Blood suction device

Abstract

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

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 350,704, filed on June 9, 2022, entitled “Blood Drawing Device,” which is incorporated herein by reference in its entirety. Technical Field

[0002] The present disclosure generally relates to a blood aspiration device for collecting a blood sample from a patient and methods of using the same. Summary of the invention

[0003] A device for collecting a blood sample from a patient is disclosed herein. In an embodiment, a blood aspiration device may include a disposable collection cassette and a reusable actuating device releasably coupled to the disposable collection cassette. The disposable collection cassette may include a housing, a puncture element, and a fluid container. The reusable actuating device may include a controller in electronic communication with the disposable collection cassette, a power source in electronic communication with the disposable collection cassette, and a vacuum source in fluid communication with the disposable collection cassette.

[0004] In an embodiment, the disposable collection box may further include a heating element connected to the surface of the housing extending from the reusable actuating device. The heating element may include a flexible printed circuit board (PCB) and a compliant layer. The heating element may include an orifice, and the puncture element may be able to move between a retracted position and an extended position relative to the housing. The puncture element may be completely contained in the housing in the retracted position, and the puncture element may extend through the orifice of the heating element in the extended position. The heating element may be planar and have a circular portion surrounding the orifice 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 actuating device. In an embodiment, the disposable collection box may include an adhesive tape, and the orifice of the disposable collection box may include an anticoagulant film.

[0005] In an embodiment, the reusable actuation device may further include a controller. The controller may be configured to control: a vacuum source, wherein the vacuum source is a vacuum pump; a mechanical actuation system configured to actuate the puncture element; a temperature sensor coupled to the heating element; a pressure sensor disposed within the disposable collection cassette; and a sample detection sensor disposed within the 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 a temperature detected by the temperature sensor and a desired temperature. The reusable actuation device may include an adjustable knob coupled to the controller and configured to control the desired temperature of the heating element.

[0006] In embodiments, the vacuum source may be a vacuum pump configured to provide a vacuum near the target area when the puncture element is in the retracted position and during movement of the puncture element into the extended position. The vacuum pump may be configured to maintain a predetermined pressure profile in the disposable collection cassette during collection of the blood sample. In some embodiments, the vacuum pump may be configured to apply one or more variable vacuum profiles in the disposable collection cassette during collection of the blood sample.

[0007] In an embodiment, the fluid container may include a capillary channel that is in fluid communication with the open end fluid of the fluid container. In certain embodiments, the capillary channel may include an anticoagulant. In certain embodiments, the fluid container may include a lip extending axially from its end portion. In certain embodiments, the blood suction device may further include a fluid reservoir that includes a liquid reagent. In certain embodiments, the liquid reagent may process blood during the collection of a blood sample. The liquid reagent may include at least one of lithium heparin, K2-EDTA, K3-EDTA, trisodium citrate or another acceptable anticoagulant reagent.

[0008] In embodiments, the puncture 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 cassette before and during collection of the blood sample. In some embodiments, the fluid container may be coupled to the disposable collection cassette via a threaded coupling. In some embodiments, when the disposable collection cassette is coupled to the reusable actuating device, the fluid container may be positioned at an oblique angle relative to the puncture element. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The following detailed description of embodiments of the blood aspirating device will be better understood when read in conjunction with the appended drawings of exemplary embodiments. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0010] In the attached picture:

[0011] Figure 1 is a front perspective view of a blood aspirating device according to an exemplary embodiment of the present disclosure;

[0012] Figure 2 yes Figure 1 A rear perspective view of a blood aspiration device;

[0013] Figure 3 yes Figure 1 A perspective view of a disposable collection cassette of a blood aspiration device shown in FIG.

[0014] Figure 4 yes Figure 3 A side cross-sectional view of a disposable collection box;

[0015] Figure 5 yes Figure 3 A rear perspective cross-sectional view of a disposable collection box;

[0016] Figure 6 yes Figure 3 A side cross-sectional view of a disposable collection cassette showing the piercing element in an extended position;

[0017] Figure 7 yes Figure 1 A front view of a heating element of a blood aspiration device;

[0018] Figure 8 yes Figure 1 A perspective partial cross-sectional view of the blood aspiration device shown in;

[0019] Fig. 9 yes Figure 1 An enlarged side cross-sectional view of a blood aspirating device of claim 1, the blood aspirating device being shown having an adhesive tape on a compliant layer;

[0020] Fig.10 is used in Figure 1 A perspective view of a first exemplary lancet for use in a blood aspiration device shown in; and

[0021] Fig.11 is used in Figure 1 A perspective view of a second exemplary lancet for use in a blood aspiration device is shown in FIG. DETAILED DESCRIPTION

[0022] Blood sampling and analysis are an integral part of patient diagnosis. Blood quality is the most important indicator in clinical chemistry / pathology. Traditional blood extraction methods are based on technology from decades ago, such as venipuncture (phlebotomy). But for some patients, the phlebotomy process can be traumatic and inconvenient. Some methods such as finger pricks (using a lancet) allow blood to be drawn without the need for phlebotomy. This method is the most commonly used method for checking blood sugar levels. For newborns, a healing prick is used to extract a small amount of blood sample for selected screening tests. The main disadvantage of these methods is that the volume of blood extracted is limited by the amount of blood available in the capillaries that have been cut off due to the puncture process before the body begins the repair process. Repeated squeezing (squeezing) can be used to slightly increase the volume of blood discharged, but this method is quite uncomfortable and laborious.

