EP4601541A1

EP4601541A1 - Capillary blood sampling device and method of use

Info

Publication number: EP4601541A1
Application number: EP23878048.0A
Authority: EP
Inventors: Lucien Vouillamoz; Philippe Margairaz; Shay ZYMAN; Alain Jaccard
Original assignee: Preci Health SA
Current assignee: Preci Health SA
Priority date: 2022-10-15
Filing date: 2023-10-16
Publication date: 2025-08-20
Also published as: WO2024081436A1; CN120187350A; EP4601541A4

Abstract

A disposable fluid sampling device including a body fluid sampling means, optionally body fluid sampling means for auto-sampling; and optionally, analysis means using one or more dropletfs) of sampled fluid to analyze the fluid; and an interface for at least one sample tube or medical analysis tube, the at least one sample tube or medical analysis tube adapted to be tilled with a sample of fluid for analysis in a point of care or medical lab, wherein the device includes an interface for and at least one vacuum tube or vacuum source, the vacuum tube or vacuum source adapted to provide suction necessary to fill the at least one sample tube with the fluid.

Description

CAPILLARY BLOOD SAMPLING DEVICE AND METHOD OF USE

Copyright & Legal Notice

A portion of the disclosure of this patent document contains material which is subject to copyright protection. The Applicant has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. Further, no references to third party patents or articles made herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

Field of the Invention

This invention relates to devices allowing for the sampling of capillary blood. In many cases it is preferable to avoid venipuncture to sample blood, be it because the patient’s veins are too fragile, or for comfort reasons, or because trained personnel for phlebotomy are not available in sufficient numbers.

Background of the Invention

The sampling of capillary blood is often preferable to venous blood extraction because a patient’s veins may be fragile or for comfort reasons, or because trained personnel for phlebotomy is not available in sufficient numbers.

What is needed is a capillary fluid sampling device adapted to be used safely and able to provide the necessary blood samples for analysis devices or analysis systems at the point of care or at a medical laboratory. What is needed is a capillary blood collection device that can, using a single laceration or puncture system at a single location, collect one or ideally successively multiple blood samples of at least 500μl per sample per tube, in one or ideally in multiple standard tubes for the purpose of performing blood tests, using vacuum from a vacuum tube or several vacuum tubes or from an external vacuum source. Summary of the Invention

A disposable body fluid sampling device provides a user with the ability to sample capillary blood and fill one or more sample tubes for analyses. The disposable body fluid sampling device may include: a body fluid reservoir for containing the sampled body fluid and a fluid extraction mechanism including at least one conduit or hollow needle connected to a vacuum reservoir or external vacuum source. When connecting the vacuum reservoir or external vacuum source to the body fluid reservoir, a seal of the vacuum reservoir or external vacuum source is adapted to be broken, pierced or opened so as to cause the sucking of blood into the body fluid reservoir. The sampling device of the invention permits collecting capillary blood samples without the intervention of medically trained personnel, in particular in the absence of personnel trained in phlebotomy. The sampling device enables the user to: (a) sample a body fluid, or optionally carry out auto-sampling; (b) optionally using one or more droplet(s) of the sampled body fluid, to immediately analyze the body fluid; and (c) provide one or more medical analysis tubes filled with the sampled body fluid for analysis at a point of care or in a medical lab. The sampling device may include a vacuum tube or external vacuum source and an interface therefor. The vacuum tube or external vacuum source provides the suction necessary to draw the body fluid from the user/patient and to fill the body fluid reservoir with the body fluid.

The task is solved by a fluid sampling device adapted to take a sample of a body fluid, preferably the sample of the body fluid formed from one or more droplets of the body fluid for optional immediate analysis and from larger quantities of body fluid (0.5 to 1.5ml per sample tube) similar to those collected by phlebotomy for further analysis at a point of care or in a medical lab, the disposable fluid sampling device optionally adapted for auto-sampling, wherein the disposable fluid sampling device includes a vacuum interface for interfacing a first vacuum source and a second vacuum source, the vacuum sources interconnected to the at least one receptacle for providing suction necessary to fill the at least one receptacle with the body fluid. Preferably the body fluid is blood. The fluid sampling device is optionally disposable.

In the present disclosure the description of the body fluid sampling device is described in particular for the case of sampling capillary blood, but the same invention can also be used for the sampling of other body fluids, such as puss or venom. Within a further embodiment the fluid sampling device, at least one, preferably two, of the vacuum sources is formed as a receptacle for accommodating body fluid. Therefore by activating the first vacuum source, the first vacuum source is fillable with the body fluid, thereby forming a first body fluid reservoir, and by activating the second vacuum source, the second vacuum source may be fillable with body fluid, thereby forming a second body fluid reservoir. Therefore, at least one vacuum source is adapted to be filled with the body fluid.

Alternatively, the fluid sampling device includes a tube interface, the tube interface adapted to interface at least one receptacle, the receptacle preferably being a sample receptacle or a medical analysis receptacle. Such a receptacle is therefore forming a body fluid reservoir. Therefore, the vacuum sources may be different from the at least one receptacle. This is advantageous due to the fact that the vacuum sources do not have to be formed as body fluid reservoirs. Such a medical analysis receptacle may be adapted to be filled with the sample of the body fluid for optionally performing a further analysis in a point of care or medical lab. A single vacuum source may be formed of one vacuum tube.

The first vacuum source may be interconnected to a first of the receptacles, and the second vacuum source may be interconnected to a second of the receptacles. Therefore, the activation of the first vacuum source activates the filling of the first receptacle. Afterwards by activation of the second vacuum source the second receptacle is fillable with body fluid.

According to the above at least one of the vacuum sources and/or at least one additional receptacle can form a body fluid reservoir.

