WO2005034741A1 - Coiffe terminale d'autopiqueur comprenant des machoires venant en prise avec la peau - Google Patents

Coiffe terminale d'autopiqueur comprenant des machoires venant en prise avec la peau Download PDF

Info

Publication number
WO2005034741A1
WO2005034741A1 PCT/US2004/024393 US2004024393W WO2005034741A1 WO 2005034741 A1 WO2005034741 A1 WO 2005034741A1 US 2004024393 W US2004024393 W US 2004024393W WO 2005034741 A1 WO2005034741 A1 WO 2005034741A1
Authority
WO
WIPO (PCT)
Prior art keywords
endcap
lancing device
jaws
slot
contact face
Prior art date
Application number
PCT/US2004/024393
Other languages
English (en)
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
Publication of WO2005034741A1 publication Critical patent/WO2005034741A1/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
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades

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 sampling sites, resulting in greater pain sensation from fingertip lancing than lancing at alternate sites.
  • alternate sampling sites typically contain a lower density of capillaries or a deeper capillary bed than the fingertips, alternate sampling sites often yield insufficient
  • 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 sampling site of a human or animal subject.
  • the device of the present invention is suitable for use at fingertip sampling sites, but is also well suited for use at alternate sampling 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 sampling site.
  • the present invention is an endcap for a lancing device.
  • the endcap preferably has a first end for connection to the lancing device and a second end including an opening for passage of a sharp tip portion of a lancet.
  • the endcap preferably further includes a contact face around the opening and a slot extending through the contact face, the slot separating at least the second end of the endcap into an opposed pair of jaws.
  • 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 the endcap.
  • the endcap preferably has first and second opposed jaws movable between an unbiased position wherein the jaws are spaced a distance apart from one another, and a biased position wherein the jaws are squeezed toward one another.
  • the invention is a method of lancing skin to collect a fluid sample, the method preferably including the steps of placing a contact face of a lancing device against a subject's skin at a sampling site, the contact face having first and second portions separated by a slot; lancing the skin at the sampling site; and pinching the first and second portions of the contact face toward one another to compress the skin at the sampling site.
  • FIGURE 1 shows a perspective view of an endcap for a lancing device according to an example embodiment of the present invention.
  • FIGURE 2 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.
  • FIG. 1 and 2 show two example embodiments of endcaps 10 (corresponding reference numbers are indicated with primes in Fig. 2) 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. Alternatively, 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 appropriate configuration of coupling or attachment features of the first end 12.
  • the second end 14 of the endcap 10 preferably defines an opening 16 through which the sharp lancet tip projects in its extended position to penetrate the skin at the intended sampling site.
  • the endcap is preferably formed of an engineering or medical-grade polymer, plastic, or other material.
  • a slot 20 preferably extends across the contact face 22 of the second end 14 of the endcap, preferably through the center of the opening 16, and through at least a portion of the length of the endcap body along opposite sidewall portions thereof.
  • the slot 20 separates the second end 14 of the endcap into opposed first and second jaws 30a, 30b.
  • the slot 20 does not extend through the entire length of the endcap 10, so that a base portion proximal the first end 12 of the endcap joins the first and second jaws 30a, 30b and allows the jaws to be pinched together at their free ends and resiliently return to their separated positions when released.
  • the width of the slot 20 in the contact face 22 is preferably at least about 1 mm, to permit passage of the sharp lancet tip and to capture an amount of tissue between the jaws sufficient to stimulate a desired amount of blood-flow toward the sampling site when pinched together.
  • the width of the slot 20 is preferably no more than about 4 to 5 mm, to prevent a standard lancet body from passing completely therethrough and being discharged from the lancing device or becoming stuck in the opening 16. More preferably, the width of the slot 20 is between about 2 mm and about 3 mm.
  • the width of the slot 20 is preferably between about 10% to about 25%, and more preferably about 15%, of the overall diameter or outside dimension of the contact face 22.
  • the contact face 22 optionally includes one or more surface features, such as a raised contact ring 40, one or more ribs or protuberances, recesses, or the like, for increasing the surface area of contact with the skin around the sampling site and/or stimulating blood-flow to the sampling site.
  • flats 50 are formed along the sides of the endcap body, on each jaw 30a, 30b opposite the slot 20, fH ⁇ lGILf S ⁇ .gi?J nc ?h .the Jaws. together. Injhe ⁇ rpbodiment of
  • the sides of the endcap body are ribbed or knurled to provide a gripping surface 60' on each jaw 30a', 30b' opposite the slot 20'.
  • the contact face 22 is placed against the skin around the sampling site, the device is triggered to lance the skin at the sampling site, and the user alternately squeezes the jaws 30a, 30b together and releases the jaws to spring back apart under the bias of the endcap material's internal resiliency. This squeezing and releasing can be repeated as necessary until the desired sample size is expressed from the sampling site wound.
  • a steady light pressure and/or a twisting, rocking and/or toggling motion is applied to the lancing device against the skin around the sampling site.