[0023] In contrast to venous blood, some existing methods for collecting capillary blood allow for the collection of larger volumes of blood. Therefore, some methods allow for the generation of several puncture wounds for the collection of approximately 200uL of blood from capillaries after several minutes of use. However, one of the problems with testing capillary blood is the fact that this blood extraction method has an adverse effect on some blood parameters, which will then cause misdiagnosis of the patient. The most susceptible parameters are white blood cell (WBC) count, red blood cell (RBC) count, platelet count and potassium, more generally complete blood cell count (CBC) and electrolyte panel. CBC and electrolyte panels are two of the most commonly requested panels, and these parameters are some of the most important parameters that doctors consider to determine the overall health of the patient. Therefore, any deviation from the actual value can lead to misdiagnosis, and therefore lead to mistreatment of the patient.

[0024] Non-phlebotomy blood collection methods are complicated compared to phlebotomy-based methods due to an increase in WBC counts (which can be caused by the body's response to treating the wound and potential aggregation of platelets that are mistakenly counted as WBCs), a decrease in RBC counts (these fragile cells are damaged through the process of hemolysis due to shear forces when blood is forced through flesh wounds), a decrease in platelet counts (these cells are responsible for blood clotting and when they come into contact with air and also due to shear forces (when blood is forced through flesh wounds), these cells aggregate and attempt to stop bleeding), and an increase in potassium concentration (a side effect of hemolysis, as red blood cells include a large amount of potassium inside, which does not indicate the true concentration of potassium).

[0025] In general, capillary blood collection methods are unable to address the above-mentioned issues and therefore have limited clinical utility as a general blood extraction method. In addition to blood quality issues, pricking a finger can be an uncomfortable and painful procedure because there are many nerve endings at the fingertips. The amount of blood available for collection is also limited, which means that the finger will have to be "milked" in order to increase the sample volume, which reduces the quality of the extracted blood.

[0026] Referring to the drawings in detail, wherein like reference numerals refer to like elements throughout, Figures 1 to 111 shows a blood aspirating device generally designated as 10 according to an exemplary embodiment of the present invention. The blood aspirating device 10 may include two main components: a reusable actuating device 12 and a disposable collection box 14. Because the reusable actuating device does not contact the patient's blood or blood sample, one reusable actuating device 12 can be used with two or more disposable collection boxes 14. Before and after collecting the blood sample, the disposable collection box 14 can be separated from the reusable actuating device 12. During the collection of the blood sample, the disposable collection box 14 can be connected to the reusable actuating device 12, which can control the operation of the components in the disposable collection box 14. By separating the blood aspirating device 10 into multiple pieces, it may be possible to enhance the blood aspiration process by applying an active control system, which can be configured to adjust blood aspiration parameters based on the needs of the patient. By including active elements in the reusable actuating device 12, it may be possible to reduce the waste and costs associated with including these features in traditional single-use blood aspirating devices.

[0027] refer to Figure 1 , the blood aspiration device 10 may have a reusable actuation device 12 that is used in conjunction with a disposable collection cassette 14 configured to capture a blood sample from a patient. The disposable collection cassette 14 may be discarded after use. As discussed in more detail below, the disposable collection cassette 14 may be used to pierce a patient's body and collect a blood sample from the patient's body through the piercing portion, such that the collected blood is transferred to the disposable collection cassette 14. Figure 1 The blood aspirating device 10 is shown with the reusable actuating device 12 and the disposable collection cassette 14 separated.

[0028] like Figure 1 As shown in , the reusable actuator 12 may include a body 16 having a proximal end and a handle 18 coupled 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 actuator 12 does not have a handle. The body 16 of the reusable actuator 12 may have a cavity 20, which is configured to releasably receive a disposable collection box 14 to be coupled to the reusable actuator 12 and the disposable collection box 14. The body 16 and handle 18 of the reusable actuator 12 can be separated by a bend. The bend between the body 16 and the handle 18 can be configured to extend the body 16 forward relative to the handle 18. This orientation of the reusable actuator 12 allows the user to grasp the handle 18 without interfering with the application of the disposable collection box 14 in the body 16.

[0029] like Figures 3 to 5As shown in , in some embodiments, the disposable collection box 14 includes a housing 22, a puncture element 24 and a fluid container 26. The disposable collection box 14 may further include a heating element 28 connected to the disposable collection box 14. In one embodiment, the surface containing the heating element 28 is the surface of the disposable collection box 14 opposite to the surface connected to the reusable actuating device 12. The heating element 28 can apply heat near a target area of ​​the patient's skin before and during the collection of the blood sample. By applying heat near the target area, the thermal energy can cause the blood in this area of ​​the skin to flow more quickly, which can allow more blood to be collected. The heating element 28 can apply constant heat throughout the collection process of the sample. In some embodiments, the heating element 28 can apply variable heat according to predetermined intervals.

[0030] The heating element may be configured to apply a temperature of between 30-45 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 25 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 30 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 35 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 40 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 45 degrees Celsius near the target area. The heating element may be configured to apply a temperature of approximately 50 degrees Celsius near the target area.

[0031] The disposable collection box 14 may further include at least one fastening element 88, which is configured to be releasably connected to the reusable actuating device. The fastening element 88 may be configured to be received in the cavity 20. In some embodiments, the fastening element 88 may be a magnet. The reusable actuating device 12 may include an alignment feature to ensure that the disposable collection box 14 is properly oriented in the cavity 20. There may be an indication that the disposable collection box 14 has been properly connected to the reusable actuating device 12. For example, there may be an audible or visual confirmation. When the disposable collection box 14 is properly oriented in the cavity 20, the light on the reusable actuating device 12 may be turned on. In some embodiments, a click or other noise may confirm that the disposable collection box 14 is properly oriented in the cavity 20.

