CA2715443A1 - Lancer - Google Patents

Lancer Download PDF

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Publication number
CA2715443A1
CA2715443A1 CA2715443A CA2715443A CA2715443A1 CA 2715443 A1 CA2715443 A1 CA 2715443A1 CA 2715443 A CA2715443 A CA 2715443A CA 2715443 A CA2715443 A CA 2715443A CA 2715443 A1 CA2715443 A1 CA 2715443A1
Authority
CA
Canada
Prior art keywords
guide member
lancet
body assembly
disposed
distal
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.)
Granted
Application number
CA2715443A
Other languages
French (fr)
Other versions
CA2715443C (en
Inventor
Todd M. Chelak
Jonathan B. Gabel
Robert E. West
Michael A. Di Biasi
Amir Ali Sharifi-Mehr
William J. Allen
Alan Bachman
Scott Reed
Ray Adams
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.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
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 Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of CA2715443A1 publication Critical patent/CA2715443A1/en
Application granted granted Critical
Publication of CA2715443C publication Critical patent/CA2715443C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/14Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405Devices for taking blood samples
    • A61B5/1411Devices for taking blood samples by percutaneous method, e.g. by lancet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150106Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • A61B5/15019Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/150587Joining techniques used for protective means by friction fit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15117Driving 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/15192Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Landscapes

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

Abstract

A lancer device that enables a user to draw blood from a patient and discard the used lancet without touching it. The device also has an adjustable tip for selecting the depth of stylet penetration into the patient and a triggering mechanism that utilizes a yoke latch and a leaf spring to discharge the lancet. The lancer also has a dampening feature to reduce vibrations when the lancet is moving.

Claims (33)

1. An adjustment assembly, attachable to a lancer body assembly, comprising:
an outer member, having a distal portion and a proximal portion, the distal portion having an exterior surface and an interior surface and an orifice; and an inner member, having a distal portion and a proximal portion, the distal portion having an interior surface and an exterior surface;
wherein the inner member is positioned relative to the outer member such that when the outer member is rotated, the inner member moves relative to the body assembly, thereby adjusting the distance between the inner member exterior surface, and outer member interior surface.
2. The apparatus according to Claim 1, wherein the outer member is prevented from substantial axial motion, relative to the body assembly.
3. The apparatus according to Claim 2, wherein the outer member comprises an adjustment member that rotates relative to the body assembly.
4. The apparatus according to Claim 3, wherein the inner member further comprises at least one protrusion, disposed on the exterior surface, for engaging a portion of the adjustment member to maintain an axial position of the inner member.
5. The apparatus according to Claim 1, wherein the outer member has one or more slots in the interior surface, the inner member has one or more protrusions, for interacting with the one or more slots of the outer member, for restricting rotation of the inner member and providing linear movement of the inner member.
6. The apparatus according to Claim 1, wherein the adjustment assembly further comprises markings for indicating the relative positions of inner member and outer member.
7. The apparatus according to Claim 1, further comprising an aperture for exposing a depth setting.
8. The apparatus according to Claim 7, further comprising a covering mounted on the aperture.
9. An apparatus for propelling a lancet, comprising:
a body assembly, having a proximal portion, distal portion, and an orifice disposed at the distal portion;
a guide member, disposed in the body assembly, for guiding the propelled lancet; and an ejection mechanism, disposed in the body assembly, for preventing retraction of the lancet relative to the body assembly when the guide member is retracted to a second position, which is proximal to an arming position, thereby releasing the lancet from the guide member.
10. The apparatus according to Claim 9, further comprising:
a cap connected to the body assembly and detachable therefrom; and an arming mechanism for retracting the guide member to a first position when arming the apparatus and to the second position when the cap has been detached from the body assembly.
11. The apparatus according to Claim 9, wherein the ejection mechanism further comprises:
an ejection spring, disposed around the guide member, for compressing upon retraction of the guide member to the second position; and an ejection element, disposed in the body assembly, for interfacing with the lancet and preventing retraction of the lancet when the guide member is retracted to the second position.
12. The apparatus according to Claim 10, further comprising a sleeve member, disposed in the body assembly, interacting with the ejection mechanism and for moving axially relative to the body.
13. The apparatus according to Claim 10, wherein the guide member further comprises at least one spline for preventing rotation of the guide member.
14. An apparatus for actuating a lancet, comprising:
guidance means, disposed in the apparatus for guiding the lancet;
actuating means for actuating the guidance means, the actuating means having a substantially U-shape, having at least one notch, the actuating means engaging the guidance means when the guidance means is retracted, and releasing the guidance means therefrom when actuated.
15. An apparatus for propelling a lancet, comprising:
a body assembly, having a proximal portion, a distal portion, and an orifice disposed at the distal portion;
a guide member, disposed in the body assembly, for guiding the propelled lancet;
a latch, disposed in the body assembly, for retaining the guide member in a retracted position and for actuating the retracted guide member; and means for dampening vibration of the guide member when the guide member is in a state of motion.
16. The apparatus according to Claim 15, wherein the means for dampening creates a frictional force between the guide member and the body assembly.
17. The apparatus according to Claim 15, wherein the means for dampening vibration is mounted on the guide member, for engaging an inner surface of the body assembly.
18. An apparatus for propelling a lancet, comprising:
a body assembly, having a proximal portion, a distal portion, and an orifice disposed at the distal portion;
a guide member, disposed in the body assembly, for guiding the lancet;

