Blood lancet device

• US 4,924,879 A
• Filed: 10/07/1988
• Issued: 05/15/1990
• Est. Priority Date: 10/07/1988
• Status: Expired due to Term

• Current Assignee: Walter J O'Brien
• Original Assignee: Walter J O'Brien
• Inventors: O'Brien, Walter J.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/254,860
• Time in Patent Office: 585 Days
• Field of Search: 128/314, 128/315, 128/329 R, 128/329 A, 128/330, 128/637, 128/638, 128/770, 604/22, 604/46, 604/47, 604/136, 604/156, 604/157, 606/167, 606/181, 606/182, 606/185, 606/189
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• 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

Abstract

A blood letting lancet assembly for puncturing the skin of the finger tip for home use that causes less pain includes a mechanism for reproducibly orienting the assembly on the finger tip. The blade may be moved to any of a plurality of indexed positions within the device. By indexing the blade to the next position and reproducibly orienting the device on the finger tip, the user can avoid a second puncture close to the first puncture which reduces pain. A new method for rapidly advancing and retracting the blade further reduces pain. An accessory capillary collects the exact volume of blood required for a test and avoids needless attempts to collect excessive blood. A magnetic blade holder simplifies blade changing.

Claims

1. A device for puncturing the skin for blood sampling with a blade, comprising:

a) blade holder means for holding said blade in said device;

b) blade moving means connected to said blade holder means for rapidly moving said blade holder with said blade exclusively in a rectilinear motion in a first or puncturing direction motion immediately followed by a second or retracting direction motion for rapid puncturing and retraction to minimize pain;

c) said blade moving means including a rotary to translatory motion conversion means including a rotary driving element, whereby said rotary driving element, while moving in a single continuous motion in one direction, moves said blade holder through said first and then said second direction motions.

2. The device according to claim 1, including spring means for biasing said rotary driving element to drive said moving means, said spring means providing spring bias to said rotary driving element.

3. The device according to claim 2, in which said blade holder means includes means for removably holding said blade.

4. The device according to claim 1, in which said blade holder means includes means for removably holding said blade.

5. A device for puncturing the skin of the finger for blood sampling with a replaceable blade, comprising:

(a) finger engaging means for engaging said finger in a reproducible orientation to control the location of said puncturing;

(b) positioning means attached to said finger engaging means for positioning said finger engaging means at a fixed orientation to a landmark on said finger;

(c) blade holder means for removably holding said blade in said device;

(d) blade moving means connected to said blade holder means for rapidly moving said blade holder with said blade downward in a first or puncturing direction immediately followed by an upward or retracting direction motion for rapid puncturing and rectraction to minimize pain;

(e) lancet assembly means containing said blade holder, and said blade moving means;

(f) lancet assembly carrier means movably connected to said finger engaging means by indexable means to move said blade to a plurality of exact indexed positions relative to said finger, said lancet assembly means mounted within said lancet carrier means in axially moving condition;

(g) skin surface sensing means attached to said lancet assembly means and adapted to engage said skin and position said assembly means axially within said carrier means a fixed distance above said skin to control the depth of said puncturing.

6. The device according to claim 5, in which said blade moving means includes a spring.

7. The device according to claim 6, in which said moving means includes a rotary to translatory motion conversion means.

8. The device according to claim 5, including capillary holding means for removably holding a disposable capillary for collecting a fixed volume of blood.

