Devices for collecting capillary blood and methods for same

Information

  • Patent Grant
  • 11478175
  • Patent Number
    11,478,175
  • Date Filed
    Wednesday, February 2, 2022
    2 years ago
  • Date Issued
    Tuesday, October 25, 2022
    2 years ago
Abstract
A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device including a collection cup subassembly having a cantilevered, concave slide for transporting blood down and away from a blood sampling location; a mid-body subassembly couplable to the collection cup assembly and including a housing having a proximal end and a distal end and defining a plenum space; and a plunger subassembly having a first end and a second end and including a plunger formed at the second end and one or more lancet elements attached to the plunger. Advantageously, the plunger and lancet elements are structured and arranged to translate through the mid-body subassembly and the collection cup subassembly to the blood sampling location.
Description
FIELD OF THE INVENTION

The present invention relates to devices and methods for collecting capillary blood from a mammalian subject and, more specifically, to blood collecting devices and methods that include a cantilevered slide that slopes down and away from the blood sampling site to draw blood by gravity feed rather than by spontaneous capillary flow.


BACKGROUND OF INVENTION

Conventional blood sampling requires a trained medical professional, e.g., a phlebotomist, who collects blood samples from a mammalian subject, e.g., a human, through venipuncture, for example, using a needle and syringe. Disadvantageously, venipuncture using a needle and syringe is not suitable if the subject prefers to collect a blood sample by herself. Other methods for collecting a blood sample, for example, at the subject's residence, involve collecting capillary blood samples, which do not require a needle, a syringe, venipuncture, or a trained medical professional.


In some applications, capillary blood sample collection includes the use of a lancet and a blood collection tube. More particularly, the lancet may be used to pierce the subject's epidermis, causing blood to rise to the surface of the subject's skin typically from subject's fingertip. Blood is either dripped directly into the blood collection tube, or a capillary tube is employed to transfer blood from the fingertip to the capillary tube. Using either method can sometimes cause spillage of blood. Although such a method and device lend themselves to home use by laypersons who are not trained medical professionals it is a relatively difficult process to drip blood into a vial from the finger.


BRIEF SUMMARY OF THE INVENTION

Accordingly, it would be desirable to provide a device for collecting capillary blood samples that does not suffer from the shortcomings of the prior art. More specifically, the capillary blood samples may be collected at home or at a medical facility by trained medical professionals as well as laypersons. Moreover, by making it easier to collect by a layperson, more samples will be successfully collected.


In a first aspect, the present invention relates to a device for collecting a blood sample. More specifically, in some embodiments, the device includes a collection cup subassembly that has a housing and a cantilevered slide structured and arranged in the housing for transporting blood down and away from a blood sampling location. In some implementations, the slide is cantilevered at an obtuse angle from the opening in the housing in the collection cup subassembly and/or the slide has a shape is selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide. In some variations, a hydrophobic agent may be applied to the slide.


In some applications, the collection cup subassembly may also include sidewall elements that are formed within and about one or more openings in the housing and that are structured and arranged to funnel blood from the blood sampling location to the slide. In one implementation, the one or more openings include multiple openings. In some variations, the device may also include a blood diverter that is configured to divert blood flow originating in a first opening around a second opening. Preferably, blood flow is diverted along a path that exceeds 2 mm.


Furthermore, the collection cup subassembly may include one or more of the following: a one-way valve disposed in the housing for creating a negative pressure within a plenum space within the housing, an opening formed therethrough for placement against the epidermis of the subject, and/or the housing of the collection cup subassembly may include a connection opening structured and arranged for releasably connecting a blood sample container to the housing of the collection cup subassembly.


In some implementations, the device may also include a mid-body subassembly couplable to the collection cup assembly and comprising a housing having a proximal end and a distal end and defining a plenum space and/or a plunger subassembly having a first end and a second end. In some variations, the mid-body subassembly further includes comprises a pair of opposing tabs formed at the distal end of the housing, wherein the opposing tabs are configured to retain at least one biasing element (e.g., a pair of springs) and/or a tab formed at the proximal end of the housing for retaining a plunger within the plenum space.


In some implementations, the plunger subassembly may include one or more of the following: a first end and a second end with a base portion formed at the first end and a plunger formed at the second end. The base portion may include a pair of protrusions that are structured and arranged to retain a biasing element. At least one lancet element may be attached to the plunger. At least one sealing device may be disposed about the plunger.


