WO2024145476A1 - Timbre dermique avec bandelette de test de diagnostic - Google Patents

Timbre dermique avec bandelette de test de diagnostic Download PDF

Info

Publication number
WO2024145476A1
WO2024145476A1 PCT/US2023/086234 US2023086234W WO2024145476A1 WO 2024145476 A1 WO2024145476 A1 WO 2024145476A1 US 2023086234 W US2023086234 W US 2023086234W WO 2024145476 A1 WO2024145476 A1 WO 2024145476A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
lancet
physiological sample
test strip
vacuum
Prior art date
Application number
PCT/US2023/086234
Other languages
English (en)
Inventor
Namal NAWANA
Ziad Tarik Al-Shamsie
Original Assignee
Satio, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/090,063 external-priority patent/US20230142316A1/en
Application filed by Satio, Inc. filed Critical Satio, Inc.
Publication of WO2024145476A1 publication Critical patent/WO2024145476A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/150854—Communication to or from blood sampling device long distance, e.g. between patient's home and doctor's office
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150847—Communication to or from blood sampling device
    • A61B5/150862—Communication to or from blood sampling device intermediate range, e.g. within room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15111—Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150748—Having means for aiding positioning of the piercing device at a location where the body is to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150763—Details with identification means
    • A61B5/150786—Optical identification systems, e.g. bar codes, colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap

Definitions

  • the present teachings are generally directed to dermal patches that can be employed to detect a biomarker in a drawn physiological sample.
  • the cartridge further includes a vacuum chamber, wherein the vacuum pin is moveable between the undeployed position and the deployed position within the vacuum chamber.
  • the cartridge further includes a physiological sample channel in open communication with the vacuum chamber, wherein the physiological sample channel is configured to carry the drawn physiological sample, and wherein the vacuum draws the physiological sample to the diagnostic test strip via the physiological sample channel.
  • the cartridge further includes a moveable button that is configured to compress the processing fluid pack.
  • the button is configured to move from a locked position to a deployed position, and the cartridge is configured to prevent the button from compressing the processing fluid pack when the button is in the locked position and is configured to allow the button to compress the processing fluid pack when the button is in the deployed position.
  • the cartridge further includes a piercing element, and the button is configured to compress the processing fluid pack into the piercing element to rupture the processing fluid pack, thereby releasing a processing fluid contained in the fluid pack.
  • FIGs. 11A and 11B depict a housing of the lancet in accordance with an exemplary embodiment of the present disclosure
  • Fig. 13 depicts an inner sleeve of the lancet in accordance with an exemplary embodiment of the present disclosure
  • Figs. 23A and 23B - 40A and 40B depict a base of the dermal patch system in accordance with an exemplary embodiment of the present disclosure
  • Figs. 42A and 42B depict a vacuum pin of the dermal patch system in accordance with an exemplary embodiment of the present disclosure
  • Fig. 50 depicts the lancet of the dermal patch system in a deployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 51 depicts the lancet of the dermal patch system in a retracted position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 52 depicts the lancet coupled to the cartridge, wherein the lancet is in a deployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 56 diagrammatically depicts an electronic medical record database, a computer system, and a dermal patch system with a quick response (“QR”) code in accordance with an exemplary embodiment of the present disclosure
  • biomarker refers to a biological molecule that is an indicator of a biological state or condition.
  • the mechanism can also include a lower locking member that retains a lower spring in a compressed state.
  • the downward movement of the needle platform can cause the release of the lower locking member to allow the lower spring to decompress and exert a restoring force on the needle platform to cause the retraction of the needle into the lancet housing.
  • the dermal patch system 10 includes a cartridge 12 that can be affixed to a subject’s skin via an adhesive layer 14. (Figs. 4A and 4B).
  • the dermal patch system 10 also includes a lancet 100 that can engage with the cartridge 12 to deploy a needle disposed within the lancet 100.
  • the cartridge 12 includes a cover 200 and a base 300 that can couple to the cover 200.
  • the cover 200 and the base 300 can be formed as two or more separate components that are removably coupled to one another (e.g., via a snap fitting).
  • the cover 200 and the base 300 form an integral unitary cartridge 12.
  • the cover 200 can be bonded or coupled to the base 300 via an adhesive, laser welding, heat sealing, heat activated adhesive, etc.
  • the dermal patch system 10 also includes a vacuum pin 400. As will be discussed in further detail herein, the vacuum pin 400 can be disposed within the cartridge 12 and is configured to create a vacuum within the cartridge 12.
  • the cartridge 12 may be formed using a variety of suitable materials including, but not limited to, polymeric materials (e.g., polyolefins, polyethylene terephthalate (PET), polyurethanes, polynorbomenes, polyethers, polyacrylates, polyamides (Polyether block amide also referred to as Pebax®), poly siloxanes, polyether amides, polyether esters, transpolyisoprenes, polymethyl methacrylates (PMMA), cross-linked trans-polyoctylenes, cross-linked polyethylenes, cross-linked polyisoprenes, cross-linked polycyclooctenes, inorganic-organic hybrid polymers, co-polymer blends with polyethylene and Kraton®, styrene-butadiene copolymers, urethane-butadiene co-polymers, polycaprolactone or oligo caprolactone copolymers, polylactic acid (PLLA) or polyl
  • the cartridge 12 further includes a sealed processing fluid pack 16 that is disposed in the base 300 of the cartridge 12 and a button 500 that extends through the cover 200.
  • the processing fluid pack 16 is disposed within the cartridge 12 and contains a processing fluid (e.g., TBS-T, Tris Buffered Saline-Tween, and TENT, Tris Buffered saline with EDTA, etc.) for processing a physiological sample drawn form a subject.
  • the processing fluid pack 16 is formed of a frangible membrane.
  • the button 500 is configured to apply a pressure upon the processing fluid pack 16 which causes the processing fluid pack 16 to rupture thereby releasing the processing fluid.
  • the lancet 100 includes a housing 102 in which various components of the lancet are disposed and a cap 104 that is coupled to the housing 102.
  • the lancet 100 can further include an inner sleeve 106 within the housing 102 and a needle frame 108 that is disposed within the inner sleeve 106 and onto which a needle 110 is mounted.
  • the lancet 100 also can include an injection spring 112 and a retraction spring 114 that move a needle of the lancet between various positions.
  • the outer surface 116a defines a notch 122 that extends circumferentially around the outer surface 116a of the side wall 116. As will be discussed in further detail herein, the notch 122 is shaped and dimensioned to couple to a locking member of the cartridge 12 via a snap fit.
  • the housing 102 further includes a rim 124 that extends circumferentially around the outer surface extend vertically from the inner surface 118b of the bottom wall 118.
  • the columns 126 includes an inner surface 126a and a top surface 126b.
  • the inner surface 126a extends vertically between the inner surface 118b of the bottom wall 118 and the top surface 126b.
  • the top surface 126b extends longitudinally between the inner surface 116b of the side wall 116 and the inner surface 126a.
  • the injection spring 112 (Fig. 10) extends vertically between the cap 104 and the needle frame 108. More specifically, a distal end of the injection spring 112 contacts the inner surface 130b of the top wall 130 and a proximal end of the injection spring 112 contacts the top surface 154c of the second cylinder 154. The distal end of the injection spring 112 extends circumferentially around the outer surface 134a of the inner cylinder 134. The proximal end of the injection spring 112 extends circumferentially around the third cylinder 156 and around the protrusion 158.
  • the barrel 406 includes a first groove 416 and a second groove 416 shaped and dimensioned to accommodate a first and second elastomeric O-ring 418.
  • the elastomeric O-rings 418 contact the inner surface of the chamber 314 such that the vacuum pin 400 creates an airtight seal within the chamber 314. This seal allows for the application of positive or negative pressure as needed.
  • the lancet includes a mechanism can be transition the lancet between a locked state and a released state.
  • this mechanism includes the columns 126, the ledges 144, and the locking members 146.
  • An upper locking portion of the mechanism refers to the columns 126 and the ledges 144 while a locker locking portion refers to the locking members 146 as the columns 126 and the ledges 144 can be positioned vertically above the locking members 146.
  • the term upper interference portion refers to the top surface 144a of the ledges 144 as this surface interferes with the needle frame’s 108 ability to transition to the deployed position when the mechanism is in the locked state.
  • a lower interference member refers to the columns 142 as the columns 142 interfere with the needle frame’s 108 ability to further extend beyond a desired position.
  • the user can remove the dermal patch system 10 from the skin of the subject and can send the dermal patch system to a medical professional.
  • the medical professional can then view the diagnostic test strip 18 to determine if a biomarker is present in the drawn physiological sample.
  • the computer system 30 may include an application that provides access to the EMR database 34 via a network connection and allows a user to photograph of scan the QR code 22.
  • the EMR database 34 includes a plurality of EMRs 32 each of which is associated with an individual subject.
  • the application causes the computer system 30 to scan or retrieve an image of the QR code 22, analyze the QR code 22 and associate the QR code 22 with an EMR 32.
  • the computer system 30 may then update the associated EMR 32 to indicate a diagnostic test has been run on the drawn physiological sample.
  • the computer system 30 may automatically update the EMR 32 automatically or based on a user input.
  • a method 900 for running a diagnostic test on a drawn physiological sample is shown in accordance with an exemplary embodiment.
  • a user e.g., a medical professional, a subject, etc.
  • applies the cartridge 12 to the skin of the subject via the adhesive layer 14 at a suitable location e.gb., on a leg, arm, etc.
  • the user removes the dermal patch system 10 from the skin of the subject and determines the presence or absence of a biomarker in the drawn physiological sample by viewing the test strip as previously discussed herein.
  • the computer system 30 or another computer system that is in communication with the computer system 30 associates the QR code 22 with an EMR 32 and updates the associated EMR 32 to indicate a diagnostic test has been performed on the drawn physiological sample.
  • the computer system 30 automatically updates the associated EMR 32.
  • the user of the computer system 30 updates the associated EMR 32.
  • the user of the computer system 30 photographs the diagnostic test strip 18 and the computer system 30 associates the photograph with the EMR 32 in the EMR database 34.
  • the computer system 30 or another computer system connected to the EMR database 34 analyzes the photograph to determine the result of the diagnostic test (i.e., the presence or absence of a biomarkcr in the drawn physiological sample) and updates the associated EMR 32 to include the determined result.
  • the diagnostic test i.e., the presence or absence of a biomarkcr in the drawn physiological sample