[0032] In some embodiments, the heating element 28 includes a flexible printed circuit board (PCB) 30. The heating element 28 may include a disposable limiting circuit on the flexible PCB 30. The heating element 28 may include a compliant layer 32. The compliant layer 32 may provide a cushion to soften the surface that contacts the patient's skin. The compliant layer 32 may also distribute the heat generated by the heating element 28 to improve the temperature uniformity near the target area. In some embodiments, the compliant layer 32 is a closed cell foam. In some embodiments, the thickness of the compliant layer 32 is approximately 3 mm. In some embodiments, the thickness of the compliant layer 32 is less than 5 mm. In some embodiments, the thickness of the compliant layer 32 is less than 3 mm. In some embodiments, the thickness of the compliant layer 32 is between 0.5 mm and 3 mm. In alternative embodiments, the heating element 28 may include a non-compliant layer for distributing heat and contacting the skin surface.

[0033] The flexible PCB 30 may be embedded in the compliant layer 32. In other embodiments, the flexible PCB 30 may be coupled to the rear surface of the compliant layer 32. The flexible PCB 30 may include a thermal conductor 33. The thermal conductor 33 may be made of one of a copper trace, an etched foil, or a wire. The thermal conductor 33 may be a single piece of material that extends in an organized configuration to cover the area of ​​the heating element 28. Example layouts of the thermal conductor 33 may include any or all of a serpentine layout, a double square spiral, a peripheral modified spiral, an S-shape, parallel lines, or a lens shape. When electricity is delivered to the thermal conductor, some form of resistance may be used to generate heat. In addition to resistance, the amount of heat supplied to the patient by the thermal conductor 33 may depend on multiple factors, such as the material from which the thermal conductor 33 is made, the thickness of the compliant layer 32, and the amount of electrical input delivered to the thermal conductor 33.

[0034] The thickness of heating element 28 can be less than the thickness of compliant layer 32 to allow heating element 28 to be disposed within compliant layer 32. In some embodiments, heating element 28 has a thickness of approximately 2 mm. In some embodiments, heating element 28 has a thickness of less than 4 mm. In some embodiments, heating element 28 has a thickness of less than 2 mm. In some embodiments, heating element 28 has a thickness between 0.1 mm and 3 mm.

[0035] like Figure 7As shown in , in some embodiments, the heating element 28 is planar. The heating element 28 may have a generally circular portion surrounding the orifice 34 and a tab 36 extending radially from the circular portion. In order to avoid interfering with the movement of the piercing element 24, the heating element 28 may include an opening 31. The opening 31 may be shaped and sized to fit around the orifice 34. The opening 31 may have substantially the same size as the orifice 34. In some embodiments, the opening 31 is larger than the orifice 34. In some embodiments, the heating element 28 may have a generally square shape surrounding the orifice 34. The tab 36 may be shaped and sized to achieve a desired application, such as a generally circular (such as Figure 3 ) or a generally rectangular shape (as shown in Figure 7 The tab 36 may include at least one exposed electrical contact 38a, 38b that may interact with an electrical contact 41 (not shown) disposed on the housing 22 to supply power to the heating element 28.

[0036] The electrical contacts 38a, 38b may be configured to electrically couple the heating element 28 to the reusable actuating device 12 when the disposable collection cassette 14 is received in the cavity 20. The electrical contacts 41 may include more than one electrical contacts. The housing may include the electrical contacts 41 on a surface to which the heating element 28 is coupled. When the heating element 28 is coupled to the housing 22, the electrical contacts 41 of the housing 22 may be positioned adjacent to the electrical contacts 38a, 38b of the heating element 28. The electrical contacts 41 of the housing 22 may extend within the housing 22 from a surface adjacent to the heating element 28 to a surface of the housing 22 that contacts the reusable actuating device 12 when the disposable collection cassette 14 is received in the cavity 20. The housing 22 may include electrical contacts 43 on a portion of the surface that contacts the reusable actuating device 12. The electrical contacts 43 may include more than one electrical contacts. The reusable actuating device 12 may include electrical contacts 45 on a surface adjacent to the electrical contacts 43 of the housing. The electrical contacts 45 may include more than one electrical contact. The electrical contacts 45 of the reusable actuator 12 may be electrically coupled to the power source 48 via a wired connection. Although the electrical contacts are described above as providing power from the power source 48 to the heating element 28, any acceptable form of electrical communication may be provided. For example, wireless power transmission or electromagnetic power transmission.

[0037] In some embodiments, the heating element 28 is positioned along a plane perpendicular to the path of the puncture element 24. Figure 7 As shown in FIG. 3 , the heating element 28 may include an opening 31 . In some embodiments, the heating element 28 covers the entire surface of the disposable collection cassette 14 surrounding the aperture 34 . In some embodiments, the heating element 28 covers only a portion of the surface of the disposable collection cassette 14 surrounding the aperture 34 .

[0038] 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 detected by the temperature sensor 54 and the 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 aspiration process to maintain the provided temperature within a predetermined tolerable range. In some embodiments, it is necessary and useful to implement different temperature distributions within the system to optimize blood flow throughout the blood aspiration 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 detects the user's heat distribution and provides feedback to the controller 46 so that the vacuum source 50 is enabled due to the disposable collection box 14 being pressed against the patient's skin.

