Apparatus and method for minimally invasive blood sampling

• US 5,938,679 A
• Filed: 10/14/1997
• Issued: 08/17/1999
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Hewlett-Packard Company (HP Inc.)
• Inventors: Greenstein, Michael, Freeman, Dominique, Simons, Tad, Lum, Paul, King, David
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/949,727
• Time in Patent Office: 672 Days
• Field of Search: 606/181-185, 606/166, 606/169, 604/164
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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

Abstract

A blood sampling device for penetrating skin to obtain a blood sample is disclosed. The blood sampling device has a blade structure that can be extended from a housing to pierce the skin and then retracted. The blade structure has at least two blades each including a cutting edge. The blades abut one another to form a rigid joint from which the blades extend. The blades each have a distal portion in which the distance from the rigid joint to the cutting edge decreases towards and terminates at a sharp point at a distal end. Each blade generally forms an angle less than 180 degrees with at least one neighboring blade. This structure decreases the tendency of the blade structure to flex as the distal end of the blade structure penetrates the skin to yield blood.

Claims

1. A blood sampling device for penetrating skin to sample blood therefrom, comprising:

(a) a housing;

(b) a blade structure retractably connected in the housing, the blade structure having at least two blades each including a cutting edge, the blades abutting one another to form one or more rigid joints such that the cutting edges are remote from the corresponding one or more rigid joints, the blade structure having a distal portion in which for each blade the distance from the rigid joint to the cutting edge associated with the blade decreases towards a distal end of the blade structure, to terminate at a sharp point, such that a plane that passes through the mid-line of a blade (center plane) forms an angle less than 180 degree with at least one neighboring center plane of blades neighboring thereto, thereby decreasing the tendency of the blade structure to flex as the distal end of the blade structure is driven into the skin to yield blood therefrom;

(c) means connecting to the blade structure and the housing for limiting the penetration of the blade structure to a distance in the skin sufficiently deep to cause bleeding.

2. The blood sampling device according to claim 1 wherein the blades are planar and extend radially from the rigid joint.

3. The blood sampling device according to claim 2 further comprising at least one capillary, the capillary extending along the rigid joint at the distal portion of the blade structure and being cradled between two blades that abut at an angle less than 180 degrees, the capillary having a distal opening proximate to the distal end of the blade structure.

4. The blood sampling device according to claim 3 wherein the capillary is detachable at least in part from the distal portion of the blade structure such that after penetrating the skin the blade structure is retractable from the skin, thereby leaving the distal opening of the capillary to stay proximate to the skin for allowing blood to enter the capillary therefrom.

5. The blood sampling device according to claim 3 wherein the blade structure has three or more planar blades and the same number of capillaries as the blades, each capillary being cradled between two blades forming an angle between 70 degrees and 120 degrees.

6. The blood sampling device according to claim 2 wherein the housing has an annular wall surrounding a distal opening to a chamber in the housing from which the distal end of the blade structure can protrude to penetrate the skin, such that blood can enter through the distal opening to the chamber after the blade structure is retracted from the skin.

7. The blood sampling device according to claim 1 wherein the blades are adapted to have arc surfaces such that cross sections of the distal portion of the blade structure vary in shape dependent on the distance from the distal end, each cross section including abutting arcs with their arc-tips generally facing away from the mid point of the cross section, the arcs in the cross sections increasing in length progressively from a rigid point at the distal end to become shaped as a continuous ring at a location more remote from the distal end such that the blades change progressively from a point at the distal end to each become a capillary through which blood can pass at the location more remote from the distal end.

8. The blood sampling device according to claim 1 further comprising an actuator associated with the blade structure for driving the blade structure and retracting the distal end of the blade structure into the housing, the device further comprising a means associated with the housing proximate to the blade structure for accepting blood after the blade structure incises the skin.

9. The blood sampling device according to claim 1 wherein the cutting edges have no sharp bends to penetrate the skin.

10. The blood sampling device according to claim 1 further comprising a suction means for removing blood from the skin after incision by the blade structure.

