Patent Application
20210161446
The present disclosure relates generally to a biological fluid collection system. More particularly, the present disclosure relates to a power source for a collection module for collecting a small sample of blood and dispensing a portion of the sample into a device for analyzing the sample such as a point-of-care or a near-patient-testing device.
A need exists for a device which enables collection of a micro-sample, such as less than 500 microliters of collected sample for analysis, for patient point-of-care applications. Current devices require conventional sample collection and the subsequent use of a 1 ml syringe or pipette to transfer a small blood sample to a point-of-care cartridge or instrument receiving port. Such an open system approach results in an increased blood exposure risk for personnel performing the testing, as well as the collection of excess specimen required for a specified test procedure.
It is therefore desirable to have a blood sample collection and dispensing tool for point-of-care applications which incorporates conventional automatic blood draw and includes a novel controlled sample dispensing capability while minimizing exposure risk.
The present disclosure provides a biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications.
In accordance with an embodiment of the present invention, a biological fluid collection system includes a collection module adapted to receive a sample, the collection module comprising a housing having an inlet port and an outlet port, the inlet port and the outlet port in fluid communication; a mixing chamber disposed between the inlet port and the outlet port; and a collection chamber disposed between the mixing chamber and the outlet port, the collection chamber including an actuation portion, wherein the actuation portion is transitionable between a first position in which the sample is containable within the collection chamber and a second position in which a portion of the sample is expelled from the collection chamber; and a power source removably connectable with the collection module, the power source creates a vacuum that draws the sample within the collection chamber, the power source comprising a barrel in communication with the collection chamber, the barrel defining an interior and having a first end, a second end, and a sidewall therebetween; a piston slidably disposed within the interior of the barrel, the piston sized relative to the interior to provide sealing engagement with the sidewall of the barrel, the piston transitionable between a first piston position, in which the piston is a first distance from the first end of the barrel, and a second piston position, in which the piston is a second distance from the first end of the barrel, the second distance greater than the first distance; and a spring disposed between the first end of the barrel and the piston.
In one configuration, the power source includes an activation button disposed on a portion of the barrel; and a lock in communication with the spring and the activation button, the lock transitionable between a locked position, in which the lock locks the piston in the first piston position and maintains the spring in a compressed position, and an unlocked position, in which the piston is unlocked and the spring is permitted to drive the piston to the second piston position thereby creating a vacuum that draws the sample within the collection chamber, wherein actuation of the activation button moves the lock to the unlocked position. In another configuration, the barrel is removably connectable with a portion of the collection module. In yet another configuration, the collection module includes a sample stabilizer disposed between the inlet port and the mixing chamber; and a cap having a venting plug, the cap seals the outlet port, wherein the venting plug allows air to pass therethrough and prevents the sample from passing therethrough. In one configuration, the biological fluid collection system includes a material including pores disposed between the inlet port and the mixing chamber; and a dry anticoagulant powder within the pores of the material. In another configuration, the sample dissolves and mixes with the dry anticoagulant powder while passing through the material. In yet another configuration, the material is an open cell foam. In one configuration, the sample stabilizer is the dry anticoagulant powder. In another configuration, the biological fluid collection system includes a closure covering the inlet port. In yet another configuration, the sample is a blood sample.
In accordance with another embodiment of the present invention, a biological fluid collection system includes a collection module adapted to receive a sample, the collection module comprising a housing having an inlet port and an outlet port, the inlet port and the outlet port in fluid communication; a mixing chamber disposed between the inlet port and the outlet port; and a collection chamber disposed between the mixing chamber and the outlet port, the collection chamber including an actuation portion, wherein the actuation portion is transitionable between a first position in which the sample is containable within the collection chamber and a second position in which a portion of the sample is expelled from the collection chamber; and a power source removably connectable with the collection module, the power source having a vacuum that draws the sample within the collection chamber, the power source comprising a spike in communication with the collection chamber; an evacuated tube having a first tube end, a second tube end, and a sidewall extending therebetween and defining a tube interior, the evacuated tube containing the vacuum; and a closure sealing the first tube end, wherein, with the evacuated tube engaged with the spike such that a portion of the spike pierces the closure and enters the tube interior, the vacuum of the evacuated tube draws the sample within the collection chamber.