[0039] As below combined Figure 10 to Figure 11 As described, the puncture element 24 may include one or more puncture elements 68 (e.g., lancets or needles) fixed thereto to puncture the patient's skin and facilitate blood aspiration, as described in more detail below. The puncture element 24 may be capable of moving relative to the housing to move the (multiple) puncture elements into the patient's skin. The puncture element 24 may have a retracted position and an extended position. In some embodiments, the puncture element 24 is completely contained within the housing in the retracted position. In some embodiments, the puncture element extends through the orifice 34 of the heating element 28 in the extended position. The puncture element 24 can move along a path that is substantially perpendicular to the body 16 of the reusable actuating device 12.

[0040] like Figures 4 to 5As shown in, in some embodiments, the puncture element 24 is powered by a first biasing element 74, which drives the puncture element 24 from the retracted position to the extended position. The first biasing element 74 can be threadedly connected to the housing 22 by an anchor 75 at the first side. The size and shape of the anchor 75 can vary depending on the size and shape requirements of the first biasing element 74. When the puncture element is in the extended position, the anchor 75 can prevent the first side of the first biasing element 74 from moving relative to the housing. The first biasing element 74 can be received in the position of the puncture element at the second side. The puncture element 24 may include a recess 77, which is configured to receive the second side of the first biasing element 74. The first biasing element 74 may be a spring. In some embodiments, the puncture element 24 returns to the retracted position from the extended position by the second biasing element 76. The second biasing element 76 may be a spring. In some embodiments, the first biasing element 74 generates a greater force than the second biasing element 76. After the puncture element 24 has been returned to the retracted position, the disposable collection box 14 can be used as a sharps containment device. The disposable collection box 14 can cover the puncture element 24 after use.

[0041] The second biasing element 76 may provide a biasing force sufficient to allow the puncture element 24 to extend approximately 3 mm from the disposable collection cassette 14 before returning the puncture element 24 to the retracted position. The second biasing element 76 may provide a biasing force sufficient to allow the puncture element 24 to extend approximately 2.5 mm from the disposable collection cassette 14 before returning the puncture element 24 to the retracted position. The second biasing element 76 may provide a biasing force sufficient to allow the puncture element 24 to extend approximately 3.5 mm from the disposable collection cassette 14 before returning it to the retracted position.

[0042] like Figures 4 to 5 As shown in the figure, the puncture element can be actuated by a firing mechanism 78 located in the disposable collection box 14. The firing mechanism 78 can be controlled by the user. In some embodiments, the firing mechanism is located in a reusable actuation device. In some embodiments, the firing mechanism 78 consists of an actuation button 80 and a release element 82. In the locked position, the release element 82 can be positioned to prevent the puncture element 24 from moving from the retracted position to the extended position.

[0043] In some embodiments, the actuation button 80 has a proximal end and a distal end. Figures 4 to 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 can extend into the housing 22 and interact with the release element 82. The distal end 83a can have a thickness less than the thickness of the proximal end 83b of the actuation button 80, and can be angled or inclined to be received by a portion of the release element 82. The actuation button 80 can be pushed toward the proximal end 83b by the third biasing element 84 to prevent accidental actuation of the firing mechanism 78. The third biasing element 84 can be a spring. The rear housing 53 connected to the housing 22 can block and prevent 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 replacement of the first biasing element 74 and / or the puncture element 24.

[0044] The housing may include a button guide 79 surrounding the actuation button 80, such as Figures 4 to 5 The button guide 79 may be sized to allow the actuation button 80 to slide therein, but prevent accidental rotation or movement of the actuation button 80. The button guide 79 may include a track 81 extending therefrom that engages the actuation button 80 to prevent the actuation button 80 from rotating relative to the housing 22 when biased by a user.

[0045] In some embodiments, the release element 82 has a proximal end 85a and a distal end 85b. Figures 4 to 5 The distal end 85b of the release element 82 can be configured to engage the puncture element 24 to prevent movement before the actuation button 80 is moved. The proximal end 85a of the release element 82 can be shaped to receive the distal end 83a of the actuation button 80. The shape of the proximal end 85a of the release element 82 can be at about the same angle as the shape of the distal end 83a of the actuation button 80.

[0046] like Figures 4 to 5 , the release element 82 can be pushed into the locked position by the fourth biasing element 86. The fourth biasing element 86 can be a spring. The proximal end 85a of the release element 82 may include a buckle 87 configured to securely receive the fourth biasing element 86. The buckle 87 may be generally cylindrical and have a periphery similar to the periphery of the fourth biasing element 86. The housing 22 may include a buckle 89 configured to securely receive the fourth biasing element 86. The buckle 89 may be generally cylindrical and have a periphery similar to the periphery of the fourth biasing element 86.

[0047] When the user presses the proximal end of the actuation button 80, the release element 82 may be pushed by the distal end of the actuation button 80 toward the proximal end of the release element 82. When the release element 82 is displaced proximally, the puncture element 24 may not be restricted by the distal end 85b of the release element 82 and may move from the retracted position to the extended position.

