EP4622547A1 - Timbre dermique pour collecter un échantillon physiologique avec un flacon amovible - Google Patents

Timbre dermique pour collecter un échantillon physiologique avec un flacon amovible

Info

Publication number
EP4622547A1
EP4622547A1 EP23833257.1A EP23833257A EP4622547A1 EP 4622547 A1 EP4622547 A1 EP 4622547A1 EP 23833257 A EP23833257 A EP 23833257A EP 4622547 A1 EP4622547 A1 EP 4622547A1
Authority
EP
European Patent Office
Prior art keywords
vial
physiological sample
plunger
cartridge
needle
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP23833257.1A
Other languages
German (de)
English (en)
Inventor
Namal NAWANA
Ziad Tarik Al-Shamsie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Satio Inc
Satio Inc
Original Assignee
Satio Inc
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 US17/991,284 external-priority patent/US12048543B2/en
Application filed by Satio Inc, Satio Inc filed Critical Satio Inc
Publication of EP4622547A1 publication Critical patent/EP4622547A1/fr
Pending legal-status Critical Current

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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel 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
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel 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
    • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
    • 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
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting 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
    • A61B5/150763—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
    • A61B5/150007—Details
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • 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
    • A61B5/150885—Preventing re-use
    • A61B5/150923—Preventing re-use by means for destroying components or parts, e.g. by cutting or piercing
    • 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
    • A61B5/15101—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
    • 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