a latch, disposed in the body assembly, having at least one notch for engaging the guide member when the guide member is retracted;
wherein actuation of the latch causes the guide member to disengage from the notch and propel the lancet toward the orifice at the distal portion of the body section;

a cap, connected to the body assembly and detachable therefrom, having an outer member and an inner member;

the outer member, having distal portion and a proximal portion, the distal portion having an exterior surface and an interior surface and an orifice; and the inner member, having a distal portion and a proximal portion, the distal portion having an interior surface and an exterior surface and an orifice;

wherein the inner member is positioned relative to the outer member such that when the outer member is rotated, the inner member moves relative to the body assembly, thereby adjusting the distance between the inner member exterior surface and the outer member interior surface;
an arming mechanism for retracting the guide member to a first position when arming the apparatus and to a second position when the cap has been detached from the body assembly;

an ejection mechanism, disposed in the body assembly, for preventing retraction of the lancet when the guide member is retracted to the second position, thereby releasing the lancet from the guide member; and means for vibration dampening, disposed in the apparatus, for reducing a vibrating of the guide member when it is actuated.
19. An apparatus for propelling a lancet, comprising:

a body assembly, having a proximal portion, a distal portion, and an orifice disposed at the distal portion;

a guide member, disposed in the body assembly, for guiding the propelled lancet;
a latch, disposed in the housing assembly, having at least one notch for engaging the guide member when the guide member is retracted;

wherein actuation of the latch causes the guide member to disengage from the notch and propel the lancet toward the orifice at the distal portion of the body assembly; and a retention mechanism, disposed in parallel with the longitudinal axis of the apparatus, for abutting a portion of the guide member and thereby preventing axial motion of the lancet.
20. The apparatus according to Claim 19, wherein the retention mechanism comprises one or more elongated members for abutting a portion of the latch when the guide member has been actuated.
21. A method for ejecting a lancet from a device, having a body assembly, and a guide member comprising the steps of:

loading the lancet onto a wide member;
retracting the guide member proximally to a first position;

