Capillary collector with rotatable connection

Abstract

A device for acquiring a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engaging portion connected to the holder; and a collection container removably connectable to the container engaging portion, the container defining a collection cavity, where the container engaging portion allows rotation of the collection container between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202080021988.3, which is the national phase entry of International Application PCT / US2020 / 017635 with the invention name of "Capillary Sampler with Rotatable Connection" and the international filing date of February 11, 2020.

[0002] Cross - reference to Related Applications

[0003] This application claims the priority of U.S. Provisional Application No. 62 / 805,398, filed on February 14, 2019, entitled "Capillary Sampler with Rotatable Connection", the entire disclosure of which is incorporated herein by reference. Technical Field

[0004] The present disclosure generally relates to a device for obtaining a biological sample. More specifically, the present disclosure relates to an integrated finger - based capillary blood sampling device that is capable of piercing and squeezing a finger in a controlled manner, collecting, stabilizing, and dispensing a blood sample. Background Art

[0005] Devices for obtaining and collecting biological samples (such as blood samples) are commonly used in the medical industry. One type of blood sampling that is commonly performed in the medical field is capillary blood sampling, which is typically used to collect blood samples for testing. Certain diseases (such as diabetes) require regular testing of a patient's blood to monitor, for example, the patient's blood sugar level. In addition, test kits (such as cholesterol test kits) typically require a blood sample for analysis. The blood sampling procedure generally involves piercing a finger or other suitable body part in order to obtain a blood sample. Generally, the amount of blood required for such tests is relatively small, and a small puncture wound or incision can typically provide sufficient blood volume for these tests. Various types of lancet devices have been developed that are used to pierce a patient's skin to obtain a capillary blood sample from the patient.

[0006] Many different types of lancet devices are available for purchase by hospitals, clinics, doctor's offices, etc., as well as individual consumers. Such devices typically include a pointed member (such as a needle) or a sharp - edged member (such as a blade) that is used to form a quick puncture wound or incision in the patient's skin to provide a small amount of blood flow. Many people often have difficulty, both physically and psychologically, in piercing their own fingers with a handheld needle or blade. As a result, lancet devices have evolved into automatic devices that puncture or cut the patient's skin when a trigger mechanism is actuated. In some devices, the needle or blade remains in a standby position until it is triggered by a user, who can be a medical professional responsible for drawing blood from the patient or the patient themselves. Upon triggering, the needle or blade punctures or cuts the patient's skin, such as the skin on a finger. Generally, a spring is incorporated into the device to provide the "automatic" force required to puncture or cut the patient's skin.

[0007] One type of contact-activated lancet device is U.S. Patent No. 9,380,975, which belongs to the assignee of the present application, Becton, Dickinson and Company. The contact-activated lancet device is characterized in that the piercing or cutting element automatically pops out and retracts from the device. The lancet device includes a housing and a lancet structure having a piercing element. The lancet structure is disposed within the housing and is adapted to move between a holding or pre-actuated position where the piercing element is held within the housing and a piercing position where the piercing element extends through the front end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the piercing position, and a holding seat for holding the lancet structure in the retracted position against the bias of the drive spring. The holding seat includes a pivot rod that interferingly engages with the lancet structure. An actuator within the housing pivots the rod, causing the lancet structure to move toward the rear end of the housing to at least partially compress the drive spring and releasing the rod from its interfereng engagement with the lancet structure. Then a blood sample received is collected and / or tested. The testing can be done by a point-of-care (POC) testing device, or it can be collected and sent to a testing facility.

[0008] Currently, the capillary blood sampling workflow is a complex multi-step process that requires a high skill level. The multi-step nature of the process introduces several variables that can lead to sample quality problems, such as hemolysis, insufficient sample stability, and microclots. Obtaining a blood sample using a lancet device can result in several variables that affect capillary blood sampling, including but not limited to keeping the lancet stationary during testing, obtaining sufficient blood flow from the puncture site, adequately collecting the blood, preventing clotting, etc. Some of the most common sources of process variability are: (1) inadequate cleaning of the blood sampling site and removal of the first drop of blood, which can potentially lead to sample contamination; (2) inconsistent puncture location and depth, which can potentially lead to insufficient sample volume and a large proportion of interstitial fluid; (3) inconsistent squeezing techniques and excessive pressure near the puncture site to facilitate blood extraction (e.g., milking the blood), which can potentially lead to sample hemolysis; (4) variable transfer interfaces and collection techniques that can potentially lead to hemolysis or sample contamination; and (5) inadequate mixing of the sample with an anticoagulant, which can potentially lead to microclots.

[0009] Accordingly, there is a need in the art for a device that can pierce and squeeze a finger in a controlled manner, collect a sample, stabilize the sample, and subsequently dispense the sample. There is also a need in the art for a device that simplifies and streamlines capillary blood sampling by eliminating workflow variability typically associated with low sample quality, including hemolysis and microclots. There is a further need in the art to eliminate closed system collection and transfer of blood exposure and device reuse. There is a further need in the art for a device that: (1) introduces flexibility in the adaptation of different capillary collection and transfer containers; (2) has the ability to produce high-quality, uniformly mixed / stable capillary blood samples; (3) has the ability to produce on-board plasma from capillary plasma samples; (4) has the ability to collect a large volume of capillary blood samples (>50 - 500 μL) with reduced pain; (5) includes a unique sample identifier that is paired with patient information at the time of collection; (6) has the ability to collect capillary blood and perform on-board diagnostics; (7) has multiple collection ports for collecting blood samples into different containers with the same or different anticoagulants. Summary of the Invention

[0010] The present disclosure relates to a device for obtaining a biological sample, such as a capillary blood sampling device, that meets the above needs and has the ability to pierce and squeeze a finger in a controlled manner, collect a sample, stabilize the sample, and then dispense the sample. The device also simplifies and streamlines capillary blood sampling by eliminating workflow variability typically associated with low sample quality, including hemolysis and microclots.

[0011] The present disclosure includes a self - contained and fully integrated finger - based capillary blood sampling device that has the ability to pierce, collect, and stabilize a large volume of capillary blood samples (e.g., up to or exceeding 500 microliters). The device simplifies and streamlines large - volume capillary blood sampling by eliminating workflow steps and variability typically associated with low sample quality, including hemolysis, microclots, and patient discomfort. The device includes a retractable piercing mechanism capable of piercing a finger and an associated blood flow path that ensures capillary blood attachment and transfer from the punctured finger site to a collection container. The device also includes a retainer that can be cyclically squeezed to stimulate (i.e., pump) blood flowing out of the finger, and the device further includes an anticoagulant deposited in the flow path or collection container to stabilize the collected sample.

[0012] According to one design, the device may include separating components such as a retainer, a lancet, and a collection container. According to another design, the lancet and the collection container may be integrated into one device, which is then used together with the retainer. According to yet another design, the retainer, the lancet, and the collection container may be integrated into a single system. Any of these designs is contemplated to be used as a self-standing disposable device and / or in combination with an external power source for pain relief control. The capillary blood sampling device can be used as a platform for various capillary blood collection containers (from small tubes to capillary dispensers) and an on-board plasma separation module. This capability extends product flexibility to various applications, including dispensing into a point-of-care (POC) cartridge or small collection tube transfer for use in a centrifuge or an analytical instrument.

[0013] According to an embodiment of the present invention, a device for obtaining a blood sample may include a retainer for receiving a sample source, the retainer having an actuating portion and a port, a container engaging portion connected to the retainer, and a collection container, the collection container being removably connectable to the container engaging portion, the container defining a collection chamber, wherein the container engaging portion allows the collection container to rotate between a first position in which the collection container is spaced apart from the port and a second position in which the collection container is in fluid communication with the port.

[0014] According to another embodiment of the present invention, the actuating portion may be convertible between a first position in which the retainer defines a first ellipse and a second position in which the retainer defines a second ellipse, wherein the second ellipse is different from the first ellipse. The actuating portion may include a contact member. The actuating portion may be convertible between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position. When the contact member is in the engaged position, the contact member may apply pressure to the sample source. The actuating portion may include a pumping member for applying pressure to the sample source. The pumping member may include a pair of opposing tabs. The sample source may be a finger. In the case where the finger is received within the retainer, the port may communicate with a portion of the finger. The container engaging portion and the retainer may be connected by a ball-and-socket joint, a stud and hole pivot joint, a pin and C-clamp pivot joint, or a pin and socket pivot joint. The retainer may include a movable hinge connectable to the container engaging portion. The movable hinge may be connected to the container engaging portion by a bonded snap device, a hook and snap device, a C-clamp and snap device, or a stud and profile engaging device.

