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Systems and methods for collection and/or manipulation of blood spots or other bodily fluids

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Systems and methods for collection and/or manipulation of blood spots or other bodily fluids


The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed.

Browse recent Seventh Sense Biosystems, Inc. patents - Cambridge, MA, US
Inventors: Howard Bernstein, Donald E. Chickering, III, Shawn Davis, Ping Gong, Kristin Horton, Scott James
USPTO Applicaton #: #20120277629 - Class: 600578 (USPTO) - 11/01/12 - Class 600 
Surgery > Diagnostic Testing >Liquid Collection >Manually Supported Collector With Rigid Intake Tube (e.g., A Hollow Needle, Etc.) >Mechanical Means For Drawing Liquid Into Collection Reservoir



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The Patent Description & Claims data below is from USPTO Patent Application 20120277629, Systems and methods for collection and/or manipulation of blood spots or other bodily fluids.

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RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/480,941, filed Apr. 29, 2011, entitled “Plasma or Serum Production and Removal of Fluids under Reduced Pressure,” by Haghgooie, et al.; and of U.S. Provisional Patent Application Ser. No. 61/549,437, filed Oct. 20, 2011, entitled “Systems and Methods for Collection and/or Manipulation of Blood Spots or Other Bodily Fluids,” by Bernstein, et al. Each of these is incorporated herein by reference.

FIELD OF INVENTION

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate.

BACKGROUND

Phlebotomy or venipuncture is the process of obtaining intravenous access for the purpose of intravenous therapy or obtaining a sample of venous blood. This process is typically practiced by medical practitioners, including paramedics, phlebotomists, doctors, nurses, and the like. Substantial equipment is needed to obtain blood from a subject, including the use of evacuated (vacuum) tubes, e.g., such as the Vacutainer™ (Becton, Dickinson and company) and Vacuette™ (Greiner Bio-One GmBH) systems. Other equipment includes hypodermic needles, syringes, and the like. However, such procedures are complicated and require sophisticated training of practitioners, and often cannot be done in non-medical settings. Accordingly, improvements in methods of obtaining blood or other fluids from the skin are still needed.

SUMMARY

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. The subject matter of the present invention involves, in some cases, interrelated products, alternative solutions to a particular problem, and/or a plurality of different uses of one or more systems and/or articles.

In one aspect, the present invention is generally directed to a device for receiving blood from the skin and/or from beneath the skin of a subject. In one set of embodiments, the device includes a substance transfer component for receiving blood from the skin of the subject, a vacuum chamber having an internal pressure less than atmospheric pressure before blood is received into the device from the substance transfer component, and a substrate for absorbing blood received from the subject

In another set of embodiments, the device includes a substance transfer component for receiving the bodily fluid from the skin of the subject, a vacuum chamber having an internal pressure less than atmospheric pressure before the bodily fluid is received into the device from the substance transfer component, and a substrate for absorbing the bodily fluid received from the subject

The invention, in another set of embodiments, is generally directed to a method. In one set of embodiments, the method includes acts of applying a device to the skin of a subject, where in some cases, the device may apply reduced pressure to the skin of the subject, and withdrawing blood from the skin of the subject into the device such that at least a portion of the blood contacts a substrate for absorbing the blood.

The method in another set of embodiments, includes an act of receiving blood into a device by applying reduced pressure to the skin of the subject, where at least a portion of the blood within the device contacts a substrate for absorbing the blood.

In one aspect, the present invention is generally directed to a simple, one-piece, low-profile, high acceleration, high energy, actuation mechanism for inserting microneedles (or other objects) into the skin for the purpose of receiving substances, such as blood or interstitial fluid. In one set of embodiments, a device of the invention is actuated by a deployment actuator which can provide advantages in ease of operation, speed of operation, reduction or elimination of pain, etc.

In another aspect, the present invention is directed to a method of making one or more of the embodiments described herein, for example, devices for receiving a fluid such as blood from a subject. In another aspect, the present invention is directed to a method of using one or more of the embodiments described herein, for example, devices for receiving a fluid such as blood from a subject.

Other advantages and novel features of the present invention will become apparent from the following detailed description of various non-limiting embodiments of the invention when considered in conjunction with the accompanying figures. In cases where the present specification and a document incorporated by reference include conflicting and/or inconsistent disclosure, the present specification shall control. If two or more documents incorporated by reference include conflicting and/or inconsistent disclosure with respect to each other, then the document having the later effective date shall control.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the figures:

FIGS. 1A-1B illustrate devices including a substrate for absorbing blood or other bodily fluids, according to certain embodiments of the invention;

FIGS. 2A-2B illustrate additional devices including a substrate for absorbing blood or other bodily fluids, according to various embodiments of the invention

FIG. 3 illustrates one embodiment including a plurality of substrates;

FIG. 4 illustrates various substrates including tabs or handles, in certain embodiments of the invention;

FIGS. 5A-5B illustrate an applicator region in accordance with certain embodiments of the invention;

FIGS. 6A-6B illustrate the formation of a pool of bodily fluid on the surface of the skin, in certain embodiments of the invention;

FIGS. 7A-7B illustrate various capillaries in accordance with certain embodiments of the invention; and

FIGS. 8A-8C illustrate a device in still another embodiment, illustrating a deployment actuator.

DETAILED DESCRIPTION

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

As mentioned, certain aspects of the present invention are directed to substrates for absorbing blood and/or other bodily fluids, for example, a blood spot membrane. Thus, in some embodiments, blood spots may be produced on a blood spot membrane. In these cases, a channel within the device may have a small volume relative to the volume of a blood spot membrane which may be very porous and may collect fluid. The blood spot membrane is used to collect fluid in certain embodiments. The blood spot membrane is not used to separate cells/plasma (as opposed to the separation membranes discussed herein), in certain cases. Fluid may fill all, or a portion of, the blood spot membrane. A second hydrophobic membrane may be positioned on top of the collection membrane in some embodiments. Once fluid contacts the hydrophobic membrane, fluid collection may cease. The blood spot membrane may remain in the device to dry and can then be removed from the device. In some embodiments, the blood spot membrane may be removed from the device and dried outside of the device. In some cases, the membrane is not dried. If a vacuum is used to draw blood towards the blood spot membrane, the vacuum may be released prior to removal of the blood spot membrane from the device, at least in some embodiments.

