Handheld measuring device for the analysis of body fluids with nuclear magnetic resonance sensor unit, a unit for recording a body fluid, and a puncture unit for minimally invasive puncture of a body.
Patent Information
- Application Number
- DE502019013592
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-08-27
- Filing Date
- 2019-08-20
- Publication Date
- 2025-07-31
- Estimated Expiration
- 2039-08-20
AI Technical Summary
Existing handheld devices for analyzing body fluids, such as blood, face challenges in performing minimally invasive sampling while ensuring reliability and user comfort, with a need for improved methods to extract and analyze small fluid samples efficiently.
A handheld device equipped with a nuclear magnetic resonance sensor unit, a microcapillary unit for fluid reception, and a minimally invasive puncture unit, utilizing mechanisms like ultrasound or laser ablation to create access channels, combined with a vacuum system for fluid extraction and optical measurement capabilities, allowing for precise and reliable sampling.
Enables comfortable, minimally invasive fluid sampling with reduced pain, reliable fluid collection, and efficient analysis, minimizing the need for additional samples through integrated mechanisms for puncture control and fluid conveyance.
Description
State of the art
[0001] US2005 / 0021019 A1 already proposes a handheld measuring device for analyzing body fluids, in particular blood, comprising at least one magnetic resonance sensor unit, at least one evaluation unit for evaluating a measurement signal supplied by the magnetic resonance sensor unit, and at least one recording unit, in particular a microcapillary unit, for recording the body fluid. Furthermore, the handheld measuring device proposed in US2005 / 0021019 A1 includes a biopsy needle designed to guide a sensor unit into a body and actively excise a tissue sample from the body.
[0002] Peng Weng Kung et al. published a scientific paper titled "Development of miniaturized, portable magnetic resonance relaxometry system for point-of-care medical diagnosis" in REVIEW OF SCIENTIFIC INSTRUMENTS, AIP, Vol. 83, No. 9, September 1, 2012 (2012-09-01), pages 95115 - 95115, XP012162672, ISSN: 0034-6748, D01: 10.1063 / 1.4754296. Peng Weng Kung et al. disclose a measuring device for analyzing body fluids.
[0003] US 2015 / 018638 A1 describes techniques for non-invasive measurement of blood-related parameters, whereby the measurements are based on an NMR relaxation technique.
[0004] DE 10 2015 111712 A1 discloses a test strip having a test strip body with a liquid reservoir.
[0005] From US 2003 / 114785 A1 a blood analysis device is known which comprises a microcapillary, wherein the microcapillary is applied to a substrate by means of a microfabrication process.
[0006] Cistola David P et al. provide a review publication on compact NMR instruments for blood analysis with "Compact NMR relaxometry of human blood and blood components" in TRAC TRENDS IN ANALYTICAL CHEMISTRY, ELSEVIER, Vol. 83, May 4, 2016 (2016-05-04), pages 53 - 64, XP029727418, ISSN: 0165-9936, DOI: 10.1016 / J.TRAC.2016.04.020. Disclosure of the invention
[0007] The invention relates to a handheld measuring device designed for the analysis of body fluids, in particular blood, with at least one nuclear magnetic resonance sensor unit, with at least one evaluation unit designed for the evaluation of a measurement signal supplied by the nuclear magnetic resonance sensor unit and with at least one recording unit, in particular microcapillary unit, designed for recording the body fluid.
[0008] It is proposed that the handheld measuring device comprise at least one puncture unit for minimally invasive puncture of a body, in particular a capillary bed of a body. Preferably, the handheld measuring device is intended to analyze blood. It is also conceivable that other body fluids, in particular in addition to blood, can be analyzed with the handheld measuring device, for example, lymph, urine, and / or saliva. Preferably, the body fluid is taken from the body for analysis.
[0009] Preferably, the body is punctured to remove the bodily fluid. During a puncture, an access channel is preferably created into the body to allow access to the bodily fluid located therein. During a puncture, an access channel is preferably created through which the bodily fluid exits the body, particularly through the action of a force generated by the measuring device. It is particularly conceivable for the puncture unit to be formed at least partially in one piece with the receiving unit.
[0010] In particular, the puncture unit is intended to create an access channel for a body fluid into a body. For example, the puncture unit comprises at least one piercing, cutting, milling, etching and / or drilling unit for creating an access channel in a body. The puncture unit preferably comprises a control unit for controlling the puncture. The puncture unit preferably comprises a sensor unit for detecting a puncture parameter, for example a penetration depth of the created access channel into the body and / or a hardness of the body. The sensor unit is preferably intended, in particular together with the control unit, for regulating the puncture. The handheld measuring device preferably has a contact surface which is intended to be applied to a body. The contact surface preferably lies in a contact plane.The puncture unit is preferably designed to perform a puncture substantially perpendicular to the application plane. In particular, a puncture direction for creating an access channel is substantially perpendicular to the application plane. The term "substantially perpendicular" is intended here to define, in particular, an orientation of a direction relative to a reference direction, wherein the direction and the reference direction, particularly viewed in a plane, enclose an angle of 90°, and the angle has a maximum deviation of, in particular, less than 8°, advantageously less than 5°, and particularly advantageously less than 2°.In particular, a puncture performed by the puncture unit is to be regarded as "minimally invasive" if a maximum effective area of the puncture unit for creating an access channel in a plane perpendicular to the puncture direction, in particular in the application plane, is less than 5 mm 2< , preferably less than 2.5 mm 2< and particularly preferably less than 0.5 mm 2<.