Definitions

  • Some recently developed devices that allow for continuous monitoring of a target analyte typically suffer from several shortcomings, such as low sensitivity and/or specificity. Therefore, there is still a need for devices that allow collection of a physiological sample (e.g., a blood sample) for monitoring a target analyte.
  • a physiological sample e.g., a blood sample
  • the device further includes a cartridge that is configured to couple to the lancet.
  • the lancet is configured to automatically deploy the needle when coupled to the cartridge, which in turn allows the needle to puncture the subject’s skin and draw a physiological sample.
  • the device also includes a vial disposed within the cartridge and configured to receive the drawn physiological sample.
  • the vial is removable from the cartridge.
  • the vial is configured to be placed into a centrifuge.
  • the vial includes a lysis buffer and/or a preservative and/or an anticoagulant.
  • the device further includes a plunger that is at least partially disposed within the vial and is configured to create a vacuum within the vial and the cartridge, wherein the vacuum can draw the physiological sample into the vial.
  • the cartridge further includes a physiological sample well, and a needle in open communication with the physiological sample well and configured to carry the physiological sample from the physiological sample well to the vial.
  • the plunger includes a snap-off joint that allows a user to separate a portion of the plunger from the rest of the plunger.
  • the snap-off joint can be implemented, without limitation, as a reduced diameter portion, a notch, a perforation, among other structures.
  • the device further includes a self-healing cap coupled to the vial.
  • the self-healing cap is configured to seal the vial after being punctured.
  • the needle is configured to puncture the self-healing cap to carry the physiological sample to the vial.
  • the cartridge includes a cover, and a base removably coupled to the cover.
  • the cover includes a vial viewing aperture configured to provide visual access to the vial disposed within the cartridge.
  • the device includes a quick response (QR) code disposed on an outer surface of the vial.
  • the cover includes a quick response code viewing aperture configured to provide visual access to the quick response code.
  • a method for obtaining a physiological sample from a subject includes attaching a cartridge of a dermal patch to the skin of a subject.
  • the cartridge includes a vial disposed therein and a plunger at least partially disposed within the vial.
  • the method also includes engaging a lancet having a needle to the cartridge so as to activate the needle for puncturing the skin so as to draw a physiological sample (e.g., a blood sample).
  • the method further includes moving the plunger from a first position to a second position to facilitate drawing the physiological sample into the vial.
  • the needle of the lancet automatically retracts into the lancet after drawing the physiological sample.
  • the method further includes removing the vial from the cartridge, breaking the plunger at its snap-off joint such that a portion of the plunger remains disposed within the vial, placing the vial with the portion of the plunger into a medical device, and performing an analysis of the physiological sample within the vial via the medical device.
  • the vial includes a lysis buffer or a preservative or an anticoagulant.
  • the cartridge includes a physiological sample well and the drawn physiological sample pools within the physiological sample well and wherein moving the plunger from the first position to the second position draws the physiological sample from the physiological sample to the vial.
  • the cartridge or the vial includes a quick response code, and the method further includes scanning the quick response code to update an electronic medical record associated with the quick response code.
  • FIGs. 1A and IB depict a dermal patch system in accordance with an exemplary embodiment of the present disclosure
  • Figs. 2 and 3 depict a lancet of the dermal patch system in accordance with an exemplary embodiment of the present disclosure
  • Figs. 4A and 4B depict a housing of the lancet in accordance with an exemplary embodiment of the present disclosure
  • FIGs. 5A and 5B depict a cap of the lancet in accordance with an exemplary embodiment of the present disclosure
  • Fig. 7 diagrammatically depicts a needle frame of the lancet in accordance with an exemplary embodiment of the present disclosure
  • FIGs. 10A and 10B - 14A and 14B depict a cover of the cartridge in accordance with an exemplary embodiment of the present disclosure
  • FIGs. 15A and 15B - 21A and 21B depict a base of the cartridge in accordance with an exemplary embodiment of the present disclosure
  • FIG. 21A and 21B depict a portion of the base of the cartridge in accordance with an exemplary embodiment of the present disclosure
  • Figs. 22A and 22B depict the cover coupled to the base in accordance with an exemplary embodiment of the present disclosure
  • Fig. 23 diagrammatically depicts a lancet receiving element of the base in accordance with an exemplary embodiment of the present disclosure
  • Figs. 24A and 24B - 27 depict a syringe for use with the cartridge in accordance with an exemplary embodiment of the present disclosure
  • FIGs. 28A and 28B depict a plunger of the syringe with an elastomeric ring in accordance with an exemplary embodiment of the present disclosure
  • Figs. 29A and 29B - 33 depict the plunger in accordance with an exemplary embodiment of the present disclosure
  • Figs. 34 and 35 depict the elastomeric ring for use with the plunger in accordance with an exemplary embodiment of the present disclosure
  • Figs. 36A and 36B - Figs. 44A and 44B depict a vial assembly in accordance with an exemplary embodiment of the present disclosure
  • Figs. 45A and 45B - 52A and 52B depict a vial of the vial assembly in accordance with an exemplary embodiment of the present disclosure
  • Fig. 53 and 54 depict a cap of the vial assembly in accordance with an exemplary embodiment of the present disclosure
  • Figs. 55A and 55B depict a locking member of the vial assembly in accordance with an exemplary embodiment of the present disclosure
  • Fig. 56 depicts the lancet in an undeployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 57 depicts the lancet in a deployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 58 depicts the lancet in a retracted position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 59 depicts the lancet couped to the base wherein the lancet is in the deployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 60 depicts the lancet couped to the base wherein the lancet is in the retracted position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 61 depicts the dermal patch system wherein the plunger is in an undeployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 62 depicts the dermal patch system wherein the plunger is in a deployed position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 63 depicts the dermal patch system wherein the vial assembly is in a vial removal position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 64 depicts the dermal patch system wherein the vial assembly is in a vial storage position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 65 depicts the vial assembly in the vial storage position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 66 depicts the vial assembly in the vial storage position in accordance with an exemplary embodiment of the present disclosure