In one set of embodiments, the substrate is contained within a device for receiving blood from the skin of a subject. Examples of such devices, and details of such devices able to contain a substrate for absorbing blood and/or other bodily fluids, are discussed in detail below. Additional examples of devices in which a substrate for absorbing blood and/or other bodily fluids may be utilized can be found in U.S. Provisional Patent Application Ser. No. 61/480,977, filed Apr. 29, 2011, entitled “Delivering and/or Receiving Fluids,” by Gonzales-Zugasti, et al., incorporated herein by reference in its entirety for all purposes.

In one set of embodiments, the substrate for absorbing blood may comprise paper, e.g., that is able to absorb blood or other bodily fluids received by the device. The substrate may be able to partially or wholly absorb any blood (or other bodily fluid) that it comes into contact with. For example, the substrate may comprise filter paper, cellulose filters, cotton-based paper, e.g., made from cellulose filters, cotton fibers (e.g., cotton linters), glass fibers, or the like. Specific non-limiting examples that are commercially available include Schleicher & Schuell 903™ or Whatman 903™ paper (Whatman 903™ Specimen Collection Paper) (Whatman International Limited, Kent, UK), or Ahlstrom 226 specimen collection paper (Ahistrom Filtration LLC, Mount Holly Springs, Pa.). In some embodiments, the paper may be one that is validated in compliance with the requirements of the CLSI (Clinical and Laboratory Standards Institute) LA4-A5 consensus standard. However, other materials may also be used for the substrate for absorbing blood, instead of and/or in addition to paper. For example, the substrate for absorbing blood (or other bodily fluids) may comprise gauze, cloth, cardboard, foam, foamboard, paperboard, a polymer, a gel, or the like. In some cases, the absorbent substrate may have a surface area of at least about 0.001 m2/g, at least about 0.003 m2/g, at least about 0.005 m2/g, at least about 0.01 m2/g, at least about 0.03 m2/g, at least about 0.05 m2/g, at least about 0.1 m2/g, at least about 0.3 m2/g, at least about 0.5 m2/g, or at least about 1 m2/g. In some cases, the absorbent substrate may have a surface area of about 100 g/m2 to about 200 g/m2, or about 150 g/m2 to about 200 g/m2.

The blood (or other bodily fluid) may be absorbed into the substrate such that the blood becomes embedded within fibers or other materials forming the substrate, and/or such that the blood becomes embedded in spaces between the fibers or other materials forming the substrate. For example, the blood may be held within or on the substrate mechanically and/or chemically (e.g., via clotting and/or reaction with fibers or other materials forming the substrate).

In some cases, the substrate may absorb a relatively small amount of blood. For example, less than about 1 ml, less than about 800 microliters, less than about 600 microliters, less than about 500 microliters, less than about 400 microliters, less than about 300 microliters, less than about 200 microliters, less than about 100 microliters, less than about 80 microliters, less than about 60 microliters, less than about 40 microliters, less than about 30 microliters, less than about 20 microliters, less than about 10 microliters, or less than about 1 microliter of blood may be absorbed into the substrate.

The substrate may be of any shape or size. In some embodiments, the substrate may be substantially circular, although in other embodiments, other shapes are possible, e.g., square or rectangular. The substrate may have any suitable area. For example, the substrate may be large enough to contain only one spot, of blood (e.g., of the above volumes), or more than one spot in some embodiments. For example, the substrate may have an area of no more than about 1 cm2, no more than about 3 cm2, no more than about 5 cm2, no more than about 7 cm2, no more than about 10 cm2, no more than about 30 cm2, no more than about 50 cm2, no more than about 100 cm2, no more than about 300 cm2, no more than about 500 cm2, no more than about 1000 cm2, or no more than about 3000 cm2.

In some embodiments, a “tab” or a handle, or other separate portion, may be present on or proximate the substrate, e.g., to facilitate analysis and/or manipulation of the absorbed blood or other bodily fluid. The handle may be any portion that can be used to manipulate the substrate. For example, a handle may be used to remove the substrate from the device for subsequent shipping and/or analysis, e.g., without requiring a person to touch the blood spot itself in order to manipulate the substrate. The handle may be formed from the substrate, and/or different material, for example, plastic, cardboard, wood, metal, etc. In some cases, the handle may surround all, or at least a portion of, the substrate. Non-limiting examples of such handles are illustrated in FIG. 4. For instance, in FIG. 4A, a tab 41 is formed as an integral part of the substrate 20. In FIG. 4B, a separate handle 44 surrounds substrate 20, including a separate tab 41.

In certain embodiments, the substrate may include stabilizers or other agents, e.g., for stabilizing and/or treating the blood in the substrate. Non-limiting examples of stabilizers include chelating agents, enzyme inhibitors, or lysing agents. Examples of chelating agents include, but are not limited to, EDTA (ethylenediaminetetraacetic acid) or dimercaprol. Examples of enzyme inhibitors include, but are not limited to, protease inhibitors (e.g., aprotinin, bestatin, calpain inhibitor I and II, chymostatin, E-64, leupeptin or N-acetyl-L-leucyl-L-leucyl-L-argininal, alpha-2-macroglobuline, Pefabloc SC, pepstatin, PMSF or phenylmethanesulfonyl fluoride, TLCK, a trypsin inhibitor, etc.) or reverse transcriptase inhibitors (e.g., zidovudine, didanosine, zalcitabine, stavudine, lamivudine, abacavir, emtricitabine, entecavir, apricitabine, etc.). Non-limiting examples of lysing agents include distilled water or guanidinium thiocyanate.

One non-limiting example of a substrate able to absorb blood and/or other bodily fluids within a device may be seen in FIG. 1A. In this figure, device 10 is placed on the surface of skin 15. Additional examples of such devices are discussed in more detail below, and/or in documents incorporated herein by reference. In FIG. 1A, blood 30 (or another bodily fluid, such as interstitial fluid) from skin 15 enters device 10 via a substance transfer component 25. For example, a flow activator of the substance transfer component 25, such as one or more microneedles (not shown here) may be used to cause blood to flow into device 10 towards substrate 20. In this figure, substrate 20 is positioned so that blood entering device 10 will come into contact with substrate 20. At least a portion of the blood entering the device may be absorbed into the substrate. It should be understood, however, that other configurations are also possible. Thus, the substrate may be positioned at any suitable location within a device, e.g., such that blood (or other bodily fluid) is able to come into contact with at least a portion of the substrate when blood is received into the device. As non-limiting examples, a substrate may be positioned flush with the skin or in a recess, e.g., of the of the substance transfer component, the substrate may be positioned further away from the substance transfer component such that the blood flows through a portion of the device (e.g., through one or more channels) in order to reach the substrate, or the like. In some embodiments, the substrate may be positioned no more than about 1 mm, no more than about 2 mm, no more than about 3 mm, no more than about 4 mm, or no more than about 5 mm away from the surface of the skin when the device is applied to the surface of the skin of a subject.

