Blood collection device

Abstract

A blood collection device for collecting a blood sample from a patient. The blood collection device includes a disposable collection cartridge and a reusable actuator releasably coupled to the disposable collection cartridge. The disposable collection cartridge includes a housing, a piercing element, and a fluid container. The reusable actuator includes a controller, a power source, and a vacuum source.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 350,704, entitled "Blood Drawing Device," filed on June 9, 2022, which is hereby incorporated by reference in its entirety.

[0002]

[0003] The present disclosure generally relates to a blood drawing device for collecting a blood sample from a patient, and a method of using the blood drawing device.

Summary of the Invention

Means for Solving the Problems

[0003]

[0004] Disclosed herein is a device for collecting a blood sample from a patient. In one embodiment, the blood drawing device may comprise a disposable collection cartridge and a reusable actuation device releasably coupled to the disposable collection cartridge. The disposable collection cartridge may include a housing, a piercing element, and a fluid container. The reusable actuation device may include a controller in electronic communication with the disposable collection cartridge, a power source in electronic communication with the disposable collection cartridge, and a vacuum source in fluid communication with the disposable collection cartridge.

[0004]

[0005] In one embodiment, the disposable collection cartridge may further include a heating element coupled to a surface of a housing extending from a reusable actuator. The heating element may include a flexible printed circuit board (PCB) and a flexible layer. The heating element may include an opening, and the piercing element may be movable relative to the housing between a retracted position and an extended position. The piercing element may be fully contained within the housing in the retracted position, and the piercing element may extend through the opening of the heating element in the extended position. The heating element may be planar and may have a circular portion surrounding the opening and a tab extending radially from the circular portion. The tab may include at least one exposed electrical contact that electrically couples the heating element to the reusable actuator. In one embodiment, the disposable collection cartridge may include an adhesive tape, and the opening of the disposable collection cartridge may include an anticoagulant film.

[0005]

[0006] In one embodiment, the reusable actuator may further include a controller. The controller may be configured to control a vacuum source that is a vacuum pump, a mechanical actuation system configured to actuate the piercing element, a temperature sensor coupled to the heating element, a pressure sensor disposed within the disposable collection cartridge, and a sample detection sensor disposed within a fluid container. The temperature sensor may be coupled to the controller, and the controller may be configured to adjust the temperature of the heating element based on the temperature detected by the temperature sensor and a desired temperature. The reusable actuator may include an adjustable knob that is coupled to the controller and is configured to control the desired temperature of the heating element.

[0006]

[0007] In one embodiment, the vacuum source may be a vacuum pump configured to provide a vacuum proximate to the target area while the piercing element is in the retracted position and during movement of the piercing element to the extended position. The vacuum pump may be configured to maintain a pressure of a predetermined characteristic within the disposable collection cartridge during collection of a blood sample. In some embodiments, the vacuum pump may be configured to apply one or more variable vacuum characteristics within the disposable collection cartridge during collection of the blood sample.

[0007]

[0008] In one embodiment, the fluid container may include a capillary channel in fluid communication with the open end of the fluid container. In some embodiments, the capillary channel may contain an anticoagulant. In some embodiments, the fluid container may include a flange extending axially from its end portion. In some embodiments, the blood collection device may further include a fluid reservoir containing a liquid reagent. In some embodiments, the liquid reagent may process blood during blood sample collection. The liquid reagent may include at least one of lithium heparin, K2-EDTA, K3-EDTA, trisodium citrate, or another acceptable anticoagulant reagent.

[0008]

[0009] In one embodiment, the piercing element may include one or more lancets. In some embodiments, the vacuum source may be a vacuum pump configured to continuously pump air out of the disposable collection cartridge before and during blood sample collection. In some embodiments, the fluid container may be connected to the disposable collection cartridge by a threaded connection. In some embodiments, the fluid container may be positioned at an oblique angle relative to the piercing element when the disposable collection cartridge is connected to the reusable actuator.

[0009]

[0010] The following detailed description of embodiments of the blood collection device will be better understood when read in conjunction with the accompanying drawings of the exemplary embodiments. However, it should be understood that the present invention is not limited to the exact arrangements and means shown in the drawings.

[0010]

[0011] In the drawings,

Brief Description of the Drawings

[0011]

Figure 1

[0012] FIG. 1 is a front perspective view of a blood collection device according to an exemplary embodiment of the present disclosure.

Figure 2

[0013] FIG. 2 is a rear perspective view of the blood collection device of FIG. 1.

Figure 3

[0014] It is a perspective view of a disposable collection cartridge of the blood collection device shown in FIG. 1.

Figure 4

[0015] It is a side cross-sectional view of the disposable collection cartridge of FIG. 3.

Figure 5

[0016] It is a rear perspective cross-sectional view of the disposable collection cartridge of FIG. 3.

Figure 6

[0017] It is a side cross-sectional view of the disposable collection cartridge of FIG. 3 showing the piercing element in the extended position.

Figure 7

[0018] It is a front view of the heating element of the blood collection device of FIG. 1.

Figure 8

[0019] It is a partial cross-sectional perspective view of the blood collection device shown in FIG. 1.

Figure 9

[0020] It is an enlarged side cross-sectional view of the blood collection device of FIG. 1 showing the adhesive tape on the flexible layer.

Figure 10

[0021] It is a perspective view of a first exemplary lancet for use with the blood collection device shown in FIG. 1.

Figure 11

[0022] It is a perspective view of a second exemplary lancet for use with the blood collection device shown in FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

[0012]

[0023] Blood sampling and analysis are an integral part of patient diagnosis. Blood quality is the most important measurement criterion in clinical chemistry / pathology. Conventional methods of blood extraction are based on decades-old techniques such as venipuncture (phlebotomy). However, phlebotomy procedures can be psychologically traumatic and inconvenient for some patients. Some techniques, such as finger prick (using a lancet), enable blood collection without the need for phlebotomy. This method is the most common method for examining blood glucose levels. For newborns, heel prick is used to extract a small blood sample for a selected few screening tests. The main drawback of these methods is that the volume of blood extracted is limited by the amount of blood available in the capillaries cut as a result of the lancet incision procedure before the body begins the repair process. Repeated squeezing (extraction method) can be used to slightly increase the volume of blood discharged, but this is quite cumbersome and laborious.