  • Fig. 67 depicts a lid removal tool in accordance with an exemplary embodiment of the present disclosure
  • Fig. 68 depicts the lid removal tool decoupling the cover from the base in accordance with an exemplary embodiment of the present disclosure
  • Fig. 69 depicts a broken plunger in accordance with an exemplary embodiment of the present disclosure
  • Fig. 70 depicts a base of a dermal patch system with a pipette in accordance with an exemplary embodiment of the present disclosure
  • Fig. 71 depicts a pipette for use with the dermal patch system in accordance with an exemplary embodiment of the present disclosure
  • Fig. 72 diagrammatically depicts an electronic medical record database, a computer system, and a physiological sample collection pad with a quick response (“QR”) code in accordance with an exemplary embodiment of the present disclosure
  • FIG. 73 diagrammatically depicts a computer system in accordance with an exemplary embodiment of the present disclosure
  • Fig. 74 diagrammatically depicts a cloud computing environment in accordance with an exemplary embodiment of the present disclosure.
  • Fig. 75 is a flow chart of a method for obtaining a physiological sample from a subject in accordance with an exemplary embodiment of the present disclosure.
  • the present disclosure generally relates to a dermal patch that may be utilized to collect and/or store a collected physiological sample.
  • a dermal patch may be used to collect a physiological sample and the collected sample may then be stored within a vial of the dermal patch.
  • Dermal patches disclosed herein may allow for the collection and analysis of a physiological sample in a variety of environments (e.g., in the home, in the field, in a medical facility, etc.).
  • subject refers to a human subject or an animal subject (i.e., chicken, pig, cattle, dog, cat, etc.).
  • physiological sample includes fluid drawn from a subject and includes, but is not limited to, blood and interstitial fluid.
  • the term “lancet,” as used herein refers broadly to an element that can be used to provide a passageway, or facilitate the production of a passageway, in the skin for the collection of a physiological sample.
  • transparent indicates that light can substantially pass through an object (e.g., a window) to allow visualization of a material disposed behind the object.
  • a transparent object allows the passageway of at least 70%, or at least 80%, or at least 90% of visible light therethrough.
  • the term “vacuum,” as used herein, refers to a pressure less than atmospheric pressure and more particularly to a pressure that can facilitate the movement of a fluid (e.g., a physiological sample) within a dermal patch.
  • a fluid e.g., a physiological sample
  • syringe refers to a device that includes a hollow barrel (also referred to as a “vial” herein) that is fitted with a plunger.
  • a syringe may or may not include a needle.
  • needle refers to a component with a pointed tip that is configured to pierce an outer surface of an element (e.g., skin of a subject) to provide a passageway.
  • pipette refers to an apparatus for collecting a liquid that consists of a narrow tube and a barrel that retains the liquid. Liquid may travel into the barrel via the suction or capillary action and as such, a pipette may or may not include a bulb.
  • the present disclosure generally relates to a device, which is herein also referred to as a dermal patch or a dermal patch system, for collecting a physiological sample (e.g., bodily fluids such as blood, interstitial fluids, etc.) from a subject.
  • a physiological sample e.g., bodily fluids such as blood, interstitial fluids, etc.
  • a dermal patch system can include a cartridge that can be affixed to a to a subject’s skin (e.g., via an adhesive layer) and a separate lancet that can be engaged with the cartridge to puncture the skin, thereby providing a passageway for extracting the physiological sample.
  • the lancet can include a housing in which at least one needle that is configured for puncturing the skin is disposed.
  • the lancet can further include a mechanism that can be transitioned between at least two states, wherein in one state (herein referred to as a locked state), the mechanism retains the needle within the lancet in an undeployed position when the lancet is not engaged with the cartridge and in another state (herein referred to as a released state), the mechanism allows the needle to be deployed for puncturing the skin in response to engagement of the lancet with the cartridge.
  • a locked state in one state
  • the mechanism retains the needle within the lancet in an undeployed position when the lancet is not engaged with the cartridge
  • a released state the mechanism allows the needle to be deployed for puncturing the skin in response to engagement of the lancet with the cartridge.
  • the engagement of the lancet with the cartridge transitions the mechanism from the locked state to the released state, where in the released state, the mechanism allows the needle to be deployed for puncturing the skin.
  • the mechanism can include an upper locking portion that can retain an upper spring that is coupled to a needle platform (to which a needle is mounted) in a compressed state, thereby preventing the needle from transitioning into a deployed position.
  • the mechanism can include an upper interference member that prevents the movement of the needle platform when the mechanism is in the locked state.
  • the engagement of the lancet with the cartridge results in an automatic transition of the mechanism from the locked state to the released state, which transitions the needle into a deployed position in which the needle extends beyond the lancet and the cartridge housing to puncture the subject’s skin.
  • the engagement of the lancet with the cartridge causes the upper locking member to release the needle platform, which in turn allows the upper spring to decompress and thus push down the needle platform thereby deploying the needle.
  • the mechanism can further include a lower interference member that restricts the downward movement of the needle platform, when the needle platform is released. In this manner the extent of the penetration of the needle into the skin can be controlled.
  • 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 force on the needle platform to cause the retraction of the needle into the lancet housing.
  • the lancet remains safe before it is engaged with the cartridge as the lancet is not capable of deploying the needle when the lancet is not engaged with the cartridge. Furthermore, in this manner, the lancet remains safe after drawing a physiological sample as the needle automatically retracts back into the lancet after being deployed.
  • the dermal patch system 10 includes a lancet 100, a cartridge 12 that can be affixed to a subject’s skin via an adhesive layer 14 (Figs. 9A and 9B), and a syringe 16 (Figs. 24A and 24B - 27) that can be at least partially disposed within the cartridge 12.
  • the lancet 100 can engage with the cartridge 12 to deploy a needle disposed within the lancet housing to puncture the subject’s skin thereby drawing a physiological sample from the subject.
