Device for the adherent flow of blood

Abstract

A collection device (10) is disclosed that directs blood flow into a container (14) and provides a controlled blood flow path that ensures blood flow from a collection site to the collection container.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2017 / 048147, Chinese application number 201780062303.8, application date August 23, 2017, and name “Device for the attachment flow of blood”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 378,971, filed on August 24, 2016, entitled “Finger-Based Capillary Blood Collection Device,” the entire disclosure of which is incorporated herein by reference. Background of the Invention 1. Technical Field

[0005] The present disclosure generally relates to devices suitable for use with biological fluids. More particularly, the present disclosure relates to devices for controlling the flow of blood. 2. Background Technology

[0007] Taking a blood sample is a common health care procedure that involves withdrawing at least one drop of blood from a patient. Blood samples are typically obtained from hospitalized, home care, and emergency room patients via fingerstick, heel stick, or venipuncture. After collection, the blood sample can be analyzed to obtain medically useful information, including, for example, chemical composition, blood disorders, or coagulation. Blood tests determine the patient's physiological and biochemical status, such as disease, mineral content, drug effectiveness, and organ function. Blood tests can be performed in a clinical laboratory or at a point of care near the patient.

[0008] Lancet devices are used in the medical field to puncture a patient's skin to obtain a small capillary blood sample from the patient. Certain conditions, such as diabetes, require regular testing of the patient's blood to monitor, for example, the patient's blood sugar level. Furthermore, test kits, such as cholesterol test kits, often require a small blood sample for analysis. The blood sampling procedure typically involves pricking a finger or other suitable body part to obtain the blood sample. Generally, the amount of blood required for these tests is relatively small, and a small puncture wound or incision often provides a sufficient amount of blood for these tests.

[0009] After puncturing the patient's skin with the lancet device, blood will flow out and remain on the surface of the finger. Summary of the Invention

[0010] The present disclosure provides a collection device that directs blood flow into a container and provides a controlled blood flow path that ensures blood flow from a collection site to the collection container.

[0011] The device for the adherent flow of blood disclosed herein uses three key technical elements to control the flow of blood in a desired manner to achieve this purpose. First, the blood sample is controlled and guided from the patient's skin surface to the collection shell via the first flow guiding attachment portion. Second, the blood sample is controlled and guided from the first end of the collection shell to the second end of the collection shell via capillary transfer. Third, the blood sample is controlled and guided from the second end of the collection shell to the collection chamber of the collection container via the second flow guiding attachment portion. With the first end of the shell connected to the blood source, the first flow guiding attachment portion, the flow channel, the second flow guiding attachment portion and the inner wall surface of the container provide an attachment portion from the first end of the shell to the collection chamber of the container to establish adherent flow of blood for the first drop of blood and subsequent blood tracking.

[0012] According to one embodiment of the present invention, a device for the attachment flow of blood includes: a shell defining a center line and having a first end, a second end, and a flow channel having an inlet and an outlet, a portion of the flow channel being offset from the center line of the shell, the flow channel having a first flow guiding attachment portion adjacent to the inlet and a second flow guiding attachment portion adjacent to the outlet; a container removably connected to the shell, the container defining a collection chamber and having an inner wall, wherein, when the container is connected to the shell, the outlet of the flow channel is fluidically connected to the collection chamber of the container, and the outlet of the flow channel is adjacent to the inner wall of the container.

[0013] In one configuration, a first flow guiding attachment portion provides a first fluid attachment point for blood to adhere to, thereby controlling the flow of blood from the skin surface to a portion of the housing. In another configuration, a second flow guiding attachment portion provides a second fluid attachment point for blood to adhere to, thereby controlling the flow of blood from a portion of the housing to a collection chamber of the container. In another configuration, when the first end of the housing is connected to a blood source, the first flow guiding attachment portion, the flow channel, the second flow guiding attachment portion, and the inner wall of the container provide attachment points to form an attachment flow for the first drop of blood and subsequent drops of blood to reach the collection chamber of the container from the first end of the housing. In one configuration, when the inlet of the flow channel is connected to the blood source, blood fluidly adheres to the first flow guiding attachment portion and flows from the first flow guiding attachment portion to the flow channel. In another configuration, the blood is subsequently drawn through the flow channel to the second flow guiding attachment portion via capillary action. In another configuration, the blood fluidly adheres to the second flow guiding attachment portion and the inner wall of the container to flow from the flow channel into the collection chamber of the container. In one configuration, the first end of the shell includes an inclined wall surface, the first flow guide attachment portion extends from the inclined wall surface, and the inclined wall surface defines an inlet of the flow channel. In another configuration, the first flow guide attachment portion is an attachment post. In another configuration, the first flow guide attachment portion includes a plurality of attachment posts. In one configuration, the second flow guide attachment portion is an attachment lip. In another configuration, the second flow guide attachment portion is an extended capillary portion. In another configuration, the second flow guide attachment portion is an inwardly curved lip. In one configuration, the second flow guide attachment portion is a flat cut lip. In another configuration, the second flow guide attachment portion is an extended column structure. In another configuration, the outlet of the flow channel extends beyond the second end of the shell.