In some variations, the plunger and lancet elements are structured and arranged to translate through the collection cup subassembly to the blood sampling location. Advantageously, the plunger may be structured and arranged to create a negative pressure within the collection cup subassembly.


In a second aspect, the present invention relates to a method for collecting a blood sample. More specifically, in some embodiments, the method includes providing a blood collecting device; placing the device at a blood sampling point; applying a force to compress a biasing device, such that the plunger and lancet elements advance towards the blood sampling location; funneling blood down and away from the blood sampling location towards the slide; and collecting blood traveling by a gravity feed via the slide in a blood sample container disposed through an opening in the housing of the collection cup subassembly. In some applications, the device includes a collection cup subassembly having a cantilevered slide for transporting blood down and away from a blood sampling location; a mid-body subassembly couplable to the collection cup assembly and comprising a housing having a proximal end and a distal end and defining a plenum space; and a plunger subassembly having a first end and a second end. In some variations, a plunger may be formed at the second end and at least one lancet element maybe attached to the plunger.


In some implementations, the slide may be cantilevered at an obtuse angle from the opening in the housing in the collection cup subassembly and/or compressing the biasing device causes air within the device to be expelled, creating a negative pressure within the device. For example, the negative pressure may be created by expelling air via a one-way valve.





DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which:



FIG. 1 shows a bottom perspective view of a device for collecting blood samples, in accordance with some embodiments of the present invention;



FIG. 2 shows a top perspective view of the device of FIG. 1, in accordance with some embodiments of the present invention;



FIG. 3 shows an exploded view of a top perspective view of the device of FIG. 1, in accordance with some embodiments of the present invention;



FIG. 4 shows a bottom perspective view of the device of FIG. 1 with a portion of the mid-body subassembly removed, in accordance with some embodiments of the present invention;



FIG. 5A shows a bottom perspective view of the collection cup subassembly of the device of FIG. 1, in accordance with some embodiments of the present invention;



FIG. 5B shows a detail of the collection cup subassembly of the device of FIG. 5A, in accordance with some embodiments of the present invention;



FIG. 6 shows a cross-sectional side (elevation) view of the device of FIG. 1 with the lancets advanced towards the subject's epidermis, in accordance with some embodiments of the present invention;



FIG. 7 shows a cross-sectional side (elevation) view of the device of FIG. 6 with the lancets retracted, in accordance with some embodiments of the present invention;



FIG. 8 shows a flow chart of a method of collecting a capillary blood sample, in accordance with some embodiments of the present invention; and



FIG. 9 shows a collection cup subassembly having a plurality of smaller openings, in accordance with some embodiments of the present invention.





DETAILED DESCRIPTION

Referring to FIGS. 1-4, an illustrative embodiment of a device for collecting a blood sample from a mammalian subject is shown. Advantageously, the device 100 is structured and arranged so that blood is not collected using spontaneous capillary flow. In some implementations, the device 100 consists or consists essentially of a collection (or suction) cup subassembly 10, as well as two other subassemblies: a mid-body subassembly 20, and a plunger subassembly 30. In some applications, the (e.g., elongate, rectangular or rounded rectangular) collection cup subassembly 10 may include a (e.g., plastic) suction cup 11 having a housing 12 that is formed to provide an open, proximal end 13; a partially open, distal end 14; and a plenum space 15. In some variations, the distal end 14 includes an (e.g., planar, concave, convex, and so forth) upper surface 16 having an opening 17 formed therein to provide access to the plenum space 15. Although the opening 17 shown in FIGS. 1-4 is polygonal (e.g., substantially rectangular) in shape and there is but a single opening 17, as shown in FIG. 9, in an alternate embodiment, the distal end 14′ may include a plurality of (e.g., two) smaller-dimensioned openings 17a, 17b formed therein to provide access to the plenum space 15. Advantageously, smaller-dimensioned openings 17a, 17b suck in a smaller amount of the subject's skin 60 during blood draw; hence, their use results in less subject discomfort. Although the shape of the openings 17a, 17b in FIG. 9 is circular, that is done for illustrative purposes only. Those of ordinary skill in the art can appreciate that any logical shape may be used to provide a conduit between the puncture points 64a, 64b in the subject's epidermis 60 and the plenum space 15.


In some variations, a blood diverter 91 may be formed between the openings 17a, 17b, such that the blood diverter 91 is capable of directing the flow of blood originating at the first opening 17a around the second opening 17b. Preferably, to avoid microfluidic flow conditions, there is sufficient clearance (e.g., 2-3 mm) 92 between the blood diverter 91 and a sidewall 93 formed about the openings 17a, 17b.


