JP2005503538A - Blood tester - Google Patents

Abstract

The blood test device (10) comprises a proximal end (12) and a distal end (14) and an intermediate portion (20) between the proximal end (12) and the distal end (14). A distal end cap (60) having a first opening (62) configured to receive a test strip (104), and a pressure compensation system for adjusting the pressure of the intermediate portion (20) ) At the distal end (14). The intermediate portion (20) comprises a proximal end (36) having one or more openings (44) and a distal end (38) of the intermediate portion (20), the proximal end ( 36) and a hollow central chamber (40) surrounded by an outer wall between the distal end (38). One or more of the openings (44) can optionally include a flow valve (118).

Description

[Background]
[0001]
Cross-reference of related applications
This application claims the benefit of US Provisional Patent Application No. 60 / 281,957, entitled “One-way Self-sealing Blood Test Device”, filed on April 6, 2001, the provisional patent The contents of the application are referred to as being integral with the present application.
[0002]
background
In medical activities, blood is examined for the presence or amount of one or more components such as glucose, myocardial enzymes, or red blood cells, or the blood is examined to determine the level of one or more parameters such as pH. Is often required. Such a test involves contacting the blood obtained from the distal end of the intravascular entry device with the end of the test strip while performing the intravascular entry procedure, and then attaching the test strip to the appropriate test strip. This is often done by inserting it into a reader. This could be done, for example, by letting blood leak into the test strip from a catheter that has already entered the vasculature before attaching the intravenous infusion tube. Another way to gain access to the patient's blood is to push blood from the vascular access device onto the test strip.
DISCLOSURE OF THE INVENTION
[Problems to be solved by the invention]
[0003]
However, intravascular access procedures are often performed by emergency medical staff or paramedics under adverse environmental conditions such as rough weather. Furthermore, intravascular entry procedures are often performed by emergency medical staff or paramedics in a moving vehicle. Such conditions increase the likelihood that blood test results will be inaccurate due to test strip contamination and the risk that emergency medical staff or paramedics will be exposed to pathogens present in the blood being tested. Increase.
[0004]
Thus, it would be beneficial to have a device for testing blood conditions that reduces the likelihood of blood test results being inaccurate due to test strip contamination. In addition, it would be beneficial to have a device for testing a blood condition that reduces the risk that a health care provider is exposed to a pathogen present in the blood.
[Means for Solving the Problems]
[0005]
Disclosure of the invention
In one embodiment, to test blood for the presence or amount of one or more components or amount thereof, or to test blood to determine the level of one or more parameters, or a combination of the above A blood test device for testing blood for is provided.
[0006]
The blood tester includes a proximal end and a distal end of the blood tester, an intermediate portion between the proximal end of the blood tester and the distal end of the blood tester, and a pressure in the intermediate portion. A pressure compensation system for adjusting the intermediate portion, the intermediate portion comprising a proximal end of the intermediate portion having one or more openings and a distal end of the intermediate portion; Between the distal end and the distal end of the intermediate portion, there is a hollow central chamber surrounded by an outer wall.
[0007]
In one preferred embodiment, the pressure compensation system separates a distal portion located between the proximal end of the blood tester and the distal end of the blood tester and an intermediate portion from the distal portion. An inner membrane, the distal portion comprising the proximal end of the distal portion and the distal end of the distal portion, the proximal end of the distal portion and the distal end of the distal portion A hollow central chamber surrounded by an outer wall is provided between the two portions.
[0008]
In other desirable embodiments, the pressure compensation system comprises a pressure compensation valve, which may be a duckbill valve.
[0009]
In one embodiment, the blood tester further comprises a distal end cap having a first opening configured to receive a test strip at a distal end of the blood tester. Embodiments using an end cap that is a semi-permeable member and embodiments using an end cap that is a non-permeable member are described.
[0010]
In other embodiments, the outer wall of the intermediate portion is generally cylindrical.
[0011]
In other embodiments, the outer wall of the distal portion is generally cylindrical.
[0012]
In another preferred embodiment, the blood tester further comprises a proximal portion between the proximal end of the blood tester and the proximal end of the intermediate portion. In another embodiment, the proximal portion comprises a hollow central chamber surrounded by an outer wall, and the proximal portion is configured to couple with a blood storage device. In another embodiment, the blood storage device is selected from the group consisting of a syringe and an introducer portion of an intravascular entry device. In another embodiment, the outer wall of the proximal portion is generally cylindrical.
[0013]
In another preferred embodiment, the hollow central chamber of the intermediate portion and the hollow central chamber of the distal portion each comprise a generally rectangular lower portion configured to communicate with each other and receive a test strip. In another particularly preferred embodiment, the hollow central chamber of the distal portion further comprises one or more ridges extending axially from the proximal to the distal axis.
[0014]
In other embodiments, the outer wall of the intermediate portion is generally transparent.
[0015]
In other embodiments, the distal end cap is an integral part of the distal portion of the blood tester.
[0016]
In other embodiments, the distal end cap is removably attached to the distal portion of the blood tester.
[0017]
In other embodiments, the distal end cap further has one or more second openings to allow venting out of the distal portion of the blood tester.
[0018]
In other preferred embodiments, the inner membrane is a semipermeable member.
[0019]
In other embodiments, the inner membrane has one or more vents.
[0020]
In other embodiments, the outer wall of the intermediate portion has one or more vents.
[0021]
In other embodiments, the inner membrane has an opening configured to allow passage of a test strip from a distal portion of the blood tester to an intermediate portion of the blood tester.