  • the lancet 100 is shown in accordance with an exemplary embodiment.
  • 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 housing 102 includes a side wall 116 and a bottom wall 118.
  • the side wall 116 includes an outer surface 116a and an opposed inner surface 116b.
  • the bottom wall 118 includes an outer surface 118a and an opposed inner surface 118b.
  • the side wall 116 extends vertically from the bottom wall 118.
  • the side wall 116 has a generally cylindrical shape and the bottom wall 118 is generally circular in shape and is concentric relative to a longitudinal axis of the generally cylindrical side wall and covers a lower opening formed by the generally cylindrical side wall.
  • the inner surface 116b of the side wall 116 and the inner surface 118b of the bottom wall 118 define an inner volume 120.
  • 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 116a of the side wall 116.
  • the inner surface 116b defines a first and second column 126 that 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 columns 126 retain the needle 110 of the lancet 100 in an undeployed position.
  • the bottom wall 118 defines an aperture 128 that extends through the bottom wall 118. Stated another way, the aperture 128 extends between the outer surface 118a and the inner surface 118b of the bottom wall 118.
  • the needle of the lancet 100 is activated to extend through the aperture 128 and puncture the subject’s skin thereby providing a passageway through which a physiological sample can be drawn from a subject.
  • the cap 104 includes a top wall 130 with an outer surfaced 130a and an opposed inner surface 130b.
  • the cap 104 also includes a side wall 132 with an outer surface 132a and an opposed inner surface 132b.
  • the top wall 130 extends longitudinally from and perpendicular to the side wall 132.
  • the side wall 132 extends vertically from and perpendicular to the top wall 130.
  • the top wall 130 and the side wall 132 are generally circular in shape and are concentric with one another.
  • the cap 104 also includes an inner cylinder 134 with an outer surface 134a and an opposed outer surface 134b.
  • the inner cylinder 134 extends vertically from and perpendicular to the top wall 130.
  • the inner cylinder 134 is concentric with the top wall 130 and the side wall 132.
  • the side wall 132 extends into the inner volume 120 of the housing 102 and at least a portion of the side wall 132 contacts the inner surface 116b of the side wall 116 such that the cap 104 couples to the housing 102 via an interference fit.
  • the inner sleeve 106 includes a side wall 136 and a bottom wall 138.
  • the side wall 136 includes an outer surface 136a and an opposed inner surface 136b.
  • the bottom wall 138 includes an outer surface 138a and an opposed inner surface 138b.
  • the side wall 136 extends vertically from the bottom wall 138.
  • the side wall 136 and the bottom wall 138 are generally circular in shape and are concentric with one another.
  • the inner surface 136b of the side wall 136 and the inner surface 138b of the bottom wall 138 define an inner volume 140.
  • the inner surface 136b defines a plurality of columns 142 each of which extends vertically from and perpendicular to the inner surface 138b of the bottom wall 138.
  • the inner sleeve 106 further includes a plurality of ledges 144 that extend circumferentially about the side wall 136. Each ledge 144 includes a top surface 144a, an opposed bottom surface 144b and an outer surface 144c that extends between the top surface 144a and the bottom surface 144b.
  • the inner sleeve 106 also includes a plurality of locking members 146 that extend from the inner surface 136b of the side wall 136. As will be discussed in further detail herein, the proximal end of the locking members 146 retains the retraction spring 114 in a compressed state in absence of engagement between the lancet 100 and the cartridge 12.
  • the side wall 136 further defines a plurality of openings 148 that extend through the side wall 136. Stated another way, the openings 148 extend between the outer surface 136a and the inner surface 136b of the side wall 136. Each of the openings 148 are aligned with a proximal end of a locking member 146 to allow the proximal end of a locking member 146 to extend therethrough.
  • the bottom wall 138 defines an aperture 150 that extends through the bottom wall 138. Stated another way, the aperture 150 extends between the outer surface 138a and the inner surface 138b of the bottom wall 138. The aperture 150 is concentric with the aperture 128 of the housing 102. As will be discussed in further detail herein, when in a deployed position, the needle 110 of the lancet 100 extends through the aperture 150 of the inner sleeve 106 as well as the aperture 128 of the housing 102.
  • the top surface 154c of the second cylinder 154 extends longitudinally between the outer surface 154b of the second cylinder and the outer surface 156a of the third cylinder 156.
  • the outer surface 156a extends vertically between the top surface 154c of the second cylinder and the top surface 156b of the third cylinder.
  • the top surface 156b of the third cylinder extends longitudinally between the outer surface 156a of the third cylinder 156 and the outer surface 158a of the protrusion 158.
  • the outer surface 158a extends vertically between the top surface 156b of the third cylinder and the top surface 158b of the protrusion 158.
  • the top surface 158b of the protrusion 158 extends across a proximal end of the outer surface 158a.
  • the lid 202 defines a lancet aperture 206 that is generally circular in shape.
  • the lancet aperture 206 extends through the lid 202. Stated another way, the lancet aperture 206 extends between the outer surface 202a and the inner surface 202b of the lid 202.
  • the lancet aperture 206 is shaped to accommodate at least a portion of the lancet 100.
  • the lancet aperture 206 allows the lancet 100 to couple to the base 300. That is, the lancet aperture 206 is shaped to accommodate the lancet 100 such that at least a portion of the lancet 100 can extend through the lid 202.
  • QR code 18 is depicted as on the vial assembly 500, it is understood that the QR code 18 may be positioned elsewhere on the cartridge 12 (e.g., on the outer surface 202a of the lid 202). As will be discussed in further detail herein, the QR code 18 can be associated with an electronic medical record (“EMR”) stored in an electronic medical record database.
  • EMR electronic medical record
  • the cover 200 also includes a locking wall 218 and a vial guide 220.
  • the locking wall 218 and the vial guide 220 each extend vertically from and perpendicular to the inner surface 202b of the lid 202 and are disposed at opposite ends of the vial viewing aperture 208.
  • the vial guide 220 extends longitudinally between the locking members 214.
  • the locking wall 218 prevents movement of the vial assembly 500 when the vial assembly 500 is arranged in a first position and the vial guide 220 is shaped and dimensioned to guide movement of the vial assembly 500 when the vial assembly 500 is arranged in different position.
  • the cover 200 further includes a stopping wall 224 that extends partially around the vial viewing aperture 208.
  • the stopping wall 224 extends around the distal end of the vial viewing aperture 208. As will be discussed in further detail herein, the stopping wall 224 prevents horizontal movement of the vial assembly 500.
