阅读说明：本技术 用于分析体液的诊断测试单元 (Diagnostic test unit for analyzing body fluids ) 是由 B·布兰斯格洛夫 于 2018-06-02 设计创作，主要内容包括：在一个实施例中,提供了一种用于分析体液的诊断测试单元,其利用板簧(6)与位于供应室开口的至少一个部分中的密封件(8)相结合,以将存储在供应室(2)中的测试带(3)或测试条与腔室(2)外部的环境隔离。在腔室已装入测试带或测试条和干燥剂后,将板簧(6)直接施加在存储室(2)的开口上方,将其封闭以外部环境隔离。闭合的板簧(6)被密封到邻接开口的腔室的表面上,并且该表面的至少一个部分由密封件形成。测试带或测试条(3)通过闭合板簧和密封件之间的间隙离开。(In embodiments, diagnostic test units for analyzing body fluids are provided which utilize leaf springs (6) in combination with seals (8) located in at least portions of the supply chamber opening to isolate a test strip (3) or test strip stored in the supply chamber (2) from the environment outside the chamber (2). after the chamber has been loaded with test strips or test strips and desiccant, the leaf springs (6) are applied directly over the opening of the storage chamber (2), closing it from the external environment.)

A diagnostic test unit for analyzing bodily fluids, the test unit comprising (i) a test strip having a test area for receiving the bodily fluid, and (ii) a chamber for containing the test strip, wherein the chamber defines an opening that is bordered at least in portions by a seal, the opening being isolated from the environment outside the chamber by a closure leaf spring that seals against a surface on the chamber that is bordered by the opening, at least a portion of the surface being formed by the seal and the test strip operatively exiting the chamber through an outlet gap formed between the closure leaf spring and the seal.

2. The test unit of claim 1, wherein a roll of test tape is mounted into the chamber through the opening.

3. The test unit of claim 1, wherein the test strips include (i) carrier strips with test areas spaced at intervals, and (ii) test-zone-free areas of the carrier strips that are located in the exit gap during storage.

4. The test unit of claim 1, wherein the chamber is part of a tape cartridge, the test tape being adapted to be removed from a storage compartment through an application position into a waste compartment, the exit gap being located adjacent the storage compartment.

5. The test unit of claim 1, wherein the seal and leaf spring seal against the test strip.

6. The test unit of claim 1, wherein a rear side of the test strip facing away from the test field is operable to slide over the seal.

7, a diagnostic test unit for analyzing body fluids, the diagnostic test unit comprising (i) a plurality of test strips, each test strip having at least test areas for receiving body fluids, and (ii) a chamber for containing the test strips, wherein an opening of the chamber is bordered at least in parts by a seal, the opening being isolated from the environment outside the chamber by a closing leaf spring sealed against a surface of the chamber bordering the opening, at least parts of the surface being formed by the seal, wherein a test strip leaves the chamber through an outlet gap formed between the closing leaf spring and the seal.

8. The test unit of claim 7, wherein a test strip is mounted into the chamber through the opening.

9. The test unit of claim 7, wherein the chamber is an portion of a cartridge, wherein the test strip is adapted to be transported out of the chamber to an application position.

10. The test unit of claim 7, wherein the gap is formed when the closing leaf spring is applied.

11. The test unit of claim 7, wherein the closure leaf spring is connected with the chamber and/or the seal along a seal line.

12. The test unit of claim 7, wherein the closing leaf spring is made of spring steel with a heat seal coating.

13. The testing unit of claim 7 wherein the seal is (i) a one-part injection molded component or (i) in combination with the chamber as a co-molded component formed of TPE (thermoplastic elastomer).

14, a diagnostic test unit for analysing body fluids, comprising (i) a test strip provided with a test field for applying body fluids, and (ii) a chamber for containing the test strip, wherein the opening of the chamber is bordered at least in regions by a seal, the opening being (i) isolated from the environment outside the chamber by a closing leaf spring, and (ii) serving as a passage for mounting components of the chamber prior to application of the closing leaf spring, the test strip in use passing through a gap formed between the closing leaf spring and the seal.

15, a diagnostic test unit for analyzing body fluid, the diagnostic test unit comprising (i) a plurality of test strips, each test strip having at least test areas for receiving body fluid, and (ii) a chamber containing the test strips, wherein an opening of the chamber is bordered at least in portions by a seal, the opening being isolated from the environment outside the chamber by a closing leaf spring sealed against a surface of the chamber bordering the opening, wherein at least portions of the surface are formed by the seal, the test strips operatively leave through a gap formed between the closing leaf spring and the seal, the opening being adapted to allow mounting of components of the chamber prior to application of the closing leaf spring, wherein the test strips are moved out of the chamber to an application position through the gap formed between the closing leaf spring and the seal.