[0015] In another embodiment of the present invention, a device for obtaining a blood sample may include a retainer for receiving a sample source, the retainer having an actuating portion and a port, and a container engaging portion connected to the retainer and configured to hold a collection container, wherein the container engaging portion allows the collection container to rotate between a first position in which the collection container is spaced apart from the port and a second position in which the collection container is in fluid communication with the port.

[0016] In another embodiment of the present invention, the actuating portion can be convertible between a first position where the retainer defines a first ellipse and a second position where the retainer defines a second ellipse, wherein the second ellipse is different from the first ellipse. The actuating portion can include a contact member. The actuating portion can be convertible between a first position where the contact member is in a disengaged position and a second position where the contact member is in an engaged position. When the contact member is in the engaged position, the contact member can apply pressure on the sample source. The actuating portion can include a pumping member for applying pressure to the sample source. The pumping member can include a pair of opposing tabs. The sample source can be a finger. In the case where the finger is received within the retainer, the port can communicate with a portion of the finger. The container engagement portion and the retainer can be connected by a ball-and-socket joint, a stud-and-hole pivot joint, a pin-and-C-clamp pivot joint, or a pin-and-recess pivot joint. The retainer can include a movable hinge that can be connected to the container engagement portion. The movable hinge can be connected to the container engagement portion by a bonded snap device, a hook-and-snap device, a C-clamp-and-snap device, or a stud-and-profile engagement device.

[0017] In another embodiment of the present invention, a tray for holding components for obtaining a blood sample can include a plurality of sections for holding components for obtaining a blood sample, the plurality of sections including: a first section for holding a finger measurement card; a second section for holding at least two retainers; a third section for holding a lancet; and a fourth section for holding a collection container for holding the blood sample, wherein each section includes a label corresponding to a sequential step in the method of obtaining a blood sample.

[0018] The present disclosure is also defined by the following clauses:

[0019] Clause 1: A device for obtaining a blood sample, the device comprising: a retainer for receiving a sample source, the retainer having an actuating portion and a port; a container engagement portion connected to the retainer; a collection container that can be removably connected to the container engagement portion, the container defining a collection chamber, wherein the container engagement portion allows the collection container to rotate between a first position where the collection container is spaced apart from the port and a second position where the collection container is in fluid communication with the port.

[0020] Clause 2: The device according to Clause 1, wherein the actuating portion is convertible between a first position where the retainer defines a first ellipse and a second position where the retainer defines a second ellipse, wherein the second ellipse is different from the first ellipse.

[0021] Clause 3: The device according to Clause 1 or Clause 2, wherein the actuating portion includes a contact member.

[0022] Clause 4: The device according to Clause 3, wherein the actuating part is convertible between a first position where the contact member is in the disengaged position and a second position where the contact member is in the engaged position.

[0023] Clause 5: The device according to Clause 4, wherein when the contact member is in the engaged position, the contact member applies pressure on the sample source.

[0024] Clause 6: The device according to any one of Clauses 1 - 5, wherein the actuating part includes a pumping member for applying pressure to the sample source.

[0025] Clause 7: The device according to Clause 6, wherein the pumping member includes a pair of opposing tabs.

[0026] Clause 8: The device according to any one of Clauses 1 - 7, wherein the sample source is a finger.

[0027] Clause 9: The device according to Clause 8, wherein when the finger is received in the holder, the port is in communication with a part of the finger.

[0028] Clause 10: The device according to any one of Clauses 1 - 9, wherein the container engaging part and the holder are connected via a ball and socket joint, a stud and hole pivot joint, a pin and C - clip pivot joint, or a pin and socket pivot joint.

[0029] Clause 11: The device according to any one of Clauses 1 - 10, wherein the holder includes a movable hinge that can be connected to the container engaging part.

[0030] Clause 12: The device according to Clause 11, wherein the movable hinge is connected to the container engaging part by a bonded snap - fit device, a hook and snap - fit device, a C - clip and snap - fit device, or a stud and shaped engagement.

[0031] Clause 13: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuating part and a port; a container engaging part connected to the holder and configured to hold a collection container; wherein the container engaging part allows the collection container to rotate between a first position where the collection container is spaced apart from the port and a second position where the collection container is in fluid communication with the port.

[0032] Clause 14: The device according to Clause 13, wherein the actuating part is convertible between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, wherein the second ellipse is different from the first ellipse.

[0033] Clause 15: The device according to Clause 13 or Clause 14, wherein the actuating part includes a contact member.

[0034] Clause 16: The device according to Clause 15, wherein the actuating part is convertible between a first position where the contact member is in the disengaged position and a second position where the contact member is in the engaged position.

[0035] Clause 17: The device according to Clause 16, wherein, when the contact member is in the engaged position, the contact member applies pressure on the sample source.

[0036] Clause 18: The device according to any one of Clauses 13 - 17, wherein the actuating part includes a pumping member for applying pressure to the sample source.

[0037] Clause 19: The device according to Clause 18, wherein the pumping member includes a pair of opposing tabs.

[0038] Clause 20: The device according to any one of Clauses 13 - 19, wherein the sample source is a finger.

[0039] Clause 21: The device according to Clause 20, wherein, when the finger is received in the holder, the port is in communication with a part of the finger.

[0040] Clause 22: The device according to any one of Clauses 13 - 21, wherein the container engaging part and the holder are connected via a ball - and - socket joint, a stud - and - hole pivot joint, a pin - and - C - clip pivot joint, or a pin - and - socket - recess pivot joint.

[0041] Clause 23: The device according to any one of Clauses 13 - 22, wherein the holder includes a movable hinge that can be connected to the container engaging part.

[0042] Clause 24: The device according to Clause 23, wherein the movable hinge is connected to the container engaging part by a bonded snap - fit device, a hook - and - snap device, a C - clip - and - snap device, or a stud - and - shaped engagement.

[0043] Clause 25: A tray for holding components for obtaining a blood sample, the tray comprising: a plurality of sections for holding components for obtaining a blood sample, the plurality of sections including: a first section for holding a finger measurement card; a second section for holding at least two holders; a third section for placing a lancet; and a fourth section for holding a collection container to hold the blood sample, wherein each section includes a label corresponding to a sequential step in a method for obtaining a blood sample. Description of the Drawings

[0044] The above and other features and advantages of the present disclosure, and the manner of obtaining them, will become more apparent by reference to the embodiments of the present disclosure described below in conjunction with the accompanying drawings, and the present disclosure itself will be better understood, in which:

[0045] Figure 1 is a perspective view of a retainer according to an embodiment of the present invention.

[0046] Figure 2 is a perspective view of a retainer in a first position according to an embodiment of the present invention.

[0047] Figure 3 is a perspective view of a retainer in a second position according to an embodiment of the present invention.

[0048] Figure 4A is a perspective view of a retainer according to another embodiment of the present invention.

[0049] Figure 4B is a perspective view of a retainer according to another embodiment of the present invention.

[0050] Figure 5 is a perspective view of a retainer according to another embodiment of the present invention.

[0051] Figure 6A is a perspective view of a retainer according to another embodiment of the present invention.

[0052] Figure 6B is a perspective view of a retainer according to another embodiment of the present invention.

[0053] Figure 7A is a perspective view of a retainer according to another embodiment of the present invention.

[0054] Figure 7B is a perspective view of a retainer according to another embodiment of the present invention.

[0055] Figure 8 is an exploded perspective view of a device for obtaining a blood sample having a separation component according to an embodiment of the present invention.

[0056] Figure 9 is a perspective view of a retainer having a lancet housing fixed within a port according to an embodiment of the present invention.

[0057] Figure 10 is a perspective view of a retainer having a container fixed within a port according to an embodiment of the present invention.

[0058] Figure 11 is a perspective view of a semi - integrated device for obtaining a blood sample having an angled flow according to another embodiment of the present invention.

[0059] Figure 12 is a perspective view of a retainer having a lancet housing and a container fixed within a port according to another embodiment of the present invention.

[0060] Figure 13 is of another embodiment according to the present invention Figure 12 of the device in cross-section.

[0061] Figure 14 is a perspective view of a semi-integrated device with a straight flow for obtaining a blood sample according to another embodiment of the present invention.

[0062] Figure 15 is a perspective view of a holder with a lancet housing and a container fixed within a port according to another embodiment of the present invention.

[0063] Figure 16 is of another embodiment according to the present invention Figure 15 of the device in cross-section.

[0064] Figure 17 is a perspective view of an integrated device with an angled flow for obtaining a blood sample according to another embodiment of the present invention.

[0065] Figure 18 is of another embodiment according to the present invention Figure 17 of the device in cross-section.

[0066] Figure 19 is Figure 17 a cross-section of the device, which shows a blood flow path according to another embodiment of the present invention.

