Patent Application
20220031211
The present disclosure relates generally to a device for obtaining a biological sample. More particularly, the present disclosure relates to an integrated finger-based capillary blood collection device with the ability to lance and squeeze a finger, collect, stabilize, and dispense a blood sample in a controlled manner
Devices for obtaining and collecting biological samples, such as blood samples, are commonly used in the medical industry. One type of blood collection that is commonly done in the medial field is capillary blood collection which is often done to collect blood samples for testing. Certain diseases, such as diabetes, require that the patient's blood 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 body part in order to obtain the blood sample. Typically, the amount of blood needed for such tests is relatively small and a small puncture wound or incision normally provides a sufficient amount of blood for these tests. Various types of lancet devices have been developed which are used for puncturing the skin of a patient to obtain a capillary blood sample from the patient.
Many different types of lancet devices are commercially available to hospitals, clinics, doctors' offices, and the like, as well as to individual consumers. Such devices typically include a sharp-pointed member such as a needle, or a sharp-edged member such as a blade, that is used to make a quick puncture wound or incision in the patient's skin in order to provide a small outflow of blood. It is often physiologically and psychologically difficult for many people to prick their own finger with a hand-held needle or blade. As a result, lancet devices have evolved into automatic devices that puncture or cut the skin of the patient upon the actuation of a triggering mechanism. In some devices, the needle or blade is kept in a standby position until it is triggered by the user, who may be a medical professional in charge of drawing blood from the patient, or the patient himself or herself Upon triggering, the needle or blade punctures or cuts the skin of the patient, for example, on the finger. Often, a spring is incorporated into the device to provide the “automatic” force necessary to puncture or cut the skin of the patient.
One type of contact activated lancet device that features automatic ejection and retraction of the puncturing or cutting element from and into the device is U.S. Pat. No. 9,380,975, which is owned by Becton, Dickinson and Company, the assignee of the present application. This lancet device includes a housing and a lancet structure having a puncturing element. The lancet structure is disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure. The blood sample that is received is then collected and/or tested. This testing can be done by a Point-of-Care (POC) testing device or it can be collected and sent to a testing facility.
Currently, capillary blood collection workflow is a complex multi-step process requiring high skill level. The multi-step nature of this process introduces several variables that could cause sample quality issues such as hemolysis, inadequate sample stabilization, and micro-clots. The use of lancet devices for obtaining blood samples can result in several variables that effect the collection of the capillary blood sample, including, but not limited to, holding the lancet still during the testing, obtaining sufficient blood flow from the puncture site, adequately collecting the blood, preventing clotting, and the like. Some of the most common sources of process variability are: (1) inadequate lancing site cleaning and first drop removal which can potentially result in a contaminated sample; (2) inconsistent lancing location and depth which could potentially result in insufficient sample volume and a large fraction of interstitial fluid; (3) inconsistent squeezing technique and excessive pressure near the lancing site to promote blood extraction (e.g., blood milking) which could potentially result in a hemolyzed sample; (4) variable transfer interfaces and collection technique which could potentially result in a hemolyzed or contaminated sample; and (5) inadequate sample mixing with anticoagulant which could potentially result in micro-clots.
Thus, there is a need in the art for a device that has the ability to lance and squeeze the finger, collect the 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 the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots. There is still a further need in the art for a closed system collection and transfer that eliminate blood exposure and device reuse. There is still a further need in the art for a device that: (1) introduces flexibility in the accommodation of different capillary blood collection and transfer container; (2) has the capability to generate high quality uniformly mixed/stabilized capillary blood samples; (3) has the capability to generate on-board plasma from capillary plasma samples; (4) has the capability to collect large capillary blood samples (>50-500 μL) at reduced pain; (5) contains a unique sample identifier that is paired with patient information at the time of collection; (6) has the capability to collect capillary blood and perform on-board diagnostics; and (7) has multiple collection ports to collect a blood sample into different containers having the same or different anticoagulants.
The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the needs set forth above and has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots.
