CARTRIDGE DEVICE FOR A MEASURING SYSTEM FOR MEASURING VISCOELASTIC CHARACTERISTICS OF A SAMPLE LIQUID, A CORRESPONDING MEASURING SYSTEM, AND A CORRESPONDING METHOD
20250027959 ยท 2025-01-23
Assignee
Inventors
Cpc classification
B01L2300/0636
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0627
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/10
PERFORMING OPERATIONS; TRANSPORTING
G01N11/00
PHYSICS
B01L3/502
PERFORMING OPERATIONS; TRANSPORTING
G01N33/86
PHYSICS
B01L2400/0475
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0861
PERFORMING OPERATIONS; TRANSPORTING
B01L3/52
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/087
PERFORMING OPERATIONS; TRANSPORTING
International classification
G01N33/86
PHYSICS
B01L3/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
The present invention is directed to a cartridge device for a measuring system for measuring viscoelastic characteristics of a sample liquid, in particular a blood sample, comprising a cartridge body having at least one measurement cavity formed therein and having at least one probe element arranged in said at least one measurement cavity for performing a test on said sample liquid; and a cover being attachable on said cartridge body; wherein said cover covers at least partially said at least one measurement cavity and forms a retaining element for retaining said probe element in a predetermined position within said at least one measurement cavity. The invention is directed to a measurement system and a method for measuring viscoelastic characteristics of a sample liquid.
Claims
1-18. (canceled)
19. A cartridge configured to couple to a system, the system being configured to determine at least one viscoelastic property associated with portions of a test sample, the cartridge comprising: a plurality of measurement cavities, including a first measurement cavity and a second measurement cavity; a plurality of receiving cavities, including a first receiving cavity to receive a first portion of the test sample and a second receiving cavity to receive a second portion of the test sample, the first receiving cavity being empty prior to receiving the first portion of the test sample, and the second receiving cavity being empty prior to receiving the second portion of the test sample; a first fluid pathway fluidically connecting the first measurement cavity and the first receiving cavity, the first fluid pathway to transport the first portion of the test sample from the first receiving cavity to mix with a first reagent or combination of reagents; and a second fluid pathway fluidically connecting the second measurement cavity and the second receiving cavity, the second fluid pathway to transport the second portion of the test sample from the second receiving cavity to mix with a second reagent or combination of reagents; wherein the first measurement cavity is configured to receive a first mixture based the first portion of the test sample and the first reagent or combination of reagents, the first measurement cavity being configured to enable the system to determine at least one first viscoelastic property based on the first mixture; and wherein the second measurement cavity is configured to receive a second mixture based the second portion of the test sample and the second reagent or combination of reagents, the second measurement cavity being configured to enable the system to determine at least one second viscoelastic property based on the second mixture.
20. The cartridge of claim 18, wherein the first receiving cavity is associated with a single measurement cavity which is the first measurement cavity; and wherein the second receiving cavity is associated with a single measurement cavity which is the second measurement cavity.
21. The cartridge of claim 19, wherein the first fluid pathway is configured to mix the first portion of the test sample with the first reagent or combination of reagents during transport; and wherein the second fluid pathway is configured to mix the second portion of the test sample with the second reagent or combination of reagents during transport.
22. The cartridge of claim 19, further comprising: a first reagent cavity to hold the first reagent or combination of reagents; and a second reagent cavity to hold the second reagent or combination of reagents; wherein the first fluid pathway and the second fluid pathway comprise ductwork, the ductwork comprising: a first duct between the first reagent cavity and the first measurement cavity through which the first mixture passes; and a second duct between the second reagent cavity and the second measurement cavity through which the second mixture passes; wherein reagents contained in the first and second reagent cavities are in a solid form, the solid form having a dimension that is greater than a corresponding dimension of a duct of the ductwork.
23. The cartridge of claim 19, wherein the first fluid pathway and the second fluid pathway are configured to connect to at least one pump; wherein a change in pressure in the first fluid pathway produced by the at least one pump enables mixing of the first portion of the test sample and the first reagent or combination of reagents; and wherein a change in pressure in the second fluid pathway produced by the at least one pump enables mixing of the second portion of the test sample and the second reagent or combination of reagents.