In a further embodiment, the fluid sampling device includes an analysis arrangement, whereby the analysis arrangement is adapted to analyze the body fluid. Optionally the tube interface is connectable to the analysis arrangement.

A further embodiment of the fluid sampling device comprises a valve, preferably a stopcock, for changing the inlet from the at least first to an at least second body fluid reservoir, each of the body fluid reservoirs being formed of said vacuum source or said receptacle. Therefore, it is controllable how the body fluid reservoirs are fillable. To control which body fluid reservoir is fed, the valve can be turned into an appropriate position to allow the flow from the patient’ s wound to the chosen reservoir or receptacle respectively.

In yet a further embodiment of the fluid sampling device more than one body fluid reservoir may be used to store drawn body fluid. In an aspect of the embodiment the body fluid may be flowing into a first body fluid reservoir and subsequently into a second body fluid reservoir or even into further reservoirs. Switching from one reservoir to the next may be accomplished by means of a valve, preferably a stopcock.

A further embodiment of the fluid sampling device includes a watertight fluid extraction passage or conduit for connecting a patient’s wound and the receptacle, the watertight fluid extraction passage or conduit respectively comprising a flexible tube. This is advantageous due to the fact that the disposable fluid sampling device is placeable on the body and operatable from a third person independently from the patient lying or standing.

A further embodiment of the fluid sampling device comprises a heating element which is attachable to the skin in the vicinity of an area, wherein the body fluid is drawn from the body. This simplifies the operability of the disposable fluid sampling device. Therefore, the skin of the patient around the position where the body fluid, especially blood, is drawn from the body of the patient, can be heated. That heating widens the blood capillaries in the immediate vicinity of the mentioned position, leading to a higher rate of blood drawable from the body of the person.

The heating element may be thin enough to be located between the blood collecting device and the patient’s skin during the blood collection process, preferably between 0.5 mm and 4 mm, more preferably between 1 mm and 3 mm thick. Such a heating element may contain Capsicum extract, which is derived from chili peppers and helps to increase blood flow by lowering blood pressure and stimulating the release of nitric oxide and other substances that relax and widen the blood vessels, leading to a higher rate of blood drawable from the body of the person. Heat plasters containing capsicum are known in applications unrelated to blood collection (see, on the world wide web, for exampl e ninelife.ch/products/hansaplast-lion-heat-plaster-capsicumplaster-intensive-long-lasting-4- sheets-x-12-total-48-sheets?gclid=EAIaIQobChMIpazOsODPgAMVE- F3 Ch3 QEglmEAQY AS ABEglfzPD BwE. the contents of which are incorporated herein by reference and relied upon, and shown in Appendix A).

Alternatively, rather than containing any active agents which stimulate the skin, a heating element may provide direct external heat for example by means of an exothermic chemical reaction. Such a reaction may be initiated for example by exposing the active agent(s) to air. The active agent(s) may for example contain iron powder or any other easily oxidizable substance which upon the exposure to air are oxidized and thereby produce heat. Other exothermic chemical reactions may be used, such as Calcium chloride or Magnesium sulfate dissolution in water, or Sodium Acetate crystallization.

Within a further embodiment of the fluid sampling device, the receptacle for accommodating the body fluid is made from translucent material, the translucent material preferably being colored and/or containing an additive adapted to contact the body fluid and after contact, changing the color without affecting measurable blood characteristics.

The body fluid reservoir may be made of translucent material and is preferably colored. Therefore, the color of the body fluid seen by the user may be different or even very different from the original color of the body fluid. The user may therefor see that the body fluid reservoir is filling, but because the color is no longer dark red, the non-dark-red color decreases the visual discomfort for people with blood phobia (a.k.a. hemophobia or hematophobia). Alternatively or additionally, the body fluid sampling device may contain an additive adapted to get in contact with the body fluid to be stored within the body fluid reservoirs so as to change the color of the body fluid without affecting its parameters or characteristics which are measured later on. Furthermore, instead of containing an additive which changes the color of the body fluid, the body fluid sampling device may comprise means present on the outside of the body fluid reservoirs which just seem to change the color of the body fluid without really changing it. Such a means may for example consist of a layer of cholesteric liquid crystal on the outside of the fluid reservoir, such liquid crystal changing color upon the filling of the fluid reservoir with warm body fluid.

The task is also solvable by a method for sampling body fluid, optionally self sampling, the method including the following steps: a) in a first step, installing the fluid sampling device according to claim 1 on the patient’s arm, the disposable fluid sampling device including a first vacuum source insertable into a vacuum interface; b) in a second step, triggering the skin laceration or incision respectively for lacerating the skin; c) in a third step, inserting a first vacuum source into the vacuum interface; d) in a fourth step, filling a receptacle of the fluid sampling device with a body fluid; and e) in a fifth step, removing the first vacuum source.

A further embodiment of the method includes a repetition of steps (c), (d), (e) executed for activating a second vacuum source of the fluid sampling device and optionally to fill a second receptacle with a sample of the body fluid.

Within a further embodiment of the method, a heating element of the body fluid sampling device is activated for a period of time, to keep the patient’s skin at an elevated temperature in order to increase body fluid draw during the sampling process. Preferably the heating element remains activated during the entire sampling process.

The task can also be solved by a receptacle to be used with the disposable device, where a tamper evident label is connectable to a cap of the receptacle, so that be only opened in an non-tamper- evident manner at the lab performing the body fluid sample analysis, thereby allowing confirmation of the body fluid sample origin.

Within a further embodiment of the fluid sampling device, an extra vacuum source is used to collect the body fluid by providing vacuum to a non-vented first tube.