[0067] Figure 20 is a perspective view of an integrated device with a straight flow for obtaining a blood sample according to another embodiment of the present invention.

[0068] Figure 21 is of another embodiment according to the present invention Figure 20 of the device in cross-section.

[0069] Figure 22 is Figure 20 a cross-section of the device, which shows a blood flow path according to another embodiment of the present invention.

[0070] Figure 23 is a perspective view of the first step of using the integrated device disclosed herein according to one embodiment of the present invention.

[0071] Figure 24 is a perspective view of the second step of using the integrated device disclosed herein according to one embodiment of the present invention.

[0072] Figure 25 is a perspective view of the third step of using the integrated device disclosed herein according to one embodiment of the present invention.

[0073] Figure 26 is a perspective view of the fourth step of using the integrated device of the present disclosure according to an embodiment of the present invention.

[0074] Figure 27 is a perspective view of the first step of using the device with separated components of the present disclosure according to another embodiment of the present invention.

[0075] Figure 28 is a perspective view of the second step of using the device with separated components of the present disclosure according to another embodiment of the present invention.

[0076] Figure 29 is a perspective view of the third step of using the device with separated components of the present disclosure according to another embodiment of the present invention.

[0077] Figure 30 is a perspective view of the fourth step of using the device with separated components of the present disclosure according to another embodiment of the present invention.

[0078] Figure 31 is a perspective view of the fifth step of using the device with separated components of the present disclosure according to another embodiment of the present invention.

[0079] Figure 32 is an assembled perspective view of the device according to another embodiment of the present invention.

[0080] Figure 33 is Figure 32 another assembled perspective view of the device.

[0081] Figure 34a is a perspective view of the connection arrangement between the connection interface and the container joint portion according to an embodiment of the present invention.

[0082] Figure 34b is a perspective view of the connection arrangement between the connection interface and the container joint portion according to an embodiment of the present invention.

[0083] Figure 34c is a perspective view of the connection arrangement between the connection interface and the container joint portion according to an embodiment of the present invention.

[0084] Figure 34d is a perspective view of the connection arrangement between the connection interface and the container joint portion according to an embodiment of the present invention.

[0085] Figure 35 is an assembled perspective view of the device according to an embodiment of the present invention.

[0086] Figure 36 is Figure 35 another assembled perspective view of the device.

[0087] Figure 37a is a perspective view of a connection arrangement between a connection interface and a container engagement portion according to an embodiment of the present invention.

[0088] Figure 37b is a perspective view of a connection arrangement between a connection interface and a container engagement portion according to an embodiment of the present invention.

[0089] Figure 37c is a perspective view of a connection arrangement between a connection interface and a container engagement portion according to an embodiment of the present invention.

[0090] Figure 37d is a perspective view of a connection arrangement between a connection interface and a container engagement portion according to an embodiment of the present invention.

[0091] Figure 38 is a perspective view of a device according to an embodiment of the present invention in a pre - actuated position.

[0092] Figure 39 is Figure 38 a perspective view of a device in which a lancet is inserted into a patient's finger.

[0093] Figure 40 is Figure 38 a perspective view of a device showing a collection container rotated to be connected to a holder of the device.

[0094] Figure 41 is Figure 38 a perspective view of a device showing a blood sample being collected from a patient's finger into a collection container.

[0095] Figure 42 is Figure 38 a perspective view of a device showing a collection container being removed from a holder of the device.

[0096] Figure 43 is an illustration of a tray for holding a device according to an embodiment of the present invention and a method for determining the size of the device held in the tray and its use.

[0097] In several views, corresponding reference numerals denote corresponding parts. The examples set forth herein illustrate exemplary embodiments of the present disclosure, and such examples should not be construed in any way as limiting the scope of the present disclosure. Detailed Description

[0098] The following description is provided to enable a person skilled in the art to make and use embodiments that implement the described inventive concept. However, various modifications, equivalents, variations, and alternatives will remain apparent to a person skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0099] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall relate to the orientation of the present invention in the accompanying drawings. However, it should be understood that the present invention may contemplate alternative variations and sequences of steps unless explicitly stated otherwise. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0100] The present disclosure relates to a device for obtaining a biological sample, such as a capillary blood sampling device, that meets the above needs and has the ability to puncture and squeeze a finger in a controlled manner, collect a sample, stabilize the sample, and then dispense the sample. The device also simplifies and streamlines capillary blood sampling by eliminating workflow variability typically associated with low sample quality (including hemolysis and microclots).

[0101] The present disclosure includes a self - contained and fully integrated finger - based capillary blood sampling device that has the ability to puncture, collect, and stabilize a high - volume capillary blood sample (e.g., up to or exceeding 500 microliters). The device simplifies and streamlines high - volume capillary blood sampling by eliminating workflow steps and variability typically associated with low sample quality (including hemolysis, microclots, and patient discomfort). The device includes a retractable puncturing mechanism capable of puncturing a finger and an associated blood flow path that ensures capillary blood adheres to and is transferred from the punctured finger site to a collection container. The device also includes a retainer that can be cyclically squeezed to stimulate (i.e., pump out) blood flowing out of the finger, and the device further includes an anticoagulant deposited in the flow path or collection container to stabilize the collected sample.

[0102] According to one design, the device can include separation components such as a retainer, a lancet, and a collection container. According to another design, the lancet and the collection container can be integrated into one device, and then the device is used together with the retainer. According to yet another design, the retainer, the lancet, and the collection container can be integrated into a single system. Any of these designs is contemplated to be used as a self - standing disposable device and / or in combination with an external power source for pain relief control. The capillary blood collection device can be used as a platform for a variety of capillary blood collection containers ranging from small tubes to capillary dispensers, as well as an on - board plasma separation module. This capability extends product flexibility to a variety of applications, including dispensing into point - of - care (POC) cartridges or small collection tube transfers that can be used with centrifuges or analytical instruments.

[0103] Referring to Figure 8 -10, in one exemplary embodiment, the device 10 of the present disclosure includes separation components such as a retainer 12 (as shown in Figure 1 -7B), a lancet housing or lancet 14, and a collection container 16.

[0104] Referring to Figure 11 -13, in another exemplary embodiment, the semi - integrated device 300 of the present disclosure has an angled flow and includes an integrated lancet housing and a collection container that can be connected to a separate retainer. Referring to 14 - 16, in another exemplary embodiment, the semi - integrated device 400 of the present disclosure has a straight flow and includes an integrated lancet housing and a collection container that can be connected to a separate retainer.

[0105] Referring to Figure 17 -19, in another exemplary embodiment, the integrated device 100 of the present disclosure has an angled flow and includes an integrated retainer, a lancet housing, and a collection container. Referring to Figure 20 -22, in another exemplary embodiment, the integrated device 200 of the present disclosure has a straight flow and includes an integrated retainer, a lancet housing, and a collection container.

[0106] Referring to Figure 8 -10, in one exemplary embodiment, the device 10 for obtaining a blood sample 18 includes separate components such as a retainer 12, a lancet housing or lancet 14, and a collection container 16. Figure 1 -7B shows an exemplary embodiment of the retainer or finger housing 12 of the present disclosure.

[0107] Referring to Figure 1 -7B, an exemplary embodiment of the retainer 12 of the present disclosure is shown, which is capable of receiving a sample source (such as a finger 19) for supplying a biological sample (such as a blood sample 18). The retainer 12 of the present disclosure generally includes a finger receiving portion 20, and the finger receiving portion 20 has a first opening 22 (Figure 5 ) the actuating part 24, a port 26 having a second opening 28, and a fingertip protection device 30. In one embodiment, the fingertip protection device 30 provides a stop portion for correctly aligning the finger 19 and fixing the finger 19 within the retainer 12.

[0108] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source (such as the finger 19) for supplying a biological sample (such as the blood sample 18). It can be understood that the sample source may include other parts of the body that can be assembled within the first opening 22. The port 26 is in communication with the finger receiving portion 20. For example, in the case where the finger 19 is received within the retainer 12, the port 26 is in communication with a portion of the finger 19. The retainer 12 of the present disclosure can be sized to accommodate all finger sizes.

[0109] The second opening 28 of the port 26 is configured to receive the lancet housing 14 and the collection container 16, as described in more detail below. In one embodiment, the port 26 includes a locking portion 32 for firmly receiving the lancet housing 14 and the collection container 16 within the port 26.

