Blunt end cannula assembly and blood plasma analyzing method and kit having blunt end cannula assembly
Abstract
[Task] Traditional blunt cannulas cannot separate plasma from blood and efficiently supply plasma to point-of-care test cartridges for analysis.
Solution.Kit K1Has a point of care inspection cartridge 12 and a blunt-end cannula assembly 14. This blunt cannula assembly 14 includes a blunt cannula 64 with a filter that filters cellular components from whole blood and allows plasma to be fed to the test cartridge 12 by the blunt cannula 64.

Term
Term ended
Projected expiry passed 1 April 2022, 4.5 years ago.
- Priority
- Filed
- Published
- Projected expiry
- Today
10 claims: 4 independent, 6 dependent
- 1【特許請求の範囲】 【請求項1】 基端部と末端部とこれらの間に延在する管状空間とを有し、前記管状空間の前記基端部に隣接する部分がルアーチップと接続するような寸法形状に形成されたテーパー状開口を画成するカニューレと、 前記基端部と前記末端部との間の前記管状空間に取り付けられるフィルタとを具えたことを特徴とする鈍端カニューレアセンブリ。
- 2【請求項2】 前記フィルタは、相互に隣接する第1および第2のフィルタ層を有する二重フィルタを具えていることを特徴とする請求項1に記載の鈍端カニューレ。
- 3【請求項3】 前記第1および第2のフィルタ層は、相互に連結されていることを特徴とする請求項2に記載の鈍端カニューレアセンブリ。
- 4【請求項4】 前記フィルタは、0.2から5.0マイクロメートルの間の孔径を有することを特徴とする請求項1から請求項3の何れかに記載の鈍端カニューレ。
- 5【請求項5】 前記フィルタは、ガラス繊維,グラスウール,ナイロンおよびセラミック繊維からなるグループから選択されることを特徴とする請求項1から請求項4の何れかに記載の鈍端カニューレアセンブリ。
- 6【請求項6】 前記管状空間は、前記基端部と前記末端部との間に座部を含み、この座部の基端部側の前記管状空間の部分は、前記ルアーチップと接続するように形成された円錐状のテーパ部を画成し、前記フィルタは前記座部にほぼ隣接して固定されていることを特徴とする請求項1から請求項5の何れかに記載の鈍端カニューレアセンブリィ。
- 7【請求項7】 前記末端部に隣接する前記鈍端カニューレの部分は、前記末端部にテーパー状先端部を持つ細い円筒を画成していることを特徴とする請求項1から請求項6の何れかに記載の鈍端カニューレアセンブリ。
- 8【請求項8】 前記フィルタは、前記フィルタを通過する選択された液体成分の凝固を妨げるための抗凝固剤を具えていることを特徴とする請求項1から請求項7の何れかに記載の鈍端カニューレアセンブリ。
- 9【請求項9】 注射器を用意するステップと、 前記注射器に被検血液を得るステップと、 フィルタを有する鈍端カニューレを用意するステップと、 前記注射器に前記鈍端カニューレを取り付けるステップと、 前記鈍端カニューレをポイントオブケア検査カートリッジと連通状態に置くステップと、 前記血漿が前記フィルタを通って前記検査カートリッジに流れるように、前記血液を前記検査カートリッジの前記フィルタの方に付勢するために前記注射器内の血液に圧力を加えるステップとを具えたことを特徴とする血漿分析方法。
- 10【請求項10】 分析のための流体サンプルを受容する内部のリザーバと、このリザーバに連通する入口とを有し、この入口が選択された断面寸法形状を規定しているポイントオブケア検査カートリッジを具えたキットであって、 このキットは鈍端カニューレアセンブリをさらに具え、この鈍端カニューレアセンブリは、注射器の取り付けのために形成された基端部と、前記検査カートリッジの前記入口ポートへの挿入のために形成された末端部と、これら基端部と末端部との間に延在する管状空間とを持った鈍端カニューレを有し、前記鈍端カニューレアセンブリは、前記基端部と前記末端部との間の前記管状空間に固定され、液体成分を前記検査カートリッジの前記入口ポートに供給する前に、前記液体成分を濾過するためのフィルタをさらに具えていることを特徴とするキット。
Independent claims10
119 paragraphs in 1 section, as filed
Description: TECHNICAL FIELD [Detailed description of the invention]
【0001】
[Technical field to which the invention belongs]
The present invention relates to a blunt-end cannula assembly with a filter material placed therein to separate components of body fluids such as blood. The present invention also relates to a plasma analysis method using a blunt-end cannula assembly and a point-of-care test cartridge, and a kit including these blunt-end cannula assemblies and a point-of-care test cartridge.
