Capillary collector with rotatable connection

Abstract

A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuating 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 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 fluidically connected to the port.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 62 / 805,398, filed on February 14, 2019, entitled “CAPILLARY COLLECTOR WITH ROTATABLE CONNECTION,” the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] 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 collection device that can pierce and squeeze a finger, collect, stabilize, and dispense a blood sample in a controlled manner. Background Art

[0004] Devices for obtaining and collecting biological samples (e.g., blood samples) are commonly used in the medical industry. One type of blood sampling commonly performed in the medical field is capillary blood sampling, which is commonly used to collect blood samples for testing. Certain diseases (e.g., diabetes) require regular testing of the patient's blood to monitor, for example, the patient's blood sugar level. In addition, test kits (e.g., cholesterol test kits) typically require blood samples for analysis. The blood sampling procedure generally includes pricking a finger or other suitable body part in order to obtain a blood sample. Typically, the amount of blood required for such tests is relatively small, and a small puncture wound or incision can usually provide enough blood for these tests. Various types of lancet devices have been developed for piercing the patient's skin to obtain a capillary blood sample from the patient.

[0005] 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 (e.g., a needle) or a sharp-edged member (e.g., a blade) for forming a quick puncture wound or incision on the patient's skin to provide a small amount of blood to flow out. Many people often find it physically and psychologically difficult to prick 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 may be a medical professional or the patient himself who is responsible for drawing blood from the patient. When triggered, the needle or blade punctures or cuts the patient's skin, such as the skin on a finger. Typically, a spring is incorporated into the device to provide the "automatic" force required to puncture or cut the patient's skin.

[0006] One type of contact-activated lancet device is U.S. Pat. No. 9,380,975, which belongs to the assignee of the present application, Becton Dickinson, and is characterized in that the puncture or cutting element automatically pops out and retracts from the device. The lancet device includes a housing and a lancet structure having a puncture element. The lancet structure is arranged in the housing and is suitable for moving between a holding or pre-actuated position in which the puncture element is held in the housing and a puncture position in which the puncture element extends through the front end of the housing. The lancet device includes a drive spring arranged in the housing for biasing the lancet structure toward the puncture position, and a retaining seat that resists the bias of the drive spring to retain the lancet structure in the retracted position. The retaining seat includes a pivot rod that interferes with the lancet structure. An actuator in the housing pivots the rod, thereby moving the lancet structure toward the rear end of the housing to at least partially compress the drive spring and release the rod from the interference engagement with the lancet structure. The received blood sample is then collected and / or tested. The test can be done via a point-of-care (POC) testing device, or it can be collected and sent to a testing facility.

[0007] Currently, the capillary blood collection workflow is a complex, multi-step process that requires a high level of skill. The multi-step nature of the process introduces several variables that can lead to sample quality issues, such as hemolysis, insufficient sample stability, and microclotting. Using a lancet device to obtain a blood sample results in several variables that affect the collection of a capillary blood sample, including but not limited to keeping the lancet stationary during testing, obtaining adequate blood flow from the puncture site, adequately collecting blood, preventing coagulation, etc. Some of the most common sources of process variability are: (1) inadequate cleaning of the blood collection 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 technique and excessive pressure near the puncture site to facilitate blood extraction (e.g., milking), 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 the anticoagulant, which can potentially lead to microclotting.

[0008] Therefore, there is a need in the art for a device that can pierce and compress a finger, collect a sample, stabilize the sample, and subsequently dispense the sample in a controlled manner. There is also a need in the art for a device that simplifies and streamlines capillary blood collection by eliminating workflow variability that is often associated with poor sample quality, including hemolysis and microclotting. There is a further need in the art for closed system collection and transfer that eliminates blood exposure and device reuse. There is also a further need in the art for a device that: (1) introduces flexibility in adapting to different capillary collection and transfer containers; (2) has the ability to produce high quality uniformly mixed / stabilized capillary blood samples; (3) has the ability to produce onboard plasma from capillary plasma samples; (4) has the ability to collect large capillary blood samples (>50-500 μL) with reduced pain; (5) contains 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 onboard diagnostics; (7) has multiple collection ports to collect blood samples into different containers with the same or different anticoagulants. Summary of the invention

[0009] The present disclosure relates to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the above needs and has the ability to pierce and squeeze a finger, collect a sample, stabilize the sample, and then dispense the sample in a controlled manner. The device also simplifies and streamlines capillary blood collection by eliminating the workflow variability commonly associated with poor sample quality (including hemolysis and microclotting).

[0010] The present disclosure includes a self-contained and fully integrated finger-based capillary blood sampling device having the ability to puncture, collect and stabilize large-volume capillary blood samples (e.g., up to or in excess of 500 microliters). The device simplifies and streamlines large-volume capillary blood sampling by eliminating workflow steps and variability typically associated with poor sample quality, including hemolysis, microclotting, and patient discomfort. The device includes a retractable puncture mechanism capable of puncturing a finger and an associated blood flow path that ensures capillary blood adherence 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 out of the finger, and the device also includes an anticoagulant deposited in the flow path or collection container to stabilize the collected sample.

[0011] According to one design, the device can include separate components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into a device that is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are contemplated for use as a self-contained disposable device and / or in conjunction 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 (from small tubes to capillary dispensers) as well as an onboard plasma separation module. This capability extends product flexibility to a variety of applications, including distribution to point-of-care (POC) boxes or transfer of small collection tubes that can be used in centrifuges or analytical instruments.

[0012] According to one embodiment of the present invention, a device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuating portion and a port, a container coupling portion connected to the holder, and a collection container, the collection container being removably connectable to the container coupling portion, the container defining a collection chamber, wherein the container coupling 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 fluidically connected to the port.

[0013] According to another embodiment of the present invention, the actuating portion may be 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. 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 on 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 in the holder, the port may be communicated with a portion of the finger. The container engagement portion and the holder may be connected by a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint. The holder may include a living hinge that may be connected to the container engagement portion. The living hinge may be connected to the container engagement portion by a keyed snap-fit ​​device, a hook and snap-fit ​​device, a C-clip and snap-fit ​​device, or a peg and profile engagement device.

[0014] In another embodiment of the present invention, a device for obtaining a blood sample may include 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 constructed 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 fluidically connected to the port.

[0015] In another embodiment of the present invention, the actuating portion may be 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. 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 on 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 in the holder, the port may be communicated with a portion of the finger. The container engagement portion and the holder may be connected by a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint. The holder may include a living hinge that may be connected to the container engagement portion. The living hinge may be connected to the container engagement portion by a keyed snap-fit ​​device, a hook and snap-fit ​​device, a C-clip and snap-fit ​​device, or a peg and profile engagement device.