16, a portable device for analyzing body fluids, the device comprising a receiving bay for loading a diagnostic test unit, the test unit comprising (i) a plurality of test strips, each test strip having at least test areas for receiving body fluids, and (ii) a chamber containing the test strips, wherein an opening of the chamber is bordered at least in portions by a seal, the opening being isolated from the environment outside the chamber by a closing leaf spring sealed against a surface of the chamber bordering the opening, at least portions of the surface being formed by the seal, wherein test strips exit to an application position through a gap formed between the closing leaf spring and the seal, the opening being adapted to allow mounting of components of the chamber prior to application of the closing leaf spring.

Technical Field

The present invention relates to diagnostic test units for analysing body fluids and in particular, but not exclusively, to diagnostic test units for analysing body fluids such as blood, interstitial fluid and urine.

Background

storage containers are needed that allow the test to be taken out without the user opening and closing a lid, such as those found in tape cassettes and cartridges (magazines) that contain test strips or strips.

US5,077,010 to Ishizaka et al describes cassette housings, transparent carrier tapes with information and test fields for diagnostic use, moisture is excluded from unused tape compartments by means of flexible gaskets or series of flexible gaskets, unused tape is kept for a few days by a sealing strip, US7,582,258 to Ruhl et al describes cassettes with hydraulic sealing means for preventing moisture from entering unused test compartments, said sealing means being expanded by the downward pressure exerted by a compression mold, which causes the sealing means to press directly against the carrier tape, sealing it against the cassette, which patent also describes seals similar to US5,077,010, but with two gaskets inclined in opposite directions to each other.

Object of the Invention

It is an object of the present invention to provide diagnostic test units for analyzing body fluids, which solve or at least alleviate the above-mentioned disadvantages of the prior art or provide a useful alternative.

Disclosure of Invention

According to , there is disclosed diagnostic test unit for analyzing bodily fluids, the test unit comprising (i) a test strip having a test region for receiving bodily fluids, and (ii) a chamber for containing the test strip, wherein the chamber defines an opening, the opening being bordered at least in parts by a seal, the opening being isolated from the environment outside the chamber by a closure leaf spring, the closure leaf spring being sealed against a surface on the chamber bordering the opening, at least parts of the surface being formed by the seal and the test strip being operable to exit the chamber through an exit gap formed between the closure leaf spring and the seal.

Preferably, the roll test strip is installed into the chamber through the opening.

Preferably, the test strips include (i) carrier tapes with test areas spaced at intervals, and (ii) test area free areas of the carrier tapes that are located in the exit gap during storage.

Preferably the compartment is the portion of the cartridge, the test strip being adapted to be removed from the storage compartment through the application position into the waste compartment, the exit gap being located adjacent the storage compartment.

Preferably, the seal and leaf spring seal against the test strip.

Preferably, the rear side of the test strip facing away from the test field is operatively slid over the seal.

According to a second aspect, diagnostic test units for analyzing bodily fluids are disclosed, the diagnostic test units comprising (i) a plurality of test strips, each test strip having at least test areas for receiving bodily fluids, and (ii) a chamber for containing the test strips, wherein an opening of the chamber is bordered at least in parts by a seal, the opening being isolated from the environment outside the chamber by a closing leaf spring, the closing leaf spring sealing against a surface of the chamber bordering the opening, at least parts of the surface being formed by the seal, wherein the test strips exit the chamber through an outlet gap formed between the closing leaf spring and the seal.

Preferably, the test strip is mounted into the chamber through an opening.

Preferably, the chamber is the portion of the cartridge, wherein the test strip is adapted to be transported out of the chamber to an application location

Preferably, a gap is formed when the closing leaf spring is applied.

Preferably, the closing leaf spring is connected with the chamber and/or the seal along a sealing line.

Preferably, the closing leaf spring is made of spring steel with a heat seal coating.

Preferably, the seal is (i) a one-component injection molded part or (i) in combination with the chamber as a co-molded part formed from a TPE (thermoplastic elastomer).

According to a third aspect, diagnostic test units for analyzing body fluids are disclosed, comprising (i) a test strip provided with a test field for applying body fluids, and (ii) a chamber for containing the test strip, wherein an opening of the chamber is bordered by a seal at least in regions , the opening being (i) isolated from the environment outside the chamber by a closing leaf spring, and (ii) a channel for mounting a component of the chamber prior to applying the closing leaf spring, the test strip in use passing through a gap formed between the closing leaf spring and the seal.