【0002】
[Background technology]
Many medical procedures require diagnostic tests performed on fluid samples. Some of these tests require fluids to be separated into their constituents. For example, plasma is a liquid component of blood. Some diagnostic tests require that plasma, which has its coagulation mechanism in susceptibility, is separated from the other solid components of blood.
【0003】
The prior art includes the placement of glass fibers within the device and a filter device to separate the plasma from the blood. Such systems are described, for example, in US Pat. No. 4619639, US Pat. No. 4810394 and US Pat. No. 5,460777. In addition, techniques are used to separate body fluids into their constituents when filtering in blood bags, test strips, card analysis systems and in-line filter systems.
【0004】
Blood and other body fluids are usually analyzed in a laboratory away from the patient. However, a point of care testing system has recently been developed. The point-of-care testing system of the prior art includes a portable clinical analyzer (hereinafter referred to as a portable clinical analyzer) and a testing cartridge. The test cartridge comprises a small housing with an internal reservoir for receiving small volumes, typically 65 μl to 110 μl of blood. The inspection cartridge further includes an inlet port that communicates with the internal reservoir and a plurality of contact pads and sensors. Blood is collected by a common prior art syringe and can be injected from the syringe into the inlet port of the test cartridge. The contact pad and sensor of the test cartridge are then engaged with the receptacle of the portable clinical analyzer. Portable clinical analyzers perform specific diagnostic tests and provide point-of-care output of test results. The portable clinical analyzer can be used with a printer that provides print output and an interface that controls communication with the central data station, allowing test results to be stored and used appropriately. Examples of point-of-care test systems as described above are provided by i-STAT, Inc., Diametrics Medical, Inc. and AVL Scientific, Inc.
【0005】
Plastic cannulas are a good alternative to sharp-pointed metal cannulas in many situations, including situations where the cannula must perforate a septum or where connection with an IV (intravenous) connector is desired. It is a product. The prior art plastic cannula is integrally molded from plastic and includes a proximal end, an end portion, and a tubular space extending between these proximal ends and the distal end. The tubular space has a large opening and is tapered at the base end of the plastic cannula so that it does not leak, that is, frictionally engages with the tapered tip of a normal luer connection member. Will be done. The base end of the plastic cannula may further have protrusions with opposite peaks and valleys formed in a dimensional shape that engages the threads of the luer collar.
【0006】
The end of a prior art plastic cannula includes a thin cylindrical wall that surrounds a tubular space that penetrates the cannula. This narrow cylindrical wall can be tapered in a conical shape to define a pointed tip that is barely pointed. However, some of the prior art plastic cannulas have a sufficiently sharp end tip to penetrate the rubber film. In this regard, the sharpness of the tip of the end will usually be limited by the diameter of the tubular space that penetrates the cannula. This results in a barely pointed tip that may not be able to penetrate many septa. However, for plastic cannulas, a triangular extension opposite the tubular side wall has been developed at the very end of the plastic cannula. These triangular extensions converge and meet at a well-defined point at the very end of the plastic cannula. A pair of identical side ports open laterally at the portion between the end and the converging triangular extension. This type of plastic cannula is often used to deliver the drug intravenously through the septum of the IV connecting member. A blunt cannula (hereinafter referred to as a blunt cannula) is sharp enough to pierce the septum, but it does not accidentally pierce the patient.
【0007】
[Problems to be Solved by the Invention]
The Point of Care test cartridge first accepts whole blood that has been prevented from coagulating for analysis. This may require a cartridge to separate the cellular components of the blood, as in the Abbott Vision System. Alternatively, the cartridge needs to use a sensor for direct measurement of the analyte, such as in the Abbott i-STAT system.