In one configuration, the power source includes a tube holder removably connectable with a portion of the collection module, the tube holder defining an interior and having a first end, a second end, and a tube holder sidewall therebetween. In another configuration, the evacuated tube is movably disposed within the interior of the tube holder between a first tube position, in which the evacuated tube is disengaged from the spike, and a second tube position, in which the closure of the evacuated tube is pierced by the spike. In yet another configuration, with the evacuated tube in the first tube position, a portion of the second tube end is exposed from the second end of the tube holder and the second tube end can be pushed to move the evacuated tube to the second tube position. In one configuration, the second tube end comprises an arcuate surface. In another configuration, the collection module includes a sample stabilizer disposed between the inlet port and the mixing chamber; and a cap having a venting plug, the cap seals the outlet port, wherein the venting plug allows air to pass therethrough and prevents the sample from passing therethrough. In yet another configuration, the biological fluid collection system includes a material including pores disposed between the inlet port and the mixing chamber; and a dry anticoagulant powder within the pores of the material. In one configuration, the sample dissolves and mixes with the dry anticoagulant powder while passing through the material. In another configuration, the material is an open cell foam. In yet another configuration, the sample stabilizer is the dry anticoagulant powder. In one configuration, the biological fluid collection system includes a collection module closure covering the inlet port. In another configuration, the sample is a blood sample.
In accordance with another embodiment of the present invention, a biological fluid collection system includes a collection module adapted to receive a sample, the collection module comprising a housing having an inlet port and an outlet port, the inlet port and the outlet port in fluid communication; a mixing chamber disposed between the inlet port and the outlet port; and a collection chamber disposed between the mixing chamber and the outlet port, the collection chamber including an actuation portion, wherein the actuation portion is transitionable between a first position in which the sample is containable within the collection chamber and a second position in which a portion of the sample is expelled from the collection chamber; and a power source removably connectable with the collection module, the power source creates a vacuum that draws the sample within the collection chamber, the power source comprising a barrel in communication with the collection chamber, the barrel defining an interior and having a first end, a second end, and a sidewall therebetween; a stopper slidably disposed within the interior of the barrel, the stopper sized relative to the interior to provide sealing engagement with the sidewall of the barrel, the stopper transitionable between a first stopper position, in which the stopper is a first distance from the first end of the barrel, and a second stopper position, in which the stopper is a second distance from the first end of the barrel, the second distance greater than the first distance; and a plunger having a first plunger end and a second plunger end, a portion of the first plunger end engaged with the stopper, wherein movement of the plunger away from the first end of the barrel moves the stopper to the second stopper position thereby creating a vacuum that draws the sample within the collection chamber.
In one configuration, the barrel is removably connectable with a portion of the collection module. In another configuration, the collection module includes a sample stabilizer disposed between the inlet port and the mixing chamber; and a cap having a venting plug, the cap seals the outlet port, wherein the venting plug allows air to pass therethrough and prevents the sample from passing therethrough. In yet another configuration, the biological fluid collection system includes a material including pores disposed between the inlet port and the mixing chamber; and a dry anticoagulant powder within the pores of the material. In one configuration, the sample dissolves and mixes with the dry anticoagulant powder while passing through the material. In another configuration, the material is an open cell foam. In yet another configuration, the sample stabilizer is the dry anticoagulant powder. In one configuration, the biological fluid collection system includes a closure covering the inlet port. In another configuration, the sample is a 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 various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices 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 provides a biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications. A collection module of the present disclosure is able to effectuate distributed mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this manner, a biological fluid collection system of the present disclosure enables blood micro-sample management, e.g., passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near patient testing applications.
Advantageously, a biological fluid collection system of the present disclosure provides a consistent blood sample management tool for point-of-care and near patient testing applications, automatic blood draw, passive mixing technology, and controlled small sample dispensing capability to point-of-care cartridge and standard luer interfaces with near patient testing receiving ports.
Referring to
In one embodiment, the housing 20 of the collection module 14 includes an inlet port 32 and an outlet port 34. The inlet port 32 and the outlet port 34 are in fluid communication via a passageway 36 extending therebetween.