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Un système d'analyse d'un échantillon physiologique comprend une cartouche configurée pour se fixer à la peau d'un sujet. La cartouche comprend : un bloc de fluide de traitement qui est configuré pour libérer un fluide de traitement stocké à l'intérieur de celui-ci, une bandelette de test de diagnostic et une broche à vide. Le système comprend également une lancette avec une aiguille. La lancette est configurée pour déployer l'aiguille lors de la mise en prise avec la cartouche pour prélever un échantillon physiologique du sujet. La broche à vide est configurée pour créer un vide à l'intérieur de la cartouche pour aspirer le fluide de traitement libéré et l'échantillon physiologique prélevé vers la bandelette de test de diagnostic.
PCT/US2023/086234 2022-12-28 2023-12-28 Timbre dermique avec bandelette de test de diagnostic WO2024145476A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18/090,063 US20230142316A1 (en) 2021-10-13 2022-12-28 Dermal Patch with a Diagnostic Test Strip
US18/090,063 2022-12-28

Publications (1)

Publication Number Publication Date
WO2024145476A1 true WO2024145476A1 (fr) 2024-07-04

Family

ID=89854323

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2023/086234 WO2024145476A1 (fr) 2022-12-28 2023-12-28 Timbre dermique avec bandelette de test de diagnostic

Country Status (1)

Country Link
WO (1) WO2024145476A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014172247A1 (fr) * 2013-04-15 2014-10-23 Becton, Dickinson And Company Dispositif de transfert d'échantillon de sang
WO2018132515A1 (fr) * 2017-01-10 2018-07-19 Drawbridge Health, Inc. Dispositifs, systèmes et procédés de collecte d'échantillons
US11452474B1 (en) * 2021-04-14 2022-09-27 Satio, Inc. Dual lever dermal patch system
US20220330861A1 (en) * 2021-04-14 2022-10-20 Satio, Inc. Self-Contained Dermal Patch for Detection of Physiological Analytes
US11510602B1 (en) * 2021-11-08 2022-11-29 Satio, Inc. Dermal patch for collecting a physiological sample

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014172247A1 (fr) * 2013-04-15 2014-10-23 Becton, Dickinson And Company Dispositif de transfert d'échantillon de sang
WO2018132515A1 (fr) * 2017-01-10 2018-07-19 Drawbridge Health, Inc. Dispositifs, systèmes et procédés de collecte d'échantillons
US11452474B1 (en) * 2021-04-14 2022-09-27 Satio, Inc. Dual lever dermal patch system
US20220330861A1 (en) * 2021-04-14 2022-10-20 Satio, Inc. Self-Contained Dermal Patch for Detection of Physiological Analytes
US11510602B1 (en) * 2021-11-08 2022-11-29 Satio, Inc. Dermal patch for collecting a physiological sample

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