RU2783086C1 - Capillary collector with rotary connection - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: apparatus for sampling blood, containing: a holder for receiving a sample source with an actuating section and a hole. The engagement section of the container is attached to the holder. The collection container is attached detachably to the engagement section of the container. The container defines a collection cavity. The engagement section of the container enables rotation of the collection container between a first position wherein the collection container is spaced from the hole and a second position wherein the collection container is in fluid communication with the hole. Disclosed are an alternative method for manufacturing the apparatus for sampling blood and a tray for retaining the components used to sample blood.

EFFECT: ensured collection of a blood sample, stabilisation and dosing thereof in a controlled way.

25 cl, 43 dwg

Description

Cross-reference to related application

[0001] This application claims preference over U.S. provisional application serial number 62/805,398, entitled "Capillary Collector with Rotatable Connection", filed February 14, 2019, the entire contents of which are hereby incorporated by reference.

State of the art

The field of technology to which the invention belongs

[0002] The present invention relates generally to a device for obtaining a biological sample. More specifically, the present invention relates to an integrated finger capillary blood collection device with the ability to prick and pinch a finger, collect, stabilize and dose a blood sample in a controlled manner.

Description of the prior art

[0003] Devices for obtaining and collecting biological samples, such as blood samples, are widely used in the medical industry. One type of blood collection that is widely performed in the medical field is capillary blood collection, which is often performed to collect blood samples for testing. Some diseases, such as diabetes, require the patient's blood to be tested on a regular basis to monitor, for example, the patient's blood sugar levels. Additionally, test kits, such as cholesterol test kits, often require a blood sample for analysis. The blood collection procedure usually involves pricking a finger or other suitable part of the body in order to obtain a blood sample. Typically, the amount of blood needed for such tests is relatively small, and a small puncture wound or incision usually provides sufficient blood for such tests. Various types of lancet devices have been developed that are used to puncture a patient's skin in order to obtain a capillary blood sample from the patient.

[0004] Many different types of lancet devices are commercially available for hospitals, clinics, doctors' offices, and the like, as well as for individual consumers. Such devices typically include a pointed element, such as a needle, or a sharp-edged element, such as a blade, which is used to create a quick puncture wound or incision in the patient's skin in order to provide a small release of blood. It is often physiologically and psychologically difficult for many people to pierce their own finger with a hand needle or blade. As a result, lancet devices have evolved into automatic devices that pierce or incise the patient's skin when triggered. In some devices, the needle or blade is held in the ready position until it is initiated by the user, which may be a healthcare professional in the field of blood sampling from a patient, or the patient himself. After actuation, the needle or blade pierces or cuts the patient's skin, for example, on a finger. Often a spring is incorporated into the device to provide the "automatic" force needed to puncture or incise the patient's skin.

[0005] One type of contact-activated lancing device that features automatic ejection and retraction of a piercing or notching element from and into the device is US Pat. This lancet device includes a body and a lancet structure having a piercing element. The lancet structure is housed in the body and is adapted to move between a holding or pre-firing position in which the piercing element is held within the body and a piercing position in which the piercing element is extended through the front end of the body. The lancet device includes a drive spring housed in the housing to bias the lancet structure toward a puncture position, and a retaining sleeve holding the lancet structure in a retracted position against displacement of the drive spring. The holding sleeve includes a pivot arm in interference with the lancet structure. An actuator in the housing rotates the arm, thereby moving the lancet structure toward the rear end of the housing to at least partially compress the drive spring and releasing the arm from engagement with the lancet structure. The blood sample that is taken is then collected and/or tested. This testing can be done with a point-of-care (POC) testing device, or a sample can be collected and sent to the testing facility.

[0006] At present, capillary blood collection workflow is a complex multi-step process requiring a high level of skill. The multi-step nature of this process introduces several variables that can cause sample quality problems such as hemolysis, insufficient sample stabilization, and microclots. The use of lancet devices to obtain blood samples can result in several variables that affect the collection of a capillary blood sample, including, but not limited to, holding the lancet still during testing, obtaining sufficient blood flow from the puncture site, sufficient blood collection , clotting prevention, and the like. Some of the most common sources of process inconsistency are: (1) insufficient cleaning of the puncture site and removal of the first drop, which could potentially result in a contaminated sample; (2) inappropriate puncture site and depth, which could potentially result in insufficient sample volume and high interstitial fluid; (3) inappropriate squeezing method and excessive pressure near the puncture site to stimulate bleeding (eg, milking out of blood), which can potentially result in a hemolyzed sample; (4) non-persistent transmission interfaces and collection method that could potentially result in a hemolyzed or contaminated sample; and (5) insufficient mixing of the sample with the anticoagulant, which can potentially result in microclots.

[0007] Thus, there is a need in the art for a device that has the ability to pierce and squeeze 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, eliminating the sequencing inconsistencies that are typically associated with poor sample quality, including hemolysis and microclots. There is still an additional need in the art for a closed collection and transfer system that eliminates blood exposure and reuse of the device. There is still a further need in the art for a device that: (1) brings flexibility to the placement of various capillary blood collection and transfer containers; (2) has the ability to generate high quality uniformly mixed/stabilized capillary blood samples; (3) has the ability to form plasma in situ 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 during collection; (6) has the ability to collect capillary blood and perform on-site diagnosis; and (7) has a plurality of collection holes to collect a blood sample into different containers having the same or different anticoagulants.

The essence of the invention

[0008] The present invention is directed to a biological sample acquiring device, such as a capillary blood collection device, that satisfies the needs set forth above and has the ability to pierce and pinch a finger, collect a sample, stabilize the sample, and subsequently dose the sample in a controlled manner. The device also simplifies and improves capillary blood collection by eliminating sequencing inconsistencies that are typically associated with poor sample quality, including hemolysis and microclots.

[0009] The present invention includes a self-contained and fully integrated fingertip capillary blood collection device with the ability to pierce, collect and stabilize a high volume capillary blood sample, for example up to or above 500 microliters. The device simplifies and improves high volume capillary blood collection by eliminating the sequencing steps and inconsistencies typically associated with poor sample quality including hemolysis, microclots and patient discomfort. The device includes a retractable piercing mechanism that can pierce a finger and an associated blood flow channel that allows capillary blood to be attached and transferred from the punctured area of the finger to a collection container. The device also includes a holder that can be cyclically compressed to stimulate, for example, pump, blood flow from a finger, and an anticoagulant applied to the flow channel or collection container to stabilize the collected sample.

[0010] According to one design, the device may include discrete components such as a holder, a lancet, and a collection container. According to another project, the lancet and the collection container can be combined into one device, which is then used with a holder. According to another project, the holder, lancet and collection container can be combined into a single system. Any of these designs are intended to be used as a stand-alone disposable device and/or in association with an external power source to manage pain reduction. The capillary blood collection device can serve as a platform for various capillary blood collection containers ranging from small tubes to capillary dispensers, as well as built-in plasma separation modules. This capability extends the product's flexibility to a variety of applications, including dispensing into a point-of-care (POC) cartridge or a small portable collection tube that can be used in a centrifuge or analytical instrument.

[0011] According to an embodiment of the present invention, a blood sample acquiring device may include a holder for receiving a sample source, the holder having an actuation portion and an opening, a container engagement portion attached to the holder, and a collection container in a detachable manner. attached to the container engagement portion, the container defines a collection cavity, wherein the container engagement portion allows the collection container to rotate between a first position where the collection container is spaced apart from the opening and a second position where the collection container is in liquid message with a hole.

[0012] According to another embodiment of the present invention, the actuation portion may be movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse. The actuation portion may include a contact element. The actuation portion may be movable between a first position where the contact element is in the disengaged position and a second position where the contact element is in the engaged position. With the contact element in the engaged position, the contact element can exert pressure on the sample source. The actuation portion may include a pumping element for applying pressure to the sample source. The pumping element may include a pair of opposed tabs. The sample source may be a finger. With the finger accepted into the holder, the hole may be in communication with the finger site. The container engagement portion and the holder may be connected via a ball joint, a pin and hole type swivel, a tongue and circlip type swivel, or a tongue and groove type swivel. The holder may include a flexible hinge that is capable of being attached to the container engagement portion. The flexible hinge may be connected to the engagement portion of the container through a keyed snap connection arrangement, a hook and snap connection arrangement, a retaining ring and snap connection arrangement, or a pin and profiled engagement.