[0011] Preferably, the body fluid exiting the access channel after the puncture is received by the receiving unit in a receiving space of the receiving unit. Preferably, the receiving unit exerts a force on the body fluid that assists it to exit the body. Preferably, the receiving unit is designed as a microcapillary unit. Preferably, the receiving unit has at least one capillary, in particular a microcapillary. Preferably, the capillary has a largest inner diameter of less than 0.5 mm, particularly preferably less than 0.3 mm, in a plane perpendicular to a maximum extent of an inner surface of the capillary. Preferably, the capillary has a largest inner diameter of between 0.05 and 0.5 mm, particularly preferably between 0.1 and 0.3 mm, in a plane perpendicular to a maximum extent of an inner surface of the capillary.Preferably, an interior of a capillary is provided as a receiving space for receiving the body fluid. The receiving space preferably has a receiving opening. The body fluid preferably enters the receiving space through the receiving opening, in particular due to capillary force. Preferably, an edge of the receiving unit delimiting the receiving opening lies in an opening plane that runs essentially parallel to the contact plane. Preferably, the edge faces the contact plane. Preferably, the opening plane is essentially flush with the contact plane in at least one operating state of the handheld measuring device. In this context, "at least essentially flush" is to be understood in particular to mean that the opening plane has a maximum distance from the contact plane that is at least less than 5 mm, preferably less than 1 mm, and particularly preferably less than 0.5 mm.
[0012] The nuclear magnetic resonance sensor unit preferably comprises at least one magnetic field unit for generating a static magnetic field. The magnetic field unit is preferably designed as a permanent magnet. However, it is also conceivable for the magnetic field unit to be designed as an electromagnet, in particular for adjusting and / or scanning the amplitude of a generated magnetic field. The nuclear magnetic resonance sensor unit preferably comprises at least one transmitting unit for transmitting and / or receiving an alternating magnetic field. The transmitting unit preferably has an induction coil for transmitting and / or receiving an alternating magnetic field. The nuclear magnetic resonance sensor unit preferably has a control unit for carrying out a spectroscopic method. The nuclear magnetic resonance sensor unit is preferably provided for detecting measurement signals relating to a body fluid located in the receiving space of the receiving unit.
[0013] Preferably, measurement signals generated by the magnetic resonance sensor unit are evaluated by the evaluation unit, in particular to generate a magnetic resonance spectrum. In particular, the evaluation unit is provided to determine a characteristic of the body fluid from the measurement signals of the magnetic resonance sensor unit. In particular, a characteristic is designed as an absolute and / or relative amount, in particular a concentration, of a substance contained in the body fluid, for example glucose, alcohol, hemoglobin and / or lactate. Preferably, the evaluation unit is arranged in a housing of the handheld measuring device. Alternatively, it is also conceivable for the evaluation unit to be designed separately from the handheld measuring device, wherein the measurement signals of the magnetic resonance sensor unit are transmitted via a data interface, in particular a wireless one.Alternatively or additionally, the evaluation unit transmits a result of the evaluation for output and / or storage to an external device, such as a PC, a smartphone, a tablet, a laptop or the like, by means of the data interface, in particular a wireless one.
[0014] "Handheld" is understood in particular to mean that the measuring device can be transported by hand, in particular with one hand, without the aid of a transport machine and / or a holding device, and can be operated, in particular, to collect body fluid. In particular, the mass of the measuring device is less than 10 kg, preferably less than 5 kg, and particularly preferably less than 1 kg.
[0015] "Intended" should be understood in particular to mean specifically programmed, designed, and / or equipped. The fact that an object is intended for a specific function should be understood in particular to mean that the object fulfills and / or performs this specific function in at least one application and / or operating state.
[0016] The inventive design of the handheld measuring device allows for an advantageously comfortable sampling of a body fluid. In particular, a minimally invasive puncture minimizes the sensation of pain. In particular, a minimally invasive puncture allows the fluid exiting the access channel to be limited to the amount necessary for analysis.
[0017] Furthermore, it is proposed that the puncture unit comprise at least one puncture element, in particular a lancet, which has a maximum outer diameter of less than 1 mm, at least in an area intended for puncture. A "puncture element" is understood, in particular, to be an element that penetrates the body during a puncture to create an access channel, in particular penetrating a surface of the body. The puncture element is preferably a piercing tool, in particular a lancet. However, it is also conceivable for the puncture element to be designed as a cutting element, milling element, etching element, drilling element, and / or as another tool deemed appropriate by a person skilled in the art for creating an access channel. The puncture element preferably has a tapered end region.Preferably, the tapered end region is intended to penetrate the body during a puncture. In particular, the region intended for puncture has a maximum outer diameter of less than 1 mm, preferably less than 0.7 mm, particularly preferably less than 0.4 mm, in a plane perpendicular to the puncture direction. It is also conceivable for the puncture element to be formed integrally with the receiving unit, in particular with a capillary, and in particular to be arranged on an edge of the receiving unit delimiting the receiving opening. The inventive design of the handheld measuring device advantageously makes it easy to achieve a minimally invasive puncture of a body.