[0014] According to another embodiment of the present invention, a device for the adherent flow of blood includes: a shell defining a center line and having a first end, a second end, a hollow needle, and a flow channel having an inlet and an outlet, a portion of the flow channel being offset from the center line of the shell, the flow channel having a flow guiding attachment portion adjacent to the outlet, and the hollow needle being between the first end of the shell and the flow channel; a container removably connected to the shell, the container defining a collection chamber and having an inner wall, wherein, when the container is connected to the shell, the outlet of the flow channel is fluidically connected to the collection chamber of the container, and the outlet of the flow channel is adjacent to the inner wall of the container.

[0015] In one configuration, a flow-guiding attachment portion provides a fluid attachment point for blood to adhere to, thereby controlling the flow of blood from a portion of the housing to a collection chamber of the container. In another configuration, when the first end of the housing is connected to a blood source, the hollow needle, the flow channel, the flow-guiding attachment portion, and the inner wall of the container provide an attachment portion to form an attachment flow for the first drop of blood and subsequent drops of blood to reach the collection chamber of the container from the first end of the housing. In another configuration, when the inlet of the flow channel is connected to the blood source, blood fluidly adheres to a portion of the hollow needle and flows through the hollow needle to the flow channel. In one configuration, blood is then drawn from the flow channel to the flow-guiding attachment portion via capillary action. In another configuration, blood fluidly adheres to the flow-guiding attachment portion and the inner wall of the container to flow from the flow channel into the collection chamber of the container. In another configuration, the housing includes an inclined wall surface between the hollow needle and the flow channel, which defines the flow channel inlet. In one configuration, the flow-guiding attachment portion is an attachment lip. In another configuration, the flow-guiding attachment portion is a protruding capillary portion. In another configuration, the flow guiding attachment portion is an inwardly curved lip. In one configuration, the flow guiding attachment portion is a flat cutting lip. In another configuration, the flow guiding attachment portion is an extended column structure. In another configuration, the outlet of the flow channel extends beyond the second end of the housing. In one configuration, the device also includes a flow guiding ring around the hollow needle. In another configuration, the hollow needle includes a cutting edge. In another configuration, with the first end of the housing in fluid communication with a blood source, a first drop of blood adheres to the cutting edge and flows through the hollow needle to the flow channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The above-mentioned and other features and advantages of the present invention, as well as methods of obtaining them, will become more apparent and the present invention itself will be better understood by referring to the following description of embodiments of the present invention in conjunction with the accompanying drawings, in which:

[0017] Figure 1 is a cross-sectional view of a device for adherent flow of blood according to one embodiment of the present invention.

[0018] Figure 2 is engaged with a finger according to an embodiment of the present invention Figure 1 device.

[0019] Figure 3 FIG. 1 is a perspective view of a first flow guide attachment portion of a device for adherent flow of blood according to one embodiment of the present invention.

[0020] Figure 4 FIG. 1 is a perspective view of a first flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0021] Figure 5 FIG. 1 is a perspective view of a first flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0022] Figure 6 FIG. 1 is a perspective view of a first flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0023] Figure 7A FIG. 1 is a perspective view of a second flow guide attachment portion of a device for adherent flow of blood according to one embodiment of the present invention.

[0024] Figure 7B is a perspective view of the adhered flow of blood adhered to the second flow guide attachment portion and the inner wall of the container according to one embodiment of the present invention.

[0025] Figure 8A FIG. 1 is a perspective view of a second flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0026] Figure 8B is a perspective view of an adherent flow of blood adhered to a second flow guide attachment portion and an inner wall of a container according to another embodiment of the present invention.

[0027] Figure 9A FIG. 1 is a perspective view of a second flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0028] Figure 9B is a perspective view of an adherent flow of blood adhered to a second flow guide attachment portion and an inner wall of a container according to another embodiment of the present invention.

[0029] Figure 10A FIG. 1 is a perspective view of a second flow guide attachment portion of a device for adherent flow of blood according to another embodiment of the present invention.

[0030] Figure 10B is a perspective view of an adherent flow of blood adhered to a second flow guide attachment portion and an inner wall of a container according to another embodiment of the present invention.

[0031] Figure 11 is a cross-sectional view of a device for adherent flow of blood according to another embodiment of the present invention.

[0032] Figure 12 According to another embodiment of the present invention, Figure 11 12 is an enlarged view of the open-cell foam material obtained from the cross section.

[0033] Figure 13 is a perspective view of a container having a sample stabilizer according to one embodiment of the present invention.

[0034] Figure 14 is a perspective view of a container having a sample stabilizer according to another embodiment of the present invention.

[0035] Figure 15 is a perspective view of a container having a sample stabilizer according to another embodiment of the present invention.

[0036] Figure 16 is a perspective view of a container having a sample stabilizer according to another embodiment of the present invention.

[0037] Figure 17 is a cross-sectional view of a device for adherent flow of blood engaged with a finger according to another embodiment of the present invention.

[0038] Figure 18 is a perspective view of a hollow needle of a device for adherent flow of blood according to one embodiment of the present invention.

