WO2005035018A2 - Bouchon pour autopiqueur presentant des caracteristiques de surface actionnees par balancement - Google Patents

Bouchon pour autopiqueur presentant des caracteristiques de surface actionnees par balancement Download PDF

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Publication number
WO2005035018A2
WO2005035018A2 PCT/US2004/024407 US2004024407W WO2005035018A2 WO 2005035018 A2 WO2005035018 A2 WO 2005035018A2 US 2004024407 W US2004024407 W US 2004024407W WO 2005035018 A2 WO2005035018 A2 WO 2005035018A2
Authority
WO
WIPO (PCT)
Prior art keywords
endcap
opening
contact face
lancing device
lancing
Prior art date
Application number
PCT/US2004/024407
Other languages
English (en)
Other versions
WO2005035018A3 (fr
Inventor
Stephen Flynn
Richard W. Levaughn
Christopher J. Ruf
Gwenn E. Kennedy
Michael V. Lipoma
Juan D. Salleras
Jac Holzaepfel
Sylvia Ramos
Original Assignee
Facet Technologies, Llc
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
Application filed by Facet Technologies, Llc filed Critical Facet Technologies, Llc
Priority to EP04779455A priority Critical patent/EP1670372A4/fr
Priority to US10/572,267 priority patent/US20080195131A1/en
Publication of WO2005035018A2 publication Critical patent/WO2005035018A2/fr
Publication of WO2005035018A3 publication Critical patent/WO2005035018A3/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
    • A61B5/150053—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
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area 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
    • A61B5/150015—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
    • A61B5/150748—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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • 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
    • A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
    • 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

