Patent Application
20240315618
The present disclosure relates generally to collection containers for containing a biological sample, such as a blood sample. More particularly, the present disclosure relates to a sample collection container configured to connect to and receive a blood sample from a finger-based capillary blood collection device including features for ensuring that the container remains appropriately closed and sealed to avoid leakage and/or contamination of the blood sample.
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 medical field is capillary blood collection, which is often done to collect blood samples for testing. Certain diseases, such as diabetes, require that a 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. In order to simplify capillary blood collection, lancet devices have evolved into automatic devices that puncture or cut the skin of the patient upon 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. 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.
Use of lancet devices for capillary blood collection can be complex requiring a high skill level for the healthcare worker performing the blood collection procedure. The multi-step nature of the capillary blood collection process can introduce several variables that may 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 an anticoagulant which could potentially result in micro-clots.
In view of such common sources of process variability and associated sample quality issues, there is a need for blood collection devices and associated containers for securely receiving and storing biological samples in sealed containers with minimal risk of leakage or contamination. In particular, the collection containers of the present disclosure are configured to receive fluid samples from blood collection devices and to retain the received fluid samples in a securely sealed container until ready for use. Further, the containers of the present disclosure are configured to be easy to use, meaning that the containers are easy to close or otherwise manipulate without requiring users to exert substantial force on the container or blood collection devices during use.
According to an aspect of the disclosure, a sample collection container configured to be removably mounted to a blood collection device includes a container body and a lid. The container body defines an interior configured to receive a sample provided from the blood collection device. The container body includes an upper portion having an open top and a lower portion having a closed bottom. The lid includes: a lid body; a flexible connection between the lid body and the upper portion of the container body that moves the lid between a closed position, in which the lid covers the open top of the upper portion, and an open position, where the open top of the upper portion is uncovered; a pierceable septum mounted to the lid body that seals the upper portion of the open top when the lid is in the closed position; and a latch. The latch extends from the lid body and engages a catch on the upper portion of the container body to secure the lid in the closed position.
According to another aspect of the disclosure, a blood collection container includes a container body having a container body closed bottom, a container body open top, and a container body annular sidewall extending therebetween. The container further includes a cap that is separable from the container body. The cap includes a cap open bottom removably inserted over the container body open top, a cap open top, and a cap annular sidewall extending therebetween. The container further includes a lid removably mounted over the cap open top. The cap is sized to be press fit over the container body and, when fully seated on the container body, the cap is restricted from rotation relative to the container body.
According to another aspect of the disclosure, a blood collection assembly includes: a finger holder having a finger receiving portion and an actuation portion; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion. The container includes a container body defining an interior configured to receive a sample provided from the blood collection device, and a lid. The container body includes an upper portion comprising an open top and a lower portion comprising a closed bottom. The lid includes: a lid body; a flexible connection between the lid body and the upper portion of the container body that moves the lid between a closed position, in which the lid covers the open top of the upper portion and an open position, where the open top of the upper portion is uncovered; a pierceable septum mounted to the lid body that seals the upper portion open top when the lid is in the closed position; and a latch extending from the lid body that engages a catch on the upper portion of the container body to secure the lid in the closed position.
According to another aspect of the disclosure, a cap removal assembly for disassembly of a cap of a blood collection container from a container body of the blood collection container includes: a stand configured to support the blood collection container in an upright position and to restrict rotation of the container relative to the stand and a tool. The tool includes a cap remover and a handle extending therefrom. The cap remover includes a body defining an opening or recess sized to receive a cap of the blood collection container, and at least one protrusion extending from the body into the opening or recess positioned to engage a portion of the cap, such that rotation of the tool relative to the cap releases the cap from a body of the container.
Non-limiting illustrative examples of embodiments of the present disclosure will now be described in the following numbered clauses:
Clause 1: A sample collection container configured to be removably mounted to a blood collection device, the collection container comprising: a container body defining an interior configured to receive a sample provided from the blood collection device, the container body comprising an upper portion comprising an open top and a lower portion comprising a closed bottom; and a lid comprising: a lid body; a flexible connection between the lid body and the upper portion of the container body that moves the lid between a closed position, in which the lid covers the open top of the upper portion, and an open position, where the open top of the upper portion is uncovered; a pierceable septum mounted to the lid body that seals the upper portion open top when the lid is in the closed position; and a latch extending from the lid body that engages a catch on the upper portion of the container body to secure the lid in the closed position.
Clause 2: The collection container of clause 1, wherein the latch comprises a frame formed from a first material and a cushion formed from a second material that is less rigid than the first material, wherein the cushion is positioned proximate to a leading edge of the frame of the lid and is configured to restrict the latch from being disengaged from the catch.
Clause 3: The collection container of clause 2, wherein the frame comprises an opening that receives the catch of the upper portion when the lid is in the closed position, and wherein the cushion is positioned on the frame between the opening and the leading edge of the frame.
Clause 4: The collection container of clause 2 or clause 3, wherein the lid body, the flexible connection, and the container body comprise the first material, and wherein the septum comprises the second material.
Clause 5: The collection container of any of clauses 2-4, wherein the first material is a semi-rigid plastic, such as polypropylene, and the second material is a thermoplastic elastomer, such as liquid silicone rubber (LSR), urethane rubber, and latex rubber.