Another embodiment is now described with reference to FIG. 1B; further details of this and other devices in accordance with certain aspects of the present invention are also described in further detail below. In this example figure, device 10 is applied to the skin 15 of a subject. The device in this figure is self-contained, i.e., such that the device is able to function to withdraw blood from a subject to produce plasma or serum without requiring external connections such as an external source of vacuum, an external source of power, or the like. In other embodiments, however, the device need not be self-contained.

A vacuum or a reduced pressure less than atmospheric or ambient pressure may be used to facilitate the movement of blood 30 into the device, as follows. The vacuum may be contained within device 10, for example, within vacuum chamber 35. Blood 30 on the skin 15 of the subject may become exposed to the vacuum or reduced pressure, which causes the blood to enter device 10, e.g., through applicator region 40 into inlet 42 of channel 45, moving towards substrate 50, which can be a substrate for absorbing blood, e.g., as previously discussed. Thus, when blood 30 reaches substrate 50, at least a portion of the blood may become absorbed into substrate 50. In some cases, some blood may also pass through substrate 50 into vacuum chamber 35.

Upon actuation of the device shown in FIG. 1B, for example, remotely or by pressing button 22, flow activators 25 are deployed into skin 15 of the subject. The flow activators may include one or more needles or microneedles, or other flow activators as discussed in detail below and/or in documents incorporated herein by reference. As shown in this figure, the deployment of flow activators 25 into skin 15 of the subject may be accomplished using a deployment actuator 28, or by other techniques such as those described herein. The deployment actuator 28 may include suitable components to deploy the flow activators 25, such as a button, a switch, a lever, a slider, a dial, a compression spring, a Belleville spring, a servo, rotary or linear electric motor, and/or a pneumatic apparatus, or other suitable device.

As another non-limiting example, FIG. 2A shows an underside of a fluid receiving device 10 according to another embodiment of the invention; a top view of the device may be seen in FIG. 2B. FIG. 2A shows a fluid transporter 120 that includes an opening 130, an applicator region 131, and a flow activator 90. In this embodiment, the flow activator 90 includes one or more needles. As described in more detail below, the needles may be extended from the opening 130 to pierce a subject's skin, and then retracted back into the opening to allow blood or other fluid to enter the opening 130. That is, to use device 10 to receive blood from a subject, the base 100 may be placed on the skin so that the opening 130 is adjacent the skin. Thereafter, a device actuator may be depressed to cause the needles to be deployed, piercing the skin and causing blood to be released. Blood may enter the opening and be collected in the storage chamber 140. In one embodiment, blood may flow into the storage chamber 140 as a result of a relatively low pressure (vacuum) in the device 10 that draws blood from the opening 130 and into a storage chamber internally of the device (not shown here). A substrate 20 for absorbing blood and/or other bodily fluids may be positioned within the storage chamber, and/or as part of base 100 of the device as is shown in FIG. 2B.

After being absorbed on the substrate, the blood (or other bodily fluid) may be allowed to dry and/or clot, in certain embodiments of the invention. Clotting of blood may occur naturally, e.g., upon exposure to air. Drying or clotting, in some cases, may occur through gaseous exchange with the external environment, and/or with an internal environment contained within the device, e.g., an environment with a relatively low relative humidity. For example, the internal or external environment may be one in which the relative humidity is less than about 50%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, or less than about 5%. As a specific example, the internal environment may be “pre-packaged” such that the device has a relatively low relative humidity before use, and/or a dessicant may be used to control the relative humidity within the device. In some cases, the device may include a heat source, such as a resistive heater, to facilitate drying and/or clotting.

Thus, in some embodiments, the device may contain desiccant. The desiccant may be “pre-packaged” in the device, and/or desiccant may be added after blood or other bodily fluids has been received into the device. For example, a cover or a lid may be put on the device after blood has been received into the device, where the cover or lid contains desiccant. Non-limiting examples of desiccant potentially suitable for the device include solid desiccants such as P2O5, CaSO4, CaCl2, silica, or the like. The desiccant may be present in the same chamber within the device as the substrate comprising absorbed blood (or other bodily fluids), and/or the desiccant may be present in a different chamber within the device, e.g., one in gaseous communication with the substrate.

In one set of embodiments, after blood is received on the substrate, the device may be manipulated in order to create an airtight seal around the substrate. For example, an internal portion of the device may be sealed off to create an airtight seal, e.g., forming an enclosed airtight chamber surrounding the substrate. In some embodiments, for instance, a portion of the device may be moveable or sealable to create an airtight portion within the device, or a cover or a lid may be added to the device, and/or brought into position on the device to create an airtight portion. A user of the device may manipulate the device to create the airtight portion, and/or the device may itself create the airtight portion, for example, upon removal of at least a portion of the substance transfer component from the subject. For example, in one set of embodiments, a cover or lid may be used to seal the substance transfer component from the external environment surrounding the device, thereby preventing exchange of gases from the substrate with the external environment. The cover or lid may be formed out of any suitable material, e.g., plastic, rubber, metal, or the like. As another example, a valve may be closed or the device may close a valve in order to form an airtight portion within the device containing the substrate. For example, a valve may be positioned on channel 45 in FIG. 1B that can be closed (manually or automatically) in order to form an airtight seal around substrate 50.

In some embodiments, blood or other bodily fluids may be stored within the device for later use and/or analysis, e.g., on a substrate such as previously discussed. For example, the substrate and/or the device may, in some embodiments, be sent to a clinical and/or laboratory setting, e.g., for analysis or storage. In some embodiments, the entire device and/or substrate may be sent to a clinical and/or laboratory setting; in other embodiments, however, only a portion of the device and/or substrate may be sent to a clinical and/or laboratory setting. For example, the substrate may be removed from the device, or a module containing the substrate may be removed from the device, e.g., for shipping or other transport. In some cases, the substrate and/or the device may be shipped using any suitable technique (e.g., by mail, by hand, etc.). Blood or other bodily fluids may be present during shipping in dried form (e.g., clotted), or while at least partially liquid, in some cases. In certain instances, the subject may give the substrate and/or the device to appropriate personnel at a clinical visit. For instance, a doctor may prescribe a device as discussed above for use by the subject, and at the next doctor visit, the subject may give the doctor the substrate and/or the device.