A one-way valve 18 may be formed on a first portion of the housing 12 of the suction cup 11, while a connection 19 for connecting a blood sample container 40 to the suction cup 11 may be formed on a second portion of the housing 12. In some embodiments, the one-way valve 18 and the connection 19 are disposed on opposing sides of the housing 12 of the suction cup 11.


In some variations, the connection 19 is structured and arranged to releasably couple a blood sample container 40 to the housing 12 of the suction cup 11 for the purpose of collecting capillary blood. For example, in some implementations, the connection 19 may include a (e.g., circular) connection opening 21 formed through the housing 12. In some variations, the lumen of the blood sample container 40 passes through the connection opening 21, such that, during use, the opening 45 in the blood sample container 40 may be held at a pressure that is less than atmospheric pressure. Preferably, the (e.g., circular) connection opening 21 may be dimensioned to be slightly greater that the largest outer dimension (e.g., diameter) of the opening 45 of the blood sample container 40. A sealing device(s) 22 may be operatively disposed about the connection opening 21. In some variations, the sealing device 22 may be an (e.g., plastic, elastomer, rubber, silicone, and so forth) O-ring. The sealing device 22 may be a separate item or may be integrated into the connection 19 and the housing 12 of the suction cup 11. One or more collection container locks or clips 23 may be disposed about the connection opening 21 that are structured and arranged so as to (e.g., tightly) compress the sealing device 22 between the connection opening 21 in the housing 12 of the suction cup 11 and the blood sample container 40.


Referring to FIGS. 5A and 5B, a device for transporting or channeling blood from the sampling point into the lumen of a blood sample container 40 without using spontaneous capillary flow will be described. In some embodiments, the transporting or channeling device may include a slide 50 and sidewall elements 55 and may be formed between the opening 17 of the housing 12 of the suction cup 11 and the connection opening 21 of the connection 19. The slide 50 may be manufactured of rigid plastic, an elastomer, and the like. In some variations, a hydrophobic agent may be applied to the slide 50 to better repel the blood, making it slide more easily down the slide 50 toward the blood sample container 40.


Although the shape of the slide 50 will be described as being highly rounded or concave, that is done for illustrative purposes only. Those of ordinary skill in the art can appreciate that, in addition to being concave, the shape of the slide 50 can be rectangular, rounded rectangular, and so forth. In some applications, a first end of the (e.g., concave) slide 50 is cantilevered (e.g., at an obtuse angle) from the housing 12 of the suction cup 11 near the opening 17 of the housing 12, while the second, opposing end is a free end under which a blood sample container 40 may be placed. Advantageously, the (e.g., concave) slide 50 may be structured and arranged to provide gravity-fed, open channel flow to transport or channel blood down and away from the sampling point and the opening 17 in the housing 12 of the suction cup 11. In some variations, the sidewall elements 55 are structured and arranged to channel or funnel blood (e.g., using gravity) from the sampling point into cantilevered end of the (e.g., concave) slide 50. Advantageously, the (e.g., concave) slide 50 is sufficient wide so that it does not transport or channel blood via spontaneous capillary flow, relying, instead on gravity and the hydrophobic nature of the surface of the (e.g., concave) slide 50. Slide widths in excess of 1 mm may be used to avoid open, microfluidic conditions. For example, the width of the slide 50 may be between about 3 mm and about 5 mm; although, widths in excess of 5 mm or less than 3 mm may be used.


In some implementations, the sidewall elements 55 may be formed about the opening 17 of the housing 12 of the suction cup 11 for the purpose of channeling or funneling blood towards the (e.g., concave) slide 50 and the blood sample container 40. For example, in some variations, the sidewall elements 55 may be formed at the same end of the housing 12 of the suction cup 11 as the connection 19. The (e.g., concave) slide 50 may be formed on the housing 12 of the suction cup 11 within the plenum space 15, fixedly attached, at a first, proximal end, to the sidewall elements 55. The second, distal end of the (e.g., concave) slide 50 may be structured and arranged to hang freely over the opening 45 of any blood sample container 40 connected to the connection 19 to the housing 12 of the suction cup 11.