The mixing chamber 22 and the collection chamber 26 are provided in fluid communication with the passageway 36. The mixing chamber 22 and the collection chamber 26 are positioned such that a biological fluid sample, such as a blood sample 12, introduced into the inlet port 32 of the collection module 14 will first pass through a sample stabilizer 24, then the blood sample 12 and the sample stabilizer 24 pass through the mixing chamber 22, and subsequently the sample 12 with the sample stabilizer 24 properly mixed therein flow into the collection chamber 26, prior to reaching the outlet port 34 of the collection module 14. In this way, the blood sample 12 may be mixed with a sample stabilizer 24, such as an anticoagulant or other additive, provided within the collection module 14, before passing through the mixing chamber 22 for proper mixing of the sample stabilizer 24 within the blood sample 12, and then the stabilized sample is received and stored within the collection chamber 26.
In one embodiment, a sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. The collection module 14 of the present disclosure provides passive and fast mixing of a blood sample 12 with the sample stabilizer 24. For example, the collection module 14 includes a mixing chamber 22 that allows for passive mixing of the blood sample 12 with an anticoagulant or another additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 22.
The sample stabilizer can be an anticoagulant, or a substance designed to preserve a specific element within the blood such as, for example, RNA, protein analyte, or other element. In one embodiment, the sample stabilizer 24 is disposed between the inlet port 32 and the mixing chamber 22. In other embodiments, the sample stabilizer 24 may be disposed in other areas within the housing 20 of the collection module 14.
Referring to
In one embodiment, the open cell foam may be treated with an anticoagulant to form a dry anticoagulant powder finely distributed throughout the pores of the open cell foam. As the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open cell foam and is exposed to the anticoagulant powder available throughout the internal pore structure of the open cell foam. In this manner, the sample 12 dissolves and mixes with the dry anticoagulant powder 44 while passing through the material 40 or open cell foam.
The open cell foam may be a soft deformable open cell foam that is inert to blood, for example, a melamine foam, such as Basotect® foam commercially available from BASF, or may consist of a formaldehyde-melamine-sodium bisulfite copolymer. The open cell foam may also be a flexible, hydrophilic open cell foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may include a sponge material.
The anticoagulant or other additive may be introduced into the open cell foam by soaking the foam in a liquid solution of the additive and water and subsequently evaporating the water forming a dry additive powder finely distributed throughout the internal structure of the foam.
The collection module 14 includes a mixing chamber 22 that allows for passive mixing of the blood sample 12 with an anticoagulant or another additive, such as a blood stabilizer, as the blood sample 12 flows through the mixing chamber 22. In one embodiment, the mixing chamber 22 is disposed between the inlet port 32 and the outlet port 34.
The internal portion of the mixing chamber 22 may have any suitable structure or form as long as it provides for the mixing of the blood sample 12 with an anticoagulant or another additive as the blood sample 12 passes through the passageway 36 of the collection module 14. Referring to
The mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and effectuates distributed mixing of the sample stabilizer 24 within the sample 12. The mixing chamber 22 effectuates distributed mixing of the sample stabilizer 24 within the sample 12 and prevents a very high sample stabilizer concentration in any portion of the blood sample 12. This prevents underdosing of the sample stabilizer 24 in any portion of the blood sample 12. The mixing chamber 22 effectuates distributed mixing of the sample stabilizer 24 within the sample 12 so that an approximately equal amount and/or concentration of the sample stabilizer 24 is dissolved throughout the blood sample 12, e.g., an approximately equal amount and/or concentration of the sample stabilizer 24 is dissolved into the blood sample 12 from a front portion of the blood sample 12 to a rear portion of the blood sample 12.