24. The cartridge of claim 19, further comprising: a first reagent cavity to hold the first reagent or combination of reagents; and a second reagent cavity to hold the second reagent or combination of reagents; wherein mixing of the first portion of the test sample and the first reagent or combination of reagents occurs, at least in part, in the first reagent cavity; and wherein mixing of the second portion of the test sample and the second reagent or combination of reagents occurs, at least in part, in the second reagent cavity.
25. The cartridge of claim 19, wherein the first measurement cavity is arranged to enable a first test on the first mixture in the first measurement cavity, the first test for measuring a first viscoelastic property based on the first mixture; wherein the second measurement cavity is arranged to enable a second test on a second mixture in the second measurement cavity, the second test for measuring a second viscoelastic property based on the second mixture; and wherein the first test and the second test are different and reagents used for the first test and the second test are different.
26. The cartridge of claim 19, wherein the first reagent or combination of reagents and the second reagent or combination of reagents comprise globules configured to dissolve in a respective first or second portion of the test sample.
27. The cartridge of claim 19, wherein the first fluid pathway includes a first bend preceding the first measurement cavity; and wherein the second fluid pathway includes a second bend preceding the second measurement cavity.
28. The cartridge of claim 18, wherein the first fluid pathway is configured for transport of the first portion of the test sample from a bottom of the first receiving cavity; and wherein the second fluid pathway is configured for transport of the second portion of the test sample from a bottom of the second receiving cavity.
29. The system configured to receive the cartridge of claim 19, wherein the system comprises first and second probes associated with the first and second measurement cavities, respectively, the first and second probes being configured to measure viscoelastic properties based on the first and second mixtures in the first and second measurement cavities, respectively.
30. A method of performing viscoelastic testing using a cartridge coupled to a measuring system, the method comprising: performing first operations comprising: receiving a first portion of a test sample in a first receiving cavity on the cartridge, the first receiving cavity being empty prior to receiving the first portion of the test sample; transporting the first portion of the test sample out of the first receiving cavity and along a first fluid flow path to a location containing a first reagent or combination of reagents, the first portion of the test sample mixing with the first reagent or combination of reagents during transport; transporting, to a first measurement cavity along the first fluid flow path, a first mixture that is based on the first portion of the test sample and the first reagent or combination of reagents; and performing a first viscoelastic test on the first mixture in the first measurement cavity; performing second operations comprising: receiving a second portion of the test sample in a second receiving cavity on the cartridge, the second receiving cavity being empty prior to receiving the second portion of the test sample; transporting the second portion of the test sample out of the second receiving cavity and along a second fluid flow path to a location containing a second reagent or combination of reagents, the second portion of the test sample mixing with the second reagent or combination of reagents during transport; transporting, to a second measurement cavity along the second fluid flow path, a second mixture that is based on the second portion of the test sample and the second reagent or combination of reagents; and performing a second viscoelastic test on the second mixture in the second measurement cavity.
31. The cartridge of claim 30, wherein the first receiving cavity is associated with a single measurement cavity which is the first measurement cavity, and the second receiving cavity is associated with a single measurement cavity which is the second measurement cavity.
32. The method of claim 30, further comprising: operating a pump to transport the first portion of the test sample out of the first receiving cavity.
33. The method of claim 30, wherein mixing of the first portion of the test sample and the first reagent or combination of reagents occurs, at least in part, in a first reagent cavity on the cartridge; and wherein mixing of the second portion of the test sample and the second reagent or combination of reagents occurs, at least in part, in a second reagent cavity on the cartridge.
34. The method of claim 33, wherein the first mixture is transported to the first measurement cavity through a bend in the first fluid flow path; and wherein the second mixture is transported to the second measurement cavity through a bend in the second fluid flow path.
35. The method of claim 30, wherein the first reagent or combination of reagents and the second reagent or combination of reagents comprise globules that dissolve during mixing in a respective first or second portion of the test sample.