  • the base 300 also includes a lancet receiving element 316 that is shaped and dimensioned to accept the proximal end of the lancet 100.
  • the lancet receiving element 316 includes an outer circular projection 318 and an inner circular projection 320 with each extending vertically from and perpendicular to the top surface 302a of the bottom wall 302.
  • the outer circular projection 318 includes an outer surface 318a, an opposed inner surface 318b, and a top surface 318c that extends between the outer surface 318a and the inner surface 318b.
  • the top surface 318c extends perpendicular to and longitudinally between the outer surface 318a and the inner surface 318b.
  • the outer surface 318a and the inner surface 318b extend vertically from and perpendicular to the top surface 302a of the bottom wall 302 such that the outer surface 318a and the inner surface 318b extend between the top surface 302a and the top surface 318c.
  • the outer circular projection 318 is shaped to accept the lancet 100.
  • the base 300 further includes a plurality of locking members 322 that extend vertically from and perpendicular to the top surface 318c of the outer circular projection 318.
  • Each locking member 322 includes a hook 324 that extends inwardly from a top of a locking member 322 towards the inner circular projection 320.
  • the hooks 324 of the locking members 322 couple to the lancet 100 to retain the lancet 100 within the base 300.
  • the base 300 includes a physiological sample well 326 and a channel 328 that that is in open communication with and extends from the physiological sample well 326.
  • a physiological sample when drawn from a subject, the physiological sample pools within the physiological sample well 326.
  • the channel 328 is shaped and dimensioned to retain a bent hollow needle 330.
  • the channel 328 includes an opening opposite the physiological sample well 326 which allows the needle 330 into the channel 328.
  • the needle 330 is configured to carry a drawn physiological sample from the physiological sample well 326 to the vial assembly 500.
  • the second vial holder 334 includes an end wall 340 through which the channel 328 extends.
  • the second vial holder 334 also includes a semi-circular wall 342 that has a similar shape and dimension as the vial assembly 500.
  • the end wall 340 extends vertically from and perpendicular to the top surface 302a of the bottom wall 302.
  • the semi-circular wall 342 extends longitudinally from and perpendicular to the end wall 340.
  • the connection member 338 extends between the first vial holder 332 and the semi-circular wall 342.
  • the second vial holder 334 also includes latches 344 that extend longitudinally from the semi-circular wall 342.
  • the latches 344 are angled inwardly towards a middle of the base 300.
  • the latches 344 allow the vial assembly 500 to move from one position wherein the needle 330 extends into the vial assembly 500 to another wherein the needle 330 is removed from the vial assembly 500.
  • the latches 344 prevent a user from transitioning the vial assembly 500 back to its original position.
  • the extension member 338 further includes a protrusion 346 that extends vertically from the extension member 338.
  • a protrusion 346 that extends vertically from the extension member 338.
  • the rounded surface of the first vial holder 332, the rounded surface of the extension member 338, and the surface of the semi-circular wall 342 angle downward at an angle of about 85° away from the plunger support 350 and towards the end wall 340 such that the vial assembly 500 has an angled orientation when disposed within the cartridge 12. Furthermore, the plunger support 350 and the U-shaped locking feature 348 are oriented such that the plunger 400 has an angled orientation when disposed within the cartridge 12.
  • the plunger 400 includes a handle 402, a shaft 404, a rod 406, and an elastomeric ring 408.
  • the handle 402 defines a proximal end of the plunger 400
  • the shaft 404 extends between the handle 402 and the rod 406, and the rod 406 extends from the shaft 404 and defines a proximal end of the plunger 400.
  • the elastomeric ring 408 surrounds the proximal end of the rod 406.
  • the shaft 404 is generally cylindrical in shape and includes opposing rounded surfaces 410 and opposing flat surfaces 412 that are disposed between the opposing rounded surfaces 410. As will be discussed in further detail herein, the profile of the shaft 404 prevents the plunger 400 from rotating until the plunger 400 is moved from a first position to a second position.
  • the rod 406 is generally cylindrical in shape and has a smaller diameter than the shaft 404. As will be discussed in further detail herein, this smaller diameter allows the rod 406 to rotate when the syringe 16 is disposed within the cartridge 12.
  • the rod 406 includes a plurality of projection members 414 that are disposed within a groove 416 of the rod 406. Each projection member 414 includes an angled top surface 418 and a first projection member and a second projection members each include a side surface 420 that extends vertically from a top surface 418.
  • the rod 406 further includes a stopping wall 422 that is also disposed within the groove 416.
  • the stopping wall 422 includes a top surface 424 and a side surface 426 that extends vertically from and perpendicular to the top surface 424.
  • the rod 406 also includes a snap-off joint 428.
  • the snap-off joint 428 serves as a break point of the plunger 400 (Fig. 31) which allows the handle 402 and the shaft 404 to sperate from a remainder of the plunger 400.
  • the plunger 400 also includes a projection 430 that extends longitudinally from the proximal end of the rod 406. The projection 430 is shaped and dimensioned to be inserted into the elastomeric ring 408.
  • the elastomeric ring 408 is shown in accordance with an exemplary embodiment.
  • the elastomeric ring 408 is generally cylindrical in shape and includes a first end surface 432, an opposed second end surface 434, and an outer wall 436.
  • the outer wall 436 extends longitudinally between the first end surface 432 and the second end surface 434.
  • the elastomeric ring 408 also includes a bore 438 that extends from the second end surface 434 and into the elastomeric ring 408.
  • the outer wall 436 includes an outer surface 436a and an inner surface 436b.
  • the inner surface 436b defines a length of the bore 438 and further defines an inner volume 440 that is in open communication with the bore 438.
  • the bore 438 and the inner volume 440 is shaped and dimensioned to accept the projection 430. That is, when the projection 430 is inserted into the elastomeric ring 408, the projection 430 is disposed within the bore 438 and the inner volume 440.
  • the elastomeric ring 408 further includes a first and second band 442 that extend vertically from and perpendicular to the outer surface 436a.
  • the bands 442 extend circumferentially around the outer wall 436. As will be discussed in further detail herein, when the plunger 400 is inserted into the vial assembly 500, the bands 442 provide an airtight seal within the vial assembly 500.
  • the vial assembly 500 is shown in accordance with an exemplary embodiment.
  • the vial assembly 500 includes a vial 502, an elastomeric cap 504, and a stopping member 506.
  • the vial 502 is formed of PDMS such that the vial 502 is transparent.
