CA2481873A1 - Medical device package, kit and associated methods - Google Patents

Medical device package, kit and associated methods Download PDF

Info

Publication number
CA2481873A1
CA2481873A1 CA002481873A CA2481873A CA2481873A1 CA 2481873 A1 CA2481873 A1 CA 2481873A1 CA 002481873 A CA002481873 A CA 002481873A CA 2481873 A CA2481873 A CA 2481873A CA 2481873 A1 CA2481873 A1 CA 2481873A1
Authority
CA
Canada
Prior art keywords
medical device
cavity
cap member
connector
device package
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
CA002481873A
Other languages
French (fr)
Other versions
CA2481873C (en
Inventor
Bryan Windus-Smith
John Allen
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.)
LifeScan Scotland Ltd
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2481873A1 publication Critical patent/CA2481873A1/en
Application granted granted Critical
Publication of CA2481873C publication Critical patent/CA2481873C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150305—Packages specially adapted for piercing devices or blood sampling 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
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • 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
    • A61B5/151—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/3001—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for sharps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/3211—Surgical scalpels, knives; Accessories therefor
    • A61B17/3215—Packages or dispensers for scalpel blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A61B50/36—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles
    • A61B50/362—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for collecting or disposing of used articles for sharps

Abstract

A medical device package for receiving, and securely and removably retaining, a medical device includes main and minor cap members. The main cap member has a proximal end, a distal end and a cavity with a cavity opening at the proximal end. The cavity is configured to receive, and to securely and removably retain, the medical device at least partially therein. The minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity. Kits further include a connector adapted for engaging the medical device member and breaching the minor cap member. A
method for extracting a medical device from a medical device package includes first providing a medical device package as described above, with a medical device therein, and a connector. The method also includes breaching the minor cap member with the connector such that at least a portion of the connector enters the cavity of the medical device package.
Next, the medical device is engaged by the connector and extracted from the medical device package.

Claims (18)

1. A medical device package comprising:
a main cap member with a cavity therein, the main cap member including:
a proximal end; and a distal end; and a minor cap member, wherein:
the cavity has a cavity opening at the proximal end of the main cap member;
the cavity is configured to receive, and to securely and removably retain, medical device at least partially therein, and the minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity.
2. The medical device package of claim 1, wherein the main cap member includes at least one lateral channel and wherein the medical device is securely and removably retained by a friction fit between the medical device and the at least one lateral channel.
3. The medical device package of claim 1, wherein the main cap member includes a directional marker.
4. The medical device package of claim 1, wherein the main cap member cavity is configured to receive, and to securely and removably retain, an integrated medical device that includes electrical contacts such that the electrical contacts project from the cavity opening and minor cap member.
5. The medical device package of claim 1, wherein the minor cap member includes ribs that seal the cavity opening.
6. The medical device package of claim 1, wherein the minor cap member is a breachable minor cap member.
7. The medical device package of claim 1, wherein the minor cap member is configured for permanent attachment to the medical device.
8. The medical device package of claim 1, wherein the main cap member further includes a distal end cavity configured for disabling the medical device.
9. A medical device package kit comprising:
a main cap member with a cavity therein, the main cap member including:
a proximal end; and a distal end;
a minor cap member; and a connector, wherein:
the cavity has a cavity opening of the proximal end of the main cap member;
the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein;
the minor cap member is configured to seal the cavity opening once the medical device has been received in the cavity; and the connector is configured to engage the medical device during removal of tile medical device from the cavity.
10. The medical device package kit of claim 9, wherein the connector includes a connector directional marker.
11. The medical device package kit of claim 9, wherein the connector is further configured to breach the minor cap member.
12. The medical device package kit of claim 9, wherein the connector includes at least one strip engaging element for contacting electrical contacts of the medical device.
13. A method for extracting a medical device from a medical device package, the method comprising:
providing:
a medical device package with a medical device contained therein, the medical device package including:
a main cap member with a cavity therein, the main cap member including:
a proximal end; and a distal end;
a minor cap member; and wherein:
the cavity has a cavity opening at the proximal end of the main cap member;
the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein; and the minor cap member is sealing the cavity opening; and a connector;
breaching the minor cap member with the connector such that at least a portion of the connector has entered the cavity of the medical device cavity;
engaging the medical device with the connector; and extracting the connector and engaged medical device from the cavity of the medical device package.
14. The method of claim 13, wherein the medical device is an integrated medical device that includes a tissue penetration member and a test strip.
15. A method for extracting a medical device from a medical device package and subsequently disabling the medical device, the method comprising:
providing:
a medical device package with a medical device contained therein at a first position, the medical device package including:
a main cap member with a cavity therein, the main cap member including:
a proximal end; and a distal end;
a minor cap member; and wherein:
the cavity has a cavity opening at the proximal end of the main cap member;
the cavity is configured to receive, and to securely and removably retain, a medical device at least partially therein;
the minor cap member is sealing the cavity opening; and a connector;

breaching the minor cap member with the connector such that at least a portion of the connector has entered the cavity of the medical device cavity;
engaging the medical device with the connector;
extracting the connector and engaged medical device from the cavity of the medical device package; and subsequently inserting the connector and engaged medical device into a cavity of the medical device package to a second position whereby the medical device is disabled from subsequent use.
16. The method of claim 15, wherein the inserting step includes inserting the engaged medical device into the cavity of the main cap member.
17. The method of claim 16, wherein the inserting step includes inserting the engaged medical device into a distal end cavity of the medical device package.
18. The method of claim 16 further including:
disengaging the connector from the disabled medical device; and withdrawing the connector from the medical device package.
CA2481873A 2003-09-19 2004-09-17 Medical device package, kit and associated methods Expired - Fee Related CA2481873C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/666,154 2003-09-19
US10/666,154 US7617932B2 (en) 2003-09-19 2003-09-19 Medical device package, kit and associated methods

Publications (2)

Publication Number Publication Date
CA2481873A1 true CA2481873A1 (en) 2005-03-19
CA2481873C CA2481873C (en) 2012-12-04

Family

ID=34194775

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2481873A Expired - Fee Related CA2481873C (en) 2003-09-19 2004-09-17 Medical device package, kit and associated methods

Country Status (15)

Country Link
US (4) US7617932B2 (en)
EP (1) EP1518509B1 (en)
JP (1) JP5132870B2 (en)
KR (1) KR101157810B1 (en)
CN (1) CN100584709C (en)
AU (1) AU2004212582B2 (en)
CA (1) CA2481873C (en)
ES (1) ES2527856T3 (en)
HK (1) HK1074987A1 (en)
IL (1) IL164128A (en)
MX (1) MXPA04009128A (en)
NO (1) NO20043898L (en)
RU (1) RU2358683C2 (en)
SG (2) SG149046A1 (en)
TW (1) TWI348366B (en)

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