[0016] In another embodiment of the present invention, a tray for holding components for obtaining a blood sample may 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 holders; a third section for holding a lancet; and a fourth section for holding a collection container for holding a blood sample, wherein each section includes a label corresponding to a sequential step in the method for obtaining a blood sample.

[0017] This disclosure is also defined by the following terms:

[0018] Item 1: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuating portion and a port; a container coupling portion connected to the holder; a collection container, which is removably connectable to the container coupling portion, the container defining a collection chamber, wherein the container coupling portion allows the collection container to be rotated 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 fluidically connected to the port.

[0019] Clause 2: The device of clause 1, wherein the actuation portion is transitionable 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.

[0020] Clause 3: The device of clause 1 or clause 2, wherein the actuation portion comprises a contact member.

[0021] Clause 4: The device of clause 3, wherein the actuation portion is transitionable 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.

[0022] Clause 5: The device of clause 4, wherein the contact member applies pressure on the sample source when the contact member is in the engaged position.

[0023] Clause 6: The device of any of clauses 1 - 5, wherein the actuation portion comprises a pumping member for applying pressure to the sample source.

[0024] Clause 7: The device of clause 6, wherein the pumping member comprises a pair of opposing tabs.

[0025] Clause 8: The apparatus of any of clauses 1 - 7, wherein the sample source is a finger.

[0026] Clause 9: The device of clause 8, wherein the port is in communication with a portion of the finger when the finger is received in the holder.

[0027] Clause 10: The device of any of clauses 1-9, wherein the container engaging portion and the retainer are connected via a ball and socket joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint.

[0028] Clause 11: The device of any of clauses 1 - 10, wherein the retainer comprises a living hinge connectable to the container engaging portion.

[0029] Clause 12: The device of clause 11, wherein the living hinge is connected to the container engaging portion by a keyed snap arrangement, a hook and snap arrangement, a C-clip and snap arrangement, or a peg and profiled joint.

[0030] Item 13: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuating portion and a port; a container engaging portion, which is connected to the holder and is constructed 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 fluidically connected to the port.

[0031] Clause 14: The device of clause 13, wherein the actuation portion is transitionable 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.

[0032] Clause 15: The device of clause 13 or clause 14, wherein the actuation portion comprises a contact member.

[0033] Clause 16: The device of clause 15, wherein the actuation portion is transitionable 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.

[0034] Clause 17: The device of clause 16, wherein the contact member applies pressure on the sample source when the contact member is in the engaged position.

[0035] Clause 18: The device of any of clauses 13-17, wherein the actuation portion comprises a pumping member for applying pressure to the sample source.

[0036] Clause 19: The device of clause 18, wherein the pumping member comprises a pair of opposing tabs.

[0037] Clause 20: The apparatus of any of clauses 13-19, wherein the sample source is a finger.

[0038] Clause 21: The device of clause 20, wherein the port is in communication with a portion of the finger when the finger is received in the holder.

[0039] Clause 22: The device of any of clauses 13-21, wherein the container engaging portion and the retainer are connected via a ball and socket joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint.

[0040] Clause 23: The device of any of clauses 13-22, wherein the retainer comprises a living hinge connectable to the container engaging portion.

[0041] Clause 24: The device of clause 23, wherein the living hinge is connected to the container engaging portion by a keyed snap arrangement, a hook and snap arrangement, a C-clip and snap arrangement, or a peg and profiled joint.

[0042] Item 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 comprising: 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 for holding a blood sample, wherein each section comprises a label corresponding to a sequential step in a method for obtaining a blood sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The above and other features and advantages of the present disclosure, and the manner in which they are obtained, will become more apparent and the present disclosure itself will be better understood by referring to the embodiments of the present disclosure described below in conjunction with the accompanying drawings, in which:

[0044] Figure 1 is a perspective view of a holder according to one embodiment of the present invention.

[0045] Figure 2 is a perspective view of a retainer in a first position according to one embodiment of the present invention.

[0046] Figure 3 is a perspective view of a retainer in a second position according to one embodiment of the present invention.

[0047] Figure 4A is a perspective view of a holder according to another embodiment of the present invention.

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

[0049] Figure 5 is a perspective view of a holder according to another embodiment of the present invention.

[0050] Fig. 6A is a perspective view of a holder according to another embodiment of the present invention.

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

[0052] Fig. 7A is a perspective view of a holder according to another embodiment of the present invention.

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

[0054] Figure 8 is an exploded perspective view of a device for obtaining a blood sample having separate components according to one embodiment of the present invention.

[0055] Fig. 9 is a perspective view of a holder with a lancet housing secured within a port according to one embodiment of the present invention.

[0056] Fig.10 is a perspective view of a holder with a container secured within a port according to one embodiment of the present invention.

[0057] Fig.11 is a perspective view of a semi-integrated device for obtaining a blood sample with angled flow according to another embodiment of the present invention.

[0058] Fig.12 is a perspective view of a holder having a lancet housing and a container secured within a port according to another embodiment of the present invention.

[0059] Fig.13 According to another embodiment of the present invention Fig.12 A cross-sectional view of the device.

[0060] Fig.14 is a perspective view of a semi-integrated device for obtaining a blood sample with linear flow according to another embodiment of the present invention.

[0061] Fig.15 is a perspective view of a holder having a lancet housing and a container secured within a port according to another embodiment of the present invention.

[0062] Fig.16 According to another embodiment of the present invention Fig.15 A cross-sectional view of the device.

[0063] Fig.17 is a perspective view of an integrated device for obtaining a blood sample with angled flow according to another embodiment of the present invention.

[0064] Fig.18 According to another embodiment of the present invention Fig.17 A cross-sectional view of the device.

[0065] Fig.19 yes Fig.17 A cross-sectional view of a device showing a blood flow path according to another embodiment of the present invention.

[0066] Fig. 20 is a perspective view of an integrated device for obtaining a blood sample with linear flow according to another embodiment of the present invention.

[0067] Fig.21 According to another embodiment of the present invention Fig. 20 A cross-sectional view of the device.

[0068] Fig. 22 yes Fig. 20 A cross-sectional view of a device showing a blood flow path according to another embodiment of the present invention.

[0069] Fig.23 is a perspective view of a first step in using the integrated device of the present disclosure according to one embodiment of the present invention.

[0070] Fig.24 is a perspective view of a second step of using the integrated device of the present disclosure according to one embodiment of the present invention.

[0071] Fig.25 is a perspective view of a third step of using the integrated device of the present disclosure according to one embodiment of the present invention.

[0072] Fig.26 is a perspective view of a fourth step of using the integrated device of the present disclosure according to one embodiment of the present invention.

[0073] Fig. 27 is a perspective view of a first step in using a device with separate components of the present disclosure according to another embodiment of the present invention.