[0110] In one embodiment, the actuating part 24 can be switched between a first position where the retainer 12 defines a first diameter ( Figure 2 ) and a second position where the retainer 12 defines a second diameter ( Figure 3 ), wherein the second diameter is smaller than the first diameter. In one embodiment, the actuating part 24 can be switched between a first position where the retainer 12 defines a first elliptical shape ( Figure 2 ) and a second position where the retainer 12 defines a second elliptical shape ( Figure 3 ), wherein the first elliptical shape is different from the second elliptical shape. In this way, when the retainer 12 is in the second position with a reduced diameter, a portion of the retainer 12 contacts the sample source and the actuating part 24 of the retainer 12 can pump and / or draw blood 18, as described in more detail below.

[0111] Referring to Figure 2 and Figure 3 , in one embodiment, the actuating part 24 includes a contact member 34. Referring to Figure 2 , when the actuating part 24 is in the first position, the contact member 34 is in a disengaged position, that is: the contact member 34 is disposed in a first position relative to the sample source (such as the finger 19) such that the contact member 34 can be in slight contact therewith. Referring to Figure 3, when the actuating portion 24 is in the second position, the contact member 34 is in the engaged position, that is: the contact member 34 is arranged in the second position relative to the sample source (such as finger 19), so that the contact member 34 contacts the finger 19 with an applied pressure, and the actuating portion 24 of the retainer 12 can pump and / or draw blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure on the sample source.

[0112] Referring to Figure 2 and Figure 3 , in one embodiment, the actuating portion 24 includes a pumping member 36 for applying pressure to the sample source (such as finger 19). In one embodiment, the pumping member 36 includes a pair of opposing tabs or wings 38. In such an embodiment, each tab 38 may include the contact member 34. Referring to Figure 1 -3, in one embodiment, the retainer 12 includes a movable hinge portion 42. The movable hinge portion 42 allows the user to squeeze the wings 38 between a first position ( Figure 2 ) and a second position ( Figure 3 ).

[0113] Advantageously, the retainer 12 of the present disclosure allows the user to repeatedly squeeze and release the wings 38 to pump and / or draw blood 18 from the finger 19 until a desired amount of blood 18 is filled in the collection container 16.

[0114] Advantageously, when the retainer 12 is placed on the finger 19, the retainer 12 does not restrict blood flow and defines the puncture and finger squeezing positions. Squeezing the tabs or wings 38 provides a predefined range of squeezing pressure, which is uniformly applied over the entire finger 19. By doing so, the retainer 12 provides a gentle and controlled finger massage, so as to stimulate blood extraction and minimize any potential hemolysis.

[0115] Referring to Figure 5 , in one embodiment, the retainer 12 includes a stability extension portion 40. This provides additional support for the retainer 12 to be firmly placed on the finger 19. In one embodiment, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of internal gripping members for providing additional gripping and support for the retainer 12 to firmly place the retainer 12 on the finger 19.

[0116] In one embodiment, the finger receiving portion 20 is formed of a flexible material. In some embodiments, the finger receiving portion 20 and the port 26 are formed of a flexible material.

[0117] Figure 4A -7B shows other exemplary embodiments of the retainer 12 of the present disclosure. Referring to Figure 4A-4B, the retainer 12 includes a leaf spring 44. Refer to Figure 6A -6B, the retainer 12 includes a double leaf spring 46. Refer to Figure 7A -7B, the retainer 12 includes a triple leaf spring 48.

[0118] The device 10 for obtaining a blood sample 18 of the present disclosure includes a lancet housing or lancet 14, and the lancet housing or lancet 14 can be removably connected to the port 26 of the retainer 12. Refer to Figure 8 、 9 and 13, in one embodiment, the lancet housing 14 includes an inlet or opening 50, an interior 52, a piercing element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the piercing element 54 can move between a pre-actuated position where the piercing element 54 is held within the interior 52 of the lancet housing 14 and a piercing position where at least a portion of the piercing element 54 extends through the inlet 50 of the lancet housing 14 to pierce a portion of the finger 19.

[0119] In one embodiment, the lancet 14 of the present disclosure is a contact-activated lancet and can be constructed according to the features disclosed in U.S. Patent Application Publication No. 2006 / 0052809, titled "Contact Activated Lancet Deivce" and commonly assigned with this application, filed on May 6, 2005, the entire disclosure of which is hereby expressly incorporated herein by reference.

[0120] Refer to Figure 8 -10, in one embodiment, the lancet housing 14 can be a separate component separate from the retainer 12 and the collection container 16. Refer to Figure 11 -16, in some embodiments, the collection container 16 and the lancet housing 14 form a single component that is removably connected to the port 26 of the retainer 12. Refer to Figure 17 -22, in some embodiments, the collection container 16, the lancet housing 14, and the retainer 12 form a single component.

[0121] Refer to Figure 8 -10, in one embodiment, in the case where the retainer 12 and the lancet housing 14 are separate components, the lancet housing 14 can be removably connected to the port 26 of the retainer 12. In such an embodiment, the lancet housing 14 includes an engagement portion 56. Refer to Figure 9, in one embodiment, the lancet housing 14 is pushed into the port 26 of the retainer 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the retainer 12. In this manner, the lancet housing 14 is securely attached and locked to the retainer 12 such that the piercing element 54 of the lancet housing 14 can be activated to pierce or puncture a sample source, such as a finger 19. In some embodiments, the port 26 of the retainer 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 within the port 26.

[0122] To activate the lancet 14, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the lancet 14 to pierce the finger 19. The lancet 14 of the present disclosure consistently provides the correct lancet depth and a predetermined lancet location, thereby ensuring an adequate sample volume.

[0123] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the piercing element 54 toward the piercing position. After piercing, the piercing element 54 immediately retracts and is securely fixed within the interior 52 of the lancet housing 14.

[0124] Referring Figure 8 -10, in one embodiment, the lancet 14 of the present disclosure is used to pierce the skin of a finger 19 and then squeeze a blood sample 18 into a collection container 16, as described in more detail below.

[0125] Referring Figure 19 , in one embodiment, the lancet housing 14 of the present disclosure is used to pierce the skin of a finger 19 along a piercing path, and then the blood sample 18 flows downward at an angle along a blood flow path to the piercing path, as described in more detail below.

[0126] Referring Figure 21 and 22 , in one embodiment, the lancet 14 includes a hollow needle 62. In such an embodiment, the lancet housing 14 of the present disclosure is used to pierce the skin of a finger 19 along a lancet path, and then the blood sample 18 flows through the hollow needle 62 along a parallel blood flow path, as described in detail below.

[0127] The device 10 for obtaining a blood sample 18 according to the present disclosure includes a collection container 16 that can be removably connected to a port 26 of a holder 12. The collection container 16 defines a collection chamber 70 for receiving the blood sample 18, a container engagement portion 72, a blood collection portion 74, and a cap or septum 76. Once the desired amount of blood 18 is collected within the container 16, the blood collection portion 74 is separated from the collection device 10 to send the collected sample 18 to a diagnostic instrument and / or a testing device. Once removed from the collection device 10, the blood collection portion 74 is sealed via the cap or septum 76 to protectively seal the blood sample 18 within the collection chamber 70.

[0128] Referring Figure 8 -10, in one embodiment, the collection container 16 can be a separate component from the holder 12 and the lancet housing 14. Referring Figure 11 -16, in some embodiments, the collection container 16 and the lancet housing 14 form a single component that can be removably connected to the port 26 of the holder 12. Referring Figure 17 -22, in some embodiments, the collection container 16, the lancet housing 14, and the holder 12 form a single component.

[0129] Referring Figure 8 -10, in one embodiment, where the holder 12 and the collection container 16 are separate components, the container 16 can be removably connected to the port 26 of the holder 12. In such an embodiment, the container 16 includes a container engagement portion 72. Referring Figure 10 , in one embodiment, the container 16 is pushed into the port 26 of the holder 12 such that the container engagement portion 72 of the container 16 is locked within the locking portion 32 of the holder 12. In this way, the container 16 is firmly connected and locked to the holder 12 such that the blood sample 18 can safely flow from the finger 19 within the holder 12 into the collection chamber 70 of the container 16.

[0130] It can be understood that various types of collection containers 16 can be used with the device 10 of the present disclosure. It can also be understood that the collection container 16 can be associated with a separate dispensing unit, or the collection container 16 can include an integrated dispensing portion for dispensing the blood 18 into a testing device.

[0131] Referring Figure 8 -10 and 27-31, the use of the device 10 of the present disclosure having separate components (e.g., the holder 12, the lancet housing or lancet 14, and the collection container 16) will now be described.

[0132] Referring Figure 27, first, clean the desired finger 19 and select a retainer 12 of a suitable size that fits the desired finger 19 and place it firmly on the finger 19. Next, referring to Figure 28 , the lancet housing 14 is connected to the port 26 of the retainer 12. As described above, the lancet housing 14 is pushed into the port 26 of the retainer 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the retainer 12. In this way, the lancet housing 14 is firmly connected and locked to the retainer 12 such that the piercing element 54 of the lancet housing 14 ( Figure 13 ) can be activated to pierce or puncture a sample source, such as the finger 19. When the lancet 14 is connected to the port 26 of the retainer 12, the lancet communicates with the finger 19.