Clause 6: The collection container of any of clauses 1-5, wherein the catch on the upper portion of the container body comprises a sloped surface positioned such that, as the lid transitions between the open position and the closed position, the latch deflects over the catch prior to engaging the catch.
Clause 7: The collection container of any of clauses 1-6, wherein the septum comprises an inwardly facing surface that faces the interior of the container body and an outwardly facing surface opposite the inwardly facing surface, the outwardly facing surface comprising a recess or well positioned to collect any fluid that escapes from the interior of the container body during retraction of a needle through the septum.
Clause 8: The collection container of any of clauses 1-7, wherein the lid body comprises an annular flange defining an opening and wherein the septum is inserted through the opening with the annular flange received within an annular notch of the septum.
Clause 9: The collection container of any of clauses 1-8, wherein the septum comprises an inwardly facing surface that faces the interior of the container body when the lid is in the closed position, the inwardly facing surface of the septum comprising a chamfered peripheral edge.
Clause 10: The collection container of clause 9, wherein the inwardly facing surface of the septum defines a central cavity, which enhances radial deformation of the septum during centrifugation.
Clause 11: The collection container of clause 10, wherein the central cavity comprises a tapered annular surface.
Clause 12: The collection container of any of clauses 1-11, wherein the upper portion open top comprises an annular chamfered edge positioned to contact a chamfered peripheral edge of the septum as the lid moves to the closed position.
Clause 13: The collection container of clause 12, wherein the annular chamfered edge of the upper portion deforms the septum when the lid is in the closed position, thereby scaling the interior of the container body.
Clause 14: The collection container of clause 13, wherein the septum is configured to radially expand during centrifugation, thereby enhancing the sealing of the interior of the container body.
Clause 15: The collection container of any of clauses 1-14, wherein the lower portion of the container body and the upper portion of the container body are separable and removably attached together.
Clause 16: The collection container of clause 15, wherein the upper portion is sized to be press fit over the lower portion and, when fully seated on the lower portion, the upper portion is restricted from rotation relative to the lower portion.
Clause 17: The collection container of any of clauses 1-16, wherein the lower portion of the container body comprises the lower portion closed bottom, a lower portion open top, and a lower portion annular sidewall extending therebetween, and wherein the upper portion of the container body comprises an upper portion open bottom inserted over the lower portion open top of the container body, the upper portion open top, and an upper portion annular sidewall extending therebetween.
Clause 18: The collection container of clause 17, wherein the lower portion of the container body comprises an annular flange extending radially outwardly from an outer surface of the lower portion annular sidewall, and wherein, when the upper portion is inserted onto the lower portion, the upper portion open bottom contacts the annular flange of the lower portion to restrict rotation of the upper portion relative to the lower portion.
Clause 19: The collection container of clause 18, wherein the annular flange extending from the lower portion and the upper portion open bottom comprise corresponding ramp surfaces configured to be axially aligned when the upper portion is inserted onto the lower portion.
Clause 20: The collection container of clause 19, wherein rotation of the upper portion relative to the lower portion causes the ramp surface of the upper portion to slide along the ramp surface of the annular flange of the lower portion, thereby lifting the upper portion off of the lower portion.
Clause 21: The collection container of any of clauses 17-20, wherein the lower portion comprises an annular protrusion extending radially outward from the outer surface of the lower portion sidewall, and wherein an inner surface of the upper portion sidewall comprises an annular recess that receives the annular protrusion of the lower portion.
Clause 22: The collection container of clause 21, wherein the annular protrusion extending from the lower portion comprises a sloped upper surface, a substantially planar lower surface, and a cylindrical peripheral edge extending therebetween.
Clause 23: The collection container of any of clauses 17-22, wherein an inner surface of the lower portion sidewall comprises a tapered portion that tapers radially inwardly from the lower portion open top.
Clause 24: The collection container of clause 23, wherein there is tapered interference fit between the outer surface of the lower portion sidewall and the inner surface of the upper portion sidewall.
Clause 25: The collection container of any of clauses 1-24, wherein the flexible connection comprises a hinge.
Clause 26: A blood collection container comprising: a container body comprising a container body closed bottom, a container body open top, and a container body annular sidewall extending therebetween; a cap that is separable from the container body, the cap comprising a cap open bottom removably inserted over the container body open top, a cap open top, and a cap annular sidewall extending therebetween; and a lid removably mounted over the cap open top, wherein the cap is sized to be press fit over the container body and, when fully seated on the container body, the cap is restricted from rotation relative to the container body.
Clause 27: A blood collection assembly comprising: a finger holder comprising a finger receiving portion and an actuation portion; a container engagement portion connected to the holder; and a collection container removably connectable to the container engagement portion, the container comprising a container body defining an interior configured to receive a sample provided from the blood collection device, the container body comprising an upper portion comprising an open top and a lower portion comprising a closed bottom, and a lid comprising: a lid body; a flexible connection between the lid body and the upper portion of the container body that moves the lid between a closed position, in which the lid covers the open top of the upper portion and an open position, where the open top of the upper portion is uncovered; a pierceable septum mounted to the lid body that seals the upper portion open top when the lid is in the closed position; and a latch extending from the lid body that engages a catch on the upper portion of the container body to secure the lid in the closed position.