[0013] In another embodiment of the present invention, a blood sample acquiring device may include a holder for receiving a sample source, a holder having an actuation portion and an opening, and a container engagement portion attached to the holder and configured to hold the collection container wherein the container engagement portion allows the collection container to pivot between a first position where the collection container is spaced apart from the opening and a second position where the collection container is in fluid communication with the opening.

[0014] In another embodiment of the present invention, the actuation portion may be movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse. The actuation portion may include a contact element. The actuation portion may be movable between a first position where the contact element is in the disengaged position and a second position where the contact element is in the engaged position. With the contact element in the engaged position, the contact element can exert pressure on the sample source. The actuation portion may include a pumping element for applying pressure to the sample source. The pumping element may include a pair of opposed tabs. The sample source may be a finger. With the finger accepted into the holder, the hole may be in communication with the finger site. The container engagement portion and the holder may be connected via a ball joint, a pin and hole type swivel, a tongue and circlip type swivel, or a tongue and groove type swivel. The holder may include a flexible hinge that is capable of being attached to the container engagement portion. The flexible hinge may be connected to the engagement portion of the container through a keyed snap connection arrangement, a hook and snap connection arrangement, a retaining ring and snap connection arrangement, or a pin and profiled engagement.

[0015] In another embodiment of the present invention, a tray for holding components used to obtain a blood sample may include a plurality of sections for holding components used to obtain a blood sample, comprising: a first section for holding a finger measurement card; a second section for holding at least two holders; a third section to hold the lancet; and a fourth section for holding a collection container for storing a blood sample, each section including a mark corresponding to a sequential step in the method for obtaining a blood sample.

[0016] The present invention is also defined by the following paragraphs:

[0017] Item 1: A device for obtaining a blood sample, the device comprises: a holder for receiving a sample source, the holder has an actuation portion and an opening; a container engaging portion connected to the holder; and a collection container removably attachable to the container engagement portion, the container defines a collection cavity, wherein the container engagement portion allows the collection container to pivot between a first position in which the collection container is spaced apart from the opening and a second position, in which the collection container is in fluid communication with the opening.

[0018] Item 2: The apparatus of claim 1, wherein the actuation portion is movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse .

[0019] Item 3: The device according to claim 1 or claim 2, wherein the actuation portion includes a contact element.

[0020] Claim 4: The apparatus of claim 3, wherein the actuation portion is movable between a first position where the contact element is in the disengaged position and a second position where the contact element is in the engaged position.

[0021] Item 5: The apparatus of claim 4, wherein, with the contact element in the engaged position, the contact element exerts pressure on the sample source.

[0022] Item 6: The device according to any one of paragraphs. 1-5, wherein the actuation portion includes a pumping element for applying pressure to the sample source.

[0023] Claim 7: The device of claim 6, wherein the pumping element comprises a pair of opposing legs.

[0024] Item 8: The device according to any one of paragraphs. 1-7, with the sample source being a finger.

[0025] Claim 9: The device of claim 8, wherein, with the finger received in the holder, the hole is in communication with the finger portion.

[0026] Item 10: The device according to any one of paragraphs. 1-9, wherein the container engagement portion and the holder are connected by a ball joint, a pin and hole type swivel, a stud and retaining ring type swivel, or a tongue and groove type swivel.

[0027] Item 11: The device according to any one of paragraphs. 1-10, wherein the holder includes a flexible hinge that is attachable to the container engagement portion.

[0028] Claim 12: The apparatus of claim 11, wherein the flexible hinge is connected to the engagement portion of the container by a keyed snap connection arrangement, a hook and snap connection arrangement, a retaining ring and snap connection arrangement, or a pin and profiled engagement.

[0029] Item 13: A device for obtaining a blood sample, the device comprises: a holder for receiving a sample source, the holder has an actuation portion and an opening; and a container engagement portion connected to the holder and configured to hold the collection container; wherein the container engagement portion allows the collection container to pivot between a first position where the collection container is spaced apart from the opening and a second position where the collection container is in fluid communication with the opening.

[0030] Item 14: The apparatus of claim 13, wherein the actuation portion is movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse .

[0031] Item 15: The device according to claim 13 or claim 14, wherein the actuation portion includes a contact element.

[0032] Claim 16: The apparatus of claim 15, wherein the actuation portion is movable between a first position in which the contact element is in the disengaged position and a second position in which the contact element is in the engaged position.

[0033] Item 17: The apparatus of claim 16, wherein, with the contact element in the engaged position, the contact element exerts pressure on the sample source.

[0034] Item 18: The device according to any one of paragraphs. 13-17, wherein the actuation portion includes a pumping element for applying pressure to the sample source.

[0035] Claim 19: The device of claim 18, wherein the pumping element comprises a pair of opposing legs.

[0036] Item 20: The device according to any one of paragraphs. 13-19, with the sample source being a finger.

[0037] Claim 21: The device of claim 20, wherein, with the finger received in the holder, the hole is in communication with the finger portion.

[0038] Item 22: The device according to any one of paragraphs. 13-21, wherein the container engagement portion and the holder are connected by a ball joint, a pin and hole type swivel, a stud and retaining ring type swivel, or a tongue and groove type swivel.

[0039] Item 23: The device according to any one of paragraphs. 13-22, wherein the carrier includes a flexible hinge that is attachable to the container engaging portion.

[0040] Item 24: The apparatus of claim 23, wherein the flexible hinge is connected to the engagement portion of the container by a keyed snap connection arrangement, a hook and snap connection arrangement, a retaining ring and snap connection arrangement, or a pin and profiled engagement.

[0041] Item 25: A tray for holding components used to obtain a blood sample, comprising: a plurality of sections for holding components used to obtain a blood sample, containing: a first section for holding a finger measurement card; a second section for holding at least two holders; a third section to hold the lancet; and a fourth section for holding a collection container for storing a blood sample, each section including a mark corresponding to a sequential step in the method for obtaining a blood sample.

Brief description of the drawings

[0042] The above and other features and advantages of this invention, and the method of achieving them, will become more apparent, and the invention itself will be better understood by reference to the following descriptions of embodiments of the invention, taken together with the accompanying drawings, in which:

[0043] FIG. 1 is a perspective view of a holder according to an embodiment of the present invention.

[0044] FIG. 2 is a perspective view of a holder in a first position according to an embodiment of the present invention.

[0045] FIG. 3 is a perspective view of a holder in a second position according to an embodiment of the present invention.

[0046] FIG. 4A is a perspective view of a holder according to another embodiment of the present invention.

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

[0048] FIG. 5 is a perspective view of a holder according to another embodiment of the present invention.

[0049] FIG. 6A is a perspective view of a holder according to another embodiment of the present invention.

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

[0051] FIG. 7A is a perspective view of a holder according to another embodiment of the present invention.

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

[0053] FIG. 8 is an exploded perspective view of a device having separate components for obtaining a blood sample in accordance with an embodiment of the present invention.

[0054] FIG. 9 is a perspective view of a holder with a lancet body fixed in a hole in accordance with an embodiment of the present invention.

[0055] FIG. 10 is a perspective view of a holder with a container secured in an opening in accordance with an embodiment of the present invention.

[0056] FIG. 11 is a perspective view of a semi-integrated oblique flow blood sampler according to another embodiment of the present invention.

[0057] FIG. 12 is a perspective view of a holder with a lancet body and container secured in an opening in accordance with another embodiment of the present invention.

[0058] FIG. 13 is a cross-sectional view of the device in FIG. 12 in accordance with another embodiment of the present invention.

[0059] FIG. 14 is a perspective view of a semi-integrated unidirectional flow blood sampler according to another embodiment of the present invention.

[0060] FIG. 15 is a perspective view of a holder with a lancet body and container secured in an opening in accordance with another embodiment of the present invention.

[0061] FIG. 16 is a cross-sectional view of the device in FIG. 15 in accordance with another embodiment of the present invention.

[0062] FIG. 17 is a perspective view of an integrated oblique flow blood sampler according to another embodiment of the present invention.

[0063] FIG. 18 is a cross-sectional view of the device in FIG. 17 in accordance with another embodiment of the present invention.

[0064] FIG. 19 is a cross-sectional view of the device in FIG. 17 showing a blood flow path in accordance with another embodiment of the present invention.