The second, mid-body subassembly 20 may consist or consist essentially of a (e.g., elongate, rectangular or rounded rectangular) housing 29 that is formed to provide an open, proximal end 24; an open, distal end 25; and a plenum space 26 therebetween. Preferably, the outer, peripheral dimensions of the second, mid-body subassembly 20 are configured to provide a tight interference fit between the outer, peripheral surfaces of the (e.g., elongate, rectangular or rounded rectangular) housing 29 and the corresponding inner surfaces of the suction cup 11 of the collection cup subassembly 10. Optionally, the outer, peripheral dimensions of the second, mid-body subassembly 20 may be fixedly attached (e.g., using an adhesive, plastic welding, and the like) to the corresponding inner surfaces of the housing 12 of the suction cup 10 of the collection cup subassembly 10. Although the mid-body subassembly 20 is described as a separate element of the device 100, those of ordinary skill in the art can appreciate that, in some implementations, the collection cup subassembly 10 and the mid-body subassembly 20 could be manufactured of unitary or monolithic construction.


A pair of tabs or projections 27 may be formed proximate the open, distal end 25 of the mid-body subassembly 20, such that the tabs or projections 27 extend from opposing ends of the (e.g., elongate, rectangular or rounded rectangular) housing 29. A (e.g., cylindrical) protrusion 28 may be formed on each tab or projection 27, for example, to accommodate and retain a biasing element(s) 38 (e.g., a pair of springs). The tabs or projections 27 may be configured to provide a resisting force when the biasing element(s) 38 of the plunger assembly 30 is forced or compressed into the tabs or projections 27.


A lock or tab 37 for preventing the plunger assembly 30 from coming out of the plenum space 26 of the mid-body subassembly 20 may be formed on the housing 29 at the open, proximal end 24. Although FIG. 1 shows a lock or tab 37 that includes projections formed on opposing ends of the (e.g., elongate, rectangular or rounded rectangular) housing 29, this is done for the purpose of illustration rather than limitation. Those of ordinary skill in the art understand that the invention may include any sort of lock or tab 37 that permits the plunger assembly 30 to slidingly translate along the inside surface of the housing 29 of the mid-body subassembly 20; but that prevents the plunger assembly 30, after being inserted into the plenum space 26 of the housing 29 of the mid-body subassembly 20, from coming out of the plenum space 26 of the housing 29 of the mid-body subassembly 20.


The plunger subassembly 30 may consist or consist essentially of a (e.g., elongate, rectangular or rounded rectangular) housing 31 that, at a first, proximal end, is fixedly attached to a (e.g., elongate) pressure plate or base portion 32 and, at a second, distal end, is fixedly attached to a plunger 33. Preferably, the outer dimensions of the plunger 33 are dimensioned to be slightly less than each of the corresponding inner dimensions of the open, proximal end 24 of the mid-body subassembly 20. One or more sealing devices 34 may be operatively disposed about the outer periphery of the plunger 33, such that, when the plunger 33 is inserted into the open, proximal end 24 of the housing 29 of the mid-body subassembly 20, the sealing device 34 creates an airtight seal between the plunger 33 and the open, proximal end 24 of the housing 29 of the mid-body subassembly 20. In some variations, the sealing device 34 may be an (e.g., plastic, elastomer, rubber, silicone, and so forth) O-ring.


In some implementations, a pair of (e.g., cylindrical) protrusions 39 may be formed on opposing ends of the (e.g., elongate) pressure plate or base portion 32 for example, to accommodate and retain a biasing element 38 (e.g., a pair of springs). Each protrusion 39 on the (e.g., elongate) pressure plate or base portion 32 is configured to accommodate a first end of the biasing elements 38, while each protrusion 28 formed on the tabs 27 of the mid-body subassembly 20 is configured to accommodate an opposing, second end of the biasing elements 38.


In some variations, the plunger 33 includes an (e.g., planar) upper surface 35 on which one or more lancet elements 36 are formed. Lancet elements 36 are commercially available and may be pressure activated, such that when an end of the lancet element 36 contacts the epidermis, a needle disposed within the lancet element 36 is, initially, propelled into the epidermis and then retracted. Although the device 100 in the figures includes two lancet elements 36 on the upper surface 35, this is done for illustrative purposes only. Those of ordinary skill in the art can include a single lancet element 36 or more than two lancet elements 36.