9. The device according to claim 5, including spring bias means for urging said lancet assembly means toward said skin.

10. The device according to claim 5, in which said blade holder means includes magnet means for easier blade changing.

11. A device for puncturing the skin comprising

(a) skin puncturing means;

(b) mounting means for mounting said skin puncturing means exclusively for translational, rectilinear motion in a predetermined direction between a retracted position in which said skin puncturing means is in a non-skin puncturing location and an extended position in which said skin puncturing means can affect said puncturing of said skin; and

(c) actuation means for actuating said translational rectilinear motion of said mounting means, said actuation means including drive means movable over a predetermined path between a first end position, an intermediate position, and a second end position, and connection means for connecting said drive means to said mounting means;

said drive means, said predetermined path, and said connection means being so arranged that as said drive means moves from said first end position through said intermediate position to said second end position in a continuous motion in one direction said mounting means moves said skin puncturing means from said retracted position when said drive means is in said first end position, to said extended position when said drive means is in said intermediate position, to said retracted position when said drive means is in said second end position, thereby rapidly and continuously moving said skin puncturing means through said extended position for puncturing said skin in order to minimize the pain created thereby.

12. The device of claim 11, including a housing that encloses said mounting means and said actuation means said housing extending longitudinally in said predetermined direction and said housing including an aperture, whereby said skin puncturing means extends through said aperture in said housing when in said extended position and is contained within said housing when in said retracted position.

13. The device of claim 12 wherein said housing includes a first portion and a second portion, said second housing portion being longitudinally displaceable from and relatively rotatably displaceable with respect to said first housing portion in a plane transverse to said predetermined direction, and wherein said skin puncturing means is affixed to said second housing portion.

14. The device of claim 13 wherein said first housing portion includes body part engaging means for mounting said device relative to a predetermined location with respect to a body part, whereby upon said rotation of said second housing portion with respect to said first housing portion said skin puncturing means can be aligned with different sites on said body part while said first housing portion remains stationary.

15. The device of claim 13 wherein said first portion of said housing includes locator means for locating said first portion of said housing with respect to a predetermined location on said skin where said puncture is desired.

16. The device of claim 12 wherein said housing includes an internal housing portion and an external housing portion, said mounting means being mounted within said internal housing portion.

17. The device of claim 16 wherein said internal housing portion is relatively longitudinally displaceable within said external housing portion.

18. The device of claim 17 including skin surface sensor means extending from said internal housing portion adapted to engage said skin whereby said internal housing portion can be longitudinally located within said external housing portion at a predetermined location such that said skin puncturing means will extend from said housing to puncture said skin by a predetermined depth when in said extended position.

19. The device of claim 17 including spring bias means for biasing said internal housing portion relative to said external housing portion so as to urge said internal housing portion towards said housing aperture.

20. The device of claim 11 wherein said drive means includes a rotary member.

21. The device of claim 20 wherein said drive means includes spring means for biasing said rotary member from said first end position towards said second end position, and catch means for maintaining said rotary member in said first end position.

22. The device of claim 21 wherein said actuation means includes release means for releasing said catch means whereby said spring means can drive said rotary member from said first end position towards said second end position.

23. The device of claim 21 wherein said drive means includes rewind means for returning said rotary member from said second end position to said first end position against said bias of said spring means.

24. The device of claim 11 wherein said skin puncturing means comprises a blade.

25. The device of claim 11 wherein said mounting means includes skin puncturing means holding means.

26. The device of claim 25 wherein said skin puncturing means comprises metal, and including magnet means mounted on said skin puncturing means holding means for releasably mounting said skin puncturing means thereon.

27. The device of claim 25 including pin means extending from said skin puncturing means holding means, and wherein said skin puncturing means includes aperture means corresponding to said pin means for releasably mounting said skin puncturing means on said skin puncturing means holding means by inserting said pin means into said aperture means.

28. The device of claim 11 including capillary holding means for removably holding a disposable capillary holding tube for collecting a fixed volume of blood upon said puncturing of said skin.

