HK1129929A - Mechanical device for mixing a fluid sample with a treatment solution - Google Patents

Description

Mechanical device for mixing a fluid sample with a treatment solution

Technical Field

The present invention relates to a mechanical device for mixing a fluid sample (which may optionally be a blood sample) with a processing solution (which may optionally be a buffer or diluent).

Background

U.S. patent application 2005/0196872, published under the serial number 11/043,510 and entitled "Mechanical Device For Mixing a Fluid Sample With a processing Solution," describes a two-part Device For Mixing a blood Sample With a processing Solution prior to releasing the processed Sample into a Fluid analysis instrument. A disadvantage of this system is that it is difficult to control the pressurization in the device in order to deliver the correct sample volume into the test cartridge. As will be shown, the present invention overcomes this disadvantage.

Disclosure of Invention

The present invention provides an integrated system for mixing a fluid sample with a treatment solution and for delivering the mixed fluid sample and treatment solution into a meter. In a preferred aspect, the fluid sample is a blood sample, the processing solution is a buffer, and the meter is a blood analyzer, however, the invention is not so limited. In alternative aspects, the fluid sample may be a bodily fluid sample comprising interstitial fluid or a fluid sample comprising prostate-specific antigen. Further, although the blood analyzer may optionally include a hemoglobin alc (HbAlc) or lipid panel meter, the invention is not so limited.

In one aspect, the present invention provides an apparatus for preparing a fluid sample for use in a fluid analyzer, comprising a first portion comprising a septum-piercing protrusion, a capillary channel, and an outlet on an exterior surface of the first portion; the second part comprises a treatment solution chamber and a septum sealing the treatment solution chamber, wherein the outlet is open when the first part of the device is initially inserted into the second part of the device, and wherein the outlet is closed when the first part of the device is fully inserted into the second part of the device.

According to the invention, said outlet allows air to escape from inside the second part of the device when the first part of the device is inserted into the second part of the device. The outlet may comprise a groove extending along a portion of the outer surface of the first part of the device. Alternatively, the slot may extend away from a leading edge of the outer surface portion along the length of the outer surface of the first part of the device.

In another aspect, the present invention provides an apparatus for preparing a fluid sample for use in a fluid analyzer, comprising a first portion having a capillary channel sized to receive the fluid sample therein, and an outlet on an outer surface; the second part having a treatment solution chamber bounded by first and second diaphragms, wherein the first part penetrates the first diaphragm when the first part is inserted into the second part so that the contents of the treatment solution chamber mix with the contents of the capillary channel, wherein the outlet is open when the first part of the device is initially inserted into the second part of the device, and wherein the outlet is closed when the first part of the device is fully inserted into the second part of the device, the mechanism being adapted to penetrate the second diaphragm so that the contents of the treatment solution chamber and the capillary channel can be removed from the device.

In yet another aspect, the present invention provides an apparatus for preparing a fluid sample for use in a fluid analyzer, comprising a first portion having a capillary channel sized to receive the fluid sample therein, a second portion, and a plunger; the second part having a treatment solution chamber bounded by first and second diaphragms, wherein the first part penetrates the first diaphragm when the first part is inserted into the second part so that the contents of the treatment solution chamber mix with the contents of the capillary channel; the plunger has a mechanism for penetrating the second membrane to expel the contents of the treatment solution chamber and capillary channel through the plunger. In a preferred aspect, the mechanism for penetrating the second septum may comprise a spike on the plunger. Further, the plunger may include a central flow channel, and wherein the spike is positioned adjacent the central flow channel. The tip of the spike may be positioned above the central flow channel.

Drawings

FIG. 1A is a perspective view of a prior art embodiment of the present invention, as shown in U.S. patent application No. 2005/0196872, entitled "mechanical apparatus for mixing a fluid sample with a processing solution," published as Serial No. 11/043,510.

FIG. 1B is a side view of the apparatus of FIG. 1A.

Fig. 1C is a partial side view corresponding to fig. 1B.

Fig. 1D is a side view of a first portion of the device inserted into a second portion of the device.

Fig. 1E is a partial side view corresponding to fig. 1D.

Fig. 1F is a perspective view of the device inserted into the instrument.

Fig. 1G is a partial side view corresponding to fig. 1F.

FIG. 1H is an illustration of a system for easier flushing in the first section of the device.

FIG. 2A is a perspective view of an embodiment of the present invention showing a first portion of a device, with an exit slot therein.