[0018] It is further proposed that the puncture unit for puncturing the body have a mechanical unit, in particular an ultrasound-driven one. A "mechanical unit" is to be understood in particular as a unit for generating a movement and / or a mechanical oscillation, in particular for a puncture. Preferably, the mechanical unit generates a relative movement of an element of the puncture unit, in particular the puncture element, relative to the application plane, in particular along the puncture direction. Preferably, the relative movement for puncturing the body is provided by means of the element, in particular the puncture element. Preferably, the mechanical unit comprises a guide element for guiding the element along a constrained path, in particular along the puncture direction. Preferably, the mechanical unit comprises a drive unit for generating the relative movement of the puncture element.The drive unit is preferably electromechanical, in particular as a linear motor or linear actuator. Alternatively, a drive can be mechanical, in particular by means of at least one spring-elastic element and / or by means of a transmission unit, for transmitting a force and / or torque applied, in particular by a user, to the puncture element. The mechanical unit preferably comprises an ultrasound unit. The ultrasound unit is preferably provided to excite the puncture element of the puncture unit, which can be driven by the mechanical unit, to oscillate. Preferably, at least during a puncture, the relative movement of the puncture element caused by the mechanical unit is superimposed with an oscillation of the puncture element caused by the ultrasound unit.In a further embodiment of the mechanical unit, it is conceivable for the mechanical unit to comprise an ultrasound unit designed for direct puncture of a body. The inventive design of the handheld measuring device advantageously allows a puncture parameter to be adjusted. In particular, the force required and the depth of penetration of the element of the puncture unit into the body can be limited to a necessary minimum. In particular, a minimally invasive puncture can advantageously be designed to be reliable and reproducible.
[0019] It is further proposed that the puncture unit for puncturing the body have a laser unit. The laser unit preferably comprises at least one beam source unit, in particular a laser diode, for generating a laser beam. In particular, the laser unit generates a laser beam that propagates along the puncture direction, in particular during the puncture. The laser unit preferably comprises an optical unit for focusing the laser beam, in particular onto a body lying against the contact surface. The laser unit is preferably provided to create an access channel into the body by means of laser ablation. In particular, the laser beam provided for puncture has a maximum outer diameter of less than 1 mm, preferably less than 0.7 mm, particularly preferably less than 0.4 mm, in a plane perpendicular to the puncture direction.The inventive design of the handheld measuring device advantageously allows a puncture parameter to be adjusted. In particular, the penetration depth of the puncture unit element into the body can be limited to a necessary minimum. In particular, a minimally invasive puncture can be advantageously designed to be reliable and reproducible. In particular, wear can be reduced compared to a mechanical puncture unit. In particular, replacement of the puncture element for hygienic reasons can be avoided.
[0020] It is further proposed that the receiving unit has a vacuum unit for generating a vacuum which is intended to convey the body fluid. The vacuum unit preferably comprises a sealing unit which, at least in a cross-section perpendicular to the puncture direction, completely encloses the puncture direction, in particular the puncture element and / or the laser beam for puncture, as well as the receiving opening of the receiving unit. The sealing unit preferably closes off in the contact plane with a contact element, in particular an elastic one. The sealing unit preferably encompasses an area around the receiving opening of the receiving unit which is open towards the contact plane. In particular, the sealing unit is intended to seal an area around the receiving opening when the measuring device is arranged on a body with the contact element.The vacuum unit is preferably provided to reduce the air pressure in the area enclosed by the sealing unit and the body. In particular, the vacuum unit is provided to assist the escape of a body fluid through an access channel created by the puncture unit by reducing the air pressure. Preferably, due to the vacuum, an amount of body fluid of at least 0.1 µl, particularly preferably of at least 0.5 µl, is conveyed through the access channel created by the puncture unit. Preferably, due to the vacuum, an amount of body fluid of 0.1 µl to 15 µl, particularly preferably of 0.5 µl to 4 µl, is conveyed through the access channel created by the puncture unit. The sealing unit preferably comprises a venting valve to restore normal pressure in the area enclosed by the sealing unit.Due to the inventive design of the handheld measuring device, a sufficient amount of body fluid can be extracted for analysis despite an access channel to the body fluid created by a minimally invasive puncture.
[0021] Furthermore, it is proposed that the vacuum unit has at least one heating element for generating a negative pressure, which heating element is provided at least for increasing the temperature of an area at a receiving opening of a receiving space of the receiving unit. The heating element is preferably designed as a radiant heater. The heating element is preferably arranged on an inner wall of the sealing unit. It is also conceivable for the heating element to be integrated into a wall of the sealing unit. The sealing element is preferably provided to seal an area with an elevated temperature, in particular by closing the ventilation valve. Alternatively, the area with the elevated temperature can also be sealed by attaching the handheld measuring device to the body. The vacuum unit preferably has a temperature sensor unit for regulating the heating element.In particular, the vacuum unit has a switching unit for switching off the heating element, in particular when a predeterminable temperature is reached. Alternatively or additionally, the switching unit has a timer unit and / or a monostable flip-flop for controlling a heating duration. In an alternative embodiment of the handheld measuring device, the vacuum unit has a pump unit for generating a negative pressure in an area at a receiving opening of a receiving space of the receiving unit. The inventive embodiment of the handheld measuring device advantageously makes it easy to generate a negative pressure for conveying a body fluid through an access channel created by a minimally invasive puncture.
