Single-step disposable safety lancet apparatus and methods

• US 6,358,265 B1
• Filed: 07/18/2000
• Issued: 03/19/2002
• Est. Priority Date: 07/18/2000
• Status: Expired due to Fees

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Wilson, Michael A., Bagley, B. Chance, Thorne, David L., Thorne, Gale H. Jr., Owen, Charles V.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/619,043
• Time in Patent Office: 609 Days
• Field of Search: 606/181, 606/182, 606/185, 604/198, 604/192, 604/263, 303/40, 303/42
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150885 Preventing re-use
• CPC Class Codes: A61B 5/15111 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
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

Three embodiments of a single-step lancet are disclosed. Each such lancet embodiment provides true one-step operation. In a single operational step requiring only a unidirectional displacement of an actuator into a housing, a lancet blade is removed from an aseptic environment which protects and retains the lancet blade in a pre-sterilized state within the housing prior to use, stores energy in an energy storage medium, activates the lancet blade to perform a lance and for safety retracts the lancet blade into the housing.

Claims

1. A self-contained lancet which requires but one operational step to perform a lancing procedure, said lancet comprising:

a housing comprising an elongated contiguous side wall which surrounds and shelters lancet parts residing within said housing, said housing further comprising a substantially open first end wherethrough an actuator is unidirectionally displaced to energize and activate a lancing cycle and a slot on the other end through which a lancet blade is displaced;

the lancet blade, disposed for transport before use and for disposal after use, within said housing;

a covering, removed as a part of the single operational step, being protectively disposed to provide a sterile encasement about the lancet blade before use, said cover maintaining the lancet blade in an uncontaminated state until the lancet is uncovered during the single operational step;

the actuator which is displaceable from a first state whereat digital access is provided toward and to a second state whereby the lancet is activated;

an energy storing member which communicates with the actuator at a first site and is securely affixed to the lancet blade at a second site and which stores energy during a first portion of actuator displacement from the first state to the second state and released during a second portion of actuator displacement from the first state to the second state to discharge the lancet outward from the housing and then to return the lancet to protective safety of the housing; and

a stripping apparatus which separates the lancet blade from the removable covering during the first portion of actuator displacement.

2. A self-contained lancet according to claim 1 further comprising apparatus for sweeping undesirable material within said housing from the region of said slot to clear an unobstructed pathway for said lancet blade.

3. A self-contained lancet according to claim 1 wherein said actuator and said energy storing member are formed as a single integrated part.

4. A self-contained lancet according to claim 1 wherein said removable covering and a portion of said stripping apparatus are formed as a single integrated part.

5. A method for using a self-contained lancet which requires but one operational step to perform a lancing procedure, comprising the steps of:

providing a lancet comprising;

a housing comprising an elongated contiguous side wall which surrounds and shelters lancet parts residing within said housing, said housing further comprising an open first end wherethrough an actuator is unidirectionally displaced to energize and activate a lancing cycle and a slot on the other end through which a lancet blade is displaced;

the lancet blade, disposed for transport before use and for disposal after use, within said housing;

a lancet blade covering, removable by action of the single operational step, being protectively disposed to provide a sterile encasement about the lancet blade before use, said cover maintaining the lancet blade in an uncontaminated state until the lancet is uncovered therefrom;

the actuator which is displaceable from a first state whereat digital access is provided toward and to a second state whereby the lancet is activated;

an energy storing member which communicates with the actuator at a first site and is securely affixed to the lancet blade at a second site and which stores energy during a first portion of actuator displacement from the first state to the second state and released during a second portion of actuator displacement from the first state to the second state to discharge the lancet outward from the housing and then to return the lancet to protective safety of the housing; and

a stripping apparatus which separates the lancet blade from the removable covering during the first portion of displacement of the actuator;

displacing the actuator unidirectionally from the first state to the second state thereby storing energy in the energy storing member and separating the lancet blade from the removable covering during the first portion of actuator displacement from the first state to the second state and then releasing the energy storing member during the second portion of actuator displacement from the first state to the second state to discharge the lancet from the housing and return the lancet into the housing.

6. A method for using a self-contained lancet according to claim 5 comprising the further steps of providing apparatus for sweeping undesirable material within said housing from the region of said slot to clear an unobstructed pathway for said lancet blade and sweeping unwanted material from the region of said slot during the first portion of displacement of the actuator from the first state to the second state.