[0039] Figure 19 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0040] Figure 20 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0041] Figure 21 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0042] Figure 22 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0043] Figure 23 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0044] Figure 24 is a perspective view of a hollow needle of a device for adherent flow of blood according to another embodiment of the present invention.

[0045] Figure 25A is a perspective view of a container of a device for adherent flow of blood according to one embodiment of the present invention, wherein the container is connected to a housing.

[0046] Figure 25Bis a perspective view of a container of a device for adherent flow of blood according to one embodiment of the present invention, wherein the container is removed from a housing in a first position.

[0047] Figure 25C is a perspective view of a container of a device for adherent flow of blood according to one embodiment of the present invention, wherein the container is removed from the housing in a second position.

[0048] Figure 26A is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is connected to a housing.

[0049] Figure 26B is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is removed from the housing.

[0050] Figure 27A is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is connected to a housing.

[0051] Figure 27B is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is removed from the housing in a first position.

[0052] Figure 27C is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is removed from the housing in a second position.

[0053] Figure 28A is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is connected to a housing.

[0054] Figure 28B is a perspective view of a container of a device for adherent flow of blood according to another embodiment of the present invention, wherein the container is removed from the housing.

[0055] Corresponding reference characters indicate corresponding parts throughout the several views.The exemplifications set out herein illustrate exemplary embodiments of the disclosure and are not to be construed in any way as limiting the scope of the disclosure. DETAILED DESCRIPTION

[0056] The following description is provided to enable those skilled in the art to make and use the embodiments proposed for practicing the present invention. However, various modifications, equivalents, variations, and alternatives will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0057] For the purposes of the subsequent description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives will relate to the orientation of the present invention in the accompanying drawings. However, it should be understood that the present invention may assume alternative variations and step sequences unless expressly specified to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following detailed description are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0058] The device 10 for the adherent flow of blood disclosed herein provides a controlled blood flow path that ensures adherent flow of blood from a collection location to a collection container. The device 10 for the adherent flow of blood disclosed herein uses three key technical elements to control the flow of blood in a desired manner to achieve this purpose. First, the blood sample is controlled and guided from the patient's skin surface to the collection shell via a first flow guiding attachment portion. Second, the blood sample is controlled and guided from the first end of the collection shell to the second end of the collection shell via capillary transfer. Third, the blood sample is controlled and guided from the second end of the collection shell to the collection chamber of the collection container via a second flow attachment portion.

[0059] Figure 1-10B An exemplary embodiment of the device for attached flow of blood disclosed herein is shown. Figure 1-10B The device 10 for adherent flow of blood of the present disclosure provides a controlled blood flow path that ensures adherent flow of blood from a collection site to a collection container.

[0060] After piercing the patient's skin with a typical lancet device, blood will flow out and remain on the surface of the finger. Without controlling the blood and blood flow, the blood will remain on the surface of the finger and will not easily flow into the collection container.

[0061] See also Figure 1-10BIn one exemplary embodiment, a device 10 for attaching and flowing blood (i.e., providing a flow-guiding attachment for attaching a blood sample so as to control and direct the flow of blood from a collection site to a collection container) generally includes a housing 12 and a collection container 14 removably connected to the housing 12. The container 14 defines a collection chamber 70 and includes an inner wall or inner wall surface 72.

[0062] See also Figure 1-10B , the housing 12 defines a centerline CL and includes a first end 20, a second end 22, and a flow channel 24. The flow channel 24 includes an inlet 26 and an outlet 28. A portion of the flow channel 24 (e.g., the middle portion 30) is offset from the centerline CL of the housing 12. This ensures that the outlet 28 of the flow channel 24 is adjacent to the inner wall surface 72 of the container 14, as described in more detail below. The flow channel 24 also includes a first flow guide attachment portion 32 at the inlet 26 and a second flow guide attachment portion 34 at the outlet 28. In one embodiment, the outlet 28 of the flow channel 24 extends beyond the second end 22 of the housing 12, as shown in FIG. Figure 1 and Figure 2 As shown in .

[0063] See also Figure 1 and Figure 2 When the container 14 is connected to the housing 12 , the outlet 28 of the flow channel 24 is in fluid communication with the collection chamber 70 of the container 14 , and the outlet 28 of the flow channel 24 is adjacent to the inner wall surface 72 of the container 14 .

[0064] In one embodiment, the first end 20 of the housing 12 includes an inclined wall surface 36. As such, the inclined wall surface 36 provides a physical structure, i.e., a wall surface, from which the first flow guide attachment portion 32 can extend upwardly. For example, see Figure 1 The first flow guide attachment portion 32 extends upward from the inclined wall surface 36 to the inlet 26 of the housing 12. In one embodiment, the inclined wall surface 38 defines a flow passage inlet 38.

[0065] The device 10 for the adherent flow of blood disclosed herein provides a controlled blood flow path that ensures adherent flow of blood from a collection location to a collection container. The device 10 for the adherent flow of blood disclosed herein uses three key technical elements to control the blood flow in a desired manner to achieve this purpose. First, the blood sample is controlled and guided from the patient's skin surface to the collection shell via a first flow guiding attachment portion. Second, the blood sample is controlled and guided from the first end of the collection shell to the second end of the collection shell via capillary transfer. Third, the blood sample is controlled and guided from the second end of the collection shell to the collection chamber of the collection container via a second flow attachment portion.