[0074] Fig.28 is a perspective view of a second step of using the device with separate components of the present disclosure according to another embodiment of the present invention.

[0075] Fig.29 is a perspective view of a third step of using the device with separation components of the present disclosure according to another embodiment of the present invention.

[0076] Fig.30 is a perspective view of a fourth step of using the device with separation components of the present disclosure according to another embodiment of the present invention.

[0077] Fig.31 is a perspective view of a fifth step of using the device with separation components of the present disclosure according to another embodiment of the present invention.

[0078] Fig.32 is an assembled perspective view of a device according to another embodiment of the present invention.

[0079] Fig.33 yes Fig.32 Another assembled perspective view of the device.

[0080] Fig.34a is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0081] Fig.34b is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0082] Fig.34c is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0083] Fig.34d is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0084] Fig.35 is an assembled perspective view of a device according to one embodiment of the present invention.

[0085] Fig.36 yes Fig.35 Another assembled perspective view of the device.

[0086] Fig.37a is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0087] Fig.37b is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0088] Fig.37c is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0089] Fig.37d is a perspective view of a connection arrangement between a connection interface and a container engaging portion according to one embodiment of the present invention.

[0090] Fig.38 is a perspective view of a device according to one embodiment of the present invention in a pre-actuated position.

[0091] Fig.39 yes Fig.38 A perspective view of a device in which a lancet is inserted into a patient's finger.

[0092] Fig.40 yes Fig.38 A perspective view of a device showing a collection container rotated into connection with a holder of the device.

[0093] Fig.41 yes Fig.38 A perspective view of a device showing the collection of a blood sample from a patient's finger into a collection container.

[0094] Fig.42 yes Fig.38 A perspective view of a device showing the collection container being removed from the holder of the device.

[0095] Fig.43 is an illustration of a tray for holding devices and a method for determining the size of devices held in the tray and use thereof according to one embodiment of the present invention.

[0096] Corresponding reference characters indicate corresponding parts throughout the several views.The examples set out herein illustrate exemplary embodiments of the disclosure, and such examples should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0097] The following description is provided to enable those skilled in the art to make and use the described concept to implement embodiments of the present invention. However, various modifications, equivalents, variations and substitutions remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents and substitutions are intended to fall within the spirit and scope of the present invention.

[0098] For the purpose of 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 is to be understood that the present invention may contemplate alternative variations and step sequences unless expressly stated. It is also to 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. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0099] The present disclosure relates to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the above needs and has the ability to pierce and squeeze a finger, collect a sample, stabilize the sample, and then dispense the sample in a controlled manner. The device also simplifies and streamlines capillary blood collection by eliminating workflow variability commonly associated with poor sample quality, including hemolysis and microclotting.

[0100] The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device having the ability to puncture, collect and stabilize high-volume capillary blood samples (e.g., up to or in excess of 500 microliters). The device simplifies and streamlines high-volume capillary blood collection by eliminating workflow steps and variability typically associated with poor sample quality, including hemolysis, microclotting, and patient discomfort. The device includes a retractable puncture mechanism capable of puncturing a finger and an associated blood flow path that ensures capillary blood adheres and transfers 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 also includes an anticoagulant that is deposited in the flow path or collection container to stabilize the collected sample.

[0101] According to one design, the device can include separate components, such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into one device, which is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are contemplated for use as a self-contained disposable device and / or in conjunction 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 onboard plasma separation module. This capability extends product flexibility to a variety of applications, including dispensing into point-of-care (POC) boxes or small collection tube transfers that can be used in centrifuges or analytical instruments.

[0102] Reference Figure 8 -10, in an exemplary embodiment, the device 10 of the present disclosure includes separate components, such as a retainer 12 (eg, Figure 1 -7B), a lancet housing or lancet 14, and a collection container 16.

[0103] Reference Fig.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 holder. 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 holder.

[0104] Reference Fig.17 -19, In ​​another exemplary embodiment, the integrated device 100 of the present disclosure has an angled flow and includes an integrated holder, lancet housing, and collection container. Fig. 20 -22. In another exemplary embodiment, the integrated device 200 of the present disclosure has a linear flow and includes an integrated holder, lancet housing, and collection container.

[0105] Reference Figure 8 −10 , in an exemplary embodiment, a device 10 for obtaining a blood sample 18 includes separate components, such as a holder 12 , a lancet housing or lancet 14 , and a collection container 16 . Figure 1 −7B shows an exemplary embodiment of a holder or finger housing 12 of the present disclosure.

[0106] Reference Figure 1 7B shows an exemplary embodiment of a holder 12 of the present disclosure, which is capable of receiving a sample source (e.g., a finger 19) for supplying a biological sample (e.g., a blood sample 18). The holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 ( Figure 5 ), an actuation portion 24, a port 26 having a second opening 28, and a fingertip guard 30. In one embodiment, the fingertip guard 30 provides a stop for properly aligning the finger 19 and securing the finger 19 within the holder 12.

[0107] The first opening 22 of the finger receiving portion 20 is configured to receive a sample source (e.g., a finger 19) for supplying a biological sample (e.g., a blood sample 18). It will be appreciated that the sample source may include other portions of a body that can fit 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 holder 12, the port 26 is in communication with a portion of the finger 19. The size of the holder 12 of the present disclosure can be designed to accommodate all finger sizes.

[0108] 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 securely receiving the lancet housing 14 and the collection container 16 within the port 26 .

[0109] In one embodiment, the actuation portion 24 may be in a first position ( Figure 2 ) and the retainer 12 define a second position of the second diameter ( Figure 3 ), wherein the second diameter is smaller than the first diameter. In one embodiment, the actuating portion 24 can be in a first position ( Figure 2 ) and the retainer 12 define a second position of a second elliptical shape ( Figure 3 ), wherein the first elliptical shape is different from the second elliptical shape. In this way, when the holder 12 is in the second position with the reduced diameter, a portion of the holder 12 contacts the sample source and the actuating portion 24 of the holder 12 is able to pump and / or extract the blood 18, as described in more detail below.

[0110] Reference Figure 2 and Figure 3 In one embodiment, the actuation portion 24 includes a contact member 34. Figure 2 When the actuating portion 24 is in the first position, the contact member 34 is in the disengaged position, that is, the contact member 34 is arranged in the first position relative to the sample source (eg, the finger 19), so that the contact member 34 can slightly contact the sample source. Figure 3, with the actuation portion 24 in the second position, the contact member 34 is in the engaged position, i.e., the contact member 34 is disposed in the second position relative to the sample source (e.g., finger 19) such that the contact member 34 contacts the finger 19 with applied pressure, and the actuation portion 24 of the holder 12 is able to pump and / or extract the blood 18. For example, with the contact member 34 in the engaged position, the contact member 34 applies pressure on the sample source.

