Method for manufacturing a disposable-retractable finger stick device

• US 5,212,879 A
• Filed: 04/14/1992
• Issued: 05/25/1993
• Est. Priority Date: 05/15/1991
• Status: Expired due to Term

• Current Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Biro, Ladislau, Cusack, Robert F., Mintz, Michael D.
• Primary Examiner(s): Rosenbaum, Mark
• Assistant Examiner(s): VO, PETER DUNG BA
• Application Number:
  US07/868,630
• Time in Patent Office: 406 Days
• Field of Search: 29/434, 29/437, 29/445, 29/450, 29/453, 29/463, 29/DIG. 29, 606/167, 606/181, 606/182, 606/183, 264/109
• US Class Current: 29/437
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads 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
• CPC Class Codes: Y10S 29/029 Molding with other step
• CPC Class Codes: Y10T 29/49845 by deforming interlock
• CPC Class Codes: Y10T 29/49861 Sizing mating parts during final positional association
• CPC Class Codes: Y10T 29/49876 by snap fit

Abstract

A finger stick device for making a skin incision includes a blade pivot arm having a first end pivotally coupled to a housing and a second end having an upper sloped surface and a lower surface. A blade is affixed to the second end such that its cutting edge extends away from the lower surface. A resilient bias member when actuated traverses the upper surface and depresses the second end of the blade pivot arm, such that the blade exits the housing and incises the skin. The incising operation is complete upon the bias member traversing the sloped upper surface of the blade pivot arm. Also disclosed herein is a method for manufacturing the finger stick device, in which the bias member and blade pivot arm are molded as a monolithic unit. A blade is attached to the blade pivot arm, and the blade and monolithic unit are inserted into the housing. Further disclosed is an embodiment in which the housing is formed of two uniformly shaped halves, which when joined, provide an internal space for the monolithic unit. In this manner, the two halves are joined with the monolithic unit aligned therebetween so that the housing appears as an integral unit.

Claims

1. Method of manufacturing a device for making a skin incision, comprising the steps of:

(a) providing a case having an internal hollow, an open end aperture, a open side aperture and an elongated slot located on a surface of said case adapted to be placed flushed against the skin;

(b) molding a monolithic finger stick mechanism having a blade support arm and an actuatable arm whereby said actuatable arm is biased against said blade support arm causing said blade support arm to move when said actuatable arm is manually depressed;

(c) attaching a blade to said blade support arm;

(d) inserting said monolithic finger stick mechanism through said open end aperture into said case, whereby said actuatable arm extends through said open side aperture and said blade support arm holds said blade proximate said elongated slot so that said blade extends through said elongated slot when said actuatable arm is depressed and biased against said blade support arm; and

(e) attaching said monolithic finger stick mechanism to said case.

2. The method according to claim 1, wherein said monolithic finger stick mechanism includes a projecting pin, wherein said case has an aperture for receiving said projecting pin, and wherein said method further includes the step of inserting said projecting pin through said aperture and attaching said monolithic finger stick mechanism to said case.

3. The method according to claim 1, wherein said monolithic finger stick mechanism includes a cover member that is receivable by said open end aperture of said case, and wherein said method further includes the steps of positioning said cover member at said open end aperture of said case thereby obstructing said open end aperture.

4. Method of manufacturing a device for making a skin incision, comprising the steps of:

(a) providing a case having an internal hollow, an upper aperture, a side aperture and an elongated slot, said case being fabricated from a first half and a second half, each of said first and second halves being uniformly shaped, and in which said first half is formed with first attachment means, and said second half is formed with second attachment means, such that when said first and second halves are joined said upper aperture, said side aperture and said elongated slot are formed where said first and second grooves meet and said first attachment means coact with said second attachment means for forming said case as an integral unit;

(b) molding a monolithic finger stick mechanism having a blade support arm and an actuatable arm, whereby said actuatable arm is biased against said blade support arm causing said blade support arm to move when said actuatable arm is manually depressed;

(c) attaching a blade to said blade support arm;

(d) positioning said monolithic finger stick mechanism between said first and second halves of said case;

(e) causing said first attachment means to coact with said second attachment means to form said case as an integral unit, whereby said monolithic finger stick mechanism is contained within said internal hollow of said case; and

whereby said actuatable arm extends through said side aperture and said blade support arm holds said blade proximate said elongated slot so that said blade extends through said elongated slot when said actuatable arm is manually depressed and is biased against said blade support arm.

5. The method according to claim 4, wherein said first attachment means comprises five locator pins and said second attachment means comprises five locator holes.

6. Method of manufacturing a device for making a skin incision, comprising the steps of:

(a) providing a case having an internal hollow, an open end, a closed end having a surface adapted to be placed flush against the skin an elongated slit located on said surface and an aperture opposite said open end

(b) molding a monolithic finger stick mechanism having support means, a projecting pin extending from said support means, blade pivoting means for pivotally guiding a blade, said blade pivoting means having a first end which is pivotally attached to a first end of said support means and a second end having an upper surface and a lower surface, said upper surface being sloped, and actuatable depressing means for depressing said upper surface of said second end of said pivoting means;

(c) attaching a blade to said second end of said bade pivoting means, such that it cutting edge extends away from said lower surface;

(d) inserting said monolithic finger stick mechanism through the open end of the case whereby said projecting pin on said support means passes through said aperture in said case and attaches said support means to said case;

7. The method according to claim 6, wherein a second end of said support means is attached to a cover member that is receivable by said open end of said case, and wherein said method further includes the steps of positioning said second member at said open end of said case for covering said case.

8. The method according to claim 6, wherein said depressing means further includes a lever arm having one end pivotally attached to said cover member, wherein said case has an aperture that receives the other end of said lever arm, and wherein said method further includes the step of inserting said other end of said lever arm through said aperture after performing step (f).

9. The method according to claim 6, wherein said blade pivoting means further includes engaging means for engaging said depressing means with said blade pivoting means, and wherein said method further includes the step of engaging said depressing means to said blade pivoting means prior to performing step (d).