The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with ability to lance, collect and stabilize high volume capillary blood sample, e.g., up to or above 500 microliters. The device simplifies and streamlines high volume capillary blood collection by eliminating workflow steps and variabilities which are typically associated with low sample quality including hemolysis, micro-clots, and patient discomfort. The device comprises a retractable lancing mechanism that can lance the finger and an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container. The device also includes a holder that can be cyclically squeezed to stimulate, i.e., pump, blood flow out of the finger and also anticoagulant deposited in the flow path or collection container to stabilize collected sample.
According to one design, the device can comprise discrete components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into one device which is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are envisioned to be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. 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 on-board plasma separation modules. This capability extends the product flexibility to various applications including dispensing to a Point-of-Care (POC) cartridge or to a small collection tube transfer which can be used in a centrifuge or an analytical instrument.
In accordance with an embodiment of the present invention, a device for obtaining a blood sample may include a holder for receiving a sample source, the holder having an actuation portion and a port, a container engagement portion connected to the holder, and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.
In accordance with another embodiment of the present invention, the actuation portion may be transitionable between a first position in which the holder defines a first ellipse and a second position in which the holder defines a second ellipse, wherein the second ellipse is different than the first ellipse. The actuation portion may include a contact member. The actuation portion may be transitionable between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position. With the contact member in the engaged position, the contact member may exert a pressure on the sample source. The actuation portion may include a pumping member for applying pressure to the sample source. The pumping member may include a pair of opposed tabs. The sample source may be a finger. With the finger received within the holder, the port may be in communication with a portion of the finger. The container engagement portion and the holder may be connected via a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and pocket pivot joint. The holder may include a living hinge that is connectable to the container engagement portion. The living hinge may be connected to the container engagement portion via a keyed snap-fit arrangement, a hook and snap-fit arrangement, a C-clip and snap-fit arrangement, or a peg and profiled engagement.
In another embodiment of the present invention, a device for obtaining a blood sample, may include a holder for receiving a sample source, the holder having an actuation portion and a port, and a container engagement portion connected to the holder and configured to hold a collection container, wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.
In another embodiment of the present invention, the actuation portion may be transitionable between a first position in which the holder defines a first ellipse and a second position in which the holder defines a second ellipse, wherein the second ellipse is different than the first ellipse. The actuation portion may include a contact member. The actuation portion may be transitionable between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position. With the contact member in the engaged position, the contact member may exert a pressure on the sample source. The actuation portion may include a pumping member for applying pressure to the sample source. The pumping member may include a pair of opposed tabs. The sample source may be a finger. With the finger received within the holder, the port may be in communication with a portion of the finger. The container engagement portion and the holder may be connected via a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and pocket pivot joint. The holder may include a living hinge that is connectable to the container engagement portion. The living hinge may be connected to the container engagement portion via a keyed snap-fit arrangement, a hook and snap-fit arrangement, a C-clip and snap-fit arrangement, or a peg and profiled engagement.
In another embodiment of the present invention, a tray for holding components used for obtaining a blood sample may include a plurality of sections for holding the components used for obtaining the blood sample, comprising: a first section for holding a finger measuring card; a second section for holding at least two holders; a third section for holding a lancet; and a fourth section for holding a collection container to hold the blood sample, wherein each section includes a label corresponding to a sequential step in a method for obtaining the blood sample.
The present disclosure is also defined by the following clauses:
Clause 1: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion, the container defining a collection cavity, wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.
Clause 2: The device of Clause 1, wherein the actuation portion is transitionable between a first position in which the holder defines a first ellipse and a second position in which the holder defines a second ellipse, wherein the second ellipse is different than the first ellipse.
Clause 3: The device of Clause 1 or Clause 2, wherein the actuation portion includes a contact member.
Clause 4: The device of Clause 3, wherein the actuation portion is transitionable between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position.
Clause 5: The device of Clause 4, wherein, with the contact member in the engaged position, the contact member exerts a pressure on the sample source.