Having described a device 100 for collecting blood samples, a method for collecting blood samples in a blood sample container 40 using the device 100 will be described using FIGS. 6-8. FIGS. 1, 2, and 4 show an illustrative embodiment of an uncompressed or at-rest device 100. In a first step, the user places the upper surface 16 of the collection cup subassembly 10 against the skin 60 (e.g., on an upper arm) of the subject (STEP 1). The uncompressed or at-rest device 100 may be characterized as the collection cup subassembly 10 and mid-body subassembly being in a tight interference fit and the plunger assembly subassembly 30 disposed within the plenum spaces 15, 26 of the collection cup subassembly 10 and mid-body subassembly such that the sealing device(s) 34 on the plunger 33 of the plunger subassembly 30 forms an airtight seal with the mid-body subassembly 20 and collection cup assembly 10. Biasing devices 38 (e.g., springs) may be retained, for example, about protrusions 28 on the tabs or projections 27 on the mid-body subassembly 20 and protrusions 39 on the pressure plate or base portion 32 of the plunger subassembly 30.


The user may then force the pressure plate or base portion 32 of the plunger subassembly 30 towards the tabs or projections 27 on the mid-body subassembly 20 and the blood sampling site, so as to compress the biasing device 38 (STEP 2). As shown in FIG. 6, forcing the pressure plate or base portion 32 of the plunger subassembly 30 towards the tabs or projections 27 on the mid-body subassembly 20 causes the lancet elements 36 to advance towards and puncture the epidermis 60 at the blood sampling site (STEP 3). Forcing the pressure plate or base portion 32 of the plunger subassembly 30 towards the tabs or projections 27 on the mid-body subassembly 20 also compresses and, subsequently, expels air contained within the plenum spaces 15, 26 of the collection cup subassembly 10 and mid-body subassembly 20 out of the plenum spaces 15, 26 via the one-way valve 18 (STEP 4).


Once the lancet elements 36 have punctured the subject's skin 60, the user may then remove the force from the pressure plate or base portion 32 of the plunger subassembly 30, which causes the compressed biasing device 38 to return the device 100 to its uncompressed or at-rest state while the upper surface 16 of the collection cup subassembly 10 remains in contact with and pressed against the subject's epidermis 60 (STEP 5). In some application, an adhesive may be placed on the upper surface 16 of the housing 12 of the collection cup subassembly 10 to improve the seal. Advantageously, the lock or tab 37 on the housing 29 of the mid-body assembly 20 prevents the plunger 33 of the plunger subassembly 30 from retracting from the plenum space 26 of the mid-body subassembly 20. As the biasing device 38 causes the plunger subassembly 30 return to its uncompressed or at-rest state, a negative pressure (i.e., a pressure less than atmospheric or ambient pressure) may be created within the plenum spaces 15, 26 of the collection cup subassembly 10 and mid-body subassembly 20 (STEP 6). As shown in FIG. 7, the negative pressure created in the plenum spaces 15, 26 draws the subject's epidermis 60 into the plenum space 15 via the opening 17 in the housing 12 of the collection cup subassembly 10, creating a bulge 62 in the epidermis 60. Advantageously, the negative pressure further encourages blood 65 to leave the body through the one or more puncture points or openings 64 created by the lancet elements 36 (STEP 7).


As shown in FIG. 7, the device 100 is structured and arrange so that gravity—rather than spontaneous capillary flow—will cause the blood 65 to flow down the subject's epidermis 60 towards the sidewall elements 55. Once sufficient blood 65 pools on the sidewall elements 55, the sidewall elements 55 will channel or funnel the pooled blood 65 towards the fixed end of the cantilevered (e.g., concave) slide 50 (STEP 8). The blood 65 may then travel down the (e.g., concave) slide 50 towards its free end that is disposed above the opening 45 of a blood sample container 40. Once the blood reached the free end of the (e.g., concave) slide 50, the blood 65 may fall into the lumen of the blood sample container 40 (STEP 9).


Once sufficient blood has been collected in the blood sample container 40, the user may remove the device 100 from against the subject's epidermis 60 and staunch the further flow of blood 65.


Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous. Other steps or stages may be provided, or steps or stages may be eliminated, from the described processes. Accordingly, other implementations are within the scope of the following claims.