[0013]

[0024] Existing techniques for capillary blood collection enable collection of a larger volume of blood compared to venous blood. Thus, some techniques enable creation of multiple punctures to collect approximately 200 μL of blood from the capillaries several minutes after use. However, one of the concerns with testing capillary blood is the fact that this method of blood extraction has an adverse effect on some blood parameters, which in turn could lead to misdiagnosis of the patient. The most affected parameters are white blood cell (WBC) count, red blood cell (RBC) count, platelet count, and potassium, and more generally, complete blood count (CBC) and electrolyte panel tests. CBC and electrolyte panel tests are two of the most commonly requested panel tests, and these parameters are part of the parameters considered most important by physicians to determine the overall health of the patient. Thus, any deviation from the actual values could lead to misdiagnosis of the patient and hence treatment errors.

[0014]

[0025] Compared to the venipuncture technique, non-venipuncture techniques for blood collection are complicated due to an increase in the WBC count (which can be caused by the body's response to treating the wound and the potential aggregation of platelets that are erroneously counted as WBCs), a decrease in the RBC count (destruction of these fragile blood cells due to the hemolysis process as a result of shear forces while the blood is being extruded through the minor wound), a decrease in the platelet count (these cells are responsible for blood clotting and aggregate when in contact with air and as a result of shear forces when the blood is being extruded through the minor wound, attempting to stop the bleeding), and an increase in potassium concentration (a secondary effect of RBC hemolysis which contains a large amount of potassium inside and does not indicate the correct concentration of potassium).

[0015]

[0026] Generally, capillary blood collection methods have not been able to address the above problems and thus have limited the clinical usefulness as a general blood extraction method. In addition to the blood quality issue, since there are many nerve endings at the tip of the finger, lancet incision of the finger can be an unpleasant and painful procedure. The amount of blood available for collection is also limited, i.e., the finger has to be "squeezed" to increase the sample volume, which compromises the quality of the extracted blood.

[0016]

[0027] Referring to the drawings in detail, like reference numerals indicate like elements throughout, and FIGS. 1-11 show a blood collection device generally designated 10, according to an exemplary embodiment of the present invention. The blood collection device 10 can include two main components, a reusable actuator 12 and a disposable collection cartridge 14. Since the reusable actuator does not contact the patient's blood or blood sample, one reusable actuator 12 may be used with two or more disposable collection cartridges 14. The disposable collection cartridge 14 can be separated from the reusable actuator 12 before and after collection of the blood sample. During collection of the blood sample, the disposable collection cartridge 14 can be connected to the reusable actuator 12, and the reusable actuator 12 can operate the operation of components within the disposable collection cartridge 14. By separating the blood collection device 10 into multiple parts and applying an active control system configured to adjust the blood collection parameters according to the patient's needs, it may be possible to enhance the blood collection process. By including active elements within the reusable actuator 12, it may be possible to reduce the waste and costs associated with including these features in conventional single-use blood collection devices.

[0017]

[0028] Referring to FIG. 1, the blood collection device 10 can have a reusable actuator 12 that is used in conjunction with a disposable collection cartridge 14 configured to capture a blood sample from a patient. The disposable collection cartridge 14 can be disposed of after use. As will be discussed in more detail below, the disposable collection cartridge 14 can be used to pierce the patient's body and collect a blood sample from the patient through the hole, and thus the collected blood is transferred into the disposable collection cartridge 14. FIG. 1 shows the blood collection device 10 with the reusable actuator 12 and the disposable collection cartridge 14 separated.

[0018]

[0029] As shown in FIG. 1, the reusable actuating device 12 may include a body 16, which has a proximal end and a handle 18 connected to the proximal end of the body 16. The handle 18 may have a gripping portion and other features that allow it to be conveniently held by a user. In some embodiments, the reusable actuating device 12 does not have a handle. The body 16 of the reusable actuating device 12 may have a cavity 20 configured to releasably receive the disposable collection cartridge 14 and couple the reusable actuating device 12 and the disposable collection cartridge 14. The body 16 and the handle 18 of the reusable actuating device 12 may be separated by a curved portion. The curved portion between the body 16 and the handle 18 may be configured to extend the body 16 forward relative to the handle 18. This orientation of the reusable actuating device 12 may allow a user to grip the handle 18 without interfering with the application of the disposable collection 14 to the body 16.

[0019]

[0030] As shown in FIGS. 3-5, the disposable collection cartridge 14 in some embodiments includes a housing 22, a piercing element 24, and a fluid container 26. The disposable collection cartridge 14 may further include a heating element 28 coupled to the disposable collection cartridge 14. In one embodiment, the surface encompassing the heating element 28 is the surface of the disposable collection cartridge 14 opposite the surface that couples to the reusable actuating device 12. The heating element 28 may apply heat proximate to a target area of a patient's skin before and during collection of a blood sample. By applying heat proximate to the target area, thermal energy may cause blood within that area of the skin to flow more rapidly, which may enable more blood to be collected. The heating element 28 may apply a constant amount of heat throughout the collection of the sample. In some embodiments, the heating element 28 may apply variable heat according to a predetermined interval.

[0020]

[0031] The heating element can be configured to apply a temperature between 30 and 45 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 25 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 30 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 35 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 40 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 45 degrees Celsius in proximity to the target area. The heating element can be configured to apply a temperature of approximately 50 degrees Celsius in proximity to the target area.

[0021]

[0032] The disposable collection cartridge 14 may further include at least one fastening element 88 configured to releasably couple to the reusable actuator. The fastening element 88 can be configured to be received within the cavity 20. In some embodiments, the fastening element 88 can be a magnet. The reusable actuator 12 may include alignment features to ensure that the disposable collection cartridge 14 is properly oriented within the cavity 20. There may be an indication that the disposable collection cartridge 14 is properly coupled to the reusable actuator 12. For example, there may be an audible confirmation or a visual confirmation. Illumination on the reusable actuator 12 may be activated when the disposable collection cartridge 14 is properly oriented within the cavity 20. In some embodiments, a clicking sound or other sound may confirm that the disposable collection cartridge 14 is properly oriented within the cavity 20.