[0065] FIG. 20 is a perspective view of an integrated unidirectional flow blood sampler according to another embodiment of the present invention.

[0066] FIG. 21 is a cross-sectional view of the device in FIG. 20 in accordance with another embodiment of the present invention.

[0067] FIG. 22 is a cross-sectional view of the device in FIG. 20 showing a blood flow path in accordance with another embodiment of the present invention.

[0068] FIG. 23 is a perspective view of the first step of using the integrated device of the present invention according to an embodiment of the present invention.

[0069] FIG. 24 is a perspective view of the second step of using the integrated device of the present invention according to an embodiment of the present invention.

[0070] FIG. 25 is a perspective view of the third step of using the integrated apparatus of the present invention according to an embodiment of the present invention.

[0071] FIG. 26 is a perspective view of the fourth step of using the integrated apparatus of the present invention according to an embodiment of the present invention.

[0072] FIG. 27 is a perspective view of a first step in using an apparatus having separate components of the present invention in accordance with another embodiment of the present invention.

[0073] FIG. 28 is a perspective view of a second step in using an apparatus having separate components of the present invention in accordance with another embodiment of the present invention.

[0074] FIG. 29 is a perspective view of the third step of using an apparatus having separate components of the present invention, in accordance with another embodiment of the present invention.

[0075] FIG. 30 is a perspective view of a fourth step in using an apparatus having separate components of the present invention, in accordance with another embodiment of the present invention.

[0076] FIG. 31 is a perspective view of a fifth step in using an apparatus having separate components of the present invention, in accordance with another embodiment of the present invention.

[0077] FIG. 32 is a perspective view of a device assembly according to another embodiment of the present invention.

[0078] FIG. 33 is another perspective view of the device assembly of FIG. 32.

[0079] FIG. 34a is a perspective view of a connection layout between a connection interface and a container engagement portion according to one embodiment of the present invention.

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

[0081] FIG. 34c is a perspective view of a connection layout between a connection interface and a container engagement portion according to one embodiment of the present invention.

[0082] FIG. 34d is a perspective view of a connection layout between a connection interface and a container engagement portion according to one embodiment of the present invention.

[0083] FIG. 35 is a perspective view of a device assembly according to one embodiment of the present invention.

[0084] FIG. 36 is another perspective view of the device assembly of FIG. 35.

[0085] FIG. 37a is a perspective view of a connection arrangement between a connection interface and a container engagement portion according to one embodiment of the present invention.

[0086] FIG. 37b is a perspective view of a connection layout between a connection interface and a container engagement portion according to one embodiment of the present invention.

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

[0088] FIG. 37d is a perspective view of a connection layout between a connection interface and a container engagement portion according to one embodiment of the present invention.

[0089] FIG. 38 is a perspective view of a device according to one embodiment of the present invention in position before being activated.

[0090] FIG. 39 is a perspective view of the device in FIG. 38 with a lancet inserted into the patient's finger.

[0091] FIG. 40 is a perspective view of the device in FIG. 38 showing the rotation of the collection container into connection with the device holder.

[0092] FIG. 41 is a perspective view of the device in FIG. 38 showing the collection of a blood sample from a patient's finger into a collection container.

[0093] FIG. 42 is a perspective view of the device in FIG. 38 showing removal of the collection container from the device holder.

[0094] FIG. 43 is an illustration of a tray used to hold a device according to one embodiment of the present invention and a method for determining the size and use of the device held in the tray.

[0095] Corresponding reference symbols indicate corresponding parts throughout several views. The exemplary explanations set forth herein illustrate exemplary embodiments of the invention, and such exemplary explanations should not be construed as limiting the scope of the invention in any way.

Detailed description

[0096] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents and alternatives are intended to be within the spirit and scope of the present invention.

[0097] For purposes of description later in this document, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal " and their derivatives should refer to the invention as it is oriented in the drawings. However, it should be understood that the invention may contemplate alternative variations and sequences of steps, except where expressly stated to the contrary. It should also be understood that the specific devices and processes illustrated in the attached drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics relating to the embodiments described herein should not be considered limiting.

[0098] The present invention is directed to a biological sample acquiring device, such as a capillary blood collection device, that satisfies the needs set forth above and has the ability to pierce and pinch a finger, collect a sample, stabilize the sample, and subsequently dose the sample in a controlled manner. The device also simplifies and improves capillary blood collection by eliminating sequencing inconsistencies that are typically associated with poor sample quality, including hemolysis and microclots.

[0099] The present invention includes a self-contained and fully integrated fingertip capillary blood collection device with the ability to pierce, collect and stabilize a high volume capillary blood sample, for example up to or above 500 microliters. The device simplifies and improves high volume capillary blood collection by eliminating the sequencing steps and inconsistencies typically associated with poor sample quality including hemolysis, microclots and patient discomfort. The device includes a retractable piercing mechanism that can pierce a finger and an associated blood flow path that allows capillary blood to be attached and transferred from the punctured area of the finger to a collection container. The device also includes a holder that can be cyclically compressed to stimulate, for example, pump, blood flow from a finger, and an anticoagulant applied to the flow channel or collection container to stabilize the collected sample.

[00100] According to one design, the device may include discrete components such as a holder, a lancet, and a collection container. According to another project, the lancet and the collection container can be combined into one device, which is then used with a holder. According to another project, the holder, lancet and collection container can be combined into a single system. Any of these designs are intended to be used as a stand-alone disposable device and/or in association with an external power source to manage pain reduction. The capillary blood collection device can serve as a platform for various capillary blood collection containers ranging from small tubes to capillary dispensers, as well as built-in plasma separation modules. This capability extends the product's flexibility to a variety of applications, including dispensing into a point-of-care (POC) cartridge or a small portable collection tube that can be used in a centrifuge or analytical instrument.

[00101] Referring to FIG. 8-10, in an exemplary embodiment, the device 10 of the present invention includes separate components, such as a holder 12 (as shown in FIGS. 1-7B), a lancet body or lancet 14, and a collection container 16.

[00102] Referring to FIG. 11-13, in another exemplary embodiment, the semi-integrated device 300 of the present invention has an angled flow and includes an integrated lancet body and a collection container that can be connected to a separate holder. Referring to FIG. 14-16, in another exemplary embodiment, the semi-integrated device 400 of the present invention has unidirectional flow and includes an integrated lancet body and a collection container that can be connected to a separate holder.

[00103] Referring to FIG. 17-19, in another exemplary embodiment, the integrated device 100 of the present invention has an angled flow and includes an integrated holder, a lancet body, and a collection container. Referring to FIG. 20-22, in another exemplary embodiment, the integrated device 200 of the present invention has a unidirectional flow and includes an integrated holder, a lancet body, and a collection container.

[00104] Referring to FIG. 8-10, in an exemplary embodiment, the device 10 for obtaining a blood sample 18 includes separate components, for example, a holder 12, a lancet body or lancet 14, and a collection container 16. Fig. 1-7B illustrate exemplary embodiments of the finger holder or body 12 of the present invention.

[00105] Referring to FIG. 1-7B, exemplary embodiments of holders 12 of the present invention that are adapted to receive a sample source, such as a finger 19, for delivering a biological sample, such as a blood sample 18. The holder 12 of the present invention generally includes a finger receiving portion 20 having a first opening 22 (FIG. 5), an actuation portion 24, a portion 26 having a second opening 28, and a fingertip guard 30. In one embodiment, the fingertip guard 30 provides a stop portion for proper alignment and securing of the finger 19 in the holder 12.

[00106] The first opening 22 of the finger-receiving portion 20 is configured to receive a sample source, such as a finger 19, to supply a biological sample, such as a blood sample 18. It can be appreciated that the sample source may include other body parts adapted to be inserted into the first hole 22. The hole 26 is in communication with the finger receiving portion 20. For example, with the finger 19 received in the holder 12, the hole 26 is in communication with finger portion 19. Holder 12 of the present invention may be sized to accommodate all sizes of fingers.

[00107] The second opening 28 of the opening 26 is configured to receive the lancet body 14 and the collection container 16, as described in more detail below. In one embodiment, opening 26 includes a locking portion 32 to securely receive lancet body 14 and collection container 16 in opening 26.