  • the elastomeric cap 504 is formed of a self-healing material.
  • the vial 502 includes a top wall 508 and a side wall 510 that extends vertically from and perpendicular to the top wall 508.
  • the top wall 508 and the side wall 510 are generally cylindrical in shape and are concentric with one another.
  • the top wall 508 includes a top surface 508a, an opposed bottom surface 508b, and a side surface 508c that extends between the top surface 508a and the bottom surface 508b.
  • the side surface 508c extends longitudinally from and perpendicular to the top surface 508a and the bottom surface 508b.
  • Opposing sides of the top wall 508 extend beyond the side wall 510 such that the top wall 508 includes flanges 512.
  • the flanges 512 prevent the vial assembly 500 from moving from one position to another position until the vial assembly 500 is rotated.
  • the top surface 508a of the top wall 508 defines an opening 514 that is shaped and dimensioned to accept a portion of the elastomeric cap 504.
  • the side wall 510 includes an outer surface 510a, an opposed inner surface 510b, and the bottom surface 510c.
  • the outer surface 510a and the inner surface 510b extend vertically from and perpendicular to the bottom surface 508b of the top wall 508 and the bottom surface 510c.
  • the vial 502 further includes a notch 522 that extends vertically from the bottom surface 510c and extends between the outer surface 510a and the inner surface 510b.
  • the notch 522 is shaped and dimensioned to accept a distal portion of the stopping member 506.
  • the notch 520 and the notch 522 are aligned with one another such that the notches 520 and 522 retain the stopping member 506 when the stopping member 506 is coupled to the vial 502.
  • the bottom surface 510c of the side wall 510 defines an opening 524 that is shaped and dimensioned to accept the elastomeric ring 408 and a portion of the plunger 400.
  • the inner surface 510b defines a bore 526 that extends between the opening 514 and the opening 524. When the plunger 400 is disposed within the bore 526 the bands 442 contact the inner surface 510b of the side wall 510.
  • the vial 502 further includes a plurality of ribs 528a-528e that extend from and along the outer surface 510a of the side wall 510.
  • the ribs 528a-528c have the same length.
  • the ribs 528d and 528e have a shorter length than the ribs 528a-258c.
  • at least two of the ribs 528 prevent the vial assembly 500 from rotating beyond a given position.
  • the elastomeric cap 504 includes a top wall 530 and a side wall 532 that extends vertically from the top wall 530.
  • the top wall 530 includes a top surface 530a, an opposed bottom surface 530b, and a side surface 530c that extends between the top surface 530a and the bottom surface 530b.
  • the side wall 532 includes an outer surface 532a, an opposed inner surface 532b, and a bottom surface 532c that extends longitudinally from and perpendicular to the outer surface 532a and the inner surface 532b.
  • the outer surface 532a and the inner surface 532b extends vertically from the bottom surface 530b of the top wall 530 and the bottom surface 532c.
  • the top wall 530 is shaped and dimensioned to fit between the first cap retention member 516 and the second cap retention member 518 such that the first cap retention member 516 and the second cap retention member 518 couple the elastomeric cap 504 to the vial 502.
  • the side wall 532 extends into the bore 526 such that the outer surface 532a of the side wall 532 contacts the inner surface 510b of the side wall 510 of the vial 502.
  • the elastomeric ring 408 of the plunger 400 and the elastomeric cap 504 when both the elastomeric ring 408 of the plunger 400 and the elastomeric cap 504 are disposed within the bore 526, the elastomeric ring 408 and the elastomeric cap 504 provide an airtight seal. As such, the region of the bore 526 between the elastomeric ring 408 and the elastomeric cap 504 includes an airtight environment.
  • the top surface 530a of the top wall 530 defines a top recess 534 and the inner surface 532b of the side wall 532 defines a bottom recess 536 such that the elastomeric cap 504 includes a region of elastomeric material between the recesses 534 and 536.
  • the needle 330 extends through the region of the elastomeric cap 504 between the recesses 534 and 536 and into the bore 526 of the vial 502.
  • the top wall 530 also includes a notch 538 that extends between the top surface 530a and the bottom surface 530b.
  • the notch 538 is shaped and dimensioned to accept a proximal end of the stopping member 506 such that the notch 538 retains a portion of the stopping member 506 when the stopping member 506 is coupled to the vial 502.
  • the stopping member 506 includes a plunger interface 540, a neck 542, and a hook 544.
  • the plunger interface 540 defines a distal end and a proximal end of the stopping member 506 and the neck 542 extends between the plunger interface 540 and the hook 544.
  • the plunger interface 540 includes a distal end surface 546, a bottom surface 548, and a proximal end surface 550.
  • the bottom surface 548 extends between the distal end surface 546 and the proximal end surface 550.
  • the distal end surface 546 is positioned opposite to the proximal end surface 550.
  • the bottom surface 548 has a similar shape and dimension as the top surface 418 of a projection member 414.
  • the plunger interface 540 and the neck 542 define a notch 552.
  • the plunger interface 540 is disposed within the notch 522 of the 502.
  • the notch 522 contacts a portion of the side wall 510 that defines an end of the notch 522. As such, in this position, the notch 522 retains the stopping member 506.
  • the neck 542 has a length that is similar to a distance between the notch 522 and the top surface 508a of the vial 502. As such, when the stopping member 506 is coupled to the vial 502, a portion of the neck 542 extends through the notch 520 of the first cap retention member 516 and the hook 544 extends over and contacts the top surface 508a to couple the stopping member 506 to the vial 502.
  • the lancet 100 is moveable between an undeployed position (Fig. 56), a deployed position (Fig. 57), and a retracted position (Fig. 58).
  • the injection spring 112 and the retraction spring 114 are in a compressed state.
  • the retraction spring 114 extends vertically between the bottom wall 138 (Fig. 56) and a proximal end of the locking members 146. More specifically, a distal end of the retraction spring 114 contacts a lower surface of the proximal end of the locking members 146 and a proximal end of the retraction spring 114 contacts the inner surface 138b (Fig. 56) of the bottom wall 138.
  • the outer surface 144c contacts the inner surface 126a of the columns 126 which compresses the side wall 136 inwardly. Furthermore, the bottom surface 154a of the second cylinder 154 contacts and rests upon the top surfaces 144a of the ledges 144 (Fig. 56) such that the ledges 144 support the needle frame 108 in the undeployed position. In this position, the injection spring 112 is prevented from decompressing (due to the second cylinder 154 (Fig. 56) resting upon the ledges 144) and the needle 110 is disposed completely within the inner volume 140 (Fig. 56) of the inner sleeve 106.