【0008】
Point-of-care testing systems offer much effectiveness compared to laboratory analysis. However, it is difficult to accurately transfer blood from the syringe to the test cartridge. More specifically, it is unsafe and undesirable to use a contaminated and pointed metal needle cannula while operating a very small inspection cartridge. Therefore, it is preferable to manually remove the used needle cannula from the syringe. The user must then direct the syringe's short, relatively thick luer tip to the small inlet port of the test cartridge. There is a significant risk of losing at least a portion of the collected blood that is missed in this inlet port. This stray blood poses a risk for pollution and can leave an insufficient amount of blood to complete a diagnostic test. Therefore, the medical technician may have to make another tedious and painful blood sampling from the patient. In addition, partially filled test cartridges may have to be discarded, which increases the cost associated with fairly simple diagnostic tests.
【0009】
[Purpose of Invention]
An object of the present invention is to provide a blunt cannula assembly capable of separating plasma from blood and efficiently supplying plasma to a point of care test cartridge for analysis.
【0010】
Another object of the present invention is to provide a plasma analysis method using the above-mentioned blunt-ended cannula assembly and a kit used for this plasma analysis method.
【0011】
[Means for solving problems]
The first embodiment of the present invention has a proximal end portion, an terminal portion, and a tubular space extending between them, such that a portion of the tubular space adjacent to the proximal end portion is connected to a lure tip. The blunt-ended cannula assembly comprises a cannula that defines a tapered opening formed in a dimensional shape and a filter that is attached to the tubular space between the base end and the end. ..
【0012】
A second embodiment of the present invention includes a step of preparing a syringe, a step of obtaining blood to be tested in the syringe, a step of preparing a blunt-end cannula having a filter, and a step of attaching the blunt-end cannula to the syringe. , The step of placing the blunt-end cannula in communication with the Point of Care test cartridge, and urging the blood towards the filter of the test cartridge so that the plasma flows through the filter and into the test cartridge. This is a plasma analysis method comprising a step of applying pressure to the blood in the syringe.
【0013】
A third aspect of the invention has an internal reservoir that receives a fluid sample for analysis and an inlet that communicates with this reservoir, which defines the selected cross-sectional dimensions and shape. A kit with a care test cartridge, which further comprises a blunt-ended cannula assembly, which includes a proximal end formed for syringe mounting and the inlet port of the test cartridge. The blunt-end cannula having a blunt-ended cannula having an end formed for insertion into and a tubular space extending between these proximal ends, the blunt-end cannula assembly is said to be the proximal end. It is fixed in the tubular space between the portion and the end portion, and is further provided with a filter for filtering the liquid component before supplying the liquid component to the inlet port of the inspection cartridge. To do.
【0014】
BEST MODE FOR CARRYING OUT THE INVENTION
The blunt-ended cannula in the blunt-ended cannula assembly according to the first aspect of the invention is structurally the same as the blunt-ended cannula of the prior art, or is a plastic connector sold by Becton Dickinson under the registered trademark INTERLINKR. It may be there. More specifically, the blunt-end cannula includes opposing proximal and distal ends and a tubular space extending between these proximal and distal ends. The base end of the blunt cannula includes a tapered inlet into a tubular space made to a specific size for liquid tight engagement over the tapered luer tip of the syringe. The base end of the blunt cannula can further include protrusions that are the exact opposite of the luer collar made to a particular size for screwing with the luer collar.
【0015】
The end of the blunt cannula includes a thin cylindrical tube with an outer diameter significantly smaller than the outer diameter at the end of the tapered luer tip. This cylindrical tube is tapered to the end of a blunt end that is not pointed. The blunt end can define a conical or annular taper with a single opening along the axial direction to the tubular space at the end of this blunt cannula. Alternatively, the ends of the blunt cannula can include opposite triangular protrusions that converge with each other. The triangular protrusions can intersect at one point sharp enough to pierce the rubber film. The triangular protrusions of the blunt-ended cannula can be separated from each other by lateral ports that open laterally at the ends of the cannula.
【0016】
The blunt-end cannula assembly according to the present invention differs from the blunt-end cannula of the prior art by incorporating a filter into the blunt-end cannula. The filter communicates with the tubular space and can be placed in the tubular space at the end of the inlet of the tapered base end. The filter material can be selected to separate plasma from the cellular components of blood. The filter material can be formed as a single component or as multiple adjacent layers that are mechanically or chemically fixed. Both of these layers can be equipped with both low-density and high-density materials that are both selected to achieve efficient separation of plasma. For example, the layer of this filter material can comprise glass fiber, Orlon , glass wool, Dacron , nylon or ceramic fiber. These materials are selected to create a gradual exit from whole blood that captures cellular components, including red blood cells, white blood cells and platelets, thereby guiding the plasma fluid for analysis.