Clause 6: The device of any of Clauses 1-5, wherein the actuation portion includes a pumping member for applying pressure to the sample source.
Clause 7: The device of Clause 6, wherein the pumping member comprises a pair of opposed tabs.
Clause 8: The device of any of Clauses 1-7, wherein the sample source is a finger.
Clause 9: The device of Clause 8, wherein, with the finger received within the holder, the port is in communication with a portion of the finger.
Clause 10: The device of any of Clauses 1-9, wherein the container engagement portion and the holder are connected via a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and pocket pivot joint.
Clause 11: The device of any of Clauses 1-10, wherein the holder comprises a living hinge that is connectable to the container engagement portion.
Clause 12: The device of Clause 11, wherein the living hinge is connected to the container engagement portion via a keyed snap-fit arrangement, a hook and snap-fit arrangement, a C-clip and snap-fit arrangement, or a peg and profiled engagement.
Clause 13: A device for obtaining a blood sample, the device comprising: a holder for receiving a sample source, the holder having an actuation portion and a port; and a container engagement portion connected to the holder and configured to hold a collection container; wherein the container engagement portion allows the collection container to rotate between a first position in which the collection container is spaced from the port and a second position in which the collection container is in fluid communication with the port.
Clause 14: The device of Clause 13, wherein the actuation portion is transitionable between a first position in which the holder defines a first ellipse and a second position in which the holder defines a second ellipse, wherein the second ellipse is different than the first ellipse.
Clause 15: The device of Clause 13 or Clause 14, wherein the actuation portion includes a contact member.
Clause 16: The device of Clause 15, wherein the actuation portion is transitionable between a first position in which the contact member is in a disengaged position and a second position in which the contact member is in an engaged position.
Clause 17: The device of Clause 16, wherein, with the contact member in the engaged position, the contact member exerts a pressure on the sample source.
Clause 18: The device of any of Clauses 13-17, wherein the actuation portion includes a pumping member for applying pressure to the sample source.
Clause 19: The device of Clause 18, wherein the pumping member comprises a pair of opposed tabs.
Clause 20: The device of any of Clauses 13-19, wherein the sample source is a finger.
Clause 21: The device of Clause 20, wherein, with the finger received within the holder, the port is in communication with a portion of the finger.
Clause 22: The device of any of Clauses 13-21, wherein the container engagement portion and the holder are connected via a ball joint, a peg and hole pivot joint, a pin and C-clip pivot joint, or a pin and pocket pivot joint.
Clause 23: The device of any of Clauses 13-22, wherein the holder comprises a living hinge that is connectable to the container engagement portion.
Clause 24: The device of Clause 23, wherein the living hinge is connected to the container engagement portion via a keyed snap-fit arrangement, a hook and snap-fit arrangement, a C-clip and snap-fit arrangement, or a peg and profiled engagement.
Clause 25: A tray for holding components used for obtaining a blood sample, comprising: a plurality of sections for holding the components used for obtaining the blood sample, comprising: a first section for holding a finger measuring card; a second section for holding at least two holders; a third section for holding a lancet; and a fourth section for holding a collection container to hold the blood sample, wherein each section includes a label corresponding to a sequential step in a method for obtaining the blood sample.
The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner
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 fall within the spirit and scope of the present invention.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
The present disclosure is directed to a device for obtaining a biological sample, such as a capillary blood collection device, which meets the needs set forth above and has the ability to lance and squeeze the finger, collect the sample, stabilize the sample, and subsequently dispense the sample in a controlled manner The device also simplifies and streamlines the capillary blood collection by eliminating workflow variabilities which are typically associated with low sample quality including hemolysis and micro-clots.
The present disclosure includes a self-contained and fully integrated finger-based capillary blood collection device with ability to lance, collect and stabilize high volume capillary blood sample, e.g., up to or above 500 microliters. The device simplifies and streamlines high volume capillary blood collection by eliminating workflow steps and variabilities which are typically associated with low sample quality including hemolysis, micro-clots, and patient discomfort. The device comprises a retractable lancing mechanism that can lance the finger and an associated blood flow path which ensures attachment and transfer of the capillary blood from the pricked finger site to the collection container. The device also includes a holder that can be cyclically squeezed to stimulate, i.e., pump, blood flow out of the finger and also anticoagulant deposited in the flow path or collection container to stabilize collected sample.