According to certain embodiments, the substrate and/or the device may be shipped with only minimal preparation, for example, where blood or other bodily fluids are present as spots (e.g., dry spots) on the substrates. In some cases, as discussed herein, the spots may be relatively small. For instance, the volume of the blood in a spot, prior to drying, may be less than about 100 microliters, less than about 80 microliters, less than about 60 microliters, less than about 40 microliters, less than about 30 microliters, less than about 20 microliters, less than about 10 microliters, or less than about 1 microliter. In certain embodiments, shipping may occur at room or ambient temperature, without the need for ice or dry ice to maintain constant or colder temperatures. In some cases, shipping may also be performed without the need for biohazard labeling.

In some embodiments, the substrate and/or the device may be contained within a suitable shipping container, for instance, an envelope or a box. For example, the envelope may be a paper envelope, a cardboard envelope, or the like. The box may be, for example, a paper box, a cardboard box, a plastic box, a metal box, etc. In some cases, the shipping container may be padded, e.g., with cloth, plastic bubbles, Styrofoam pellets, etc. In some cases, the shipping container may be airtight and/or the shipping container may contain a desiccant. In some embodiments, the device and/or the substrate may be placed in a shipping container in such a form that the substrate is exposed to at least the air within the shipping container, and the use of an airtight container and/or desiccant may serve to preserve blood or other bodily fluids absorbed within the substrate in a relatively dry state. Examples of desiccant include those described herein. In other embodiments, however, desiccant and/or an airtight container may not be necessary. For example, as previously discussed, the device itself may contain desiccant, or the blood may be dried on the substrate such that further precautions are unnecessary and the substrate may be shipped or otherwise manipulated (e.g., analyzed) while exposed to ambient conditions, and/or without any subsequent preservation steps.

In one aspect, the device and/or the substrate may include, and/or may be shipped with, a tracking apparatus. The tracking apparatus may be present as part of the device or as a part of a cover or lid for the device, and/or the tracking apparatus may be separate from the device but designed to be shipped with the device and/or the substrate. For example, the tracking apparatus may be formed as or be contained within a shipping container such as an envelope or a box for shipping the device and/or the substrate. In some cases, for example, the tracking apparatus may be attached to the envelope or box, or the tracking apparatus may be part of a holder designed to be shipped with the device and/or the substrate.

In one set of embodiments, the tracking apparatus may include an RFID transmitter or “tag.” A suitable scanner may be able to determine the RFID tag, e.g., when a shipping container such as an envelope or a box for shipping the device and/or the substrate is received, e.g., at a clinical and/or laboratory setting. As another example, a scannable target may be used as a tracking apparatus. For example, the scannable target may be a bar code, such as a 1- or 2-dimensional barcode, and may code information based on lines, colors, patterns, shapes, or any other features or combinations of features. In some embodiments, a scanner able to scan the scannable target may also be used. For example, in one set of embodiments, prior to or during use, the device may be held next to the scannable target such that the device is able to scan the scannable target, e.g., in order to activate the device, or to record data from the device, etc. As additional non-limiting examples, in other embodiments, the scannable target may be formed as part of the substrate, and the scannable target may be tracked after the substrate has received blood, before or after the substrate has been shipped, before or after analysis of blood (or other bodily fluid) on the substrate, etc.

In some cases, more than one substrate for absorbing blood and/or other fluids may be present in the device. For instance, more than one substrate for absorbing blood and/or other bodily fluids may be stacked together. For instance, in certain cases, excess blood (or other bodily fluid) is received by the device, and blood is able to saturate some of the substrates within the device. By use of multiple substrates in a stacked configuration, some substrates (e.g., a middle substrate) may be used for subsequent analysis, while other substrates (e.g., on the top and/or bottom) are simply present to absorb excess blood.

However, as mentioned, in some embodiments, more than one substrate may be used for subsequent analysis. In some cases, the substrates may also be arranged separately from each other, e.g., as is illustrated with respect to FIG. 3. In this figure, substrates 31, 32, 33, and 34 are arranged about a central region 39. Blood received into the device may pass through central region 35 to some or all of substrates 31, 32, 33, and 34, and some or all of these may then be subsequently analyzed, e.g., for different analytes such as those discussed herein.

Other types of substrates or blood spot membranes may also be present within the device. For example, in some embodiments, the device may include a separation membrane that is impermeable to blood cells and other substances. The separation membrane may be positioned anywhere in the device, e.g., before or after blood contacts a substrate for absorbing blood within the device. Fluid received from the subject may flow through a separation membrane, and the received fluid may include components of various sizes. For example, the device may receive blood that includes blood cells, clotting factors, proteins, and blood plasma, among other components. Larger components such as blood cells and other larger substances may not be able to pass through the separation membrane while blood plasma is free to pass. If anticoagulant is not introduced to the blood plasma, the blood plasma, which contains clotting factors such as fibrinogen, may clot, thereby resulting in a solid clot component and a liquid component. This liquid component is known as serum, which is blood plasma without fibrinogen or other clotting factors. This serum can be collected via aspiration or other suitable method out of the storage chamber, leaving the blood clots in the storage chamber. If anticoagulant is introduced to the blood plasma, the blood plasma will not clot and blood plasma can be collected out of the storage chamber instead. Thus, the embodiments described throughout the specification may be used to produce plasma or serum. More details regarding plasma and serum production can be found in U.S. Provisional Pat. Apl. Ser. No. 61/480,941, entitled “Plasma or Serum Production and Removal of Fluids Under Reduced Pressure,” filed on Apr. 29, 2011 by Haghgooie, et al., incorporated herein by reference in its entirety.

Also shown in FIG. 3 are optional beading disruptors 51, 52, 53, and 54. Beading disruptors generally disrupt the “pooling” of bodily fluids such as blood on the surface of the skin and allow blood to flow to a desired location, e.g., to a substrate. Thus, as is shown in FIG. 3, beading disruptors 51, 52, 53, and 54 are used to direct blood towards substrates 31, 32, 33, and 34. It should be understood that this is by way of example only; in other embodiments, there may be 1, 2, 3, or any other suitable number of beading disruptors. In yet other embodiments, there may be no beading disruptors present. Non-limiting examples of additional beading disruptors suitable for use in certain embodiments of the invention are disclosed in U.S. Provisional Patent Application Ser. No. 61/480,960, filed Apr. 29, 2011, entitled “Systems and Methods for Collecting Fluid from a Subject,” by Haghgooie, et al., incorporated herein by reference in its entirety.