【0017】
As mentioned above, the point of care test cartridge may be of a general prior art design. Alternatively, the point of care test cartridge may be of a novel design specifically adapted for the analysis of plasma that can be separated from whole blood by a filter in the blunt cannula of the present invention.
【0018】
The plasma analysis method according to the second embodiment of the present invention can include a first step of using a syringe to obtain a blood sample from a patient. This first step can further comprise the step of attaching a metal needle cannula to the luer tip of the syringe and directly accessing the patient's blood vessels. Alternatively, the first step can include attaching a plastic connecting member to the syringe to access the connecting member of the blood collection set or IV line. Also, blood collection sets and IV lines can be accessed directly by syringes. This method provides a blunt-ended cannula with a filter material and then comprises the step of attaching the blunt-ended cannula to the syringe so that the filter material communicates with the passage through the syringe tip. This method proceeds by placing the end of the blunt cannula at the inlet port of the point of care test cartridge. Next, the plunger of the syringe is urged toward the end of the syringe body. As a result, the whole blood in the fluid receiving chamber of the syringe is urged towards the filter of the blunt cannula. This filter retains the cellular components of the blood, but passes the plasma through the tubular space of the blunt cannula to the inlet port of the test cartridge. The syringe and blunt cannula are then separated from the test cartridge. The inlet port to the test cartridge is then closed and the sensor of the test cartridge is placed in communication with the portable clinical analyzer for analysis of plasma in the reservoir of the test cartridge.
【0019】
The kit according to the third aspect of the present invention can be used with a syringe. This syringe is used to collect blood or other fluid samples that are filtered and analyzed. Collection of blood or other body fluids in a syringe is done in the traditional way using a metal needle cannula for direct access to blood vessels. Alternatively, blood is collected in a blood collection set that has a connecting member to which the syringe is connected. Furthermore, a plastic connecting member is attached directly to the end of the syringe and placed in communication with the IV line for taking samples of blood or other body fluids.
【0020】
The blunt-end cannula of the kit is attached to the syringe after blood or other liquid has been collected. The end of the blunt cannula is then attached to the inlet port of the kit's inspection cartridge. The plunger of the syringe assembly is then moved towards the end of the syringe body to urge blood or other liquid towards the filter. The filter retains the cellular components of the blood, but allows the liquid components to pass through the test cartridge for analysis.
【0021】
[Example]
Some of the examples according to the present invention will be described in detail with reference to FIGS. 1 to 14, but the present invention is not limited to these examples, but may be further combined or claimed in the present specification. Any modification or modification included in the concept of the invention described in the scope is possible, and therefore can be naturally applied to any other technique belonging to the spirit of the invention.
【0022】
The kit according to the present invention is shown in FIG.<sub>1</sub>It is shown as. Kit K<sub>1</sub>Includes a point of care inspection cartridge 12 as shown in FIG. 3 and a blunt cannula assembly 14 as shown in FIG.
【0023】
Kit K<sub>1</sub>Is used with the syringe assembly 10 as shown in FIG. A syringe assembly (hereinafter simply abbreviated as a syringe) 10 as shown in FIG. 2 includes a syringe body 16 having a proximal end 18 and a distal end 20. The tubular portion 22 defines a cylindrical fluid receiving chamber 24 that extends from the proximal end 18 to the distal end 20 side and has a large opening at the proximal end 18. The truncated cone-shaped tapered tip 26 extends from the tube 22 to the end 20 of the syringe body 16. The tip portion 26 is formed with a narrow cylindrical passage 28 communicating with the fluid receiving chamber 24 of the tubular portion 22. The luer collar 30 projects from the tubular portion 22 toward the end portion 20 and surrounds the tip portion 26 concentrically. The luer collar 30 is given a multi-row female thread 32. The syringe 10 further includes a plunger 34 that is slidable with respect to the fluid receiving chamber 24 and is in a liquid tightly fitted to the cylindrical wall of the fluid receiving chamber 24. Since the plunger 34 urges the fluid passing through the passage 28 of the tip 26 into or out of the fluid receiving chamber 24, it can be alternately moved to the proximal 18 side or the distal 20 side.