[0111] Reference Figure 2 and Figure 3 In one embodiment, the actuation portion 24 includes a pumping member 36 for applying pressure to a sample source (e.g., 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 a contact member 34. Figure 1 -3. In one embodiment, the holder 12 includes a movable hinge portion 42. The movable hinge portion 42 allows the user to hold the holder 12 in the first position ( Figure 2 ) and the second position ( Figure 3 ) between which the wing-shaped portion 38 is squeezed.

[0112] Advantageously, the holder 12 of the present disclosure allows a 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 .

[0113] Advantageously, the holder 12 does not restrict blood flow and defines the puncture and finger compression location with the holder 12 placed on the finger 19. The compression tabs or wings 38 provide a predefined range of compression pressures that are applied consistently across the finger 19. By doing so, the holder 12 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

[0114] Reference Figure 5 In one embodiment, the holder 12 includes a stability extension 40. This provides additional support for the holder 12 to be securely placed on the finger 19. In one embodiment, the finger receiving portion 20 is formed as a generally C-shaped member and includes a plurality of internal gripping members for providing additional grip and support for the holder 12 to be securely placed on the finger 19.

[0115] 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.

[0116] Figure 4A −7B shows another exemplary embodiment of the retainer 12 of the present disclosure. Figure 4A-4B, the retainer 12 includes a leaf spring 44. Fig. 6A -6B, the retainer 12 includes a double leaf spring 46. Fig. 7A −7B, the retainer 12 includes three leaf springs 48 .

[0117] The device 10 of the present disclosure for obtaining a blood sample 18 includes a lancet housing or lancet 14 that is removably connectable to a port 26 of a holder 12. Figure 8 , 9 and 13, in one embodiment, the lancet housing 14 includes an entrance or opening 50, an interior 52, a puncture element 54, an engagement portion 56, a retractable mechanism 58, and a drive spring 60. In one embodiment, the puncture element 54 is movable between a pre-actuated position in which the puncture element 54 remains within the interior 52 of the lancet housing 14 and a puncture position in which at least a portion of the puncture element 54 extends through the entrance 50 of the lancet housing 14 to puncture a portion of the finger 19.

[0118] 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, entitled "Contact Activated Lancet Design," filed on May 6, 2005 and commonly assigned to the present application, the entire disclosure of which is hereby expressly incorporated herein by reference.

[0119] Reference Figure 8 -10, in one embodiment, the lancet housing 14 can be a separate component from the holder 12 and the collection container 16. Fig.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 holder 12. Fig.17 -22. In some embodiments, the collection container 16, the lancet housing 14, and the holder 12 form a single component.

[0120] Reference Figure 8 -10, in one embodiment, where the holder 12 and the lancet housing 14 are separate components, the lancet housing 14 can be removably connected to the port 26 of the holder 12. In such an embodiment, the lancet housing 14 includes an engagement portion 56. Fig. 9In one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 so that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12 so that the puncture element 54 of the lancet housing 14 can be activated to puncture or pierce a sample source, such as a finger 19. In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or collection container 16 in the port 26.

[0121] 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 puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct lancing depth and predetermined lancing location, thereby ensuring adequate sample volume.

[0122] In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the puncture element 54 toward the puncture position. After puncture, the puncture element 54 is immediately retracted and securely fixed within the interior 52 of the lancet housing 14.

[0123] Reference 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.

[0124] Reference Fig.19 In one embodiment, the lancet housing 14 of the present disclosure is used to puncture the skin of a finger 19 along a puncture path, and then the blood sample 18 flows downwardly through the blood flow path to the puncture path at a certain angle, as described in more detail below.

[0125] Reference Fig.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 puncture 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.

[0126] The device 10 for obtaining a blood sample 18 of the present disclosure includes a collection container 16 that is removably connectable to the port 26 of the holder 12. The collection container 16 defines a collection chamber 70 for receiving the blood sample 18, a container engagement portion 72, a lancet portion 74, and a cap or septum 76. Once a desired amount of blood 18 is collected within the container 16, the lancet portion 74 is separated from the collection device 10 to transmit the collected sample 18 to a diagnostic instrument and / or testing device. Once removed from the collection device 10, the lancet portion 74 is sealed via the cap or septum 76 to protectively seal the blood sample 18 within the collection chamber 70.

[0127] Reference Figure 8 -10, in one embodiment, the collection container 16 can be a separate component from the holder 12 and the lancet housing 14. Fig.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. Fig.17 -22. In some embodiments, the collection container 16, the lancet housing 14, and the holder 12 form a single component.

[0128] Reference 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. Fig.10 In one embodiment, the container 16 is pushed into the port 26 of the holder 12 so 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 securely connected and locked to the holder 12 so that the blood sample 18 can safely flow from the finger 19 in the holder 12 to the collection cavity 70 of the container 16.

[0129] It will be appreciated that various types of collection containers 16 may be used with the disclosed device 10. It will also be appreciated that the collection container 16 may be associated with a separate dispensing unit, or the collection container 16 may include an integrated dispensing portion for dispensing blood 18 to a testing device.

[0130] Reference Figure 8 -10 and 27 -31, the use of the device 10 of the present disclosure having separate components (eg, the holder 12, the lancet housing or lancet 14, and the collection container 16) will now be described.

[0131] Reference Fig. 27, first clean the desired finger 19 and select a holder 12 of a suitable size to fit the desired finger 19 and place it securely on the finger 19. Next, refer to Fig.28 , the lancet housing 14 is connected to the port 26 of the holder 12. As described above, the lancet housing 14 is pushed into the port 26 of the holder 12 so that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12. In this way, the lancet housing 14 is securely connected and locked to the holder 12 so that the puncture element 54 ( Fig.13 ) can be activated to puncture or pierce a sample source, such as a finger 19. When the lancet 14 is connected to the port 26 of the holder 12, the lancet is in communication with the finger 19.

[0132] Reference Fig.28 When it is necessary to activate the lancet 14 to puncture the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 ( Fig.13 ) to puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and predetermined puncture location, thereby ensuring sufficient sample volume.

[0133] After pricking the finger 19 to produce blood 18 flowing from the finger 19 ( Fig.30 ) Afterwards, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. Fig.29 , the container 16 is pushed into the port 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked in the locking portion 32 of the holder 12. In this way, the container 16 is securely connected and locked to the holder 12 so that the blood sample 18 can flow safely from the finger 19 in the holder 12 to the collection chamber 70 of the container 16.

