WO2014166987A1

WO2014166987A1 - Protective covering for a hand-held medical device

Info

Publication number: WO2014166987A1
Application number: PCT/EP2014/057136
Authority: WO
Inventors: Herbert Harttig; Sebastian Liedtke; Matthias MOCK
Original assignee: Roche Diagnostics Gmbh; F. Hoffmann-La Roche Ag
Priority date: 2013-04-09
Filing date: 2014-04-09
Publication date: 2014-10-16
Also published as: HK1218500A1; EP2984469B1; US11324563B2; EP2984469A1; US20160022363A1; CN105120791A

Abstract

The invention concerns a protective covering for a hand-held medical device (10) that has a measuring port (20) for a disposable analytical test strip (12) comprising a sleeve (16) which has a reception opening (32) and can be slipped over the device (10) to at least partially enclose the device (10) in a usable protected state, a test strip adapter (18) formed as an integral part of the sleeve (16) to receive a test strip (12) in alignment with the measuring port (20), wherein the sleeve (16) including the test strip adapter (18) is arranged as a sealing barrier between the test strip (12) and the device (10) port in the protected state.

Description

Protective covering for a hand-held medical device Description The invention concerns a protective covering for a hand-held medical device that has a measuring port for a disposable analytical test strip to which a sample can be applied comprising a sleeve which preferably has a reception opening and can be mounted on the device to partially or fully enclose the device in a usable protected state.

A similar protective barrier for medical devices is disclosed in WO 2012/1 16798. In this document, a casing is shown which includes a plurality of perforations wherein the casing is separable along the perforations to remove the medical device after use. The medical device includes a test element receiving port 14 that is aligned with an open passage of the casing, allowing insertion of the test element through casing and into receiving port. With such a configuration, it is intended to avoid or minimize the use of disinfectants in removing contamination while preventing contamination during use of the medical device so it can be re-used at a later time.

On this basis the object of the invention is to further improve the known test protective barriers and medical devices and to achieve an improved efficiency for safe and reliable use of hand-held medical devices in patient proximity.

The combination of features stated in claim 1 is proposed to achieve this object. Advantageous embodiments and further developments of the invention are derived from the dependent claims. The invention is based on the idea of avoiding contamination of the device specifically in the area of a sample measuring interface. Correspondingly it is proposed according to the invention a test strip adapter formed as an integral part of the sleeve to receive a test strip in alignment with the device port,

wherein the sleeve including the test strip adapter is arranged as a sealing barrier between the test strip and the device port in the protected state.

Thus, the covering fulfills multiple functions, namely as a protective sheath and as an adapter replicating an instrument port. Due to these measures, a direct contact of sample fluid with instrument parts can be prevented in every case. This is specifically important where disposable test strips to which body fluid has to be applied are handled by patients eventually in impaired physical conditions, so that an accurate positioning cannot be guaranteed. Such measurements may include the direct application of fresh blood sampled from a body part, e.g. for blood coagulation or glucose measurements. Specifically in a medical environment, the function as a sealed barrier can reduce the spread of infectious material, both when the device is carried into or out of such an environment. In this connection, it is advantageous when the device is fully enclosed in the sleeve preferably using a sealing technology. Alternatively it is also possible that the device is inserted into the sleeve through the reception opening and only partly enclosed therein.

In order to further allow a precise alignment for a test strip that can be inserted into the test strip adapter by a user, it is advantageous when the test strip adapter has holding elements to engage and hold the test strip in a defined position relative to the measuring port.

A further improvement in this direction can be achieved when the test strip adapter can be detachably connected to the medical device via guiding or latching or plug-in elements. In a specific embodiment, the test strip adapter has an optical window to establish a sealed optical measuring path between the test strip and the device port. More specifically, the optical window consists of a transparent material, preferably PET, PMMA, PC, PC-ABS, PS, SAN or ASA.

In another specific embodiment intended for electrochemical measurements on disposable test strips, the test strip adapter has an electrical connector to provide a galvanic coupling between the test strip and the measuring port of the device.

In this context, it is also advantageous when the electrical connector comprises a female connector part on the outside of the sleeve to insert the test strip and a male connector part on the inside of the sleeve which can be plugged-in into the measuring port of the device.