  • the engagement of the lancet with the cartridge 12 causes the lancet 100 to automatically move from the undeployed position to the deployed position. Furthermore, when the lancet 100 is inserted into the cartridge 12, the hooks 324 of the locking members 322 are disposed within and coupled to the notch 122 via a snap fit (Fig. 59).
  • the inner circular projection 320 (Figs. 59 and 60) extends through the aperture 128 to contact the bottom wall 138.
  • the top surface 320c of the inner circular projection 329 (Figs. 59 and 60) contacts the outer surface 138a of the bottom wall 138 (Figs. 59 and 60) which forces the inner sleeve 106 to move vertically upward in the direction of arrow A (Fig. 57) within the housing 102.
  • This vertical movement causes the ledges 144 to extend vertically above the top surfaces 126b of the columns 126.
  • the expansion of the side wall 136 causes the inner volume 140 of the inner sleeve 106 to have a larger width relative to when the inner sleeve 106 is in the undeployed position such that at least a portion of the side wall 136 has a larger width than the second cylinder 154 (the widest portion of the needle frame 108 which allows the needle frame 108 to move vertically downward in the direction of arrow C).
  • the injection spring 112 also causes the needle frame 108 to move in the direction of arrow C as the ledges 144 no longer prevent the injection spring 112 from expanding.
  • the force applied by the injection spring 112 causes the needle frame 108 (and therefore the needle 110) to travel with a force that is sufficient to cause the needle 110 to puncture the skin of a subject wearing the dermal patch system 10.
  • the injection spring 112 causes the needle 110 to extend through the aperture 150 of the inner sleeve 106, through the aperture 128 of the housing 102, and through the needle aperture 314 of the base 300 to puncture the skin of a subject.
  • the bottom surface 154a of the second cylinder 154 rests upon the columns 142 and at least a portion of the outer surface 154b of the second cylinder 154 contacts the inner surface 136b of the side wall 136.
  • the outer surface 152b contacts the locking members 146 which causes a proximal portion of locking members 146 that is aligned with an opening 148 to extend into the opening. In this position, the locking members 146 no longer contact the retraction spring 114 thereby allowing the retraction spring 114 to decompress and expand. When decompressed, the retraction spring 114 contacts the outer surface 152b of the first cylinder 152 which causes needle frame 108 to also move in the direction of arrow D.
  • the retraction spring 114 causes the needle 110 to retract back into the inner volume 140 of the inner sleeve 106 via the needle aperture 314 of the base 300 and the apertures 128 and 150 of the lancet 100. After penetrating the skin of a subject, the retraction spring 114 causes the needle 110 to automatically retract back into the housing of the lancet 100 thereby placing the lancet 100 in the retraced position (Figs. 58 and 60).
  • the needle 110 retracts into the lancet 100 and a physiological sample pools within the physiological sample well 326 of the base 300.
  • a user pulls the plunger 400 in the direction of arrow E to move the plunger from a first position (Fig. 61) to a second position (Fig. 62).
  • a user moves the plunger 400 from an undeployed position to a deployed position. Moving the plunger from the undeployed position to the deployed position creates a vacuum within the vial 502. This vacuum causes the physiological sample to travel to the vial 502 via the needle 330.
  • a flange 512 of the vial 502 contacts a proximal surface of the protrusion 346 of the base 300 and another flange 512 of the vial 502 contacts a proximal surface of the locking wall 218 of the cover 200.
  • This contact prevents the vial assembly 500 from moving with the plunger 400 when a user pulls the plunger 400.
  • the user may verify that the physiological sample has been drawn by viewing the physiological sample in the vial 502 via the vial viewing aperture 208.
  • the plunger interface 540 of the stopping member 506 contacts various projection members 414 until the plunger interface 540 contacts the top surface 424 and the side surface 426 of the stopping wall 422. In this position, the plunger 400 cannot be pulled further as the flanges 512, the locking wall 218 of the cover 200, and the protrusion 346 of the base 300 prevent further movement of the plunger 400.
  • the amount the plunger moves can determine the strength of the generated vacuum and an amount of physiological sample drawn into the vial 502.
  • the inner diameter of the needle 330 can be varied between approximately 0.159 mm to 0.603 mm to control an amount of physiological sample drawn into the vial 502.
  • the shape of the projection members 414 of the plunger 400 and the shape of the plunger interface 540 of the stopping member 506 can prevent a user from pushing the plunger 400 into the vial 502 which may cause an inadvertent ejection of physiological sample.
  • an amount of the physiological sample drawn into the vial 502 is proportional to a distance travel by plunger 400 when using the plunger to generate a vacuum. That is, the greater the distance traveled by the plunger 400 the greater an amount of physiological sample drawn into the vial 502.
  • the distance traveled by the plunger 400 can be determined by a position of the stopping member 506 and a position of the plunger interface 540. While the stopping member 506 and the plunger interface 540 are depicted in one position, in other embodiments, the stopping member 506 and the plunger interface 540 may have a different position which allows the plunger 400 to draw more or less physiological sample into the vial 502 than the embodiment depicted herein.
  • the user can rotate the vial assembly 500 by rotating plunger 400. Before rotation (i.e., when the vial assembly 500 is in the collection position), a side of the rib 528e contacts the rotational stop 222 which prevents a user from rotating the plunger 400 (and therefore the vial assembly 500) in a clockwise direction (when viewing the distal end of the plunger 400). After the user draws the physiological sample into the vial 502, the user can rotate the plunger 400 in a counterclockwise direction to place the vial assembly 500 in a second position (also referred to as a “vial removal position”) (Fig. 63).
  • the lid removal tool 600 includes a base 602 and extensions 604.
  • the base 602 includes a top wall 602a, an opposed bottom wall 602b, and a side wall 602c that extends between the top wall 602a and the bottom wall 602b.
  • the side wall 602c extends vertically between and perpendicular to the top wall 602a and the bottom wall 602b.
  • the extensions 604 extend vertically from and perpendicular to the top wall 602a.
  • the extensions 604 are shaped and dimensioned to fit into the openings 306 of the base 300.
  • the user inserts the lancet 100 into the cartridge 12 thereby causing the needle 110 of the lancet 100 to draw a physiological sample (e.g., a blood sample, a sample of interstitial fluid, etc.) from the subject as previously discussed herein.
  • a physiological sample e.g., a blood sample, a sample of interstitial fluid, etc.
  • a medical professional uses the lid removal tool 600 to remove the vial assembly 500 from the cartridge 12 and scans the QR code 18 to update an EMR as previously discussed herein.
  • the medical professional breaks the plunger and performs a test on the physiological sample as previously discussed herein.