In one embodiment, the collection module 14 includes a collection chamber 26 that is disposed between the mixing chamber 22 and the outlet port 34. The collection chamber 26 includes an actuation portion 61. In one embodiment, the actuation portion 61 is transitionable between a first position (
In one embodiment, the actuation portion 61 of the collection chamber 26 includes a first deformable portion 62, a second deformable portion 64, and a rigid wall portion 66 (
In one embodiment, the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (
Advantageously, by having a first deformable portion 62 and a second deformable portion 64 that can be simultaneously squeezed, a collection module 14 of the present disclosure is able to dispense more sample 12 out of the collection chamber 26 and the outlet port 34. Furthermore, in one embodiment, by having a first deformable portion 62 on a first side 70 and a second deformable portion 64 on an opposite second side 72, a collection module 14 of the present disclosure has a symmetrical design and provides a smooth straight fluid path chamber that encourages fluid attachment flow characteristics. The smooth straight fluid path chamber of the collection module 14 is without significant geometric steps in diameter and the smooth fluid pathway inhibits the formation of air pockets or bubbles.
After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 may take any suitable shape and size to store a sufficient volume of blood necessary for the desired testing, for example, 500 μl or less. In one embodiment, the collection chamber 26 is defined by a portion of the housing 20 in combination with a first deformable portion 62, a second deformable portion 64, and a rigid wall portion 66.
The first deformable portion 62 and the second deformable portion 64 may be made of any material that is flexible, deformable, and capable of providing a fluid tight seal with the housing 20. In some embodiments, the first deformable portion 62 and the second deformable portion 64 may be made of natural or synthetic rubber, and other suitable elastomeric materials. The first deformable portion 62 and the second deformable portion 64 are secured to a portion of the housing 20 such that the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (
In another embodiment, the actuation portion 61 of the collection chamber 26 may comprise an activation member in accordance with an activation member described in U.S. patent application Ser. No. 15/065,022, filed Mar. 9, 2016, entitled “Biological Fluid Micro-Sample Management Device”, the entire disclosure of which is hereby expressly incorporated herein by reference.
In other embodiments, the actuation portion 61 of the collection chamber 26 may comprise actuation portions in accordance with actuation portions and/or deformable portions described in U.S. Patent Application Ser. No. 62/634,960, filed Feb. 26, 2018, entitled “Biological Fluid Collection Device and Collection Module”, the entire disclosure of which is hereby expressly incorporated herein by reference.
In one embodiment, the collection module 14 includes a cap 30 that is removably attachable to the outlet port 34 and that protectively covers the outlet port 34. In one embodiment, the cap 30 includes a venting plug 80 which allows air to pass therethrough and prevents the sample 12 from passing therethrough.
The construction of the cap 30 and venting plug 80 allows air to pass through the cap 30 while preventing the blood sample 12 from passing through the cap 30 and may include a hydrophobic filter. The venting plug 80 has selected air passing resistance that may be used to finely control the filling rate of the passageway 36 and/or the collection chamber 26 of the collection module 14. By varying the porosity of the plug, the velocity of the air flow out of the cap 30, and thus the velocity of the blood sample flow into the collection module 14, may be controlled.
In one embodiment, the collection module 14 includes a closure 28 that is engaged with the inlet port 32 of the collection module 14 to seal the passageway 36. The closure 28 protectively covers the inlet port 32. The closure 28 allows for introduction of a blood sample 12 into the passageway 36 of the housing 20 and may include a pierceable self-sealing stopper 82 with an outer shield 84 such as a Hemogard™ cap commercially available from Becton, Dickinson and Company.
The present disclosure provides a biological fluid collection system 10 that includes a power source 16 for a collection module 14 that receives a sample 12 and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications. A power source of the present disclosure allows a user activated vacuum source.
In one embodiment, the power source 16 includes a spring loaded device for automatic drawing of a blood sample 12 within the collection module 14. A spring loaded power source utilizes a user activated, spring powered piston to generate a vacuum on a distal end of a collection module 14. In such an embodiment, by controlling the stiffness of and travel length of the spring, a predictable vacuum can be applied to a fluid path of the collection module 14 to generate a given flow rate of blood as it fills the collection module 14. Predictable flow rates are important for the mixing structure.