[00108] In an embodiment, actuation portion 24 is movable between a first position (FIG. 2) at which holder 12 defines a first diameter and a second position (FIG. 3) at which holder 12 defines a second diameter, where the second diameter is less than the first diameter. In one embodiment, actuation portion 24 is movable between a first position (FIG. 2) in which holder 12 defines a first elliptical shape and a second position (FIG. 3) in which holder 12 defines a second elliptical shape, wherein the first the elliptical shape is different from the second elliptical shape. Thus, with the holder 12 in the reduced diameter second position, the portion of the holder 12 touches the sample source and the actuation portion 24 of the holder 12 is adapted to pump and/or withdraw blood 18, as described in more detail below.

[00109] Referring to FIG. 2 and 3, in one embodiment, actuation portion 24 includes contact member 34. Referring to FIG. 2, with the actuation portion 24 in the first position, the contact element 34 is in the disengaged position, i.e., the contact element 34 is provided in the first position with respect to the sample source, for example, the finger 19, so that the contact element 34 can be in a weak position. contact with him. Referring to FIG. 3, with the actuation portion 24 in the second position, the contact element 34 is in an engaged position, i.e., the contact element 34 is provided in a second position relative to the sample source, such as the finger 19, so that the contact element 34 is in contact with applied pressure with finger 19, and actuation portion 24 of holder 12 is adapted to pump and/or withdraw blood 18. For example, with contact member 34 in the engaged position, contact member 34 exerts pressure on the sample source.

[00110] Referring to FIG. 2 and 3, in one embodiment, actuation portion 24 includes a pumping element 36 for applying pressure to a sample source, such as a finger 19. In one embodiment, pumping element 36 includes a pair of opposing legs or wings 38. In such embodiment, each tab 38 may include a contact member 34. Referring to FIG. 1-3, in one embodiment, the holder 12 includes a flexible hinge portion 42. The flexible hinge portion 42 allows the user to compress the wings 38 between a first position (FIG. 2) and a second position (FIG. 3).

[00111] Advantageously, the holder 12 of the present invention allows the user to repeatedly squeeze and release the wings 38 to pump and/or withdraw blood 18 from the finger 19 until the desired amount of blood 18 is filled in the collection container 16.

[00112] Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not occlude the blood flow and defines the points of puncture and compression of the finger. The pinching tabs or wings 38 provide a predetermined range of pinching pressure that is consistently applied across the entire finger 19. In doing so, the holder 12 provides a gentle, controlled massage of the finger that stimulates blood extraction and minimizes any potential hemolysis.

[00113] Referring to FIG. 5, in one embodiment, holder 12 includes a stability extension portion 40. It provides additional support for the holder 12 to be securely 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 clamping members to provide additional clamping and support for so that the holder 12 is securely placed on the pin 19.

[00114] In one embodiment, the finger receiving portion 20 is formed from a flexible material. In some embodiments, the finger receiving portion 20 and opening 26 are formed from a flexible material.

[00115] FIG. 4A-7B illustrate other exemplary embodiments of holder 12 of the present invention. Referring to FIG. 4A-4B, holder 12 includes leaf spring 44. Referring to FIG. 6A-6B, holder 12 includes a double leaf spring 46. Referring to FIG. 7A-7B, holder 12 includes a triple leaf spring 48.

[00116] The device 10 for obtaining a blood sample 18 of the present invention includes a lancet body or lancet 14 that is detachably attachable to the opening 26 of the holder 12. Referring to FIG. 8, 9, and 13, in one embodiment, the lancet body 14 includes an inlet or opening 50, an interior 52, a piercing element 54, an engagement portion 56, a retractable mechanism 58, and an actuating spring 60. In one embodiment, the piercing element 54 is movable between a pre-actuation position in which the piercing member 54 is held within the interior 52 of the lancet body 14 and a piercing position in which at least a portion of the piercing member 54 extends through the inlet 50 of the lancet body 14 to pierce the finger portion 19 .

[00117] In one embodiment, the lancet 14 of the present invention is a contact-activated lancet and may be constructed in accordance with the features described in US Patent Application Publication No. 2006/0052809, filed May 6, 2005, entitled "Contact Activated Lancet Device", and owned by the same copyright holder as the present application, the full disclosure of which is thus expressly incorporated herein by reference.

[00118] Referring to FIG. 8-10, in one embodiment, the lancet body 14 may be a separate component from the holder 12 and collection container 16. Referring to FIG. 11-16, in some embodiments, the collection container 16 and the lancet body 14 form a single component that is removably attachable to the opening 26 of the holder 12. Referring to FIG. 17-22, in some embodiments, collection container 16, lancet body 14, and holder 12 form a single component.

[00119] Referring to FIG. 8-10, in one embodiment, with the holder 12 and the lancet body 14 being separate components, the lancet body 14 is detachably attachable to the opening 26 of the holder 12. In such an embodiment, the lancet body 14 includes an engagement portion 56. Referring to FIG. 9, in one embodiment, the lancet body 14 is pushed into the opening 26 of the holder 12 so that the engagement portion 56 of the lancet body 14 is locked in the locking portion 32 of the holder 12. Thus, the lancet body 14 is securely attached and locked in the holder 12 so that the piercing member 54 of lancet body 14 can be activated to pierce or pierce a sample source, such as a finger 19. In some embodiments, opening 26 of holder 12 includes a plurality of ribs for securing and locking lancet 14 or litter box 16 in opening 26.

[00120] 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 invention consistently provides the correct puncture depth and predetermined puncture location, thus providing sufficient volume sample.

[00121] In one embodiment, the lancet 14 includes an actuating spring 60 located in the interior 52 of the body 14 of the lancet to shift the piercing element 54 towards the piercing position. After piercing, the piercing element 54 is immediately retracted and secured securely in the interior 52 of the lancet body 14.

[00122] Referring to FIG. 8-10, in one embodiment, the lancet 14 of the present invention is used to puncture the skin of the finger 19, and then the blood sample 18 is extruded into the collection container 16, as described in more detail below.

[00123] Referring to FIG. 19, in one embodiment, the lancet body 14 of the present invention is used to puncture the skin of the finger 19 along the puncture path, and then the blood sample 18 flows down the blood flow path at an angle to the puncture path, as described in more detail below.

[00124] Referring to FIG. 21 and 22, in one embodiment, the lancet 14 includes a cannula 62. In such an embodiment, the body 14 of the lancet of the present invention is used to pierce the skin of the finger 19 along the puncture path, and then the blood sample 18 flows along the parallel blood flow channel through hollow needle 62, as described in more detail below.

[00125] The device 10 for obtaining a blood sample 18 of the present invention includes a collection container 16 that is detachably attachable to the opening 26 of the holder 12. The collection container 16 defines a collection cavity 70 for receiving a blood sample 18, a container engagement portion 72 , a blood collector portion 74, and a cap or membrane 76. After the desired amount of blood 18 is collected in the container 16, the blood collector portion 74 is detached from the collection device 10 in order to send the collected sample 18 to a diagnostic tool and/or testing device. The blood collector portion 74 is sealed by a cap or membrane 76 upon removal from the collection device 10 to seal the blood sample 18 in a protective manner within the collection cavity 70 .

[00126] Referring to FIG. 8-10, in one embodiment, the collection container 16 may be a separate component from the holder 12 and the body 14 of the lancet. Referring to FIG. 11-16, in some embodiments, the collection container 16 and the lancet body 14 form a single component that is removably attachable to the opening 26 of the holder 12. Referring to FIG. 17-22, in some embodiments, collection container 16, lancet body 14, and holder 12 form a single component.

[00127] Referring to FIG. 8-10, in one embodiment, with the holder 12 and the collection container 16 being separate components, the collection container 16 is detachably attachable to the opening 26 of the holder 12. In such an embodiment, the container 16 includes a container engagement portion 72. Referring to FIG. 10, in one embodiment, the container 16 is pushed into the opening 26 of the holder 12 so that the engagement portion 72 of the container 16 is locked into the locking portion 32 of the holder 12. In this way, the container 16 is securely attached and locked in the holder 12 so that the blood sample 18 can flow safely from pin 19 in holder 12 into cavity 70 for collecting container 16.

[00128] It may be appreciated that several types of collection containers 16 may be used with the device 10 of the present invention. It may also be understood 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 into the testing device.

[00129] Referring to FIG. 8-10 and 27-31, the use of the device 10 of the present invention having separate components, for example, a holder 12, a lancet body or lancet 14 and a collection container 16, will now be described.