Definitions

  • the present invention relates generally to medical devices and procedures, and more particularly to lancing devices for sampling blood or other bodily fluids.
  • the invention more particularly relates to an end cap for use in conjunction with a lancing device that allows for the collection of an increased volume of blood or bodily fluid to be sampled.
  • a lancet having a sharp lancing tip typically is mounted, permanently or releasably, to the drive mechanism of a lancing device.
  • the drive mechanism includes one or more springs, cams, motors, or other mechanism(s) for moving the lancing tip from a retracted position shielded within a housing of the lancing device to an extended position outside of the housing for lancing the subject's skin.
  • the lancing device may also include a cocking mechanism for arming the drive mechanism, and/or a triggering mechanism for firing the device.
  • the housing of the lancing device typically includes an endcap with an opening through which the lancing tip extends in its extended position. The endcap may be releasably or permanently attached to the remainder of the housing, or can comprise an integral part of the housing.
  • the fingertips have a greater density of nerve endings than alternate lancing sites, resulting in greater pain sensation from fingertip lancing than lancing at alternate sites.
  • alternate lancing sites typically contain a lower density of capillaries or a deeper capillary bed than the fingertips, alternate lancing sites often yield insufficient sample sizes or are prone to premature closure.
  • the present invention is an endcap for a lancing device that enables collection of an increased volume of blood or other body fluid to be sampled from a lancing site of a human or animal subject.
  • the device of the present invention is suitable for use at fingertip lancing sites, but is also well suited for use at alternate lancing sites such as the forearm and/or earlobe.
  • the invention is a sampling method for increasing collected sample size of blood or other body fluid from a lancing site.
  • the present invention is an endcap for a lancing device.
  • the endcap preferably includes an opening for passage of at least a sharp tip portion of a lancet, a contact face surrounding the opening, and at least one surface feature on the contact face adjacent the opening for applying pressure to tissue surrounding a lancing site by rocking of the contact face in contact with the tissue surrounding the lancing site.
  • the invention is an endcap for a lancing device, the endcap preferably including an outwardly-curved contact face for rocking contact with tissue surrounding a lancing site, and at least one slotted opening through the outwardly-curved contact face, the slotted opening being narrower at a central portion than at extremities thereof.
  • the invention is a lancing device for collecting a sample of body fluid from a sampling site on the skin of a subject.
  • the lancing device preferably includes a lancet and a housing comprising an endcap, the lancet being movable between a first position within the housing and a second position wherein at least a sharp tip portion of the lancet extends through an opening in the endcap.
  • the endcap preferably includes a contact face surrounding the opening and at least one surface feature on the contact face adjacent the opening for applying pressure to tissue surrounding the sampling site by rocking of the contact face in contact therewith.
  • the invention is a lancing device for collecting a sample of body fluid from a sampling site on the skin of a subject.
  • the lancing device preferably includes a lancet and a housing comprising an endcap, the lancet being movable between a first position within the housing and a second position wherein at least a sharp tip portion of the lancet extends through an opening in the endcap.
  • the endcap preferably includes an outwardly-curved contact face for rocking contact with tissue surrounding the sampling site, and at least one slotted opening through the outwardly-curved contact face.
  • the invention is a method of collecting a sample of blood or other body fluid, the method preferably including the steps of lancing the skin of a subject at a lancing site with a lancing device having a contact face including one or more surface contour features surrounding an opening; and rocking the lancing device with the contact face in contact with the skin surrounding the lancing site.
  • FIGURE 1 shows a perspective view of an endcap for a lancing device according to one example embodiment of the present invention.
  • FIGURES 2a and 2b show a perspective view and a side view, respectively, of an endcap for a lancing device according to another example embodiment of the present invention.
  • FIGURES 3a and 3B show a perspective view and a side view, respectively, of an endcap for a lancing device according to yet another example embodiment of the present invention.
  • FIGURE 4 shows a perspective view of an endcap for a lancing device according to another example embodiment of the present invention.
  • FIGURE 5 shows a perspective view of an endcap for a lancing device according to still another example embodiment of the present invention
  • FIGURE 6 shows a perspective view of an endcap for a lancing device according to another example embodiment of the present invention.
  • Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values . are expressed as approximations, by use of the antecedent "about,” it will be understood that the particular value forms another embodiment.
  • Figure 1 shows one example embodiment of an endcap 10 for a lancing device according to the present invention.
  • the endcap 10 preferably comprises a first end 12 for releasable or permanent attachment to the remainder of a housing of a lancing device.
  • the endcap forms an integral part of the housing of the lancing device.
  • the endcap 10 can be adapted for use with any of a variety of standard, commercially-available or later-developed lancing devices, by appropriate configuration of coupling or attachment features of the first end 12.
  • the second end 14 of the endcap 10 preferably defines the opening 16 through which the sharp lancet tip projects in its extended position to penetrate the skin at the intended lancing site.
  • the opening 16 is a slot extending substantially across the second end 14 of the endcap 10.
  • the opening has a circular, triangular, rectangular, polygonal or other shape.
  • the second end 14 of the endcap 10 preferably comprises an outwardly curved or convex contact face 20, with one or more raised surface features formed thereon.
  • the surface features comprise a raised rim 22 surrounding the slotted opening 16, and a raised side projection 24 extending laterally outward from the contact face 20 along the central portion of both sides of the slot 16.
  • the outer surfaces of the rim 22 and the projection 24 are preferably outwardly radiused to generally match the outwardly curved or convex contour of the contact face 20.
  • the user after firing the lancing device, the user leaves the contact face of the endcap in contact with the skin around the lancing site, and rocks the lancing device, preferably in the plane of the slotted opening and raised rim.
  • the outwardly curved or convex curvature of the contact face facilitates and guides this rocking motion.
  • the device is preferably initially placed with its contact face in contact with the skin at the lancing site and held generally perpendicular to the skin surface during lancing, and then is rocked back and forth in contact with the skin in at least one plane of motion, wherein that plane of motion intersects a lengthwise axis of the overall lancing device and the center of the endcap's lancet opening.
  • the endcap's lancet opening and/or the raised surface feature(s) on the endcap's contact face are preferably generally symmetric along either side of this plane of motion, and the endcap's contact face is curved along this plane of motion, whereby rocking of the lancing device in the plane of motion applies pressure symmetrically about the lancing site.
  • the endcap embodiment of Fig. 1 is rocked in a plane of motion containing the lengthwise axis of the slotted opening 16
  • the raised rim 22 and the central projection 24 will apply alternating pressure around the puncture site, directing subcutaneous fluid toward the puncture site and helping prevent premature closure of the puncture site, thereby enhancing collection of increased volume of blood or other body fluid to be sampled.
  • Figures 2a and 2b show an endcap 30 for a lancing device according to another embodiment of the present invention.
  • the contact face 32 of this endcap defines a generally circular central opening 34 for allowing passage of the sharp lancet tip.
  • Contact ribs 36 are preferably provided, extending across the contact face 32 along either side of the opening 34.
  • the distal faces of the contact ribs 36 are preferably convexly curved to facilitate and guide rocking of the lancing device in contact with the skin in a similar fashion to that described above.
  • the inner edges of the contact ribs 36 are preferably curved or angled to define a central channel 38 that is wider at its center, around the opening 34, than at its outer edges along the periphery of the endcap.
  • the contours of the contact face 32 and the contact ribs 36 preferably direct subcutaneous fluid toward the puncture site and help prevent premature closure of the puncture site, as the device is rocked back and forth, preferably in a plane of motion extending through the center of the opening and central channel, thereby enhancing collection of increased volume of blood or other body fluid to be sampled.
  • Figures 3a and 3b show an endcap 50 for a lancing device according to yet another embodiment of the present invention.
  • the contact face 52 of this endcap defines a generally circular central opening 54 for passing the sharp lancet tip.
  • the contact face 52 preferably comprises a plurality of alternating raised lobes 56 and depressions 58, forming a continuous, undulating or wave-like surface surrounding the opening 54.
  • the user toggles, rocks and/or twists the lancing device with the contact face 52 in contact with the skin around the lancing site.
  • the undulating contour of the contact face generates alternating tension and compression of the skin surrounding the lancing site, directing subcutaneous fluid toward the lancing site and helping prevent premature closure of the lancing site, thereby enhancing sample collection.
  • FIG 4 shows an endcap 70 for a lancing device according to another embodiment of the present invention.
  • the contact face 72 of this endcap defines a generally circular central opening 74 for passing the sharp lancet tip.
  • the contact face 72 preferably comprises a pair of contact ribs 76, extending across the contact face 72 along either side of the opening 74.
  • the distal faces of the contact ribs 76 are preferably convexly curved to facilitate and guide rocking of the lancing device in contact with the skin in a similar fashion to that described above.
  • the inner edges of the contact ribs 76 are preferably curved or angled to define a central channel 78 that is narrower at its center, around the opening 74, than at its outer edges along the periphery of the endcap.
  • FIG. 5 shows an endcap 90 for a lancing device according to still another embodiment of the present invention.
  • This endcap includes a convex contact face 92 and a slotted opening 94 extending across at least a portion of the width of the contact face.
  • One or more raised ribs or projections 96 are preferably provided, extending across at least a portion of the contact face 92, generally transversely or obliquely oriented relative to the lengthwise dimension of the slot 94.
  • two raised ribs extend transversely across the slot 94, each rib having a first segment on one side of the slot and a second segment on the other side of the slot.
  • FIG. 6 shows an endcap 110 for a lancing device according to another embodiment of the present invention.
  • This endcap includes a convex contact face 112 and a cross-shaped opening 114 formed in the contact face.
  • the opening 114 is formed by two or more slots intersecting at or near the center of their lengthwise dimensions, each slot being narrower at its central region than at its extremities.
  • the lancing device is toggled or rocked after lancing, preferably in the plane of one or more of the intersecting slots forming the opening 114, subcutaneous fluid is directed and squeezed toward the central intersection of the slots of the opening.
  • the inwardly-extending lobes 116 between the intersecting slots of the cross- shaped opening 114 can serve as a mechanical stop for the lancet, to limit the path of travel of the lancet at its extended position.