[0133] Referring to Figure 28 , when it is necessary to activate the lancet 14 to pierce the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the lancet 14 ( Figure 13 ) to pierce the finger 19. The lancet 14 of the present disclosure consistently provides the correct piercing depth and a predetermined piercing location, thus ensuring an adequate sample volume.

[0134] After piercing the finger 19 to produce blood 18 flowing out from the finger 19 ( Figure 30 ), the lancet 14 is removed from the retainer 12 and the collection container 16 is pushed into the port 26 of the retainer 12. Referring to Figure 29 , the container 16 is pushed into the port 26 of the retainer 12 such that the container engagement portion 72 of the container 16 is locked within the locking portion 32 of the retainer 12. In this way, the container 16 is firmly fixedly connected and locked to the retainer 12 such that the blood sample 18 can flow safely from the finger 19 within the retainer 12 to the collection chamber 70 of the container 16.

[0135] Referring to Figure 29 and Figure 30 , in the case where the container 16 is correctly fixed to the retainer 12 to collect the blood sample 18, the user can repeatedly squeeze and release the wings 38 of the retainer 12 to pump and / or draw blood 18 from the finger 19 until the desired amount of blood 18 is filled into the collection container 16. Advantageously, with the retainer 12 placed on the finger 19, the retainer 12 does not restrict blood flow and defines the piercing and finger squeezing locations. The squeeze tabs or wings 38 provide a predetermined range of squeezing pressure that is uniformly applied across the entire finger 19. By doing so, the retainer 12 provides a gentle and controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[0136] For example, referring to Figure 2 and Figure 3, in one embodiment, the actuation portion 24 includes a contact member 34. Refer to Figure 2 , when the actuation portion 24 is in the first position, the contact member 34 is in the disengaged position, that is: the contact member 34 is in the first position relative to the sample source (such as finger 19). Refer to Figure 3 , when the actuation portion 24 is in the second position, the contact member 34 is in the engaged position, that is: the contact member 34 is in the second position and is in contact with the sample source (such as finger 19) with an applied pressure, and the actuation portion 24 of the retainer 12 can pump and / or draw blood 18. For example, when the contact member 34 is in the engaged position, the contact member 34 applies pressure on the sample source.

[0137] Refer to Figure 31 , once the required amount of blood 18 is collected in the container 16, the blood collection portion 74 is separated from the collection device 10 in order to send the collected sample 18 to a diagnostic instrument and / or a testing device. Once the blood collection portion 74 is removed from the collection device 10, it is sealed via a cap or diaphragm 76 to protectively seal the blood sample 18 in the collection chamber 70.

[0138] The device of the present disclosure is compatible with any known testing device, whether the testing device is a non-site or a point-of-care testing device. Various point-of-care testing devices are known in the art. Such point-of-care testing devices include test strips, slides, diagnostic cartridges, or other detection devices for detection and analysis. Test strips, slides, and diagnostic cartridges are point-of-care testing devices that can receive a blood sample and test one or more physiological and biochemical states of the blood. There are many point-of-care devices that use a cartridge-based architecture to analyze a very small amount of blood at the bedside without sending the sample to a laboratory for analysis. In the long run, this saves time in obtaining results, but presents a series of different challenges compared to a highly routine laboratory environment. Examples of such test cartridges include those from the Abbot Group test cartridges. Test cartridges (such as cartridges) can be used to test various conditions, including the presence of chemicals and electrolytes, hematology, blood gas concentration, coagulation, or cardiac markers. Test results using such cartridges can be quickly provided to clinicians.

[0139] The collection container 16 may also contain a sample stabilizer (such as an anticoagulant) to stabilize the blood sample and / or the components of the blood sample set therein. The collection container 16 may also include at least one fill line corresponding to a predetermined amount of the sample. The collection container may also indicate / measure the amount of blood collected.

[0140] Refer to Figure 17-19, in another exemplary embodiment, the device 100 for obtaining a blood sample 18 of the present disclosure has an angled flow and includes an integrated holder 12, a lancet housing 14, and a collection container 16. In such an embodiment, the user does not have to connect a separate lancet housing 14 to the port 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12.

[0141] Referring to Figure 17 -19, the lancet housing 14 is permanently fixed within the port 26 of the holder 12. The lancet housing 14 includes a blood flow channel 120. The collection container 16 is fixed to the lancet housing 14 and includes a blood collection portion 74 that is removably connectable to a portion of the lancet housing 14.

[0142] Referring to Figure 19 , in one embodiment, with the container 16 connected to the lancet housing 14, the longitudinal axis 102 of the lancet housing 14 is angled with respect to the longitudinal axis 104 of the container 16. See Figure 19 , in one embodiment, the lancet housing 14 is configured to pierce the skin of the finger 19 along a piercing path 103, and then the blood sample 18 flows downward at an angle with respect to the piercing path 103 through a blood flow path 105.

[0143] Referring to Figure 17 -19, in one embodiment, the device 100 includes a capillary 110. Referring to Figure 19 , with the container 16 (i.e., the blood collection portion 74) connected to the lancet housing 14, the capillary 110 is in fluid communication with the inlet or opening 50 of the lancet housing 14 and the collection chamber 70 of the container 16. In one embodiment, a portion of the capillary 110 extends through the blood flow channel 120 of the lancet housing 14.

[0144] Refer to Figure 17 -19, the blood flow path 105 of the device 100 will now be described. With the finger 19 received within the holder 12 and the piercing element 54 in the piercing position, the piercing element 54 pierces the finger 19 to draw a blood sample 18. For example, when it is necessary to activate the lancet 14 to pierce the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the lancet 14 to pierce the finger 19. The lancet 14 of the present disclosure consistently provides the correct piercing depth and a predetermined piercing position, thereby ensuring an adequate sample volume.

[0145] Blood 18 will flow from finger 19 into the blood flow channel 120 of the lancet housing 14. The blood 18 flows at an angle with respect to the lancet path 103 via the blood flow path 105. For example, the blood sample 18 flows through the capillary 110 into the collection chamber 70 of the container 16.

[0146] See Figure 20 -22, in another exemplary embodiment, the device 200 for obtaining a blood sample 18 of the present disclosure has a straight flow and includes an integrated holder 12, a lancet housing 14, and a collection container 16. In such an embodiment, the user does not have to connect a separate lancet housing 14 to the port 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12.

[0147] Refer to Figure 20 -22, the lancet housing 14 is permanently fixed within the port 26 of the holder 12. The lancet housing 14 includes a hollow needle 62. For example, the piercing element 54 of the lancet 14 includes a hollow needle 62. The collection container 16 is fixed to the lancet housing 14 and includes a blood collection portion 74 that can be removably connected to a portion of the lancet housing 14.

[0148] Refer to Figure 21 , in one embodiment, when the container 16 is connected to the lancet housing 14, the longitudinal axis 202 of the port 26, the lancet housing 14, and the container 16 are aligned.

[0149] Refer to Figure 21 and Figure 22 , in one embodiment, the lancet 14 includes a hollow needle 62. In such an embodiment, the lancet housing 14 of the present disclosure is used to pierce the skin of the finger 19 along the piercing path 203, and then the blood sample 18 flows through the hollow needle 62 along a parallel blood flow path 205.

[0150] Refer to Figure 20 -22, in one embodiment, the lancet housing 14 includes an outlet 210. When the container 16 is connected to the lancet housing 14, the outlet 210 of the lancet housing 14 is in fluid communication with the collection chamber 70 of the container 16.

[0151] Refer to Figure 20-22, the blood flow path 205 of the device 200 will now be described. When the finger 19 is received within the retainer 12 and the piercing element 54 is in the piercing position, the piercing element 54 pierces the finger 19 to withdraw a blood sample 18. For example, when it is desired to activate the lancet 14 to pierce the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 of the lancet 14 to pierce the finger 19. The lancet 14 of the present disclosure consistently provides the correct piercing depth and a predetermined piercing location, thereby ensuring an adequate sample volume.

[0152] The blood 18 will flow from the finger 19 through the hollow needle 62 to the outlet 210 of the lancet housing 14 to the collection chamber 70 of the container 16. The blood 18 flows in a straight line via the blood flow path 205 in line with the piercing path 203.

[0153] Refer to Figure 23 -26, the use of the device 200 of the present disclosure having a straight flow and including an integrated retainer 12, lancet housing 14, and collection container 16 will now be described.