Fig. 2B is a side view corresponding to fig. 2A before the first portion of the device is inserted into the second portion of the device.

Fig. 2C is a side view corresponding to fig. 2A showing a first portion of the device partially inserted into a second portion of the device.

Fig. 2D is a side view corresponding to fig. 2A with the first part of the display device fully inserted into the second part of the device.

Fig. 3A is an exploded view of another embodiment of the present invention.

Fig. 30B is a cross-sectional view of the second portion, plunger and cap of fig. 3A prior to use.

Fig. 3C is a cross-sectional view similar to fig. 3B, but with the first portion of the device fully inserted into the second portion of the device.

Fig. 3D is a cross-sectional view similar to fig. 3C, but with the cover removed and the plunger fully inserted into the second portion of the device.

Detailed Description

Figures 1A through 1H show a prior art device described in figures 8A through 8H of U.S. patent application No. 2005/0196872, entitled "mechanical device for mixing a fluid sample with a processing solution," published as 11/043,510, as follows.

The device 100 includes a first portion 102 having a septum piercing portion 103 with a capillary channel 105 therein and a second portion 104 including a treatment solution chamber 106 and a top septum 108 sealing the treatment solution chamber 106.

In a preferred method of operation, the user drops a drop of blood from his finger to the tip of capillary channel 105. Termination junctions 107 are provided at opposite ends of capillary channel 105. The termination junctions may preferably comprise holes through the first portion 102 of the device 100. Thus, terminating junction 107 facilitates the containment of a predetermined amount of blood within capillary channel 105.

As shown in fig. 1D and 1E, after capillary channel 105 has been filled with a blood sample, first portion 102 is then inserted into second portion 104 such that septum piercing projection 103 pierces top septum 108 and capillary channel 105 is received within processing solution chamber 106. Thus, the contents of the capillary channel 105 and the treatment solution chamber 106 are mixed together. In addition, mixing can be enhanced by shaking the device.

Finally, as shown in FIGS. 1F and 1G, dispensing spout 101 may be moved relative to first portion 102 such that second (i.e., bottom) septum 109 is penetrated by first portion 102. When this condition occurs, the mixed blood/treatment solution is discharged from the apparatus through dispensing spout 101. In a preferred embodiment, the distal end 101A of dispensing spout 101 is sized to be received within a port of a hematology analyzer 10 (which may optionally include a hemoglobin Alc hemometer). The apparatus may be used with any suitable fluid analyser or even with a simple containment vessel (for example for preparing a sample of sediment in a well so that it can be analysed in the future).

Referring back to FIG. 1C, optional internal features of the dispensing spout 101 are illustrated. For example, (as opposed to fig. 1C), the internal passage 120 may be flared, through which the fluid is discharged. This has the advantage of slowing the flow of solution into the meter 10, which avoids splashing inside the meter 10. In addition, a vent 120 may also be provided for air pressure increases during operation.

As illustrated, dispensing spout 101 is received within first portion 104. This has the advantage of capturing the blood/treatment solution mixture so that it can be completely discharged through the dispensing spout 101.

The first and second diaphragms 108 and 109 may be made of sheet metal or any suitable material, including plastic or rubber.

The system 100 may also be used to prepare a blood sample for use with the blood analyzer 10 by: dripping blood into a capillary channel 105 in the body 102 with a septum piercing projection 103; piercing a first septum 108 covering the treatment solution chamber 106 with a septum piercing projection 103, thereby exposing blood in the capillary channel 105 to the contents of the treatment solution chamber 106; shaking the treatment solution chamber 106 with the capillary channel 105 contained therein, thereby mixing the blood with the contents of the treatment solution chamber 106; and piercing the second septum 109 so that the mixed blood and processing solution chamber contents are contained within the blood analyzer 10.

The system 100 may also be used to prepare a blood sample for use with the blood analyzer 10 by: dripping a blood sample into a capillary channel 105 in the first part 102 of the device; moving the first part 102 of the device relative to the second part 104 to penetrate the membrane 108 of the treatment solution chamber 106 so as to mix the contents of the treatment solution chamber 106 with the blood sample in the capillary channel 105; and discharging the mixed processing solution and blood sample through dispensing spout 106 and into hematology analyzer 10.

Fig. 1H illustrates a system for more easily flushing the capillary channels 105 in the septum piercing projections 103 of the first portion 102, as described below. A window 109 is provided on the side of capillary channel 105 to allow easier flushing of the fluid sample for better mixing.