Referring to
The barrel 110 is in communication with the collection chamber 26 of the collection module 14. The barrel 110 defines an interior 120 and includes a first end 122, a second end 124, and a sidewall 126 therebetween. The barrel 110 is removably connectable with a portion of the collection module 14. For example, in one embodiment, the barrel 110 is removably connectable with the cap 30 of the collection module 14 such that a vacuum created by the power source 16 is able to draw a sample 12 within the collection chamber 26 of the collection module 14. As discussed above, the cap 30 includes a venting plug 80 which allows air to pass therethrough and prevents the sample 12 from passing therethrough. In this manner, the vacuum created within the barrel 110 of the power source 16 is in communication with the collection chamber 26 of the collection module 14 such that a vacuum created by the power source 16 is able to draw a sample 12 within the collection chamber 26 of the collection module 14.
The piston 112 is slidably disposed within the interior 120 of the barrel 110. The piston 112 is sized relative to the interior 120 of the barrel 110 to provide sealing engagement with the sidewall 126 of the barrel 110. The piston 112 is transitionable between a first piston position (
Referring to
The power source 16 also includes a lock 118 that is in communication with the spring 114 and the activation button 116. The lock 118 is transitionable between a locked position, in which the lock 118 locks the piston 112 in the first piston position (
Exemplary embodiments of a lock 118 of a power source of the present disclosure will now be discussed. Referring to
The barrel 210 is in communication with the collection chamber 26 of the collection module 14. The barrel 210 defines an interior 220 and includes a first end 222, a second end 224, and a sidewall 226 therebetween. The barrel 210 is removably connectable with a portion of the collection module 14. For example, the barrel 210 is removably connectable with the cap 30 of the collection module 14 such that a vacuum created by the power source 206 is able to draw a sample 12 within the collection chamber 26 of the collection module 14. As discussed above, the cap 30 includes a venting plug 80 which allows air to pass therethrough and prevents the sample 12 from passing therethrough. In this manner, the vacuum created within the barrel 210 of the power source 206 is in communication with the collection chamber 26 of the collection module 14 such that a vacuum created by the power source 206 is able to draw a sample 12 within the collection chamber 26 of the collection module 14.
The piston 212 is slidably disposed within the interior 220 of the barrel 210. The piston 212 is sized relative to the interior 220 of the barrel 210 to provide sealing engagement with the sidewall 226 of the barrel 210. The piston 212 is transitionable between a first piston position (
Referring to
The power source 206 also includes a lock 218 that is in communication with the spring 214 and the activation button 216. The lock 218 is transitionable between a locked position, in which the lock 218 locks the piston 212 in the first piston position (
Referring to
Referring to
Referring to
When a user desires to pull a blood sample 12 into the collection module 14 from the conventional tube holder 102 by the draw of a vacuum created within the power source 206, the user actuates, i.e., pushes down, the activation button 216 which moves the lock 218 to the unlocked position (
With the lock 218 in the unlocked position (
Advantageously, a collection module and a power source of the present disclosure can be engaged with many different sources through which biological fluid, such as a blood sample 12, is passed. For example, in some embodiments, a collection module and a power source of the present disclosure can be engaged with a conventional tube holder 102 as described above. In other embodiments, a user activated power source of the present disclosure enables the user to connect directly to a Luer-line, e.g., IV Catheter, wingset, PICC, or similar device. In other embodiments, if the collection module and the power source are used with a HemoLuer, a user may connect the collection module and the power source to either a Luer (by removing the HemoLuer) or a conventional tube holder (using the HemoLuer as an interface). Advantageously, the system of the present disclosure also allows for direct Luer access without the use of an LLAD (Luer Line Access Device) or any other holder.
The blood sample 12 is pulled into the passageway 36 of the housing 20 of the collection module 14 from the conventional tube holder 102 by the draw of the vacuum created in the barrel 210. In one embodiment, the blood sample 12 fills the entire passageway 36 such that, as the blood sample 12 enters the collection module 14, the blood sample 12 passes through the open cell foam, e.g., the material 40, and is exposed to the anticoagulant powder 44 available throughout the internal pore 42 structure of the open cell foam. In this manner, the sample 12 dissolves and mixes with the dry anticoagulant powder 44 while passing through the material 40 or open cell foam. Next, the mixing chamber 22 receives the sample 12 and the sample stabilizer 24 therein and effectuates distributed mixing of the sample stabilizer 24 within the sample 12. After passing through the mixing chamber 22, the stabilized sample is directed to the collection chamber 26. The collection chamber 26 may take any suitable shape and size to store a sufficient volume of blood necessary for the desired testing, for example, 500 μl or less. In one embodiment, the cap 30 stops the collection of the blood sample 12 when the passageway 36, the mixing chamber 22, and the collection chamber 26 of the collection module 14 have been fully filled. The venting plug 80 of the cap 30 allows air to pass through the cap 30 while preventing the blood sample 12 from passing through the cap 30 into the barrel 210 of the power source 206.
