Suction applying device, an apparatus for sampling a bodily fluid and a method for detecting a component in a bodily fluid
11363977 · 2022-06-21
Assignee
Inventors
- Markus Renlund (Åkersberga, SE)
- Pelle Rangsten (Storvreta, SE)
- Mikael Hillmering (Solna, SE)
- Mikael Franzén (Drottningholm, SE)
Cpc classification
A61B5/157
HUMAN NECESSITIES
A61B5/150099
HUMAN NECESSITIES
A61B5/15105
HUMAN NECESSITIES
International classification
Abstract
A suction applying device (10) for applying suction to a sampling unit (50) for sampling bodily fluid, wherein the suction applying device comprises a syringe body (12) with a hollow interior (14) and a piston (20) movable inside the hollow interior of the syringe body. The syringe body has a rear end (16) through which a piston rod (21) connected to the piston extends outside of the syringe body and by means of which the piston can be moved, and a front end (18) opposite the rear end. The suction applying device further comprises a connection arrangement (130) configured for connection of a sampling unit, wherein the connection arrangement is located at the front end of the syringe body. The suction applying device also comprises a first conduit (40) having a rear opening (41) connecting the first conduit to a rear portion (14b) of the hollow interior, in which rear portion a sub-pressure is created when the piston is moved forward inside the hollow interior, and a front opening (42) by means of which the first conduit is connectable to a sampling unit. The suction applying device also comprises a second conduit (46) that connects a front portion (14a) of the hollow interior with the exterior of the syringe body, and which front portion is located between the piston and the front end of the syringe body. Also disclosed is an apparatus for sampling bodily fluid, comprising a suction applying device and a sampling unit, as well as a method for detecting a component in a bodily fluid.
Claims
1. A suction applying device for applying suction to a sampling unit for sampling bodily fluid, wherein the suction applying device comprises: a syringe body with a hollow interior, a longitudinal wall surrounding the hollow interior, and a piston movable inside the hollow interior of the syringe body, wherein the syringe body has a rear end through which a piston rod connected to the piston extends outside of the syringe body and by means of which the piston can be moved, and a front end opposite the rear end, a connection arrangement configured for connection of a sampling unit, wherein the connection arrangement is located at the front end of the syringe body, a first conduit comprising a longitudinal tube having a front opening connected to the sampling unit by the connection arrangement and having a rear opening connecting the first conduit to a rear portion of the hollow interior of the syringe body, the first conduit extending longitudinally, from the front opening to the rear opening, through the longitudinal wall of the syringe body, wherein a sub-pressure is created in the rear portion of the hollow interior of the syringe body when the piston is moved forward inside the hollow interior, and a second conduit, which second conduit connects a front portion of the hollow interior of the syringe body with the exterior of the syringe body, and which front portion is located between the piston and the front end of the syringe body, wherein the second conduit comprises a longitudinal tube having a first opening into the front portion of the hollow interior of the syringe body, and a second opening through the syringe body to the exterior, wherein the second conduit extends through the longitudinal wall of the syringe body from the first opening to the second opening.
2. The suction applying device according to claim 1, wherein the connection arrangement configured for connection of a sampling unit comprises a compartment configured for housing a sampling unit, and said front opening of the first conduit leading into the compartment.
3. The suction applying device according to claim 1, wherein the connection arrangement comprises a holder device for fixating a sampling unit to the suction applying device.
4. The suction applying device according to claim 1, wherein the connection arrangement comprises at least one electrical contact, by means of which electric connection of a sampling unit to the suction applying device can be provided.
5. The suction applying device according to claim 1, further comprising a detection unit configured for digitalization of a measurement derived from an extracted sample of bodily fluid, wherein said measurement is related to a component to be detected in the bodily fluid.
6. The suction applying device according to claim 5, further comprising a display device configured for displaying a result obtained from the detection unit.
7. An apparatus for sampling bodily fluid, comprising the suction applying device and the sampling unit according to claim 1, wherein the sampling unit comprises a microneedle device, which microneedle device comprises a plurality of hollow microneedles configured for extraction of a sample of bodily fluid, and said sampling unit further comprising a sample recipient device configured for receiving bodily fluid extracted by the microneedle device, and said sampling unit is connected to the suction applying device, whereby a suction force can be applied to the plurality of hollow microneedles of the microneedle device.
8. The apparatus according to claim 7, wherein a fluid path is provided in the sampling unit between the microneedle device and the sample recipient device, and the fluid path continues from the sample recipient device to the front opening of the first conduit, whereby the fluid path forms a suction path such that a suction force can be applied from the front opening of the first conduit to the microneedle device, when the piston is moved in a direction towards the front end of the syringe body.