Within a further embodiment of the fluid sampling device, an amount of additives present in the receptacles for capillary sampling is adapted to the amount of body fluid to be collected. Typically 0.5 to 1.5 ml is the amount of body fluid to be collected.

Within a further embodiment of the fluid sampling device, the level of vacuum in the vacuum source is adapted to the need of capillary sampling, and so may differ from Annex B of a norm of ISO- 6710. Advantageously, laceration of the skin for body fluid sampling is made in a direction parallel to the receptacle, or parallel to the main length of the conduit or main fluidic passage leading the body fluid to the receptacle. This favors the process of blood collection.

Those skilled in the art will appreciate that elements in the Figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, dimensions may be exaggerated relative to other elements to help improve understanding of the invention and its embodiments. Furthermore, when the terms 'first' , 'second', and the like are used herein, their use is intended for distinguishing between similar elements and not necessanly for describing a sequential or chronological order. Moreover, relative terms like 'front', 'back', 'top' and bottom', and the like in the Description and/or in the claims are not necessarily used for describing exclusive relative position. Those skilled in the art will therefore understand that such terms may be interchangeable with other terms, and that the embodiments described herein are capable of operating in other orientations than those explicitly illustrated or otherwise described.

Brief Description of the Drawings

FIG. 1 is an image of the upper arm of a patient with an attached capillary blood sampling device.

FIG. 2 is an image of a capillary blood sampling device during the insertion of a vacuum tube.

FIG. 3 is an image of a capillary blood sampling device with inserted vacuum tube.

FIG. 4A is a top view of a capillary blood sampling device comprising a thin heating element.

FIG. 4B is a first side view of a capillary blood sampling device comprising a thin heating element.

FIG. 4C is a second side view (rear vew of the first) of a capillary blood sampling device comprising a thin heating element.

FIG. 5 is a drawing of three sample tubes attached to a sampling device showing the subsequent filling of each.

FIG. 6 is a drawing of a capillary blood sampling device with a larger vacuum tube connected to a smaller sample tube.

FIG. 7 is a flowchart of a method of the invention, showing subsequent stages of removal and replacement of sample tubes.

FIG. 8A is an image of a sample tube comprising a cap with a tamper evident feature (TEF).

FIG. 8B is an image of various forms of sample tubes. FIG. 9 is a drawing of a vent mechanism providing release of remaining vacuum after blood sampling.

FIG. 10 is an image of a patient’s upper arm with incisions for blood sampling.

FIG. 11A is an image of a capillary blood sampling device with connexion to an external vacuum source.

FIG. 11B is an image of a capillary blood sampling device with connexion for a vacuum tube that is different from the blood sample tube.

FIG. 11C is schematic cross-section view of the inside of the sample tube connection when the vacuum source is different from the blood sample tube.

Detailed Description of the Preferred Embodiment

The following description is not intended to limit the scope of the invention in any way as they are exemplary in nature, serving to describe the best mode of the invention known the inventors as of the filing date hereof. Consequently, changes may be made in the arrangement and/or function of any of the elements described in the exemplary embodiments disclosed herein without departing from the spirit and scope of the invention.

Note that in this application, where ever blood or capillary blood sampling is mentioned, it should be understood that puss or venom can be substituted for blood.

Note also that the terms body fluid reservoir, fluid reservoir, vacuum tube, sample tube and analysis tube may refer to the same object, depending on the details of the body fluid sampling device of the invention.

As the sampling device may be used by non-trained users, even in some cases for autosampling, the main parts to be manipulated by the user may be color-coded for easier instructions dispensing and recognition, as mentioned below.

Referring now to FIGs. 1 to 3, a first embodiment of a capillary body fluid sampling device comprises (a) a capillary blood sampling device 10 according, for example, to PCT/IB2021/000187 and/or PCT7IB2021/000580, the contents of which are incorporated herein by reference and relied upon, the capillary blood sampling device 10 being shown mounted against the skin 12 of a patient 14. A flexible tube 16 is disposed between the blood sampling device 10 and a vacuum tube 20, which in operation is inserted in a vacuum tube connector 20’ or an external vacuum source, thereby providing a watertight extraction passage or conduit between the patient’s wound 100 and the sample tube (vacuum tube 20). This arrangement allows for easy insertion/removal of one or more vacuum tubes in a row without risking destabilizing or detaching the blood sampler from the patient’s skin 12.

The level of vacuum in the vacuum tube or in the external vacuum source is adapted to the need of capillary sampling, and may differ from the Annex B of ISO-6710 norm.

Referring now to FIG. 4A, a second embodiment of the fluid sampling device 10, which is optionally disposable, optionally includes a heating element 22. Preferably, the heating element 22 has a thickness in a range of about 0.5 to 4 mm, or even more preferably about 1 to 3 mm. The fluid sampling device 10 with the heating element 22 s shown here in a top view. The heating element 22 is disposed to provide heating of the area around the patient’s wound from which the body fluid, preferably blood, is to be drawn. The fluid sampling device is attachable to the skin 12 and so when the skin 12 is heated with the help of the heating element 22, the capillaries are widened, so that more body fluid can be drawn from the body. Note that here, the vacuum source 20 or external vacuum source is optionally directly connected to the fluid sampling device 10 and not via a flexible tube 16.

Referring now to FIGs. 4B and 4C the fluid sampling device 10 of the second embodiment, which is optionally disposable and comprises the optional heating element 22, is shown in two side views. The heating element 22 is locatable in direct contact to the skin of the patient, i.e. on the side of the patient’s skin In other words, the heating element 22 is thin enough to be located between the blood collecting device and the patient’s skin during the blood collection process. Such a heating element 22 may contain Capsicum extract, which is derived from chili peppers and helps to increase blood flow by lowering blood pressure and stimulating the release of nitric oxide and other substances that relax and widen the blood vessels, leading to a higher rate of blood drawable from the body of the person. When attached to the skin 12 and heated, the capillaries are widened, so more blood can be drawn from the body.