According to a fourth aspect, diagnostic test units for analyzing bodily fluids are disclosed, the diagnostic test units comprising (i) a plurality of test strips, each test strip having at least test zones for receiving bodily fluids, and (ii) a chamber containing the test strips, wherein an opening of the chamber is bordered by a seal in at least portions , the opening being separated from an environment outside the chamber by a closing leaf spring sealed against a surface of the chamber bordering the opening, wherein at least a portion of the surface is formed by the seal, the test strips operatively leave through a gap formed between the closing leaf spring and the seal, the opening being adapted to allow mounting of components of the chamber prior to application of the closing leaf spring, wherein the test strips are moved out of the chamber to an application position through the gap formed between the closing leaf spring and the seal.

According to a fifth aspect, a portable device for analyzing bodily fluids is disclosed, the device comprising a receiving bay for loading a diagnostic test unit, the test unit comprising (i) a plurality of test strips, each test strip having at least test areas for receiving bodily fluids, and (ii) a chamber containing the test strips, wherein an opening of the chamber is bordered by a seal at least in portions , the opening being isolated from the environment outside the chamber by a closing leaf spring, the closing leaf spring sealing against a surface of the chamber bordering the opening, at least portion of the surface being formed by the seal, wherein the test strips leave to an application position through a gap formed between the closing leaf spring and the seal, the opening being adapted to allow mounting of components of the chamber prior to application of the closing leaf spring.

The preferred embodiment utilizes a leaf spring in combination with seals located in at least portions of the supply chamber opening to isolate a test strip or strip stored in the supply chamber from the environment outside the chamber after the chamber has been loaded with the test strip or strip and desiccant, the leaf spring is applied directly over the opening of the storage chamber, closing it off from the outside environment.

The leaf spring may be applied to the surface adjacent the chamber opening using any suitable method to ensure a tight fit. It may be heat fused, heat welded or ultrasonically welded directly to the surface.

In a preferred embodiment, the present invention utilizes leaf springs laminated with a heat seal material, such as cast polypropylene (CPP). The cassette bay is made of a material compatible with the heat seal material, such as polypropylene (PP).The test strip includes a PET carrier tape having spaced apart test regions when a leaf spring is welded to the surface adjacent the chamber opening, it will not be welded to the carrier tape because it is formed of a material that is incompatible with the heat seal layer (e.g., polyethylene terephthalate (PET))<0.1g/m²24 hours at 37.8C 85% RH). The strip exits above a seal formed in the rim of the chamber. The seal may be made of TPE (thermoplastic elastomer) co-molded with the cartridge housing. Very soft TPE (Shore A) is preferably used<50) To improve the seal around the belt.

the leaf spring, once in place, will apply downward pressure to the belt at the point where the belt exits the chamber above the seal.

Drawings

Preferred embodiments of the present invention will hereinafter be described, by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 is a schematic perspective view of an th embodiment diagnostic test unit for analyzing bodily fluids;

FIG. 2 is another schematic perspective view of the diagnostic test unit of FIG. 1;

FIG. 3 is a schematic perspective view of a second embodiment diagnostic test unit for analyzing a body fluid;

FIG. 4 is a schematic cross-sectional view of a spring cover of the diagnostic test unit of FIG. 3;

FIG. 5a is a cross-sectional view of the housing and storage chamber of the diagnostic test unit of FIG. 3 after ultrasonic welding;

FIG. 5b is a schematic perspective view of the diagnostic test unit of FIG. 5a after the spring cover has been welded in place;

FIG. 5c is a schematic top view of the chamber of the diagnostic test unit of FIG. 3 prior to ultrasonic welding;

FIG. 6 is a schematic top view of a third embodiment diagnostic test unit for analyzing bodily fluids with the test strip exiting the storage compartment thereof; and

FIG. 7 is a schematic perspective view of the diagnostic test unit of FIG. 6 having a leaf spring with a heat seal layer before and after heat welding on the storage chamber.

Detailed Description

It is important to understand that it is not intended to limit the scope of the invention, and that variations, modifications, and further applications of the principles of the invention shown in the drawings are contemplated as would normally occur to one skilled in the art to which the invention relates, and that several embodiments of the invention are shown in detail, but for the purpose of facilitating understanding aspects that are not relevant to the invention have been omitted.

Fig. 1 depicts a storage compartment (2) in a housing (1) with a carrier tape (3) protruding from above the top of a seal (8), the seal (8) forming loops around an opening to the storage compartment (2) the carrier tape (3) is pulled out of the storage compartment (2) by a driver (5), which driver (5) may be motor driven or manually rotated until a test area (4) is above a read head (not shown) on which a sample is supplied for analysis.a spring cover (6) is shown before a resting surface (7) is fixed, the surface (7) abutting the opening to the storage compartment (2), the plane occupied by the surface (7) being below the top surface of the seal (8). the distance between the two planes is fixed by the mould that makes the co-moulded parts (housing and seal).