[0066] For example, see Figure 2When the first end 20 of the shell 12 is connected to the source of blood 16, the first flow guiding attachment portion 32, the flow channel 24, the second flow guiding attachment portion 34, and the inner wall surface 72 of the container 14 provide an attachment portion to establish an attachment flow of blood for the first drop of blood 16 and subsequent blood 16 to reach the collection chamber 70 of the container 14 from the first end 20 of the shell 12.

[0067] The first key blood flow path element 40 involves directing the first drop of blood 16 away from the surface S of the finger F in a direction toward the collection container 14. In one embodiment, with the first end 20 of the housing 12 in communication with a source of blood 16, the first flow guiding attachment portion 32 provides a column to which the first drop of blood 16 attaches and flows in a controlled manner downwardly into the flow channel 24 of the housing 12. In other words, the first drop of blood 16 attaches to the first flow guiding attachment portion 32 and flows from the first flow guiding attachment portion 32 to the flow channel 24.

[0068] In one embodiment, the inclined wall surface 36 provides a downwardly adhering flow path from the first flow guide attachment portion 32 to the flow channel 24 of the housing 12. After the first drop of blood 16 adheres to the first flow guide attachment portion 32 and flows downward, the subsequent blood 16 follows the blood adhering flow path of the first drop of blood 16 from the first end 20 of the housing 12 to the collection chamber 70 of the container 14.

[0069] The second key blood flow path element 42 involves directing the blood 16 along the flow channel 24 downwardly toward the collection container 14 to the second flow guiding attachment 34. For example, the first drop of blood 16 and subsequent drops of blood 16 are pulled through the flow channel 24 to the second flow guiding attachment 34 via capillary motion. In one embodiment, the flow channel 24 is a capillary flow channel. In one embodiment, the flow channel 24 is a capillary tube that uses capillary forces to pull the blood 16 downwardly along the flow channel 24 and away from the surface S of the finger F.

[0070] The third key blood flow path element 44 involves directing the blood 16 from the flow channel 24 into the collection container 14. The device 10 of the present disclosure ensures the transition from the flow channel 24 to the container 14 via adherent flow. For example, the blood 16 adheres to the second flow directing attachment portion 34 and the inner wall surface 72 of the container 14 to flow from the flow channel 24 into the collection chamber 70 of the container 14.

[0071] The third key blood flow path element 44 involved in directing the blood 16 from the flow channel 24 into the collection container 14 is the reason for the following feature: Importantly, a portion of the flow channel 24 (i.e., the intermediate portion 30) is offset from the centerline CL of the housing 12. This ensures that the outlet 28 of the flow channel 24 and the second flow directing attachment portion 34 are adjacent to the inner wall surface 72 of the container 14 to ensure a cohesive flow transition of the blood from the flow channel 24 to the container 14.

[0072] If the blood 16 can find another portion to attach to, the blood 16 will simply flow downward and out of the flow channel 24 into the container 14. The second flow guiding attachment portion 34 and the inner wall surface 72 of the container 14 provide these attachment portions to control the blood 16 from reaching the collection chamber 70 of the container 14 via the attached flow of blood.

[0073] As described above, once the blood adherence flow path is established, subsequent blood 16 follows the blood adherence flow path and flows along the blood adherence flow path. In the manner described above, the device 10 of the present disclosure establishes a blood adherence flow from the first end 20 of the housing 12 to the collection chamber 70 of the container 14, for the first drop of blood 16 and subsequent blood 16 to follow.

[0074] The first flow guide attachment portion 32 may include a variety of different designs and structures, such as Figure 3-6 As shown in . Other alternative designs and structures of the first flow guide attachment portion 32 can be envisioned. For example, see Figure 3 In one embodiment, the first flow-guiding attachment portion 32 is an attachment column 50. The attachment column 50 is a single column structure that can have varying diameters and lengths. The column 50 can include hydrophilic surface properties to attract the first drop of blood and establish a flow path to the second capillary portion. In one embodiment, the column 50 can have a diameter of 0.25 mm to 4 mm and a length of 2 mm to 20 mm.

[0075] See also Figure 4 In another embodiment, the first flow guiding attachment portion 32 is a plurality of attachment columns 52. The plurality of attachment columns 52 may include columns having different sizes and structures, including a variety of different numbers of columns. In one configuration, the plurality of attachment columns 52 provide multiple surfaces for the first drop of blood to establish a flow path without fouling the sides of the structure or accumulating in undesirable locations. Due to the multiple capillary portions formed between the individual column structures, the multiple columns 52 may also provide additional capillary action. In one configuration, the multiple attachment columns 52 may include 2 to 10 attachment columns, such as 5 to 10 attachment columns. In one embodiment, each column may have a diameter of 0.25 mm to 4 mm and a length of 2 mm to 20 mm.

[0076] See also Figure 5 In another embodiment, the first flow-guiding attachment portion 32 is a protruding structure 54. This protruding structure 54 guides the adherent flow of blood and can include various shapes, sizes, and structures. In this configuration, the inclined structure provides a hydrophilic surface for the first drop of blood to adhere to and be guided to the second capillary portion. Optionally, the thickness of the inclined structure can range from approximately 0.25 to approximately 5 mm.