In an aspect of the embodiment, rather than containing any reactive agents which stimulate the skin, a heating element 22 may provide direct external heat for example by means of an exothermic chemical reaction. Such a reaction may be initiated for example by exposing the reactive agent(s) to air. The reactive agent(s) may for example contain iron powder or any other easily oxidizable substance which upon the exposure to air are oxidized and thereby produce heat. The oxidation of the oxidizable substance and hence the initiation of the heating may optionally be initiated by lifting a flap 24 on heating element 22, thereby letting air penetrate into the oxidizable substance.

In another aspect of the embodiment a heating element 22 may consist of at least two compartments the oxidizable substances in which can separately be exposed to air by successively drawing flaps 24 in order to keep a patient’s skin at an optimal temperature for an extended time in which blood can be drawn during a sampling process. Other exothermic chemical reactions may be used, such as Calcium chloride or Magnesium sulfate dissolution in water, or Sodium Acetate crystallization.

As mentioned above, he main parts to be manipulated by the user may be color-coded for easier instructions dispensing and recognition. For example the lever 11 may be colored in yellow and the push-button 9 may be colored in green, while the sampling device itself may be essentially white. It should be understood however that other color codes providing sufficient contrast for the same purpose may be used.

Referring now to FIG. 5, in a third embodiment of the fluid sampling device 10 for example three body fluid reservoirs 30, 32, 34 are connected to a valve 40 communicating with the wound 100 in the patient’s skin 12 from which the body fluid is to be drawn. The valve 40 may consist of a stopcock. The body fluid 50 drawn from the wound 100 in the patient’s skin 12 can flow into one of the body fluid reservoirs 30, 32, 34 at a time. To control which body fluid reservoir 30, 32, 34 is fed, the valve 40 can be turned. On the left of FIG. 5, the valve is in a position 42, such that only the first fluid reservoir 30 is filled. In the middle of FIG. 5 the valve 40 has been turned to a position 44, such that the second fluid reservoirs 32 is filled. Finally, on the right of FIG. 5 all three reservoirs 30, 32, 34 are filled, after the valve 40 has been turned into position 46. The body fluid reservoirs 30, 32, 34 described in all embodiments here need not be identical and so they may be of different sizes and/or colors. The identifiable first receptacle may contain specific reactants different from the reactants in the other receptacles, permitting certain tests to be carried out on the contents of the first receptacle. Referring to FIG. 6, a fourth embodiment of a fluid sampling device 10 comprises two optionally different receptacles. A first receptacle 20 may be smaller receptacle already validated by the FDA for capillary blood sampling, and so is expected to be easier to get through FDA approval. A larger second receptacle 60, connected via a flexible tube 62 adapted to pass through the septum 23 of the first receptacle 20, creates vacuum in the device and in the smaller first receptacle and thereby helps filling the smaller first receptacle 20.

In all four embodiments of the fluid sampling device 10, the incision or laceration of the skin made for blood sampling is preferably made in a direction parallel to a sample receptacle 20, or parallel to the main length of the conduit 16 or main fluidic passage leading the body fluid to the receptacle. This favors multiple incisions to be made for faster capillary blood sampling.

Referring now to FIG. 7, steps of a method 700 for sample receptacle 20 removal and/or replacement are shown. In a first step 70, the user presses a color-coded flag actuator such as a green flag 9 of the fluid sampling device 10 to lift up the lever 11 fixing receptacle 20. Pushing the green button 9 disengages the tube 20 from the hollow needle (so that the septum closes) and lifts the lever 11, so that the tube 20 can be removed and replaced by the next tube. The "color-coded flag" aspect of the actuator helps make it easier to spot by the user/patient in case of self-sampling, such as by authentification software such as mentioned in PCT application PCT/US2021/25087 filed March 31st, 2023, the content of which is incorporated herein in its entirety and relied upon. In a second step 72, the user removes the receptacle 20. In a third step 74, the user seeks a second receptacle 20. In a fourth step 76, the user installs the next receptacle 20. In a fifth step 78, the user optionally closes the lever 11, thereby fixing the receptacle 20 and pushing out the color-coded flag actuator 9, and so continues the sampling process.

Referring now to FIG. 8A, an embodiment of a sample receptacle 80 optionally has a size about twice as large as the volume of body fluid, preferably blood, to be collected (e.g. 4 ml tube volume to collect 2 ml of blood). Optionally, the sample receptacle 80 of the embodiment provides a excess vacuum beyond the vacuum level needed to fill the sample receptacle 80 in order to speed up the blood collection process (for example from -0.85 bar to -0.30 bar). The size of the sample receptacle 80 and the amount of excess vacuum are particularly adapted for drawing blood from the capillaries in a patient’s skin, as blood drawn from skin capillaries does not flow as fast as blood drawn from a punctured vein. The vacuum level in the sample receptacle 80 may differ from the standard phlebotomy norm, given its larger volume, depending on the volume of blood to be collected and/or on the sensitivity of a patient to suction pressure.

Optionally, the interior of the sample receptacle 80 has a coating 82 to avoid blood coagulation (for example a heparin coating or or a similar coating). The sample receptacle 80 may also contain additives 84 and/or a separation gel 86 for the conservation/transport of blood cells separate from the plasma.