[00130] Referring to FIG. 27, first, the desired finger 19 is cleaned, and a holder 12 having an appropriate size for the desired finger 19 is selected and placed on the finger 19 in a secure manner. Further, referring to FIG. 28, the lancet body 14 is attached to the opening 26 of the holder 12. As discussed above, the holder body 14 is pushed into the opening 26 of the holder 12 so that the engagement portion 56 of the lancet body 14 is locked in the locking portion 32 of the holder 12. Thus, the lancet body 14 is securely attached and locks into the holder 12 so that the piercing member 54 (FIG. 13) of the lancet body 14 can be activated to pierce or puncture a sample source, such as a finger 19. With the lancet 14 attached to the opening 26 of the holder 12, the lancet is in communication with finger 19.

[00131] Referring to FIG. 28, 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 retraction mechanism 58 (FIG. 13) of the lancet 14 to pierce the finger 19. The lancet 14 of the present invention consistently provides the correct puncture depth and a predetermined puncture location, thus ensuring sufficient sample volume.

[00132] After finger 19 is pierced to create blood flow 18 (FIG. 30) from finger 19, lancet 14 is removed from holder 12 and collection container 16 is pushed into opening 26 of holder 12. Referring to FIG. 29, the container 16 is pushed into the opening 26 of the holder 12 so that the container engagement portion 72 of the container 16 is locked into the locking portion 32 of the holder 12. In this way, the container 16 is securely attached and locked in the holder 12 so that the blood sample 18 can safely flow from finger 19 in the holder 12 into the cavity 70 for collecting the container 16.

[00133] Referring to FIG. 29 and 30, with the container 16 correctly attached to the blood sample holder 12 18, the user is able to repeatedly squeeze and release the wings 38 of the holder 12 to pump and/or withdraw blood 18 from the finger 19 until the desired amount of blood 18 will not be filled in the container 16 for collection. Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not occlude the blood flow and defines the puncture and pressure points of the finger. The compressive tabs or wings 38 provide a predetermined range of compressive pressure that is consistently applied throughout the finger 19. In doing so, the holder 12 provides a gentle, controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[00134] For example, referring to FIG. 2 and 3, in one embodiment, actuation portion 24 includes contact member 34. Referring to FIG. 2, with the actuation portion 24 in the first position, the contact element 34 is in the disengaged position, i.e., the contact element 34 is in the first position with respect to the sample source, eg the finger 19. Referring to FIG. 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 applied pressure contact with a sample source, such as a finger 19, and the portion 24 actuating holder 12 is capable of pumping and/or withdrawing blood 18. For example, with contact element 34 in the engaged position, contact element 34 exerts pressure on the sample source.

[00135] Referring to FIG. 31, after the desired amount of blood 18 is collected in the container 16, the blood collector portion 74 is detached from the collection device 10 in order to send the collected sample 18 to a diagnostic tool and/or testing device. The blood collector portion 74 is sealed by a cap or membrane 76 upon removal from the collection device 10 to seal the blood sample 18 in a protective manner within the collection cavity 70 .

[00136] The devices of the present invention are compatible with any known testing device, whether the testing device is a third-party or 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 testing devices for testing and analysis. Test strips, slides, and diagnostic cartridges are point-of-care testing devices that take a blood sample and test that blood for one or more physiological and biochemical conditions. There are many point-of-care devices that use cartridge-based architecture to analyze very small amounts of blood at the bedside without having to send the sample to a lab for analysis. This saves time in getting results in the long run, but creates a different set of problems compared to the most common laboratory environment. Examples of such test cartridges include the i- ^STAT® test cartridge from the Abbot group of companies. Test cartridges such as the i- ^STAT® cartridges can be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, clotting, and cardiotonic markers. The results of tests using such cartridges are quickly provided to the attending physician.

[00137] The collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood sample and/or the blood sample component placed therein. The collection container 16 may also include at least one filling line(s) corresponding to a predetermined sample volume. The collection container may also indicate/measure the volume of blood collected.

[00138] Referring to FIG. 17-19, in another exemplary embodiment, the blood sample collection device 100 of the present invention has an angled flow and includes an integrated holder 12, a lancet body 14, and a collection container 16. In such an embodiment, the user does not have to attach the separate lancet body 14 to the hole 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then attach the collection container 16 to the hole 26 of the holder 12.

[00139] Referring to FIG. 17-19, the lancet body 14 is permanently fixed in the opening 26 of the holder 12. The lancet body 14 includes a channel 120 for blood flow. The collection container 16 is attached to the lancet body 14 and includes a blood collector portion 74 that is removably attachable to the lancet body 14 portion.

[00140] Referring to FIG. 19, in one embodiment, with the container 16 attached to the lancet body 14, the longitudinal axis 102 of the lancet body 14 is at an angle to the longitudinal axis 104 of the container 16. Referring to FIG. 19, in one embodiment, the lancet body 14 is used to puncture the skin of the finger 19 along the puncture path 103 and then the blood sample 18 flows down the blood flow path 105 at an angle to the puncture path 103.

[00141] Referring to FIG. 17-19, in one embodiment, device 100 includes capillary tube 110. Referring to FIG. 19, with container 16, i.e., blood collector portion 74, attached to lancet body 14, capillary tube 110 is in fluid communication with inlet or opening 50 of lancet body 14 and collection cavity 70 of container 16. In one embodiment, the portion capillary tube 110 is pulled through the channel 120 of the blood flow of the body 14 of the lancet.

[00142] Referring 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 piercing element 54 in the piercing position, the piercing element 54 pierces the finger 19 to collect 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 invention consistently provides the correct puncture depth and predetermined puncture location, thus ensuring sufficient sample volume.

[00143] The blood 18 will flow from the finger 19 into the blood flow channel 120 of the lancet body 14. The blood 18 flows, along the blood flow path 105, at an angle to the puncture path 103 . For example, blood sample 18 flows through capillary tube 110 into collection cavity 70 of container 16.

[00144] Referring to FIG. 20-22, in another exemplary embodiment, the blood sample collection device 200 of the present invention has unidirectional flow and includes an integrated holder 12, a lancet body 14, and a collection container 16. In such an embodiment, the user does not have to attach the separate lancet body 14 to the hole 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then attach the collection container 16 to the hole 26 of the holder 12.

[00145] Referring to FIG. 20-22, the lancet body 14 is permanently fixed in the opening 26 of the holder 12. The lancet body 14 includes a hollow needle 62. For example, the piercing element 54 of the lancet 14 includes a hollow needle 62. itself section 74 of the collector of blood, which is removable way attached to the section of the body 14 of the lancet.

[00146] Referring to FIG. 21, in one embodiment, with container 16 attached to lancet body 14, longitudinal axis 202 of opening 26, lancet body 14, and container 16 are aligned.

[00147] Referring to FIG. 21 and 22, in one embodiment, the lancet 14 includes a cannula 62. In such an embodiment, the body 14 of the lancet of the present invention is used to pierce the skin of the finger 19 along the puncture path 203, and then the blood sample 18 flows along the parallel flow path 205 blood through a hollow needle 62.

[00148] Referring to FIG. 20-22, in one embodiment, the lancet body 14 includes an outlet 210. With the container 16 attached to the lancet body 14, the outlet 210 of the lancet body 14 is in fluid communication with the collection cavity 70 of the container 16.

[00149] Referring to FIG. 20-22, the blood flow path 205 of the device 200 will now be described. With the finger 19 received in the holder 12 and the piercing element 54 in the piercing position, the piercing element 54 pierces the finger 19 to collect 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 invention consistently provides the correct puncture depth and predetermined puncture location, thus ensuring sufficient sample volume.

[00150] Blood 18 will flow from finger 19 through cannula 62 into outlet 210 of lancet body 14 into collection cavity 70 of container 16. Blood 18 flows, along blood flow path 205, in line with puncture path 203.

[00151] Referring to FIG. 23-26, the use of a single-line flow device 200 of the present invention, including an integrated holder 12, a lancet body 14, and a collection container 16, will now be described.

[00152] Referring to FIG. 23, first, the desired finger 19 is cleaned, and a holder 12 having an appropriate size for the desired finger 19 is selected and placed on the finger 19 in a secure manner. In the integrated device 200 of the present invention, a separate lancet 14 and container 16 do not need to be selected and attached to the opening 26 of the holder 12, since the holder 12, the lancet body 14 and the collection container 16 are each combined into a single component.