[0022]
In other embodiments, the intermediate portion is integrally attached to the introducer portion of the intravascular access device. In another embodiment, the intermediate portion is configured to be attached to the introducer portion of the intravascular access device.
[0023]
In another preferred embodiment, the distal end of the blood tester is integrally attached to the blood collection device. In another embodiment, the distal end of the blood tester is configured to be attached to a blood collection device. In one embodiment, the blood collection device can be a syringe.
[0024]
In other preferred embodiments, the intermediate portion is integrally attached to or configured to be attached to the introducer portion of the intravascular access device and the distal end is integrally attached to the blood collection device. It is attached or configured to be attached to it. In one embodiment, the blood collection device can be a syringe.
[0025]
In another embodiment, the present invention is a blood test apparatus comprising a plurality of blood test instruments of the present invention connected to each other.
[0026]
In other embodiments, the present invention examines blood for the presence or amount of one or more components or the amount thereof, or for examining blood to determine the level of one or more parameters, or A method for examining blood for a combination of the above. The method first comprises a blood test device according to the present invention, a test strip comprising a proximal end and a distal end, a test strip reader configured to receive the distal end of the test strip, Providing a blood containing device. Next, the blood tester is attached to the blood storage device, and the blood existing in the blood storage device is allowed to enter the middle part of the blood tester. The distal end of the test strip is then inserted into the test strip reader and the proximal end of the test strip is inserted into the middle portion of the blood tester. The operator can then determine the presence or amount of one or more components of blood, or the level of one or more parameters, or a combination thereof, to determine the test strip. Use the information provided by the reader. In one embodiment, the blood test device is selected from the group consisting of an intravascular access device and a syringe. The blood tester and the blood storage device can be integrally attached.
[0027]
In other embodiments, the method of the present invention further includes selecting a patient to undergo a blood test and accessing the patient's intravascular blood using a blood containment device. In other embodiments, the method further comprises discarding the blood tester.
[0028]
In another embodiment, the one or more openings at the proximal end of the intermediate portion of the blood test device comprise a flow valve. In yet another embodiment, the flow valve can be a duckbill valve or a flap valve.
BEST MODE FOR CARRYING OUT THE INVENTION
[0029]
The above and other features, aspects and advantages of the present invention will be more fully understood by reference to the following description, claims and accompanying drawings.
[0030]
According to one embodiment of the invention, the level of one or more parameters, such as pH, for testing blood for the presence or amount of one or more components such as glucose, myocardial enzymes or red blood cells, or for pH is determined. Therefore, a blood tester is provided for testing blood for testing blood or for a combination of the above. This blood tester reduces the likelihood that blood test results will be inaccurate due to contamination of the test strip, and reduces the risk that the operator will be exposed to pathogens present in the blood.
[0031]
According to other embodiments of the invention, the level of one or more parameters, such as pH, for testing blood for the presence or amount of one or more components such as glucose, myocardial enzymes or red blood cells, or for the amount thereof is determined. In order to test blood for this purpose, or a method for testing blood for a combination of the above is provided. The method comprises the steps of providing a test means that reduces the likelihood of blood test results being inaccurate due to test strip contamination and reduces the risk of operators being exposed to pathogens present in the blood. Including. These embodiments are described in further detail in the following disclosure.
[0032]
1, 2, and 3, respectively, a side perspective view of blood test device 10 according to one embodiment of the present invention, and a cross-sectional side view of blood test device 10 shown in FIG. 1. A perspective view and a side perspective view of blood test instrument 10 shown in FIG. 1 coupled to intravascular access device 100 are shown. As can be seen, in this embodiment, blood tester 10 includes a proximal end 12 and a distal end 14. Blood test instrument 10 includes a proximal portion 16, a distal portion 18, and an intermediate portion 20 between the proximal and distal portions between proximal end 12 and distal end 14. It has more.
[0033]
The proximal portion 16 includes a proximal end 22 and a distal end 24 with a longitudinal axis extending between the proximal end 22 and the distal end 24 extending in a proximal-to-distal direction. It further comprises a hollow central chamber 26 having and surrounded by an outer wall 28. The outer wall 28 of the proximal portion 16 is a distal end of a blood containment device, such as a syringe (not shown) or an introducer portion 102 of an intravascular access device 100, as shown in FIG. Is configured to be coupled or engaged with. The outer wall 28 of the proximal portion 16 is a standard vessel such as an Introcan® Safety ™ IV Catheter (B. Braun Medical, Bethlehem, PA, USA) or other standard intravascular access device. The outer wall 28 of the proximal portion 16 is configured to couple or engage with the distal end of the introducer portion of the inner entry device, and as will be appreciated by those skilled in the art with reference to this disclosure, It is preferable that the structure changes according to the intravascular entry device used together with the blood test apparatus 10 of the present invention.
[0034]
As shown in FIGS. 1 and 2, in the preferred embodiment, the outer wall 28 of the proximal portion 16 has a generally tapered proximal portion 30 that tapers toward the tip and a generally cylindrical farthest. And a positioning portion 32. The proximal portion 30 of the outer wall 28 allows the hollow central chamber 26 to communicate with the exterior or to communicate with the blood storage portion of the blood storage device when combined with the blood storage device 1. Or it is preferable to further have two or more openings 34. The one or more openings 34 are configured to allow blood present in the blood storage device to pass into the hollow central chamber 26 of the proximal portion 16.