According to one design, the device can comprise discrete components such as a holder, a lancet, and a collection container. According to another design, the lancet and collection container can be integrated into one device which is then used with the holder. According to yet another design, the holder, lancet, and collection container can be integrated into a single system. Any of these designs are envisioned to be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. 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 on-board plasma separation modules. This capability extends the product flexibility to various applications including dispensing to a Point-of-Care (POC) cartridge or to a small collection tube transfer which can be used in a centrifuge or an analytical instrument.
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The first opening 22 of the finger receiving portion 20 is configured for receiving a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample 18. It can be appreciated that the sample source could include other parts of the body capable of fitting within the first opening 22. The port 26 is in communication with the finger receiving portion 20. For example, with a finger 19 received within the holder 12, the port 26 is in communication with a portion of the finger 19. A holder 12 of the present disclosure can be sized to accommodate all finger sizes.
The second opening 28 of the port 26 is configured for receiving a lancet housing 14 and a collection container 16 as described in more detail below. In one embodiment, the port 26 includes a locking portion 32 for securely receiving the lancet housing 14 and the collection container 16 within the port 26.
In one embodiment, the actuation portion 24 is transitionable between a first position (
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Advantageously, the holder 12 of the present disclosure allow a user to repeatedly squeeze and release the wings 38 to pump and/or extract blood 18 from a finger 19 until a desired amount of blood 18 is filled in a collection container 16.
Advantageously, with the holder 12 placed onto a finger 19, the holder 12 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 38 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 12 provides a gentle controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.
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In one embodiment, the finger receiving portion 20 is formed of a flexible material. In some embodiments, the finger receiving portion 20 and the port 26 are formed from a flexible material.
A device 10 for obtaining a blood sample 18 of the present disclosure includes a lancet housing or lancet 14 that is removably connectable to a port 26 of a holder 12. Referring to
In one embodiment, the lancet 14 of the present disclosure is a contact activated lancet and may be constructed in accordance with the features disclosed in U.S. Patent Application Publication No. 2006/0052809 filed May 6, 2005, entitled “Contact Activated Lancet Device”, and commonly assigned with the present application, the entire disclosure of which is hereby expressly incorporated herein by reference thereto.
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To activate the lancet 14, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 of the lancet 14 to lance a finger 19. The lancet 14 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.
In one embodiment, the lancet 14 includes a drive spring 60 disposed within the interior 52 of the lancet housing 14 for biasing the puncturing element 54 toward the puncturing position. After puncturing, the puncturing element 54 is immediately retracted and safely secured within the interior 52 of the lancet housing 14.
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A device 10 for obtaining a blood sample 18 of the present disclosure includes a collection container 16 that is removably connectable to the port 26 of the holder 12. The collection container 16 defines a collection cavity 70 for receiving a blood sample 18, a container engagement portion 72, a blood collector portion 74, and a cap or septum 76. Once a desired amount of blood 18 is collected within the container 16, a blood collector portion 74 is detached from the collection device 10 in order to send a collected sample 18 to a diagnostic instrument and/or testing device. The blood collector portion 74 is sealed via the cap or septum 76 once removed from the collection device 10 to protectively seal the blood sample 18 within the collection cavity 70.
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It can be appreciated that several types of collection containers 16 can be used with the device 10 of the present disclosure. It can also be appreciated that the collection container 16 can be associated with a separate dispensing unit or the collection container 16 can include an integral dispensing portion for dispensing the blood 18 to a testing device.