[0022]

[0033] In some embodiments, the heating element 28 includes a flexible printed circuit board (PCB) 30. The heating element 28 may include a disposable and restrictive circuit on the flexible PCB 30. The heating element 28 may include a flexible layer 32. The flexible layer 32 may provide a cushion that softens the surface that contacts the patient's skin. The flexible layer 32 may also disperse the heat generated by the heating element 28 to improve the temperature uniformity in the target area. In some embodiments, the flexible layer 32 is a closed-cell foam. In some embodiments, the flexible layer 32 has a thickness of approximately 3 mm. In some embodiments, the flexible layer 32 has a thickness of less than 5 mm. In some embodiments, the flexible layer 32 has a thickness of less than 3 mm. In some embodiments, the flexible layer 32 has a thickness between 0.5 mm and 3 mm. In alternative embodiments, the heating element 28 can include a non-flexible layer for dispersing heat and contacting the skin surface.

[0023]

[0034] The flexible PCB 30 can be embedded in the flexible layer 32. In other embodiments, the flexible PCB 30 can be connected to the back of the flexible layer 32. The flexible PCB 30 may include a heat conductor 33. The heat conductor 33 can be made from one of a copper trace, an etched foil, or a wire. The heat conductor 33 can be a single piece of material that extends in an organized configuration to cover the area of the heating element 28. Exemplary wiring of the heat conductor 33 can include any or all of serpentine wiring, double square spirals, spirals with a decorated perimeter, S-shaped, parallel lines, or lens-shaped. Some form of resistance can be used to generate heat when electricity is delivered to the heat conductor. The amount of heat supplied to the patient by the heat conductor 33 can depend on multiple factors such as the material the heat conductor 33 is made of, the thickness of the flexible layer 32, and the amount of electrical input delivered to the heat conductor 33, in addition to the resistance.

[0024]

[0035] The thickness of the heating element 28 can be less than the thickness of the flexible layer 32 so as to enable the heating element 28 to be disposed within the flexible layer 32. In some embodiments, the heating element 28 is approximately 2 mm thick. In some embodiments, the heating element 28 is less than 4 mm thick. In some embodiments, the heating element 28 is less than 2 mm thick. In some embodiments, the heating element 28 is between 0.1 mm and 3 mm thick.

[0025]

[0036] As shown in FIG. 7, in some embodiments, the heating element 28 is planar. The heating element 28 can have a generally circular portion surrounding the opening 34 and tabs 36 extending radially from the circular portion. To prevent interference with the movement of the piercing element 24, the heating element 28 can include an opening 31. The opening 31 can be shaped and sized to fit around the opening 34. The opening 31 can be substantially the same size as the opening 34. In some embodiments, the opening 31 is larger than the opening 34. In some embodiments, the heating element 28 can have a generally square shape surrounding the opening 34. The tabs 36 can be shaped and sized to achieve the desired application, such as generally circular as shown in FIG. 3 or generally rectangular as shown in FIG. 7. The tabs 36 can include at least one exposed electrical contact 38a, 38b that can interact with an electrical contact 41 (not shown) disposed on the housing 22 to supply power to the heating element 28.

[0026]

[0037] The electrical contact parts 38a, 38b can be configured to electrically connect the heating element 28 to the reusable operating device 12 when the disposable collection cartridge 14 is received in the cavity 20. The electrical contact part 41 can include two or more electrical contact parts. The housing can include the electrical contact part 41 on the surface to which the heating element 28 is connected. The electrical contact part 41 of the housing 22 can be arranged adjacent to the electrical contact parts 38a, 38b of the heating element 28 when the heating element 28 is connected to the housing 22. The electrical contact part 41 of the housing 22 can extend within the housing 22 from the surface adjacent to the heating element 28 to the surface of the housing 22 that contacts the reusable operating device 12 when the disposable collection cartridge 14 is received in the cavity 20. The housing 22 can include the electrical contact part 43 on a part of the surface that contacts the reusable operating device 12. The electrical contact part 43 can include two or more electrical contact parts. The reusable operating device 12 can include the electrical contact part 45 on the surface adjacent to the electrical contact part 43 of the housing. The electrical contact part 45 can include two or more electrical contact parts. The electrical contact part 45 of the reusable operating device 12 can be electrically connected to the power source 48 by a wired connection. In the above, the electrical contact parts are described as providing power from the power source 48 to the heating element 28, while any acceptable form of electrical communication may be provided. For example, wireless power transmission or electromagnetic power transmission.

[0027]

[0038] In some embodiments, the heating element 28 is positioned along a plane perpendicular to the path of the piercing element 24. As shown in FIG. 7, the heating element 28 can include an opening 31. In some embodiments, the heating element 28 covers the entire surface of the disposable collection cartridge 14 surrounding the opening 34. In some embodiments, the heating element 28 covers only a part of the surface of the disposable collection cartridge 14 surrounding the opening 34.

[0028]

[0039] In some embodiments, the temperature sensor 54 is electrically coupled to the controller 46. The controller 46 may be configured to adjust the temperature of the heating element 28 based on the difference between the temperature sensed by the temperature sensor 54 and a desired temperature. In some embodiments, the temperature sensor 54 provides feedback to the controller 46 as a means of performing active temperature control throughout the blood collection process to maintain the provided temperature within a predetermined tolerance range. In some embodiments, it is necessary and useful to implement different temperature characteristics within the system to optimize blood flow throughout the blood collection process. The reusable actuator 12 may include an adjustable knob 60 coupled to the controller 46. In some embodiments, the user can manipulate the adjustable knob 60 to control the temperature of the heating element 28. In some embodiments, the temperature sensor 54 senses the user's thermal characteristics and provides feedback to the controller 46 to activate the vacuum source 50 as a result of the disposable collection cartridge 14 being pressed against the patient's skin.