[0022] It is further proposed that a fill level output unit be provided for outputting a fill level of the receiving unit. Preferably, the fill level output unit is provided to output a fill level of the receiving space of the receiving unit with a bodily fluid. For example, the fill level output unit is provided to indicate that a sufficient amount of bodily fluid for analysis is present in the receiving space. In particular, the fill level output unit indicates that at least more than 0.1 µl, preferably more than 0.5 µl, is present in the receiving space of the receiving unit. For example, the fill level output unit is provided to indicate that an insufficient amount of bodily fluid for analysis is present in the receiving space. Preferably, a fill level is detected electronically, in particular by means of a capacitive sensor unit of the fill level output unit.However, it is also conceivable for the fill level output unit to have an ultrasound unit or a transmission unit for electromagnetic radiation, for example in the form of at least one light barrier, to detect the fill level. The detected fill level can be output visually, acoustically and / or haptically. For example, the fill level output unit can have a display, control lights, loudspeakers and / or a vibration element. Preferably, if the fill level is insufficient for analysis, a further vacuum cycle is automatically activated to additionally transport body fluid out of the body. Alternatively or additionally, the fill level output unit can have a viewing window embedded in a housing of the handheld measuring device. The viewing window is preferably provided to allow a view of the receiving space from the outside.In particular, the receiving space has a transparent wall at the visible location and preferably a scale element, in particular a mark indicating a minimum required fill level. The inventive design of the handheld measuring device advantageously makes it possible to at least monitor the reliability of the intake of a body fluid through an access channel to a body fluid created by means of a minimally invasive puncture. In particular, a high level of reliability of the intake of a body fluid through an access channel to a body fluid created by means of a minimally invasive puncture can be achieved by electronic detection of the fill level in combination with control of the vacuum unit.
[0023] Furthermore, it is proposed that the receiving unit has an at least partially transparent wall, in particular at least partially delimiting a receiving space, for performing an optical measurement, in particular NIR spectroscopy, of the body fluid. Preferably, the handheld measuring device has an optical measuring unit. Preferably, the optical measuring unit is intended to perform an optical measurement. Preferably, the optical measuring unit is intended to perform near-infrared (NIR) spectroscopy. An "at least partially transparent wall for performing an optical measurement" is to be understood in particular as a wall made of a material that has a transmittance of at least 50%, preferably at least 75%, at least at a center frequency of the electromagnetic radiation used in the optical measurement.In particular, the at least partially transparent wall at least partially delimits the receiving space. Preferably, the partially transparent wall allows for interaction of electromagnetic radiation used in the optical measurement, in particular generated outside the receiving unit, with a body fluid located in the receiving space. The inventive design of the handheld measuring device advantageously allows additional measurement data to be obtained from a single sample of a body fluid. In particular, taking a further sample of the body fluid can be avoided.
[0024] It is further proposed that the receiving unit comprise at least one movably mounted receiving element for receiving the body fluid. In particular, the receiving element comprises the receiving space for receiving the body fluid. Preferably, the receiving unit comprises a guide element for guiding the movably mounted receiving element. Preferably, the receiving unit comprises a drive unit for carrying out a movement of the movably mounted receiving element. Preferably, the drive unit is provided to transport the movably mounted receiving element into various functional areas of the handheld measuring device. For example, the movably mounted receiving element is provided to be moved from a receiving area for receiving the body fluid into an analysis area for recording the characteristic of the received body fluid.It is also conceivable that a distance of the receiving element from the application plane, in particular from an adjacent body, is controlled and / or regulated for receiving the body fluid. Alternatively or additionally, the receiving element is mounted via a spring-elastic element to absorb a force acting on the receiving element in the puncture direction, in particular when the handheld measuring device is applied to a body. The inventive design of the handheld measuring device advantageously makes it possible to achieve a high level of reliability in the collection of a body fluid through an access channel to a body fluid created by means of a minimally invasive puncture by adjusting the distance. In particular, different areas, for example for different measurements, can advantageously be spatially separated in order to minimize mutual interference.
[0025] It is further proposed that the receiving unit has at least two receiving elements, which are movably mounted in particular substantially perpendicular to the puncture direction and which are interchangeable for receiving the body fluid, in particular within the receiving unit. In particular, a receiving element comprises a receiving space for receiving the body fluid. In particular, different receiving elements are provided for receiving the body fluid during different measurements with the handheld measuring device. Preferably, the receiving unit comprises more than 5, preferably more than 15, particularly preferably more than 30 receiving elements. Preferably, the receiving unit comprises a magazine unit for storing unused receiving elements. Preferably, the magazine unit is designed as a drum magazine. Preferably, a rotation axis of the drum magazine is arranged substantially parallel to the puncture direction."Substantially parallel" is understood here to mean, in particular, an alignment of a direction relative to a reference direction, in particular in a plane, wherein the direction has a deviation from the reference direction of, in particular, less than 8°, advantageously less than 5°, and particularly advantageously less than 2°. However, it is also conceivable for the magazine unit to be designed as a box or rod magazine. Preferably, the magazine unit is arranged, in particular tool-free and non-destructively detachable, on a housing and / or a holding unit within the housing of the handheld measuring device, in particular for exchanging the magazine by a user. The inventive design of the handheld measuring device advantageously allows a high level of user comfort to be achieved.In particular, several measurements can be carried out before an exchange of a receiving element located in the hand-held measuring device, in particular a filled one, with a receiving element located outside the hand-held measuring device, in particular an empty one, has to be carried out, in particular by a user.