One non-limiting example of such a device comprising a beading disruptor is now described with reference to FIGS. 5A and 5B. In these figures, device 10 is used to receive blood or other bodily fluids from the skin and/or from beneath the skin of a subject. Device 10 is shown positioned on skin 15 of a subject. Bodily fluid 30 is caused to reach the surface of the skin using one or more flow activators that include, for example, microneedles 25 as shown in this figure. In other embodiments, however, as discussed below and/or in documents incorporated herein by reference, other flow activator arrangements may be used in addition to and/or instead of flow activators that include microneedles 25. The bodily fluid collects on the surface of skin 15 within applicator region 40, and at least some of the bodily fluid may enter device 10 through inlet 42. FIG. 5A shows a side view while FIG. 5B shows an angled view of a cross-section of an applicator region of certain devices.

The bodily fluid 30 on the surface of the skin typically will from a “pool” or a “bead” of liquid on the surface of the skin. However, this beading of the liquid may prevent, or at least delay, the movement of the bodily fluid 30 to inlet 42. To counter the natural tendency of the bodily fluid to form a bead on the surface, one or more beading disruptors may be used. As depicted in FIGS. 5A and 5B, beading disruptor 80 can take the form of one or more protrusions extending from a portion of the surface defining applicator region 40. However, in other embodiments, the beading disruptor may take other forms, instead of and/or in addition to one or more protrusions. Upon contact of bodily fluid 30 with beading disruptor 80, at least a portion of the bead of fluid may be deformed or otherwise be caused to move towards inlet 42 for entry into the device, e.g., for processing, analysis, storage, etc. as is discussed in detail below.

In some embodiments, the applicator region may include a capillary that may facilitate fluid flow. Fluid may move along the capillary with, or without, capillary action, e.g. it may be moved due to a vacuum, pneumatic force, gravity feed, or other suitable manner. Additionally, the capillary may be of any cross-sectional shape, length, diameter, and is not limited to any particular arrangement. The some cases, the capillary may be a capillary slit, e.g., including a relatively narrow groove. However, a capillary slit is only one arrangement and others are possible. For example, fluid may flow through a closed tube of any suitable cross-sectional shape. Also, it should be noted that beading disruptor 80 and capillary slit 90 are not necessarily required in all embodiments; in certain cases, one or both of these may be absent. As shown in FIG. 5B, capillary slit 90 may be positioned such that it is in fluidic communication with inlet 42. In this embodiment, a single capillary slit is shown that forms a closed circuit or circle along the surface of the applicator region 40 (note that FIG. 5B has been cut in half for clarity). However, in other embodiments, more than one capillary may be present and/or the capillary may not necessarily form a closed circuit along the surface of the applicator region 40. In addition, in this figure, capillary slit 90 is depicted as being oriented substantially parallel to the opening of the applicator region and skin 15 of the subject, although in other embodiments, other orientations are also possible. Capillary slit 90, in this example, is illustrated as having two substantially parallel walls 92, 93, and a cross-sectional shape that is substantially rectangular.

A bodily fluid 30 on the surface of the skin may come into contact with capillary slit 90 during use, and at least a portion of the bodily fluid may then flow along capillary slit 90, e.g., due to capillary action. The capillaries may thereby guide bodily fluid 30 towards inlet 42 into the device. As shown in FIG. 5, beading disruptor 80 is formed as part of the bottom plane of capillary slit 90, such that at least a portion of the bead of bodily fluid may be caused to enter capillary slit 90, and the fluid can then be moved towards inlet 42, e.g., as previously discussed.

The applicator region may contain, in one set of embodiments, one or more beading disruptors for disrupting the pooling of bodily fluids on the surface of the skin. This is now illustrated with reference to the example shown in FIG. 6. In FIG. 6A, a bodily fluid 30, such as blood, is present on the surface of the skin 15, e.g., transported thereto by one or more flow activators such as is discussed herein. The bodily fluid typically forms a bead or pool on the surface of the skin, instead of wetting the skin. The shape of the bead (e.g., the contact angle) may be controlled by the condition of the skin (for example, its hydrophobicity) and/or the bodily fluid on the skin. For example, the bodily fluid may pool on the skin of the subject at a contact angle of about 30°, about 40°, about 45°, about 50°, about 55°, etc. in a substantially circular region on the surface of the skin. In many cases, the skin is relatively hydrophobic, thereby causing the bodily fluid to form a bead instead of wetting or spreading on the surface of the skin. Furthermore, as more bodily fluid enters the bead, the bead typically grows in size while keeping substantially the same shape. Thus, before the bead is able to contact a surface of the applicator region, a certain amount of bodily fluid must flow from the body into the bead on the surface of the skin.

In FIG. 6B, beading disruptor 80 is also shown, in addition to bodily fluid 30 on the surface of skin 15. Beading disruptor 80 is shaped and positioned to disrupt the shape of bodily fluid 30 to prevent or at least alter the ability of bodily fluid 30 to pool on the surface of the skin. Thus, in this example, bodily fluid exiting the skin within the applicator region (e.g., from the center of the applicator region) will first come into contact with the beading disruptor, which can disrupt the shape of the pool of bodily fluid on the surface of the skin. In some cases, as is shown in this figure, at least a portion of bodily fluid 30 may be caused to move away from the pool of fluid, e.g., towards an inlet of the device, or another suitable location as is shown by arrow 88, due to the presence of beading disruptor 80.

The beading disruptor may take any of a variety of forms. In one set of embodiments, the beading disruptor is present within an applicator region, such as a recess, in which a bodily fluid is transported thereto by a flow activator, for example, one or more needles and/or microneedles. More than one beading disruptor may also be present, in some embodiments.

In one set of embodiments, in a protrusion having a first end in contact with the applicator region and a second end that is located closest to the geometrical center of the applicator region, a ratio of the width of the first end to the distance between the first end and the second end, may be about 1, greater than 1, or less than 1. This ratio may have any suitable value. For example, the ratio may be about 1 (i.e., such that the protrusion is substantially square), less than 1, or greater than 1. As specific non-limiting examples, this ratio may be less than or greater than 1, less than or greater than 2, less than or greater than 3, less than or greater than 4, less than or greater than 5, less than or greater than 7, less than or greater than 10, etc.

It should be understood, however, that the beading disruptor is not necessarily limited to projections or protrusions. For example, in certain embodiments, the beading disruptor may be connected at two portions to the applicator region, e.g., forming a “span” across the applicator region. In some embodiments the beading disruptor includes the geometric center of the applicator region, but in other embodiments, the geometric center of the applicator region is not included. More complex shapes may also be used in some embodiments, for example, where the beading disruptor physically contacts the applicator region at three ends, at four ends (e.g., defining an “X” or a cross shape), or more in some cases.

In one set of embodiments, the beading disruptor may comprise a “shelf” or a “lip” along a portion of the applicator region. In some, the beading disruptor may be positioned along a portion of the applicator region, for example, such that an imaginary plane can be positioned that divides the applicator region into two halves that have the same volume such that only one of the two halves comprises the beading disruptor.