[00153] Referring to FIG. 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 (FIG. 21) of the lancet 14 to pierce the finger 19. The lancet 14 of the present invention consistently provides the correct puncture depth and a predetermined puncture location, thus ensuring sufficient sample volume.

[00154] Referring to FIG. 25, after the finger 19 is pierced to create 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 withdraw blood 18 from the finger 19 until the desired amount of blood 18 will not be filled in the container 16 for collection. Advantageously, with the holder 12 placed on the finger 19, the holder 12 does not occlude the blood flow and defines the puncture and pressure points of the finger. The compressive tabs or wings 38 provide a predetermined range of compressive pressure that is consistently applied throughout the finger 19. In doing so, the holder 12 provides a gentle, controlled massage of the finger 19 that stimulates blood 18 to be drawn and minimizes any potential hemolysis.

[00155] Referring to FIG. 26, after the desired amount 18 of blood is collected in the container 16, the blood collector portion 74 is detached from the collection device 200 and sealed with a cap or membrane 76 to send the collected sample 18 to a diagnostic tool and/or testing device. As discussed above, the collection container 16 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood and fill lines to indicate/measure the volume of blood 18 collected.

[00156] Referring to FIG. 11-16, using the device 300 (FIGS. 11-13) having an angled flow and including an integrated lancet body 14 and a collection container 302 that can be connected to a separate holder 12; and an apparatus 400 (FIGS. 14-16) having a co-linear flow and including an integrated lancet body 14 and a collection container 402 that can be connected to a separate holder 12 will now be described.

[00157] Referring to FIG. 11-13, the semi-integrated device 300 is used in the same manner as the oblique flow device 100, including the integrated holder, lancet body, and collection container described above with reference to FIGS. 17-19. With the semi-integrated device 300, the user does not have to attach a separate lancet body 14 to the hole 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then attach the collection container 16 to the hole 26 of the holder 12. In the embodiment shown in FIG. 11-13, the user need only attach the integrated lancet body and the collection container component 302 to the opening 26 of the holder 12.

[00158] Referring to FIG. 14-16, the semi-integrated device 400 is used in the same manner as the co-flow device 200, including the integrated holder, lancet body, and collection container described above with reference to FIGS. 20-22. With the semi-integrated device 400, the user does not have to attach a separate lancet body 14 to the hole 26 of the holder 12, remove the lancet 14 after piercing the skin of the finger 19, and then attach the collection container 16 to the hole 26 of the holder 12. In the embodiment shown in FIG. 14-16, the user need only attach the integrated lancet body and the collection container component 402 to the opening 26 of the holder 12.

[00159] Any of the blood sampling devices of the present invention can be used as a stand-alone disposable device and/or in association with an external power source to control pain reduction. For example, the holder portion 12 may include embedded electrodes that receive a signal from an external pain control module to deliver at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TENS) to control pain reduction. The blood sample collection devices of the present invention may also include various options for in situ plasma separation. The blood sample collection devices of the present invention may also include a unique sample identifier that can be paired with patient information at the time of collection. The blood sample collection devices of the present invention may also include on-site diagnostic feedback at the time of collection. The blood sample acquiring device of the present invention may also allow for dual collection, such as collecting two samples in two separate containers, using a plurality of collection ports, which allow the collection of multiple samples from the same source and treatment of the samples with different stabilizers. sample, such as anticoagulants.

[00160] The blood sample collection device of the present invention greatly simplifies and reduces the skill requirement for large volume capillary fingertip collection relative to traditional capillary collection using a lancet and a capillary tube. The devices of the present invention eliminate exposure of the blood and prevent reuse of the device.

[00161] The blood sampling devices of the present invention simplify, reduce skill requirements, and improve the collection process. This is all achieved through a self-contained closed system device which, once placed on the finger, will provide the functions of puncture, blood extraction, stabilization and sealing, all in one unit.

[00162] The blood sample acquiring devices of the present invention may be associated with a stand-alone unit that provides automatic inflation, controlled finger squeezing, and automatic sample labeling and handling.

[00163] Referring to FIG. 32-37d, exemplary embodiments of the holders 112 of the present invention are described that are adapted to receive a sample source, such as a finger 19, for delivering a biological sample, such as a blood sample. The holder 112 of the present invention generally includes a finger receiving portion 120 having a first opening 122, an actuation portion 124, an opening 126 having a second opening 128, and a fingertip guard 130. In one embodiment, the fingertip guard 130 provides a stop portion for proper alignment and securing of the finger 19 in the holder 112.

[00164] The first opening 122 of the finger-receiving portion 120 is configured to receive a sample source, such as a finger 19, to supply a biological sample, such as a blood sample. It can be appreciated that the sample source may include other body parts adapted for insertion into the first hole 122. The hole 126 is in communication with the finger receiving portion 120. For example, with the finger 19 received in the holder 112, the hole 126 is in communication with finger portion 19. Holder 112 of the present invention may be sized to accommodate all sizes of fingers.

[00165] The second opening 128 of the opening 126 is configured to receive the lancet body 14 and the collection container 116, as described in more detail below. In one embodiment, opening 126 includes a locking portion 132 for securely receiving lancet body 14 and collection container 116 at opening 126.

[00166] In one embodiment, actuation portion 124 is movable between a first position where holder 112 defines a first diameter and a second position where holder 112 defines a second diameter, where the second diameter is smaller than the first diameter. In one embodiment, actuation portion 124 is movable between a first position where holder 112 defines a first elliptical shape and a second position where holder 112 defines a second elliptical shape, with the first elliptical shape different from the second elliptical shape. Thus, with the holder 112 in the reduced diameter second position, the portion of the holder 112 touches the sample source, and the actuation portion 124 of the holder 112 is adapted to pump and/or withdraw blood, as described in more detail below.

[00167] In one embodiment, the actuation portion 124 includes a contact element 134. With the actuating portion 124 in the first position, the contact member 134 is in the disengaged position, i.e., the contact member 134 is provided in the first position relative to sample source, such as finger 19, so that the contact element 134 may be in light contact with it. With the actuation portion 124 in the second position, the contact element 134 is in the engaged position, i.e., the contact element 134 is provided in the second position relative to the sample source, such as the finger 19, so that the contact element 134 is in contact with the applied pressure. with a finger 19, and the actuation portion 124 of the holder 112 is adapted to pump and/or withdraw blood. For example, with the contact element 134 in the engaged position, the contact element 134 exerts pressure on the sample source.

[00168] In one embodiment, actuation portion 124 includes a pumping element 136 for applying pressure to a sample source, such as a finger 19. In one embodiment, pumping element 136 includes a pair of opposed tabs or wings 138. In such an embodiment, each tab 138 may include a contact member 134. In one embodiment, the holder 112 includes a flexible hinge portion 142. The flexible hinge portion 142 allows a user to compress the wings 138 between a first position and a second position.

[00169] Advantageously, the holder 112 of the present invention allows the user to repeatedly squeeze and release the wings 138 to pump and/or draw blood from the finger 19 until the desired amount of blood is filled in the collection container 116.

[00170] Advantageously, with the holder 112 placed on the finger 19, the holder 112 does not occlude the blood flow and defines the points of puncture and compression of the finger. The pinch tabs or wings 138 provide a predetermined range of pinch pressure that is consistently applied across the entire finger 19. In doing so, the holder 112 provides a gentle, controlled massage of the finger that stimulates blood extraction and minimizes any potential hemolysis.

[00171] In one embodiment, holder 112 includes a stability extension portion 140. It 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 clamping members to provide additional clamping and support for so that holder 112 is securely placed on pin 19.

[00172] In one embodiment, the finger receiving portion 120 is formed from a flexible material. In some embodiments, the finger receiving portion 120 and opening 126 are formed from a flexible material.

[00173] The device 350 for obtaining a blood sample of the present invention includes a lancet body or lancet 114, which is detachably attached to the opening 126 of the holder 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 herein. In one embodiment, the piercing element is movable between a pre-actuation position in which the piercing element is held within the interior of the lancet 114 and a piercing position in which at least a portion of the piercing element extends through the inlet of the lancet 114 to pierce the finger portion. 19.

[00174] In one embodiment, the lancet 114 of the present invention is a contact-activated lancet and may be constructed in accordance with the features described in US Patent Application Publication No. 2006/0052809, filed May 6, 2005, entitled "Contact Activated Lancet Device", and owned by the same copyright holder as the present application, the full disclosure of which is thus expressly incorporated herein by reference.