[0035]
The intermediate portion 20 includes a proximal end 36 and a distal end 38 having a longitudinal axis extending between the proximal end 36 and the distal end 38 in a proximal-to-distal direction. And a hollow central chamber 40 surrounded by the outer wall 42. The outer wall 42 of the intermediate portion 20 is preferably generally cylindrical, but other forms are suitable as will be appreciated by those skilled in the art upon reviewing this disclosure. The proximal end 36 of the intermediate portion 20 has one or more openings 44 that allow the hollow central chamber 40 of the intermediate portion 20 to communicate with the hollow central chamber 26 of the proximal portion 16.
[0036]
As the test strip 104 passes through the inner membrane 66, a slight air leak may result, and the encapsulated blood may slowly drip from the proximal portion 16. This can be most apparent when the hollow central chamber 40 is completely filled with blood. As shown in FIG. 18, one or more openings 44 optionally allow blood to flow into the intermediate portion 20 but prevent blood from flowing back through the proximal portion 16. A one-way flow valve 118 adapted to block can be provided. Any valve that restricts blood from flowing in substantially one direction functions as an optional flow valve 118. Examples of valves suitable for such applications include duckbill valves and flap valves.
[0037]
The distal portion 18 includes a proximal end 48 and a distal end 46 with a longitudinal axis extending between the proximal end 48 and the distal end 46 extending proximally to distally. It further includes a hollow central chamber 50 that is enclosed by an outer wall 52. The outer wall 52 of the distal portion 18 is preferably generally cylindrical, but other forms are suitable as will be appreciated by those of skill in the art with reference to this disclosure.
[0038]
The hollow central chamber 50 is sized and sufficient to receive a test strip 104 or other test device inserted into the hollow central chamber 50 from the distal end 14 to the proximal end 12 of the blood tester 10. It has a shape suitable for this. As used in this disclosure, the term “test strip” is intended to include other test devices that are not linear strip shapes but are suitable for use in the blood tester 10 of the present invention. Accordingly, the configuration of the hollow central chamber 50 of the distal portion 18 will depend on the configuration of the test strip used, as will be appreciated by those skilled in the art with reference to this disclosure. Suitable test strips include chemical test strips such as One Touch® FastTake® (LifeScan, Milpitas, Calif., USA) and Precision QID (MediSense, Bedford, Mass., USA). Such electrochemical test strips are included.
[0039]
As shown in FIGS. 1, 2 and 3, in a particularly preferred embodiment, the hollow central chamber 50 of the distal portion 18 and the hollow central chamber 40 of the intermediate portion 20 are shown in the figures, respectively. As shown, the lower portion 54 and the lower portion 56 are substantially rectangular (when viewed from below), and the lower portions 54 and 56 are configured to communicate with each other and receive the test strip 104. The proximal end 58 of the outer wall of the lower portion 56 of the intermediate portion 20 is closed.
[0040]
In another preferred embodiment, as shown in FIG. 9, the lower portion 54 of the central chamber 50 of the distal portion 18 has one or more ridges 55 having a longitudinal axis extending in a proximal to distal direction. It has more. The raised portion 55 serves as a guide for the test strip 104 in the lower portion 54 and also serves to prevent blood from entering the upper space of the hollow central chamber 50. The raised portion 55 can extend over a part or the whole of the length of the central chamber 50, and can extend over a part or the whole of the width of the central chamber 50.
[0041]
The outer wall 28 of the proximal portion 16, the outer wall 42 of the intermediate portion 20, and the outer wall 52 of the distal portion 18 are preferably composed of a plastic material such as polycarbonate that does not affect the blood component or parameter being examined. However, other materials are suitable as will be appreciated by those of skill in the art with reference to this disclosure. Since blood tester 10 is intended to be discarded after a single use, the materials used are inexpensive and manufactured in the proper shape according to standard technical means known to those skilled in the art, such as injection molding. Preferably it can be done. In addition, the material is preferably substantially transparent or sufficiently transparent to allow visual confirmation that blood is present in the hollow central chamber 40 of at least the intermediate portion 20.
[0042]
The distal end 14 of the blood test device 10 further includes a distal end cap 60. In one embodiment (not shown), the distal end cap 60 is an integral part of the distal portion 18 of the blood tester 10 and is made of the same or different material as the outer wall 52 of the distal portion 18. is there. As shown in FIGS. 1, 2, and 3, in a preferred embodiment, the distal end cap 60 is a separate piece that is removable from the distal portion 18 and the distal portion 18 of the blood tester 10. Of the elastic material, such as natural rubber or synthetic rubber, which tends to remain attached to the distal portion 18 of the blood tester 10 due to the elasticity of the material.
[0043]
In one embodiment, the distal end cap 60 further includes a first opening configured to snugly receive a test strip 104 that is inserted into the hollow central chamber 50 of the distal portion 18 of the blood tester 10. At least part 62 is included. Accordingly, as will be appreciated by those skilled in the art with reference to this disclosure, the configuration of the first opening 62 of the distal end cap 60 will depend on the configuration of the test strip used. In a preferred embodiment, the first opening 62 is generally slit-shaped as shown in FIGS. The first opening 62 can be a simple opening leading to the hollow central chamber 50 of the distal portion 18 as shown, or a duckbill valve as shown in FIGS. 10A and 10B. A valve such as 65 can also be provided. As shown in FIGS. 1, 2 and 3, in a particularly preferred embodiment, distal portion 18 and intermediate portion 20 each have a generally rectangular lower portion 54 and 56, respectively, and a first opening. Reference numeral 62 denotes a slit whose longitudinal axis is disposed in a direction perpendicular to the direction in which the longitudinal axis of the test strip 104 is inserted into the distal portion 18.