[0026] It is further proposed that the puncture unit have at least two puncture elements which are movably mounted, in particular substantially perpendicular to the puncture direction, and which are interchangeable, in particular, together with movably mounted receiving elements of the receiving unit. In particular, different puncture elements are provided to be used for different punctures with the handheld measuring device. The receiving unit preferably comprises more than 5, preferably more than 15, particularly preferably more than 30 puncture elements. The receiving unit preferably comprises a puncture magazine unit for storing unused puncture elements. The puncture magazine unit is preferably designed as a drum magazine. Preferably, an axis of rotation of the drum magazine is arranged substantially parallel to the puncture direction. However, it is also conceivable for the puncture magazine unit to be designed as a box or rod magazine.The puncture magazine unit is preferably arranged, in particular without tools, in a non-destructively detachable manner on a housing and / or a holding unit within the housing of the handheld measuring device, in particular for replacement of the puncture magazine unit by a user. The puncture magazine unit is particularly preferably formed integrally or at least positively and / or non-positively with the magazine unit of the receiving unit. In particular, it is also conceivable for the puncture elements to be formed integrally or at least positively and / or non-positively with a receiving element each, in particular for storage in a common magazine unit. It is also conceivable for the puncture magazine unit and the magazine unit to be mounted independently of one another so that they can be moved and / or detached non-destructively. The inventive design of the handheld measuring device advantageously achieves a high level of user comfort.In particular, several measurements can be taken before a puncture element located in the handheld measuring device, in particular one partially wetted with a body fluid, has to be replaced with a puncture element located outside the handheld measuring device, in particular a clean puncture element, in particular by a user.
[0027] Furthermore, a method for operating a handheld measuring device according to the invention for analyzing body fluids, in particular blood, is proposed. According to the invention, the method comprises at least one method step for minimally invasively puncturing a body using the puncture unit of the handheld measuring device; a method step in which a body fluid escaping from the body as a result of the puncture is collected by the collection unit, in particular using a negative pressure; and a method step for detecting measurement signals of the body fluid located in the collection unit using the nuclear magnetic resonance sensor unit.
[0028] Preferably, the method steps are carried out automatically one after the other and / or in parallel, in particular by means of a central control and / or regulating unit, in particular at least substantially free of user intervention. The inventive design of the method allows for convenient operation of the handheld measuring device, which advantageously enables convenient sampling of a body fluid.
[0029] The handheld measuring device according to the invention and / or the method according to the invention should not be limited to the application and embodiment described above. In particular, the handheld measuring device according to the invention and / or the method according to the invention can have a number of individual elements, components, method steps, and units that differs from the number stated herein to fulfill a functionality described herein, provided this falls within the scope of protection defined by the claims. Furthermore, in the value ranges specified in this disclosure, values within the stated limits should also be considered disclosed and can be used as desired. Drawings
[0030] Further advantages will become apparent from the following description of the drawings. The drawings illustrate three exemplary embodiments of the invention. The drawings, the description, and the claims contain numerous features in combination. Those skilled in the art will also expediently consider the features individually and combine them into meaningful further combinations, provided this falls within the scope of protection defined by the claims.
[0031] They show: Fig. 1 is a schematic representation of a handheld measuring device according to the invention with a puncture element for puncture, Fig. 2 is a flow chart of a method according to the invention for operating the handheld measuring device according to the invention, Fig. 3 is a schematic representation of an alternative handheld measuring device according to the invention with a laser unit for puncture, Fig. 4 is a schematic representation of a further alternative handheld measuring device according to the invention with a drum magazine and Fig. 5 is a schematic representation of a further alternative handheld measuring device according to the invention with a puncture magazine. Description of the embodiments
[0032] Figure 1shows a schematic representation of a handheld measuring device 10a for analyzing body fluids, in particular blood, with at least one nuclear magnetic resonance sensor unit 12a. The nuclear magnetic resonance sensor unit 12a preferably comprises at least one magnetic field unit 50a for generating a static magnetic field. The magnetic field unit 50a is preferably designed as a permanent magnet. The nuclear magnetic resonance sensor unit 12a preferably has an induction coil 52a for emitting and / or receiving an alternating magnetic field. The nuclear magnetic resonance sensor unit 12a preferably has a control unit 54a for carrying out a spectroscopic method. The handheld measuring device 10a has at least one evaluation unit 14a for evaluating a measurement signal supplied by the nuclear magnetic resonance sensor unit 12a.The handheld measuring device 10a comprises at least one receiving unit 16a, in particular a microcapillary unit, for receiving the body fluid. The receiving unit 16a preferably has at least one receiving element 44a with a receiving space 38a for receiving the body fluid. In particular, the receiving element 44a is designed as a capillary 56a, in particular as a microcapillary. The capillary 56a preferably has a largest inner diameter 58a of between 0.05 and 0.5 mm, particularly preferably between 0.1 and 0.3 mm, in a plane perpendicular to a maximum extension of an inner surface of the capillary 56a. The receiving space 38a preferably has a receiving opening 36a. The body fluid preferably passes through the receiving opening 36a into the receiving space 38a, in particular due to capillary force. The handheld measuring device 10a preferably has an application surface 60a, which is intended to be applied to a body.The handheld measuring device 10a comprises at least one puncture unit 18a for minimally invasive puncture of the body, in particular a capillary bed of the body. The puncture unit 18a has at least one puncture element 20a, in particular a lancet, which has a maximum outer diameter 24a of less than 1 mm at least in a region 22a intended for puncture. The puncture element 20a is preferably a piercing tool, in particular a lancet. Alternatively, the puncture element 20a can also be formed integrally with the receiving unit 16a for simultaneous reception of a body fluid, for example as a cannula. The puncture element 20a can be formed integrally with the receiving element 44a of the receiving unit 16a. The puncture unit 18a has a mechanical unit 26a, in particular an ultrasound-driven one, for puncturing the body.The mechanical unit 26a preferably comprises an electrostatic, electromagnetic, and / or magnetostrictive linear actuator for generating a relative movement of a puncture element 20a. The mechanical unit 26a preferably comprises a pulse generator for controlling the linear actuator. The puncture element 20a is preferably connected to the linear actuator in a non-destructively detachable manner. In particular, the puncture element 20a can be replaced by a user, particularly without tools. Alternatively, the mechanical unit 26a has a spring-elastic drive element.