[0077] See also Figure 6 In another embodiment, the first flow guiding attachment portion 32 is a capillary groove portion 56. The capillary groove portion 56 guides the attachment flow of blood and can include grooves of different shapes, sizes, and numbers. In this configuration, the column structure with grooves assists with higher capillary forces due to the increased surface area in the grooves, thereby serving as a capillary channel for the first drop of blood that is carried away from the finger and transferred to the second capillary channel by capillary action. In one configuration, the number of grooves provided can be between 1 and 20, and the diameter of each groove can be between 0.25 mm and 1 mm.

[0078] The second flow guide attachment portion 34 may include a variety of different designs and structures, such as Figures 7A-10B As shown in . Other alternative designs and structures of the second flow guide attachment portion 34 can be envisioned. For example, see Figure 1 and Figure 2 In one embodiment, the second flow directing attachment portion 34 is an attachment lip 60. The attachment lip 60 is a lip designed to establish an attachment flow of blood entering the collection chamber 70 of the container 14 as described above. The attachment lip 60 provides a surface for the blood to expand and form droplets to establish attachment to the collection chamber.

[0079] See also Figure 7A and Figure 7B In another embodiment, the second flow guiding attachment portion 34 is an extended capillary portion 62. In one configuration, the extended capillary portion can extend 2 mm to 10 mm beyond the flow channel 24. The extended capillary portion 62 can be spaced apart from the wall of the collection container by a distance of less than 1 mm.

[0080] See also Figure 8A and Figure 8B In another embodiment, the second flow guide attachment portion 34 is an inwardly curved lip 64. This inwardly curved lip structure assists in the adhesion of blood from a portion of the housing to the surface of the collection chamber. In one configuration, the inwardly curved lip structure can extend beyond the flow channel 24 by approximately 0.5 to approximately 10 mm.

[0081] See also Figure 9A and Figure 9BIn another embodiment, the second flow guide attachment portion 34 is a planar cut lip 66. The planar cut lip 66 also assists in the formation of blood droplets and assists in establishing adhesion of blood to the surface of the collection chamber. In one configuration, the planar cut lip can have an angle of about 10° to about 80°.

[0082] See also Figure 10A and Figure 10B In another embodiment, the second flow guide attachment portion 34 is a protruding post structure 68. In one configuration, the protruding post structure may extend beyond the flow channel 24 by a distance of about 0.5 mm to about 10 mm.

[0083] See also Figure 1 、 2 , 17 and 25A-28B, illustrate exemplary embodiments of the collection container 14 of the present disclosure. Additional alternative designs and structures of the collection container 14 are contemplated. The collection container 14 of the present disclosure is removably connected to the housing 12. The container 14 defines a collection chamber 70 and includes an inner wall or inner wall surface 72. See Figure 1 and Figure 2 With the container 14 connected to the housing 12, the outlet 28 of the flow channel 24 is in fluid communication with the collection chamber 70 of the container 14, and the outlet 28 of the flow channel 24 is adjacent to the inner wall surface 72 of the container 14. In one configuration, the inner diameter of the flow channel 24 can be about 0.5 mm to about 2 mm.

[0084] See also Figures 25A-25C In one embodiment, the container 14 includes a removable connection cover 74 and a tethering element 76. In this embodiment, the cover 74 is removed when the container 14 is connected to the housing 12, as shown in FIG. Figure 25A The tether element 76 ensures that the lid 74 remains secured to a portion of the container 14 in the event that the lid 74 is disconnected from the open top end 78 of the container 14, as shown in FIG. Figure 25B Once the desired amount of blood 16 is collected within the container 14, the container 14 is removed from the housing 12 and the cap 74 is attached to the container 14 to protectively seal the blood 16 within the container 14, as shown. Figure 25C As shown in .

[0085] See also Figures 26A-26B In one embodiment, the container 14 includes a resealable septum 80. In this embodiment, with the container 14 connected to the housing 12, a portion of the flow channel 24 pierces the septum 80 to facilitate fluid communication between the flow channel 24 and the collection chamber 70 of the container 14. Once the desired amount of blood 16 has been collected within the container 14, the container 14 is removed from the housing 12 and the septum 80 automatically reseals to a closed, sealed position to protectively seal the blood 16 within the container 14. Figure 26B As shown in .

[0086] See also Figures 27A-27C In one embodiment, the container 14 includes a deformable dispensing portion 82. In this embodiment, when the container 14 is removed from the housing 12, a portion of the blood 16 can be dispensed from the container 14 by activating the deformable portion 82. For example, the deformable portion 82 can be in an initial position ( Figures 27A-27B ) and deformation position ( Figure 27C ) transition between the initial position, in which the blood 16 is contained in the collection chamber 70, and the deformed position, in which a portion of the blood 16 is discharged from the collection chamber 70 of the container 14. The deformable portion 82 is squeezed to transition from the initial position ( Figures 27A-27B ) transition to the deformed position ( Figure 27C In this way, the blood 16 can be transferred to a device intended for analysis of the sample, such as a point-of-care test device, a cartridge test device, or a nearby patient test device, while minimizing the possibility of a physician contacting the blood sample. In one embodiment, the container 14 also includes an end cap 84 to securely seal the outlet 86 of the container 14. When the user is ready to remove a portion of the blood 16 from the container 14, the end cap 84 is removed from the outlet 86 of the container 14 before dispensing the blood 16.