Clause 28: A cap removal assembly for disassembly of a cap of a blood collection container from a container body of the blood collection container, the cap removal assembly comprising: a stand configured to support the blood collection container in an upright position and to restrict rotation of the container relative to the stand; and a tool comprising a cap remover and a handle extending therefrom, the cap remover comprising a body defining an opening or recess sized to receive a cap of the blood collection container, and at least one protrusion extending from the body into the opening or recess positioned to engage a portion of the cap, such that rotation of the tool relative to the cap releases the cap from a body of the container.
Clause 29: The cap removal assembly of clause 28, wherein once the cap is released from the body, the cap can be removed from the body by lifting the cap axially from the body.
Clause 30: The cap removal assembly of clause 28 or clause 29, wherein the body comprises a ring defining the opening, and wherein the cap can be inserted through the opening when the tool is in either an upwardly facing orientation or a downwardly facing orientation.
Clause 31: The cap removal assembly of clause 30, wherein the tool permits right handed operation when in the upwardly facing orientation and left handed operation when in the downwardly facing orientation.
Clause 32: The cap removal assembly of any of clauses 28-31, wherein the tool further comprises a pressing member mounted to the handle and comprising a distal end extending over the opening of the removal portion, the pressing member being positioned to press against a top of the cap when the cap is inserted through the opening, thereby preventing the container from lifting out of the stand when the tool and cap are rotated relative to the container body.
Clause 33: The cap removal assembly of any of clauses 28-32, wherein the cap remover comprises two protrusions extending into the opening or recess.
Clause 34: The cap removal assembly of clause 33, wherein the two protrusions are positioned such that a virtual line passing between the two protrusions through a center of the opening or recess is sloped relative to a longitudinal axis of the handle.
Clause 35: The cap removal assembly of clause 34, wherein the slope is from about 5 degrees to about 25 degrees, preferably about 15 degrees.
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 relates to blood collection devices 10 or assemblies configured to collect a capillary blood sample and including a sample collection container 16 for receiving the blood sample. The sample collection container 16 can be used for centrifuging the sample. In particular, the present disclosure is directed to closures for the container 16, which can include, for example, a cap and integrated lid. The cap and integrated lid are configured to provide a sufficiently robust closure to maintain an appropriate seal for the container 16 during and after centrifugation. The container 16 can be made from a rigid or semi-rigid material, such as polypropylene. The integrated lid can be made from a mixture of a rigid or semi-rigid material and a flexible material, such as a thermoplastic elastomer. The materials and geometry of the lid are selected to allow for one-handed closure and initial sealing of the container 16, meaning that the lid can be closed easily with little required force. The closure should also provide a high sealing pressure during centrifugation to prevent leaking. In some examples, the centrifugation process can be a reverse centrifugation process, in which the container 16 is inserted into the centrifuge in an upside-down orientation (i.e., with the lid of the container 16 positioned in the bottom of a receptacle receiving cavity or well of the centrifuge). Accordingly, the lid can be designed to withstand forces exerted on the lid during reverse centrifuging. In some examples, a latch is provided to secure the lid in the closed position and to ensure proper insertion-depth of a flexible septum or sealing element of the lid.
The present disclosure is also directed to a two-piece sample collection container 16 formed from a lower portion or container body and an upper portion or cap. The two portions can be separable and connected together at a joining interface. The joining interface between the portions of the container body can be configured to allow for simple assembly of the container body, while also providing a secure air-tight seal between the portions of the container body. It is also important to allow for controlled removal of the upper portion or cap from the lower portion of the container body so that the fluid contents of the collection container 16 are accessible for analysis. For example, as described in further detail herein, the upper portion and/or the lower portion of the container body can include ramp or cam surfaces arranged such that rotation of the upper portion relative to the lower portion causes the upper portion or cap to separate from the lower portion of the container body.
Examples of blood collection devices 10 or assemblies including features of the present disclosure are shown in
With reference to
The holder 12 is configured to receive a sample source, e.g., the finger 19 of a patient, for supplying a biological sample, such as a blood sample. As shown in
The first opening 22 of the finger receiving portion 20 is configured for receiving the sample source, e.g., the finger 19. The sample source may also include other parts of the body capable of fitting within the first opening 22, such as toes or other extremities. 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. The second opening 28 of the port 26 is configured for receiving the lancet housing or lancet 14 (shown in
The actuation portion 24 of the device 10 is transitionable between a first position, in which the holder 12 defines a first diameter, and a second position, in which the holder 12 defines a second diameter, with the second diameter being less than the first diameter. Further, in the first position, the holder 12 defines a first elliptical shape. In the second position, the holder 12 defines a second elliptical shape, with the first elliptical shape being different than the second elliptical shape. In this manner, with the holder 12 in the second position with a reduced diameter, a portion of the holder 12 contacts the sample source (i.e., the finger 19) and the actuation portion 24 of the holder 12 is able to pump and/or extract blood, as described in more detail below.