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After the finger 19 is lanced to create blood 18 (
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The devices of the present disclosure are compatible with any known testing device, whether the testing device is off-site or a point-of-care testing device. Various point-of-care testing devices are known in the art. Such point-of-care testing devices include test strips, glass slides, diagnostic cartridges, or other testing devices for testing and analysis. Test strips, glass slides, and diagnostic cartridges are point-of-care testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states. There are many point-of-care devices that use cartridge based architecture to analyze very small amounts of blood bedside without the need to send the sample to a lab for analysis. This saves time in getting results over the long run, but creates a different set of challenges versus the highly routine lab environment. Examples of such testing cartridges include the i-STAT® testing cartridge from the Abbot group of companies. Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician.
The collection container 16 may also contain a sample stabilizer, e.g., an anticoagulant, to stabilize a blood sample and/or a component of a blood sample disposed therein. The collection container 16 may also include at least one fill line(s) corresponding to a predetermined volume of sample. The collection container may also indicate/meter a collected volume of blood.
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The blood 18 will flow from the finger 19 to the blood flow channel 120 of the lancet housing 14. The blood 18 flows, via blood flow path 105, at an angle to the lance path 103. For example, the blood sample 18 flows through the capillary tube 110 to the collection cavity 70 of the container 16.
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The blood 18 will flow from the finger 19 through the hollow needle 62 to the outlet 210 of the lancet housing 14 to the collection cavity 70 of the container 16. The blood 18 flows, via blood flow path 205, in line with the lance path 203.
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Any of the devices for obtaining a blood sample of the present disclosure can be used as a self-standing disposable device and/or in association with an external power source for pain reduction control. For example, a portion of holder 12 may include embedded electrodes which receive a signal from an external pain control module to deliver at least one of heat, vibration, or transcutaneous electrical nerve stimulation (TENS) for pain reduction control. The devices for obtaining a blood sample of the present disclosure may also include various options for on-board plasma separation. The devices for obtaining a blood sample of the present disclosure may also include a unique sample identifier that can be paired with patient information at the time of collection. The devices for obtaining a blood sample of the present disclosure may also include on-board diagnostic feedback at the time of collection. A device for obtaining a blood sample of the present disclosure may also allow for dual collection, e.g., the collection of two samples into two separate containers, using multiple collection ports which enable the collection of multiple samples from the same source and treating the samples with different sample stabilizers, such as anticoagulants.
A device for obtaining a blood sample of the present disclosure significantly simplifies and de-skills large volume capillary collection from a finger relative to the conventional capillary collection using lancet and capillary tube. The devices of the present disclosure eliminate blood exposure and prevents device reuse.
The devices for obtaining a blood sample of the present disclosure simplify, deskill, and streamline the collection process. This is all achieved by a self-contained closed system device which after it is placed onto a finger will provide lancing, blood extraction, stabilization and containment functions, all in one unit.
The devices for obtaining a blood sample of the present disclosure may be associated with a self-standing unit that provides automated pumping, controlled finger squeezing, and automated sample labeling and processing.
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The first opening 122 of the finger receiving portion 120 is configured for receiving a sample source, e.g., a finger 19, for supplying a biological sample, such as a blood sample. It can be appreciated that the sample source could include other parts of the body capable of fitting within the first opening 122. The port 126 is in communication with the finger receiving portion 120. For example, with a finger 19 received within the holder 112, the port 126 is in communication with a portion of the finger 19. A holder 112 of the present disclosure can be sized to accommodate all finger sizes.
The second opening 128 of the port 126 is configured for receiving a lancet housing 14 and a collection container 116 as described in more detail below. In one embodiment, the port 126 includes a locking portion 132 for securely receiving the lancet housing 14 and the collection container 116 within the port 126.
In one embodiment, the actuation portion 124 is transitionable between a first position in which the holder 112 defines a first diameter and a second position in which the holder 112 defines a second diameter, wherein the second diameter is less than the first diameter. In one embodiment, the actuation portion 124 is transitionable between a first position in which the holder 112 defines a first elliptical shape, and a second position in which the holder 112 defines a second elliptical shape, wherein the first elliptical shape is different than the second elliptical shape. In this manner, with the holder 112 in the second position with a reduced diameter, a portion of the holder 112 contacts the sample source and the actuation portion 124 of the holder 112 is able to pump and/or extract blood as described in more detail below.