[0134] Reference Fig.29 and Fig.30 , with the container 16 properly secured to the holder 12 to collect the blood sample 18, the user is able to repeatedly squeeze and release the wings 38 of the holder 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 holder 12 placed on the finger 19, the holder 12 does not restrict blood flow and defines the puncture and finger compression location. The compression tabs or wings 38 provide a predetermined range of compression pressures that are applied consistently across the entire finger 19. By doing so, the holder 12 provides a gentle, controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[0135] For example, refer to Figure 2 and Figure 3In one embodiment, the actuation portion 24 includes a contact member 34. Figure 2 When the actuating 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 (eg, the finger 19). Figure 3 , with the actuation portion 24 in the second position, the contact member 34 is in the engaged position, i.e., the contact member 34 is in the second position and in contact with the sample source (e.g., finger 19) with applied pressure, and the actuation portion 24 of the holder 12 is able to pump and / or extract blood 18. For example, with the contact member 34 in the engaged position, the contact member 34 applies pressure on the sample source.

[0136] Reference Fig.31 Once the desired amount of blood 18 is collected in the container 16, the lancet portion 74 is separated from the collection device 10 in order to send the collected sample 18 to a diagnostic instrument and / or testing device. Once removed from the collection device 10, the lancet portion 74 is sealed via a cap or septum 76 to protectively seal the blood sample 18 within the collection chamber 70.

[0137] The device of the present disclosure is compatible with any known test device, whether the test device is an off-site or bedside detection device. Various bedside detection devices are known in the art. Such bedside detection devices include test strips, slides, diagnostic boxes, or other detection devices for detection and analysis. Test strips, slides, and diagnostic boxes are bedside detection devices that can receive blood samples and test one or more physiological and biochemical states of the blood. There are many bedside devices that use a box-based architecture to analyze very small amounts 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 it creates a different set of challenges compared to a highly routine laboratory environment. Examples of such test boxes include the Abbot Group's Test kit. Test kit (e.g. The cassettes can be used to test various conditions, including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. Test results using such cassettes can be quickly provided to clinicians.

[0138] The collection container 16 may also include a sample stabilizer (e.g., an anticoagulant) to stabilize the blood sample and / or components of the blood sample disposed therein. The collection container 16 may also include at least one fill line corresponding to a predetermined amount of sample. The collection container may also indicate / meter the amount of blood collected.

[0139] Reference Fig.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 pricking the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12.

[0140] Reference Fig.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 lancet portion 74 that is removably connectable to a portion of the lancet housing 14.

[0141] Reference Fig.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 the longitudinal axis 104 of the container 16. Fig.19 In one embodiment, the lancet housing 14 is used to puncture the skin of a finger 19 along a puncture path 103 , and then the blood sample 18 flows downward through a blood flow path 105 at a certain angle to the puncture path 103 .

[0142] Reference Fig.17 -19. In one embodiment, the device 100 includes a capillary tube 110. Fig.19 , when the container 16 (i.e., the lancet portion 74) is 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.

[0143] refer to Fig.17 -19, the blood flow path 105 of the device 100 will now be described. With the finger 19 received in the holder 12 and the puncture element 54 in the puncture position, the puncture element 54 punctures the finger 19 to extract the blood sample 18. For example, when it is necessary to activate the lancet 14 to puncture 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 puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and the predetermined puncture position, thereby ensuring a sufficient sample volume.

[0144] Blood 18 will flow from the finger 19 to the blood flow channel 120 of the lancet housing 14. The blood 18 flows at an angle to the lancet path 103 via the blood flow path 105. For example, the blood sample 18 flows through the capillary 110 to the collection chamber 70 of the container 16.

[0145] See also Fig. 20 -22, in another exemplary embodiment, the device 200 for obtaining a blood sample 18 of the present disclosure has a linear 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 pricking the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12.

[0146] Reference Fig. 20 -22, the lancet housing 14 is permanently fixed in the port 26 of the holder 12. The lancet housing 14 includes a hollow needle 62. For example, the puncture element 54 of the lancet 14 includes the hollow needle 62. The collection container 16 is fixed to the lancet housing 14 and includes a lancet portion 74 that can be removably connected to a portion of the lancet housing 14.

[0147] Reference Fig.21 In one embodiment, with the container 16 connected to the lancet housing 14, the longitudinal axes 202 of the port 26, the lancet housing 14, and the container 16 are aligned.

[0148] Reference Fig.21 and Fig. 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 puncture the skin of the finger 19 along the puncture path 203, and then the blood sample 18 flows through the hollow needle 62 along the parallel blood flow path 205.

[0149] Reference Fig. 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.

[0150] Reference Fig. 20-22, the blood flow path 205 of the device 200 will now be described. When the finger 19 is received in the holder 12 and the puncture element 54 is in the puncture position, the puncture element 54 punctures the finger 19 to extract the blood sample 18. For example, when it is necessary to activate the lancet 14 to puncture 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 puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and the predetermined puncture position, thereby ensuring a sufficient sample volume.

[0151] 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 with the puncture path 203 via the blood flow path 205.

[0152] Reference Fig.23 −26, the use of the device 200 of the present disclosure having a linear flow and including an integrated retainer 12, lancet housing 14 and collection container 16 will now be described.

[0153] Reference Fig.23 , first clean the desired finger 19 and select a holder 12 having a suitable size suitable for the desired finger 19 and place it securely 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 holder 12, because each of the holder 12, the lancet housing 14 and the collection container 16 is integrated into a single component.

[0154] Reference Fig.24 When it is necessary to activate the lancet 14 to puncture the skin of the finger 19, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 ( Fig.21 ) to puncture the finger 19. The lancet 14 of the present disclosure consistently provides the correct puncture depth and predetermined puncture location, thereby ensuring sufficient sample volume.

[0155] Reference Fig.25 , after the finger 19 is punctured to generate a flow of blood 18 from the finger 19, the user is able to repeatedly squeeze and release the wings 38 of the holder 12 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. Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not restrict blood flow and defines the puncture and finger compression location. The squeezing tabs or wings 38 provide a predefined range of squeezing pressures that are uniformly applied across the entire finger 19. By doing so, the holder 12 provides a gentle, controlled massage of the finger 19, which stimulates the extraction of blood 18 and minimizes any potential hemolysis.

[0156] Reference Fig.26 Once the desired amount of blood 18 is collected in the container 16, the blood collection device 200 is separated from the blood collection device 200 and sealed with a cap or septum 76 to send the collected sample 18 to a diagnostic instrument and / or testing device. As described above, the collection container 16 may also include a sample stabilizer (e.g., an anticoagulant) to stabilize the blood and a fill line to indicate / meter the amount of blood 18 collected.

[0157] Reference Fig.11 -16, the device 300 ( Figure 11-13 ) and device 400( Fig.14 ﹣16) usage, the device 300 has an angled flow and includes an integrated blood-letting needle 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 blood-letting needle housing 14 and a collection container 402, which can be connected to a separate holder 12.