Landscapes

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

Abstract

L'invention concerne une coiffe terminale (10) destinée à un autopiqueur et comprenant une surface de contact (22) à mettre en contact avec la peau entourant un site d'échantillonnage, ainsi qu'une fente (20) ménagée à travers la surface de contact (22), afin de former une paire opposée de mâchoires (30a,b) pouvant être pincées en direction l'une de l'autre et se séparant de manière élastique quand elles sont libérées, lesquelles pincent et mettent sous tension le tissu autour du site d'échantillonnage de façon alternée, de manière à améliorer le recueil d'un échantillon et à empêcher une fermeture prématurée de la blessure.
PCT/US2004/024393 2003-09-18 2004-07-28 Coiffe terminale d'autopiqueur comprenant des machoires venant en prise avec la peau WO2005034741A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US50391003P 2003-09-18 2003-09-18
US60/503,910 2003-09-18

Publications (1)

Publication Number Publication Date
WO2005034741A1 true WO2005034741A1 (fr) 2005-04-21

Family

ID=34434868

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/024393 WO2005034741A1 (fr) 2003-09-18 2004-07-28 Coiffe terminale d'autopiqueur comprenant des machoires venant en prise avec la peau

Country Status (1)

Country Link
WO (1) WO2005034741A1 (fr)

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US8945910B2 (en) 2003-09-29 2015-02-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
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
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9089678B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
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
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
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
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

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4620549A (en) * 1985-01-25 1986-11-04 Becton, Dickinson And Company Blood collection assembly
US6045567A (en) * 1999-02-23 2000-04-04 Lifescan Inc. Lancing device causing reduced pain
US6283982B1 (en) * 1999-10-19 2001-09-04 Facet Technologies, Inc. Lancing device and method of sample collection
US6451040B1 (en) * 2000-09-01 2002-09-17 Bayer Corporation Adjustable endcap for lancing device
US6464649B1 (en) * 1997-11-21 2002-10-15 Amira Medical Body fluid sampling device
US20020151920A1 (en) * 1999-12-08 2002-10-17 Jeremy Marshall Integration of a lancette with its capturing and removing cap
US6752817B2 (en) * 2001-03-26 2004-06-22 Bayer Corporation Split pressure ring for lancing device and method of operation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4620549A (en) * 1985-01-25 1986-11-04 Becton, Dickinson And Company Blood collection assembly
US6464649B1 (en) * 1997-11-21 2002-10-15 Amira Medical Body fluid sampling device
US6045567A (en) * 1999-02-23 2000-04-04 Lifescan Inc. Lancing device causing reduced pain
US6283982B1 (en) * 1999-10-19 2001-09-04 Facet Technologies, Inc. Lancing device and method of sample collection
US20020151920A1 (en) * 1999-12-08 2002-10-17 Jeremy Marshall Integration of a lancette with its capturing and removing cap
US6451040B1 (en) * 2000-09-01 2002-09-17 Bayer Corporation Adjustable endcap for lancing device
US6752817B2 (en) * 2001-03-26 2004-06-22 Bayer Corporation Split pressure ring for lancing device and method of operation

Cited By (30)

* 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
US8845550B2 (en) 2001-06-12 2014-09-30 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
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9072842B2 (en) 2002-04-19 2015-07-07 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
US9089678B2 (en) 2002-04-19 2015-07-28 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
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US8690796B2 (en) 2002-04-19 2014-04-08 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
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method 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
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US8945910B2 (en) 2003-09-29 2015-02-03 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
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
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
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
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation

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