In some examples, the actuation portion 24 includes a contact member 34. With the actuation portion 24 in the first position, the contact member 34 is in a disengaged position, i.e., the contact member 34 is provided in a first position with respect to the sample source, such that the contact member 34 may be in slight contact therewith. With the actuation portion 24 in the second position, the contact member 34 is in an engaged position, i.e., the contact member 34 is provided in a second position with respect to the finger 19, such that the contact member 34 is in an applied pressure contact with the finger 19, and the actuation portion 24 of the holder 12 is able to pump and/or extract blood. For example, with the contact member 34 in the engaged position, the contact member 34 exerts a pressure on the sample source.
In some examples, the actuation portion 24 includes a pumping member 36 for applying pressure to the finger 19, such as a pair of opposed tabs or wings 38. Each wing 38 can include a contact member 34. The holder 12 can also include a living hinge portion 42. The living hinge portion 42 allows the user to squeeze the wings 38 between a first position (passive state) and a second position (active state). It is believed that use of the tabs or wings 38 to draw blood out of a patient's finger 19 minimizes hemolysis while maintaining an adequate flow of blood from the patient's finger 19. A resting position and hinge of the wings 38 are designed to maintain contact and retention with the smallest patient finger that can fit into a holder 12, while flexing to accommodate the largest patient fingers within a holder 12 without blood occlusion. In some examples, the wings 38 may be positioned on the finger receiving portion 20 at a position located proximal of a patient's fingernail and distal of a patient's first knuckle to avoid hard tissues on the patient's finger 19.
The holder 12 can be configured to allow a user to repeatedly squeeze and release the wings 38 to pump and/or extract blood from a finger 19 until a desired amount of blood is filled in the collection container 16. The wings 38 are configured to flex to maintain gentle contact with a range of patient finger sizes that may be used with the holder 12 and to retain the holder 12 on the patient's finger 19. The wings 38 may also provide active pressure features for the holder 12.
In some examples, the holder 12 can include a stability extension portion 40. This provides additional support for the holder 12 to be securely placed onto the finger 19. In one example, the finger receiving portion 20 forms a generally C-shaped member and includes a plurality of inner gripping members for providing additional grip and support for the holder 12 to be securely placed onto a patient's finger 19. The stability extension portion 40 assists in maintaining contact with the patient's finger 19 during use of the holder 12 while avoiding the blood supply and knuckles of the patient's finger 19.
The blood collection device 10 for obtaining the blood sample also includes the lancet housing or lancet 14 (shown in
In some examples, the holder 12 and the lancet housing or lancet 14 are separate components that can be removably connectable to the port 26 of the holder 12. In such examples, the lancet housing or lancet 14 includes the engagement portion 56. The lancet housing or lancet 14 can be pushed into the port 26 of the holder 12, such that the engagement portion 56 of the lancet housing or lancet 14 is locked within the locking portion 32 of the holder 12. In this manner, the lancet housing 14 is securely connected and locked to the holder 12, such that the puncturing element 54 of the lancet housing 14 can be activated to lance or puncture a sample source, e.g., the finger 19. In some examples, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26.
To activate the lancet 14, the lancet 14 is pushed against the finger 19 to activate the retractable mechanism 58 and drive spring 60 of the lancet 14 to lance the finger 19. After puncturing, the puncturing element 54 is immediately retracted and safely secured within the interior 52 of the lancet housing 14. Once the finger 19 is punctured, the blood sample is squeezed from the finger 19 into the collection container 16. 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 16 may also indicate/meter a collected volume of blood.
In order to use the capillary blood collection device 10 shown in
When it is desired to activate the lancet 14 to lance the skin of the finger 19, the lancet 14 is pushed against a finger 19 to activate a retractable mechanism 58 of the lancet 14 to lance the finger 19. After the finger 19 is lanced to create blood flow from the finger 19, the lancet 14 is removed from the holder 12 and the collection container 16 is pushed into the port 26 of the holder 12. With the container 16 properly secured to the holder 12 for collection of a blood sample, the user repeatedly squeezes and releases the wings 38 of the holder 12 to pump and/or extract blood from the finger 19 until a desired amount of blood is collected in the 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 19 massage that stimulates blood extraction and minimizes any potential hemolysis.
Once a desired amount of blood is collected within the container 16, a blood collector portion including the collection container 16 can be detached from the collection device 10 in order to send a collected sample to a diagnostic instrument and/or testing device. The blood collector portion can be sealed via the cap or septum once removed from the collection device 10 to protectively seal the blood sample within the collection container 16.