[0044]
The distal end cap 60, as shown in FIG. 11, is a half that allows blood fluid and cellular components to remain in the distal portion 18 while allowing air to selectively pass from the distal portion 18. A permeable membrane can be provided. Semi-permeable membranes are available from Porex T3 # X-7744 (Porex Medical Products Group, Fairburn, GA, USA) or Type TTTP Isopore Membrane (suitable from Millipore, Bedford, Massachusetts, USA). However, other materials are suitable as will be appreciated by those of skill in the art with reference to this disclosure.
[0045]
In particular, if the distal end cap 60 does not include a semi-permeable membrane, the distal end cap 60 can be vented out of the distal portion 18 of the blood test device 10 by one or more second ones. It is more preferable to have a vent of the opening 64. The second opening 64 may be in any suitable form, such as a generally slit shape as shown in FIG. 1, as will be appreciated by those skilled in the art with reference to the present disclosure. Alternatively or additionally, the outer wall 52 of the distal portion 18 can have one or more vents 53, as shown in FIG.
[0046]
In one preferred embodiment, blood tester 10 includes an inner membrane 66 that separates distal end 38 of hollow central chamber 40 of intermediate portion 20 from proximal end 48 of hollow central chamber 50 of distal portion 18. It has more. In a preferred embodiment, the inner membrane 66 is a semipermeable member. In other embodiments, the inner membrane 66 is not permeable and has one or more vents (not shown). Alternatively and additionally, as shown in FIGS. 13 and 15, the outer wall 42 of the intermediate section 20 can have one or more vents 43.
[0047]
Inner membrane 66 may be composed of any suitable material such as rubber or Porex T3 # X-7744 (Porex Medical Products Group, Fairburn, GA, USA), as will be appreciated by those of skill in the art with reference to this disclosure. Furthermore, it can be further processed so as to be hydrophobic.
[0048]
Referring now to FIG. 4, there is shown a side perspective view of one embodiment of an inner membrane 66 that forms part of the embodiment of the blood tester 10 shown in FIGS. ing. The inner membrane 66 selectively allows air to pass through the inner membrane 66 between the distal end 38 of the hollow central chamber 40 of the intermediate portion 20 and the proximal end 48 of the hollow central chamber 50 of the distal portion 18. While permitting blood fluids and cellular components to pass through the inner membrane 66.
[0049]
Inner membrane 66 is further configured to allow test strip 104 to pass from distal portion 18 of blood test device 10 into intermediate portion 20 of blood test device 10. For example, as shown in FIG. 12, the inner membrane 66 can have a slit 67 aligned with the location of the first opening 62 of the distal end cap 60. In another embodiment, the inner membrane 66 can have a hole (not shown) aligned with the location of the first opening 62 of the distal end cap 60. In this embodiment, the holes can be configured to be breached by insertion of the test strip 104.
[0050]
As shown in FIGS. 1, 2 and 3, in a preferred embodiment, the intermediate portion 20 and the distal portion 18 each comprise a generally rectangular lower portion 54 and 56, and the first opening 62 is an inspection. A slit disposed in a direction orthogonal to the direction in which the longitudinal axis of the strip 104 is inserted into the distal portion 18, the inner membrane 66 further divides the lower portion 54 of the distal portion 18 from the lower portion 56 of the intermediate portion 20. A lower extension 68 is provided.
[0051]
When the test strip is inserted through the distal end cap 60 into the hollow central chamber 50 of the lower portion 54 of the distal portion 18, the lower extension 68 of the inner membrane 66 moves proximally so that the test strip is in the middle portion. 20 can be further inserted into the lower portion 56 of the blood, allowing blood in the hollow central chamber 40 of the intermediate portion 20 to contact the proximal end 106 of the test strip 104.
[0052]
Referring now to FIGS. 5, 14 and 15, there is shown a side perspective view of blood test apparatus 10 according to another embodiment of the present invention. As can be seen, in these embodiments, blood tester 10 does not include proximal portion 16 and intermediate portion 20 is integral with the distal end of introducer portion 102 of a standard intravascular access device 100. Manufactured in a state attached to. In these embodiments, the blood tester 10 and the introducer portion 102 of the intravascular access device 100 are inserted into the blood vessel as a unit and from within the blood vessel, as will be appreciated by those skilled in the art with reference to the present disclosure. To be removed.
[0053]
As will be appreciated by those skilled in the art with reference to this disclosure, the pressure in the central chamber 50 increases as the test strip is inserted through the distal end cap 60 into the hollow central chamber 50. If the blood tester does not include a pressure compensation system to improve this pressure increase, depending on the nature of the material selected for the inner membrane 66, the resulting pressure in the central chamber 40 of the intermediate portion 20 will correspond. And can increase. If no pressure compensation system is included to equalize the pressure in the central chamber 40, a small amount of blood can be pushed out from one or more openings 34 in the proximal portion 30 of the outer wall 28 of the proximal portion 16. . This may be undesirable for medical personnel inserting test strips. As the test strip is further inserted into the lower portion 56 of the intermediate portion 20, the pressure in the central chamber 40 further increases, increasing the likelihood of blood leaking from the opening 34.
