Single-use skin puncture device

• US 5,026,388 A
• Filed: 09/26/1989
• Issued: 06/25/1991
• Est. Priority Date: 09/26/1989
• Status: Expired due to Fees

• Current Assignee: Thomas J. Ingalz
• Original Assignee: Thomas J. Ingalz
• Inventors: Ingalz, Thomas J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/412,511
• Time in Patent Office: 637 Days
• Field of Search: 606/181, 606/182, 128/637, 128/638, 604/46, 604/136, 604/137, 604/156, 604/157
• US Class Current: 606/182
• 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 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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

A single-use puncture device having an escapement assembly, a cylindrical sidewall and a helical spring encircling a lance. The escapement assembly includes cantilevered catch members which abut a stop turn of the helical spring to hold the helical spring in a stressed condition. Pressure at the front end of the puncture device causes a deformation of a thin diaphragm which supports the cantilevered catch members at ends opposite the abutment to the stop turn. The deformation is a flexing which moves the catch members radially outwardly to release the stop turn. The spring thrusts the lance forwardly from an armed position to a propelled position in which the puncture point of the lance extends from the front end of the device. The helical spring thereafter recoils to locate the lance in a neutral position encased within a housing. Rearmament of the device is thereby prevented. The front end of the puncture device includes the central access aperture, a skin-engagement region outward of the access aperture, a raised annulus which defines the skin-engagement region, and the thin flexible diaphragm.

Claims

1. A single-use skin puncture device comprising,

a housing having a skin-engagement region and an access aperture through said skin-engagement region, said housing further having a sidewall and a flexible diaphragm connecting said skin engagement region to said sidewall at a front end of said housing, the application of force at said skin-engagement region causing deformation of said diaphragm about said skin-engagement region, said deformation defining a limited range of motion of said skin-engagement region relative to said sidewall,

movable lance means aligned with said access aperture for piercing skin, said lance means having a puncture point having an armed position within said housing, a neutral position within said housing and a propelled position wherein said puncture point is at the exterior of said housing,

spring means coupled to said lance means for displacing said puncture point in and out of said housing, from said armed position to said propelled position, and

catch means for releasably holding said spring means in a condition in which potential energy is stored for said displacing of said puncture point, said spring means coupled to said housing in a manner to release said spring means in response to said deformation, said spring means moving toward a relaxed condition after said displacing to locate said puncture point in said neutral position spaced apart from said skin-engagement region by a distance exceeding said limited range of motion of the skin-engagement region.

2. The single-use puncture device of claim 1 wherein said spring means is a helical spring encircling a portion of said lance means.

3. The single-use puncture device of claim 1 wherein said sidewall is generally cylindrical.

4. The single-use puncture device of claim 3 wherein said catch means is a plurality of catch members contacting said spring means to hold said spring means in said position to store potential energy, said catch members being displaced from said spring means by said deformation of said diaphragm.

5. The single-use puncture device of claim 4 wherein said spring means is a helical spring having a stop turn, said stop turn being in contact with said catch members prior to said deformation.

6. The single-use puncture device of claim 1 wherein said lance means is one of a lance needle and a lance blade.

7. A puncture device comprising,

an elongated housing having a generally cylindrical rigid sidewall and a skin-engagement region at the front end,

movable lance means disposed within said housing,

a spring connected to said housing for propelling said lance means to extend a portion of said puncture means through said skin-engagement region,

catch means for releasably holding said spring in a stressed position for said propelling of said lance means, and

trigger means, fixed at opposed ends to said rigid sidewall and said skin-engagement region, for releasing said spring from said catch means, said trigger means being a deformable member diagonal to allow flexure of said front end into a concave position relative to said rigid sidewall, said flexure defining a range of relative motion between said skin-engagement region and said rigid sidewall, said spring being disposed such that relaxation of said spring following said release spaces apart said lance means from said skin-engagement region by a distance greater than said range of relative motion.

8. The puncture device of claim 7 wherein said trigger means is a flexible diaphragm.

9. The puncture device of claim 8 wherein said diaphragm is an annular member.

10. The puncture device of claim 8 wherein said catch means is a plurality of catch members connected to said diaphragm at a first end and to said spring at a second end, flexing of said diaphragm causing lateral movement of said catch members to release said spring.

11. The puncture device of claim 7 wherein said spring is a helical spring encircling said lance means.

12. A single-use puncture device comprising,

a housing having a rigid sidewall and a front end, said front end having a deformable region made of a flexible material and having a skin-engagement region, said skin-engagement region being displaced axially upon application of axial force at said front end, said front end having an access aperture therethrough,

lance means disposed within said housing in alignment with said access aperture,

a spring having a first end attached to said housing and having a free end, said free end coupled to said lance means, and

a plurality of catch members connected to said front end of said housing and disposed to hold said spring in a stressed condition for storage of potential energy, said catch members being displaced by axial deformation of said front end to release said spring, thereby causing said spring to propel a portion of said lance means through said access aperture, said spring having a relaxed condition in which said lance means is encased within said housing and is spaced apart from said skin-engagement region by a distance exceeding said axial displacement of said skin-engagement region.

13. The puncture device of claim 12 wherein said lance means is a lance needle.

14. The puncture device of claim 12 wherein said sidewall has a cylindrical shape and wherein said front end has a central skin-engagement region connected to said sidewall by a flexible diaphragm.

15. The puncture device of claim 14 wherein said skin-engagement region includes a raised annulus and a depressed area within said raised annulus.

16. The puncture device of claim 14 wherein said flexible diaphragm has an annular configuration.

17. The puncture device of claim 12 wherein said spring is a helical spring encircling said lance means.

18. A single-use skin puncture device comprising,

a housing having a skin-engagement region and an access aperture through said skin-engagement region, said housing having the characteristic such that the application of force at said skin-engagement region causes deformation about said skin-engagement region, said deformation defining a limited range of region motion,

movable lance means aligned with said access aperture for piercing skin, said lance means having a puncture point having an armed position within said housing, a neutral position within said housing and a propelled position wherein said puncture point is at the exterior of said housing,

spring means coupled to said lance means for displacing said puncture point in and out of said housing, from said armed position to said propelled position, said spring means having a helical spring encircling said puncture point when said puncture point is in said neutral position, and

catch means for releasably holding said spring means in a condition in which potential energy is stored for said displacing of said puncture point, said spring means coupled to said housing in a manner to release said spring means in response to said deformation, said spring means moving toward a relaxed condition after said displacing to locate said puncture point in said neutral position spaced apart from said skin-engagement region by a distance exceeding said limited range of region motion.