METHOD AND APPARATUS FOR PIERCING THE SKIN AND DELIVERY OR COLLECTION OF LIQUIDS

• US 20090099478A1
• Filed: 03/13/2007
• Published: 04/16/2009
• Est. Priority Date: 03/13/2006
• Status: Abandoned Application

• Current Assignee: Microsample Ltd.
• Original Assignee: Microsample Ltd.
• Inventors: Harman, Anthony David, Cassells, John Maclaren
• Application Number:
  US12/282,425
• Publication Number:
  US 20090099478A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

The single use medical device includes a lancet piston slidingly and sealingly located in a bore of a lancet housing. The lancet piston operates as a positive displacement piston within the bore, allowing dispensing and/or aspiration of liquid into the bore. The lancet piston includes a sharp tip for pricking skin, and is particular applicability for allergen testing and blood or ISF sampling. The actuator device has an actuator member for releasable engagement with the lancet piston at a before-use position of the lancet piston via a clutch mechanism. The engagement of the actuator member with the lancet piston allows the actuator member to push/pull the lancet piston forwardly/rearwardly along the bore. At positions forward of the before-use position of the lancet piston, the engagement of the actuator member with the lancet piston is interlocked, assisting in the prevention of accidental needlestick injuries.

Claims

1. A kit of a disposable single use medical device and an actuator device, the single use medical device being for delivering liquid to skin before lancing and/or aspirating liquid after lancing, the single use medical device having:

a lancet housing having attachment means for releasable attachment of the lancet housing to the actuator device;

a lancet piston having a sharp tip suitable for pricking skin at a forward end and a gripping feature at a rearward end;

the actuator device having an actuator member, the actuator member having;

lancet piston engagement means comprising a set of normally sprung-open clutch jaws;

activation means comprising a cylindrical housing moveable with respect to the clutch jaws so that on extension of the cylindrical housing with respect to the normally sprung-open jaws, the jaws are closed,

wherein the lancet piston engagement means and the activation means are operable to cause releasable engagement between the lancet piston and the actuator member at a first axial position of said lancet piston such that the lancet piston remains fixed in said first axial position relative to the actuator device and the lancet housing until said jaws are closed, and wherein the lancet piston is moveable with respect to the lancet housing axially along an internal space of the lancet housing, the lancet piston slidably and sealingly fitting in at least one section of the bore of the lancet housing, the device having a before-use configuration in which the sharp tip of the lancet piston is held shielded by the lancet housing, the releasable engagement between the actuator member and the lancet piston being operable to allow movement of the lancet piston to expose the sharp tip forwardly from the lancet housing to prick the skin and to move the sharp tip of the lancet piston to an after-use configuration in which the sharp tip of the lancet piston is again held shielded by the lancet housing, there being a liquid-containing space in the bore forwardly of the lancet piston in either the before-use configuration or in the after-use configuration or both.

2. A kit according to claim 1 wherein the activation means is operable to cause release of the engagement between the lancet piston and the actuator member at a second axial position of the lancet piston, the sharp tip of the lancet piston being shielded by the lancet housing in said second position.

3. A kit according to claim 1 wherein a section of the lancet housing forward of the first axial position acts as an interlock to constrain and prevent release of the engagement between the lancet piston and actuator member at a position forward of the before-use and/or after-use location of the lancet piston.

4. A kit according to claim 1 having at least one stop element for urging against accidental exposure of the sharp tip of the lancet piston from the lancet housing before or after the lancet piston engagement means is engaged with the actuator member.

5. A kit according to claim 1 wherein the lancet piston and lancet housing co-operate to hold the lancet piston in a fixed axial position relative to the lancet housing, such co-operation being capable of being overcome by operation of the actuator in use.

6. A kit according to claim 1 including at least one locator lancet piston guide element for maintaining the axial and/or radial position of the lancet piston with respect to the lancet housing before and/or after engagement with the actuator member.

7. A kit according to claim 1 wherein seal means is provided, operable substantially to prevent flow of liquid from the liquid-containing space and substantially to prevent air flow into the liquid-containing space past the seal means on movement of the lancet piston or liquid from the liquid-containing space past the seal means on movement of the lancet piston, the seal means being in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet piston at least during forward displacement of the lancet piston, so that displacement of the lancet piston either from the before-use configuration to the exposed position or from the exposed position to the after-use configuration provides at least one of:

(i) suction for drawing liquid into and along the liquid-containing space from a forward end of the bore, and

(ii) pressure for expelling liquid from the liquid-containing space via a forward end of the bore.

8. A kit according to claim 1 including a plurality of said disposable medical devices.

9. A method of operating a kit according to claim 1, including the steps:

releasably attaching the actuator device to the lancet housing of the disposable medical device;

releasably engaging the actuator member and the lancet piston via said activation means.

10. A method according to claim 9 further including the steps of:

releasing engagement between the lancet piston and actuator member, optionally via said activation means at the after-use position; and

removing or ejecting the disposable medical device from the actuator, so that the lancet piston tip remains shielded by the lancet housing.

11-23. -23. (canceled)