【0024】
Kit K<sub>1</sub>Point of Care Test Cartridge (hereinafter simply referred to as Test Cartridge) 12 is shown in Figure 3, which may be any of the prior art designs, i-STAT, Inc., Diametrics Medical, AVL. Includes those manufactured by Scientific Corporation and any other inspection cartridges that are or will be usable. One such inspection cartridge is disclosed in US Pat. No. 5,638,828, the disclosure of which is incorporated herein by reference.
【0025】
The inspection cartridge 12 includes a generally rectangular body, housing 56, having a length of approximately 38.1-50.8 mm, a width of approximately 25.4 mm and a thickness of approximately 6.35 mm. The liquid reservoir 58 is formed inside the housing 56 of the inspection cartridge 12 and has a volume ranging from 65 μl to 110 μl. Housing 56 further includes an inlet port 60 that communicates with reservoir 58. The inlet port 60 is slightly tapered from the relative large diameter on the outside of the housing 56 to the relative small cross section closer to the reservoir 58. The test cartridge 12 provides various output data that can be used by medical technicians to perform various point-of-care diagnostic tests on blood samples in reservoir 58 and / or at remote locations. Therefore, it further has a plurality of contact pads and sensors 62, each of which can be placed in communication with a portable clinical analyzer.
【0026】
Kit K<sub>1</sub>The blunt-end cannula assembly 14 of is more clearly shown in FIGS. 4-6. The blunt-end cannula assembly 14 includes a blunt-end cannula 64, which is named Becton Dickinson under the registered trademark INTERLINKR. It may be of the model sold by. As more clearly shown in FIG. 5, the blunt-ended cannula 64 includes a base end 68 and an end portion 70 that are integrally molded from a plastic material and define a length of just over 25.4 mm. A tubular space 72 extends between the proximal end 68 and the distal end 70. The portion of the tubular space 72 adjacent to the proximal end 68 defines a tapered inlet that closely matches the dimensions and shape of the tapered passage in the hub of the needle assembly (not shown). Thus, the tapered inlet to the tubular space 72 at the base end 68 of the blunt cannula 64 can provide a liquid-tight friction engagement with the tapered tip 26 of the syringe body 16. The portion of the tubular space 72 adjacent to the proximal end 68 defines a maximum inner diameter of approximately 4.2926 mm. A seat 73 is defined at the end of the tapered base end entrance to the tubular space 72. The tubular space 72 extends from the seat portion 73 to the end portion 70 side with a constant inner diameter of about 1.3716 mm. The base end 68 of the blunt cannula 64 is further characterized by a dimensional shape that engages the multi-row female thread 32 of the luer collar 30, i.e. a pair of protrusions 74 with opposite peaks and valleys. Therefore, the protrusion 74 brings the tapered base end opening end of the tubular space 72 into a liquid-tight friction fitting state with respect to the tapered tip portion 26 of the end portion 20 of the syringe body 16, so that the luer collar 30 Can be screwed into and screwed into. In other embodiments, the syringe does not have to have a luer collar, in which case the blunt-end cannula 64 is simply moved axially into a liquid-tight frictional fit with respect to the tip 26 of the end 20. Can be done.
【0027】
The portion of the blunt cannula 64 adjacent to the end 70 has a minimum outer diameter of approximately 1.8288 mm at the end 70 to a maximum outer diameter of 2.54 mm at a distance of approximately 1.143 mm from the end 70. A truncated cone-shaped taper is defined. The blunt-end cannula 64 extends approximately 10.16 mm from the end 70 with a nearly constant outer diameter of approximately 2.54 mm. Both the minimum outer diameter at the end 70 and the maximum outer diameter of 2.54 mm adjacent to the truncated cone taper are well smaller than the corresponding dimensions of the tip 26 at the end 20 of the syringe body 16. Further, the taper angle at the end 70 of the blunt cannula 64 is greater than the taper angle at the tip 26 of the syringe body 16.