[0029]

[0040]

[0041] As described below in connection with FIGS. 10-11, the piercing element 24 may include one or more piercing elements 68 (e.g., a lancet or a needle) fixed thereto to smoothly advance blood collection by piercing the patient's skin, which will be described in more detail below. The piercing element 24 may be movable relative to the housing to move the piercing element into the patient's skin. The piercing element 24 may have a retracted position and an extended position. In some embodiments, the piercing element 24 is completely contained within the housing in the retracted position. In some embodiments, the piercing element extends through the opening 34 of the heating element 28 in the extended position. The piercing element 24 may move along a path that is substantially perpendicular to the body 16 of the reusable actuator 12.

[0030]

[0042] As shown in FIGS. 4-5, in some embodiments, the piercing element 24 is moved by a first biasing element 74 that drives the piercing element 24 from a retracted position to an extended position. The first biasing element 74 can be screwed to the housing 22 by a fixture 75 on the first side. The fixture 75 can vary in size and shape depending on the requirements of the size and shape of the first biasing element 74. The fixture 75 can prevent the first side of the first biasing element 74 from moving relative to the housing when the piercing element is in the extended position. The first biasing element 74 can be received within the position of the piercing element on the second side. The piercing element 24 can include a recess 77 configured to receive the second side of the first biasing element 74. The first biasing element 74 can be a spring. In some embodiments, the piercing element 24 is returned from the withdrawn position to the retracted position by a second biasing element 76. The second biasing element 76 can be a spring. In some embodiments, the first biasing element 74 generates a greater force than the second biasing element 76. The disposable collection cartridge 14 can function as a sharp storage device after the piercing element 24 is returned to the retracted position. The disposable collection cartridge 14 can enclose the piercing element 24 after use.

[0031]

[0043] The second biasing element 76 can provide a biasing force sufficient to allow the piercing element 24 to extend approximately 3 mm outside the disposable collection cartridge 14 before the piercing element 24 is returned to the retracted position. The second biasing element 76 can provide a biasing force sufficient to allow the piercing element 24 to extend approximately 2.5 mm outside the disposable collection cartridge 14 before the piercing element 24 is returned to the retracted position. The second biasing element 76 can provide a biasing force sufficient to allow the piercing element 24 to extend approximately 3.5 mm outside the disposable collection cartridge 14 before the piercing element 24 is returned to the retracted position.

[0032]

[0044] As shown in FIGS. 4-5, the piercing element can be actuated by a firing mechanism 78 disposed within the disposable collection cartridge 14. The firing mechanism 78 can be operated by the user. In some embodiments, the firing mechanism is disposed within a reusable actuation device. In some embodiments, the firing mechanism 78 comprises an actuation button 80 and a release element 82. In the locked position, the release element 82 can be positioned to prevent the piercing element 24 from moving from the retracted position to the extended position.

[0033]

[0045] In some embodiments, the actuation button 80 has a proximal end and a distal end, as shown in FIGS. 4-5. The proximal end of the actuation button 80 can be biased by the user to actuate the firing mechanism 78. The distal end 83 of the actuation button 80 extends into the housing 22 and can interact with the release element 82. The distal end 83a can have a thickness smaller than the thickness of the proximal end 83b of the actuation button 80 and can be angled or tilted to be received by a portion of the release element 82. The actuation button 80 can be strongly biased toward the proximal end 83b by a third biasing element 84 to prevent unintentional actuation of the firing mechanism 78. The third biasing element 84 can be a spring. A rear housing 53 coupled to the housing 22 can prevent and inhibit the third biasing element 84 from moving the actuation button 80 beyond the housing 22. In some embodiments, the rear housing 53 can be removable to allow the first biasing element 74 and / or the piercing element 24 to be replaced.

[0034]

[0046] As shown in FIGS. 4-5, a button guide portion 79 can be included around the actuation button 80 within the housing. The button guide portion 79 can be sized to allow the actuation button 80 to slide internally but prevent unintentional rotation or movement of the actuation button 80. The button guide portion 79 can include a path 81 extending therefrom that engages the actuation button 80 to prevent the actuation button 80 from rotating relative to the housing 22 when actuated by the user.

[0035]

[0047] In some embodiments, as shown in FIGS. 4-5, the release element 82 has a proximal end portion 85a and a distal end portion 85b. The distal end portion 85b of the release element 82 can be configured to engage the piercing element 24 to prevent movement before the activation button 80 is moved. The proximal end portion 85a of the release element 82 can be shaped to receive the distal end portion 83a of the activation button 80. The shape of the proximal end portion 85a of the release element 82 can be substantially the same angle as the angle of the distal end portion 83a of the activation button 80.

[0036]

[0048] As shown in FIGS. 4-5, the release element 82 can be strongly urged to the locked position by a fourth biasing element 86. The fourth biasing element 86 can be a spring. The proximal end portion 85a of the release element 82 can include a fastener 87 configured to fixedly receive the fourth biasing element 86. The fastener 87 can be of a generally cylindrical shape and can have a circumference similar to the circumference of the fourth biasing element 86. The housing 22 can include a fastener 89 configured to fixedly receive the fourth biasing element 86. The fastener 89 can be of a generally cylindrical shape and can have a circumference similar to the circumference of the fourth biasing element 86.

[0037]

[0049] When the user presses the proximal end of the activation button 80, the release element 82 can be strongly pushed toward the proximal end of the release element 82 by the distal end of the activation button 80. When the release element 82 is shifted proximally, the piercing element 24 can become unconstrained by the distal end portion 85b of the release element 82 and can move from the retracted position to the extended position.

[0038]

[0050] Reducing the movement of the disposable collection cartridge 14 can improve the performance of the blood collection device 10 by ensuring repeatability accuracy. As shown in FIG. 9, in some embodiments, the disposable collection cartridge 14 includes an adhesive tape 40 on an outer contact surface of the flexible layer 32. The adhesive tape 40 can prevent the disposable collection cartridge 14 from moving relative to the patient's skin during sample collection. The adhesive tape 40 can include a release liner (e.g., a plastic film) (not shown) that covers the adhesive tape 40 until use to reduce unintentional adhesion. The release liner can cover the opening 34 to prevent contamination of the components of the disposable collection cartridge 14 before use. In some embodiments, the release liner can cover only the adhesive tape 40. The adhesive tape 40 can form an airtight seal between the disposable collection cartridge 14 and the patient when the disposable collection cartridge 14 is pressed against the patient's skin. In some embodiments, the opening 34 includes an anticoagulant film 44 that remains in contact with the user's skin throughout the blood collection process. The anticoagulant film 44 can cover the entire opening defined by the opening 34. In some embodiments, the anticoagulant film 44 can cover only a portion of the opening defined by the opening 34.