[00175] In one embodiment, the lancet 114 may 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 is detachably attachable to the opening 126 of the holder 112. In some embodiments, the collection container 116, the lancet 114 and the holder 112 form a single component.

[00176] In one embodiment, with the holder 112 and the lancet 114 being separate components, the lancet 114 is detachably attachable to the opening 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 opening 126 of the holder 112 so that the engagement portion of the lancet 114 is locked into the opening 126 of the holder 112. In this way, the lancet 114 is securely attached and locked in the holder 112 so that the lancing element of the lancet 114 can be activated to impale or pierce a sample source, such as finger 19. In some embodiments, opening 126 of holder 112 includes a plurality of ribs for securing and locking lancet 114 or litter box 116 in opening 126.

[00177] 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 invention consistently provides the correct puncture depth and predetermined puncture location, thus providing sufficient sample volume .

[00178] In one embodiment, the lancet 114 includes an actuating spring located within the interior of the lancet 114 to bias the piercing element toward the piercing position. After piercing, the piercing element is immediately retracted and securely secured in the interior of the lancet 114.

[00179] In one embodiment, the lancet 114 of the present invention is used to pierce the skin of the finger 19, and then the blood sample is extruded into the collection container 116, as described in more detail below.

[00180] In one embodiment, the lancet 114 of the present invention is used to pierce the skin of the finger 19 along the puncture path, and then the blood sample flows down the blood flow path at an angle to the puncture path, as described in more detail below.

[00181] In one embodiment, the lancet 114 includes a cannula. In such an embodiment, the lancet 114 of the present invention is used to pierce the skin of the finger 19 along the puncture path, and then the blood sample flows along the parallel blood flow path through the cannula, as described in more detail below.

[00182] The blood sample acquisition device 350 of the present invention includes a collection container 116 that is detachably attachable to the opening 126 of the holder 112. The collection container 116 defines a collection cavity 170 for receiving a blood sample, a blood collector portion 174, and a cap or a membrane 176. After the desired amount of blood is collected in the container 116, the blood collector portion 174 is detached from the collection device 350 in order to send the collected sample to a diagnostic tool and/or testing device. The blood collector portion 174 is sealed by a cap or membrane 176 upon removal from the collection device 350 to seal the blood sample in the collection cavity 170 in a protective manner.

[00183] In one embodiment, with the holder 112 and the collection container 116 being separate components, the container engagement portion 182 that holds the collection container 116 may be detachable or permanently attachable to the connection interface 180 of the holder 112. The engagement portion 182 container may define an opening for receiving and holding container 116 for collection. The collection container 116 may be retained in the container engagement portion 182 through any suitable means, including friction fit, mechanical fit, or any alternative releasable connection, to allow the collection container 116 to separate from the container engagement portion 182 after the blood sample was collected in the cavity 170 for collection. The container engaging portion 182 may also include a container locking portion 172 that is configured to engage with the opening 126 of the holder 112 to lock the container engaging portion 182 in the opening 126. Referring to FIG. 32, in one embodiment, the container engagement portion 182 includes a protrusion 184 that is pushed or guided into the connector interface 180 of the holder 112 such that the container engagement portion 182 of the container 116 locks into the connector interface 180 of the holder 112. Thus, the container 116 securely attaches and locks into the holder 112 so that the blood sample can safely flow from the finger 19 in the holder 112 into the collection cavity 170 of the container 116. The connection interface 180 and the container engagement portion 182 may be connected before puncture or at the point of manufacture. This pre-connected swivel mechanism provides a quick and connected connection of the collection container 116 to the holder 112. Due to the connection between the connecting interface 180 of the holder 112 and the container engagement portion 182, the container engagement portion 182 is pivotally movable relative to the holder 112. Therefore, with the collection container 116 held in the container engaging portion 182, the collection container 116 can be pivotally moved between a first position, in which the collection container 116 is positioned at a distance from the opening 126 on the holder 112, and a second position, in which the collection container 116 is positioned in one line with the hole 126 of the holder 112 to collect a blood sample from the finger 19 of the patient.

[00184] With reference to FIG. 34a-34d, alternative connection arrangements between connection interface 180 and ledge 184 are illustrated and described. As shown in FIG. 34a, connecting interface 180 and protrusion 184 may include a ball joint type connection. It is contemplated that either 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 for receiving the ball. As shown in FIG. 34b, connecting interface 180 and protrusion 184 may include a pin-and-hole swivel type connection. It is contemplated that either the connector interface 180 or the protrusion 184 may include a pin, and the other of the connector interface 180 and the protrusion 184 may include a hole or socket to receive the pin. With reference to FIG. 34c, connecting interface 180 and protrusion 184 may include a swivel type connection with a stud and retaining ring. It is contemplated that either the connecting interface 180 or the protrusion 184 may include a stud, and the other of the connecting interface 180 and the protrusion 184 may include a retaining ring to receive the stud. With reference to FIG. 34d, connecting interface 180 and protrusion 184 may include a tongue and groove swivel type connection. It is contemplated that either the connection interface 180 or the protrusion 184 may include a tenon, and the other of the connection interface 180 and the protrusion 184 may include a notch for receiving the tenon. It is further contemplated herein that other alternative connection arrangements between connection interface 180 and ledge 184 may also be used in the present invention. The previously described compounds are non-limiting.

[00185] Referring to FIG. 35 and 36, in one embodiment, the connecting interface 180 of the holder 112 may include a flexible hinge 186 and a connecting tab 188 that is received in a slot 190 defined in the container engagement portion 182. Thus, the container 116 is securely attached to and locked in the holder 112 so that the blood sample can safely flow from the finger 19 in the holder 112 into the collection cavity 170 of the collection container 116. The connecting interface 180 and the container engagement portion 182 may be connected prior to puncture or at the point of manufacture. This pre-connected swivel mechanism provides a quick and coherent connection of the collection container 116 to the holder 112. Due to the flexible hinge 186 provided with the connecting interface 180 of the holder 112, the container engagement portion 182 is pivotally movable relative to the holder 112. Therefore, with the collection container 116 held in the container engaging portion 182, the collection container 116 can be pivotally moved between a first position, in which the collection container 116 is positioned at a distance from the opening 126 on the holder 112, and a second position, in which the collection container 116 is positioned in line with opening 126 of the holder 112 to collect a blood sample from the finger 19 of the patient.

[00186] With reference to FIG. 37a-37d, alternative connecting arrangements between the connecting tab 188 and slot 190 are illustrated and described. As shown in FIG. 37a, the connecting tab 188 and the slot 190 may include a keyed snap connection. It is contemplated that the connecting tab 188 may be keyed to be received in the slot 190, which is shaped to match the key of the connecting tab 188. The connecting tab 188 may be snapped into the slot 190. As shown in FIG. 37b, the connecting tab 188 and the slit 190 may include a hook-and-loop connection. It is contemplated that the connecting tab 188 may be a hook element to be received into the slot 190 in a pivotal manner. The connecting tab 188 can be snapped into the slot 190. The first end of the hook of the connecting tab 188 can be snapped into the slot 190, and then the second end of the hook of the connecting tab 188 can be rotated in the opposite direction to snap into the opposite end of the slot 190. As shown in fig. 37c, the connecting tab 188 and slot 190 may include a snap ring and latch connection. It is contemplated that the connecting tab 188 may be a retaining ring that is to be received in the slot 190 with a snap fit. The protruding tab stop ring 188 may include internal extensions 192 that snap into corresponding holes 194 defined in slot 190. As shown in FIG. 37d, the connecting tab 188 and the slot 190 may include a connection with a pin and a profiled engagement. It is contemplated that the connecting tab 188 may be a pin to be received in a slot 190 which has a profile to match the pin. The connecting tab 188 may snap into the slot 190. It is further contemplated herein that other alternative connecting arrangements between the connecting interface 188 and the slot 190 may also be applied in the present invention. The previously described compounds are non-limiting.

[00187] Referring to FIG. 32, in one embodiment, the container 116 is pushed into the opening 126 of the holder 112 so that the container locking portion 172 of the container engaging portion 182 is locked into the locking portion 132 of the holder 112. Thus, the collection container 116 is securely attached and locked in the holder 112, so that the blood sample can safely flow from the finger 19 in the holder 112 into the collection cavity 170 of the collection container 116.