For a further reduction of the constructional expenditure it is advantageous when the electrical connector comprises conducting elements formed from metal, preferably comprising at least partly a noble metal, organic conductors or carbon derivatives, contained in a non-conducting matrix.

A further safeguard improvement can be achieved by a closure to close the reception opening for the device after the sleeve is slipped over the device.

For a simplified use it is advantageous when the closure is construed as a hook-and-pile (velcro) or foil slide-locking or foil folding fastener. In order to sanitarily enclose the device, it is advantageous when the sleeve has a first closed end, and when the closure provides a second closed end, such that the device is fully protected against the environment.

Another particularly advantageous embodiment provides that the sleeve is construed as a flexible, unshaped or shapeless member which can be fitted to the shape of the device, such that the sleeve is conformed or adopted to a 3-dimensional design of the device. In this context, it is also preferred when the sleeve consists of a flexible foil material which can be elastically adapted to an outer contour of the device.

With regard to design and usability of the device, it is advantageous when the sleeve is transparent at least in an area covering a display or a control unit of the device, so that the usual handling of the device is not affected.

It is also conceivable that the sleeve comprises first and second sleeve parts which can be connected by adherence in an overlapping joint region, such that the device is fully enclosed in the combined sleeve.

In order to simplify application, it is advantageous when the sleeve comprises a sack-like part which can be turned inside-out or everted over test strip adapter when mouted onto the device.

For a further improvement in convenience it is advantageous when the sleeve comprises tear-off parts in a multi-layered arrangement which can be successively detached from the device for sequential use. In this arrangement, it is also conceivable that the device is designed as a disposable and is discarded after consumption of all tear-off parts.

In a further preferred embodiment the sleeve is sterile and forms an aseptic shielding for the device. The invention also concerns a hand-held medical device comprising a measuring port for a disposable analytical test strip and a protective covering as outlined above.

The invention is further elucidated in the following on the basis of embodiment examples shown schematically in the drawings, where Fig. 1 is a perspective, exploded view of a blood glucose meter and a protective covering in an initial state;

Fig. 2 shows a partly assembled state of the covering on the meter of fig.

1 ;

Fig. 3 shows the meter inside the covering in a protected state ready for use of a test strip; Fig. 4 is a perspective, exploded view of a second embodiment with a one-piece covering;

Fig. 5 shows the assembled state of the embodiment of Fig. 4; Fig. 6 and 7 is a top view of a third embodiment in the initial and assembled state;

Fig. 8 is an expanded view of a test strip adapter of the covering of fig. 6 and 7;

Fig. 9 is a sectional top view of a sleeve including a test strip adapter for optical measurements.

The drawings show an arrangement of a medical device configured as a portable blood glucose meter 10 for processing of disposable analytical test strips 12 and a protective covering 14 comprising a one- or two-part sleeve 16 which can be mounted on the meter 10 and an integrated test strip adapter 18 for inserting a test strip 12 in the assembled state. As illustrated in fig. 1 the meter 10 has a measuring port 20 to which the test strip adapter 18 can be aligned. The measuring port 20 is intended for optical measurements on a test strip 12 and comprises a transparent inset 22 closely embedded in a tray 24 of the device housing 26. The transparent inset 22 is arranged in the optical path of a reflectometric measuring device of the meter 10 for a reflectance measurement on a separate test strip 12 loaded with a blood sample, where the result can be obtained on the spot and shown to the user via display 28. Such glucose measurements are known per se to the skilled person and need not to be explained in further detail.

In order to provide a sealing barrier between the measuring port 20 and the test strip 12, the sleeve 16 can be slipped over the device housing 26 and mounted such that an optical window 30 of the test strip adapter 18 is aligned with the transparent inset 22 of the housing 26. For this purpose, both parts 16', 16" of the sleeve 16 have an opening 32 for receiving or being imposed on opposed portions of the elongate housing 26. In order to ensure a tight sealing, the sleeve 16 consists of a flexible foil material which can be elastically adapted to an outer contour of the housing 26 and is preferably transparent at least in an area covering the display 28.