In one embodiment, the actuation portion 124 includes a contact member 134. With the actuation portion 124 in the first position, the contact member 134 is in a disengaged position, i.e., the contact member 134 is provided in a first position with respect to a sample source, e.g., the finger 19, such that the contact member 134 may be in slight contact therewith. With the actuation portion 124 in the second position, the contact member 134 is in an engaged position, i.e., the contact member 134 is provided in a second position with respect to the sample source, e.g., the finger 19, such that the contact member 134 is in an applied pressure contact with the finer 19, and the actuation portion 124 of the holder 112 is able to pump and/or extract blood. For example, with the contact member 134 in the engaged position, the contact member 134 exerts a pressure on the sample source.
In one embodiment, the actuation portion 124 includes a pumping member 136 for applying pressure to the sample source, e.g., the finger 19. In one embodiment, the pumping member 136 comprises 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 living hinge portion 142. The living hinge portion 142 allows a user to squeeze the wings 138 between a first position and a second position.
Advantageously, the holder 112 of the present disclosure allows a user to repeatedly squeeze and release the wings 138 to pump and/or extract blood from a finger 19 until a desired amount of blood is filled in a collection container 116.
Advantageously, with the holder 112 placed onto a finger 19, the holder 112 does not constrict the blood flow and defines lancing and finger squeezing locations. The squeezing tabs or wings 138 provide a pre-defined range of squeezing pressure that is consistently applied throughout a finger 19. By doing so, the holder 112 provides a gentle controlled finger massage that stimulates blood extraction and minimizes any potential hemolysis.
In one embodiment, the holder 112 includes a stability extension portion 140. This provides additional support for the holder 112 to be securely placed onto a finger 19. In one embodiment, the finger receiving portion 120 forms a generally C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for the holder 112 to be securely placed onto a finger 19.
In one embodiment, the finger receiving portion 120 is formed of a flexible material. In some embodiments, the finger receiving portion 120 and the port 126 are formed from a flexible material.
A device 350 for obtaining a blood sample of the present disclosure includes a lancet housing or lancet 114 that is removably connectable to a port 126 of a holder 112. In one embodiment, the lancet 114 includes an inlet or opening, an interior, a puncturing element, an engagement portion, a retractable mechanism, and a drive spring, similar to the lancet 14 described hereinabove. In one embodiment, the puncturing element is moveable between a pre-actuated position wherein the puncturing element is retained within the interior of the lancet 114 and a puncturing position wherein at least a portion of the puncturing element extends through the inlet of the lancet 114 to lance a portion of a finger 19.
In one embodiment, the lancet 114 of the present disclosure is a contact activated lancet and may be constructed in accordance with the features disclosed in U.S. Patent Application Publication No. 2006/0052809 filed May 6, 2005, entitled “Contact Activated Lancet Device”, and commonly assigned with the present application, the entire disclosure of which is hereby expressly incorporated herein by reference thereto.
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 removably connectable to the port 126 of the holder 112. In some embodiments, the collection container 116, the lancet 114, and the holder 112 form a single component.
In one embodiment, with the holder 112 and the lancet 114 being separate components, the lancet 114 is removably connectable to the port 126 of the holder 112. In such an embodiment, the lancet 114 includes an engagement portion. In one embodiment, the lancet 114 is pushed into the port 126 of the holder 112 such that the engagement portion of the lancet 114 is locked within the port 126 of the holder 112. In this manner, the lancet 114 is securely connected and locked to the holder 112 such that the puncturing element of the lancet 114 can be activated to lance or puncture a sample source, e.g., a finger 19. In some embodiments, the port 126 of the holder 112 includes a plurality of ribs for securing and locking the lancet 114 or the collection container 116 in the port 126.
To activate the lancet 114, the lancet 114 is pushed against a finger 19 to activate a retractable mechanism of the lancet 114 to lance a finger 19. The lancet 114 of the present disclosure consistently delivers correct lancing depth and a pre-defined lancing location, thus ensuring a sufficient sample volume.