Features of the cap and lid of the collection container 16 are shown in
As shown in
In other examples, as shown most clearly in
The sample collection container 16 further includes a lid 130 including a lid body 132, a flexible connection, such as a hinge 134 or living hinge, a pierceable septum 136, and a latch 138. The flexible connection or hinge 134 is connected between the lid body 132 and the upper portion 114 or cap of the container body 110. The hinge 134 is a flexible member that is configured to open and close, thereby moving the lid 130 between a closed position (shown, for example, in
As shown most clearly in
One benefit of the latch 138 is that it helps to align the open top 116 of the upper portion 114 or cap with the septum 136 even when the user attempts to close the lid 130 with one hand. Thus, the latch 138 beneficially avoids errors caused by improper alignment of the lid 130 and container body 110. The latch 138, septum 136, and flexible connection or hinge 134 of the lid 130 of the present disclosure also contribute to creating the secure engagement between the lid 130 and the container body 110. The present inventors have recognized that the easy closure and secure engagement are needed because the lid 130 of the container 16 can be subjected to several different types of loads during normal use and/or during anticipated or likely misuse of the container 16. The lid 130 and the latch 138 of the present disclosure are configured to overcome such loads so that the lid 130 remains in the closed position protecting the blood sample contained in the container 16. For example, forces may be exerted on the lid 130 and/or the latch 138 during automated handling, where the collection container 16 is dropped (in the upside-down or lid 130 down orientation) a distance of from about 4 inches to about 18 inches into the well of the centrifuge. The collection container 16 may also be subjected to forces during loading, torqueing, and/or impacts during automated handling by blood analyzer instruments. The collection container 16 may also be subjected to accidental drops by users, where a user may drop the collection container 16 a vertical distance of far greater than 18 inches. Forces may also be exerted on the lid 130 and/or latch 138 during loading, unloading, and/or during transport from a sample collection site to a lab. Forces may also be exerted on the lid 130 and/or latch 138 when, for example, an aspiration needle withdraws through the pierceable septum 136, which could pull the lid 130 away from the upper portion 114 or cap of the container body 110. The latch 138 also acts as an anti-tamper system to prevent accidental opening and blood spillage from the collection container 16.
With reference again to
The latch 138 also includes a cushion 148 or spacer positioned on or proximate to a leading edge 150 of the frame 142 of the lid 130. The cushion 148 is provided to restrict the latch 138 from being easily and/or inadvertently disengaged from the catch 140. As used herein, a restricting structure, such as the cushion, “restricts” another structure (i.e., the latch 138) from disengaging when additional force, time, or performance of a more complex action is needed to cause the disengagement to occur than if the restricting structure were not present. In particular, for the present disclosure, it is understood that the cushion 148 does not entirely prevent the latch 138 from being disengaged from the catch 140. Instead, as described in further detail herein, the cushion 148 makes it more difficult for a user to disengage the latch 138 from the catch 140 than if the cushion 148 were not present, meaning that accidental release of the latch 138 is less likely to occur.
The cushion 148 can be formed from a flexible material (i.e., a material that is more flexible than the material used to form the frame 142, flexible connection or hinge 134, and/or container body 110). For example, the cushion 148 can be formed from a thermoplastic elastomer. The septum 136 may also be formed from the thermoplastic elastomer, such as liquid silicone rubber (LSR), urethane rubber, latex rubber, and the like. In other examples, the cushion 148 and/or septum 136 can be formed from other flexible, elastomeric materials, such as silicone.
When moving the lid 130 to the closed position, the rigidity of the frame 142 works to secure the latch 138 against the catch 140. In particular, the latch 138 can be configured to work as a cantilever beam, meaning that the latch 138 flexes over the catch 140, and then snaps into place, thereby creating the secure engagement between the latch 138 and the catch 140. The cushion 148 acts as an anti-tamper mechanism. In particular, the cushion 148 on the leading edge 150 of the latch 138 makes it more difficult for the user (i.e., the user's fingers or some unintended removal tool) to gain sufficient leverage to peel-back the latch 138 by blocking any spaces that the user's fingernails or a tool could be inserted to pry the latch 138 open. Beneficially, when the cushion 148 is present, it would be nearly impossible for a user to insert a gloved hand under the latch 138 to gain sufficient leverage to release the latch 138, making inadvertent opening very unlikely to occur in a medical setting. In order to release the latch 138, a purpose-built removal tool can be provided that is sized to be inserted under the cushion 148 to release the latch 138. Providing a lid 130 and latch 138 that can only be easily opened using a specific and specially designed removal tool ensures that the lid 130 is only opened in a controlled and purposeful manner.
Another advantage of the cushion 148 is that it increases flexibility of the latch 138 compared to if no cushion 148 were present. Specifically, because the cushion 148 is present on the latch 138, the frame 142 of the latch 138 can be rather thin without risk of breaking. The combination of the thin frame 142 and flexible cushion 148 means that the latch 138 can be easily bent in a backwards direction (i.e., radially away from the container body 110). Due to this inherent flexibility of the latch 138, during closing, the latch 138 easily deflects over the catch 140, aided by the ramped or sloped surface 146 of the catch 140, and then snaps back into position to engage the catch 140. Accordingly, the cushion 148 also contributes to the easy one-handed closure provided by the lid 130 and latch 138 of the present disclosure.
In some examples, the lid body 132 can include an annular flange 152 defining an opening 154. As shown in
In some examples, the septum 136 can include an inwardly facing surface 158 that faces the interior 112 of the container body 110 and an outwardly facing surface 160 opposite the inwardly facing surface 158. In some examples, the inwardly facing surface 158 of the septum 136 comprises a chamfered peripheral edge 162. As used herein, a “chamfered” edge refers to an edge that is inwardly sloped, angled, or tapered to facilitate insertion of the septum 136 into the container body 110. In some examples, the chamfered edge 162 includes an annular angled surface. In other examples, as shown in
The chamfered edges 162, 164 can also contribute to the low closure force of the lid 130 and container body 110 interface that allows for one handed closure without requiring any tools. In particular, the chamfered edges 162, 164 are shaped and positioned to easily slide past one another so that minimal pressing force is needed to close the lid 130. The latch 138 also contributes to ensuring that a proper seal is formed by providing visual confirmation that the septum 136 is inserted into the container body 110 to a proper insertion depth. In particular, the user can see and often hear when the opening 144 of the latch 138 snaps onto and/or engages the catch 140.