Claims
  • 1. A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device comprising: a collection cup subassembly comprising: a housing; anda cantilevered slide structured and arranged in the housing for transporting blood down and away from a blood sampling location; anda mid-body subassembly couplable to the collection cup subassembly and comprising: a housing having a proximal end and a distal end and defining a plenum space; anda tab formed at the proximal end of the housing for retaining a plunger subassembly within the plenum space.
  • 2. The device of claim 1, wherein the slide is cantilevered at an obtuse angle from an opening in the housing in the collection cup subassembly.
  • 3. The device of claim 1, wherein the slide has a shape is selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide.
  • 4. The device of claim 1, wherein a hydrophobic agent is applied to the slide.
  • 5. The device of claim 1, wherein the collection cup subassembly further comprises a plurality of sidewall elements that are formed within and about at least one opening in the housing and that are structured and arranged to funnel blood from the blood sampling location to the slide.
  • 6. The device of claim 1, wherein the collection cup subassembly further comprises a one-way valve disposed in the housing for creating a negative pressure within a plenum space within the housing.
  • 7. The device of claim 1, wherein the housing of the collection cup subassembly comprises a connection opening structured and arranged for releasably connecting a blood sample container to the housing of the collection cup subassembly.
  • 8. The device of claim 1, wherein the housing comprises at least one opening formed therethrough for placement against the epidermis of the subject.
  • 9. The device of claim 8, wherein the at least one opening comprises a plurality of openings.
  • 10. The device of claim 9 further comprising a blood diverter configured to divert blood flow originating from a first opening around a second opening.
  • 11. The device of claim 10, wherein blood flow is diverted along a path that exceeds 2 mm.
  • 12. The device of claim 1, wherein the mid-body subassembly further comprises a pair of opposing tabs formed at the distal end of the housing, wherein the opposing tabs are configured to retain at least one biasing element.
  • 13. The device of claim 12, wherein the biasing element comprises a pair of springs.
  • 14. The device of claim 1, wherein the plunger subassembly includes a first end and a second end and comprises: a plunger formed at the second end; andat least one lancet elements attached to the plunger.
  • 15. The device of claim 14, wherein the plunger and lancet elements are structured and arranged to translate through the collection cup subassembly to the blood sampling location.
  • 16. The device of claim 14, wherein the plunger subassembly further comprises a base portion formed at the first end.
  • 17. The device of claim 16, wherein the base portion comprises a pair of protrusions that are structured and arranged to retain a biasing element.
  • 18. The device of claim 14, wherein the plunger is structured and arranged to create a negative pressure within the collection cup subassembly.
  • 19. The device of claim 14, wherein the plunger subassembly further comprises at least one sealing device disposed about the plunger.
  • 20. A method for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the method comprising: providing a blood collecting device comprising: a collection cup subassembly comprising a cantilevered slide for transporting blood down and away from a blood sampling location;a mid-body subassembly couplable to the collection cup assembly and comprising: a housing having a proximal end and a distal end and defining a plenum space anda tab formed at the proximal end of the housing for retaining a plunger subassembly within the plenum space; andthe plunger subassembly having a first end and a second end and comprising:a plunger formed at the second end; andat least one lancet elements attached to the plunger;placing the device at a blood sampling point;applying a force to compress a biasing device, such that the plunger and lancet elements advance towards the blood sampling location;funneling blood down and away from the blood sampling location towards the slide; andcollecting blood traveling by a gravity feed via the slide in a blood sample container disposed through an opening in the housing of the collection cup subassembly.
  • 21. The method of claim 20, wherein the slide is cantilevered at an obtuse angle from the opening in the housing in the collection cup subassembly.
  • 22. The method of claim 20, wherein compressing the biasing device causes air within the device to be expelled, creating a negative pressure within the device.
  • 23. The method of claim 22, wherein the negative pressure is created by expelling air via a one-way valve.
  • 24. A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device comprising: a collection cup subassembly comprising: a housing comprising a plurality of openings formed therethrough for placement against the epidermis of the mammalian subject; anda cantilevered slide structured and arranged in the housing for transporting blood down and away from a blood sampling location; anda mid-body subassembly couplable to the collection cup assembly and comprising: a housing having a proximal end and a distal end and defining a plenum space anda pair of opposing tabs formed at the distal end of the housing, wherein the opposing tabs are configured to retain at least one biasing element.
  • 25. The device of claim 24, wherein the biasing element comprises a pair of springs.
  • 26. A device for collecting blood from a mammalian subject without using spontaneous capillary blood flow, the device comprising: a collection cup subassembly comprising: a housing anda cantilevered slide structured and arranged in the housing for transporting blood down and away from a blood sampling location;a plunger subassembly having a first end and a second end and comprising: a plunger formed at the second end;at least one lancet elements attached to the plunger; anda base portion formed at the first end and comprising a pair of protrusions that are structured and arranged to retain a biasing element.
CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application No. 63/257,630 filed on Oct. 20, 2021, the entire contents of which are incorporated herein in their entirety.