[0048] Reducing the movement of the disposable collection cassette 14 can improve the performance of the blood aspiration device 10 by ensuring repeatability. Fig. 9 As shown in, in some embodiments, the disposable collection box 14 includes an adhesive tape 40 on the outwardly facing surface of the compliant layer 32. The adhesive tape 40 can prevent the disposable collection box 14 from moving relative to the patient's skin during the collection of the sample. The adhesive tape 40 may include a release liner (e.g., a plastic film) (not shown), which covers the adhesive tape 40 until use to reduce accidental adhesion. The release liner can cover the orifice 34 to prevent contamination of the components of the disposable collection box 14 before use. In some embodiments, the release liner can only cover the adhesive tape 40. When the disposable collection box 14 is pressed against the patient's skin, the adhesive tape 40 can form an airtight seal between the disposable collection box 14 and the patient. In some embodiments, the orifice 34 includes an anticoagulation film 44, which remains in contact with the user's skin during the entire blood aspiration process. The anticoagulation film 44 can cover the entire opening defined by the orifice 34. In some embodiments, the anticoagulation film 44 can only cover the portion of the opening defined by the orifice 34.

[0049] Increasing the pressure near the target area can improve the patient's experience and facilitate a higher volume and faster blood aspiration than would be possible without increasing the pressure. In addition, in order to promote blood flow without causing pain or damaging the target area, it is important to precisely control the amount of pressure applied. As such, the vacuum can adjust the amount of pressure near the target area, as described in more detail below. The vacuum can further reduce the amount of punctures and repeated squeezes required to collect the desired amount of blood.

[0050] like Figures 8 to 9 As shown in , the reusable actuating device 12 may include a controller 46 in electronic communication with the disposable collection box 14, a power source 48 in electronic communication with the disposable collection box 14, and a vacuum source 50 in fluid communication with the disposable collection box 14 via a vacuum line 51. In some embodiments, the vacuum line 51 is a pneumatic tube, a pipe or other conduit. The reusable actuating device 12 can be powered by a battery. In some embodiments, the reusable actuating device 12 is powered by a power cord plugged into an energy source.

[0051] In some embodiments, the controller 46 is configured to control a 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 actuation system 52 that actuates the puncture element 24 when the disposable collection cassette 14 is received in 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 cassette 14 is received in 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 cassette 14 is received in the cavity 20. In some embodiments, the pressure sensor 56 is disposed within the reusable actuation device 12. The pressure sensor 56 may be disposed within a vacuum conduit 51 of the reusable actuation device 12.

[0052] In some embodiments, the controller 46 is configured to control a sample detection sensor 58 disposed in the fluid container 26 when the disposable collection box 14 is received in 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 in a reusable actuating device 12. If the sample detection sensor 58 is disposed in a reusable actuating device 12, the sample detection sensor 58 can detect the sample through, for example, a transparent window of the fluid container 26.

[0053] In some embodiments, the controller 46 may be implemented in the form of hardware, in the form of software, or in the form of a combination thereof. In some embodiments, the controller 46 according to an exemplary embodiment of the present disclosure may be a processor (e.g., a computer, a microprocessor, a CPU, an ASIC, a circuit, a logic circuit, etc.). The processor may be implemented by a non-transitory memory storing, for example, (multiple) programs, software instructions of a reproduction algorithm, etc., and a processor configured to execute (multiple) programs, software instructions of a reproduction algorithm, etc., which, when executed, may 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. In some embodiments, the memory and the processor may be implemented as separate semiconductor circuits. Alternatively, the memory and the processor may be implemented as a single integrated semiconductor circuit. In some embodiments, the processor may embody one or more processors.

[0054] In some embodiments, the vacuum source 50 is a vacuum pump configured to provide a vacuum in the housing 22 near the target area when the puncture element 24 is in the retracted position. The vacuum source 50 may be a vacuum pump configured to provide a vacuum in the housing 22 near the target area when the puncture element 24 is in the extended position. The pressure sensor 56 may provide feedback to the controller 46 as a means of performing active pressure control throughout the blood aspiration process.

[0055] As described in more detail below, active control of the vacuum source 50 can improve the accuracy and efficiency of blood collection. The pressure generated by the vacuum source 50 in the housing 22 can be increased to facilitate greater blood flow from the target area. The pressure generated by the vacuum source 50 in the housing 22 can be reduced to facilitate less blood flow from the target area. In some embodiments, the vacuum source 50 allows suction between 3psi and 10psi. In some embodiments, the vacuum source 50 allows suction up to 2psi. In some embodiments, the vacuum source 50 allows suction up to 3psi. In some embodiments, the vacuum source 50 allows suction up to 4psi. In some embodiments, the vacuum source 50 allows suction up to 5psi. In some embodiments, the vacuum source 50 allows suction up to 6psi. In some embodiments, the vacuum source 50 allows suction up to 7psi. In some embodiments, the vacuum source 50 allows suction up to 8psi. In some embodiments, the vacuum source 50 allows suction up to 9psi. In some embodiments, the vacuum source 50 allows suction up to 10psi. In some embodiments, the vacuum source 50 allows suction up to 11psi.

[0056] The vacuum source 50 in the reusable actuation device 12 can be in fluid communication with the vacuum channel 90 in the disposable collection cassette 14. Figures 5 to 7 As shown in , vacuum channel 90 can extend from exterior side 92a to interior side 92b. Vacuum channel 90 can form a fluid path between the target area and vacuum source 50 to allow vacuum source 50 to control the pressure near the target area. Vacuum channel 90 can extend from exterior side 92a through housing 22 to an area near firing mechanism 78. Vacuum channel 90 can then extend through a separate portion of housing 22 to opening 92c near puncture element 24 and opening 92d near fluid container 26. The flow path of vacuum channel 90 is Figure 4 In some embodiments, the vacuum channel 90 may include all open areas within the housing 22, including but not limited to all areas surrounding the firing mechanism 78, the fluid container 26, and the piercing element 24, as shown in FIG. Figure 6 Shown by dotted lines.