29. A device for puncturing the skin comprising:

(a) skin puncturing means;

(b) mounting means for mounting said skin puncturing means for translational motion in a predetermined direction between a retracted position in which said puncturing means is in a non-skin puncturing location and an extended position in which said skin puncturing means can effect said puncturing of said skin;

(c) actuation means for actuating said translational motion of said mounting means; and

(d) a housing extending longitudinally in said predetermined direction and including an aperture, said mounting means and said actuation means being mounted within said housing such that said skin puncturing means extends from said aperture in said housing when in said extended position and is contained within said housing when in said retracted position, said housing including a first portion and a second portion, said second housing portion being longitudinally displaced from and relatively rotatable with respect to said first housing portion in a plane transverse to said predetermined direction, said skin puncturing means being affixed to said second housing portion, said first housing portion including body part engaging means for mounting said device relative to a predetermined location with respect to a body part, whereby upon said rotation of said second housing portion with respect to said first housing portion said skin puncturing means can be aligned with different sites on said body part while said first housing portion remains stationary.

30. The device of claim 29 wherein said second housing portion includes an internal housing portion and an external housing portion, said mounting means and said actuation means being mounted within said internal housing portion.

31. The device of claim 30 wherein said internal housing portion is relatively longitudinally displaceable with respect to said external housing portion.

32. The device of claim 29 wherein said actuation means includes drive means movable over a predetermined path between a first end position, an intermediate position, and a second end position, and connection means for connecting said drive means to said mounting means;

said drive means, said predetermined path, and said connection means being so arranged that as said drive means moves from said first end position through said intermediate position to said second end position said mounting means moves said skin puncturing means from said retracted position when said drive means is in said first end position, to said extended position when said drive means is in said intermediate position, to said retracted position when said drive means is in said second end position, thereby rapidly and continuously moving said skin puncturing means through said extended position for puncturing said skin in order to minimize the pain created thereby.

33. The device of claim 32 wherein said drive means includes a rotary member.

34. The device of claim 33 wherein said drive means includes spring means for biasing said rotary member from said first end position towards said second end position, and catch means for maintaining said rotary member in said first end position.

35. The device of claim 34 wherein said actuation means includes release means for releasing said catch means whereby said spring means can drive said rotary member from said first end position to said second end position.

36. The device of claim 34 wherein said drive means includes rewind means for returning said rotary member from said second end position to said first end position against said bias of said spring means.

37. A device for puncturing the skin comprising:

(a) skin puncturing means;

(b) mounting means for mounting said skin puncturing means for translational rectilinear motion in a predetermined direction between a retracted position in which said skin puncturing means is in a non-skin puncturing location and an extended position in which said skin puncturing means can affect said puncturing of said skin;

(c) actuation means for actuating said translational rectilinear motion of said mounting means;

(d) a housing extending longitudinally in said predetermined direction, and including an aperture, said mounting means and said actuation means being mounted within said housing such that said skin puncturing means extends from said aperture in said housing when in said extended position and is contained within said housing when in said retracted position, said housing including an internal housing portion and an external housing portion, said mounting means and said actuation means being mounted within said internal housing portion, said internal housing portion being entirely enclosed within said external housing portion and relatively longitudinally displaceable within said external housing portion independent of said translational motion of said skin puncturing means; and

(e) skin sensor means extending from said internal housing portion for engaging said skin whereby said internal housing portion can be and for longitudinally locating said internal housing portion within said external housing portion at a predetermined distance from the skin that will not change during said puncturing such that said skin puncturing means will extend from said housing to puncture said skin by a predetermined depth when in said extended position.

38. The device of claim 37 including spring bias means for biasing said internal housing portion relative to said external housing portion so as to urge said internal housing portion towards said housing aperture.

39. The device of claim 37 including limit means for limiting said longitudinal displacement of said internal housing portion with respect to said external housing portion.

40. The device of claim 37 wherein said external housing portion includes a first external housing portion and a second external housing portion, said second external housing portion being relatively rotatable with respect to said first external housing portion in a plane transverse to said predetermined direction.

41. The device of claim 40 wherein said second external housing portion includes body part engaging means for mounting said device relative to a predetermined location with respect to a body part, whereby upon said rotation of said second external housing portion with respect to said first external housing portion said skin puncturing means can be aligned with different sites on a body part while said first external housing portion remains stationary.