Referring now again to FIG. 8A the sample receptacle 80 is typically closed by a cap or stopper 88. Optionally the cap 88 may be provided with a tamper evident feature (TEF) 89 (additional feature to ensure blood is the one of the user) may advantageously be provided. With such a feature 89, only a laboratory may open the sample receptacle. The laboratory can check if the tube was tampered with prior to testing its contents. The TEF 89 also marks the tube 80 with a mark 87 during blood collection process, which shows that this tube has already been in use.

Referring now to FIG. 8B, various anti -tampering features are useful for blood collection or body fluid collection at home. Such anti -tampering features include for example a plastic covering of the tube cap or a tape on the tube to cap junction.

In an aspect of the embodiment the body fluid reservoir 20, 80 may include a body 87 made of color changing and/or translucent and/or opaque, and/or thermocromic material such as glass, colored glass, PET, colored PET, PET charged with thermochromic dyes. Therefore, the color of the body fluid seen by the user may be different or even very different from the original color of the body fluid. The user may therefor see that the body fluid reservoir is filling, but because the color is no longer dark red, the non-dark-red color decreases the visual discomfort for people with blood phobia (a.k.a. hemophobia or hematophobia). Alternatively or additionally, the body fluid sampling device may contain an additive adapted to get in contact with the body fluid to be stored within the body fluid reservoirs so as to change the color of the body fluid without affecting its parameters or characteristics which are measured later on. Furthermore, instead of containing an additive which changes the color of the body fluid, the body fluid sampling device may comprise means present on the outside of the body fluid reservoirs which just seem to change the color of the body fluid without really changing it. Such a means may for example consist of a layer of cholesteric liquid crystal on the outside of the fluid reservoir, such liquid crystal changing color upon the filling of the fluid reservoir with warm body fluid.

The amount of any eventual additives present in the body fluid reservoir for capillary sampling is adapted to the amount of body fluid 50 to be collected (0.5-1.5ml).

Referring now to FIG. 9, in an aspect of the embodiment of a sample receptacle 80, a vent 90 may optionally provided to release any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during conservation or transport. The vent 90 can be pulled axially away from the cap 88’, such as to separate a vent surface 92 from a corresponding cap surface 94, thereby releasing any remaining vacuum through a passageway 96 in the vent 90. A knob 91 can be grasped by the user with her/his fingers in order to pull the vent 90, separating surfaces 92, 94 and thereby release the remaining vacuum.

Referring now to FIG. 10, a wound 100 for blood collection example in a patient’s upper arm 12 may consist of at least one incision or laceration 102, 104 formed parallel to the direction of blood collection/ sample receptacle, or parallel to the main length of the conduit 16 or main fluidic passage leading the body fluid to the receptacle. The laceration in the direction of blood collection is particularly advantageous when more than one incision 102, 104 is to be made for faster capillary blood flow, because in case of laceration perpendicular to the direction of the blood flow, blood flowing from the upper incision would flow over the lower incision.

Method of use

1. FIG.l: The user (medical personnel or untrained person) installs the fluid sampling device 10 on the patient’s skin 12 with an adhesive pad (such as a a thin heating element 22 but one which does not need to be heated). Any other appropriate means known in the industry may be used to install the fluid sampling device 10. It may for example simply be held or pressed against the skin by the patient himself or by a third person)

2. The user triggers the skin incision or laceration 3. FIG.2: The user inserts a vacuum source 20 into the connector 20’ (irrespective of being connected to the device via a flexible tube 16) (N.B: steps 2 and 3 may also be executed in the reverse order)

4. FIG.3: The vacuum tube 20 is filling with the body fluid 50, typically with blood.

5. The user removes the vacuum source 20

6. Optionally the user inserts a second vacuum source 20, repeating steps 4 to 6 as many times as necessary

7. The user removes the device 10 from the patient’s skin 12, and cleans and dresses the wound

8. The user sends the sample tube(s) 20 to the laboratory for analyses

In any of the embodiments mentioned herein, where the sample tube 20 is different from the vacuum tube 60 (FIG.6), the user also changes the sample tube when he changes the vacuum tube.

In any of the embodiments mentioned herein, where there is more than one sample tube 30, 32, 34 connected to the sampling device 10 and the vacuum source is more than one vacuum tube (a combination of FIG.5 and FIG.6), the user may change the vacuum tube 60 to have a fresh vacuum tube to fill each sample tubes (30, 32, 34), even without the need of a valve when the tubes are swapped in a certain order. If a valve were to be used, it would be advantageously placed at the T-junction between tubes 112 and 116.

Referring now to FIGs. 11A, the fluid sampling device 10 includes a connector 114 connected to the device 10 via a flexible tube 112 to receive the blood collection/ sample receptacle, and a conduit 116 to connect the receptacle to a vacuum source, as usually available in medical centers. In such configurations, the user can connect sequentially several receptacles to the connector 114, thereby providing more than one receptacle containing a blood sample.

Referring now to FIGs. 11B, the fluid sampling device 10 includes a connector 114 connected to the device 10 via a flexible tube 112 to receive the blood collection/sample receptacle, and a second connector 118 connected to the receptacle via a conduit 116 to connect to a vacuum tube 20. In such a configurations, after the fluid sampling device 10 has beenbeing installed on the patient’s skin 12, the user executes the following steps:

1. In a first step, connecting a first receptacle to the connector 114

2. In a second step, connecting a first vacuum tube to the second connector 118.

3. In a third step, triggering the skin incision or laceration

(step 3 may also be executed before the first step or before the second step)

4. In a fourth step, waiting for the first receptacle to be filled with blood

5. In a fifth step, disconnecting the first vacuum tube from the second connector 118

6. In a sixth step, disconnecting the first receptacle from the connector 114

7. In a seventh step, connecting a second receptacle to the connector 114

8. In an eighth step, connecting a second vacuum tube to the second connector 118

9. In a ninth step, repeating steps 4 to 8, respectively steps 4 to 6 until having obtained a sufficient number of receptacles filled with a blood sample.