9. The apparatus according to claim 7, wherein the sample recipient device comprises a filter member configured for absorbing bodily fluid that is extracted by the microneedle device.
10. The apparatus according to claim 7, wherein the sampling unit comprises a sensor device configured for detecting the presence of a component to be detected in the bodily fluid, and wherein said sensor device comprises said sample recipient device.
11. The apparatus according to claim 10, wherein the sensor device is configured to provide a measurement related to the presence of a component to be detected in the bodily fluid.
12. The apparatus according to claim 10, wherein the sensor device comprises at least one electrical contact element that is connectable to at least one electrical contact provided as part of the connection arrangement, and by means of which electric connection of the sampling unit to the suction applying device can be provided.
13. The apparatus according to claim 10, wherein the sensor device comprises an electrochemical sensor, and wherein a reagent configured to react when in contact with a component to be detected in the bodily fluid is provided in the sample recipient device.
14. The apparatus according to claim 10, wherein the sensor device comprises a RF sensor.
15. A method for detecting a component in a bodily fluid, comprising providing an apparatus according to claim 7, applying the front end of the suction applying device with the microneedle device onto a stratum corneum of a person, and applying a pressure force onto the apparatus such that the microneedles penetrate the stratum corneum into epidermis, pushing the piston towards the front end of the syringe body and creating a suction force through the first conduit and the sampling unit whereby a suction force is created in the microneedles, whereby bodily fluid is extracted through the microneedles and further directed to the sample recipient device of the sampling unit, performing a measurement of the extracted sample of bodily fluid in a sensor device, wherein the measurement is related to the presence of a component to be detected in the bodily fluid, and detecting the component based on the performed measurement.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The invention will now be described in more detail, with reference being made to the enclosed schematic drawings illustrating different aspects and embodiments of the invention, given as examples only, and in which:
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(10) Elements that are the same or represent corresponding or equivalent elements have been given the same reference numbers in the different figures.
DETAILED DESCRIPTION
(11) In
(12) The suction applying device comprises a connection arrangement 30, as shown in
(13) The suction applying device 10, as shown in
(14) By suction applying is meant that the device is capable of creating a sub-pressure in relation to the surrounding atmospheric pressure, i.e. an air pressure, or gas pressure, that is below the pressure in the surrounding atmosphere. In particular it is capable of creating sub-pressure and a suction effect in a sampling unit when such a sampling unit is connected to the suction applying device.
(15) The suction applying device 10 functions as follows. When the piston 20 is retracted in the hollow interior 14 as far as possible, it will stop at the rear end 16 of the syringe body 12. In this retracted position, the piston 20 will block the rear opening 41 of the first conduit 40. When the piston 20 is pushed forward inside the hollow interior 14, the rear opening 41 of the first conduit 40 will become free. As the piston continues to be moved forward, by pushing on the piston rod, an increasing sub-pressure will be created in the rear portion 14b of the hollow interior 14 and also in the first conduit 40. In the case when there is a sampling unit 50 connected to the suction applying device 10, the front opening 42 of the first conduit 40 will be connected to the sampling unit 50 and thereby the sampling unit will be affected by the sub-pressure and a suction effect is applied to the sampling unit. The first conduit 40 thus functions as a suction conduit. It should be mentioned that the forward movement of the piston 20 inside the hollow interior is facilitated by the existence of second conduit 46 by means of which air inside the front portion 14a of the hollow interior 14 may be evacuated to the exterior. The second conduit thus can be described as functioning as an evacuation conduit.
(16) In a conventional way, the piston 20 will be configured to fit snugly into the hollow interior 14 such that air should not be allowed to pass between the piston and the syringe wall, from the rear portion 14b of the hollow interior to the front portion 14a, or vice versa. If necessary, the piston may be provided with some sort of external seal that will improve the sealing effect between the piston and the syringe wall.
(17) Naturally, the piston does not have to be retracted all the way to the rear end 16 of the syringe body 12, and it does not have to block the rear opening 41 of the first conduit 40. A sub-pressure will be created in the rear portion 14b of the hollow interior 14 as soon as the piston 20 is moved forward, and a suction effect will be created in the first conduit 40, even if the piston starts the forward motion further down in the hollow interior. The suction effect will be created as soon as the rear opening is in communication with the portion of the hollow interior 14 that is between the piston 20 and the rear end 16 of the syringe 12 when the piston is moved forward, and this portion will be the rear portion 14b.
(18) The connection arrangement 30 may comprise a compartment 32 configured for housing a sampling unit 50, and said front opening 42 of the first conduit 40 leading into the compartment. This is schematically illustrated in
(19) The connection arrangement may comprise a holder device 33, 133, 233 for fixating a sampling unit 50 to the suction applying device. When there is a compartment, the holder device is preferably configured to fixate the sampling unit in the compartment.