[0158] Reference Fig.11 -13, the semi-integrated device 300 is similar to the one having the above reference Figures 17 to 19 The device 100 described above with angled flow and including an integrated holder, lancet housing, and collection container can be used in a similar manner. 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. Fig.11 In the embodiment shown in −13 , the user need only connect the integrated lancet housing and collection container component 302 to the port 26 of the holder 12 .

[0159] Reference Fig.14 -16, semi-integrated device 400 with reference to the above Fig. 20 -22 described with straight-line flow and including an integrated holder, lancet housing, and collection container. 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 pricking the skin of the finger 19, and then connect the collection container 16 to the port 26 of the holder 12. Fig.14 In the embodiment shown in −16 , the user need only connect the integrated lancet housing and collection container component 402 to the port 26 of the holder 12 .

[0160] Any of the devices for obtaining blood samples disclosed herein can be used as a self-supporting disposable device and / or in combination with an external power source for pain relief control. For example, a portion of the holder 12 may include an embedded electrode that receives a signal 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 blood samples disclosed herein may also include various options for onboard plasma separation. The devices for obtaining blood samples disclosed herein may also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for obtaining blood samples disclosed herein may also include onboard diagnostic feedback at the time of collection. The devices for obtaining blood samples disclosed herein may also allow dual collection, for example, using multiple collection ports to collect two samples into two separate containers, the multiple collection ports enabling multiple samples to be collected from the same source and treated with different sample stabilizers (such as anticoagulants).

[0161] The disclosed device for obtaining a blood sample significantly simplifies and democratizes large volume capillary collection from a finger relative to conventional capillary collection using a lancet and capillary tube. The disclosed device eliminates blood exposure and prevents reuse of the device.

[0162] The device for obtaining a blood sample disclosed herein simplifies, de-skills and streamlines the collection process. This is all achieved through a self-contained closed system device that, when placed on the finger, provides the functions of lancing, blood extraction, stabilization and containment in one unit.

[0163] The disclosed device for obtaining a blood sample may be associated with a self-contained unit that provides automated pumping, controlled finger compression, and automated sample labeling and processing.

[0164] Reference Fig.32 -37d, describes an exemplary embodiment of a holder 112 of the present disclosure, which is capable of receiving a sample source (e.g., a finger 19) for supplying a biological sample (e.g., a blood sample). The holder 112 of the present disclosure generally includes a finger receiving portion 120 having a first opening 122, an actuating portion 124, a port 126 having a second opening 128, and a fingertip guard 130. In one embodiment, the fingertip guard 130 provides a stop portion for properly aligning and fixing the finger 19 within the holder 112.

[0165] The first opening 122 of the finger receiving portion 120 is configured to receive a sample source (e.g., a 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 fit 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 in the holder 112, the port 126 is in communication with a portion of the finger 19. The size of the holder 112 of the present disclosure can be designed to accommodate all finger sizes.

[0166] 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 .

[0167] In one embodiment, the actuation portion 124 is transitionable between a first position in which the holder 112 defines a first diameter and a second position in which the holder 112 defines a second diameter, wherein the second diameter is smaller than the first diameter. In one embodiment, the actuation portion 124 is transitionable between a first position in which the holder 112 defines a first elliptical shape and a second position in which the holder 112 defines a second elliptical shape, wherein the first elliptical shape is different from the second elliptical shape. In this manner, with the holder 112 in the second position having a reduced diameter, a portion of the holder 112 contacts the sample source and the actuation portion 124 of the holder 112 is able to pump and / or extract blood as described in more detail below.

[0168] In one embodiment, the actuation portion 124 includes a contact member 134. When the actuation 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) so that the contact member 134 can be in light contact therewith. When the actuation 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) so that the contact member 134 is in contact with the finger 19 with an applied pressure, and the actuation portion 124 of the holder 112 is able to pump and / or extract blood. For example, when the contact member 134 is in the engaged position, the contact member 134 applies pressure on the sample source.

[0169] In one embodiment, the actuation portion 124 includes a pumping member 136 for applying pressure to a sample source, such as a 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 can include a contact member 134. In one embodiment, the holder 112 includes a living hinge portion 142. The living hinge portion 142 allows a user to squeeze the wings 138 between a first position and a second position.

[0170] Advantageously, the holder 112 of the present disclosure allows a 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 .

[0171] Advantageously, the holder 112 does not restrict blood flow and defines a puncture location and a finger compression location when the holder 112 is placed on the finger 19. The compression tabs or wings 138 provide a predefined range of compression pressures that are applied consistently across the finger 19. By doing so, the holder 112 provides a gentle, controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.

[0172] In one embodiment, the holder 112 includes a stability extension 140. This provides additional support for the holder 112 to be securely 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 holder 112 to be securely placed on the finger 19.

[0173] 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.

[0174] The device 350 for obtaining a blood sample of the present disclosure includes a lancet housing or lancet 114 that is removably connectable to the port 126 of the holder 112. In one embodiment, the lancet 114 includes an entrance or opening, an interior, a puncture element, an engagement portion, a retractable mechanism, and a drive spring similar to the lancet 14 described above. In one embodiment, the puncture element is movable between a pre-actuated position in which the puncture element is retained within the lancet 114 and a puncture position in which at least a portion of the puncture element extends through the entrance of the lancet 114 to puncture a portion of the finger 19.

[0175] In one embodiment, the lancet 114 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, entitled “Contact Activated Lancet Device,” filed on May 6, 2005, which is commonly assigned with the present application and the entire disclosure of which is expressly incorporated herein by reference.

[0176] In one embodiment, the lancet 114 can be a separate component from the holder 112 and the collection container 116. In some embodiments, the collection container 116 and the lancet 114 form a single component that can be removably connected to the port 126 of the holder 112. In some embodiments, the collection container 116, the lancet 114, and the holder 112 form a single component.

[0177] In one embodiment, where the holder 112 and the lancet 114 are separate components, the lancet 114 can be removably connected to a port 126 of the holder 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 holder 112 so that the engagement portion of the lancet 114 is locked within the port 126 of the holder 112. In this way, the lancet 114 is securely connected and locked to the holder 112 so that the puncture element of the lancet 114 can be activated to puncture or pierce a sample source (e.g., a finger 19). In some embodiments, the port 126 of the holder 112 includes a plurality of ribs for securing and locking the lancet 114 or collection container 116 in the port 126.

[0178] To activate the lancet 114, the lancet 114 is pushed against the finger 19 to activate the retractable mechanism of the lancet 114 to puncture the finger 19. The lancet 114 of the present disclosure consistently provides the correct puncture depth and predetermined blood collection location, thereby ensuring sufficient sample volume.