[0057] The vacuum source 50 can be fluidly coupled to the disposable collection box 14. The outer side 92a can engage the vacuum source, and the inner side 92b can direct vacuum suction to a location near the target area. The outer side 92a can include a tip 91 that protrudes from the housing 22. The tip 91 can be tapered to facilitate connection between the vacuum channel 90 and the vacuum conduit 51 when the disposable collection box 14 is received in the cavity 20. The shape and size of the tip 91 can form an airtight seal with the vacuum conduit 51 when the disposable collection box 14 is received in the cavity 20. In some embodiments, the tip 91 includes a sheath to ensure that the shape and size of the tip 91 forms an airtight seal with the vacuum conduit 51 when the disposable collection box 14 is received in the cavity 20.

[0058] refer to Figure 4 , the tip 91 may need to be first inserted into the reusable actuating device 12 because the tip 91 protrudes from the housing 22 of the disposable collection cassette 14. As such, the housing 22 may include a cutout near the tip 91 to receive a portion of the reusable actuating device 12 to facilitate insertion of the tip 91 into the reusable actuating device 12. Once the tip 91 is inserted into the reusable actuating device 12, the disposable collection cassette 14 may be pivoted about the cutout 97 until the disposable collection cassette 14 is fully received in the cavity 20 of the reusable actuating device 12. The cutout 97 may be generally rounded to facilitate rotation of the disposable collection cassette 14 relative to the reusable actuating device 12 when disposed in the reusable actuating device 12.

[0059] In some embodiments, the vacuum source 50 is configured to maintain a predetermined pressure profile in the disposable collection cassette 14 during the collection of the blood sample. For example, during the collection of the blood sample, a constant pressure (e.g., 7 psi) may be applied by the vacuum source 50 to draw the sample from the patient and into the fluid container 26. In some embodiments, the vacuum source 50 is configured to apply one or more variable vacuum profiles in the disposable collection cassette 14 during the collection of the blood sample. For example, the pressure applied by the vacuum source 50 may be repeatedly increased for a set amount of time (e.g., 5 seconds) and then decreased for a set amount of time (e.g., 5 seconds) during the collection of the blood sample. The vacuum source 50 may be configured to continuously pump air out of the disposable collection cassette 14 prior to the collection of the blood sample. The vacuum source 50 may be configured to continuously pump air out of the disposable collection cassette 14 during the collection of the blood sample. When air is constantly and continuously pumped out of the disposable collection cassette 14, the internal pressure of the housing 22 may not rise over time, and the most consistent results may be allowed. The controller 46 may adjust the pressure sensor 56 during collection of a blood sample depending on feedback the controller receives from the sample detection sensor 58 (eg, the rate of blood flow).

[0060] The processing of blood during the blood collection process can further enhance the accuracy of the test results. The processing may include when the blood travels between the blood collection site to the open end 64 of the fluid container 26 or when the blood is in the fluid container 26, the reagent interacts with the blood at the blood collection site. In some embodiments, the fluid container 26 includes a capillary channel 62 (not shown) that is fluidically connected to the open end 64 of the fluid container 26. The capillary channel 62 may be referred to as a capillary tube. The housing 22 may include a ledge 93 extending from a portion thereof. The ledge 93 may be located near the open end 64 to orient the fluid capture element relative to the housing 22 during use. The ledge 93 may prevent the open end 64 from rotating relative to the housing 22 during use. In some embodiments, the open end 64 is tapered. In some embodiments, the capillary channel 62 includes an anticoagulant. This anticoagulant may be essential to maintaining blood quality (especially for platelets and potassium). In some embodiments, more than one capillary channel 62 may be used to guide a blood sample to more than one fluid container 26. The open end 64 may include a lip 66 extending from an end portion thereof and include sidewalls treated with an appropriate anticoagulant agent in dry form. The lip 66 may extend beyond the compliant layer 32 to contact the user during the blood collection process.

[0061] In some embodiments, the disposable collection cassette 14 includes a fluid reservoir 65 disposed within the fluid container 26. The fluid reservoir 65 may be separate from the fluid container 26 but in fluid communication with the fluid container 26. The fluid reservoir 65 may be located near the lip 66, such as Figure 3 . The fluid reservoir 65 may contain a liquid reagent. During the blood collection process, a volume of the liquid reagent may be displaced from the fluid reservoir to treat the blood as it is collected during the blood collection process. In some embodiments, the liquid reagent is applied directly to the collection site to treat the blood as it is collected during the blood collection process. The liquid reagent may be one of lithium heparin, dipotassium ethylenediaminetetraacetate (K2-EDTA), tripotassium ethylenediaminetetraacetate (K3-EDTA), trisodium citrate, or another acceptable test reagent necessary for performing a specific test on the collected blood.

[0062] In some embodiments, the fluid container 26 is coupled to the disposable collection cassette 14 via a threaded coupling having an end retaining cap 95, such as Figures 4 to 5. In some embodiments, the fluid container 26 is directly coupled to the housing 22 without an end retaining cap 95. The end retaining cap 95 may include a threaded collar 27 at one end thereof. The housing 22 may include a threaded receiver 29 that is shaped and sized to receive the threaded collar 27. Rotation of the end retaining cap 95 relative to the housing 22 in a first direction may secure the fluid container 26 to the housing 22. Rotation of the end retaining cap 95 relative to the housing 22 in a second direction opposite to the first direction may release the fluid container 26 from the housing 22.