36. The method of claim 30, wherein transporting the first portion of the test sample out of the first receiving cavity comprises applying pressure along the first fluid flow path; and wherein transporting the second portion of the test sample out of the second receiving cavity comprises applying pressure along the second fluid flow path.
37. The method of claim 30, wherein the first portion of the test sample is transported from a bottom of the first receiving cavity; and wherein the second portion of the test sample is transported from a bottom of the second receiving cavity.
38. The method of claim 38, wherein at least one of the first operations is performed at a same time as at least one of the second operations
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] The figures are showing the following:
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
[0068]
[0069]
[0070]
[0071]
[0072]
[0073]
[0074]
[0075]
[0076]
[0077]
[0078]
[0079]
[0080]
[0081]
[0082]
[0083]
[0084]
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0085] Parts and components having same functions are depicted with same references.
[0086] Prior to a detailed description of the preferred embodiments the basic features and a basic practical implementation are summoned as follows. All embodiments refer to a cartridge device 50 (see
[0087] A first embodiment of a cartridge device 50 of the invention will be described with reference to
[0088] In this embodiment the receiving cavity 16 consists of a cavity within the cartridge device 50. The sample liquid 1 can be applied by means of a syringe, pipette etc, e.g. through a self sealing cap shown as a receiving cavity cover 33a in
[0089] In an alternative embodiment the reagent cavity 19 is integral formed with the pump means 18 and/or with the measurement cavity 20 and/or with the ductwork. The transport of the sample liquid 1 can be controlled by said control apparatus.
[0090]
[0091] In a preferred embodiment the cartridge device 50 comprises four arrangements of
[0092] Regarding e.g. blood coagulation there are different reagents available which activate or suppress different parts of the coagulation cascade. Pentapharm GmbH (Munich, Germany) for example amongst others provide tests for intrinsic and extrinsic activation of a blood sample (INTEM or EXTEM respectively), and also a test for extrinsic activation in which the thrombocyte function is suppressed by administration of cytochalasin D (FIBTEM). It is state of the art that it is possible by wise combination of such tests to be able to determine very precisely at which point within the coagulation cascade a problem occurs. This is of great importance in order to determine a proper medication. By comparison of the results on an EXTEM test of a pathologic sample to those of a FIBTEM test of the same sample it is possible to e.g. precisely determine if a coagulation disorder results from lack of fibrinogen or a malfunction of platelets. Generally, there are different typical medical scenarios in which coagulation disorders are very likely to occur. For example coagulation disorders occurring during liver transplantation are merely caused by lack of certain coagulation factors etc., while coagulation disorders during open heart surgery are most likely due to the influence of heparin. This means basically that different medical settings require different coagulation tests. Referring to
[0093] It is important to note that the cartridge devices 50 of the described embodiments are suitable for different diagnostic tests like thromboelastometry, thromboelastography, platelet aggregometry and others. Depending on which type of test or tests the cartridge device 50 is designed for, there are different additional parts required which interact with the sample during measurement and/or an external control apparatus. Possible adaptations for thromboelastometry and platelet aggregometry are described below.
[0094]
[0095] The probe element 22 comprises the probe pin 3 (see
[0096] The probe element 22 is arranged in the measurement cavity 20 of the cartridge body 30 of the cartridge device 50 as shown in
[0097] During attaching the cartridge device 50 to the measuring system 40 (see also
[0098] It is also possible to insert the insert section 6a of the shaft 6 into the connector section 26 of the probe element 22 and push the probe element 22 down until its bottom contacts the bottom of the measurement cavity 20, 20 ensuring that the insert section 6a is completely inserted into the connector section 26. Then the shaft 6 will be moved up into the measuring resp. working position of the probe element 22 as shown in
[0099]
[0100] Now a third embodiment of the cartridge device 50 will be described with reference to
[0101]
[0102] The cartridge device 50 of this example is equipped with the ductwork 13 and 15. The ducts are formed with an diameter of approximately 1 mm in this embodiment. The ductwork requires that the cartridge device 50 comprises two parts: the cartridge body 30 and the cover 31, which are glued or welded together to obtain a leak-proof device. The cartridge body 30 is relative rigid and the cover 31 is formed as an elastic part. So it is possible to integrate the pump means 18 into the cover 31. Moreover, the cover 31 covers the receiving cavity 16 with the receiving cavity cover 33a and forms a type of liner wall 33 and a separation wall 34 forming an inlet for the inlet duct 13 within the receiving cavity 16. The receiving cavity cover 33a might act as a self seal for injection of a sample liquid 1 by a syringe for example. The cover 31 forms top parts of the ductwork 13 an 15 and a cover of the measurement cavity 20 (see also
[0103] In this embodiment a reagent cavity 19, 19 is formed, e.g. by sections of the ductwork or/and the pump means 18, 18 in which the reagents can be stored resp. deposited, especially on the pump cavity bottom 36a, for example.