[0039]

[0051] Increasing the pressure proximate to the target area can improve the patient experience and facilitate faster blood collection in larger volumes more smoothly than would be possible without increasing the pressure. Further, it is important to precisely control the amount of pressure applied in order to promote blood flow without causing pain or damaging the target area. Thus, a vacuum device can adjust the amount of pressure proximate to the target area as described in more detail below. The vacuum device can further reduce the amount of lancet incision and repeated squeezing required to collect a desired amount of blood.

[0040]

[0052] As shown in FIGS. 8-9, the reusable activation device 12 can include a controller 46 in electronic communication with the disposable collection cartridge 14, a power source 48 in electronic communication with the disposable collection cartridge 14, and a vacuum source 50 in fluid communication with the disposable collection cartridge 14 via a vacuum duct 51. In some embodiments, the vacuum duct 51 is an air duct, a pipe, or other conduit. The reusable activation device 12 can be battery powered. In some embodiments, the reusable activation device 12 can be powered by a power cord plugged into an energy source.

[0041]

[0053] In some embodiments, the controller 46 is configured to control the vacuum source 50. In some embodiments, the vacuum source 50 is a vacuum pump. In some embodiments, the controller 46 is configured to control a mechanical activation system 52 that activates the piercing element 24 when the disposable collection cartridge 14 is received within the cavity 20. In some embodiments, the controller 46 is configured to control a temperature sensor 54 coupled to the heating element 28 when the disposable collection cartridge 14 is received within the cavity 20. In some embodiments, the controller 46 is configured to control a pressure sensor 56 disposed within the housing 22 when the disposable collection cartridge 14 is received within the cavity 20. In some embodiments, the pressure sensor 56 can be disposed within the reusable activation device 12. The pressure sensor 56 can be disposed within the vacuum duct 51 of the reusable activation device 12.

[0042]

[0054] In some embodiments, the controller 46 is configured to control a sample detection sensor 58 disposed within the fluid container 26 when the disposable collection cartridge 14 is received within the cavity 20. The fluid container 26 can be any container having an internal space configured to hold the collected fluid. The fluid container 26 can also be referred to as a collection tube. In some embodiments, the sample detection sensor 58 is disposed within the reusable actuator 12. When the sample detection sensor 58 is disposed within the reusable actuator 12, the sample detection sensor 58 can detect the sample, for example, through a transparent window of the fluid container 26.

[0043]

[0055] In some embodiments, the controller 46 can be implemented in the form of hardware, can be implemented in the form of software, or can be implemented in a combination thereof. In some embodiments, the controller 46 according to the exemplary embodiments of the present disclosure can be a processor (e.g., a computer, a microprocessor, a CPU, an ASIC, circuitry, a logic circuit, etc.). The processor can be implemented by non-transitory memory storage, such as a program, a software instruction playback algorithm, etc., and when executed, can perform overall control of the vacuum source 50, the mechanical actuation system 52, the temperature sensor 54, the pressure sensor, and the sample detection sensor 58, as well as a processor configured to execute a program, a software instruction playback algorithm, etc. In some embodiments, the memory and the processor can be implemented as separate semiconductor circuits. Alternatively, the memory and the processor can be implemented as a single semiconductor integrated circuit. In some embodiments, the processor can embed one or more processors.

[0044]

[0056] In some embodiments, the vacuum source 50 is a vacuum pump configured to provide a vacuum within the housing 22 proximate the target area while the piercing element 24 is in the retracted position. The vacuum source 50 can be a vacuum pump configured to provide a vacuum within the housing 22 proximate the target area while the piercing element 24 is in the deployed position. The pressure sensor 56 can provide feedback to the controller 46 as a means of performing active pressure control throughout the blood collection process.

[0045]

[0057] As will be described in more detail below, active control of the vacuum source 50 can improve the accuracy and efficiency of blood collection. The pressure within the housing 22 generated by the vacuum source 50 can be increased to promote a greater blood flow from the target area. The pressure within the housing 22 generated by the vacuum source 50 can be decreased to promote a lesser blood flow from the target area. In some embodiments, the vacuum source 50 allows a draw between 20.7 kPa (3 psi) and 68.9 kPa (10 psi). In some embodiments, the vacuum source 50 allows a draw of up to 13.9 kPa (2 psi). In some embodiments, the vacuum source 50 allows a draw of up to 20.7 kPa (3 psi). In some embodiments, the vacuum source 50 allows a draw of up to 27.6 kPa (4 psi). In some embodiments, the vacuum source 50 allows a draw of up to 34.5 kPa (5 psi). In some embodiments, the vacuum source 50 allows a draw of up to 41.4 kPa (6 psi). In some embodiments, the vacuum source 50 allows a draw of up to 48.3 kPa (7 psi). In some embodiments, the vacuum source 50 allows a draw of up to 55.2 kPa (8 psi). In some embodiments, the vacuum source 50 allows a draw of up to 62.1 kPa (9 psi). In some embodiments, the vacuum source 50 allows a draw of up to 68.9 kPa (10 psi). In some embodiments, the vacuum source 50 allows a draw of up to 75.8 kPa (11 psi).

[0046]

[0058] The vacuum source 50 within the reusable actuating device 12 may be in fluid communication with the vacuum channel 90 within the disposable collection cartridge 14. As shown in FIGS. 5 - 7, the vacuum channel 90 may extend from an outer side 92a to an inner side 92b. The vacuum channel 90 may form a fluid path between the target area and the vacuum source 50 to enable the vacuum source 50 to control the pressure proximate to the target area. From the outer side 92a, the vacuum channel 90 may extend through the housing 22 to an area proximate to the firing mechanism 78. The vacuum channel 90 then extends through a separate portion of the housing 22 to an opening 92c proximate to the piercing element 24 and an opening 92d proximate to the fluid container 26. The flow path of the vacuum channel 90 is shown by a broken line in FIG. 4 for reference. In some embodiments, the vacuum channel 90 may include all of the empty areas within the housing 22, including but not limited to all areas around the firing mechanism 78, the fluid container 26, and the piercing element 24, as shown in dotted lines in FIG. 6.