Figure 2 shows the spring cover (6) secured after the roll carrier tape and desiccant are loaded into the storage compartment figure 2 shows the spring cover (6) secured in place against the abutment surface (7) by a plastic rivet (10) which has been melted by a heat staking machine, during the heat staking process a downward force is applied to the spring cover (6) causing its contact surface (7), to release the downward force once the melted rivet has cooled the spring cover (6) is securely secured around the entire surface (7) except at the tape exit region (9) where the spring can move up and down freely as the test area (4) exits, the spring cover does not transfer water vapour and provides a shield against water entering the chamber while occupying little space in the assembly the seal (8) may be a TPE (thermoplastic elastomer) co-molded with the housing, preferably a very soft TPE (shore a <40) is used to improve the seal around the tape and the gap between the tape by forming a seal.

Stiffening ribs (not shown) may be embossed in the spring cover (6) to increase its strength and maintain flatness it is also possible to add grooves for sealing it can be seen that the spring cover is in a set position against the surface (7) which allows a certain spring force to be exerted on the seal moving the rivet closer to the tape outlet (9) may increase the spring force as the thickness of the metal spring may be varied.

FIG. 3 shows another embodiment of the invention where the spring cover (6) has plastic molded on it to enable it to be ultrasonically welded against the rim of the opening (7 not shown.) before welding, the plastic rim (11) contacts a sacrificial rim within the chamber opening (17 not shown) to prevent the spring cover from resting on the surface (7). an ultrasonic weld head is pressed against the top surface (12) to transmit energy waves that cause the plastic surface to vibrate, heat and melt to form an airtight weld.

Figure 4 shows a cross section of the spring cover (6) by ultrasonic welding the plastic rim (11) melts against the inside of the storage compartment causing the weld to extend all the way to the weld (13) at the rim the spring cover (6) rests on the rim of the opening (7) and also presses on the seal (15), which seal (15) in this example only spans the area of the tape exit that is not ultrasonically welded.

Figure 5a shows a cross section of the housing (1) and storage compartment (2) after ultrasonic welding the spring cover 6 is placed on the surface adjacent the opening of the compartment (7) which places the spring cover 6 in the correct plane relative to the top of the seal (8-not visible) this causes the spring to bend in the tape outlet region (9) forming seals sandwiching the tape (3) between the seal (15) and the spring cover (6) thereby expelling moisture from the storage chamber (2) containing the desiccant (16) and unused test tape (14).

Figure 5b shows the test chamber and housing with the spring cover welded in place.

Figure 5c shows a top view of the chamber before ultrasonic welding the seal (15) forms only part of the surface adjacent the chamber opening and can be seen extending below the band a disturbance in the form of a ledge (17) abuts the opening from the end of the seal around the chamber opening to meet the other end of the seal.

Fig. 6 depicts the housing (1) with the test strip (3), the test strip (3) exiting the storage compartment (2) above the seal (15) integrated into the opening of the storage compartment (2) the test strip (3) is pulled out of the storage compartment (2) by the driver (5), the driver (5) may be powered or manually rotated until the test area is above the read head (not shown) where the sample is applied for analysis after which the used test will be stored on the reel (18) the surface (7) abutting the opening of the storage compartment (2) provides surfaces for the closing leaf spring with a heat seal layer (not shown 19) to be heat welded to seal the storage compartment (2) to protect the unused test reel (14) contained therein and optionally the desiccant (16) the spring may also be heat welded to the seal (15) rather than to the test strip (3) located thereon.

FIG. 7 shows a leaf spring with a heat seal layer before heat welding (20) on the storage compartment (2) after loading rolls of test strip and optional desiccant material the leaf spring (19) applies a downward force on the strip at the exit point (18) thereby pressing the strip into the seal and forming barriers isolating the compartment from the outside environment the spring force applied on the strip depends on the degree of deflection of the spring which can be varied by adjusting the height of the seal relative to the surface adjacent the opening of the compartment (7) the spring is welded firmly to the surface (7) and optionally also to the seal (15) but not firmly to the strip or to the seal directly below the strip as each test area (11) exits the spring (19) rises and falls at the exit point (18) thereby reducing the friction at the exit.

Although the invention has been described above with respect to preferred embodiments, it will be understood by those skilled in the art that the invention is not limited to those embodiments, but may be embodied in many other forms.