The alignment of the optical window 30 with the transparent inset 22 can be facilitated by means of guiding or latching elements 34 to which the test strip adapter 18 can be detachably connected. In the assembled state, the optical window 30 should closely adhere to the transparent inset 22, such that air gaps are avoided and losses in the optical path are minimised. For further improvement in this regard, the optical window 30 consists of a transparent material selected from the group PET, PMMA, PC, PC-ABS, PS, SAN or ASA.

Fig. 2 further illustrates the assembly of sleeve 16 on the device 10. Opening 32 of the sleeve part 16" is sized to allow the device 10 to be inserted therethrough, so that at least a first half of housing 26 including the display 28 is hermetically sealed. Then, the test strip adapter 18 is connected to the measuring port 20, and sleeve part 16' is slipped over the second half of housing 26. Here, the flexibility of the foil material allows the user to extend and evert the sack-like sleeve part 16' in direction of arrows 36.

Fig. 3 shows the completely mounted state, in which the sleeve parts 16', 16" are connected by adherence in an overlapping joint region 38, such that the device 10 is fully enclosed in the combined sleeve 16. The sleeve parts 16', 16" each have a closed end 17', 17", such that the meter 10 is completely encased. Purposefully, the sleeve 16 including the integrated test strip adapter 18 is sterilized to form an aseptic protective covering 14. In the protected state the test strip 12 can be connected to test strip adapter 18 without direct contact to the meter 10. Test strip adapter 18 includes holding elements 40 to engage and hold the test strip 12 in a defined position relative to the measuring window 30 in alignment with the measuring port 20. If wanted, the user can tear off and discard the covering 14 as an expendable item. It is also conceivable that the sleeve 16 comprises tear-off parts 16' in a multi-layered arrangement which can be successively detached from the 10 device for sequential use. Turning to figs. 4 and 5, a further embodiment of the present invention comprising a one-part sleeve 16 can be seen. Here, similar elements have like reference numerals as previously described. As distinguished to the previous embodiment, the one-part sleeve 16 can be completely slipped over the device 10, such that housing 28 is entirely received. Thereafter, a closure 42 is used to close the reception opening 32 in the overlaying end section of the sleeve 16. The closure 42 is construed as a foil folding fastener 44 which has end flaps 46 that can be snapped on pressure locks 48 on the sleeve 16.

The embodiment shown in fig. 6 to 8 comprises a glucometer 10 with a measuring port 20 that is intended for electrochemical measurements on a test strip 12. For this purpose, the measuring port 20 is constructed as a female connector which has contact springs for a wired connection to an amperonnetric measuring device of the meter 10 (not shown). A single-part sleeve 16 is provided with an integrated electrical test strip adapter 18. As apparent from fig. 7, the sleeve 16 can be slipped over the device 10 and closed by means of a foil folding fastener 44 as previously described.

As best seen from fig. 8, the test strip adapter 18 has a distal male connector end 50 which can be plugged into the measuring port 20 and a proximal female connector end 52 which can receive the contact section 54 of test strip 12. The male end 50 is designed similar to the contact section 54, whereas the female end 52 replicates the measuring port 20. In this way, it is also conceivable that the measuring port 20 receives a test strip 12 for a measurement in an unprotected state when the protective covering 14 is removed. In the protected state, when the meter 10 is hermetically enclosed in the covering 14, the test strip adapter 18 forms an electrical connector to provide a galvanic coupling between the test strip 12 and the measuring port 20 of the device 10. Conducting paths 56 are formed within the test strip adapter 18 from metal, preferably comprising at least partly a noble metal, organic conductors or carbon derivatives, contained in the non-conducting matrix of a carrier 58.

The test strip adapter 18 may allow an automatic switch-on function of the device 10 when a test strip 12 is inserted.

In case of electrochemical measurements, a corresponding change in resistivity can be detected through the conducting paths 56, and a monitoring circuit of the device can be operable for a turn-on procedure. Fig. 9 shows an embodiment of test strip adapter 18 providing a similar switch-on function for optically working systems. The adapter 18 includes holding elements 40 formed as a pin 60 and a holding-down clamp 62 for a form-locking engagennent of an inserted test strip 12. Then, the distal end of the test strip abuts the stop edges and at the same time actuates a micro- switch 66 on the side of the device 10 to effectuate power-on. Correspondingly, an additional aspect of the invention is contemplated as follows: A protective covering 14 comprising a sleeve 16 which can be slipped over a device 10 and includes a test strip adapter 18, wherein the test strip adapter 18 is operable to provide a switch-on function of the device 10 when a test strip 12 is inserted into the test strip adapter 18.