[0047]

[0059] The vacuum source 50 may be fluidly coupled to the disposable collection cartridge 14. The outer side 92a may engage the vacuum source, and the inner side 92b may direct a vacuum draw to a location proximate to the target area. The outer side 92a may include a tip 91 that protrudes from the housing 22. The tip 91 may be tapered to facilitate a connection between the vacuum duct 51 of the vacuum channel 90 when the disposable collection cartridge 14 is received within the cavity 20. The shape and size of the tip 91 may form a gas - tight seal with the vacuum duct 51 when the disposable collection cartridge 14 is received within the cavity 20. In some embodiments, the tip 91 includes a sheath to ensure that the shape and size of the tip 91 form a gas - tight seal with the vacuum duct 51 when the disposable collection cartridge 14 is received within the cavity 20.

[0048]

[0060] Referring to FIG. 4, the tip 91 may need to be inserted into the reusable actuator 12 since it first protrudes from the housing 22 of the disposable collection cartridge 14. To that end, the housing 22 may include a notch proximate the tip 91 that receives a portion of the reusable actuator 12 to facilitate smooth insertion of the tip 91 into the reusable actuator 12. Once the tip 91 is inserted into the reusable actuator 12, the disposable collection cartridge 14 may be pivoted about the notch 97 until the disposable collection cartridge 14 is fully received within the cavity 20 of the reusable actuator 12. The notch 97 may be generally rounded to facilitate rotation with respect to the disposable collection cartridge 14 when the disposable collection cartridge 14 is disposed within the reusable actuator 12.

[0049]

[0061] In some embodiments, the vacuum source 50 is configured to maintain a pressure of a predetermined characteristic within the disposable collection cartridge 14 during collection of the blood sample. For example, during collection of the blood sample, a constant pressure (e.g., 48.3 kPa (7 psi)) may be applied by the vacuum source 50 to draw the sample from the patient into the fluid container 26. In some embodiments, the vacuum source 50 is configured to apply one or more variable vacuum characteristics within the disposable collection cartridge 14 during collection of the blood sample. For example, the pressure applied by the vacuum source 50 may repeatedly increase over a set amount of time (e.g., 5 seconds) and then decrease over a set amount of time (e.g., 5 seconds) during collection of the blood sample. The vacuum source 50 may be configured to continuously pump air out of the disposable collection cartridge 14 prior to collection of the blood sample. The vacuum source 50 may be configured to continuously pump air out of the disposable collection cartridge 14 during collection of the blood sample. When air is continuously pumped out of the disposable collection cartridge 14, the internal pressure of the housing 22 may not increase over time and may allow for a substantially constant result. The controller 46 may adjust the pressure sensor 56 in response to feedback (e.g., blood flow rate) received by the controller 46 from the sample detection sensor 58 during collection of the blood sample.

[0050]

[0062] The processing of blood during blood collection can further enhance the accuracy of test results. This processing can include a reagent that interacts with the blood at the blood collection site while the blood is moving from the blood collection site to the open end 64 of the fluid container 26 or while the blood is within the fluid container 26. In some embodiments, the fluid container 26 includes a capillary channel 62 (not shown) in fluid communication with the open end 64 of the fluid container 26. The capillary channel 62 can be referred to as a capillary tube. The housing 22 can include a shelf-like protrusion 93 extending from a portion of the housing 22. The shelf-like protrusion 93 can be disposed in the vicinity of the open end 64 to direct the fluid capture element relative to the housing 22 during use. The shelf-like protrusion 93 can prevent the open end 64 from rotating relative to the housing 22 during use. In some embodiments, the open end 64 is conical in shape. In some embodiments, the capillary channel 62 includes an anticoagulant. This anticoagulant can be important for maintaining blood quality, particularly with respect to platelets and potassium. In some embodiments, two or more capillary channels 62 can be used to send a blood sample to two or more fluid containers 26. The open end 64 can include a lip 66 extending from an end portion thereof and can include a sidewall treated with a suitable anticoagulant reagent in a dried form. The lip 66 can extend beyond the flexible layer 32 so as to contact the user during blood collection.

[0051]

[0063] In some embodiments, the disposable collection cartridge 14 includes a fluid reservoir 65 disposed within the fluid container 26. The fluid reservoir is separated from the fluid container 26 but can be in fluid communication with the fluid container 26. The fluid reservoir 65 can be disposed proximate the rim 66, as shown in FIG. 3. The fluid reservoir 65 can contain a liquid reagent. During the blood collection process, a volume of the liquid reagent can be transferred from the fluid reservoir to process the blood being collected during the blood collection process. In some embodiments, the liquid reagent is applied directly at the collection site to process the blood being collected during the blood collection process. The liquid reagent can be lithium heparin, dipotassium ethylenediaminetetraacetate (K2-EDTA), tripotassium ethylenediaminetetraacetate (K3-EDTA), trisodium citrate, or one of another acceptable assay reagent required for a particular assay to be performed on the collected blood.

[0052]

[0064] In some embodiments, the fluid container 26 is coupled to the disposable collection cartridge 14 by a threaded connection with an end retainer cap 95, as shown in FIGS. 4-5. In some embodiments, the fluid container 26 is coupled directly to the housing 22 without the end retainer cap 95. The end retainer cap 95 can include a threaded ring portion 27 at one of its ends. The housing 22 can include a threaded receiving portion 29 sized and shaped to receive the threaded ring portion 27. Rotation of the end retainer cap 95 in a first direction relative to the housing 22 can secure the fluid container 26 to the housing 22. Rotation of the end retainer cap 95 in a second direction relative to the housing 22, which is opposite the first direction, can release the fluid container 26 from the housing 22.