[0033] The receiving unit 16a has a vacuum unit 30a for generating a vacuum intended to convey the body fluid.
[0034] The vacuum unit 30a preferably comprises a sealing unit 62a, which completely encloses the puncture element 20a and the receiving opening 36a of the receiving unit 16a, at least in a cross-section perpendicular to the puncture direction 48a. The sealing unit 62a preferably terminates in the contact plane with a contact element 64a, in particular an elastic contact element. The sealing unit 62a preferably encompasses an area 34a around the receiving opening 36a of the receiving unit 16a, which area is open towards the contact surface 60a. The sealing unit 62a preferably has a privacy shield 66a and / or is made of an opaque material to prevent observation of any escaping body fluid, in particular by uninvolved persons.The vacuum unit 30a has at least one heating element 32a for generating a vacuum, which is provided at least for increasing the temperature of the area 34a at the receiving opening 36a of the receiving space 38a of the receiving unit 16a.
[0035] The handheld measuring device 10a comprises a fill level output unit 40a for outputting a fill level of the receiving unit 16a. The measuring device 10a preferably comprises a viewing window 68a for viewing the receiving space 38a through a transparent wall 42a of the capillary 56a. The handheld measuring device 10a preferably comprises a display 70a for displaying an evaluation of the evaluation unit 14a. The display 70a is preferably provided to display a fill level of the receiving unit 16a. A fill level of the receiving space 38a is preferably detected by means of a capacitive sensor unit 72a.
[0036] The handheld measuring device 10a preferably comprises a housing 74a. The housing 74a is preferably provided to protect at least the receiving element 44a. The measuring device 10a preferably comprises at least one, in particular central, control and / or regulating unit 76a with a processor unit and a memory unit, as well as with an operating program stored in the memory unit for carrying out a method 98a for operating the handheld measuring device 10a. The operating program preferably performs a self-diagnosis after the handheld measuring device 10a is switched on.
[0037] Figure 2shows a flowchart of the method 98a for operating the handheld measuring device for analyzing body fluids, in particular blood. Preferably, the handheld measuring device 10a comprises at least one operating element 78a for triggering the method 98a. Optionally, the measuring device 10a has further operating elements, in particular for setting operating parameters. Preferably, the handheld measuring device 10a is placed on a body by a user and the method is then started by actuating 100a the operating element 78a. Preferably, a negative pressure is generated in the region 34a. Preferably, after the negative pressure 102a has been generated, a puncture method step 103a is carried out. In particular, during the puncture method step 103a, the puncture element 20a pierces the body and is subsequently withdrawn.Preferably, during a recording method step 104a, an escaping amount of body fluid is recorded by the recording unit 16a, in particular automatically, into the recording chamber 38a. Preferably, a check 106a of the fill level of the recording chamber 38a with a body fluid is carried out. Preferably, when the fill level of the recording chamber 38a is sufficient, a user is notified by means of the fill level output unit 40a that the handheld measuring device 10a can be removed from the body. In particular, a measuring method 108a is started. In particular, a nuclear magnetic resonance spectrum is created. Preferably, the measurement signals generated during the measuring method 108a are evaluated in the evaluation unit 14a. Preferably, in an output method step 110a, a determined characteristic of the body fluid is output on the display 70a.Optionally, the characteristic value of the body fluid is transmitted to an external device (not shown in detail here) during the output process step 110a.
[0038] In the Figures 3 and 4 A further embodiment of the invention is shown in each case. The following descriptions and the drawings are essentially limited to the differences between the embodiments, whereby with regard to components with the same designation, in particular with regard to components with the same reference numerals, reference is also made to the drawings and / or the description of the other embodiments, in particular to the Figures 1 and 2 To distinguish the embodiments, the letter a is added to the reference numerals of the embodiment in the Figures 1 and 2 In the examples of the Figures 3 and 4 the letter a is replaced by the letters b or c.