In some embodiments, the beading disruptor can be positioned to facilitate the flow of a bodily fluid to an inlet to the device, e.g., to the inlet of a channel such as a microfluidic channel within the device. In some cases, as is discussed below, the beading disruptor may form a portion of a capillary that facilitates the flow of a bodily fluid to an inlet to the device.

In one set of embodiments, the applicator region contains one or more capillaries that can facilitate the flow of a bodily fluid to an inlet of the device, or to a substrate for absorbing blood or other fluids. A non-limiting example of a capillary is shown with respect to FIG. 7A. In this figure, the surface of a portion of applicator region 40 of device 10 is illustrated, including a capillary 90 that is in fluid communication with inlet 42 of the device. In this figure, capillary 90 is defined by walls 92, 93 which are substantially parallel to each other, thereby forming capillary 90. In some embodiments, at least a portion of capillary 90, such as one or both of walls 92, 93, may also be used as a beading disruptor.

Although only one capillary is shown in FIG. 7A, in other embodiments, more than one capillary may be present, which may be lead to one or more inlets of the device. The capillary can have any suitable configuration to facilitate the flow of a bodily fluid along at least a portion of the capillary, e.g., through capillary action. In some cases, the capillary may encircle or circumscribe at least a portion of the applicator region. For instance, the capillary may form a closed circuit such that the flow of bodily fluid in any direction along the capillary will reach the inlet. One example of this can be seen in FIG. 7B with capillary 90 and inlet 42.

The capillary may have any suitable size. For example, the capillary may have an average cross-sectional dimension (e.g., perpendicular to the flow of fluid therein) of less than about 10 mm, less than about 9 mm, less than about 8 mm, less than about 7 mm, less than about 6 mm, less than about 5 mm, less than about 4 mm, less than about 3 mm, or less than about 2 mm, less than about 1 mm, less than about 500 microns, less than about 300 microns, or less than about 100 microns. For example, the capillary may have an average cross-sectional diameter of between about 100 and about 700 micrometers, or between about 300 and about 500 micrometers. The average cross-sectional dimension may be constant or may change along the capillary, e.g., to promote flow towards the inlet. The capillary can have any cross-sectional shape, for example, circular, oval, triangular, irregular, square or rectangular (having any aspect ratio), or the like. The capillary may have, in certain embodiments, a cross-sectional shape and/or area that remains substantially constant throughout the capillary.

In some embodiments, the entire capillary may be exposed to the applicator region; in other embodiments, however, a portion of the capillary may not necessarily be open to or exposed to the applicator region. In some cases, some or all of the capillary is in fluidic communication with the applicator region, for example such that substantially each portion of the capillary can be reached by a fluid within the applicator region. For instance, in certain embodiments, no portion of the capillary is further than about 10 micrometers, about 5 micrometers, about 3 micrometers, or about 1 micrometer away from a portion of the applicator region, as determined by flow of a fluid from the applicator region to the capillary. In some embodiments, no portion of the capillary may be further than about 5 mm, about 3 mm, about 1 mm, about 500 micrometers, about 300 micrometers, about 100 micrometers, about 50 micrometers, about 30 micrometers, or about 10 micrometers away from a portion of the applicator region, as determined by flow of a fluid from the applicator region to the capillary, e.g., depending on the size of the applicator region. In some embodiments, no portion of the applicator region is greater than about 5 mm, about 3 mm, about 1 mm, about 500 micrometers, about 300 micrometers, about 100 micrometers, about 50 micrometers, about 30 micrometers, or about 10 micrometers away from a portion of the capillary

The capillary may be positioned in any suitable location within the applicator region. In some cases, a capillary may be positioned near an inlet in the applicator region, or near a substrate for absorbing blood such that at least some blood is directed towards the substrate.

The invention, in one set of embodiments, involves the determination of a condition of a subject. Blood or other bodily fluids associated with the skin, for example, absorbed on a substrate, may be analyzed, e.g., for the presence of one or more analytes, for instance, as an indication of a past, present and/or future condition of the subject, or to determine conditions that are external to the subject. Determination may occur, for instance, visually, tactilely, by odor, via instrumentation, etc. In one aspect, accordingly, the present invention is generally directed to various devices for receiving blood, or other bodily fluids, from the skin and/or from beneath the skin of a subject. In the description that follows, the discussion of blood is by way of example only, and in other embodiments, other fluids may be received from the skin in addition to and/or instead of blood, for example, interstitial fluid.

In some cases, blood or other bodily fluids (e.g., interstitial fluid) received from the subject, e.g., on a substrate, may be used for indication of a past, present and/or future condition of the subject. Thus, the condition of the subject to be determined may be one that is currently existing in the subject, and/or one that is not currently existing, but the subject is susceptible or otherwise is at an increased risk to that condition. The condition may be a medical condition, e.g., diabetes or cancer, or other physiological conditions, such as dehydration, pregnancy, illicit drug use, or the like. In one set of embodiments, the materials may include a diagnostic agent, for example, one which can determine an analyte within the subject, e.g., one that is a marker for a disease state.

In one set of embodiments, blood (or other bodily fluid) on a substrate may accordingly be determined, e.g., to determine a past, present and/or future condition of the subject. Any suitable method may be used to determine or analyze the blood present on the substrate. For example, one or more portions of the substrate may be used (e.g., cut out or punched), or the entire substrate may be used, e.g., without requiring any punching out of portions of the substrate. In some cases, for instance, the blood may be present as one or more dried spots, and portions of the substrate may be cut off (e.g., punched out as holes, cut with scissors, etc.) for analysis. As mentioned, in some embodiments, more than one substrate may be present within the device, and in some cases, some or all of the substrates can be used.

In some embodiments, the blood (or other bodily fluid) on the substrate may be analyzed on the substrate, e.g., using techniques such as spectroscopy, microscopy, etc. In other embodiments, the substrate (or cut portions thereof) may be eluted to remove at least a portion of the blood (or other bodily fluids) on the substrate. As one example, blood can be eluted out from the substrate using saline, such as phosphate buffered saline, optionally containing detergents such as Tween. The resultant eluent can be subsequently analyzed to determine analytes within the blood. Any suitable technique can be used for analysis, many of which are commercially available or are known to those of ordinary skill in the art, for example, spectroscopy, HPLC analysis, ELISA, etc.

