A61B5/150076

OPTICAL METHODS TO MODULATE LOCAL BLOOD PERFUSION AT THE SKIN

Methods and systems for collecting blood samples are described. The disclosed methods and systems employ exposure of the skin surface at a sampling location to electromagnetic radiation, such as blue light, to induce vasodilation in the skin in order to increase a rate of capillary perfusion and blood collection. Following or during the exposure process, the skin at the sampling location can be pricked with one or more lancets to generate capillary perfusion sites for the blood collection process. Following collection of a blood sample, some of the disclosed devices and methods can optionally use heat or infrared electromagnetic radiation to increase a clotting rate to close the capillary perfusion sites.

Apparatus and method for delivery of antimicrobial during a transdermal sampling and delivery process

A device for introducing at least one antimicrobial in an exposed region of a user's skin caused while accessing interstitial fluid includes a substrate having thereon at least one electrically controllable microheating element including at least a microheater portion with multiple electrodes connected to the microheater portion for forming a micropore in the user's skin. A nanofiber mat loaded with at least one antimicrobial material is arranged on the substrate such that it contacts the user's skin and encircles an opening of the micropore formed by the microheating element. In a preferred embodiment, the at least one antimicrobial material is LL-37.

Apparatus and Method For Delivery of Antimicrobial During a Transdermal Sampling and Delivery Process

A device for introducing at least one antimicrobial in an exposed region of a user's skin caused while accessing interstitial fluid includes a substrate having thereon at least one electrically controllable microheating element including at least a microheater portion with multiple electrodes connected to the microheater portion for forming a micropore in the user's skin. A nanofiber mat loaded with at least one antimicrobial material is arranged on the substrate such that it contacts the user's skin and encircles an opening of the micropore formed by the microheating element. In a preferred embodiment, the at least one antimicrobial material is LL-37.

BODY FLUID SAMPLING ARRANGEMENTS
20210307662 · 2021-10-07 ·

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Blood Flow Assist Device
20210312836 · 2021-10-07 ·

A blood flow assist device includes a flexible sleeve, at least one blood flow stimulator incorporated into the sleeve, and an actuator assembly coupled to the blood flow stimulator. The sleeve has a first portion configured to receive at least a portion of a arm and a second portion configured to engage a portion of a hand. The first and second portions of the sleeve properly position each blood flow stimulator on the arm. The actuator assembly individually controls and selectively actuates each blood flow stimulator to apply a stimulus to the arm to control blood flow through a vein in the arm or hand having a vein access device connected thereto. The blood flow assist device may be paired with a blood processing device, with a controller of the blood processing device controlling the actuator assembly based on a pressure and/or flow rate of blood into the blood processing device.

Body fluid sampling device-sampling site interface

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Methods of Manufacture to Optimize Performance of Transdermal Sampling and Analysis Device

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.

Methods, Devices, Systems, and Kits for Automated Blood Collection by Fingerstick
20210038138 · 2021-02-11 ·

Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices.

Methods include placing a cuff on a digit of a subject, inflating the cuff, and obtaining a small volume blood sample. Methods may further include warming a digit; lancing a digit; pulsing the cuff; and providing a signal indicating the end of the sample collection time period.

Kits may include a device, a sample collection vessel, and may include a disposable for use in sample collection.

These methods, devices, systems and kits for obtaining blood samples may be used to easily, reliably, and consistently obtain blood samples from subjects.

HAND WARMER DEVICE FOR CAPILLARY BLOOD COLLECTION

A device that can warm a hand of a user and/or patient to facilitate collection of blood samples (e.g., capillary blood sample collection) is described herein. The device provides controlled amounts of heat directed to the palm of a user and/or patient to facilitate collection of high-quality capillary blood samples. The device is designed in such a way to provide a comfortable resting position for the hand that allows heating the hand of the user and/or patient while simultaneously providing access to the finger of the user and/or patient to carry out one or more steps in preparation for collection of capillary blood samples from the finger. The device will also monitor the temperature to limit the max temperature to a safe level, control the palm temperature to a desired level, and use a conductive material to enable rapid heating.

Methods of manufacture to optimize performance of transdermal sampling and analysis device

Methods and systems for manufacturing a transdermal sampling and analysis device for non-invasively and transdermally obtaining biological samples from a subject and determining levels of analytes of the obtained biological samples are provided. A method of manufacturing the device may improve performance and includes forming channel structures on the lid of the device, thereby making the spacer/channel support structures physically independent and separable from the sensing electrode. Other methods of manufacturing the device may improve performance and include forming at least one of the electrodes on each of the base and the lid, and forming a recessed second spacer layer over the channel support structures, thereby separating the channel support structures and the electrode on the lid to allow a larger area of the electrode to be exposed to the biological sample.