In one embodiment, once sample collection is complete, the power source 206 and the collection module 14 are separated from the tube holder 102 (
Once the collection module 14 is separated from the power source 206, the cap 30 may then be removed from the collection module 14 (
The blood sample 12 may then be dispensed from the collection module 14 by activation of the actuation portion 61. In one embodiment, the actuation portion 61 includes a first deformable portion 62 and a second deformable portion 64. For example, the first deformable portion 62 and the second deformable portion 64 are transitionable between an initial position (
Advantageously, by having a first deformable portion 62 and a second deformable portion 64 that can be simultaneously squeezed, a collection module 14 of the present disclosure is able to dispense more sample 12 out of the collection chamber 26 and the outlet port 34. Furthermore, in one embodiment, by having a first deformable portion 62 on a first side 70 and a second deformable portion 64 on an opposite second side 72, a collection module 14 of the present disclosure has a symmetrical design and provides a smooth straight fluid path chamber that encourages fluid attachment flow characteristics.
Another exemplary embodiment of a lock 118 of a power source will now be discussed. Referring to
The barrel 310 is in communication with the collection chamber 26 of the collection module 14. The barrel 310 defines an interior 320 and includes a first end 322, a second end 324, and a sidewall 326 therebetween. The barrel 310 is removably connectable with a portion of the collection module 14. For example, the barrel 310 is removably connectable with the cap 30 of the collection module 14 such that a vacuum created by the power source 306 is able to draw a sample 12 within the collection chamber 26 of the collection module 14. As discussed above, the cap 30 includes a venting plug 80 which allows air to pass therethrough and prevents the sample 12 from passing therethrough. In this manner, the vacuum created within the barrel 310 of the power source 306 is in communication with the collection chamber 26 of the collection module 14 such that a vacuum created by the power source 306 is able to draw a sample 12 within the collection chamber 26 of the collection module 14.
The piston 312 is slidably disposed within the interior 320 of the barrel 310. The piston 312 is sized relative to the interior 320 of the barrel 310 to provide sealing engagement with the sidewall 326 of the barrel 310. The piston 312 is transitionable between a first piston position (
Referring to
The power source 306 also includes a lock 318 that is in communication with the spring 314 and the activation button 316. The lock 318 is transitionable between a locked position, in which the lock 318 locks the piston 312 in the first piston position (
Referring to
Referring to
Referring to
In use, as described above, a needle cannula 100 (
When a user desires to pull a blood sample 12 into the collection module 14 from the conventional tube holder 102 by the draw of a vacuum created within the power source 306, the user actuates, i.e., pushes in, the button portion 332 which moves the lock 318 to the unlocked position (
With the lock 318 in the unlocked position (
As described above, once sample collection is complete, the power source 306 and the collection module 14 are separated from the tube holder 102 (
Once the collection module 14 is separated from the power source 306, the cap 30 may then be removed from the collection module 14 (
As described above, the blood sample 12 may then be dispensed from the collection module 14 by activation of the actuation portion 61 as shown in
The present disclosure provides a biological fluid collection system 10 that includes a power source 16 for a collection module 14 that receives a sample 12 and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications. A power source of the present disclosure allows a user activated vacuum source.
Referring to
Referring to
The evacuated tube 410 includes a first tube end 420, a second tube end 422, and a sidewall 424 extending therebetween and defining a tube interior 426. The evacuated tube contains the vacuum. The evacuated tube 410 includes a closure 428 sealing the first tube end 420.
The tube holder 412 is removably connectable with a portion of the collection module 14. In one embodiment, the tube holder 412 defines an interior 430 and includes a first end 432, a second end 434, and a tube holder sidewall 436 therebetween.