【0028】
Returning to FIG. 4, the safety shield 66 of the blunt-end cannula assembly 14 includes a closed end 76 and an open base 78. The base end 78 of the safety shield 66 can be fitted so as to cover the end 70 of the blunt cannula 64 and rub against the portion between the base 68 and the end 70 of the blunt cannula 64. It can be in a state of coalescence.
【0029】
As shown in FIG. 5, the blunt-end cannula 64 is provided with a filter 80A adjacent to a seat 73 between the large and small cross sections of the tubular space 72. The filter 80A has a pore size of 0.2 to 5.0 micrometers and is preferably made of borosilicate glass fiber, Orlon , glass wool, Dacron , nylon or ceramic fiber. Filter 80A separates at least certain cellular components of whole blood, thereby allowing plasma to pass through filter 80A. In addition, the filter 80A can be treated with or include an anticoagulant such as heparin to delay or prevent the coagulation of plasma passing through the filter 80A.
【0030】
FIG. 6 shows a blunt-end cannula 64 with a multi-layer filter 80B having a first filter layer 81 and a second filter layer 82 that can be mechanically or chemically joined. The two filter layers 81, 82 can be selected from two of a plurality of selection materials treated as the filter 80A. However, a combination of filters is chosen to create a stepwise exit leading to complete separation of cellular components and to provide plasma fluid for analysis.
【0031】
The filter 80B should be structurally the same as the filter 80A, thus including a pore size in the range of 0.2 to 5 micrometers. Further, since each of these materials apparently has a low density of 0.13 g / cm and a high density, it is preferable to have a range from a low density of 0.13 g / cm to a high density of 0.5 g / cm.
【0032】
Kit K in Figure 1<sub>1</sub>Can be used with the syringe 10 in FIG. 2 to perform diagnostic tests on whole blood plasma collected from patients. More specifically, the syringe 10 is used in the traditional way to take a blood sample from a patient. In this case, the syringe 10 can be used with a common metal needle cannula for direct access to the patient's blood vessels. Alternatively, the tip of the syringe body 16, i.e. the luer tip 26, can be connected to a connecting member of the IV line that is previously placed in communication with the patient's blood vessels. Furthermore, the luer tip 26 of the syringe body 16 can be placed in communication with the connecting members used in turn together with the blood collection set. For each of these options, the movement of the plunger 34 towards the proximal end 18 draws blood into the fluid receiving chamber 22 of the syringe body 16. The syringe 10 is then separated from the blood source and the blunt cannula assembly 14 is attached to the luer tip 26. In particular, as shown in FIG. 7, the blunt-ended cannula assembly 14 can be engaged with the luer tip 26 of the syringe body 16. The safety cap 66 of the blunt cannula assembly 14 is then removed to expose the blunt cannula 64 as shown in FIG.
【0033】
The end 70 of the blunt cannula 64 is then inserted into the inlet port 60 of the inspection cartridge 12, as shown in FIG. Plunger 34 is urged to end 20 to direct a selected amount of blood collected through filter 80A or dual filter 80B towards the test cartridge 12. The filter 80A or dual filter 80B separates the cellular components in whole blood that are urged from the fluid receiving chamber 22 of the syringe body 16. Therefore, the force of the plunger 34 guides the plasma fluid to the test cartridge 12 for analysis. The overall yield of the blunt cannula 64 may not be high due to the relatively rapid clogging of the device. However, the test cartridge 12 requires only a very small amount (65 μl to 110 μl) of plasma fluid to achieve analysis of the collected test object. Therefore, the filters 80A, 80B will usually be able to provide a sufficient amount of plasma for the test cartridge 12 before the device is clogged. After the required amount of plasma has been supplied to the test cartridge 12, the syringe 10 and the blunt-end cannula 64 are separated from the test cartridge 12. The inlet port 60 is then closed and the test cartridge 12 is passed to a portable clinical analyzer for diagnostic testing of the collected plasma test.