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

Abstract

Dispositif de collecte d'un échantillon physiologique provenant d'un sujet, comprenant une lancette et une cartouche conçue pour s'accoupler à la lancette. L'aiguille est conçue pour perforer la peau du sujet. La lancette est conçue pour déployer automatiquement l'aiguille lorsqu'elle est accouplée à la lancette, ce qui permet à l'aiguille de perforer la peau du sujet et de prélever un échantillon physiologique. Le dispositif comprend en outre un flacon disposé à l'intérieur de la cartouche. Le flacon est conçu pour recevoir l'échantillon physiologique prélevé.
EP23833257.1A 2022-11-21 2023-11-21 Timbre dermique pour collecter un échantillon physiologique avec un flacon amovible Pending EP4622547A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/991,284 US12048543B2 (en) 2021-11-08 2022-11-21 Dermal patch for collecting a physiological sample with removable vial
PCT/US2023/080656 WO2024112732A1 (fr) 2022-11-21 2023-11-21 Timbre dermique pour collecter un échantillon physiologique avec un flacon amovible

Publications (1)

Publication Number Publication Date
EP4622547A1 true EP4622547A1 (fr) 2025-10-01

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ID=89428844

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23833257.1A Pending EP4622547A1 (fr) 2022-11-21 2023-11-21 Timbre dermique pour collecter un échantillon physiologique avec un flacon amovible

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EP (1) EP4622547A1 (fr)
WO (1) WO2024112732A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007050100A (ja) * 2005-08-18 2007-03-01 Rohm Co Ltd 被検体採取チップ
EP2986222B1 (fr) * 2013-04-15 2017-12-13 Becton, Dickinson and Company Dispositif de transfert d'un prélèvement de liquide biologique et système de séparation et d'analyse d'un liquide biologique
WO2014172247A1 (fr) * 2013-04-15 2014-10-23 Becton, Dickinson And Company Dispositif de transfert d'échantillon de sang
ES2796491T3 (es) * 2015-08-06 2020-11-27 Becton Dickinson Co Dispositivo de recogida de fluidos biológicos
GB2590814B (en) * 2017-01-10 2021-11-03 Drawbridge Health Inc Devices, systems, and methods for sample collection

Also Published As

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WO2024112732A1 (fr) 2024-05-30

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