Of course a configuration in which a valve is used to connect several receptacles, respectively several vacuum tubes, in a row similar to the configuration described in FIG .5 may also be used.

Referring now to FIG. 11C, for both configurations shown in FIG.11A and FIG.11B, the junction between tubes 112 and 116 may resembleextemally a T-junction, but the internal configuration details are provided here. Functionally, the junction between tubes 112 and 116 is advantageaously made in the connector 114 through the blood sample tube. The connector 114 provides a first connection for the device 10 through the flexible tube 112 into the sample tube 120 via a hollow needle 112.1 able to pierce the septum 124, held in the cap 122 that closes the sample tube 120. The connector 114 also provides a second connection for the vacuum source through the conduit 116 via a hollow needle 116. 1 able to pierce the septum 124, held in the cap 122 that closes the sample tube 120. Therefore, when a fresh vacuum tube is inserted into the connector 118, or when the vaccum source is activated directly or via the opening of a valve, the vacuum is established first within the sample tube 120, and then progresses through the flexible tube 112 until the sampling device 10 to provide the necessary suction for collecting the blood into the sample tube 120.

Specific embodiments of the invention can be summarized belonging to at least one of the following feature sets: 1. A disposable fluid sampling device including:

(a) body fluid sampling means, optionally body fluid sampling means for auto-sampling;

(b) optionally, analysis means using one or more droplet(s) of the sampled fluid to analyze the fluid; and

(c) a means for at least one medical body fluid reservoir, body fluid sample tube or analysis tube, the at least one tube adapted to be filled with a sample of fluid for analysis in a point of care or medical lab, wherein the means includes an interface for at least one vacuum tube or external vacuum source, the vacuum tube or external vacuum source being adapted for providing suction necessary to fill the at least one body fluid sample tube with the fluid.

2. The disposable fluid sampling device of feature set 1, wherein a watertight fluid extraction passage or conduit from the patient’s wound to the body fluid sample tube comprises a flexible tube.

3. The disposable fluid sampling device of feature set 1, wherein a thin heating element is disposed to provide heating around the area around the patient’s wound from which blood is to be drawn. The thin heating element may have a thickness in a range of about 0.5 to 4 mm, or preferably about 1 to 3 mm. When the sampling device is attached to the skin and heated, the capillaries are therefore widened, so that more blood can be drawn from the body. The vacuum tube or external vacuum source may either directly be connected to the sampling device or via a flexible tube, both providing a watertight fluid extraction passage or conduit from the patient’s wound to the body fluid sample tube.

4, The thin heating element of feature set 3, wherein said heating element contains at least one of the following ingredients:

(a) A Capsicum extract, which is derived from chili peppers and helps to increase blood flow by lowering blood pressure and stimulating the release of nitric oxide and other substances that relax and widen the blood vessels, leading to a higher rate of blood drawable from the body of the person,

(b) An reactive agent providing an exothermic chemical reaction. The reactive agent may for example contain iron powder or any other easily oxidizable substances which upon the exposure to air are oxidized and thereby produce heat. Other exothermic chemical reactions may be used, such as Calcium chloride or Magnesium sulfate dissolution in water, or Sodium Acetate Crystallization. The exothermic reaction may for example be initiated by pulling a flap by means of which the reactive agent is no longer isolated from the ambient air.

5. The disposable fluid sampling device of feature set 1, wherein more than one, for example three tubes are connected to a valve communicating with the patient’s skin from which blood is to be drawn. The valve may consist of a stopcock. The body fluid drawn from the patient’s skin can flow into at least one of the body fluid reservoirs at a time. To control which body fluid reservoir is fed, the valve can be turned. The body fluid reservoirs need not be identical, they may have different sizes and/or colors. The identifiable first tube may contain specific reactants different from the reactants in the other tubes, permitting certain tests to be carried out on the contents of the first tube.

6. The disposable fluid sampling device of feature set 1, wherein for example two optionally different tubes are used. A first tube may be a smaller tube already validated by the FDA for capillary blood sampling, and so is expected to be easier to get through FDA approval. A larger tube, connected via a flexible tube adapted to pass through the septum of the first tube, creates vacuum in the device and in the small tube and thereby helps filling the small tube.

7. The disposable fluid sampling device of feature set 1, wherein a sample tube optionally has a size about twice as large as the volume of blood to be collected (e.g. 4 ml tube volume to collect 2 ml of blood). Optionally, this sample tube provides a excess vacuum beyond the vacuum level needed for it to be filled in order to speed up the blood collection process (for example from -0.85 bar to -0.30 bar). The size of the sample tube and the amount of excess vacuum are particularly adapted for drawing blood from the capillaries in a patient’s skin, as blood drawn from skin capillaries does not flow as fast as blood drawn from a punctured vein.

The vacuum level in the sample tube may differ from the standard phlebotomy norm, given its larger volume, depending on the volume of blood to be collected and/or on the sensitivity of a patient to suction pressure.

Optionally, the interior of the sample tube has a coating to avoid blood coagulation (for example a heparin coating or or a similar coating). The sample tube may also contain additives and/or a separation gel for the conservation/transport of blood cells separate from the plasma. The sample tube is typically closed by a cap or stopper. Optionally the cap may be provided with a tamper evident feature (TEF) (additional feature to ensure blood is the one of the user) may advantageously be provided. With such a feature, only a laboratory may open the sample tube. The laboratory can check if the tube was tampered with prior to testing its contents. The TEF also marks the tube with a mark during blood collection process, which shows that this tube has already been in use. Various anti-tampering features are useful for blood collection or body fluid collection at home. Such anti-tampering features include for example a plastic covering of the tube cap or a tape on the tube to cap junction.