【0034】
Kit K in Figure 11<sub>2</sub>Is Kit K<sub>1</sub>Contains the exact same inspection cartridge 12 as the inspection cartridge 12 in. Kit K<sub>2</sub>Is Kit K<sub>1</sub>The same blunt-ended cannula assembly 14 as the blunt-ended cannula assembly 14<sub>2</sub>Includes more. However, Kit K<sub>2</sub>Dull end cannula assembly 14<sub>2</sub>Is structurally a kit K<sub>1</sub>Includes a blunt cannula 84 that is slightly different from the blunt cannula 64 of. More specifically, as shown in FIG. 12, the blunt-end cannula 84 is a tubular space 90 extending between a proximal end 86 and a distal end 88 and between these proximal ends 86 and the distal end 88. And have. The portion of the tubular space 90 adjacent to the base end portion 86 defines a tapered portion that substantially matches the tip portion 26 of the tapered end portion 20 of the syringe body 16. Therefore, the tip 26 of the tapered end 20 of the syringe body 16 can be placed in a liquidtight engagement with the proximal end of the tubular space 90 of the blunt cannula 84. The portion of the tubular space 90 adjacent to the end 88 is a much smaller cross section than the portion adjacent to the proximal 86. Therefore, a well-defined seat 91 is defined in the middle along the longitudinal direction of the tubular space 90. The base end 86 of the blunt cannula 84 is further characterized by a pair of opposite ridges and valleys 92 that are sized to engage the multi-row female thread 32 of the luer collar 30. .. Thus, the tubular space 90 through the blunt cannula 84 can be placed in communication with the passage 28 at the tip 26 and the fluid receiving chamber 24 at the syringe body 16. The end 88 of the blunt cannula 84 includes a thin cylindrical tube ending with a pair of opposing triangular protrusions 94 that converge to intersect at a well-defined tip. The triangular protrusions 94 are separated from each other by two opposing ports 96.
【0035】
The blunt-end cannula 84 further comprises a filter 80A located in a seat 91 between a large section and a small section of the tubular space 90. The filter 80A is substantially the same as the filter 80A of the first embodiment described above and shown in FIG.
【0036】
The blunt-end cannula 84 can also be used with the dual filter 80B as shown in FIG. The dual filter 80B is described above and kit K<sub></sub><sub>1</sub>Is almost the same as the double filter 80B shown in FIG.
【0037】
Kit K<sub>2</sub>Is Kit K<sub>1</sub>Is used in the same way. More specifically, a syringe 10 can be used to obtain a blood sample from a patient. In this case, the blunt-end cannula 84 can be attached to the syringe 10 as shown in FIG. In this case, as described above, the combination of the blunt-ended cannula 84 and the syringe 10 is similarly used as the combination of the blunt-ended cannula 64 and the syringe 10 as described above and shown in FIGS. 9-11. Can be
【0038】
[Effect of the invention]
According to the blunt cannula assembly of the present invention, plasma can be separated from blood and plasma can be efficiently fed to a point of care test cartridge for analysis.
【0039】
According to the plasma analysis method of the present invention, a blunt-ended cannula with a filter was attached to the injector and the blunt-ended cannula was placed in communication with the Point of Care test cartridge to allow plasma to flow through the filter into the test cartridge. Plasma can be separated from blood and efficiently fed to point-of-care test cartridges for analysis.
【0040】
According to the kit of the present invention, a point-of-care inspection cartridge and a blunt-end cannula assembly are provided, and the blunt-end cannula assembly is fixed in the tubular space between the proximal end and the distal end to inspect the liquid component of the cartridge. It also has a filter to filter the liquid component before feeding it to the inlet port, so that the liquid component can be separated from the blood and efficiently supplied to the Point of Care test cartridge for analysis. it can.
[Simple explanation of drawings]
[Figure 1]
It is a top view of the 1st Example of the kit by this invention.
[Figure 2]
FIG. 5 is a perspective view of a syringe used with the kit of FIG.
[Fig. 3]
It is a perspective view of the inspection cartridge of the kit of FIG.
[Fig. 4]
It is a partially broken side view of the blunt end cannula assembly of the kit in FIG.
[Fig. 5]
It is a vertical cross-sectional view of the blunt end cannula in FIG.
[Fig. 6]
A vertical section similar to FIG. 5, but showing another filter housed in a blunt-end cannula.
[Fig. 7]
It is a side view of the blunt end cannula assembly of FIG. 4 attached to the syringe of FIG.
[Fig. 8]
A side view similar to FIG. 7, but showing the safety cap removed from the blunt-ended cannula assembly.
[Fig. 9]
FIG. 3 is a perspective view of the syringe used with the test cartridge of FIG. 3 and the blunt-end cannula assembly of FIG.