[0154] Refer to Figure 23 , first, the desired finger 19 is cleaned and a retainer 12 having a suitable size for the desired finger 19 is selected and firmly placed on the finger 19. In the integrated device 200 of the present disclosure, there is no need to select a separate lancet 14 and container 16 and connect them to the port 26 of the retainer 12, since each of the retainer 12, lancet housing 14, and collection container 16 is integrated into a single component.

[0155] Refer to Figure 24 , when it is desired to activate the lancet 14 to pierce the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 ( Figure 21 ) of the lancet 14 to pierce the finger 19. The lancet 14 of the present disclosure consistently provides the correct piercing depth and a predetermined lancet position, thereby ensuring an adequate sample volume.

[0156] Refer to Figure 25 , after the finger 19 is pierced to create a blood flow of blood 18 from the finger 19, the user can repeatedly squeeze and release the wings 38 of the retainer 12 to pump out and / or withdraw the blood 18 from the finger 19 until the desired amount of blood 18 is filled in the collection container 16. Advantageously, with the retainer 12 placed on the finger 19, the retainer 12 does not restrict blood flow and defines the piercing and finger squeezing positions. The squeeze tabs or wings 38 provide a predefined range of squeezing pressure that is uniformly applied across the entire finger 19. By doing so, the retainer 12 provides a gentle and controlled finger 19 massage, which stimulates the withdrawal of blood 18 and minimizes any potential hemolysis.

[0157] Reference Figure 26 Once the required amount of blood 18 has been collected within the container 16, the blood collection device portion 74 is separated from the collection device 200 and sealed with a cap or diaphragm 76 to send the collected sample 18 to a diagnostic instrument and / or testing equipment. As described above, the collection container 16 may also contain a sample stabilizer (such as an anticoagulant) to stabilize the blood and a fill line to indicate / measure the amount of blood 18 collected.

[0158] Reference Figure 11 -16, the usage of device 300 ( Figure 11-13 ) and device 400 ( Figure 14 -16) will now be described. The device 300 has an angled flow and includes an integrated lancet housing 14 and a collection container 302, which can be connected to a separate holder 12; the device 400 has a straight flow and includes an integrated lancet housing 14 and a collection container 402, which can be connected to a separate holder 12.

[0159] Reference Figure 11 -13, the semi-integrated device 300 is used in a manner similar to that of device 100 with the angled flow and including an integrated holder, lancet housing, and collection container described above with reference to Figures 17 to 19 . By using the semi-integrated device 300, the user does not have to connect a separate lancet housing 14 to the port 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12. In the Figure 11 -13 shown embodiment, the user only needs to connect the integrated lancet housing and collection container component 302 to the port 26 of the holder 12.

[0160] Reference Figure 14 -16, the semi-integrated device 400 is used in a manner similar to that of device 200 with the straight flow and including an integrated holder, lancet housing, and collection container described above with reference to Figure 20 -22. In the case of using the semi-integrated device 400, the user does not have to connect a separate lancet housing 14 to the port 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12. In the Figure 14 -16 shown embodiment, the user only needs to connect the integrated lancet housing and collection container component 402 to the port 26 of the holder 12.

[0161] Any of the devices for obtaining a blood sample of the present disclosure can be used as a self - standing disposable device and / or in combination with an external power source for pain relief control. For example, a portion of the retainer 12 can include embedded electrodes that receive signals from an external pain control module to deliver at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain relief control. The devices for obtaining a blood sample of the present disclosure can also include various options for on - board plasma separation. The devices for obtaining a blood sample of the present disclosure can also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for obtaining a blood sample of the present disclosure can also include on - board diagnostic feedback at the time of collection. The devices for obtaining a blood sample of the present disclosure can also allow dual collection, for example, using multiple collection ports to collect two samples into two separate containers, the multiple collection ports enabling the collection of multiple samples from the same source and treating the samples with different sample stabilizers (such as anticoagulants).

[0162] Relative to conventional capillary collection using a lancet and a capillary tube, the devices for obtaining a blood sample of the present disclosure significantly simplify and de - skill large - volume capillary collection from a finger. The devices of the present disclosure eliminate blood exposure and prevent reuse of the device.

[0163] The devices for obtaining a blood sample of the present disclosure simplify, de - skill, and streamline the collection process. This is all achieved through a self - contained closed - system device that, after being placed on a finger, provides the functions of puncturing, blood extraction, stabilization, and containment in one unit.

[0164] The devices for obtaining a blood sample of the present disclosure can be associated with a self - standing unit that provides automatic pumping, controlled finger squeezing, and automatic sample labeling and processing.

[0165] Referring to Figure 32 -37d, an exemplary embodiment of the retainer 112 of the present disclosure is described, which is capable of receiving a sample source (such as finger 19) for supplying a biological sample (such as a blood sample). The retainer 112 of the present disclosure generally includes a finger receiving portion 120 having a first opening 122, an actuation portion 124, a port 126 having a second opening 128, and a finger tip guard 130. In one embodiment, the finger tip guard 130 provides a stop portion for properly aligning and fixing the finger 19 within the retainer 112.

[0166] The first opening 122 of the finger receiving portion 120 is configured to receive a sample source (e.g., finger 19) for supplying a biological sample (e.g., a blood sample). It is understood that the sample source may include other parts of the body that can be fitted within the first opening 122. The port 126 is in communication with the finger receiving portion 120. For example, when the finger 19 is received within the retainer 112, the port 126 is in communication with a portion of the finger 19. The retainer 112 of the present disclosure can be sized to accommodate all finger sizes.

[0167] The second opening 128 of the port 126 is configured to receive the lancet housing 14 and the collection container 116, as described in more detail below. In one embodiment, the port 126 includes a locking portion 132 for securely receiving the lancet housing 14 and the collection container 116 within the port 126.

[0168] In one embodiment, the actuating portion 124 is convertible between a first position in which the retainer 112 defines a first diameter and a second position in which the retainer 112 defines a second diameter, where the second diameter is less than the first diameter. In one embodiment, the actuating portion 124 is convertible between a first position in which the retainer 112 defines a first elliptical shape and a second position in which the retainer 112 defines a second elliptical shape, where the first elliptical shape is different from the second elliptical shape. In this way, with the retainer 112 in the second position with a reduced diameter, a portion of the retainer 112 contacts the sample source and the actuating portion 124 of the retainer 112 is capable of pumping and / or extracting blood, as described in more detail below.

[0169] In one embodiment, the actuating portion 124 includes a contact member 134. When the actuating portion 124 is in the first position, the contact member 134 is in a disengaged position, i.e., the contact member 134 is in a first position relative to the sample source (e.g., finger 19) such that the contact member 134 can be in slight contact therewith. When the actuating portion 124 is in the second position, the contact member 134 is in an engaged position, i.e., the contact member 134 is provided in a second position relative to the sample source (e.g., finger 19) such that the contact member 134 contacts the finger 19 with an applied pressure, and the actuating portion 124 of the retainer 112 is capable of pumping and / or withdrawing blood. For example, when the contact member 134 is in the engaged position, the contact member 134 applies pressure on the sample source.

[0170] In one embodiment, the actuation portion 124 includes a pumping member 136 for applying pressure to a sample source (such as finger 19). In one embodiment, the pumping member 136 includes a pair of opposing tabs or wings 138. In such an embodiment, each wing 138 may include a contact member 134. In one embodiment, the retainer 112 includes a movable hinge portion 142. The movable hinge portion 142 allows the user to squeeze the wings 138 between a first position and a second position.

[0171] Advantageously, the retainer 112 of the present disclosure allows the user to repeatedly squeeze and release the wings 138 to pump and / or draw blood from the finger 19 until a desired amount of blood is filled in the collection container 116.

[0172] Advantageously, with the retainer 112 placed on the finger 19, the retainer 112 does not restrict blood flow and defines a puncture location and a finger squeezing location. Squeezing the tabs or wings 138 provides a predefined range of squeezing pressure that is uniformly applied across the entire finger 19. By doing so, the retainer 112 provides a gentle and controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

[0173] In one embodiment, the retainer 112 includes a stability extension portion 140. This provides additional support for the retainer 112 to be firmly placed on the finger 19. In one embodiment, the finger receiving portion 120 forms a generally C-shaped member and includes a plurality of internal gripping members for providing additional grip and support for the retainer 112 to firmly place it on the finger 19.

[0174] In one embodiment, the finger receiving portion 120 is formed of a flexible material. In some embodiments, the finger receiving portion 120 and the port 126 are formed of a flexible material.