[0087] See also Figures 28A-28B In one embodiment, the container 14 includes an extension tube 88. The extension tube 88 is compatible with analyzers and analytical devices.

[0088] Figure 17-24 Another exemplary embodiment of the device for attached flow of blood of the present disclosure is shown. Figure 17-24 The device 100 for adherent flow of blood of the present disclosure provides a controlled blood flow path that ensures adherent flow of blood from a collection site to a collection container.

[0089] After piercing the patient's skin with a lancet device, blood will flow out and remain on the surface of the finger. Without controlling the blood and blood flow, the blood will remain on the surface of the finger and will not flow into the collection container.

[0090] See also Figure 17-24 In one exemplary embodiment, the device 100 for attaching and flowing blood generally includes a housing 112 and a collection container 14 removably connected to the housing 12. The container 14 defines a collection chamber 70 and includes an inner wall or inner wall surface 72. Figure 1-10B The device 10 described is compatible with the same container 14 as reference Figure 17-24 The described device 100 is compatible.

[0091] See also Figure 17, the housing 112 defines a centerline CL and includes a first end 120, a second end 122, a hollow needle 123, and a flow channel 124. The flow channel 124 includes an inlet 126 and an outlet 128. A portion of the flow channel 124 (e.g., the bottom 130) is offset from the centerline CL of the housing 112. This ensures that the outlet 128 of the flow channel 124 is adjacent to the inner wall surface 72 of the container 14, as described in more detail below. The flow channel 124 also includes a flow guiding attachment portion 134 at the outlet 128. In one embodiment, the outlet 128 of the flow channel 124 extends beyond the second end 122 of the housing 112, as shown in FIG. Figure 17 In one embodiment, the hollow needle 123 is between the first end 120 of the housing 112 and the flow channel 124 .

[0092] exist Figure 17-24 In the embodiment shown in FIG, the hollow needle 123 is the same as that in the embodiment shown in FIG. Figure 1-10B The function of the first flow guiding attachment 32 described for the device 10 shown in FIG.

[0093] See also Figure 17 When the container 14 is connected to the housing 112 , the outlet 128 of the flow channel 124 is in fluid communication with the collection chamber 70 of the container 14 , and the outlet 128 of the flow channel 124 is adjacent to the inner wall surface 72 of the container 14 .

[0094] After piercing the patient's skin with a lancet device, blood will flow out and remain on the surface of the finger. Without controlling the blood and blood flow, the blood will remain on the surface of the finger and will not flow into the collection container.

[0095] The device 100 for blood flow attachment of the present disclosure provides a controlled blood flow path that ensures blood flow attachment from a collection site to a collection container. The device 100 for blood flow attachment of the present disclosure uses three key technical elements to control the flow of blood in a desired manner to achieve this goal.

[0096] For example, see Figure 17 When the first end 120 of the shell 112 is connected to the source of blood 16, the hollow needle 123, the flow channel 124, the flow guiding attachment portion 134 and the inner wall surface 72 of the container 14 provide an attachment portion to establish an attachment flow of blood for the first drop of blood 16 and subsequent blood 16 to reach the collection chamber 70 of the container 14 from the first end 120 of the shell 112.

[0097] The first key blood flow path element 140 involves directing the first drop of blood 16 away from the surface S of the finger F in a direction toward the collection container 14. In one embodiment, with the first end 120 of the housing 112 in communication with a source of blood 16, the first drop of blood 16 adheres to a portion of the hollow needle 123 and flows through the hollow needle 123 in a controlled manner to the flow channel 124, as shown. Figure 17 As shown in .

[0098] Thus, a portion of the hollow needle 123 provides functionality similar to that described above with respect to Figure 1-10B 1. The device 100 of the present disclosure including the hollow needle 123 provides an advantage in that the hollow needle 123 can also be used to incise the skin surface S of the finger F to provide a source of blood 16. In this embodiment, a separate lancet device is not required. For example, in one embodiment, the hollow needle 123 can include a cutting edge 151, which can be used to incise the skin surface S of the finger F to provide a source of blood 16. In this embodiment, with the first end 120 of the housing 112 connected to the source of blood 16, the first drop of blood 16 and subsequent drops of blood 16 adhere to the cutting edge 151 and flow through the hollow needle 123 to reach the flow channel 124.

[0099] After the first drop of blood 16 adheres to a portion of the hollow needle 123 and flows through the hollow needle 123 , subsequent blood 16 follows the blood adhesion flow path of the first drop of blood 16 from the first end 120 of the housing 112 to the collection chamber 70 of the container 14 .