[0063] A stopper (not shown) may be disposed in the fluid container 26 to prevent the sample from escaping when the fluid container 26 is separated from the housing 22. As discussed in more detail below, the open end 64 of the fluid container 26 may receive a cap to prevent the sample from escaping from 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 oblique angle relative to the puncture element 24. Portions of the fluid container 26 may extend from the housing 22. In some embodiments, the fluid container 26 is completely contained within the housing 22.

[0064] In some embodiments, the fluid container 26 holds between 10uL and 1mL of blood. The fluid container 26 may be configured to hold up to 1mL of blood. The fluid container 26 may be configured to hold up to 900uL of blood. The fluid container 26 may be configured to hold up to 800uL of blood. The fluid container 26 may be configured to hold up to 700uL of blood. The fluid container 26 may be configured to hold up to 600uL of blood. The fluid container 26 may be configured to hold up to 500uL of blood. The fluid container 26 may be configured to hold up to 400uL of blood. The fluid container 26 may be configured to hold up to 350uL of blood. The fluid container 26 may be configured to hold up to 300uL of blood. The fluid container 26 may be configured to hold up to 250uL of blood. The fluid container 26 may be configured to hold up to 200uL of blood. The fluid container 26 may be configured to hold up to 150uL of blood. The fluid container 26 may be configured to hold up to 100 uL of blood. The fluid container 26 may be configured to hold up to 50 uL of blood.

[0065] refer to Figure 4 , the fluid container 26 may include a collar 67 extending radially at least partially therefrom. The collar 67 may extend around the periphery of the fluid container 26. In some embodiments, the collar 67 may extend around the periphery of the fluid container 26. The collar 67 may be configured to receive a cap (not shown) to secure the sample within the fluid container 26 when the fluid container 26 is separated from the housing 22. The collar 67 may be a generally flat collar. In some embodiments, the collar 67 may be threaded to receive the cap.

[0066] like Figure 10 to Figure 11As shown in, in some embodiments, the puncture element 24 includes a puncture element 68. The puncture element 24 may include a group of puncture elements 68. The puncture element 24 may include a body 72. In some embodiments, the body 72 is a cylindrical shape with a proximal end and a distal end. The body 72 may be made of plastic. The body 72 may be formed around the lancet. In some embodiments, the puncture element 68 protrudes from the distal end of the body 72. The puncture element 68 may be designed to be used for a specific cutting shape, size and depth. In some embodiments, the puncture element 24 is a laser or a liquid beam. In some embodiments, the puncture element 24 advances through the fluid container 26. The blood sample can be guided into the fluid container 26 through the capillary channel 62.

[0067] In some embodiments, the disposable collection cassette 14 includes a chemical detection element 70. The chemical detection element 70 may be capable of detecting blood characteristics during the blood collection process. The chemical detection element 70 may be capable of detecting, for example, any of red blood cells, white blood cells, platelets, neutrophils, lymphocytes, monocytes, hemoglobin, and potassium. The chemical detection element 70 may be electrically coupled to the controller 46, and the controller 46 may be configured to process data transmitted by the chemical detection element 70 in real time. In some embodiments, it may be necessary and useful to implement real-time chemical detection within the system to optimize the accuracy of the tests performed on the drawn blood during the blood aspiration process.

[0068] In some embodiments, the reusable actuation device 12 includes a button 19. The button 19 can be configured to start the operation of the vacuum source 50 to prepare for the actuation of the firing mechanism 78. In some embodiments, the vacuum source 50 is configured for pneumatic actuation without the use of the button 19. In some embodiments, the disposable collection box 14 can have a flexible diaphragm 94 located between the housing 22 and the actuation button 80. In response to the vacuum source 50 providing a target pressure inside the housing 22, the flexible diaphragm 94 can be deformed by the pressure so that it displaces the actuation button 80 and actuates the firing mechanism 78. In some embodiments, the flexible diaphragm directly displaces the firing mechanism 78. In some embodiments, the target pressure is a pressure that is expected to produce optimal blood flow during the blood aspiration process.

[0069] The blood aspiration device 10 described above can be used by a user to collect a blood sample for testing. An exemplary method may include a user receiving a reusable actuation device 12 and inserting a disposable collection cartridge 14 into a cavity 20 of the reusable actuation device 12. The user may then remove a release liner covering the adhesive tape 40 on the compliant layer 32 to expose the adhesive tape 40. The user may then press the compliant layer 32 against a target area (e.g., a shoulder or forearm) of the patient.

[0070] Once the blood suction device 10 has been placed in the desired position, the user can press the button 19 of the reusable actuator 12 to start the operation of the vacuum source 50 and / or the heating element 28 to prepare the target area for the actuation of the firing mechanism 78. In some embodiments, the vacuum source 50 and / or the heating element 28 are configured to automatically start the operation without pressing the button 19 when the blood suction device 10 is placed on the target area of ​​the patient. When the desired pressure and / or temperature at the target area has been achieved, the user can press the actuation button 80 to start the actuation of the firing mechanism 78. During the collection of the sample, the vacuum source 50 and the heating element 28 can be actively controlled by the controller 46 to ensure that the conditions around the target area are convenient for optimal blood flow. When the collection of the sample is completed, the user can rotate the end holding cap 95 of the fluid container 26 to remove the fluid container. The cap can then be placed on the fluid container 26 to prevent the sample from escaping from the fluid container 26. The disposable collection box 14 can then be discarded in an appropriate manner. A new disposable collection cassette 14 may be coupled to the same reusable actuation device 12 for subsequent use on the same patient or a different patient.