[00188] Referring to FIG. 38-42, the use of a single-line flow device 350 of the present invention including an integrated holder 112, a lancet 114, and a collection container 116 will now be described.

[00189] Referring to FIG. 38, first, the desired finger 19 is cleaned, and a holder 112 having an appropriate size for the desired finger 19 is selected and placed on the finger 19 in a secure manner.

[00190] Referring to FIG. 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 invention consistently provides the correct puncture depth and predetermined puncture location, such thus ensuring sufficient sample volume.

[00191] Referring to FIG. 40, after the finger 19 is pierced to create blood flow from the finger 19, the user can rotate the collection container 116 to the second position for locking in the holder 112. Referring to FIG. 41, once the container engagement portion 182 has been locked into the holder 112, the user is able to repeatedly squeeze and release the wings 138 of the holder 112 to pump and/or draw blood from the finger 19 until the desired amount of blood is filled into the container 116. for collection. Advantageously, with the holder 112 placed on the finger 19, the holder 112 does not occlude the blood flow and defines the points of puncture and compression of the finger. The compressive tabs or wings 138 provide a predetermined range of compressive pressure that is consistently applied across the entire finger 19. In doing so, the holder 112 provides a gentle, controlled massage of the finger 19 that stimulates blood extraction and minimizes any potential hemolysis.

[00192] Referring to FIG. 42, after the desired amount of blood is collected in the container 116, the collection container 116 is detached from the container engagement portion 182 and sealed with a cap or membrane 176 to send the collected sample to a diagnostic tool and/or testing device. As discussed above, the collection container 116 may also contain a sample stabilizer, such as an anticoagulant, to stabilize the blood and fill lines to indicate/measure the volume of blood collected. In the event that additional blood is to be collected from the patient, the 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.

[00193] With reference to FIG. 43, a tray 400 is described for holding a plurality of different holders 112 that can be sorted by size and used on a patient's finger 19. Tray 400 may also include separate sections 402a-402i that hold individual components that can assist a user in using holder 112 to collect a patient's blood sample into collection container 116. Each section 402a-402i may include a label indicating which process step each section 402a-402i corresponds to in order to indicate to the user the particular step in the process to which each section 402a-402i applies. Tray 400 can hold all necessary components that a user would need to collect a blood sample from a patient's finger 19 . The tray 400 is intended to guide the user in performing the sequence of actions in the correct sequence in a timely manner. In the first section 402a, labeled "Step 1", the finger measurement card 404 is held in a groove defined in the tray 400. The finger measurement card 404 may include several different holes that have different diameters corresponding to different sized holders 112. To To ensure that the correct holder 112 is being used on the patient, the patient will insert her/his finger 19 into various holes in the finger measurement card 404 to determine the particular holder 112 that matches the patient's finger 19.

[00194] In the second section 402b, labeled "Step 2", an instruction is provided to indicate to the user that the patient's hand/finger is to be heated. In the third section 402c, labeled "Step 3", a groove is defined to hold a plurality of disinfectant wipes 406. The user may use the disinfectant wipe 406 to disinfect the puncture site on the patient's finger 19. In the fourth section 402d, labeled "Step 4", a plurality of holes 408 are defined in section 402c of tray 400 to hold holders 112 of various sizes. for finger 19 patient. Once the correct holder 112 has been identified, the user will insert the patient's finger 19 into the holder 112 as described above.

[00195] In the fifth section 402e, labeled "Step 5", an opening 410 is defined in the tray 400 to hold the lancet 114. The user may remove the lancet 114 from the tray and use the lancet 114 to pierce the patient's finger 19 as described above. In the sixth section 402f, labeled "Step 6", an opening 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 attached to the holder 112 to collect a blood sample from the patient's finger 19 as described above.

[00196] In the seventh section 402g, labeled "Step 7", an instruction is provided to inflate the patient's finger 19 with the holder 112. In the eighth section 402h, labeled "Step 8", an opening 414 is defined in the tray 400 to hold the collection container 116, after a blood sample was taken from the finger 19 of the patient. In the ninth section 402i, labeled "Step 9", an opening 416 is defined in the tray 400 to hold dressings 418 that can be applied to the patient's finger 19 after the holder 112 has been removed from it.

[00197] While this invention has been described as having exemplary designs, the present invention may be further modified in the spirit and scope of this invention. This application is therefore intended to cover any modification, use or adaptation of the invention using its basic principles. Additionally, this application is intended to cover such departures from the present invention as fall within known or customary practice in the technical field to which this invention belongs and which fall within the limitations of the appended claims.

Claims (38)

1. A device for obtaining a blood sample, the device contains: a holder for receiving a sample source, the holder having an actuation portion and an opening; a container engaging portion connected to the holder; and a collection container removably attachable to the engagement portion of the container, the container defining a collection cavity, wherein the container engagement portion allows the collection container to pivot between a first position where the collection container is spaced apart from the opening and a second position where the collection container is in fluid communication with the opening. 2. The apparatus of claim 1, wherein the actuation portion is movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse. 3. The apparatus of claim 1, wherein the actuation portion includes a contact element. 4. The apparatus of claim 3, wherein the actuation portion is movable between a first position in which the contact element is in the disengaged position and a second position in which the contact element is in the engaged position. 5. The apparatus of claim 4, wherein with the contact element in the engaged position, the contact element exerts pressure on the sample source. 6. The apparatus of claim 1, wherein the actuation portion includes a pumping element for applying pressure to the sample source. 7. The device of claim. 6, in which the pumping element contains a pair of opposite tabs. 8. The apparatus of claim 1 wherein the sample source is a finger. 9. The device of claim. 8, in which the finger received in the holder, the hole is in communication with the area of the finger. 10. The apparatus of claim. 1, wherein the container engagement portion and the holder are connected by a ball joint, a pin-and-hole pivot, a stud-retaining ring pivot, or a tongue-and-groove pivot. 11. The device of claim. 1, in which the holder contains a flexible hinge, which is attached to the section of the engagement of the container. 12. The apparatus of claim 11, wherein the flexible hinge is connected to the engagement portion of the container through a keyed snap connection structure, a hook and snap connection structure, a retaining ring and snap connection structure, or a pin and profiled engagement. 13. The device for obtaining a blood sample contains: a sample source receiving holder, the holder having an actuating portion and an opening; and a container engagement portion connected to the holder and configured to hold the collection container; wherein the container engagement portion allows the collection container to pivot between a first position where the collection container is spaced apart from the opening and a second position where the collection container is in fluid communication with the opening. 14. The apparatus of claim 13, wherein the actuation portion is movable between a first position where the holder defines a first ellipse and a second position where the holder defines a second ellipse, the second ellipse being different from the first ellipse. 15. The apparatus of claim 13, wherein the actuation portion includes a contact element. 16. The apparatus of claim 15, wherein the actuation portion is movable between a first position in which the contact element is in the disengaged position and a second position in which the contact element is in the engaged position. 17. The apparatus of claim 16 wherein, with the contact element in the engaged position, the contact element exerts pressure on the sample source. 18. The apparatus of claim 13, wherein the actuation portion includes a pumping element for applying pressure to the sample source. 19. The device of claim 18, wherein the pumping element comprises a pair of opposing legs. 20. The apparatus of claim 13 wherein the sample source is a finger. 21. The device of claim. 20, in which the finger received in the holder, the hole is in communication with the area of the finger. 22. The apparatus of claim 13, wherein the container engagement portion and the holder are connected by a ball joint, a pin-and-hole pivot, a stud-retaining ring pivot, or a tongue-and-groove pivot. 23. The apparatus of claim. 13, wherein the carrier comprises a flexible hinge that is attachable to the container engaging portion. 24. The apparatus of claim 23, wherein the flexible hinge is connected to the engagement portion of the container by a keyed snap connection arrangement, a hook and snap connection arrangement, a retaining ring and snap connection arrangement, or a pin and profiled engagement. 25. A tray for holding components used to obtain a blood sample, containing: sections for holding components used to obtain a blood sample containing: a first section for holding a finger measurement card; a second section for holding at least two holders; a third section to hold the lancet; and a fourth section for holding the collection container according to claim 13 to hold the blood sample after the blood sample has been taken from the patient's finger, wherein each section includes a label corresponding to a sequential step in the method for obtaining a blood sample.

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