[0053]

[0065] When the fluid container 26 is separated from the housing 22, a stopper (not shown) may be disposed within the fluid container 26 to prevent the sample from leaking out. As will be discussed in more detail below, the open end 64 of the fluid container 26 may receive a lid to prevent the sample from leaking out of the fluid container 26 when the fluid container 26 is separated from the housing 22. In some embodiments, the fluid container 26 is at an angle oblique to the piercing element 24. A portion of the fluid container 26 may extend from the housing 22. In some embodiments, the fluid container 26 is entirely enclosed within the housing 22.

[0054]

[0066] In some embodiments, the fluid container 26 holds between 10 μL and 1 mL of blood. The fluid container 26 may be configured to hold up to 1 mL of blood. The fluid container 26 may be configured to hold up to 900 μL of blood. The fluid container 26 may be configured to hold up to 800 μL of blood. The fluid container 26 may be configured to hold up to 700 μL of blood. The fluid container 26 may be configured to hold up to 600 μL of blood. The fluid container 26 may be configured to hold up to 500 μL of blood. The fluid container 26 may be configured to hold up to 400 μL of blood. The fluid container 26 may be configured to hold up to 350 μL of blood. The fluid container 26 may be configured to hold up to 300 μL of blood. The fluid container 26 may be configured to hold up to 250 μL of blood. The fluid container 26 may be configured to hold up to 200 μL of blood. The fluid container 26 may be configured to hold up to 150 μL of blood. The fluid container 26 may be configured to hold up to 100 μL of blood. The fluid container 26 may be configured to hold up to 50 μL of blood.

[0055]

[0067] Referring to FIG. 4, the fluid container 26 may include an annular portion 67 that extends radially from at least a portion thereof. The annular portion 67 may extend around the circumference of the fluid container 26. In some embodiments, the annular portion 67 may extend around the circumference of the fluid container 26. The annular portion 67 may be configured to receive a lid (not shown) for securing a sample within the fluid container 26 when the fluid container 26 is separated from the housing 22. The annular portion 67 may be a generally flat annular portion. In some embodiments, the annular portion 67 may be threaded to receive the lid.

[0056]

[0068] As shown in FIGS. 10-11, in some embodiments, the piercing element 24 includes a piercing element 68. The piercing element 24 may include a group of piercing elements 68. The piercing element 24 may include a body 72. In some embodiments, the body 72 has a cylindrical shape with proximal and distal ends. The body 72 may be made of plastic. The body 72 may be formed around the lancet. In some embodiments, the piercing element 68 projects from the distal end of the body 72. The piercing element 68 may be designed for a particular cut shape, size, and depth. In some embodiments, the piercing element 24 is a liquid laser or beam. In some embodiments, the piercing element 24 travels through the fluid container 26. A blood sample may be directed into the fluid container 26 by the capillary channel 62.

[0057]

[0069] In some embodiments, the disposable collection cartridge 14 includes a chemical sensing element 70. The chemical sensing element 70 may be able to detect characteristics of the blood during the blood collection process. The chemical sensing element 70 may be able to detect, for example, any of red blood cells, white blood cells, platelets, neutrophils, lymphocytes, monocytes, hemoglobin, and potassium. The chemical sensing element 70 may be electrically coupled to the controller 46, and the controller 46 may be configured to process in real time the data transmitted by the chemical sensing element 70. In some embodiments, it may be necessary and useful to implement real-time chemical sensing within the system to optimize the accuracy of the tests performed on the blood withdrawn during the blood collection process.

[0058]

[0070] In some embodiments, the reusable actuator 12 includes a button 19. The button 19 can be configured to initiate operation of the vacuum source 50 to prepare for operation of the firing mechanism 78. In some embodiments, the vacuum source 50 is configured for pneumatic operation without use of the button 19. In some embodiments, the disposable collection cartridge 14 can have a flexible membrane 94 disposed between the housing 22 and the activation button 80. In response to the vacuum source 50 bringing a pressure to the inside of the housing 22, the flexible membrane 94 can be deformed by that pressure, thus displacing the activation button 80 and activating the firing mechanism 78. In some embodiments, the flexible membrane directly displaces the firing mechanism 78. In some embodiments, the pressure of interest is a pressure expected to create an optimal blood flow during the blood collection process.

[0059]

[0071] The blood collection device 10 described above can be used by a user to collect a blood sample for testing. An exemplary method can include the steps of the user receiving the reusable actuator 12 and inserting the disposable collection cartridge 14 into the cavity 20 of the reusable actuator 12. The user can then remove the release liner covering the adhesive tape 40 on the flexible layer 32 to expose the adhesive tape 40. The user can then press the flexible layer 32 against a target area of the patient (e.g., the shoulder or forearm).

[0060]

[0072] Once the blood collection device 10 is placed at the desired location, the user may press the button 19 of the reusable activation device 12 to initiate the operation of the vacuum source 50 and / or the heating element 28 and prepare the target area for the operation of the firing mechanism 78. In some embodiments, the vacuum source 50 and / or the heating element 28 are configured to automatically initiate operation without pressing the button 19 when the blood collection device 10 is placed on the patient's target area. When the desired pressure and / or temperature is achieved in the target area, the user may press the activation button 80 to initiate the operation of the firing mechanism 78. During sample collection, the vacuum source 50 and the heating element 28 may be actively controlled by the controller 46 to ensure that the conditions around the target area are promoting optimal blood flow. When the sample collection is complete, the user may rotate the end cap 95 of the fluid container 26 to remove the fluid container. Then, a lid may be placed on the fluid container 26 to prevent the sample from leaking out of the fluid container 26. And the disposable collection cartridge 14 may be appropriately disposed of. For subsequent use on the same patient or a different patient, a new disposable collection cartridge 14 may be connected to the same reusable activation device 12.