[0054]
A preferred embodiment of the pressure compensation system is as shown in FIGS. 1, 2 and 4 where the inner membrane 66 is a semi-permeable member and comprises a lower extension 68 and a distal end cap. Reference numeral 60 denotes an elastic material such as natural rubber or synthetic rubber, and has one or more second openings 64 vents. When the test strip 104 is inserted into the blood tester 10, the pressure compensation system of this embodiment can equalize the pressure so that little blood leaks from the intermediate portion to the distal portion, and the blood Blood does not leak from the test device 10. Furthermore, the central chamber 50 of the distal portion 18 preferably comprises one or more ridges 55 that reduce the amount of blood entering the central chamber 50.
[0055]
As shown in FIG. 11, another embodiment of the pressure compensation system allows air to selectively pass from the distal portion 18 with an inner membrane 66 of a semi-permeable member comprising a lower extension 68. A distal end cap 60 with an acceptable semi-permeable membrane is provided. In this embodiment, the second opening 64 is not required.
[0056]
The pressure compensation system of another embodiment forms an integral part of the distal portion 18 of the blood tester 10 and the outer wall 52 of the distal portion 18 with the inner membrane 66 of the semi-permeable member comprising the lower extension 68. A distal end cap 60 made of the same material or a different material. In this embodiment, a second opening 64 is provided on the distal end cap, or one or more vents 53 are provided on the outer wall 52.
[0057]
Other embodiments of the pressure compensation system include an inner membrane 66 that is not permeable and has one or more vents (not shown). Alternatively or additionally, the outer wall 42 of the intermediate portion 20 can have one or more vents 43. In this embodiment, the distal end cap 60 is optionally (1) constructed of an elastic material such as natural rubber or synthetic rubber, and the vent of the one or more second openings 64 in the end cap. Or the outer wall 52 of the distal portion 18 can have one or more vents 53, or (2) a semi-permeable membrane that allows air to selectively pass from the distal portion 18 Or (3) constitute an integral part of the distal portion 18 of the blood tester 10 made of the same material or a different material as the outer wall 52 of the distal portion 18 and have one or more second on the end cap. Or one or more vents 53 in the outer wall 52 of the distal portion 18.
[0058]
It is also possible to improve the pressure increase caused by insertion of the test strip 104 with a pressure compensation valve. Referring to FIG. 6, a side perspective view of a blood test device 10 according to another embodiment of the present invention is shown. As can be seen, in this embodiment, blood tester 10 includes a distal end cap 60 and first opening 62 includes a duckbill valve 65. FIG. 10A shows the duckbill valve in cross-section before the test strip 104 is inserted, and FIG. 10B shows the duckbill valve in cross-section after the test strip 104 is inserted. When not present, they are sealed next to each other and separated when the test strip is inserted, allowing the test strip to be inserted into the hollow central chamber 40 of the intermediate portion 20. In this embodiment of the pressure compensation system, the structure of the duckbill valve is collapsed, as shown in FIG. 10B after the test strip 104 has been inserted, and as will be appreciated by those skilled in the art with reference to this disclosure. The pressure equalization can be obtained. Therefore, in this embodiment, the opening 64 and the inner membrane 66 of the end cap 60 are not required.
[0059]
While several embodiments of the pressure compensation system have been described, it is further disclosed that the pressure compensation system can be configured with various combinations of the components described above, as shown in FIGS. 11 and 17. Will be understood by those skilled in the art.
[0060]
7 and 17, there is shown a side perspective view of blood test apparatus 10 according to two other embodiments of the present invention. As can be seen, in these embodiments, blood tester 10 is configured to replace intermediate portion 20 of blood tester 10 with syringe 108 as shown in FIG. 7, as disclosed above. The side surface of the syringe 108 by connecting directly to the side surface or by connecting the inner membrane 66 directly to the side surface of the syringe 108 as shown in FIG. It is manufactured by being integrally attached to. Other blood collection devices can be used, as will be appreciated by those skilled in the art with reference to this disclosure.
[0061]
It is also possible to eliminate the inner membrane using a pressure compensating valve in either embodiment. In these embodiments, the syringe 108 is used to draw blood from the blood source, and the blood tester 10 is used to perform a blood test within the syringe 108 without having to push the blood out of the syringe 108. The blood tester 10 can also be attached to the distal end of the plunger of the syringe 108, in which case the plunger has a central flow path (central channel) that communicates with the intermediate portion 20 of the blood tester 10 (see FIG. Not shown).
[0062]
In another embodiment, the present invention provides a blood tester comprising a plurality of blood testers 10 according to the present invention connected to one another so that a plurality of test strips can be read from blood in the same blood storage device 110. Is included. Referring to FIG. 8, a side perspective view of such a blood test apparatus 110 is shown. As can be seen, in this embodiment, the blood test device 110 is coupled or engaged with the syringe 108 and a proximal end 112 configured to couple or engage with the intravascular entry device 100. Comprising a configured distal end 114, a hollow central chamber 116 between the proximal and distal ends, and a plurality of blood test devices 10 according to the present invention, each blood test device 10 having a hollow center; It is joined to the chamber 116. In a preferred embodiment, the distal end 114 is configured to couple or engage with the proximal end of a standard flash plug or the proximal end of a syringe 108 (shown). As will be appreciated by one of ordinary skill in the art with reference to this disclosure, this embodiment allows blood from one source to be tested using multiple blood testers 10 according to the present invention.