Non-limiting examples of such analytes include, but are not limited to: acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; a-fetoprotein; amino acids such as arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, or tryptophan, etc.; andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; C-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-b hydroxycholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; D-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (PCR), e.g., to detect acetylator polymorphism, alcohol dehydrogenase, a 1-antitrypsin, cystic fibrosis, Duchenne/Becker (e.g., muscular dystrophy), glucose-6-phosphate (e.g., dehydrogenase), hemoglobinopathies (e.g., A, S, C, E, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic, neuropathy, MCAD, mRNA, PKU, plasmodium vivax, sexual differentiation); 21-deoxycortisol; desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free b-human chorionic gonadotropin; free erythrocyte prophyrin; free thyroxine (FT4); free tri-iodothyroine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyl transferase; gentamicin; glucose; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase i; 17-a hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; Immunoreactive trypsin (CF); lactate; lead; lipoproteins (a), B/A-1, and b; lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside; phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (e.g., adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky\'s disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, or yellow fever virus); spectic antigens (e.g., hepatitis B virus or HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); or throxine (T4).

As mentioned, in certain aspects, the substrate may be contained within a device for receiving blood from the skin of a subject. As used herein, the phrase “from the skin” is used to mean from the top or outer surface of the skin, from within the skin, and/or from beneath the skin. Likewise, “to the skin” is used to mean to the top or outer surface of the skin, to within the skin, and/or to beneath the skin. In some embodiments, for example, the present invention is generally directed to devices and methods for receiving or extracting blood or other bodily fluids from a subject, e.g., from the skin and/or from beneath the skin, using devices having a substance transfer component (which may include, for example, one or more microneedles and/or other skin insertion objects). The device may also contain, in some embodiments, a storage chamber and/or a vacuum chamber having an internal pressure less than atmospheric pressure prior to receiving blood or other bodily fluids. Additional non-limiting examples of devices can be found in U.S. Provisional Patent Application Ser. No. 61/480,977, filed Apr. 29, 2011, entitled “Delivering and/or Receiving Fluids,” by Gonzales-Zugasti, et al., incorporated herein by reference in its entirety. In various embodiments, those devices may include one or more substrates as discussed herein, e.g., for absorbing blood or other bodily fluids.

In some cases, the device may pierce the skin of the subject, and fluid can then be delivered and/or received from the subject. The subject is usually human, although non-human subjects may be used in certain instances, for instance, other mammals such as a dog, a cat, a horse, a rabbit, a cow, a pig, a sheep, a goat, a rat (e.g., Rattus Norvegicus), a mouse (e.g., Mus musculus), a guinea pig, a hamster, a primate (e.g., a monkey, a chimpanzee, a baboon, an ape, a gorilla, etc.), or the like.

The device may be used once, or multiple times, depending on the application. For instance, a device may be used once to receive blood, then the device and/or substrate, or a portion thereof, may be shipped, or a device may be used multiple times, e.g., by replacing a module or a substrate and replacing it with a fresh module or substrate.

In some embodiments, the device may be relatively small. For example, the device may be handheld or be applied to the skin of a subject, e.g., using an adhesive, as is discussed below. The device may be self-contained in some embodiments, i.e., such that the device is able to function to withdraw blood (or other bodily fluids) from a subject and cause at least some of the blood to be absorbed into the substrate, e.g., without requiring external connections such as an external source of vacuum, an external source of power, or the like. For instance, a vacuum source within the device, e.g., a vacuum chamber, may be used to draw blood to the substrate.

The received fluid may be any suitable bodily fluid, such as interstitial fluid, other skin-associated material, mucosal material or fluid, whole blood, perspiration, saliva, plasma, tears, lymph, urine, plasma, or any other bodily fluid, or combinations thereof. Substances received from a subject can include solid or semi-solid material such as skin, cells, or any other substance from the subject. Substances that can be delivered to a subject in accordance with some embodiments of the invention include diagnostic substances, therapeutic substances such as drugs, and the like. Various embodiments of the invention are described below in the context of delivering or receiving a fluid, such as blood, from or through the skin. It is to be understood that in all embodiments herein, regardless of the specific exemplary language used (e.g., receiving blood), the devices and methods of other embodiments of the invention can be used for receiving any substance from the skin and/or from beneath the skin of the subject, and/or for delivering any substance to the subject, e.g. to the skin and/or a location beneath the skin of the subject.

In some cases, the device can be applied to the skin, and activated to receive fluid from the subject. The device, or a portion thereof, may then be processed to determine the fluid and/or an analyte within the fluid, alone or with an external apparatus. For example, fluid may be received from the device, and/or the device may contain sensors or agents able to determine the fluid and/or an analyte suspected of being contained in the fluid.

In some embodiments, the substance transfer component may include one or more skin insertion objects, such as needles, microneedles, lancets, blades, knives, protrusions, or other suitable object. As used herein, a “skin insertion object,” may be inserted into any organ, tissue or portion of a subject and is not restricted for use with only skin.

In one set of embodiments, the device includes a substance transfer component able to deliver to or receive fluid from the subject. As used herein, “substance transfer component” is any component or combination of components that facilitates movement of a substance or a fluid from one portion of the device to another, and/or from the device to the subject or vice versa. The substance transfer component may include an opening of any size and/or geometry that is constructed to receive fluid into the device. For example, an opening of a substance transfer component may lie in a two-dimensional plane or the opening may include a three-dimensional cavity, hole, groove, slit, etc. In some embodiments, the substance transfer component may also include one or more microneedles or other skin insertion objects, arranged to cause fluid to be released from the subject, e.g., by piercing the skin of a subject. In some embodiments, if fluid may partially or fully fill an enclosure surrounding a skin insertion object or other object, then the enclosure can define at least part of a substance transfer component. A substance transfer component may include any other suitable fluid transporter or flow activator. Other components including partially or fully enclosed channels, microfluidic channels, tubes, wicking members, vacuum containers, etc. can be, or be a part of, a substance transfer component.

If needles or microneedles are used, they may be solid or hollow, i.e., blood or other fluid may travel in and/or around the needles or microneedles into or from the device. In some cases, the needles or microneedles may also be removed from the subject, e.g., after insertion into the skin, for example, to increase the flow of blood or other fluids from the subject. In one set of embodiments, the substance transfer component includes solid needles that are removed from the skin and a cup or channel to direct the flow of blood or other bodily fluids.