[0061]

[0073] The terms "about" or "approximately" are used herein to provide literal support for the actual number that it precedes, as well as for a number that is close to or approximately that number which the term precedes. When determining whether a number is close to or approximately that number which is specifically recited, a number of close or approximate recitation may be a number that results in a substantial equivalent of the specifically recited number in the context in which it is presented. It is to be understood that all numerical values and numerical ranges disclosed herein are approximate values and ranges whether or not the term "about" is used in conjunction therewith. Further, the term "about" as used herein in conjunction with a number may refer to a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive) of that number, ±2% (inclusive) of that number, ±3% (inclusive) of that number, ±5% (inclusive) of that number, ±10% (inclusive) of that number, or ±15% (inclusive) of that number. Additionally, when a numerical range is disclosed herein, it is to be understood that any numerical value falling within that range is also specifically disclosed.

[0062]

[0074] It will be apparent to those skilled in the art that modifications can be made to the exemplary embodiments illustrated and described above without departing from the broad inventive concept thereof. It is to be understood that the embodiments and claims disclosed herein are not limited to the details of the structure and arrangement of components shown in the description and drawings in their use. Rather, the description and drawings provide examples of the contemplated embodiments. The embodiments and claims disclosed herein are further capable of being other embodiments and of being practiced and carried out in various ways. Certain features of the exemplary embodiments may or may not be part of the claimed invention, and the various features of the disclosed embodiments may be combined. Unless specifically stated otherwise herein, the terms "a," "an," and "the" are not limited to one element but should instead be read to mean "at least one." Finally, unless specifically stated otherwise herein, the disclosed or claimed methods should not be limited to the execution in the written order of their steps, and those skilled in the art can easily understand that the steps can be performed in any order of execution.

Claims

1. A blood sampling device for collecting a blood sample from a patient, a disposable collection cartridge, a housing, a puncturing element, a fluid container comprising a disposable collection cartridge, a reusable actuating device releasably connected to the disposable collection cartridge, a controller in electronic communication with the disposable collection cartridge, a power source in electronic communication with the disposable collection cartridge, a vacuum source in fluid communication with the disposable collection cartridge comprising a reusable actuating device and comprising a blood sampling device.

2. The disposable collection cartridge further comprises a heating element connected to the surface of the housing extending from the reusable actuating device, The blood sampling device according to claim 1.

3. The heating element comprises a flexible printed circuit board (PCB), The blood sampling device according to claim 2.

4. The heating element comprises a flexible layer, The blood sampling device according to claim 3.

5. The heating element comprises an opening, The puncturing element, is movable relative to the housing, has a retracted position and an extended position, in the retracted position, is completely enclosed within the housing, in the extended position, extends through the opening of the heating element, The blood sampling device according to claim 2.

6. The heating element is planar and has a circular portion surrounding the opening and a tab extending radially from the circular portion, The blood sampling device according to claim 5.

7. The tab comprises at least one exposed electrical contact for electrically connecting the heating element to the reusable actuating device, The blood sampling device according to claim 6.

8. The disposable collection cartridge comprises an adhesive tape, The opening of the disposable collection cartridge comprises an anticoagulant film, The blood sampling device according to claim 1.

9. The reusable actuating device further comprises a controller, The controller, the vacuum source which is a vacuum pump, a mechanical actuation system configured to actuate the puncturing element, a temperature sensor connected to the heating element, a pressure sensor disposed within the disposable collection cartridge, a sample detection sensor disposed within the fluid container is configured to control, the temperature sensor is connected to the controller, the controller is configured to adjust the temperature of the heating element based on the temperature detected by the temperature sensor and a desired temperature. The blood collection device according to claim 1.

10. The reusable actuating device is connected to the controller and includes an adjustable knob configured to control the desired temperature of the heating element. The blood collection device according to claim 9.

11. The vacuum source is a vacuum pump configured to provide a vacuum in proximity to the target area while the piercing element is in the retracted position and during movement of the piercing element to the extended position. The blood collection device according to claim 1.

12. The vacuum pump is configured to maintain a pressure of a predetermined characteristic within the disposable collection cartridge during collection of the blood sample. The blood collection device according to claim 11.

13. The vacuum pump is configured to apply one or more variable vacuum characteristics within the disposable collection cartridge during collection of the blood sample. The blood collection device according to claim 11.

14. The fluid container includes a capillary channel in fluid communication with the open end of the fluid container. The capillary channel contains an anticoagulant. The blood collection device according to claim 1.

15. The fluid container includes a flange extending axially from its end portion. The blood collection device according to claim 14.

16. Further comprising a fluid reservoir containing a liquid reagent. The liquid reagent processes the blood during collection of the blood sample. The blood collection device according to claim 1.

17. The liquid reagent includes at least one of lithium heparin, K2-EDTA, K3-EDTA, trisodium citrate, or another acceptable assay reagent or anticoagulant reagent. The blood collection device according to claim 16.

18. The piercing element includes one or more lancets. The blood collection device according to claim 1.

19. The vacuum source is a vacuum pump configured to continuously pump air out of the disposable collection cartridge before and during collection of the blood sample. The blood collection device according to claim 1.

20. The fluid container is connected to the disposable collection cartridge by a threaded connection. The blood collection device according to claim 1.

21. The fluid container is positioned at an oblique angle relative to the piercing element when the disposable collection cartridge is connected to the reusable actuating device. The blood collection device according to claim 1.

22. A blood collection device for collecting a blood sample from a patient, A disposable collection cartridge, a housing, a piercing element movable relative to the housing, a heating element, at least one fluid container and a disposable collection cartridge comprising the same, a reusable operating device releasably coupled to the disposable collection cartridge, a vacuum pump fluidly connected to the disposable collection cartridge and configured to continuously pump air out of the disposable collection cartridge before and during collection of the blood sample, a controller in electronic communication with the disposable collection cartridge, a power supply in electronic communication with the disposable collection cartridge and a reusable operating device comprising the same, comprising, the vacuum pump being configured to maintain a pressure of a predetermined characteristic within the disposable collection cartridge during collection of the blood sample, the heating element including a flexible printed circuit board (PCB) and a flexible layer, the controller being electrically connected to the heating element and a temperature sensor being connected to the heating element to adjust the temperature of the heating element, the heating element including an opening, the piercing element having a retracted position and an extended position, in the retracted position being completely enclosed within the housing and in the extended position extending through the opening of the heating element, a blood collection device.

Images