[0179] In one embodiment, the lancet 114 includes a drive spring disposed inside the lancet 114 for biasing the puncture element toward the puncture position. After puncture, the puncture element is immediately retracted and securely fixed inside the lancet 114.

[0180] In one embodiment, the lancet 114 of the present disclosure is used to pierce the skin of a finger 19 and then express a blood sample into a collection container 116 as described in more detail below.

[0181] In one embodiment, the lancet 114 of the present disclosure is used to puncture the skin of a finger 19 along a puncture path, and the blood sample then flows downwardly through a blood flow path at an angle to the puncture path, as described in more detail below.

[0182] In one embodiment, the lancet 114 comprises a hollow needle. In such an embodiment, the lancet 114 of the present disclosure is used to puncture the skin of the finger 19 along a puncture path, and then the blood sample flows through the hollow needle along a parallel blood flow path, as described in more detail below.

[0183] The device 350 for obtaining a blood sample of the present disclosure includes a collection container 116 that can be removably connected to the port 126 of the holder 112. The collection container 116 defines a collection chamber 170 for receiving a blood sample, a lancet portion 174, and a cap or septum 176. Once a desired amount of blood is collected in the container 116, the lancet portion 174 is removed from the collection device 350 in order to send the collected sample to a diagnostic instrument and / or testing device. The lancet portion 174 is sealed via the cap or septum 176 after being removed from the device 350 to protectively seal the blood sample in the collection chamber 170.

[0184] In one embodiment, where the holder 112 and the collection container 116 are separate components, the container engaging portion 182 that holds the collection container 116 can be removably or fixedly connected to the connection interface 180 of the holder 112. The container engaging portion 182 can define an opening to receive and hold the collection container 116. The collection container 116 can be held in the container engaging portion 182 by any suitable means (including friction fit, mechanical fit, or any alternative removable connection) to allow the collection container 116 to be separated from the container engaging portion 182 after the blood sample has been collected in the collection chamber 170. The container engaging portion 182 can also include a container locking portion 172, which is configured to engage with the port 126 of the holder 112 to lock the container engaging portion 182 within the port 126. Reference Fig.32In one embodiment, the container engaging portion 182 includes a protrusion 184 that is pushed or guided into the connection interface 180 of the holder 112 so that the container engaging portion 182 of the container 116 is locked within the connection interface 180 of the holder 112. In this way, the container 116 is securely connected and locked to the holder 112 so that the blood sample can safely flow from the finger 19 in the holder 112 to the collection chamber 170 of the container 116. The connection interface 180 and the container engaging portion 182 can be connected before puncturing or at the manufacturing location. The pre-attached pivot mechanism provides a quick and connected connection of the collection container 116 to the holder 112. Due to the connection between the connection interface 180 of the holder 112 and the container engaging portion 182, the container engaging portion 182 is able to be rotatably moved relative to the holder 112. Thus, with the collection container 116 retained in the container engagement portion 182, the collection container 116 can be rotatably moved between a first position in which the collection container 116 is positioned away from the port 126 on the retainer 112 and a second position in which the collection container 116 is positioned in a straight line with the port 126 of the retainer 112 to collect a blood sample from the patient's finger 19.

[0185] Reference Fig.34a -34d, illustrates and describes an alternative connection arrangement between the connection interface 180 and the protrusion 184. Fig.34a As shown, the connection interface 180 and the protrusion 184 may include a ball joint connection. It is contemplated that the connection interface 180 or the protrusion 184 may include a ball and the other of the connection interface 180 and the protrusion 184 may include a socket to receive the ball. Fig.34b As shown, the connection interface 180 and the protrusion 184 may include a peg and hole pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 may include a peg and the other of the connection interface 180 and the protrusion 184 may include a hole or recess to receive the peg. Fig.34c , the connection interface 180 and the protrusion 184 may include a pin and C-clip pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 may include a pin and the other of the connection interface 180 and the protrusion 184 may include a C-clip to receive the pin. Fig.34d , the connection interface 180 and the protrusion 184 may include a pin and socket pivot joint connection. It is contemplated that the connection interface 180 or the protrusion 184 may include a pin and the other of the connection interface 180 and the protrusion 184 may include a socket to accommodate the pin. It is further contemplated that other alternative connection arrangements between the connection interface 180 and the protrusion 184 may also be employed in the present invention. The previously described connections are non-limiting.

[0186] Reference Fig.35 and36 In one embodiment, the connection interface 180 of the holder 112 may include a living hinge 186 and a connection tab 188 that can be received in an orifice 190 defined in the container engagement portion 182. In this way, the container 116 is securely connected and locked to the holder 112 so that the blood sample can safely flow from the finger 19 within the holder 112 to the collection chamber 170 of the collection container 116. The connection interface 180 and the container engagement portion 182 can be connected prior to puncturing or at the manufacturing site. The pre-attached pivot mechanism provides a quick and connected connection of the collection container 116 to the holder 112. Due to the living hinge 186 of the connection interface 180 of the holder 112, the container engagement portion 182 can be rotatably moved relative to the holder 112. Therefore, with the collection container 116 retained in the container engagement portion 182, the collection container 116 can be rotatably moved between a first position in which the collection container 116 is positioned away from the port 126 on the retainer 112 and a second position in which the collection container 116 is aligned with the port 126 of the retainer 112 to collect a blood sample from the patient's finger 19.

[0187] Reference Fig.37a -37d, illustrates and describes an alternative connection arrangement between the connection tab 188 and the orifice 190. Fig.37a As shown, the connecting tab 188 and the aperture 190 may include a keyed snap-fit ​​connection. It is contemplated that the connecting tab 188 may be keyed to be received within the aperture 190, which has a shape corresponding to the key of the connecting tab 188. The connecting tab 188 may snap fit into the aperture 190. Figure 37b As shown, the connecting tab 188 and the aperture 190 may include a hook and snap connection. It is contemplated that the connecting tab 188 may be a hook element that is rotatably received within the aperture 190. The connecting tab 188 may snap fit into the aperture 190. A first end of the hook element of the connecting tab 188 may snap into the aperture 190, and then a second end of the hook element of the connecting tab 188 may be rotated in the opposite direction to snap into the opposite end of the aperture 190. Fig.37c As shown, the connecting tab 188 and the aperture 190 may include a C-clip and a snap connection. It is contemplated that the connecting tab 188 may be a C-clip that is received within the aperture 190 by a snap fit. The C-clip of the protruding tab 188 may include an inner extension 192 that snap fits into a corresponding hole 194 defined in the aperture 190. Fig.37dAs shown, the connection tab 188 and the aperture 190 may include a peg and profile engagement connection. It is contemplated that the connection tab 188 may be a peg to be received within the aperture 190, which has a profile corresponding to the peg. The connection tab 188 may snap fit into the aperture 190. It is further contemplated herein that other alternative connection arrangements between the connection tab 188 and the aperture 190 may also be employed in the present invention. The previously described connections are non-limiting.