[0039] Figure 3shows a schematic representation of a handheld measuring device 10b for analyzing body fluids, in particular blood, with at least one nuclear magnetic resonance sensor unit 12b. The handheld measuring device 10b has at least one evaluation unit 14b for evaluating a measurement signal supplied by the nuclear magnetic resonance sensor unit 12b. The handheld measuring device 10b comprises at least one recording unit 16b, in particular a microcapillary unit, for recording the body fluid. The handheld measuring device 10b comprises at least one puncture unit 18b for minimally invasive puncture of the body, in particular a capillary bed of the body. The puncture unit 18b has a laser unit 28b for puncturing the body. In particular, the laser unit 28b generates a laser beam 80b, which propagates along the puncture direction 48b, in particular during the puncture method step 103b.The laser unit 28b preferably comprises an optical unit 82b for focusing the laser beam 80b. The laser unit 28b preferably has at least one safety unit. The safety unit is preferably provided to prevent a laser beam 80b from propagating from the laser unit 28b beyond the contact surface 60b. In particular, the safety unit comprises a switching element for blocking the laser beam 80b and / or interrupting the generation of the laser beam 80b, in particular depending on a safety parameter. For example, the laser unit 28b could comprise a brightness sensor that measures a quantity of light in the area 34b. For example, the laser unit 28b could comprise a laser detector and a laser evaluation unit for evaluating a backscattered portion of the laser beam 80b with respect to a traveled distance.For example, a proximity sensor for detecting the presence of a body could be arranged on the sealing unit 62b, in particular on the contact element 64b. Regarding further features and / or functions of the handheld measuring device 10b, reference may be made to the description of the . Figures 1 and 2 be referred to.
[0040] Figure 4shows a schematic representation of a handheld measuring device 10c for analyzing body fluids, in particular blood, with at least one nuclear magnetic resonance sensor unit 12c. The handheld measuring device 10c has at least one evaluation unit 14c for evaluating a measurement signal supplied by the nuclear magnetic resonance sensor unit 12c. The handheld measuring device 10c comprises at least one receiving unit 16c, in particular a microcapillary unit, for receiving the body fluid. The handheld measuring device 10c comprises at least one puncture unit 18c for minimally invasive puncture of the body, in particular a capillary bed of the body.
[0041] The receiving unit 16c has an at least partially transparent wall 42c, in particular at least partially delimiting a receiving space 38c, for performing an optical measurement, in particular NIR spectroscopy, of the body fluid. The handheld measuring device 10c preferably has an optical measuring unit 84c. The optical measuring unit 84c is preferably provided to record an NIR spectrum of the body fluid located in the receiving space 38c. Measurement data from the optical measuring unit 84c are preferably evaluated in the evaluation unit 14c.
[0042] The receiving unit 16c comprises at least one movably mounted receiving element 44c, 46c for receiving the body fluid. The receiving unit 16c comprises at least two movably mounted receiving elements 44c, 46c, in particular substantially perpendicular to the puncture direction 48c, which are interchangeable for receiving the body fluid, in particular within the receiving unit 16c. The receiving unit 16c preferably comprises a magazine unit 86c designed as a drum magazine for storing unused receiving elements 46c. A rotation axis 88c of the drum magazine is preferably arranged substantially parallel to the puncture direction 48c. The drum magazine can preferably be driven for a rotation 90c, in particular stepwise, about the rotation axis 88c by means of a rotary drive unit, in particular an electric one, of the receiving unit 16c. However, it is also conceivable for the magazine unit 86c to be rotatable manually, in particular by a user.Preferably, a receiving element 44c engages in a receiving and / or measuring position 94c of the rotation 90. Preferably, the receiving unit 16c, in particular the magazine unit 86c, comprises a guide element 96c for guiding the movably mounted receiving element 44c along a direction of movement 92c. Preferably, the receiving unit 16c comprises a drive unit for moving a receiving element 44c located in the receiving and / or measuring position 94c. Preferably, the receiving element 44c is moved toward the contact surface 60c for receiving a body fluid. Preferably, the receiving element 44c is moved away from the contact surface 60c for analyzing the body fluid by means of the optical measuring unit 84c and / or exchanging the receiving elements 44c, 46c. Preferably, the receiving unit 16c comprises a drive unit for moving the movably mounted receiving element 44c.For further features and / or functions of the handheld measuring device 10c, reference may be made to the description of the . Figures 1 to 3 be referred to.
[0043] Figure 5 shows a schematic representation of a handheld measuring device 10d for analyzing body fluids, in particular blood, with at least one magnetic resonance sensor unit 12d. The handheld measuring device 10d has at least one evaluation unit 14d for evaluating a measurement signal supplied by the magnetic resonance sensor unit 12d. The handheld measuring device 10d comprises at least one receiving unit 16d, in particular a microcapillary unit, for receiving the body fluid. The handheld measuring device 10d comprises at least one puncture unit 18d for minimally invasive puncture of the body, in particular a capillary bed of the body.