[Fig. 10]
It is a perspective view of the inspection cartridge after accommodating the test fluid and before inspection.
[Fig. 11]
FIG. 5 is a plan view of another embodiment of the kit according to the present invention.
[Fig. 12]
It is a vertical cross-sectional view of the blunt end cannula shown in the kit of FIG.
[Fig. 13]
It is a vertical cross-sectional view similar to FIG. 12, but shows a different filter.
[Fig. 14]
It is an exploded perspective view of the blunt end cannula of FIG. 12 or 13 together with the syringe of FIG.
[Explanation of symbols]
K<sub>1</sub>, K<sub>2</sub> kit 10 syringe assembly 12 Point of Care Inspection Cartridge 14 blunt-ended cannula assembly 14<sub>2</sub> Dull end cannula assembly 16 Syringe body 18 Base end of syringe body 20 End of syringe body 22 Cylinder 24 Fluid receiving chamber 26 Tip (Lure tip) 28 passage 30 lure color 32 Multi-row female thread 34 Plunger 56 Body (housing) 58 Reservoir 60 entrance port 62 Contact pads and sensors 64 blunt cannula 66 Safety Shield 68 Base end of blunt cannula 70 End of blunt cannula 72 Tubular space of blunt cannula 73 Seat 74 protrusions 76 End of safety shield 78 Base end of safety shield 80A filter 81 First filter layer 82 Second filter layer 80B multi-layer filter 84 blunt cannula 86 Base end of blunt cannula 88 End of blunt cannula 90 Tubular space of blunt cannula 91 Seat 92 Protrusions 94 Triangular protrusion 96 ports
4 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| JP2018049026A | Cited by | Japan | Search report |
| JP2018194559A | Cited by | Japan | Search report |
| US11974846B2 | Cited by | United States of America | Applicant |
| US10194851B2 | Cited by | United States of America | Applicant |
| JP2021012215A | Cited by | Japan | Search report |
| US11298061B2 | Cited by | United States of America | Applicant |
| US10595762B2 | Cited by | United States of America | Applicant |
| JP2017506340A | Cited by | Japan | Search report |
| JP2017099947A | Cited by | Japan | Search report |
| JP2016521163A | Cited by | Japan | Search report |
| US12082931B2 | Cited by | United States of America | Applicant |
| JP2018049026A | Cited by | Japan | Search report |
| US10219731B2 | Cited by | United States of America | Applicant |
| US11134875B2 | Cited by | United States of America | Applicant |
8 members in 6 offices
Priority claims10
| Document | Office | Kind | Date |
|---|---|---|---|
| 28040101 | United States of America | P | |
| 28040101 | United States of America | P | |
| 28043601 | United States of America | P | |
| 28043601 | United States of America | P | |
| 60280401 | United States of America | – | |
| 60280436 | United States of America | – | |
| 2001280401 | – | – | – |
| 2001280436 | – | – | – |
| US20010280401P | – | – | – |
| US20010280436P | – | – | – |
Members8
| Document | Office | Kind | |
|---|---|---|---|
| CA2379826A1 | Canada | A1 | |
| EP1245943A2 | European Patent Office (EPO) | A2 | |
| AU2935702A | Australia | A | |
| US2002143298A1 | United States of America | A1 | |
| CN1382966A | China | A | |
| JP2003019126AThis record | Japan | A | |
| EP1245943A3 | European Patent Office (EPO) | A3 | |
| US6869405B2 | United States of America | B2 |
Numbers
- Publication
- 2003-19126
- Publication, DOCDB
- 2003019126
- Publication, EPODOC
- JP2003019126
- Application
- 99039
- Application, DOCDB
- 2002099039
- Application, EPODOC
- JP20020099039
Titles2
- Japanese
- 【発明の名称】鈍端カニューレアセンブリおよび血漿分析方法ならびに鈍端カニューレアセンブリを具えたキット
- English
- INDUSTRIAL APPLICABILITY A kit including a blunt-end cannula assembly, a plasma analysis method, and a blunt-end cannula assembly.
Classification
- CPC, 2
- G01N1/405
- G01N1/14
- IPC, 4
- G01N33 48
- A61B5 15
- G01N1 14
- G01N1 34