8. The disposable fluid sampling device of feature set 1, wherein the body fluid reservoir includes a body made of color changing and/or translucent and/or opaque, and/or thermocromic material such as glass, colored glass, PET, colored PET, PET charged with thermocromic dyes. Therefore, the color of the body fluid seen by the user may be different or even very different from the original color of the body fluid. The user may therefor see that the body fluid reservoir is filling, but because the color is no longer dark red, the non-dark-red color decreases the visual discomfort for people with blood phobia (a.k.a. hemophobia or hematophobia). Alternatively or additionally, the body fluid sampling device may contain an additive adapted to get in contact with the body fluid to be stored within the body fluid reservoirs so as to change the color of the body fluid without affecting its parameters or characteristics which are measured later on. Furthermore, instead of containing an additive which changes the color of the body fluid, the body fluid sampling device may comprise means present on the outside of the body fluid reservoirs which just seem to change the color of the body fluid without really changing it. Such a means may for example consist of a layer of cholesteric liquid crystal on the outside of the fluid reservoir, such liquid crystal changing color upon the filling of the fluid reservoir with warm body fluid.

The amount of any eventual additives present in the body fluid reservoir for capillary sampling is adapted to the amount of body fluid to be collected (0.5-1.5ml).

9. The disposable fluid sampling device of feature set 1, wherein a vent provides the release of any remaining vacuum after blood sampling, thereby reducing the risk of hemolysis during conservation or transport. The vent can be pulled axially away from the cap of sample tube, such as to separate a vent surface from a corresponding cap surface, thereby releasing any remaining vacuum through a passageway in the vent. A knob can be grasped by the user with her/his fingers in order to pull the vent, separating vent and cap surfaces and thereby releasing the remaining vacuum.

10. A method of capillary blood sampling, optionally self sampling, the method including at least the steps of: a) In a first step, preparing the area of the patient’s arm where the blood sample will be taken, according to the standards of the profession (preheating, shaving, disinfection, etc.) b) In a second step, installing the device on the patient’s arm c) In a third step, triggering the skin laceration d) In a fourth step, inserting a vacuum tube in the connector e) In a fifth step, filling a body fluid sample tube with blood f) In a sixth step, removing the body fluid sample tube g) In a seventh step, removing the device from the patient’s arm h) In an eighth step, cleaning and dressing the wound.

11. The method of features set 10 further including the repetition of steps (d), (e), (f) to obtain more than one body fluid sample tube filled with a blood sample.

Further, the invention should be considered as comprising all possible combinations of every feature described in the instant specification, appended claims, and/or drawing figures which may be considered new, inventive and industrially applicable.

It should be appreciated that the particular implementations shown and herein described are representative of the invention and its best mode and are not intended to limit the scope of the present invention in any way.

As will be appreciated by skilled artisans, the present invention may be embodied as a system, a device, or a method.

Moreover, the system contemplates the use, sale and/or distribution of any goods, services or information having similar functionality described herein. The specification and figures should be considered in an illustrative manner, rather than a restrictive one and all modifications described herein are intended to be included within the scope of the invention claimed. Accordingly, the scope of the invention should be determined by the appended claims (as they currently exist or as later amended or added, and their legal equivalents) rather than by merely the examples described above. Steps recited in any method or process claims, unless otherwise expressly stated, may be executed in any order and are not limited to the specific order presented in any claim. Further, the elements and/or components recited in apparatus claims may be assembled or otherwise functionally configured in a variety of permutations to produce substantially the same result as the present invention. Consequently, the invention should not be interpreted as being limited to the specific configuration recited in the claims.

Benefits, other advantages and solutions mentioned herein are not to be constmed as critical, required or essential features or components of any or all the claims.

As used herein, the terms "comprises", "comprising", or variations thereof, are intended to refer to a non-exclusive listing of elements, such that any apparatus, process, method, article, or composition of the invention that comprises a list of elements, that does not include only those elements recited, but may also include other elements described in the instant specification. Unless otherwise explicitly stated, the use of the term “consisting” or “consisting of’ or “consisting essentially of’ is not intended to limit the scope of the invention to the enumerated elements named thereafter, unless otherwise indicated. Other combinations and/or modifications of the above-described elements, materials or structures used in the practice of the present invention may be varied or adapted by the skilled artisan to other designs without departing from the general principles of the invention.

The patents and articles mentioned above are hereby incorporated by reference herein, unless otherwise noted, to the extent that the same are not inconsistent with this disclosure.

Other characteristics and modes of execution of the invention are described in the appended claims. Further, the invention should be considered as comprising all possible combinations of every feature described in the instant specification, appended claims, and/or drawing figures which may be considered new, inventive and industrially applicable.

Additional features and functionality of the invention are described in the claims appended hereto. Such claims are hereby incorporated in their entirety by reference thereto in this specification and should be considered as part of the application as filed.

Multiple variations and modifications are possible in the embodiments of the invention described here. Although certain illustrative embodiments of the invention have been shown and described here, a wide range of changes, modifications, and substitutions is contemplated in the foregoing disclosure. While the above description contains many specific details, these should not be construed as limitations on the scope of the invention, but rather exemplify one or another preferred embodiment thereof. In some instances, some features of the present invention may be employed without a corresponding use of the other features. Accordingly, it is appropriate that the foregoing description be construed broadly and understood as being illustrative only, the spirit and scope of the invention being limited only by the claims which ultimately issue in this application.