[0100] The second key blood flow path element 142 involves directing or pulling the blood 16 through the flow channel 124 to the flow guiding attachment 134 via capillary motion. In one embodiment, the second key blood flow path element 142 involves directing or pulling the blood 16 through the hollow needle 123 and the flow channel 124 in a direction toward the collection container 14 and to the flow guiding attachment 134 via capillary motion. For example, the first drop of blood 16 and subsequent drops of blood 16 are pulled through the flow channel 124 to the flow guiding attachment 134 via capillary motion. In one embodiment, the flow channel 124 is a capillary flow channel. In one embodiment, the flow channel 124 is a capillary tube that uses capillary forces to pull the blood 16 downward along the flow channel 124 and away from the surface S of the finger F.

[0101] In one embodiment, the housing 112 includes an inclined wall surface 136 between the hollow needle 123 and the flow channel 124. In one embodiment, the inclined wall surface 138 defines a flow channel inlet 138. In one embodiment, the inclined wall surface 136 provides a downwardly attached flow path from the hollow needle 123 to the flow channel 124 of the housing 112.

[0102] The third key blood flow path element 144 involves directing the blood 16 from the flow channel 124 into the collection container 14. The device 100 of the present disclosure ensures the transition from the flow channel 124 to the container 14 via adherent flow. For example, the blood 16 adheres to the flow directing attachment 134 and the inner wall surface 72 of the container 14 to flow from the flow channel 124 into the collection chamber 70 of the container 14.

[0103] The third key blood flow path element 144 involves directing the blood 16 from the flow channel 124 into the collection container 14 and is the reason for the following technical features: Importantly, a portion of the flow channel 124 (e.g., the bottom 130) is offset from the centerline CL of the housing 112. This ensures that the outlet 128 of the flow channel 124 and the flow directing attachment portion 134 abut the inner wall surface 72 of the container 14 to ensure the transition of the attached flow of blood from the flow channel 124 to the container 14.

[0104] If the blood 16 can find another portion to attach to, the blood 16 will simply flow downward and out of the flow channel 124 into the container 14. The flow directing attachment portions 134 and the inner wall surface 72 of the container 14 provide these attachment portions to control the blood 16 from reaching the collection chamber 70 of the container 14 via the attached flow of the blood.

[0105] As described above, once the blood adherence flow path is established, the subsequent blood 16 follows the blood adherence flow path and flows along the blood adherence flow path. In the above manner, the device 100 of the present disclosure establishes a blood adherence flow from the first end 120 of the housing 112 to the collection chamber 70 of the container 14, for the first drop of blood 16 and the subsequent blood 16 to follow.

[0106] As discussed above, the portion of the hollow needle 123 that provides an attachment point for the flow of blood 16 is functionally similar to the portion discussed above with respect to the Figure 1-10B The first flow guiding attachment 32 described for the device 10 shown in FIG.

[0107] The hollow needle 123 may include a variety of different designs and structures, such as Figure 18-24 Other alternative designs and configurations of the hollow needle 123 are contemplated. For example, see Figure 18 and Figure 19 In one embodiment, the hollow needle 123 comprises a bevel-cut hollow needle. In one configuration, the bevel of the needle can have a length of 3 mm to 6 mm, and the inner diameter of the lumen can be between 0.25 mm and 4 mm.

[0108] As discussed above, see Figure 20 and Figure 21In one embodiment, the hollow needle 123 may include a cutting edge 151 that can be used to incise the skin surface S of the finger F to provide a source of blood 16 .

[0109] See also Figure 21 In another embodiment, the hollow needle 123 includes a flow guide ring 155 around the hollow needle 123. The flow guide ring 155 prevents the blood 16 from flowing down along the hollow needle 123 and ensures that the blood 16 flows through the hollow needle 123 to reach the flow channel 124. Figure 22-24 A further alternative design and construction of the hollow needle 123 is shown. The bevel of the needle serves as an additional first flow guide attachment, as described above with reference to Figure 3 The column structure 32 is described similarly.

[0110] The flow guide attachment portion 134 may include a variety of different designs and structures, such as Figures 7A-10B As shown in FIG. Additional alternative designs and configurations of the flow directing attachment portion 134 are contemplated. The flow directing attachment portion 134 of the device 100 may include the same as described above and as shown in FIG. Figures 7A-10B The second flow guiding attachment 34 of the device 10 shown in FIG. 1 has the same design and structure.

[0111] Another advantage of the devices 10, 100 of the present disclosure is that the devices 10, 100 are capable of completing mixing of the sample stabilizer 200 within the blood sample 16. Figure 11 and 12 In one embodiment, a sample stabilizer 200 is positioned within a portion of the flow channel 24, 124 such that as the blood sample 16 flows from the collection site to the collection container of the present disclosure along with controlled blood adherence flow, the blood sample 16 passes through the sample stabilizer 200. In this way, the blood sample 16 can be mixed with the sample stabilizer 200, such as an anticoagulant or other additive, disposed within a portion of the device 10, 100. The sample stabilizer 200 can be an anticoagulant or a substance designed to protect specific elements within the blood, such as RNA, protein analytes, or other elements.