(20) The connection arrangement 30 may comprise at least one electrical contact 31, by means of which electric connection of a sampling unit 50 to the suction applying device 10 may be provided. Such electrical contacts may e.g. be spring-loaded metal plates as schematically illustrated in
(21) In the illustrated example of
(22) The above described details of the connection arrangement, e.g. electric contacts, compartment, holder device, can be used in combination or each one separately without the others. Different variants of such a holder device will be described later.
(23) The suction applying device may comprise a detection unit 80 configured for digitalization of a measurement derived from an extracted sample of bodily fluid. The sample is obtained by the sampling unit. The measurement is a measurement related to the presence of a component to be detected in the bodily fluid. The suction applying device may also comprise a display device 90 configured for displaying a result obtained from the detection unit 80. This is illustrated in
(24) In all of the
(25) The suction applying apparatus as such may also comprise details according to the following examples, which details may be comprised separately or in combination.
(26) The first conduit 40 may be configured as a conduit made in the longitudinal wall 13 of the syringe body 12. Usually the syringe body would have a cylindrical shape with a longitudinal wall 13 extending between the rear end 16 and the front end 18 of the syringe body. Also the second conduit 46 may be configured as a conduit made in the wall of the syringe body 12. The second conduit would then have a first opening 47 into the hollow interior 14 located at the front end 18 of the syringe body. Preferably this first opening would be located in the front end wall 18a of the syringe body in order to be able to provide evacuation of air from the hollow interior 14 to the surroundings. The second conduit 46 would also then have a second opening 48 into the surrounding of the suction applying device. This second opening may be located anywhere on the exterior of the syringe, for example at the rear end 16 of the syringe body as shown in
(27) In
(28) In
(29) In
(30) In
(31) An apparatus for sampling a bodily fluid is obtained when a suction applying device 10 as described above is combined with a sampling unit, e.g. a sampling unit 50, 150, 250. Generally, the sampling unit comprises a microneedle device 51, 151, 251, which microneedle device comprises a plurality of hollow microneedles 52, 152, 252 configured for extraction of a sample of bodily fluid, and said sampling unit further comprises a sample recipient device 53, configured for receiving bodily fluid extracted by the microneedle device 51, 151, 251, and said sampling unit 50, 150, 250 being connected to the suction applying device 10, whereby a suction force can be applied to the microneedles of the microneedle device. When suction is applied to the microneedles 52, 152, 252, they can then extract bodily fluid when the microneedles have penetrated the skin of a person, and the bodily fluid is then directed to and received by the sample recipient device 53.
(32) Thus, when the sampling unit 50, 150, 250 is connected to the suction applying device 10, a fluid path is provided in the sampling unit between the microneedle device 51, 151, 251, and the sample recipient device 53, and the fluid path continues from the sample recipient device to the front opening 42 of the first conduit 40, whereby the fluid path forms a suction path such that a suction force can be applied from the front opening 42 of the first conduit 40 to the microneedle device 51, 151, 251, when the piston 20 is moved in a direction towards the front end 18 of the syringe body 12.
(33) Preferably, the sampling unit, or at least a part of it, is detachable from the suction applying device and replaceable. Generally, it is foreseen that the sampling unit can be a disposable unit, while the suction applying device is a base unit that is intended for multiple use.
(34) Some examples of a sampling unit have already been very briefly described above in connection with the description of the connection arrangement of the suction applying device.
(35) One example of a sampling unit 150 is shown in
(36) When the sampling unit 150 is attached to the suction applying device 10, a suction force can be generated at the front opening 42 of the first conduit 40 by moving the piston 20 forward in the hollow interior 14 of the syringe body 12. The suction force will act through the filter member 153 applied over the front opening 42 and through the hollow microneedles 152, whereby a sample of bodily fluid can be extracted through the microneedles when they have penetrated the skin, the stratum corneum, and into epidermis of the person from which a sample is required. Bodily fluid will then be directed from the microneedles and into the filter member 153 that will act as a sample recipient device. The sampling unit can then be removed and the filter member with the collected sample of bodily fluid can be analysed in a separate apparatus, usually comprising some type of sensor device.
(37) In one variant, the filter member may be prepared with a reagent that changes a physical or chemical property of the filter member when in contact with a component to be detected in the bodily fluid. The filter member will then offer a pre-stage for the analysis to be made. Indeed it is also possible that an analysis is not required but a simple measurement may be sufficient. If the property is a physical property, it may even be possible to have a visible indication related to the component to be detected just from looking at the filter member.