[0044] The puncture unit 18d has at least one puncture element 20d, 21d, which is formed integrally with a receiving element 44d, 46d of the receiving unit 16d. Preferably, each of the puncture elements 20d, 21d is formed integrally with a receiving element 44d, 46d. However, it is also conceivable for the puncture element 20d, 21d to be detachably arranged on a receiving element 44d, 46d, for example, by means of a positive and / or non-positive connection between the puncture element 20d, 21d and the receiving element 44d, 46d.
[0045] The puncture unit 18d has at least two puncture elements 20d, 21d, which are movably mounted, in particular substantially perpendicular to the puncture direction 48d, and which are interchangeable, in particular, together with movably mounted receiving elements 44d, 46d of the receiving unit 16d. In particular, the puncture elements 44d, 46d are arranged in and / or on a puncture magazine unit 87d, in particular a drum magazine. Preferably, the puncture magazine unit 87d for the puncture elements 20d, 21d is designed analogously to the above-described magazine unit 86c for the receiving elements 44c, 46c. Preferably, the puncture magazine unit 87d is formed integrally with the magazine unit 86d. The handheld measuring device 10d preferably comprises a common magazine unit 86d for storing the receiving elements 44d, 46d and the puncture elements 20d, 21d.Preferably, at least one puncture element 20d, 21d can be stored in the puncture magazine unit 87d per receiving element 44d, 46d. Regarding further features and / or functions of the handheld measuring device 10d, reference may be made to the description of the . Figures 1 to 4 be referred to.
Claims
1. Hand-held measuring device designed for analysing body fluids, in particular blood, having at least one nuclear magnetic resonance sensor unit (12a; 12b; 12c; 12d), having at least one evaluation unit (14a; 14b; 14c; 14d) designed for evaluating a measurement signal supplied by the nuclear magnetic resonance sensor unit (12a; 12b; 12c; 12d) and having at least one receiving unit (16a; 16b; 16c; 16d), in particular microcapillary unit, designed for receiving the body fluid, characterized by at least one puncture unit (18a; 18b; 18c; 18d) designed for minimally invasive puncturing of a body, in particular a capillary bed of a body.
2. Hand-held measuring device according to Claim 1, characterized in that the puncture unit (18a; 18d) has at least one puncture element (20a; 20d, 21d), in particular a lancet, which has a maximum outside diameter (24a; 24d) of less than 1 mm at least in a region (22a; 22d) intended to be punctured.
3. Hand-held measuring device according to Claim 1 or 2, characterized in that the puncture unit (18a; 18d) has an, in particular ultrasound-driven, mechanical unit (26a; 26d) for puncturing the body.
4. Hand-held measuring device according to any of the preceding claims, characterized in that the puncture unit (18b; 18c) has a laser unit (28b; 28c) for puncturing the body.
5. Hand-held measuring device according to any of the preceding claims, characterized in that the receiving unit (16a; 16b; 16c; 16d) has a vacuum unit (30a; 30b; 30c; 30d) for generating a vacuum, which is provided for conveying the body fluid.
6. Hand-held measuring device according to Claim 5, characterized in that the vacuum unit (30a; 30b; 30c; 30d) has, for generating a vacuum, at least one heating element (32a; 32b; 32c; 32d), which is provided at least for increasing the temperature of a region (34a; 34b; 34c; 34d) at a receiving opening (36a; 36b; 36c; 38d) of a receiving space (38a; 38b; 38c; 38d) of the receiving unit (16a; 16b; 16c; 16d).
7. Hand-held measuring device according to any of the preceding claims, <b>characterized by a filling level output unit (40a; 40b; 40c; 40d) designed for outputting a filling level of the receiving unit (16a; 16b; 16c; 16d).
8. Hand-held measuring device according to any of the preceding claims, characterized in that the receiving unit (16c; 16d) has an at least partially transparent wall (42c; 42d), in particular at least partially delimiting a receiving space (38c; 38d), designed for carrying out an optical measurement, in particular NIR spectroscopy, of the body fluid.
9. Hand-held measuring device according to any of the preceding claims, characterized in that the receiving unit (16c; 16d) comprises at least one movably mounted receiving element (44c, 46c; 44d, 46d) designed for receiving the body fluid.
10. Hand-held measuring device according to any of the preceding claims, characterized in that the receiving unit (16c; 16d) has at least two receiving elements (44c, 46c; 44d, 46d), in particular movably mounted with a maximum angular deviation of less than 8° perpendicular to a puncture direction (48c; 48d), which are interchangeable for receiving the body fluid, in particular within the receiving unit (16c; 16d).
11. Hand-held measuring device according to any of the preceding claims, characterized in that the puncture unit (18d) has at least two puncture elements (20d, 21d), in particular movably mounted with a maximum angular deviation of less than 8° perpendicular to a puncture direction (48d), which are interchangeable, in particular together with movably mounted receiving elements (44d, 46d) of the receiving unit (16d).
12. Method for operating a hand-held measuring device for analysing body fluids, in particular blood, according to any of the preceding claims, comprising at least - one method step for minimally invasive puncturing of a body by means of the puncture unit of the hand-held measuring device; - one method step in which a body fluid escaping from the body due to the puncture is collected by the receiving unit, in particular using a vacuum; - one method step for detecting measurement signals of the body fluid present in the receiving unit by means of the nuclear magnetic resonance sensor unit.