Rotatable penetration depth adjusting arrangement

• US 6,645,219 B2
• Filed: 09/07/2001
• Issued: 11/11/2003
• Est. Priority Date: 09/07/2001
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Pantuck, Bradford C
• Application Number:
  US09/948,064
• Publication Number:
  US 20030050655A1
• Time in Patent Office: 795 Days
• Field of Search: 606/172, 606/182, 606/183, 606/181
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150824 by visual feedback
• 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

An arrangement of interfitting components for adjusting the penetration depth of a lancet and for stimulating an area surrounding an incision formed by penetration of a surface of the skin by the lancet, thereby facilitating the extraction of a sample of bodily fluid with a minimally invasive incision, the arrangement includes: a bottom end adapted to be applied to the surface of the skin, and a top end opposite the bottom end; a longitudinally moveable lancing member having a sharp end; a stop member setting a longitudinal travel distance of the lancing member; a bottom surface adapted to be applied to the surface of the skin, and an opening in the bottom surface through which the lancing member projects; a penetration depth defined by the distance between the end of the lancing device and the bottom surface; an adjusting mechanism for changing the penetration depth; and a stimulation mechanism for stimulating the area surrounding the incision and facilitating the extraction of the sample of bodily fluid.

Claims

1. An adjustable arrangement, comprising:

a carrier;

a guide tube, the guide tube receiving the carrier in a longitudinally slidable manner, the guide tube comprises a stop member limiting longitudinal movement of the carrier;

an inner ring, the inner ring adjustably attached to the guide tube, the inner ring comprising a bottom surface adapted to contact a surface of the skin and to depress a ring of body tissue;

an outer ring, the outer ring receiving the inner ring in a longitudinally slidable and relatively nonrotatable manner;

a retainer ring, the retainer ring receiving the guide tube in a longitudinally fixed and relatively nonrotatable manner, the retainer ring receiving the outer ring in a longitudinally slidable and relatively rotatable manner; and

wherein the guide tube further comprises a top end comprising a retaining section;

a plurality of guide slots extending longitudinally from the top end, each guide slot comprising a stop surface;

a body section; and

connecting section comprising an internally threaded bore.

2. The arrangement of claim 1, wherein the bottom surface of the inner ring is beveled at an angle of 10 to 65°

.

3. The arrangement of claim 1, further comprising a lancet received within the carrier.

4. The arrangement of claim 1, wherein the carrier further comprises a top end having one or more projections, an elongate body section, and a bottom section having a central opening.

5. An adjustable arrangement, comprising:

a carrier;

a guide tube, the guide tube receiving the carrier in a longitudinally slidable manner, the guide tube comprises a stop member limiting longitudinal movement of the carrier;

an inner ring, the inner ring adjustably attached to the guide tube, the inner ring comprising a bottom surface adapted to contact a surface of the skin and to depress a ring of body tissue;

an outer ring, the outer ring receiving the inner ring in a longitudinally slidable and relatively nonrotatable manner;

a retainer ring, the retainer ring receiving the guide tube in a longitudinally fixed and relatively nonrotatable manner, the retainer ring receiving the outer ring in a longitudinally slidable and relatively rotatable manner; and

wherein the inner ring further comprises an opening disposed in the bottom end;

a retaining flange forming a longitudinal stop with respect to the outer ring, and one or more antirotation projections;

a plurality of internal longitudinally extending ridges receiving the carrier therein; and

a connecting section comprising external threads constructed to mate with the internal threads of the guide tube.

6. The arrangement of claim 5, wherein the outer ring further comprises a bottom surface adapted to contact a surface of the skin;

one or more longitudinally extending grooves terminating in a stop shoulder receiving the one or more antirotation projections of the inner ring;

first and second stop surfaces limiting rotational movement of the outer ring with respect to the retainer ring; and

a transition surface between the stop surfaces for limiting the longitudinal movement of the outer ring within the retainer ring.

7. The arrangement of claim 6, wherein the outer ring further comprises a bottom flange having alternating projections and grooves.

8. The arrangement of claim 6, wherein the outer ring further comprises a body section provided with indicia.

9. The arrangement of claim 6, wherein the transition surface comprises a plurality of steps.

10. The arrangement of claim 6, wherein the outer ring further comprises a body section and one or more flexible fingers extending from a top portion of the body section.

11. The arrangement of claim 6, wherein:

the outer ring includes indicia; and

the retainer ring further comprises a bottom flange comprising a pointer for cooperation with the indicia of the outer ring.