[0188] Reference Fig.32 In one embodiment, the container 116 is pushed into the port 126 of the holder 112 so that the container locking portion 172 of the container engagement portion 182 is locked within the locking portion 132 of the holder 112. In this way, the collection container 116 is securely connected and locked to the holder 112 so that the blood sample can safely flow from the finger 19 in the holder 112 to the collection cavity 170 of the collection container 116.

[0189] Reference Fig.38 -42, the use of the device 350 of the present disclosure having a linear flow and including a holder 112, a lancet 114 and a collection container 116 will now be described.

[0190] Reference Fig.38 , first clean the desired finger 19 and select a holder 112 having a suitable size to fit the desired finger 19 and place it securely on the finger 19.

[0191] Reference Fig.39 When it is necessary to activate the lancet 114 to puncture 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 puncture the finger 19. The lancet 114 of the present disclosure consistently provides the correct puncture depth and the predetermined puncture position, thereby ensuring a sufficient sample volume.

[0192] Reference Fig.40 After pricking the finger 19 to generate blood flow from the finger 19, the user can rotate the collection container 116 to the second position to lock into the holder 112. Fig.41Once the container engagement portion 182 has been locked to the holder 112, the user is able to repeatedly squeeze and release the wings 138 of the holder 112 to pump and / or extract blood from the finger 19 until the desired amount of blood is filled in the collection container 116. Advantageously, with the holder 112 placed on the finger 19, the holder 112 does not restrict blood flow and defines the puncture location and finger compression location. The squeezing tabs or wings 138 provide a predefined range of squeezing pressures that are applied consistently across the entire finger 19. By doing so, the holder 112 provides a gentle, controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[0193] Reference Fig.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 the cap or septum 176 to send the collected sample to a diagnostic instrument and / or test device. As described above, the collection container 116 may also include a sample stabilizer (e.g., an anticoagulant) to stabilize the blood and fill lines to indicate / meter the amount of blood collected. In the event that additional blood is to be collected from the patient, a second collection container 116 may be attached to the container engagement portion 182 and the holder 112 may be used again to pump blood into the second collection container 16.

[0194] Reference Fig.43 , depicts a tray 400 for holding a plurality of different holders 112 that can be adjusted in size and used on a patient's finger 19. The tray 400 may also include separate sections 402a-402i that hold separate components that can assist a user in collecting a patient's blood sample in a collection container 116 using the holder 112. Each section 402a-401i may include a label indicating which step of a 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 may hold all of the necessary components that a user needs to draw a blood sample from a patient's finger 19. The tray 400 is designed to guide a user through a workflow in the correct order and 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 sized retainers 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.

[0195] In the second section 402b, labeled "Step 2", instructions are provided to indicate to the user that the patient's hand / finger should be heated. In the third section 402c, labeled "Step 3", a slot is defined to accommodate a plurality of disinfecting wipes 406. The user can use the disinfecting wipes 406 to disinfect the puncture site on the patient's finger 19. In the fourth section 402d, labeled "Step 4", a plurality of apertures 408 are defined in the section 402c of the tray 400 to hold holders 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 holder 112 that is sized to fit the patient's finger 19. After identifying the suitable holder 112, the user inserts the patient's finger 19 into the holder 112 as described above.

[0196] In the 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 the 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 holder 112 to collect a blood sample from the patient's finger 19, as described above.

[0197] In the seventh section 402g, labeled "Step 7," instructions are provided for pumping the patient's finger 19 using the holder 112. In the eighth section 402h, labeled "Step 8," an aperture 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 the ninth section 402i, labeled "Step 9," an aperture 416 is defined in the tray 400 to hold a bandage 418 that can be applied to the patient's finger 19 after the holder 112 has been removed therefrom.

[0198] 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. Therefore, the present application is intended to cover any changes, uses or adaptations of the present disclosure using its general principles. In addition, the present application is intended to cover deviations from the present disclosure within the known or customary practices in the field to which the present disclosure belongs and within the limits of the appended claims.

Claims

1. A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion, a port, and a connection interface, the connection interface being located below at least a portion of the actuation portion; a container engaging portion connected to the connection interface of the retainer; and a collection container removably connectable to the container engagement portion, the collection container defining a collection cavity, Wherein, the connection between the connection interface and the container engagement 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 device according to claim 1, wherein: The actuation portion is transitionable 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.

3. The device according to claim 1, wherein: The actuation portion includes a contact member.

4. The device according to claim 3, wherein: The actuation portion is switchable 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.

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

6. The device according to claim 1, wherein: The actuation portion includes a pumping member for applying pressure to the sample source.

7. The device according to claim 6, wherein: The pumping member includes a pair of opposing tabs.

8. The device according to claim 1, wherein: The sample source is a finger.

9. The device according to claim 8, wherein: With the finger received in the holder, the port communicates with a portion of the finger.

10. The device according to claim 1, wherein: The container engaging portion and the retainer are connected via a ball and socket joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint.

11. The device according to claim 1, wherein: The retainer includes a living hinge connectable to the container engaging portion.

12. The device according to claim 11, wherein The living hinge is connected to the container engaging portion by a keyed snap arrangement, a hook and snap arrangement, a C-clip and snap arrangement, or a peg and profiled joint.

13. A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion, a port, and a connection interface, the connection interface being located below at least a portion of the actuation portion; a container engaging portion connected to the connecting interface of the holder and configured to hold a collection container; Wherein, the connection between the connection interface and the container engagement 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.

14. The device according to claim 13, wherein: The actuation portion is transitionable 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.

15. The device according to claim 13, wherein: The actuation portion includes a contact member.

16. The device according to claim 15, wherein: The actuation portion is switchable 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.

17. The device according to claim 16, wherein: With the contact member in the engaged position, the contact member applies pressure on the sample source.

18. The device according to claim 13, wherein: The actuation portion includes a pumping member for applying pressure to the sample source.

19. The device according to claim 18, wherein: The pumping member includes a pair of opposing tabs.

20. The device according to claim 13, wherein: The sample source is a finger.

21. The device according to claim 20, wherein: The port is in communication with a portion of the finger when the finger is received in the holder.

22. The device according to claim 13, wherein: The container engaging portion and the retainer are connected via a ball and socket joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and socket pivot joint.

23. The device according to claim 13, wherein: The retainer includes a living hinge connectable to the container engaging portion.

24. The device according to claim 23, wherein: The living hinge is connected to the container engaging portion by a keyed snap arrangement, a hook and snap arrangement, a C-clip and snap arrangement, or a peg and profiled joint.

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