When the septum 136 is inserted into the container body 110 to the proper seal depth, the septum 136 is capable of “mushrooming” when high-pressure forces of reverse centrifugation are exerted on the septum 136. Mushrooming refers to a deformation of the septum 136 where portions of the septum 136 move radially outwardly contacting and pressing against the sidewall 128 of the upper portion 114 to provide an enhanced seal between the septum 136 and container body 110. In some examples, the geometry of the septum 136 also contributes to the mushroom effect that occurs during centrifuging. For example, the inwardly facing surface 158 of the septum 136 can include or define a central cavity 166, which enhances radial deformation of the septum 136 during centrifugation. The central cavity 166 can be any shape that increases or improves radial flexibility of peripheral portions of the septum 136. For example, as shown in
With continued reference to
As known in the art, sealing structures formed from flexible materials, such as thermoplastic elastomers, can become compression-set when held in a stressed condition for extended periods of time. While this may be a disadvantage for a long-term seal, the septum 136 of the present disclosure generally is not expected to be in a stressed condition over most of its usable life. Instead, septum 136 is only expected to be placed under stress during a single use, specifically after the blood specimen is collected and the lid is closed. Thus, it is expected that a total duration that the septum 136 will be in a stressed condition (including during the reverse centrifugation process) is approximately 48 hours. It is believed that the septum 136 will not become compression-set and/or lose sealing ability in this short period of time. Further, it is believed that the material and geometry of the septum 136 of the present disclosure, when used as a single-use product, allows the septum 136 to take advantage of inherent flexibility of a material, such as a thermoplastic elastomer, to provide enhanced sealing for the container 16, especially during reverse centrifugation, without suffering from problems associated with compression set over time.
The flexible material (i.e., the thermoplastic elastomer) of the septum 136 can be readily processed by injection molding. Advantageously, features of the septum 136, such as the well 168, the cavity 166, and the notch 156, are formed without undercuts, allowing for simple injection molding for production. Further, the injection molded material can create a bond with a semi-rigid substrate, such as with the lid body 132, thereby joining the lid body 132 and the septum 136 together. Such joining of the septum 136 and lid body 132 gives a robust and easy-to-produce component that can be produced in a high-volume capacity, with little-to-no assembly. While other materials may also be used for formation of the lid body 132 and/or septum 136, lids 130 formed from most other materials may require assembly and/or bonding of the rigid/flexible parts, resulting in more costly production processes. For example, a silicone material would give excellent flexibility and exhibit less compression-set behavior than the thermoplastic elastomer materials described herein. However, a silicone septum 136 would be more difficult to produce by injection molding because silicone does not create a bond with a lid body 132 or frame 142 formed from polypropylene.
Another benefit of the sample collection container 16 of the present disclosure is that the septum 136 is integrated with the lid 130. Similarly, the lid 130 and the latch 138 are integrated with the container body 112 through the hinge 134. This construction allows for a single component configuration, which is believed to be a benefit compared to devices or assemblies formed from multiple loose components. In particular, loose components can be lost or dropped by the user, or (in the case of an O-Ring) would require additional assembly steps during manufacture. Also, an O-ring would not allow for increased seal-pressure during reverse centrifugation, as provided by the septum 136 of the present disclosure.
While sealing between the lid 130 and the container body 110 could also be achieved using two rigid materials (i.e., surface to surface contact between opposing polypropylene structures of the lid 130 and the container body 110), such engagements between rigid materials would either require high closure-force or a closure-method, such as threads or a bayonet-connection, to give a mechanical advantage to the user to force the lid 130 to the closed position. If screw threads were used, the lid 130 would need to be free-spinning relative to the container body. In that case, the lid 130 would need to be a separate component from the container body 110. While the lid 130 could be attached to the container body 110 by, for example, a tether, such an arrangement would be more difficult to assemble than the integrated container 16 of the present disclosure. Accordingly, the present inventors believe that the container 16 of the present disclosure, which includes the integrated lid 130, septum 136, and latch 138, provides advantages over other types of lids and closures, as may be known in the art.
Sample Collection Container with Separable Container Body
With reference to
As shown in
The upper portion 114 or cap and the lower portion 118 of the container body 110 are intended be securely connected together to protect the blood sample in the interior 112 of the container body 110. Further, the present inventors believe that the connection or interface between the portions 114, 118 needs to be sufficiently secure and robust enough to withstand foreseeable misuse without allowing leakage or separation of the upper portion 114 or cap from the lower portion 118 at inappropriate or unexpected times. At appropriate times, the connection or interface between the upper portion 114 or cap and the lower portion 118 should be easy to overcome in a controlled manner, thereby allowing users to easily access the blood sample contained in the interior 112 of the container body 110. As described in further detail hereinafter, this robust and secure connection is achieved by a tapered interference-fit seal connection in combination with a cam or ramp surface to give mechanical advantage for separation of the upper portion 114 or cap from the lower portion 118. Beneficially, the connection or joint interface of the present disclosure is expected to be easy to assemble and includes components for control of radial orientation. The upper portion 114 or cap and lower portion 118 also do not separate easily, meaning that it would be difficult for a user to inadvertently separate the upper portion 114 or cap from the lower portion 118 at inappropriate times.