US Referenced Citations (73)
Number Name Date Kind
8561795 Schott Oct 2013 B2
8808202 Brancazio Aug 2014 B2
8821412 Gonzalez-Zugasti et al. Sep 2014 B2
8827971 Gonzalez-Zugasti et al. Sep 2014 B2
9033898 Chickering, III et al. May 2015 B2
9041541 Levinson et al. May 2015 B2
9113836 Bernstein et al. Aug 2015 B2
9119578 Haghgooie et al. Sep 2015 B2
9289763 Berthier et al. Mar 2016 B2
9295417 Haghgooie et al. Mar 2016 B2
9730624 Gonzalez-Zugasti et al. Aug 2017 B2
9775551 Bernstein et al. Oct 2017 B2
9987629 Berthier et al. Jun 2018 B2
10188335 Haghgooie et al. Jan 2019 B2
10426390 Berthier et al. Oct 2019 B2
10492716 Berthier et al. Dec 2019 B2
10543310 Bernstein et al. Jan 2020 B2
10638963 Beyerlein May 2020 B2
10779757 Berthier et al. Sep 2020 B2
10799166 Gonzalez-Zugasti et al. Oct 2020 B2
10835163 Haghgooie et al. Nov 2020 B2
10939860 Levinson et al. Mar 2021 B2
20100069726 Levinson Mar 2010 A1
20100256524 Levinson et al. Oct 2010 A1
20100269837 Levinson et al. Oct 2010 A1
20100272652 Levinson Oct 2010 A1
20100330703 Bernstein et al. Dec 2010 A1
20110009847 Levinson et al. Jan 2011 A1
20110105872 Chickering, III et al. May 2011 A1
20110105951 Bernstein et al. May 2011 A1
20110105952 Bernstein et al. May 2011 A1
20110125058 Levinson et al. May 2011 A1
20110172508 Chickering, III et al. Jul 2011 A1
20110172510 Chickering, III et al. Jul 2011 A1
20110251562 Chickering, III et al. Oct 2011 A1
20110288389 Levinson et al. Nov 2011 A9
20120016308 Schott Jan 2012 A1
20120039809 Levinson et al. Feb 2012 A1
20120041338 Chickering, III et al. Feb 2012 A1
20120271125 Bernstein et al. Oct 2012 A1
20120277629 Bernstein et al. Nov 2012 A1
20130158468 Bernstein et al. Jun 2013 A1
20130158482 Davis et al. Jun 2013 A1
20130211289 Moga et al. Aug 2013 A1
20140186820 Queval Jul 2014 A1
20140336536 Brancazio Nov 2014 A1
20150057510 Levinson et al. Feb 2015 A1
20150087944 Levinson et al. Mar 2015 A1
20160038068 Chickering, III et al. Feb 2016 A1
20170120022 Chickering, III et al. May 2017 A1
20170120023 Davis et al. May 2017 A1
20170127991 Bernstein et al. May 2017 A1
20170154164 Levinson et al. Jun 2017 A9
20170215790 Levinson et al. Aug 2017 A1
20170224264 Brancazio Aug 2017 A1
20180008183 Chickering, III et al. Jan 2018 A1
20180078241 Moga et al. Mar 2018 A1
20180242890 Chickering, III et al. Aug 2018 A1
20190015827 Berthier et al. Jan 2019 A1
20190023473 Schott Jan 2019 A1
20190053740 Bernstein et al. Feb 2019 A1
20190159709 Barone et al. May 2019 A1
20190209820 Chickering, III et al. Jul 2019 A1
20190336058 Haghgooie et al. Nov 2019 A1
20200015751 Chickering, III et al. Jan 2020 A9
20200037940 Berthier et al. Feb 2020 A1
20200085414 Berthier et al. Mar 2020 A1
20200146606 Casavant et al. May 2020 A1
20200178870 Berthier et al. Jun 2020 A1
20200323473 Berthier et al. Oct 2020 A1
20200353155 Bernstein et al. Nov 2020 A1
20210022681 Chickering, III et al. Jan 2021 A1
20210059588 Welch et al. Mar 2021 A1
Foreign Referenced Citations (128)
Number Date Country