In one embodiment, the spike 414 includes a first spike end 440 and a second spike end 442. The spike 414 is removably connectable with a portion of the collection module 14 and with a portion of the power source 406. The spike 414 is able to be placed in communication with the collection chamber 26 of the collection module 14.
In one embodiment, the evacuated tube 410 is movably disposed within the interior 430 of the tube holder 412 between a first tube position (
In one embodiment, with the evacuated tube 410 in the first tube position (
Referring to
In use, as described above, a needle cannula 100 (
When a user desires to pull a blood sample 12 into the collection module 14 from the conventional tube holder 102 by the draw of a vacuum within the power source 406, the user actuates, i.e., pushes down, the second tube end 422 of the evacuated tube 410 which moves the evacuated tube 410 to the second tube position (
As described above, once sample collection is complete, the power source 406 and the collection module 14 are separated from the tube holder 102 (
Once the collection module 14 is separated from the power source 406, the cap 30 may then be removed from the collection module 14 (
As described above, the blood sample 12 may then be dispensed from the collection module 14 by activation of the actuation portion 61 as shown in
Referring to
The present disclosure provides a biological fluid collection system 10 that includes a power source 16 for a collection module 14 that receives a sample 12 and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications. A power source of the present disclosure allows a user activated vacuum source.
Referring to
Referring to
The barrel 510 is in communication with the collection chamber 26 of the collection module 14. The barrel 510 defines an interior 520 and includes a first end 522, a second end 524, and a sidewall 526 therebetween. The barrel 510 is removably connectable with a portion of the collection module 14. For example, the barrel 510 is removably connectable with the cap 30 of the collection module 14 such that a vacuum created by the power source 506 is able to draw a sample 12 within the collection chamber 26 of the collection module 14. As discussed above, the cap 30 includes a venting plug 80 which allows air to pass therethrough and prevents the sample 12 from passing therethrough. In this manner, the vacuum created within the barrel 510 of the power source 506 is in communication with the collection chamber 26 of the collection module 14 such that a vacuum created by the power source 506 is able to draw a sample 12 within the collection chamber 26 of the collection module 14.
The stopper 512 is slidably disposed within the interior 520 of the barrel 510. The stopper 512 is sized relative to the interior 520 of the barrel 510 to provide sealing engagement with the sidewall 526 of the barrel 510. The stopper 512 is transitionable between a first stopper position (
The plunger 514 includes a first plunger end 530 and a second plunger end 532. In one embodiment, a portion of the first plunger end 530 is engaged with the stopper 512, wherein movement of the plunger 514 away from the first end 522 of the barrel 510 moves the stopper 512 to the second stopper position (
Referring to
In use, as described above, a needle cannula 100 (
When a user desires to pull a blood sample 12 into the collection module 14 from the conventional tube holder 102 by the draw of a vacuum created within the power source 506, the user moves the plunger 514 away from the first end 522 of the barrel 510 to move the stopper to the second stopper position (
As described above, once sample collection is complete, the power source 506 and the collection module 14 are separated from the tube holder 102 (
Once the collection module 14 is separated from the power source 506, the cap 30 may then be removed from the collection module 14 (
As described above, the blood sample 12 may then be dispensed from the collection module 14 by activation of the actuation portion 61 as shown in
As described herein, the present disclosure provides a biological fluid collection system that includes a power source for a collection module that receives a sample and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications. A power source of the present disclosure provides a user activated vacuum source for drawing a biological fluid sample within a collection module.
A collection module of the present disclosure is able to effectuate distributed mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this manner, a biological fluid collection system of the present disclosure enables blood micro-sample management, e.g., passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near patient testing applications.
Advantageously, a biological fluid collection system of the present disclosure provides a consistent blood sample management tool for point-of-care and near patient testing applications, automatic blood draw, passive mixing technology, and controlled small sample dispensing capability to point-of-care cartridge and standard luer interfaces with near patient testing receiving ports.
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. 62/658,737 entitled “Biological Fluid Collection System”, filed Apr. 17, 2018, the entire disclosure of which is hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US19/27212 | 4/12/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62658737 | Apr 2018 | US |