[0063]
According to another embodiment with reference to FIG. 11, the blood tester 10 serves as a standard flash plug and the proximal end 12 of the blood tester 10 is intravascular as shown in FIG. Configured to couple or engage with the introducer portion 102 of the access device 100, and optionally, the distal end 14 of the blood test device 10 may be integral with or removable from a blood collection device such as a syringe 108. It can be configured to be coupled or engaged (not shown).
[0064]
According to other embodiments of the present invention, to test blood for the presence or amount of various components such as glucose, myocardial enzymes or red blood cells, or to determine the level of various parameters such as pH Methods are provided for testing blood or testing blood for a combination of the above. The method includes providing a blood test device according to the present invention. The method further includes providing a test strip, a test strip reader, and a blood containment device such as an intravascular entry device or syringe. The test strip can be any suitable test strip having a proximal end configured to be inserted into a distal end cap of a blood tester. The test strip reader is configured to receive the distal end of the test strip and any suitable that provides desired information regarding blood that has contacted the proximal end of the test strip after receiving the distal end. A test strip reader can be provided. The blood containment device is any intravascular entry device suitable for entering the vascular structure and suitable for joining to the proximal end of a blood test device according to the present invention, or for those skilled in the art with reference to this disclosure. As can be appreciated, any other suitable blood storage device can be used.
[0065]
The blood tester may be provided with the test strip inserted through the distal end cap into the distal and intermediate portions of the blood tester and provided with the test strip not so. May be. If a blood tester is provided with the test strip inserted through the distal end cap into the distal and intermediate portions of the blood tester, the combination of the blood tester and test strip is The distal end of the strip can be provided already inserted into the test strip reader. Furthermore, whether the blood tester is combined with a test strip or whether it is combined with a test strip and a test strip reader, its proximal end is already at the distal end of the blood containing device. The proximal end can be provided without being inserted into the distal end of the blood storage device. As will be appreciated by those skilled in the art with reference to this disclosure, the blood storage device, blood tester, test strip, and test strip reader can be assembled together during the method of the present invention and assembled in various orders. . In a particularly preferred embodiment, the distal end of the test strip is inserted into the test strip reader, after which the proximal end of the test strip is distal to the blood tester after blood has entered the middle part of the blood tester. It is inserted into the end cap and passed through the inner membrane.
[0066]
Next, a patient undergoing a blood test is selected. If the blood containment device is an intravascular access device, the patient is prepared in a standard manner, and blood vessels using the intravascular entry device according to standard techniques will be understood by those of skill in the art with reference to this disclosure. Inside entry begins. If the proximal end of the blood tester is not inserted into the distal end of the intravascular access device prior to performing the intravascular entry, replace the flush plug of the intravascular access device with the proximal portion of the blood tester The proximal end of the blood tester is inserted into the distal end of the intravascular access device. The proximal end of the blood test device is preferably inserted into the distal end of the intravascular entry device prior to insertion of the intravascular entry device. Alternatively, a blood test device according to the present invention is provided with no proximal portion and an intermediate portion integrally attached to the distal end of the introducer portion of a standard intravascular access device. .
[0067]
When an intravascular entry is made and the blood tester and the intravascular entry device are combined, the blood obtained from the patient's vasculature in which the entry has taken place is one or more openings in the proximal end of the proximal portion Through the section into the hollow central chamber of the proximal portion and then further into the hollow central chamber of the intermediate portion, or if the blood tester is integrally attached to the intravascular access device, the hollow central chamber of the intermediate portion Flows directly into. Air present in the hollow central chamber of the proximal portion (if present) and in the hollow central chamber of the intermediate portion flows through the inner membrane into the hollow central chamber of the distal portion and further out. If not already joined, the distal end of the test strip is inserted into the test strip reader, the proximal end of the test strip is inserted into the distal end cap, and passes through the distal portion of the blood tester. Inserted in the middle part. At this time, the blood in the hollow central chamber in the middle part contacts the proximal end of the test strip.
[0068]
If not previously inserted, the distal end of the test strip is then inserted into the appropriate test strip reader. The operator can determine the presence or amount of one or more components of blood such as glucose, myocardial enzymes or red blood cells, or the level of one or more parameters such as pH. Alternatively, information provided by the test strip reader, such as a numerical display or a visual display, is used to determine a combination of the above.
[0069]
In one embodiment, the operator pulls the blood tester out of the distal end of the intravascular entry device before using the test strip reader. In other embodiments, the blood tester into which the test strip is inserted is removed from the intravascular access device, and the operator can remove the blood vessel while the distal end of the test strip is inserted into the appropriate test device. Since the inner approach path is established, there is no time loss in establishing the intravascular approach path when the blood test is being performed. In a preferred embodiment, the introducer portion of the intravascular access device is removed together with the blood tester inserted into the distal end, and the operator places the proximal end of the test strip over the distal end of the blood tester. The procedure for establishing the intravascular approach path is advanced while being inserted into the part, and the efficiency of establishing the intravascular approach path when blood tests are being performed is further increased. In a particularly preferred embodiment, the blood tester provided for use in this method is that of the embodiment shown in FIG. 5 and, as will be appreciated by one of ordinary skill in the art with reference to this disclosure, a blood test Since the vessel is integrally attached to the distal end of the introducer portion of the intravascular entry device, removal of the blood tester inevitably removes the introducer portion of the intravascular entry device from the vasculature.
[0070]
After the operator makes the appropriate determination, the blood tester with the test strip inserted is removed from the test strip reader and discarded as a biohazard in an appropriate manner (used with the introducer section) It is preferably discarded together with the introducer part). As will be appreciated by those skilled in the art with reference to this disclosure, the method of the present invention reduces the likelihood that blood test results will be inaccurate due to contamination of the test strip, and allows the test subject to be tested in a standard manner. Reduces the time required to analyze blood, reduces the risk of operators being exposed to pathogens present in the blood, and simplifies the disposal of equipment used when testing blood.