Figures 2A to 2D show an embodiment of the invention having an outlet in the first part of the device. This exit ensures that the first portion 202 is inserted into the second portion 204 without regard to the user's technique or the part itself. An advantage of this controlled pressurization is that it ensures that the correct amount is delivered to the test cartridge that can be used with the device. In particular, when the second diaphragm in the second portion of the device ruptures, an accurate predicted dose of the treated sample fluid may be ejected from the device, as described below.

The embodiment of the invention depicted in fig. 2A-3D operates similarly to the above-described embodiment of the invention depicted in fig. 1A-1H, but also has novel features, including but not limited to the following aspects.

Device 200 (fig. 2A) includes a first portion 202 having a septum piercing projection 203 with a capillary channel 205 therein and a second portion 204; the second part includes a treatment solution chamber 206 having a top diaphragm 208 sealing the treatment solution chamber 206. Similar to the prior art device illustrated in fig. 1A-1H, a user drops a drop of blood into capillary channel 205. Termination junction 207 operates similarly to termination junction 205. After the capillary channel 205 has been filled with blood, the first portion 202 is then inserted into the second portion 204. Septum piercing projection 203 then pierces septum 208 so that capillary channel 205 is contained within treatment solution chamber 206 (in second portion 204).

As shown in fig. 2A to 2D, an outlet 220 is provided in an outer surface 222 of the first portion 202. The outlet 22 may simply comprise a slot cut from the first portion 202. Preferably, the outlet 220 extends from a leading edge 224 of an outer surface 222 of the first portion 202 of the device 200.

As seen in fig. 2B through 2D, when first portion 202 is inserted into second portion 204 of the device, vent 220 allows air to escape from the interior of second portion 204. Fig. 2B shows the first portion 202 prior to insertion into the second portion 204. Fig. 2C shows the first portion 202 partially inserted into the second portion 204. As can be seen, vent 220 allows air to escape from cavity 206 when first portion 202 is inserted into second portion 204. Finally, as shown in fig. 2D, first portion 202 is fully inserted into second portion 204. Thus, the contents of the capillary 205 and the solution treatment chamber 206 may be mixed together without any fluid dripping out of the outlet 220. At this point, air can no longer escape from chamber 206 through outlet 220 (because outlet 220 is completely contained within second portion 204).

As can be seen, the outer surface 220 of the first portion 202 is positioned against the inner surface of the second portion 204. In the exemplary embodiment shown, the outlet 220 is completely sealed as it passes the sealing ring 221 in the second portion 204. Typically, the first portion 202 will move about 0.001 inches past the sealing point until it is fully inserted into the second portion 204. Movement (of first portion 202 into second portion 204) along this additional small travel distance pressurizes the chamber. This ensures that the correct amount is delivered to the test cartridge which can be used with the device. Specifically, when the second membrane 209 (fig. 2B and 2C) in the second portion 204 of the device 200 ruptures, an accurate predicted dose of the treated fluid may be ejected from the device 200. Thus, the outlet 220 has the advantage that its presence ensures that the first portion 202 is inserted into the second portion 204, irrespective of the user's technique or the part itself.

Fig. 2A to 2C show the operation of the device 200, as follows. The first portion 202 and the second portion 204 operate similarly to the first and second portions 102 and 104, respectively, as shown in the prior art devices of fig. 1A through 1H. A plunger 201 is provided. The operation of the plunger 201 is the same as that described above for the dispensing spout 101. A bottom cover is also provided.

As shown in fig. 3B, the plunger 201 is initially positioned at the bottom of the second portion 204. The plunger 201 and the second portion 204 are both located inside the cover 211. Next, as shown in FIG. 3C, the first portion 202 is inserted into the second portion 204 (as described above). At this point, septum piercing projection 203 will pierce (top) septum 208 so that capillary channel 205 and the contents of sample processing chamber 206 can be mixed. Then, as shown in fig. 3D, the cover 211 is removed and the plunger 201 is pushed up into the second portion 204. At this point, spike 215 on plunger 201 will pierce (bottom) septum 209 so that the mixed contents of sample processing chamber 206 can be expelled from the bottom of device 200. For example by means of a plunger 201 (similar to the method shown in figure 1F).

In an optional aspect of the invention, the plunger 201 includes a central flow channel 217. The sharp tip of spike 215 may be positioned proximate to central flow channel 217. In an optional embodiment, the tip of spike 215 may be positioned slightly above the top of central flow channel 217.