In some examples, as shown in
More specifically, in some examples, the annular flange 170 extending from the lower portion 118 includes a first ramp surface 174a angled in a first direction and a second ramp surface 174b angled in a second direction. The bottom 126 of the upper portion 114 or cap includes corresponding ramp surfaces, such as a first ramp surface 176a and a second ramp surface 176b, configured to be axially aligned with the ramp surfaces 174a, 174b of the lower portion 118 when the upper portion 114 is inserted onto the lower portion 118. In some examples, the first ramp surface 174a and the second ramp surface 174b are adjacent to each other, creating a crown or peak 178 pointing towards the top 122 of the lower portion 118. The ramp surfaces 176a, 176b on the bottom 126 of the upper portion 114 also form a peak positioned to align with the peak 178 of the annular flange 170. In some examples, the annular flange 170 and bottom 126 of the upper portion 114 or cap can include multiple peaks 178, such as two peaks positioned on opposite sides of the annular flange 170. In other examples, the annular flange 170 and bottom 126 of the upper portion 114 or cap can include more than two peaks, such as four peaks located at the 0 degree, 90 degree, 180 degree, and 270 degree positions around the annular flange 170 and/or bottom 126.
In some examples, the ramp surfaces 174a, 174b, 176a, 176b are positioned not only to restrict rotation of the portions 114, 118, but also to assist in separating the upper portion 114 or cap from the lower portion 118 of the container body 110. For example, the ramp surfaces 174a, 174b, 176a, 176b can be positioned such that rotation of the upper portion 114 or cap relative to the lower portion 118 by a small amount (i.e., a quarter turn) causes the ramp surface 176a, 176b of the upper portion 114 to slide along the ramp surface 174a, 174b of the annular flange 170 of the lower portion 114, thereby lifting the upper portion 114 from the lower portion 118. Thus, the ramp surfaces 174a, 174b, 176a, 176b provide a mechanical advantage to control dis-assembly during de-capping. Specifically, with the lower portion 118 of the container body 110 fixed, rotation of the upper portion 114 or cap causes the ramp surfaces 174a, 174b to push the upper portion 114 or cap axially away from the lower portion 118 beyond any axial retention features, thereby releasing the upper portion 114 from the lower portion 118. Once the upper portion 114 is moved beyond any axial retention features, the upper portion 114 or cap can be fully removed with very low force, such as by grasping the upper portion 114 or cap and moving it axially away from the container body 110.
Accordingly, it is understood that the upper portion 114 or cap is not completely free of the lower portion 118 after rotating the upper portion 114 or cap by the small amount (i.e., the quarter-turn rotation). Instead, the rotation by the small amount releases the upper portion 114 or cap from the lower portion 118 so that it can be easily separated even, for example, by a user wearing gloves (i.e., with a gloved fingertip force). Further, due to the relatively simple release technique, it is believed that fluid contents in the container 16 (i.e., the blood sample) will not be disturbed during this release action from, for example, jerking or abrupt motions, which could cause spillage.
It is recognized that the upper portion 114 or cap could also be connected to the lower portion 118 by other connection interfaces as are known in the art, such as by a threaded connection or a luer lock connection. However, while a common threaded connection would join and seal the interface between the upper portion 114 or cap and the lower portion 118, a common threaded connection would not allow for controlled orientation of the upper portion 114 or cap relative to the lower portion 118. Also, a common threaded connection is not as easy for installation in a high-speed-assembly production environment compared to the axial press-fit connection of the present disclosure. Further, a common threaded connection could be easily defeated by the user at an improper time during the product's use-life. In contrast, the connection interface between the upper portion 114 or cap and the lower portion 118 of the present disclosure allows for simple assembly in high-speed automated production and a robust connection that is not easily defeated by the user.
In some examples, engagement between the upper portion 114 or cap and the lower portion 118 of the container body 110 can be further enhanced by protrusions, extended portions, textured regions, and/or similar protruding structures extending from surfaces of the sidewall of the upper portion 114 or cap and/or from the sidewall of the lower portion 118. For example, as shown in
In some examples, the engagement between the upper portion 114 or cap and the lower portion 118 is further enhanced by providing a slight taper to the lower portion sidewall 124 near the top 122 of the lower portion 118. For example, the sidewall 124 of the lower portion 118 can include a tapered portion 188 that tapers radially outwardly towards the open top 122 of the lower portion 118. The tapered portion 188 can be configured to provide a tapered interference fit between the outer surface 172 of the lower portion sidewall 124 and the inner surface 182 of the upper portion sidewall 128. In order to provide the tapered interference fit, a tapered inner diameter of the upper portion 114 or cap and a tapered upper portion diameter of the lower portion 118 are selected to allow for simple axial press-fit assembly. Further, the geometry of the taper can allow for axial alignment during assembly, guiding the two portions 114, 118 of the container body 110 together.