[0175] The device 350 for obtaining a blood sample of the present disclosure includes a lancet housing or lancet 114 that can be removably connected to the port 126 of the retainer 112. In one embodiment, the lancet 114 includes an inlet or opening, an interior, a piercing element, an engagement portion, a retractable mechanism, and a drive spring similar to the lancet 14 described above. In one embodiment, the piercing element is movable between a pre-actuated position where the piercing element is held inside the lancet 114 and a piercing position where at least a portion of the piercing element extends through the inlet of the lancet 114 to pierce a portion of the finger 19.

[0176] In one embodiment, the lancet 114 of the present disclosure is a contact-activated lancet and may be constructed in accordance with the features disclosed in U.S. Patent Application Publication No. 2006 / 0052809, entitled "Contact Activated Lancet Device," filed on May 6, 2005, which is commonly assigned with this application and the entire disclosure of which is hereby expressly incorporated herein by reference.

[0177] In one embodiment, the lancet 114 may be a separate component distinct from the retainer 112 and the collection container 116. In some embodiments, the collection container 116 and the lancet 114 form a single component that is removably connectable to the port 126 of the retainer 112. In some embodiments, the collection container 116, the lancet 114, and the retainer 112 form a single component.

[0178] In one embodiment, where the retainer 112 and the lancet 114 are separate components, the lancet 114 is removably connectable to the port 126 of the retainer 112. In such an embodiment, the lancet 114 includes an engagement portion. In one embodiment, the lancet 114 is pushed into the port 126 of the retainer 112 such that the engagement portion of the lancet 114 is locked within the port 126 of the retainer 112. In this manner, the lancet 114 is firmly connected and locked to the retainer 112 such that the piercing element of the lancet 114 can be activated to pierce or puncture a sample source (e.g., finger 19). In some embodiments, the port 126 of the retainer 112 includes a plurality of ribs for securing and locking the lancet 114 or the collection container 116 within the port 126.

[0179] To activate the lancet 114, the lancet 114 is pushed against the finger 19 to activate the retractable mechanism of the lancet 114 to pierce the finger 19. The lancet 114 of the present disclosure consistently provides the correct piercing depth and a predetermined blood collection location, thereby ensuring an adequate sample volume.

[0180] In one embodiment, the lancet 114 includes a drive spring disposed within the lancet 114 for biasing the piercing element towards the piercing position. After piercing, the piercing element immediately retracts and is safely secured within the lancet 114.

[0181] In one embodiment, the lancet 114 of the present disclosure is used to pierce the skin of the finger 19 and then, as described in more detail below, squeeze the blood sample into the collection container 116.

[0182] In one embodiment, the lancet 114 of the present disclosure is used to pierce the skin of the finger 19 along a piercing path, and then the blood sample flows downward at an angle to the piercing path through a blood flow path, as described in more detail below.

[0183] In one embodiment, the lancet 114 includes a hollow needle. In such an embodiment, the lancet 114 of the present disclosure is configured to pierce the skin of the finger 19 along a piercing path, and then a blood sample flows through the hollow needle along a parallel blood flow path, as described in more detail below.

[0184] The device 350 for obtaining a blood sample according to the present disclosure includes a collection container 116 that can be removably connected to a port 126 of the holder 112. The collection container 116 defines a collection chamber 170 for receiving the blood sample, a blood collection part 174, and a cap or diaphragm 176. Once the required amount of blood has been collected in the container 116, the blood collection part 174 is removed from the collection device 350 in order to send the collected sample to a diagnostic instrument and / or testing device. The blood collection part 174 is sealed via the cap or diaphragm 176 after being removed from the device 350 to protectively seal the blood sample in the collection chamber 170.

[0185] In one embodiment, in the case where the holder 112 and the collection container 116 are separate components, a container engagement portion 182 for holding the collection container 116 can be removably or fixedly connected to a connection interface 180 of the holder 112. The container engagement portion 182 can define an opening to receive and hold the collection container 116. The collection container 116 can be held in the container engagement portion 182 by any suitable means (including a friction fit, a mechanical fit, or any alternative removable connection) to allow the collection container 116 to be separated from the container engagement portion 182 after a blood sample has been collected in the collection chamber 170. The container engagement portion 182 can also include a container locking portion 172 configured to engage with the port 126 of the holder 112 to lock the container engagement portion 182 within the port 126. Refer to Figure 32, in one embodiment, the container engagement portion 182 includes a protrusion 184 that is pushed or guided into the connection interface 180 of the retainer 112 such that the container engagement portion 182 of the container 116 is locked within the connection interface 180 of the retainer 112. In this manner, the container 116 is firmly connected and locked to the retainer 112 such that a blood sample can flow safely from the finger 19 within the retainer 112 to the collection chamber 170 of the container 116. The connection interface 180 and the container engagement portion 182 can be connected prior to puncturing or at the manufacturing location. This pre-attached pivot mechanism provides a quick and connected connection of the collection container 116 to the retainer 112. Due to the connection between the connection interface 180 of the retainer 112 and the container engagement portion 182, the container engagement portion 182 is capable of rotating relative to the retainer 112. Thus, with the collection container 116 held within the container engagement portion 182, the collection container 116 can rotate between a first position where the collection container 116 is positioned away from the port 126 on the retainer 112 and a second position where the collection container 116 is positioned in line with the port 126 of the retainer 112 to collect a blood sample from the patient's finger 19.

[0186] Reference Figure 34a -34d illustrates and describes an alternative connection arrangement between the connection interface 180 and the protrusion 184. As Figure 34a shown, the connection interface 180 and the protrusion 184 can include a ball and socket joint connection. It is contemplated that the connection interface 180 or the protrusion 184 can include a ball and the other of the connection interface 180 and the protrusion 184 can include a socket to receive the ball. As Figure 34b shown, the connection interface 180 and the protrusion 184 can include a stud and hole pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 can include a stud and the other of the connection interface 180 and the protrusion 184 can include a hole or socket to receive the stud. Reference Figure 34c , the connection interface 180 and the protrusion 184 can include a pin and C-clip pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 can include a pin and the other of the connection interface 180 and the protrusion 184 can include a C-clip to receive the pin. Reference Figure 34d , the connection interface 180 and the protrusion 184 can include a pin and socket pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 can include a pin and the other of the connection interface 180 and the protrusion 184 can include a socket to receive the pin. It is further contemplated herein that other alternative connection arrangements between the connection interface 180 and the protrusion 184 can also be employed in the present invention. The previously described connections are non-limiting.

[0187] Reference Figure 35 and36 In one embodiment, the connection interface 180 of the retainer 112 may include a living hinge 186 and a connection tab 188 that can be received in an aperture 190 defined in a container engagement portion 182. In this way, the container 116 is securely connected and locked to the retainer 112 such that a blood sample can safely flow from a finger 19 within the retainer 112 into a collection chamber 170 of the collection container 116. The connection interface 180 and the container engagement portion 182 may be connected prior to piercing or at the manufacturing site. This pre-attached pivot mechanism provides a quick and connected connection of the collection container 116 to the retainer 112. Due to the living hinge 186 provided in the connection interface 180 of the retainer 112, the container engagement portion 182 is rotatably movable relative to the retainer 112. Thus, with the collection container 116 held in the container engagement portion 182, the collection container 116 is rotatably movable between a first position where the collection container 116 is positioned away from a port 126 on the retainer 112 and a second position where the collection container 116 is positioned in alignment with the port 126 of the retainer 112 to collect a blood sample from a patient's finger 19.

[0188] Referring to Figure 37a -37d, alternative connection arrangements between the connection tab 188 and the aperture 190 are illustrated and described. As Figure 37a shown, the connection tab 188 and the aperture 190 may include a snap-fit connection. It is contemplated that the connection tab 188 may be keyed to be received within the aperture 190, which has a shape corresponding to the key of the connection tab 188. The connection tab 188 may snap-fit into the aperture 190. As Figure 37b shown, the connection tab 188 and the aperture 190 may include a hook and snap connection. It is contemplated that the connection tab 188 may be a hook element that is rotatably received within the aperture 190. The connection tab 188 may snap-fit into the aperture 190. A first end of the hook element of the connection tab 188 may snap into the aperture 190, and then a second end of the hook element of the connection tab 188 may be rotated in the opposite direction to snap into an opposite end of the aperture 190. As Figure 37c shown, the connection tab 188 and the aperture 190 may include a C-clamp and snap connection. It is contemplated that the connection tab 188 may be a C-clamp that is received within the aperture 190 by snap-fit. The C-clamp of the protruding tab 188 may include an inner extension 192 that snap-fits into a corresponding hole 194 defined in the aperture 190. As Figure 37dAs shown, the connection tab 188 and the orifice 190 may include a stud and a profile engagement connection. It is contemplated that the connection tab 188 may be a stud that is to be received within the orifice 190, which has a profile corresponding to the stud. The connection tab 188 may snap-fit into the orifice 190. It is further contemplated herein that other alternative connection arrangements between the connection tab 188 and the orifice 190 may also be employed in the present invention. The previously described connection is non-limiting.

