read. In particular, a wall of the pressure chamber 19 is preferably transparent, at least in the region of the scale 41, so that the position of the piston 35 relative to the scale 41 can be observed through the wall of the pressure chamber 19.

[0080] Alternatively, it is possible for the piston 35 to be assigned a corresponding scale. The wall of the pressure chamber 19 then preferably has a reading mark.

[0081] According to a preferred embodiment, the standing body 5 has a fastening part 43, which is designed to fasten the adapter part 9 relative to the standing body 5 and preferably to the standing body 5. However, it is also possible for the adapter part 9 to be held in a particularly simple manner on the one hand by the working end 7 and on the other hand by the medical hollow body 11.

[0082] In this case, the medical hollow body 11 is arranged in a holder 45 which is substantially designed as a cylindrical hollow body into which the medical hollow body 11 can be introduced. In this embodiment, the medical hollow body 11 rests with a finger rest 47 on an upper edge 49 of the holder 45. The holder 45 is, for its part, fixed on a fastening foot 51 of the tension/compression measuring device 3, which can preferably be part of the standing body 5.

[0083] The fastening part 43 can also be connected to the holder 45 and/or the fastening foot 51.

[0084] As already stated, the working end 7 is in this case mechanically coupled to the coupling part 39 of the piston 35. Alternatively, however, it is also possible for the working end 7 to be directly connected in a tension and/or pressure-transmitting manner to the piston disk 37 or to a piston disk to which no coupling part 39 is assigned. In particular, the working end 7 can act directly on the piston disk 37. Furthermore, it is alternatively possible for the working end 7 itself to be displaceable as a piston in the pressure chamber 19.

[0085] The tension/compression measuring device 3 preferably has a control device 53, which is designed to be operatively connected to the pressure measuring device 33 and to record a pressure in the hollow channel 21, in particular in the pressure measuring channel 23, preferably as a function of time. The control device 53 is further preferably designed to evaluate the recorded pressure—in particular as a function of time. According to a preferred embodiment, it is possible for the control device 53 to be further designed to displace the working end 7 as a function of the recorded pressure, in particular in order to be able to automatically adjust the pressure in the hollow channel 21 and ultimately in the medical hollow body 11, in particular to a predetermined pressure value. It is also possible for the control device 53 to be designed according to a preferred embodiment to regulate the pressure in the hollow channel 21 to a predetermined target value. The control device 53 is also designed to carry out a tightness test of the medical hollow body 11 in an automated manner.

[0086] FIG. 2 shows a schematic sectional view of the test assembly 1 according to FIG. 1. Identical and functionally identical elements are provided with the same reference symbols in all figures, so that in this respect reference is made to the preceding description.

[0087] In this case, the coupling part 39 has in particular a transverse bore 55 as a securing bore, which, when installed, is aligned with a securing receptacle 57 of the working end 7. A securing pin 59 is inserted through the transverse bore 55 and the securing receptacle 57, which is preferably also designed as a transverse bore, by means of which securing pin the piston 35 is ultimately mechanically connected to the working end 7.

[0088] In an analogous manner, the holder 45 is in this case also connected to the fastening foot 51 via a second securing pin 61.

[0089] The medical hollow body 11 is in this case closed at its distal end with a closure 63, in particular in a fluid-tight manner.

[0090] The medical hollow body 11 preferably does not lie tightly on the upper edge 49 of the holder 45 with its finger rest 47, or the holder 45 has at least one pressure equalization bore, which allows pressure equalization with an external environment of the holder 45. This preferably ensures that an interior of the holder 45 always has ambient pressure, which allows the tightness of the medical hollow body 11 to be tested as precisely as possible.

[0091] FIG. 3 shows a schematic representation of a second embodiment of a test assembly 1. The fastening part 43 is connected to the holder 45 here.

[0092] The method for testing the tightness of the medical hollow body, which is explained in more detail below with reference to all FIGS. 1 to 3 is used in particular to test the tightness of the closure 63, i.e. in particular to connect the closure 63 to the medical hollow body 11.

[0093] According to a preferred embodiment, the medical hollow body 11 is tested for tightness with the aid of the test assembly 1 in the following way:

[0094] First, the medical hollow body 11 is connected to the tension/compression measuring device 3 via the adapter part 9. The medical hollow body 11 is closed in particular at the distal end thereof, in this case by means of the closure 63. A certain pressure is now set in the interior 15 of the medical hollow body 11 by displacing the working end 7, and an instantaneous pressure in the interior 15 is recorded over a certain test time. This pressure recording takes place—preferably as a function of time—preferably by means of the tension/compression measuring device 3, in particular by means of the control device 53 thereof.

[0095] The pressure recorded in this way is preferably evaluated, particularly preferably also by the tension/compression measuring device 3, in particular by the control device 53 thereof.

[0096] The working end 7 is preferably kept still after the specific pressure has been set and during the specific test time. Recording is then carried out in particular to determine whether the pressure in the interior 15 is changing, in particular whether said pressure is increasing, in particular if an underpressure was previously set in the interior 15, or whether said pressure is decreasing, in particular if an overpressure was previously set in the interior 15. A leakage rate and/or a tightness of the medical hollow body 11 can then be deduced from the detected pressure change.

[0097] However, it is also possible for the pressure in the interior 15 to be regulated over the specific test time by the tension/compression measuring device 3, in particular the control device 53, in particular to a predetermined target pressure value. In this case, the control signals or adjustment paths of the tension/compression measuring device 3, in particular of the working end 7, can be evaluated with regard to a leakage rate and thus ultimately the tightness of the medical hollow body 11. In this respect, it is obvious that there is a higher readjustment effort when the medical hollow body 11 is leaking, or that the readjustment effort is greater the higher the leakage rate is. In the optimal case, with a vanishing leakage rate, no readjustment is required.

[0098] The method for checking the tightness of the medical hollow body 11 is preferably carried out automatically or in an automated manner by the tension/compression measuring device 3, in particular without the need for user intervention.

[0099] The medical hollow body 11 is preferably checked before a medical stopper, in particular a central and/or end stopper, is arranged in the medical hollow body 11. The medical hollow body 11 can in particular be checked for tightness before or after siliconization. Such siliconization takes place in particular in order to increase the sliding ability of a central and/or end stopper in the interior 15 of the medical hollow body 11.

[0100] It is clear that, according to the technical teaching disclosed here, in particular a tension/compression measuring device 3 is used to test the tightness of a medical hollow body 11.