[0104] The pump means 18 will now be described with reference to
[0105]
[0106] In this example the pump cavity 36 is connected to the inlet duct 13 via an inlet valve 37 and to the outlet valve via an outlet valve 38. Actuation of the pump membrane 35 (shown in
[0107] An external force exerted on the pump membrane 35 increase the pressure within the pump cavity 36 and opens outlet valve 38 and closes inlet valve 37. Releasing the external force the elastic pump membrane 35 returns into the position shown in
[0108] Now the measuring system 40 according to the invention is described in an embodiment with reference to
[0109]
[0110] The measuring system 40 comprises an interface element 41 to which the cartridge device 50 is attached and fixed. The interface element 41 is shown in
[0111]
[0112] Thus it is possible to e.g. arrange a reagent receptacle 19b in a blister receptacle e.g. as shown in
[0113] It is also possible to insert reagent receptacles into provided cavities being connected to the ductwork. The reagents can be designed as globules with an appropriate diameter so that they cannot flow through openings into the ductwork before being dissolved by the sample liquid.
[0114]
[0115] The insertion section 6a can engage with a groove 28 inside the connector section 26 of the probe element 22. After that engagement which is supported by the toe bearing the shaft 6 will be drawn up together with the probe element 22 in the measuring position. It is a matter of fact that other engagement means can be used.
LIST OF REFERENCE NUMERALS
[0116] 1 Sample liquid Cup [0117] 2 Cup [0118] 3 Probe pin [0119] 4 Torsion wire [0120] 5 Rotation axis [0121] 6 Shaft [0122] 6a Insert section [0123] 7 Bearing [0124] 8 Mirror [0125] 9 Spring [0126] 10 Detecting means [0127] 11 Base plate [0128] 12 Cup holder [0129] 13, 13 Inlet duct [0130] 14, 14 Intermediate duct [0131] 15, 15 Outlet duct [0132] 16, 16 Receiving cavity [0133] 17 Branch duct [0134] 18, 18 Pump means [0135] 19, 19 Reagent cavity [0136] 19a, 19a Reagent cavity bottom [0137] 19b Reagent receptacle [0138] 20, 20 Measurement cavity [0139] 21, 21 Reagent [0140] 22, 22 Probe element [0141] 23 Intermediate section [0142] 24 Flange [0143] 25 Fixing section [0144] 26 Connector section [0145] 27 Insertion guide [0146] 28 Groove [0147] 29 Dimple [0148] 29a Nose [0149] 30 Cartridge body [0150] 31 Cover [0151] 32 Fixing means [0152] 32a Opening [0153] 33 Wall [0154] 33a Receiving cavity cover [0155] 34 Separation wall [0156] 35 Pump membrane [0157] 36 Pump cavity [0158] 36a Pump cavity bottom [0159] 37 Inlet valve [0160] 38 Outlet valve [0161] 39 Flow direction [0162] 40 Measuring system [0163] 41 Interface element [0164] 42 Pump access [0165] 43 Inlet opening [0166] 44 Shaft passage [0167] 44a Passage hole [0168] 45 Reagent cover opening [0169] 46 Retaining ring Frame [0170] 48 Bottom foil [0171] 49 Blister cover [0172] 50 Cartridge device