(38) According to another example, the apparatus comprises a sampling unit comprising a sensor device configured for detecting the presence of a component to be detected in the bodily fluid, and wherein said sensor device comprises said sample recipient device. An example of a sampling unit 50; 250 with a sensor device 56 is schematically illustrated in
(39) In one example, the sensor device may be configured to provide a measurement of an entity related to the presence of a component to be detected in the bodily fluid.
(40) The sensor device may comprise at least one electrical contact element that is connectable to at least one electrical contact provided as part of the connection arrangement, and by means of which electric connection of the sampling unit to the suction applying device can be provided.
(41) An example of a sensor device 56 is illustrated in
(42) In
(43) Each microneedle 52 comprises a capillary bore that defines a first fluid path for an extracted bodily fluid sample. The first fluid path is in fluid communication with a fluid channel 58 of the first substrate 57. The microneedle device 51 further comprises a second substrate 60 that comprises a first fluid port 61 in fluid communication with the fluid channel 58 of the first substrate 57. This substrate functions as a capillary closing layer. The sampling unit 50 further comprises a sensor device 56, which in this example is an electrochemical sensor device. The sensor device may for example be of the Clark type of electrochemical sensor.
(44) In the illustrated example, the electrochemical sensor device comprises two layers, a cavity forming layer 64 and a layer comprising an electrochemical transducer element 66. The cavity forming layer comprises a cavity 65 functioning as a sample recipient device. The cavity comprises a reagent that is chosen such that it will generate a chemical reaction when coming into contact with a component of the bodily fluid that it is desired to detect. This reaction will then influence an active area 67 the transducer element 66 and the chemical changes will be transformed into electrical signals. These signals will reflect a measurement of an entity related to the presence of the component to be detected. The cavity 65 is in fluid communication with the first fluid port 61 such that a fluid path for an extracted bodily fluid is created from each microneedle 52 to the cavity. The cavity layer 64 further comprises a connection path 69 that connects the cavity 65 with a through hole 59 in the transducer 66, which through hole is connectable with the front opening 42 of the first conduit 40 of the suction applying device. Thereby, the suction force generated at the front opening 42 can be transferred to the microneedles of the microneedle device.
(45) As shown in the example, the first fluid path extends from a first lower opening in the microneedle 52 into the capillary bore, which lower opening is in contact with the bodily fluid, to a second upper opening in the capillary bore which opening is located on the opposing upper side 54 of the first substrate 57. The openings of the capillary bores of the microneedles in the upper side 54 are all connected to the fluid channel 58. E.g. in the pattern illustrated in
(46) The microneedles 52 may for example be integrated into the first substrate 57.
(47) In
(48) When the different components of the sampling unit 50 are assembled and the sampling unit is connected to the front end 18 of the syringe body 12 of the suction applying device 10 by means of the connection arrangement 30, as shown in
(49) The sensor device 56 preferably comprises at least one electrical contact element 68 that is connectable to at least one electrical contact 31 provided as part of the connection arrangement 30 of the suction applying device 10. Electric connection of the sampling unit to the suction applying device can therefore be provided. An electric signal from the sensor device 56 can then be transmitted to the detection unit 80 forming part of the suction applying device. As mentioned, the electric signal from the transducer element 66 of the sensor device will reflect a measurement of an entity related to the presence of the component to be detected. The detection unit can then perform digitalization of said measurement derived from an extracted sample of bodily fluid. A display device 90 located on the suction applying device 10 can then be configured to display a result obtained from the detection unit, as shown in
(50) As an alternative to an electrochemical sensor device, it is possible to use a RF sensor device in combination with a microneedle device. For example an RF sensor device as described in WO 2015/187066.
(51) The concerned bodily fluid may be blood and/or interstitial fluid. The apparatus may be used for measuring e.g. glucose, i.e. the component that it is desired to detect may be glucose.
(52) The reagent in the filter or the cavity of the sensor device may e.g. be a protein, an enzyme, e.g. an oxidase reagent, or any other reagent suitable for the component in the bodily fluid that it is desired to detect.
(53) A method for detecting a component in a bodily fluid is also disclosed and illustrated in
(54) The method may also comprise optional additional steps of performing digitalization of the measurement and presenting the result derived from the detection of the component on a display unit.
(55) It should be mentioned that the sensor device mentioned in the method is not necessarily a sensor device forming part of the suction applying device, but it may alternatively be a sensor device provided as a separate unit.
(56) It should also be mentioned that the variants of the sampling unit as such that has been described above, may form part of the apparatus or can be used separately or in another type of apparatus.
(57) The invention shall not be considered limited to the illustrated embodiments, but can be modified and altered in many ways, as realised by a person skilled in the art, without departing from the scope defined in the appended claims.