actuating the guide member to propel the lancet;
retracting the guide member proximally to a second position, the second position being beyond the first position in the proximal direction;
exerting a force, in the distal direction, on the lancet sufficient to detach the lancet from the guide member.
22. The method according to Claim 21, further comprising detaching a cap portion from the device, thereby facilitating retraction of the guide member to the second position.
23. An apparatus for propelling a lancet, comprising:
a body assembly, having a proximal portion, a distal portion, and an orifice disposed at the distal portion;
a guide member, disposed in the body assembly, for guiding the propelled lancet;
means for reducing radial instability of the guide member while the guide member is propelling the lancet.
24. The apparatus according to Claim 23, wherein the means for reducing radial instability compromises:
one or more surfaces disposed on the guide member; and one or more surfaces of the body assembly for interfacing with the one or more surface disposed on the guide member.
25. The apparatus according to Claim 24, wherein the means for reducing radial instability of the guide member is selected from the group consisting of one or more disks, one or more wisps, one or more cantilevered beams, and one or more pegs.
26. A lancet apparatus comprising:
a base member; and a stylet, mounted on the base member, having a sharpened surface and a 31 gauge outer diameter.
27. A lancet apparatus comprising:
a base member; and a stylet mounted on the base member, having a sharpened portion and an outer diameter of approximately 32 gauge.
28. A lancet apparatus comprising:
a base member; and a stylet mounted on the base member, having a sharpened portion and an outer diameter of approximately 33 gauge.
29. An adjustment apparatus, attachable to a lancer body assembly, comprising:
an outer member, having a distal surface, an orifice through the distal surface, an interior surface, and at least one protrusion disposed on the interior surface;
an inner member, having a distal surface, an orifice through the distal surface, an exterior surface, and a plurality of slots for receiving the at least one protrusion on the interior surface of the outer member so as to establish a distance between the distal surface of the inner member and the distal surface of the outer member;

a spring member, disposed around the inner member, for biasing the outer member toward the inner member.
30. An adjustment apparatus, attachable to a lancer body assembly, comprising:
an outer member, having a distal surface, an orifice through the distal surface, an interior surface, and a plurality of slots disposed on the interior surface, each slot having a distinct axial depth;
an inner member, having a distal surface, an orifice through the distal surface, an exterior surface, and at least one protrusion extending from the exterior surface, the protrusion for inserting into one of the plurality of slots on the interior surface of the outer member so as to establish a distance between the distal surface of the inner member and the distal surface of the outer member;
a spring member, disposed around the inner member, for biasing the outer member toward the inner member.
31. The apparatus according to Claim 30, further comprising:
an annular ring member, disposed around the inner member; having an interior and exterior surface, for attaching the body assembly to the outer member.
32. The apparatus according to Claim 31, wherein the annular ring member has at least one camming surface on the interior surface.
33. The apparatus according to Claim 31, wherein the annular ring member has at least one protrusion extending radially outward from the exterior surface for forming a mating relationship with the outer member.
CA2715443A 1999-08-03 2000-08-02 Lancer Expired - Lifetime CA2715443C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/366,149 US6558402B1 (en) 1999-08-03 1999-08-03 Lancer
US09/366,149 1999-08-03
CA2314859A CA2314859C (en) 1999-08-03 2000-08-02 Lancer

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2314859A Division CA2314859C (en) 1999-08-03 2000-08-02 Lancer

Publications (2)

Publication Number Publication Date
CA2715443A1 true CA2715443A1 (en) 2001-02-03
CA2715443C CA2715443C (en) 2012-03-06

Family

ID=23441850

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2715443A Expired - Lifetime CA2715443C (en) 1999-08-03 2000-08-02 Lancer
CA2314859A Expired - Lifetime CA2314859C (en) 1999-08-03 2000-08-02 Lancer

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2314859A Expired - Lifetime CA2314859C (en) 1999-08-03 2000-08-02 Lancer

Country Status (6)

Country Link
US (4) US6558402B1 (en)
EP (2) EP1074219B1 (en)
JP (2) JP4689799B2 (en)
CA (2) CA2715443C (en)
DE (2) DE60024000T2 (en)
ES (2) ES2247989T3 (en)

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