2012249683 Nov 2013 AU
2012249692 Nov 2013 AU
2013293078 Feb 2015 AU
2016266112 Dec 2016 AU
2016269418 Dec 2016 AU
2015295983 Feb 2017 AU
2017272264 Jan 2018 AU
2016377659 Jul 2018 AU
2018223046 Sep 2018 AU
2020202814 May 2020 AU
112013027351 Jan 2017 BR
2833175 Nov 2012 CA
2833275 Nov 2012 CA
3009328 Jun 2017 CA
102405015 Apr 2012 CN
102405018 Apr 2012 CN
102648015 Aug 2012 CN
102791197 Nov 2012 CN
102811754 Dec 2012 CN
103068308 Apr 2013 CN
103370007 Oct 2013 CN
103874460 Jun 2014 CN
103874461 Jun 2014 CN
104434136 Mar 2015 CN
106999120 Aug 2017 CN
107115115 Sep 2017 CN
109068979 Dec 2018 CN
109996571 Jul 2019 CN
111295138 Jun 2020 CN
111657965 Sep 2020 CN
112203586 Jan 2021 CN
2329035 Jun 2011 EP
2408369 Jan 2012 EP
2408372 Jan 2012 EP
2411055 Feb 2012 EP
2411067 Feb 2012 EP
2493535 Sep 2012 EP
2493536 Sep 2012 EP
2493537 Sep 2012 EP
2523603 Nov 2012 EP
2523706 Nov 2012 EP
2593014 May 2013 EP
2603256 Jun 2013 EP
2637562 Sep 2013 EP
2649507 Oct 2013 EP
2701598 Mar 2014 EP
2701600 Mar 2014 EP
2701601 Mar 2014 EP
2702406 Mar 2014 EP
2874942 May 2015 EP
2954916 Dec 2015 EP
2992827 Mar 2016 EP
3087919 Nov 2016 EP
3106092 Dec 2016 EP
3174463 Jun 2017 EP
3235429 Oct 2017 EP
3236259 Oct 2017 EP
3243435 Nov 2017 EP
3257442 Dec 2017 EP
3393342 Oct 2018 EP
3490453 Jun 2019 EP
3515521 Jul 2019 EP
3566649 Nov 2019 EP
3760106 Jan 2021 EP
3769682 Jan 2021 EP
2015062698 Apr 2015 JP
05784031 Sep 2015 JP
05806236 Nov 2015 JP
2015211878 Nov 2015 JP
05826766 Dec 2015 JP
2016027878 Feb 2016 JP
2016039972 Mar 2016 JP
06055773 Dec 2016 JP
06058063 Jan 2017 JP
06078230 Feb 2017 JP
06078565 Feb 2017 JP
2017042641 Mar 2017 JP
2017047298 Mar 2017 JP
06121400 Apr 2017 JP
06126783 May 2017 JP
2017121582 Jul 2017 JP
2017131697 Aug 2017 JP
2017192778 Oct 2017 JP
06254545 Dec 2017 JP
2018011975 Jan 2018 JP
06312670 Apr 2018 JP
2019188182 Oct 2019 JP
2013466 Aug 2019 KR
2237667 Apr 2021 KR
WO-2009149308 Dec 2009 WO
WO-2010101620 Sep 2010 WO
WO-2010101621 Sep 2010 WO
WO-2010101625 Sep 2010 WO
WO-2010101626 Sep 2010 WO
WO-2010110916 Sep 2010 WO
WO-2010110919 Sep 2010 WO
WO-2010151329 Dec 2010 WO
WO-2011053787 May 2011 WO
WO-2011053788 May 2011 WO
WO-2011053796 May 2011 WO
WO-2011065972 Jun 2011 WO
WO-2011088211 Jul 2011 WO
WO-2011088214 Jul 2011 WO
WO-2011094573 Aug 2011 WO
WO-2011163347 Dec 2011 WO
WO-2012009613 Jan 2012 WO
WO-2012018486 Feb 2012 WO
WO-2012021792 Feb 2012 WO
WO-2012021801 Feb 2012 WO
WO-2012064802 May 2012 WO
WO-2012149126 Nov 2012 WO
WO-2012149134 Nov 2012 WO
WO-2012149143 Nov 2012 WO
WO-2012149155 Nov 2012 WO
WO-2012154362 Nov 2012 WO
WO-2013112877 Aug 2013 WO
WO-2014018558 Jan 2014 WO
WO-2015189274 Dec 2015 WO
WO-2016019388 Feb 2016 WO
WO-2016123282 Aug 2016 WO
WO-2017112793 Jun 2017 WO
WO-2018022535 Feb 2018 WO
WO-2018057760 Mar 2018 WO
WO-2019220340 Nov 2019 WO
WO-2020102281 May 2020 WO
WO-2020223710 Nov 2020 WO
WO-2021041881 Mar 2021 WO
WO-2021076846 Apr 2021 WO
Provisional Applications (1)
Number Date Country
63257630 Oct 2021 US