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

Abstract

L'invention porte sur un bouchon pour un autopiqueur, pourvu d'une face de contact définissant une ouverture, cette face de contact comprenant une ou plusieurs caractéristiques de contour de surface afin d'orienter le liquide organique vers l'ouverture lors du balancement de l'autopiqueur, la face de contact étant en contact avec la peau qui entoure le site autopiqueur.
PCT/US2004/024407 2003-09-18 2004-07-28 Bouchon pour autopiqueur presentant des caracteristiques de surface actionnees par balancement WO2005035018A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP04779455A EP1670372A4 (fr) 2003-09-18 2004-07-28 Bouchon pour autopiqueur presentant des caracteristiques de surface actionnees par balancement
US10/572,267 US20080195131A1 (en) 2004-07-28 2004-07-28 Lancing Device End Cap With Rocking-Actuated Surface Features

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50378603P 2003-09-18 2003-09-18
US60/503,786 2003-09-18

Publications (2)

Publication Number Publication Date
WO2005035018A2 true WO2005035018A2 (fr) 2005-04-21
WO2005035018A3 WO2005035018A3 (fr) 2005-08-11

Family

ID=34434863

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/024407 WO2005035018A2 (fr) 2003-09-18 2004-07-28 Bouchon pour autopiqueur presentant des caracteristiques de surface actionnees par balancement

Country Status (2)

Country Link
EP (1) EP1670372A4 (fr)
WO (1) WO2005035018A2 (fr)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9724034B2 (en) 2009-11-09 2017-08-08 Owen Mumford Limited Skin stimulus
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member

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US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7547287B2 (en) 2002-04-19 2009-06-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8282576B2 (en) 2003-09-29 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
EP2265324B1 (fr) 2008-04-11 2015-01-28 Sanofi-Aventis Deutschland GmbH Système intégré de mesure d'analytes
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device

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US20020188223A1 (en) * 2001-06-08 2002-12-12 Edward Perez Devices and methods for the expression of bodily fluids from an incision
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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9802007B2 (en) 2001-06-12 2017-10-31 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9724034B2 (en) 2009-11-09 2017-08-08 Owen Mumford Limited Skin stimulus
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation

Also Published As

Publication number Publication date
WO2005035018A3 (fr) 2005-08-11
EP1670372A2 (fr) 2006-06-21
EP1670372A4 (fr) 2010-03-24

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