It should be noted that a skin insertion object or other flow activator need not be included with all embodiments as the device may not necessarily employ a mechanism for causing fluid release from the subject. For instance, the device may receive fluid that has already been released due to another cause, such as a cut or an abrasion, fluid release due to a separate and independent device, such as a separate lancet, an open fluid access such as during a surgical operation, and so on. Additionally, fluid may be introduced into the device via urination, spitting, pouring fluid into the device, etc. If included, a skin insertion object or other substance transfer component may physically penetrate, pierce, and/or or abrade, chemically peel, corrode and/or irritate, release and/or produce electromagnetic, acoustic or other waves, other otherwise operate to cause fluid release from a subject. The substance transfer component may include a moveable mechanism, e.g., to move a needle, or may not require movement to function. For example, the substance transfer component may include a jet injector or a “hypospray” that delivers fluid under pressure to a subject, a pneumatic system that delivers and/or receives fluid, a hygroscopic agent that adsorbs or absorbs fluid, a reverse iontophoresis system, a transducer that emits ultrasonic waves, or thermal, radiofrequency and/or laser energy, and so on, any of which need not necessarily require movement of an element to cause fluid release from a subject.

In some aspects, the device may include a support structure, such as a housing. The housing may be used, as discussed herein, for applying the substance transfer component to the surface of the skin of the subject, e.g., so that fluid may be delivered and/or received from the skin of the subject. In some cases, the housing may immobilize the substance transfer component such that the substance transfer component cannot move relative to the housing; in other cases, however, the substance transfer component, or a portion thereof, may be able to move relative to the housing. In one embodiment, as a non-limiting example, the substance transfer component is immobilized relative to the housing, and the deployment actuator is positioned within the device such that application of the device to the skin causes at least a portion of the substance transfer component to pierce the skin of the subject. In some cases, as previously discussed, the housing encloses a deployment actuator.

In some embodiments, the deployment actuator, or a portion of the deployment actuator, may move from a first position to a second position. For example, the first position may be one where the deployment actuator has attached thereto a substance transfer component that is not in contact with the skin (e.g., a skin insertion object of the substance transfer component may be contained within a recess of the substance transfer component), while the second position of the deployment actuator may be one where the substance transfer component does contact the skin, e.g., to pierce the skin. The deployment actuator may be moved using any suitable technique, e.g., manually, mechanically, electromagnetically, using a servo mechanism, or the like. In one set of embodiments, for example, the deployment actuator may be moved from a first position to a second position by pushing a button on the device, which causes the deployment actuator to move (either directly, or through a mechanism linking the button with the deployment actuator). Other mechanisms (e.g., dials, levers, sliders, etc., as discussed herein) may be used in conjunction of or instead of a button. In another set of embodiments, the deployment actuator may be moved from a first position to a second position automatically, for example, upon activation by a computer, upon remote activation, after a period of time has elapsed, or the like. For example, in one embodiment, a servo connected to the deployment actuator is activated electronically, moving the deployment actuator from the first position to the second position. In some cases, the deployment actuator may include a triggering mechanism that initiates deployment.

In some cases, the deployment actuator and/or the substance transfer component may also be moved from the second position to the first position (or some other position). For example, after fluid has been delivered and/or received from the skin, e.g., using a substance transfer component, the deployment actuator may be moved, which may move the substance transfer component away from contact with the skin. The deployment actuator may be moved from the second position to the first position using any suitable technique, including those described above, and the technique for moving the deployment actuator from the second position to the first position may be the same or different as that moving the deployment actuator from the first position to the second position.

In some cases, the device may be able to draw skin towards the substance transfer component. For example, in one set of embodiments, the device may include a vacuum interface or region. The interface or region may be connected with a vacuum source (external and/or internal to the device), and when a vacuum is applied, skin may be drawn towards the device, e.g., for contact with a substance transfer component, such as one or more needles or microneedles.

In one set of embodiments, the device includes a deployment actuator able to drive a substance transfer component into the skin, e.g., so that the device can receive a fluid from the skin of a subject, and/or so that the substance transfer component can deliver a substance to a subject, e.g. deliver a substance to the skin and/or to a location beneath the skin of a subject. The deployment actuator may be a structure that can be deformed using unaided force (e.g., by a human pushing the structure), or other forces (e.g., electrically-applied forces, mechanical interactions or the like), but is able to restore its original shape after the force is removed or at least partially reduced. For example, the structure may restore its original shape spontaneously, or some action (e.g., heating) may be needed to restore the structure to its original shape. In one set of embodiments, the deployment actuator may include a flexible concave member or a reversibly deformable structure that is moveable between a first configuration and a second configuration. The deployment actuator may be formed out a suitable elastic material, in some cases. For instance, the structure may be formed from a plastic, a polymer, a metal, etc. In one set of embodiments, the structure may have a concave or convex shape. For instance, the edges of the structure may be put under compressive stress such that the structure “bows” out to form a concave or convex shape. A person pushing against the concave or convex shape may deform the structure, but after the person stops pushing on the structure, the structure may be able to return to its original concave or convex shape, e.g., spontaneously or with the aid of other forces as previously discussed. In some cases, the device may be bistable, i.e., having two different positions in which the device is stable.

In certain embodiments, quick and/or high velocity, and/or high force and/or pressure application of skin insertion objects to the skin, such as microneedles, or other substance transfer components, may in certain embodiments result in lower pain or painless deployment. Without wishing to be bound by any theory, it is believed that higher velocities, forces, etc., may result in faster penetration of the objects into the skin, which results in less damage to the skin, and thus less pain. In addition, relatively rapid insertions may give a subject less sensation of pain, and/or less time to become apprehensive to the insertion, thereby resulting in lower perceived pain. Examples of devices able to deliver objects quickly and/or at high velocity, and/or with high force and/or pressure are disclosed in detail herein, and include, but are not limited to, snap domes and other deployment actuators such as those described below.

An example of a deployment actuator is now illustrated with respect to FIG. 8. In FIG. 8A, structure 700 has a generally concave shape, and is positioned on the surface of skin 710. Structure 700 also includes a substance transfer component 720 for insertion into the skin. In FIG. 8B, a person (indicated by finger 705) pushes onto structure 700, deforming at least a portion of the structure and thereby forcing a substance transfer component 720 into at least a portion of the skin. In FIG. 8C, after the person releases structure 700, the structure is allowed to return to its original position, e.g., spontaneously, lifting substance transfer component 720 out of the skin. In some cases, e.g., if the substance transfer component includes needles or other skin insertion objects that are sufficiently large or long, blood or other fluids 750 may come out of the skin through the holes created by the needles, and optionally the fluid may be collected by the device for later storage and/or use, as discussed herein.



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stats Patent Info
Application #
US 20120277629 A1
Publish Date
11/01/2012
Document #
13456546
File Date
04/26/2012
USPTO Class
600578
Other USPTO Classes
International Class
61B5/153
Drawings
9


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