Claims

Protective covering for a hand-held medical device (10) that has a measuring port (20) for a disposable analytical test strip (12) to which a sample can be applied comprising

- a sleeve (16) which preferably has a reception opening (32) and can be mounted on the device (10) to partially or fully enclose the device (10) in a usable protected state,

characterized by

- a test strip adapter (18) formed as an integral part of the sleeve (16) to receive a test strip (12) in alignment with the measuring port (20),

- wherein the sleeve (16) including the test strip adapter (18) is arranged as a sealing barrier between the test strip (12) and the device (10) port in the protected state.

Protective covering according to claim 1 , wherein the test strip (12) can be inserted into the test strip adapter (18) by a user, wherein the test strip adapter (18) has holding elements (40) to engage and hold the test strip (12) in a defined position relative to the measuring port (20).

Protective covering according to claim 1 or 2, wherein the test strip adapter (18) can be detachably connected to the medical device (10) (10) via guiding or latching or plug-in elements (34).

Protective covering according to one of the claims 1 to 3, wherein the test strip adapter (18) has an optical window (30) to establish a sealed optical measuring path between the test strip (12) and the measuring port (20) of the device (10).

5. Protective covering according to claim 4, wherein the optical window (30) consists of a transparent material, preferably PET, PMMA, PC, PC- ABS, PS, SAN or ASA.

6. Protective covering according to one of the claims 1 to 3, wherein the test strip adapter (18) has an electrical connector (50,52,56) to provide a galvanic coupling between the test strip (12) and the measuring port (20) of the device (10).

7. Protective covering according to claim 6, wherein the electrical connector (50,52,56) comprises a female connector part (52) on the outside of the sleeve (16) to insert the test strip (12) and a male connector part (50) on the inside of the sleeve (16) which can be plugged-in into the measuring port (20) of the device (10).

8. Protective covering according to claim 6 or 7, wherein the electrical connector (50,52,56) comprises conducting elements (56) formed from metal, preferably comprising at least partly a noble metal, organic conductors or carbon derivatives, contained in a non-conducting matrix.

9. Protective covering according to one of the claims 1 to 8, further comprising a closure (42) to close the reception opening (32) for the device (10) when the sleeve (16) is slipped over the device (10).

10. Protective covering according to claim 9, wherein the closure (42) is construed as a hook-and-pile or foil slide-locking or foil folding fastener (44).

1 1 . Protective covering according to claim 9 or 10, wherein the sleeve (16) has a first closed end, and where the closure (42) provides a second closed end, such that the device (10) is fully protected against the environment.

12. Protective covering according to one of the claims 1 to 1 1 , wherein the sleeve (16) is construed as a flexible (shapeless) unshaped member which can be fitted to the shape of the device (10).

Protective covering according to one of the claims 1 to 12, wherein the sleeve (16) consists of a flexible foil material which can be elastically adapted to an outer contour of the device (10).

Protective covering according to one of the claims 1 to 13, wherein the sleeve (16) is transparent at least in an area covering a display (28) or a control unit of the device (10).

Protective covering according to one of the claims 1 to 14, wherein the sleeve (16) comprises first and second sleeve parts (16',16") which can be connected by adherence in an overlapping joint region (38), such that the device (10) is fully enclosed in the combined sleeve (16).

16. Protective covering according to claim 15, wherein each of the sleeve parts (16', 16") has a (leakproof) hermetically sealed closed end.

17. Protective covering according to one of the claims 1 to 16, wherein the sleeve (16) comprises a sack-like part which can be turned inside-out (everted) over test strip adapter (18).

18. Protective covering according to one of the claims 1 to 17, wherein the sleeve (16) comprises tear-off parts in a multi-layered arrangement which can be successively detached from the device (10) for sequential use.

19. Protective covering according to one of the claims 1 to 18, wherein the sleeve (16) is sterile and forms an aseptic shielding for the device (10). Protective covering according to one of the claims 1 to 19, wherein the test strip adapter (18) is adapted to provide an automatic switch-on function of the device (10) when a test strip (12) is inserted.