[0071]
According to other embodiments of the present invention, to test blood for the presence or amount of various components such as glucose, myocardial enzymes or red blood cells, or to determine the level of various parameters such as pH Methods are provided for testing blood or testing blood for a combination of the above. The method includes the step of providing a blood test device according to the present invention, the blood test device having a proximal end removably coupled or attached to the blood storage device and a blood storage portion of the blood storage device. A plurality of blood test devices according to the present invention are joined to a common central chamber configured to communicate. As will be appreciated by those skilled in the art with reference to this disclosure, this method is possible except that a blood test strip can be inserted into the distal end cap of each blood test device of the blood test device to expand the capacity of the blood test. Consistent with the method disclosed above.
[0072]
According to other embodiments of the invention, to test blood for the presence or amount of various components such as glucose, myocardial enzymes or red blood cells, or to determine the level of various parameters such as pH Methods are provided for testing blood or testing blood for a combination of the above. The method includes using a blood storage device such as a syringe other than the intravascular entry device. In this method, an intravascular access path directly through the distal end of the blood storage device, such as by attaching the blood storage device directly to an intravascular access device or blood storage vial and drawing blood from this source into the blood storage device. Blood is drawn into the blood storage device by a method other than obtaining
[0073]
Although the present invention has been described in considerable detail with reference to certain preferred embodiments, other embodiments are possible. Accordingly, the claims should not be limited to the description of the preferred embodiments included in this disclosure.
[Brief description of the drawings]
[0074]
FIG. 1 is a side perspective view of a blood test apparatus according to one embodiment of the present invention.
FIG. 2 is a cross-sectional side perspective view of the blood test apparatus shown in FIG.
FIG. 3 is a side perspective view of the blood test device shown in FIG. 1 attached to a standard intravascular access device.
4 is a side perspective view of a semipermeable membrane that forms part of the blood test device of FIG. 1. FIG.
FIG. 5 is a side perspective view of a blood test apparatus according to another embodiment of the present invention.
FIG. 6 is a side perspective view of a blood test apparatus according to another embodiment of the present invention.
FIG. 7 is a side perspective view of a blood test apparatus according to another embodiment of the present invention.
FIG. 8 is a side perspective view of a blood test apparatus including a plurality of blood test apparatuses according to the present invention connected to each other.
FIG. 9 is a cross-sectional side perspective view of the blood test apparatus shown in FIG. 1 according to another embodiment of the present invention.
10A is a cross-sectional view of a duckbill valve forming part of the blood test device of FIG. 6 prior to insertion of a test strip.
10B is a cross-sectional view of the duckbill valve forming part of the blood tester of FIG. 6 after insertion of a test strip.
FIG. 11 is a sectional cutaway side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 12 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 13 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 14 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 15 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 16 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 17 is a cross-sectional side view of a blood test apparatus according to another embodiment of the present invention.
FIG. 18 is a cross-sectional side perspective view of another embodiment of the blood tester shown in FIG.

Claims (46)

For testing blood for the presence or absence of one or more components or for the amount of the components, or for testing the blood to determine the level of one or more parameters, or for the presence or amount of the components and parameters A blood tester for testing blood for level determination, wherein the blood tester comprises:
a) a proximal end and a distal end of the blood test device;
b) an intermediate portion between the proximal end of the blood test device and the distal end of the blood test device;
c) a pressure compensation system for adjusting the pressure in the intermediate portion;
With
The intermediate portion comprises a proximal end of the intermediate portion having one or more openings and a distal end of the intermediate portion, wherein the proximal end of the intermediate portion and the intermediate portion A blood tester having a hollow central chamber surrounded by an outer wall between the distal end portion and the distal end portion. A distal portion located between the proximal end of the blood tester and the distal end of the blood tester, and an inner side separating the intermediate portion from the distal portion; A membrane, wherein the distal portion comprises a proximal end of the distal portion and a distal end of the distal portion, the proximal end of the distal portion and the distal portion of the distal portion The blood test device according to claim 1, further comprising a hollow central chamber surrounded by an outer wall between the distal end portion and the distal end portion. The blood test instrument according to claim 1, wherein the pressure compensation system comprises a pressure compensation valve. The blood test device according to claim 3, wherein the pressure compensation valve is a duckbill valve. The blood test instrument of claim 2, further comprising a distal end cap at the distal end of the blood test instrument having a first opening configured to receive a test strip. The blood test apparatus according to claim 1, wherein the outer wall of the intermediate portion is substantially cylindrical. The blood test apparatus according to claim 2, wherein the outer wall of the distal portion is substantially cylindrical. Further comprising a proximal portion between the proximal end of the blood test device and the proximal end of the intermediate portion;
The proximal portion has a hollow central chamber surrounded by an outer wall;