It should be understood that the present invention is not limited to use with blood samples. Instead, any other fluid analyzed in any type of fluid analyzer may be substituted. Thus, the present invention includes procedures using different fluid samples, including body fluid samples containing analytes such as prostate specific antigens, lipids, creatinine, microalbumin (microalbumin), and the like.

Preferably, the meter used with the device 200 is a HbAlc meter, however, it should be understood that the invention is not so limited. Rather, any form of analyzer (for measuring one or more analytes) is suitable for the present invention. Thus, the present invention may require (but is not limited to) mixing a blood sample with a dilution buffer. For example, the invention may also be used to mix blood with other substances, and may also be used in conjunction with other devices. In U.S. Pat. nos. 5,837,546; exemplary meter functions are described in U.S. Pat. Nos. 5,945,345 and 5,580,794, which are incorporated herein by reference in their entirety. However, it will be appreciated that the invention may also be used with any suitable fluid analyser, or even with a simple containment vessel (for example for preparing a sample of sediment in a well so that it may be analysed in the future).

In an optional aspect of the invention, the device 200 may be used with a single-use tester (as described in U.S. Pat. Nos. 5,837,546; 5,945,345 and 5,580,794) or a multi-use cartridge system as described in U.S. provisional application 60/550,410.

Claims (14)

1. An apparatus for preparing a fluid sample for use in a fluid analyzer, comprising:

a first section comprising:

the septum pierces through the protrusion and,

capillary channels, and

an outlet on an outer surface of the first portion; and

a second section comprising:

a treatment solution chamber, and

a septum sealing a treatment solution chamber, wherein the outlet is open when the first portion of the device is initially inserted into the second portion of the device, and wherein the outlet is closed when the first portion of the device is fully inserted into the second portion of the device.

2. The apparatus of claim 1, wherein the vent allows air to escape from within the second portion of the apparatus when the first portion of the apparatus is inserted into the second portion of the apparatus.

3. The apparatus of claim 1, wherein the outlet comprises a groove extending along a portion of an outer surface of the first portion of the apparatus.

4. The apparatus of claim 3, wherein the groove extends away from a leading edge of the outer surface portion along a length of the outer surface of the first portion of the apparatus.

5. The device of claim 3, wherein an outer surface of the first portion of the device is positioned against an inner surface of the second portion of the device when the first portion of the device is fully inserted into the second portion of the device.

6. An apparatus for preparing a fluid sample for use in a fluid analyzer, comprising:

a first portion having a capillary channel sized to receive a fluid sample therein and having an outlet on an outer surface;

a second part having a treatment solution chamber enclosed by first and second membranes, wherein the first part penetrates the first membrane when the first part is inserted into the second part so that the contents of the treatment solution chamber mix with the contents of the capillary channel, wherein the outlet is open when the first part of the device is initially inserted into the second part of the device, and wherein the outlet is closed when the first part of the device is fully inserted into the second part of the device; and

a mechanism for penetrating the second membrane so that the contents of the treatment solution chamber and capillary channel can be expelled from the device.

7. The apparatus of claim 6, wherein the vent allows air to escape from within the second portion of the apparatus when the first portion of the apparatus is inserted into the second portion of the apparatus.

8. The apparatus of claim 6, wherein the outlet comprises a groove extending along a portion of an outer surface of the first portion of the apparatus.

9. The apparatus of claim 7, wherein the groove extends away from a leading edge of the outer surface portion along a length of the outer surface of the first portion of the apparatus.

10. The device of claim 7, wherein an outer surface of the first portion of the device is positioned against an inner surface of the second portion of the device when the first portion of the device is fully inserted into the second portion of the device.

11. An apparatus for preparing a fluid sample for use in a fluid analyzer, comprising:

a first portion having a capillary channel sized to receive a fluid sample therein;

a second part having a treatment solution chamber enclosed by first and second diaphragms, wherein the first part penetrates the first diaphragm when the first part is inserted into the second part so that the contents of the treatment solution chamber mix with the contents of the capillary channel; and

a plunger having a mechanism for penetrating the second membrane such that the contents of the treatment solution chamber and capillary channel are expelled through the plunger.

12. The device of claim 11, wherein the mechanism for penetrating the second septum comprises a spike on the plunger.

13. The apparatus of claim 12, wherein the plunger includes a central flow channel, and wherein the spike is positioned adjacent the central flow channel.

14. The apparatus of claim 13, wherein the tip of the spike is positioned above the central flow channel.