Claims

What is claimed is:

1. A fluid sampling device (10) adapted to take a sample of a body fluid (50), preferably one or more droplets of the body fluid (50) for optional immediate analyses and quantities of body fluid similar to those collected by phlebotomy for further analyses at a point of care or in a medical lab, the disposable fluid sampling device optionally adapted for auto-sampling; (and optionally), wherein the disposable fluid sampling device (10) includes a vacuum interface for interfacing a vacuum source adapted for providing suction necessary to fill the at least one receptacle (20) with the body fluid (50).

2. The fluid sampling device (10) of claim 1, whereby the vacuum source is formed as a receptacle (20) for accommodating body fluid (50).

3. The fluid sampling device (10) of claim 1, whereby the vacuum source is different from the receptacle (20) for accommodating the body fluid (50).

4. The fluid sampling device (10) of claim 3, including a connector (114) allowing more than one receptacle (20, 120) to be connected in a sequence to the device (10) so as to fill more than one receptacle (20, 120) with a body fluid sample.

5. The fluid sampling device (10) of claim 3, whereby the vacuum source is a vacuum tube.

6. The fluid sampling device (10) of claim 5, including a connector (118) allowing more than one vacuum tube to be connected in a sequence to the device (10) so as to fill more than one receptacle (20, 120) with a body fluid sample.

7. The fluid sampling device (10) of claim 1, including a tube interface, the tube interface adapted to interface at least one receptacle, the receptacle preferably being a sample receptacle or a medical analysis receptacle (20),

8. The fluid sampling device (10) of claim 7, the first vacuum source (20, 60) is interconnected to a first of the receptacles (114, 118), and the second vacuum source (60, 20)is interconnected to a second of the receptacles (118, 114).

9. The fluid sampling device (10) of claim 2, including an analysis arrangement optionally connectable to the tube interface, whereby the analysis arrangement is adapted to analyze the body fluid (50).

10. The fluid sampling device (10) of claim 8, comprising a valve (40), preferably a stopcock for changing the inlet from the at least first to an at least second body fluid reservoir (34, 36), each of the body fluid reservoirs being formed of said vacuum source or said receptacle.

11. The fluid sampling device (10) of claim 1, including a watertight fluid extraction passage or conduit for connecting a patient’s wound (100) and the receptacle (20), the watertight fluid extraction passage or conduit respectively comprises a flexible tube (16).

12. The fluid sampling device (10) of claim 1 comprising a heating element (22) which is attachable to the skin in the vicinity of an area, wherein the body fluid (50) is drawn from the body.

13. The fluid sampling device (10) of claim 11, wherein the heating element (22) is thin enough to be located between the receptacle and the patient’s skin during the blood collection process, preferably between 0.5 mm and 4 mm, more preferably between 1 mm and 3 mm thick.

14. The fluid sampling device (10) of claim 1, where the receptacle for accommodating the body fluid (50) is made from translucent material, the translucent material preferably being colored.

15. The fluid sampling device (10) of claim 1, wherein the fluid sampling device (10) includes a connector (114) connected to the device (10) via a flexible tube (112) to receive the blood collection/sample receptacle (120), and a conduit (116) to provide vacuum to the blood collection/sample receptacle (120) and to the device (10).

16. The fluid sampling device (10) of claim 15, wherein the fluid sampling device (10) includes a second connector (118) connected to the receptacle via a conduit (116) to connect to a vacuum tube.

17. A method for sampling body fluid, optionally self sampling, the method including the following steps: a) in a first step, installing the fluid sampling device (10) according to claim 1 on the patient’s arm, the fluid sampling device (10) including a first vacuum source insertable into a vacuum interface; b) in a second step, triggering the skin laceration for lacerating the skin; c) in a third step, inserting a first vacuum source into the vacuum interface; d) in a fourth step, filling a receptacle (20) of the fluid sampling device (10) with a body fluid (50); and e) in a fifth step, removing the first vacuum source.

18. The method of claim 17, further including a repetition of steps (c), (d), (e) executed for activating a second vacuum source of the fluid sampling device (10) and optionally to fill a second receptacle with a sample of the body fluid (50).

19. The method of claim 17, wherein the fluid sampling device (10) includes a connector (114) connected to the device (10) via a flexible tube (112) to receive the blood collection/sample receptacle, and a conduit (116) to provide vacuum to the blood collection/sample receptacle (120) and to the device (10).

20. The method of claim 19, wherein the fluid sampling device (10) includes a a second connector (118) connected to the receptacle via a conduit (116) to connect to a vacuum tube.

21. The method of claim 12 or 13, where a heating element (22) of the fluid sampling device (10) is, and preferably remains, activated for a period of time, to keep the patient’s skin at an elevated temperature in order to increase body fluid draw during the sampling process.

22. A receptacle (80) to be used with the fluid sampling device (10) of claim 1, where a tamper evident label (89) is connectable to a cap (88) of the receptacle (80), so that be only opened in an non-tamper-evident manner at the lab performing the body fluid sample analysis, thereby allowing confirmation of the body fluid sample origin.

23. The fluid sampling device (10) of claim 1 wherein an extra vacuum source (60) is used to collect the body fluid (50) by providing vacuum to a non-vented first tube (20).

24. The fluid sampling device (10) of claim 1, wherein an amount of additives (84, 86) present in the receptacles (20, 80) for capillary sampling is adapted to the amount of body fluid (50) to be collected, (typically 1 to 1.5ml).

25. The fluid sampling device (10) of claim 1, wherein the level of vacuum in the vacuum source (20, 60) is adapted to the need of capillary sampling, and so may differ from Annex B of a norm of ISO-6710.

26. The method of capillary blood sampling of claim 25, wherein laceration of the skin for blood sampling is made in a direction parallel to the receptacle, or parallel to the main length of the conduit (16) or main fluidic passage leading the body fluid to the receptacle.