The blood test instrument of claim 1, wherein the proximal portion is configured to couple with a blood storage device. The blood test apparatus according to claim 8, wherein the blood storage device is selected from the group consisting of a syringe and an introducer part of an intravascular entry device. The blood test instrument according to claim 8, wherein the outer wall of the proximal portion is substantially cylindrical. The hollow central chamber of the intermediate portion and the hollow central chamber of the distal portion each have a generally rectangular lower portion configured to communicate with each other and receive a test strip. 2. The blood test apparatus according to 2. The blood test instrument according to claim 11, wherein the hollow central chamber of the distal portion further comprises one or more ridges extending axially along the axis from proximal to distal. The blood test apparatus according to claim 1, wherein the outer wall of the intermediate portion is substantially transparent. The blood test instrument according to claim 5, wherein the distal end cap is an integral part of the distal portion of the blood test instrument. The blood test instrument of claim 5, wherein the distal end cap is removably attached to the distal portion of the blood test instrument. The blood test instrument of claim 5, wherein the distal end cap further comprises one or more second openings to allow venting out of the distal portion of the blood test instrument. . The blood test instrument according to claim 5, wherein the distal end cap is a semi-permeable member. The blood test instrument according to claim 5, wherein the distal end cap is a non-permeable member. The blood test apparatus according to claim 2, wherein the inner membrane is a semipermeable member. The blood test apparatus according to claim 2, wherein the inner membrane has one or more vent holes. The blood test device according to claim 1, wherein the outer wall of the intermediate portion has one or more vent holes. The blood test of claim 2, wherein the inner membrane has an opening configured to allow passage of a test strip from the distal portion of the blood test device to the intermediate portion of the blood test device. vessel. The blood test instrument according to claim 1, wherein the intermediate part is integrally attached to an introducer part of an intravascular entry device. The blood test instrument according to claim 1, wherein the intermediate part is configured to be attached to an introducer part of an intravascular entry device. The blood test instrument according to claim 1, wherein the distal end is integrally attached to a blood collection device. The blood test apparatus according to claim 1, wherein the distal end is configured to be attached to a blood collection device. 24. The blood test instrument of claim 23, wherein the distal end is integrally attached to a blood collection device. 24. The blood test instrument of claim 23, wherein the distal end is configured to be attached to a blood collection device. The blood test apparatus according to claim 28, wherein the blood collection device is a syringe. 25. The blood test instrument of claim 24, wherein the distal end is integrally attached to a blood collection device. 25. A blood test instrument according to claim 24, wherein the distal end is configured to be attached to a blood collection device. The blood test apparatus according to claim 31, wherein the blood collection device is a syringe. A blood test apparatus comprising a plurality of blood test instruments according to claim 1 connected to each other. For testing blood for the presence or absence of one or more components or for the amount of the components, or for testing blood to determine the level of one or more parameters, or for the presence or amount of said components and parameters A method for examining blood for level determination, comprising:
a) the blood test device of claim 1, a test strip comprising a distal end and a proximal end, and a test strip reader configured to receive the distal end of the test strip; Providing a blood containing device;
b) attaching the blood test device to the blood storage device and allowing blood present in the blood storage device to enter the intermediate portion of the blood test device;
c) inserting the distal end of the test strip into the test strip reader and inserting the proximal end of the test strip into the intermediate portion of the blood tester;
d) to determine the presence or amount of one or more components of blood or the amount of that component, or to determine the level of one or more parameters, or to determine the presence or amount of said components and the level of parameters For using the information provided by the test strip reader,
Including methods. 35. The method of claim 34, wherein the blood storage device provided in step a) is selected from the group consisting of an intravascular entry device and a syringe. 35. The method of claim 34, further comprising selecting a patient to undergo a blood test and accessing the patient's intravascular blood using the blood containment device. 35. The method of claim 34, wherein the blood tester and blood storage device are attached together in step b). 35. The method of claim 34, further comprising discarding the blood tester after step c). For testing blood for the presence or absence of one or more components or for the amount of the components, or for testing blood to determine the level of one or more parameters, or for the presence or amount of said components and parameters A blood test means for testing blood for level determination, the blood test means comprising:
a) a proximal end and a distal end of the blood test device;
b) an intermediate portion between the proximal end and the distal end;
c) end means for receiving the test strip;
d) means for compensating for pressure changes in the intermediate portion;
With
The intermediate portion comprises a proximal end of the intermediate portion having one or more openings, and a distal end of the intermediate portion, wherein the proximal end of the intermediate portion and the intermediate portion The blood test means further comprising a hollow central chamber surrounded by an outer wall between the distal end portion. For testing blood for the presence or absence of one or more components or for the amount of the components, or for testing blood to determine the level of one or more parameters, or for the presence or amount of said components and parameters A method for examining blood for level determination, comprising:
a) a blood test means, a test strip comprising a distal end and a proximal end, a test strip reader configured to receive the distal end of the test strip, and a blood receiving device Steps to prepare,
b) attaching the blood test means to the blood storage device, and allowing blood existing in the blood storage device to enter the intermediate portion of the blood test device;
c) inserting the proximal end of the test strip into the intermediate portion of the blood test means and inserting the distal end of the test strip into the test strip reader;
d) to determine the presence or amount of one or more components of blood or the amount of that component, or to determine the level of one or more parameters, or to determine the presence or amount of said components and the level of parameters For using the information provided by the test strip reader,
Including methods. The blood test instrument of claim 1, wherein the one or more openings at the proximal end of the intermediate portion comprise a flow valve. The blood test apparatus according to claim 41, wherein the flow valve is a duckbill valve. The blood test apparatus according to claim 41, wherein the flow valve is a flap valve. 40. The blood test means of claim 39, wherein the one or more openings at the proximal end of the intermediate portion comprise a flow valve. The blood test means according to claim 44, wherein the flow valve is a duckbill valve. The blood test means according to claim 44, wherein the flow valve is a flap valve.

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