[0112] See also Figure 11 and 12 In one embodiment, the sample stabilizer 200 includes a material 202 having pores 204 and a dry anticoagulant powder 206 located within the pores 204 of the material 202. Thus, the device 10, 100 can include a dry anticoagulant, such as heparin or EDTA, deposited on or within a portion of the flow channel 24, 124. In one embodiment, the material 202 is an open-cell foam containing the dry anticoagulant dispersed within the pores of the open-cell foam to promote flow-through mixing and effective anticoagulant extraction. In one embodiment, the sample stabilizer 200 is a dry anticoagulant powder 206.

[0113] In one embodiment, the open-cell foam can be treated with an anticoagulant to form a dry anticoagulant powder 206 that is finely distributed throughout the pores 204 of the open-cell foam. As the blood sample 16 flows through the flow channels 24, 124, the blood sample 16 passes through the open-cell foam and comes into contact with the anticoagulant powder 206 available throughout the internal pore structure of the open-cell foam. In this way, the blood sample 16 dissolves and mixes with the dry anticoagulant 206 as it passes through the material 202 or open-cell foam.

[0114] The open-cell foam may be a soft, deformable open-cell foam that is blood-inert, such as a melamine foam, such as is commercially available from BASF. The foam may alternatively be composed of a formaldehyde-melamine-sodium bisulfite copolymer. The open-cell foam may also be a flexible, hydrophilic open-cell foam that is significantly resistant to heat and organic solvents. In one embodiment, the foam may comprise a sponge material.

[0115] Anticoagulants or other additives are introduced into open cell foams by soaking the foam in a liquid solution of the additive and water and then evaporating the water to form a dry additive powder that is finely distributed throughout the internal structure of the foam.

[0116] Figure 13-16 An exemplary embodiment of a sample stabilizer 200 included within a container 14 is shown.

[0117] For example, see Figure 13 In one embodiment, an anticoagulant lyophilized pellet 210 is disposed within the collection chamber 70 of the container 14. When the blood 16 enters the container 14 following the adherent flow of the present disclosure, the anticoagulant lyophilized pellet 210 dissolves within the blood 16 upon contact with the blood 16.

[0118] See also Figure 14 In another embodiment, the sample stabilizer 200 comprises a floating open-cell foam material 200 coated with an anticoagulant. Figure 15 In another embodiment, the sample stabilizer 200 includes a floating ball 230 coated with an anticoagulant. Figure 16 In another embodiment, the container 14 includes a wall surface 240 coated with an anticoagulant and a mixing ball 242 .

[0119] Although the present disclosure has been described as having exemplary designs, further modifications may be made to the present disclosure within the spirit and scope of the present disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of the basic principles thereof. Furthermore, this application is intended to cover any deviations from the present disclosure that fall within the known or customary practices in the art to which the present disclosure pertains and that fall within the limits of the appended claims.

Claims

1. A device for the adherent flow of blood, comprising: a housing defining a centerline and having a first end, a second end, and a flow passage having an inlet and an outlet, a portion of the flow passage being offset from the centerline of the housing, the flow passage having a first flow guide attachment portion adjacent the inlet and a second flow guide attachment portion adjacent the outlet; and a container removably connectable to the housing, the container defining a collection chamber and having an inner wall, wherein, when the container is connected to the housing, the outlet of the flow channel is in fluid communication with the collection chamber of the container, and the outlet of the flow channel and the second flow guiding attachment portion are adjacent to an inner wall of the container; wherein the first flow guiding attachment portion comprises a hollow needle; and The housing includes an inclined wall surface between the hollow needle and the flow channel, and the inclined wall surface defines an inlet of the flow channel.

2. The device according to claim 1, wherein The second flow guide attachment is offset from a centerline of the housing.

3. The device according to claim 1, wherein The first flow directing attachment portion provides a first fluid attachment point for blood to adhere to, for controlling blood flow from the skin surface to a portion of the housing.

4. The device according to claim 1, wherein The second flow directing attachment portion provides a second fluid attachment point for blood to adhere to, for controlling blood flow from a portion of the housing to the collection chamber of the container.

5. The device according to claim 1, wherein When the first end of the shell is connected to the patient's finger, the first flow guiding attachment portion, the flow channel, the second flow guiding attachment portion, and the inner wall of the container provide an attachment portion from the first end of the shell to the collection chamber of the container to form an attachment flow of blood for the first drop of blood and subsequent blood tracking.

6. The device according to claim 1, wherein With the inlet of the flow channel in communication with the patient's finger, blood fluidly adheres to the first flow guiding attachment portion and flows from the first flow guiding attachment portion to the flow channel.

7. The device according to claim 6, wherein The blood is then pulled through the flow channel via capillary action to the second flow guiding attachment.

8. The device according to claim 7, wherein The blood fluidly adheres to the second flow guiding attachment portion and the inner wall of the container to flow from the flow channel into the collection chamber of the container.

9. The device according to claim 1, wherein The second flow guiding attachment portion is an attachment lip.

10. The device according to claim 1, wherein The second flow guiding attachment portion is a protruding capillary portion.

11. The device according to claim 1, wherein The second flow guiding attachment portion is an inwardly curved lip.

12. The device according to claim 1, wherein The second flow directing attachment portion is a planar cut lip.

13. The device according to claim 1, wherein The second flow guiding attachment portion is a protruding column structure.

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