[0071] The term "approximately" or "approximately" is used herein to provide literal support for the exact number in front of it and the number close to or approximate to the number in front of the term. When determining whether a number is close to or approximate to a specifically described number, the number close to or approximate to the number not described can be a substantially equivalent number of the number of the specifically described number in the context in which it is presented. It should be recognized that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, regardless of whether "approximately" is used in conjunction with it. It should also be recognized that, as used herein, the term "approximately" combined with a number refers to a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive) of the number, ±3% (inclusive) of the number, ±5% (inclusive) of the number, ±10% (inclusive) of the number, or ±15% (inclusive) of the number. It should be further recognized that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.

[0072] Those skilled in the art will recognize that changes may be made to the exemplary embodiments without departing from the broad inventive concepts of the exemplary embodiments shown and described above. It will be understood that the embodiments and claims disclosed herein are not limited in their application to the details of the construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and drawings provide examples of contemplated embodiments. The embodiments and claims disclosed herein are further capable of other embodiments and can be practiced and implemented in various ways.

[0073] Specific features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments may be combined. Unless specifically set forth herein, the terms "a", "an", and "the" are not limited to one element, but rather should be understood to mean "at least one". Finally, unless specifically set forth herein, the disclosed or claimed methods should not be limited to performing their steps in the order in which they are written, and those skilled in the art can readily recognize that the steps can be performed in any practical order.

Claims

1. A blood suction device for collecting a blood sample from a patient, the blood suction device comprising: A disposable collection box, comprising: case, a piercing element, and a fluid container; and a reusable actuation device releasably coupled to the disposable collection cassette, the reusable actuation device comprising: a controller in electronic communication with the disposable collection cassette, a power source in electronic communication with the disposable collection cartridge, and A vacuum source is in fluid communication with the disposable collection cassette.

2. The blood aspirating device according to claim 1, wherein: The disposable collection cassette further includes a heating element coupled to a surface of the housing extending from the reusable actuation device.

3. The blood aspiration device according to claim 2, wherein: The heating element includes a flexible printed circuit board (PCB).

4. The blood aspirating device according to claim 3, wherein: The heating element includes a compliant layer.

5. The blood aspirating device according to claim 2, wherein: The heating element comprises an aperture, and wherein the piercing element is movable relative to the housing and has a retracted position in which the piercing element is completely contained within the housing and an extended position in which the piercing element extends through the aperture of the heating element.

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

7. The blood aspirating device according to claim 6, wherein: The tab includes at least one exposed electrical contact that electrically couples the heating element to the reusable actuation device.

8. The blood aspirating device according to claim 1, wherein: The disposable collection cassette comprises an adhesive strip, and wherein the aperture of the disposable collection cassette comprises an anticoagulation membrane.

9. The blood aspirating device of claim 1, wherein the reusable actuating device further comprises a controller configured to control: The vacuum source, wherein The vacuum source is a vacuum pump; a mechanical actuation system configured to actuate the puncture element; a temperature sensor coupled to the heating element; A pressure sensor, which is disposed in the disposable collection box; as well as a sample detection sensor disposed in the fluid container, Wherein, the temperature sensor is coupled to the controller, and 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.

10. The blood aspirating device according to claim 9, wherein: The reusable actuation device includes an adjustable knob coupled to the controller and configured to control the desired temperature of the heating element.

11. The blood aspirating device according to claim 1, wherein: The vacuum source is a vacuum pump configured to provide a vacuum proximate a target area when the puncture element is in the retracted position and during movement of the puncture element into the extended position.

12. The blood aspirating device according to claim 11, wherein: The vacuum pump is configured to maintain a predetermined pressure profile in the disposable collection cassette during collection of the blood sample.

13. The blood aspirating device according to claim 11, wherein: The vacuum pump is configured to apply one or more variable vacuum profiles in the disposable collection cassette during collection of the blood sample.

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

15. The blood aspirating device according to claim 14, wherein: The fluid container includes a lip extending axially from an end portion thereof.

16. The blood aspirating device according to claim 1, further comprising: a fluid reservoir comprising a liquid reagent, Wherein, the liquid reagent processes the blood during the collection of the blood sample.

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

18. The blood aspirating device according to claim 1, wherein: The puncturing element includes one or more lancets.

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

20. The blood aspirating device according to claim 1, wherein: The fluid container is coupled to the disposable collection cassette via a threaded coupling.

21. The blood aspirating device according to claim 1, wherein: When the disposable collection cassette is coupled to the reusable actuation device, the fluid container is positioned at an oblique angle relative to the puncturing element.

22. A blood aspiration device for collecting a blood sample from a patient, the blood aspiration device comprising: A disposable collection box, comprising: case, a piercing element movable relative to the housing, Heating elements, and at least one fluid container; and a reusable actuation device releasably coupled to the disposable collection cassette, the reusable actuation device comprising: a vacuum pump fluidly coupled to the disposable collection cassette and configured to continuously pump air out of the disposable collection cassette prior to and during collection of the blood sample, a controller in electronic communication with the disposable collection cassette, and a power source in electronic communication with the disposable collection cartridge, wherein the vacuum pump is configured to maintain a predetermined pressure profile in the disposable collection cassette during collection of the blood sample, Wherein, the heating element comprises a flexible printed circuit board (PCB) and a compliant layer, wherein the controller is electrically coupled to the heating element, and a temperature sensor is coupled to the heating element to adjust the temperature of the heating element, and wherein the heating element comprises an aperture, and the piercing element has a retracted position in which the piercing element is completely contained within the housing and an extended position in which the piercing element extends through the aperture of the heating element.

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