[0189] Referring Figure 32 , in one embodiment, the container 116 is pushed into the port 126 of the retainer 112 such that the container locking portion 172 of the container engagement portion 182 is locked within the locking portion 132 of the retainer 112. In this manner, the collection container 116 is securely attached and locked to the retainer 112 such that a blood sample can flow safely from the finger 19 within the retainer 112 to the collection chamber 170 of the collection container 116.

[0190] Referring Figure 38 -42, the use of the device 350 of the present disclosure will now be described, which has a linear flow and includes a retainer 112, a lancet 114, and a collection container 116.

[0191] Referring Figure 38 , first, the desired finger 19 is cleaned and a retainer 112 of a suitable size for the desired finger 19 is selected and firmly placed on the finger 19.

[0192] Referring Figure 39 , when it is desired to activate the lancet 114 to pierce the skin of the finger 19, the lancet 114 is pushed against the finger 19 to activate the retractable mechanism of the lancet 114 to pierce the finger 19. The lancet 114 of the present disclosure consistently provides the correct piercing depth and a predetermined piercing location, thereby ensuring an adequate sample volume.

[0193] Referring Figure 40 , after piercing the finger 19 to produce a blood flow from the finger 19, the user may rotate the collection container 116 to a second position to lock it into the retainer 112. Referring Figure 41, once the container engagement portion 182 has been locked to the retainer 112, the user can repeatedly squeeze and release the wings 138 of the retainer 112 to pump and / or draw blood from the finger 19 until the desired amount of blood is filled in the collection container 116. Advantageously, with the retainer 112 placed on the finger 19, the retainer 112 does not restrict blood flow and defines the puncture location and the finger squeezing location. The squeeze tabs or wings 138 provide a predefined range of squeezing pressure that is uniformly applied across the entire finger 19. By doing so, the retainer 112 provides a gentle and controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[0194] Reference Figure 42 , once the desired amount of blood has been collected within the container 116, the collection container 116 is removed from the container engagement portion 182 and sealed with a cap or diaphragm 176 to send the collected sample to a diagnostic instrument and / or testing device. As described above, the collection container 116 may also contain a sample stabilizer (such as an anticoagulant) to stabilize the blood and a fill line to indicate / measure the amount of blood collected. In the case where additional blood is to be collected from the patient, a second collection container 116 can be attached to the container engagement portion 182, and the retainer 112 can be used again to pump blood into the second collection container 16.

[0195] Reference Figure 43 , a tray 400 for holding a plurality of different retainers 112 is described, the plurality of different retainers 112 being adjustable in size and usable on a patient's finger 19. The tray 400 may also include separate sections 402a - 402i that hold separate components that can assist the user in collecting a patient's blood sample in the collection container 116 using the retainer 112. Each section 402a - 401i may include a label that indicates which step of the process each section 402a - 402i corresponds to, to indicate to the user the specific step in the process to which each section 402a - 402i is applied. The tray 400 can hold all the necessary components for the user to draw a blood sample from the patient's finger 19. The tray 400 is designed to guide the user to perform the workflow in the correct order in a timely manner. In the first section 402a labeled "Step 1", a finger measurement card 404 is held in a slot defined in the tray 400. The finger measurement card 404 may include a plurality of different apertures having different diameters corresponding to different sizes of the retainer 112. To ensure that the appropriate retainer 112 is used on the patient, the patient inserts his / her finger 19 into the different apertures of the finger measurement card 404 to determine the specific retainer 112 corresponding to the patient's finger 19.

[0196] In a second section 402b labeled "Step 2", instructions are provided to indicate to the user that the patient's hand / finger should be heated. In a third section 402c labeled "Step 3", a slot is defined to accommodate a plurality of disinfection wipes 406. The user can use the disinfection wipes 406 to disinfect the puncture site on the patient's finger 19. In a fourth section 402d labeled "Step 4", a plurality of orifices 408 are defined in section 402c of the tray 400 to hold retainers 112 of different sizes. Based on the measurement of the patient's finger 19 using the finger measurement card 404, the user will select a suitable retainer 112 that fits the patient's finger 19. After identifying the suitable retainer 112, the user inserts the patient's finger 19 into the retainer 112 as described above.

[0197] In a fifth section 402e labeled "Step 5", an orifice 410 is defined in the tray 400 to hold the lancet 114. The user can remove the lancet 114 from the tray and use the lancet 114 to puncture the patient's finger 19 as described above. In a sixth section 402f labeled "Step 6", an orifice 412 is defined in the tray 400 to hold the collection container 116. The collection container 116 can be removed from the tray 400 and attached to the container engagement portion 182 connected to the retainer 112 to collect a blood sample from the patient's finger 19 as described above.

[0198] In a seventh section 402g labeled "Step 7", instructions are provided to pump the patient's finger 19 using the retainer 112. In an eighth section 402h labeled "Step 8", an orifice 414 is defined in the tray 400 to hold the collection container 116 after a blood sample has been drawn from the patient's finger 19. In a ninth section 402i labeled "Step 9", an orifice 416 is defined in the tray 400 to hold the bandage 418, which can be applied to the patient's finger 19 after the retainer 112 has been removed from it.

[0199] Although the present disclosure has been described as having an exemplary design, the present disclosure can be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present disclosure using its general principles. Additionally, this application is intended to cover departures from the present disclosure that are within the known or customary practice in the field to which the present disclosure pertains and fall within the limits of the appended claims.

Claims

1. An apparatus for obtaining a blood sample, the apparatus comprising: a holder for receiving a sample source, the holder having an extension portion, a receiving portion, and a port; a container engaging portion connected to the holder; and a collection container that is removably connectable to the container engaging portion, the collection container defining a collection chamber, wherein the extension portion is separated from the container engaging portion by the holder, and the container engaging portion allows the collection container to rotate between a first position in which the collection container is spaced apart from the port and a second position in which the collection container is in fluid communication with the port.

2. The apparatus according to claim 1, wherein the receiving portion is convertible between a first position in which the holder defines a first ellipse and a second position in which the holder defines a second ellipse, wherein the second ellipse is different from the first ellipse.

3. The apparatus according to claim 1, wherein the receiving portion forms a C-shaped member and includes a plurality of internal gripping members.

4. The apparatus according to claim 3, wherein the receiving portion is convertible between a first position in which the C-shaped member is in a disengaged position and a second position in which the C-shaped member is in an engaged position.

5. The apparatus according to claim 4, wherein when the C-shaped member is in the engaged position, the C-shaped member exerts pressure on the sample source.

6. The apparatus according to any one of claims 1 to 5, wherein the receiving portion includes a pumping member for applying pressure to the sample source.

7. The apparatus according to claim 6, wherein the pumping member includes a pair of opposing tabs having gripping portions.

8. The apparatus according to claim 1, wherein the sample source is a finger, and a fingertip protection device provides a stop portion for correctly aligning the finger and fixing the finger within the holder.

9. The apparatus according to claim 8, wherein when the finger is received within the holder, the port is in communication with a portion of the finger.

10. The apparatus according to claim 8, wherein the finger receiving portion and the port are formed of a flexible material.

11. The apparatus according to claim 1, wherein the holder includes a movable hinge that is connectable to the container engaging portion.

12. The apparatus according to claim 1, wherein the container engaging portion is configured to hold a lancet housing.

13. An apparatus for obtaining a blood sample, the apparatus comprising: a holder for receiving a sample source, the holder having an actuating portion and a port; and a container engaging portion connected to the holder and configured to hold a lancet housing and a collection container; wherein the container engaging portion allows the collection container to rotate between a first position in which the collection container is spaced apart from the port and a second position in which both the lancet housing and the collection container are in fluid communication with the port.

14. The apparatus according to claim 13, Wherein, the lancet housing includes an opening, an interior, a piercing element, a engagement portion, a retractable mechanism, and a drive spring, wherein the piercing element is movable between a holding position and a piercing position.

15. The device according to claim 14, wherein, the piercing element extends through the opening of the lancet housing.

16. The device according to claim 13, wherein, the lancet housing is pushed into the port of the retainer such that the engagement portion of the lancet housing is locked within the locking portion of the retainer.

17. The device according to claim 14, wherein, the piercing element is a hollow needle configured to receive a sample.

18. The device according to claim 13, wherein, the lancet housing and the collection container are configured to be in a straight-through flow.

19. The device according to claim 13, wherein, the lancet housing and the retainer are connected via a ball and socket joint, a stud and hole pivot joint, a pin and C - clip pivot joint, or a pin and socket pivot joint.

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