12. An adjustable arrangement, comprising:

a carrier;

a guide tube, the guide tube receiving the carrier in a longitudinally slidable manner, the guide tube comprises a stop member limiting longitudinal movement of the carrier;

an inner ring, the inner ring adjustably attached to the guide tube, the inner ring comprising a bottom surface adapted to contact a surface of the skin and to depress a ring of body tissue;

an outer ring, the outer ring receiving the inner ring in a longitudinally slidable and relatively nonrotatable manner;

a retainer ring, the retainer ring receiving the guide tube in a longitudinally fixed and relatively nonrotatable manner, the retainer ring receiving the outer ring in a longitudinally slidable and relatively rotatable manner; and

wherein retainer ring further comprises an inner bore comprising a land having first and second stop surfaces;

an elongate body section;

a plurality of retainer projections extending from a top end of the inner bore receiving a portion of the guide tube;

one or more retention tabs disposed at the top end of the retainer ring overlying at least a portion of the carrier; and

an attachment formation.

13. An adjustable arrangement comprising:

a carrier;

a guide tube, the guide tube receiving the carrier in a longitudinally slidable manner, the guide tube comprises a stop member limiting longitudinal movement of the carrier;

an inner ring, the inner ring adjustably attached to the guide tube, the inner ring comprising a bottom surface adapted to contact a surface of the skin and to depress a ring of body tissue;

an outer ring, the outer ring receiving the inner ring in a longitudinally slidable and relatively nonrotatable manner;

a retainer ring, the retainer ring receiving the guide tube in a longitudinally fixed and relatively nonrotatable manner, the retainer ring receiving the outer ring in a longitudinally slidable and relatively rotatable manner; and

a first biasing element disposed over the carrier, the first biasing element retained between projections disposed on a top end of the carrier and a top surface of the inner ring; and

second biasing element, the second biasing element being retained between a top surface of the body section of the outer ring and retaining projections disposed on the retainer ring.

14. The arrangement of claim 13, wherein the first and second biasing elements comprise coil springs.

15. An arrangement of interfitting components for adjusting the penetration depth of a lancet and for stimulating an area surrounding an incision formed by penetration of a surface of the skin by the lancet, thereby facilitating the extraction of a sample of bodily fluid with a minimally invasive incision, the arrangement comprising;

a bottom end adapted to be applied to the surface of the skin, and a top end opposite the bottom end;

a longitudinally moveable lancing member having a sharp end;

a stop member setting a longitudinal travel distance of the lancing member;

a bottom surface adapted to be applied to the surface of the skin, and an opening in the bottom surface through which the lancing member projects;

a penetration depth defined by the distance between the end of the lancing device and the bottom surface;

adjusting means for changing the penetration depth;

stimulation means for stimulating the area surrounding the incision and facilitating the extraction of the sample of bodily fluid;

wherein the stimulation means comprises one or more stimulating members constructed to depress a ring of body tissue in a manner which at least partially surrounds the incision; and

wherein the components of the arrangement comprise an outermost ring member concentrically surrounding the other components, and at least one of the stimulating members is longitudinally moveable with respect to the outermost ring member.

16. The arrangement of claim 15, wherein the stimulation means comprises a beveled surface.

17. The arrangement of claim 15, wherein the adjusting means comprises means for changing a separation distance defined between the stop member and the bottom surface in response to relative rotation between two or more components of the arrangement.

19. The apparatus of claim 15, wherein:

the inner member has an antirotation tab; and

the outer member defines a longitudinal groove in which the tab is slidably received to minimize relative rotation between the inner member and the outer member while permitting relative longitudinal movement between the inner member and the outer member.

20. The apparatus of claim 19, further comprising a biasing element positioned between the retainer and the outer member to bias the outer member against the skin.

18. An apparatus, comprising:

a retainer;

a guide coupled to the retainer in a non-rotatable manner to minimize relative rotation between the retainer and the guide, the guide having a stop member;

a carrier slidably received in the guide tube, the retainer being configured to carry a lancet for lancing skin, the carrier having a portion configured to contact the stop member of the guide to limit penetration depth of the lancet into the skin;

an inner member defining an opening through which the lancet extends to lance the skin, the inner member having a skin-contacting surface surrounding the opening that is adapted to contact the skin, the inner member being threadedly engaged with the guide for adjusting a distance between the stop member and the skin-contacting surface in order to adjust the penetration depth of the lancet; and

an outer member slidably received around the inner member, the outer member having a skin-engaging surface adapted to engage the skin for expressing fluid from an incision formed by the lancet.

21. The apparatus of claim 18, further comprising a biasing element positioned between the retainer and the outer member to bias the outer member against the skin.

22. The apparatus of claim 21, further comprising a second biasing element positioned between the carrier and the inner member to retract the lancet after lancing the skin.

23. The apparatus of claim 21, wherein the biasing element includes a coil spring.

24. The apparatus of claim 18, further comprising the lancet.

25. The apparatus of claim 18, wherein the inner member and the outer member are ring-shaped.

26. The apparatus of claim 25, wherein the retainer and the outer member each have staircase-shaped surfaces to limit longitudinal movement of the outer member.