In some examples, the upper portion 114 or cap may also include one or more stiffener ribs 190 extending from an outer surface 194 of the sidewall 128 of the upper portion 114. For example, the stiffener ribs 190 can be annular ribs or areas of increased thickness that increase overall stiffness of the upper portion 114. Increasing stiffness of the upper portion 114 is believed to provide a more secure connection between the portions 114, 118. The axial-length of the tapered portion 188 or sealing area and the annular flange 170 on the lower portion 118 also help to make the joining interface between the portions 114, 118 more rigid and to prevent wobble. It is believed that at least these features help to stiffen the interface between the portions 114, 118 and to maintain seal-pressure across full shelf-life of the collection container 16, as well as to resist creep and material relaxation over time. In contrast, a simple annular bead/band on one of the portions 114, 118 would provide a seal, but would not give a robust mechanical connection to withstand use/abuse, eliminate wobble, and keep a liquid-tight/air-tight seal. Further, the annular bead/band would be an undercut feature in the injection mold tooling, and would require tight tolerances and/or complex tooling during production compared to providing a simple tapered interference-fit features.
In some examples, the upper portion 114 or cap and/or the lower portion 118 of the container body 110 include features to aid in de-capping using specifically designed or selected tools. For example, the upper portion 114 or cap can include u-shaped ribs 192 (shown in
A cap removal assembly 210 including features of the present disclosure for disassembly of the upper portion 114 or cap of a blood collection container 16 from a container body 110 or lower portion 118 is shown in
The assembly 210 includes a stand 212 configured to support the blood collection container 16 in an upright position and to restrict rotation of the container 16 relative to the stand 212. For example, the stand 212 can be a tubular structure including a closed bottom or base 214 and an open top 216. The open top 216 can be sized so that the collection container 16 can be securely inserted into the stand 212 through the open top 216. In some examples, there can also be ribs (not shown) on the bottom 120 of the lower portion 118 of the collection container 16, that (when inserted into the stand 212) engage anti-rotation structures of the stand 212 to resist rotation of the container 16 relative to the stand 212 during de-capping. Desirably, ribs are positioned so that they are not easily accessible to the user, so that the user is unlikely to attempt to grasp them or use them to apply torque to disconnect the upper portion 114 or cap from the lower portion 118. Instead, the ribs on the bottom 120 are desirably positioned so that they are only easily engaged by corresponding structures on the stand 212.
The cap removal assembly 210 also includes a tool 218 having a cap remover 220 and a handle 222 extending therefrom. The cap remover 220 includes a body defining an opening 224 or recess sized to receive a cap or upper portion 114 of the blood collection container 16 and at least one protrusions, such as a prong 226, extending from the body into the opening 224 or recess positioned to engage a portion of the upper portion 114 or cap. For example, the prong 226 can be positioned to engage and/or be inserted into the u-shaped rib 192 of the upper portion 114. Once the tool 218 is engaged to the upper portion 114 or cap, a user can rotate the upper portion 114 or cap relative to the lower portion 118 in a direction of arrow A1 (shown in
In some examples, the body of the tool 218 is a ring 228 that defines the opening 224 (i.e., a through-hole or bore extending through the ring 228). In some examples, the cap remover 220 includes two protrusions, such as two prongs 226, extending from an inner surface of the ring 228 into the opening 224. The prongs 226 are positioned and sized to contact the u-shaped ribs 192 on the upper portion 114 or cap of the container 16 to facilitate releasing the upper portion 114 or cap from the lower portion 118. As shown in
In order to use the cap removal assembly 210 to disconnect the upper portion 114 or cap from the lower portion 118 of the container body 110, the user first places the collection container 16 containing the fluid sample into the stand 212, as shown in
In some examples, the ring 228 is sized so that the upper portion 114 or cap can be inserted through the opening 224 when the tool 218 is in either an upwardly facing orientation or a downwardly facing orientation. This allows the tool 218 to be used by both right handed and left handed individuals. For example, the tool 218 can be configured to permit right-handed operation when in the upwardly facing orientation, meaning that a right-handed individual inserts the tool 218 over the upper portion 114 or cap with the tool 218 in the upwardly facing orientation. A left handed individual flips the tool 218 over so that the tool 218 is in the downwardly facing orientation and then inserts the cap remover 220 onto the upper portion 114 or cap. By flipping the tool 218 over, the left handed individual can rotate the tool 218 in an opposite direction, which is easier for a left handed individual to perform.
With specific reference to
While different examples of the sample containers, blood collection devices, and associated tools are shown in the accompanying figures and described hereinabove in detail, other examples will be apparent to, and readily made by, those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative rather than restrictive. The invention described hereinabove is defined by the appended claims and all changes to the invention that fall within the meaning and the range of equivalency of the claims are to be embraced within their scope.
The present application claims priority to U.S. Provisional Application Ser. No. 63/216,277, filed Jun. 29, 2021, entitled “Sample Container for Capillary Blood Collection”, the entire disclosure of which is hereby incorporated by reference in its' entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US22/34643 | 6/23/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63216277 | Jun 2021 | US |