In one embodiment, the lancet 114 includes a drive spring disposed within the interior of the lancet 114 for biasing the puncturing element toward the puncturing position. After puncturing, the puncturing element is immediately retracted and safely secured within the interior of the lancet 114.
In one embodiment, the lancet 114 of the present disclosure is used to lance the skin of a finger 19 and then a blood sample is squeezed into a collection container 116 as described in more detail below.
In one embodiment, the lancet 114 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample flows down a blood flow path at an angle to the lance path as described in more detail below.
In one embodiment, the lancet 114 includes a hollow needle. In such an embodiment, the lancet 114 of the present disclosure is used to lance the skin of a finger 19 along a lance path and then a blood sample flows along a parallel blood flow path through the hollow needle as described in more detail below.
The device 350 for obtaining a blood sample of the present disclosure includes a collection container 116 that is removably connectable to the port 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 septum 176. Once a desired amount of blood is collected within the container 116, a blood collector portion 174 is detached from the collection device 350 in order to send a collected sample to a diagnostic instrument and/or testing device. The blood collector portion 174 is sealed via the cap or septum 176 once removed from the device 350 to protectively seal the blood sample within the collection cavity 170.
In one embodiment, with the holder 112 and the collection container 116 being separate components, a container engagement portion 182 that holds the collection container 116 may be removably or fixedly connectable to a connection interface 180 of the holder 112. The container engagement portion 182 may define an opening to receive and hold the collection container 116. The collection container 116 may be held in the container engagement portion 182 via any suitable means, including a friction fit, a mechanical fit, or any alternative removable connection to permit the collection container 116 to be separated from the container engagement portion 182 after the blood sample has been collected in the collection cavity 170. The container engagement portion 182 may also include a container locking portion 172 that is configured to engage with the port 126 of the holder 112 to lock the container engagement portion 182 within the port 126. Referring to
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In the second section 402b, labelled “Step 2”, an instruction is provided to indicate to the user that the patient's hand/finger should be warmed. In the third section 402c, labelled “Step 3”, a slot is defined to hold a plurality of disinfecting wipes 406. The user can use a disinfecting wipe 406 to disinfect the puncture site on the patient's finger 19. In the fourth section 402d, labelled “Step 4”, a plurality of apertures 408 are defined in the section 402c of the tray 400 to holder the different sized holders 112. According to the measurement of the patient's finger 19 using the finger measuring card 404, the user will pick out the appropriate holder 112 that is sized for the patient's finger 19. After the proper holder 112 is identified, the user will insert the patient's finger 19 into the holder 112, as described above.
In the fifth section 402e, labelled “Step 5”, an aperture 410 is defined in the tray 400 to hold a lancet 114. The user can remove the lancet 114 from the tray and use the lancet 114 to puncture the patient's finger 19, as described above. In the sixth section 402f, labelled “Step 6”, an aperture 412 is defined in the tray 400 to hold a collection container 116. The collection container 116 can be removed from the tray 400 and attached to a container engagement portion 182 connected to the holder 112 to collect a blood sample from the patient's finger 19, as described above.
In the seventh section 402g, labelled “Step 7”, an instruction to pump the patient's finger 19 using the holder 112 is provided. In the eighth section 402h, labelled “Step 8”, an aperture 414 is defined in the tray 400 to hold the collection container 116 after the blood sample has been pulled from the patient's finger 19. In the ninth section 402i, labelled “Step 9”, an aperture 416 is defined in the tray 400 to hold bandages 418 that can be applied to the patient's finger 19 after the holder 112 has been removed therefrom.
While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.
The present application claims priority to U.S. Provisional Application Ser. No. 62/805,398, entitled “Capillary Collector with Rotatable Connection”, filed Feb. 14, 2019, the entire disclosure of which is hereby incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/017635 | 2/11/2020 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62805398 | Feb 2019 | US |
