Seventh Sense Biosystems, Inc.

Yourbio Health, Inc.

Shawn Davis

Donald E Chickering, Iii

Ramin Haghgooie

Howard Bernstein

Mark Michelman

Douglas Adam Levinson

Kelly Garbin

Wellington Kelvin Russell

Scott W James

Richard L Miller

Christopher John Morse

Javier Gonzalez-Zugasti

A David Boccuti

Maisam Dadgar

Greg Fisher

Ping Gong

Kristin Horton

David R Walt

Li Yang Chu

Robert Samuel Langer

Timothy M Blicharz

Donald E Chickering Iii

Donald E Iii Chickering

Doanld E Chickering

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for receiving or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. In another aspect, the present invention is generally directed to arrangements of skin insertion objects such as microneedles and methods of forming and arranging skin insertion objects. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Rapid delivery and/or receiving of 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. 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.

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

The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.

Techniques and devices associated with blood sampling

Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the 'pooling' of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device and have a volume that is larger than a recess of the fluid transporter that receives fluid from a surface.

Systems and methods for collecting fluid from a subject

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. A deployment actuator may actuate the flow activator in a deployment direction, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, a device actuator may enable fluid communication between the opening and the vacuum source and the flow activator may be actuated after the enablement of fluid communication.

Delivering and/or receiving fluids

The present invention generally relates to receiving bodily fluid through a device opening. In one aspect, the device includes a flow activator arranged to cause fluid to be released from a subject. The flow activator may be actuated in a deployment direction by a deployment actuator, which may in turn cause fluid release from a subject. The flow activator may also be moved in a retraction direction by a retraction actuator. In one aspect, the device may include a vacuum source that may help facilitate fluid flow into the opening of the device and/or may help facilitate fluid flow from the opening to a storage chamber. In one aspect, an effector may enable fluid communication between the opening and the vacuum source and may do so in response to actuation of the flow activator.

Delivering and/or receiving material with respect to a subject surface

In some embodiments, the present invention generally relates to the separation of blood within a device to form plasma or serum. In some embodiments, the present invention generally relates to the removal of fluids, such as blood, contained within a device. In one aspect, the present invention is generally directed to systems and methods for receiving blood from a subject and processing the blood to form plasma or serum. For example, a device may be applied to the skin of a subject to receive blood from the subject and pass the blood through a separation membrane, which separates the blood into plasma and a portion concentrated in blood cells. As another example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device. The device may contain, in some cases, a vacuum source such as a pre-packaged vacuum to facilitate receiving of blood and/or passage of the blood through the separation membrane to produce plasma or serum. In certain embodiments, plasma, serum, or other fluids may be removed from the device by inserting a needle into a portion of the device that has reduced pressure, expelling gas into the device through the needle, then receiving plasma, serum, or other fluids through the needle.

Plasma or serum production and removal of fluids under reduced pressure

Devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications

Systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g., from the skin. Beading disruptors and/or capillaries may be used for facilitating the transport of fluids from a subject into a device. Beading disruptors may disrupt the 'pooling' of bodily fluids such as blood on the surface of the skin and help influence flow in a desired way. A capillary may conduct flow of fluid in the device, e.g., to an inlet of a channel or other flow path that leads to a storage chamber. A vacuum (reduced pressure relative to ambient) may be used to receive fluid into the device, e.g., by using relatively low pressure to draw fluid into the inlet of a channel leading to a storage chamber. The vacuum source may be part of the device.

In some embodiments, the present invention generally relates to the separation of blood within a device to form plasma or serum. In some embodiments, the present invention generally relates to the removal of fluids, such as blood, contained within a device. For example, a device may be applied to the skin of a subject to receive blood from the subject and pass the blood through a separation membrane, which separates the blood into plasma and a portion concentrated in blood cells. As another example, blood or plasma may be allowed to clot within the device and serum (the unclotted portion of the blood) may be withdrawn from the device. The device may contain, in some cases, a vacuum source such as a pre-packaged vacuum to facilitate receiving of blood and/or passage of the blood through the separation membrane to produce plasma or serum.

The present invention generally relates to devices and techniques associated with diagnostics, therapies, and other applications, including skin-associated applications, for example, devices for delivering and/or withdrawing fluid from subjects, e.g., through the skin. In some embodiments, the device includes a system for accessing an extractable medium from and/or through the skin of the subject at an access site, and a pressure regulator supported by a support structure, able to create a pressure differential across the skin at least a portion of the access site. The device may also include, in some cases, a sensor supported by the support structure for determining at least one condition of the extractable medium from the subject, and optionally a signal generator supported by the support structure for generating a signal relating to the condition of the medium determined by the sensor.

Systems and methods for delivering and/or receiving a substance or substances, such as blood, from subjects. In one embodiment, devices and methods for receiving blood from a subject employ devices including a substance transfer component (such as one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, for example, using pain scales such as the WONG BAKER FACES Pain Scale. The device may be self-contained, applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may be processed to determine the blood and/or an analyte within the blood using sensors or agents in the device or an external apparatus. Other aspects of the present invention are directed at other devices for receiving bodily fluids kits involving such devices, methods of making such devices, methods of using such devices, and the like.

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Santa Monica, CA, United States of America

Shawn Davis