11. The blood sampling device according to claim 1 wherein at least three blades abut one another in the blade structure.

12. A blood sampling device for penetrating skin to sample blood therefrom, comprising:

(a) a housing;

(b) a blade structure operatively retractably connected to the housing, the blade structure having three planar blades each including a cutting edge, the blades abutting one another to form a rigid joint from which the blades extend such that the cutting edges are remote from the rigid joint, the blade structure having a distal portion in which the distance from the rigid joint to each cutting edge decreases towards a distal end terminating at a sharp point, each blade forming an angle less than 180 degrees with blades neighboring thereto;

(c) one to three capillaries, each capillary extending along the rigid joint at the distal portion of the blade structure and being cradled between two blades, each capillary having a distal opening proximate to the distal end of the blade structure for blood to enter from the skin; and

(d) an actuator associated with the blade structure for driving the blade structure to incise the skin and retracting the distal end of the blade structure into the housing after incision.

13. A method of making a blood sampling device for penetrating skin to sample blood therefrom, comprising:

installing a blade structure in a housing in such a way that the blade structure is extendable out of the housing and retractable into the housing, the blade structure having at least two blades each including a cutting edge, the blades abutting one another to form one or more rigid joints such that cutting edges are remote from the corresponding one or more rigid joints, the blade structure having a distal portion in which for each blade the distance from the rigid joint to the cutting edge associated with the blade decreases towards a distal end of the blade structure to terminate at a sharp point, such that a plane that passes through the mid-line of a blade (center plane) forms an angle less than 180 degrees with at least one neighboring center plane of blades neighboring thereto, thereby decreasing the tendency of the blade structure to flex as the distal end of the blade structure is driven into the skin to yield blood therefrom.

14. The method according to claim 13 further comprising disposing at least one capillary in the blood sampling device such that each of the at least one capillary extends along the rigid joint at a distal portion of the blade structure and is cradled between two blades that abut at an angle, the capillary having a distal opening proximate to the distal end of the blade structure.

15. The method according to claim 14 further comprising detachably disposing at least a portion of the at least one capillary on the blades such that after penetrating the skin the blade structure can be retracted from the skin to leave the distal opening of the capillary proximate to the skin to pass blood into the capillary.

16. The method according to claim 14 wherein the angle between adjacent blades is between 70 degrees and 120 degrees.

17. The method according to claim 13 wherein the rigid joint has a center and the method further comprising attaching nonplanar blades to form the blade structure, such that the cross sections of the distal portions of the blades form arcs having arc-tips facing away from the center of the rigid joint, the arcs increasing in length progressively from the distal end to become circular remote from the distal end such that the blades each become a capillary through which blood can pass.

18. The method according to claim 13 further comprising installing an actuator to associate with the housing for driving the distal end of the blade structure out of and back into the housing and further comprising installing a means associated with the housing proximate to the blade structure for accepting blood after the blade structure cuts the skin.

19. A method for sampling blood from skin, comprising:

driving a blade structure from a housing to penetrate the skin, the blade structure having at least two blades each including a cutting edge, the blades abutting one another to form a rigid joint from which the blades extend such that the cutting edges are remote from the rigid joint, the blade structure each having a distal portion in which the distance from the rigid joint to the cutting edge decreases towards a distal end to terminate at a sharp point, each blade having a center plane such that each center plane forms an angle less than 180 degrees with at least one neighboring center plane of blades neighboring thereto, such that the tissue of the skin slides along the surface of the blades to reduce tearing and such that the tendency of the blade structure to flex is reduced as the distal end of the blade structure is driven into the skin to yield blood therefrom;

stopping the blade structure after the blade structure has penetrated the skin to a distance reaching blood vessels to cause bleeding; and

withdrawing the blade structure from the skin to allow blood to exit the skin.

20. A blood sampling device for penetrating skin to sample blood therefrom, comprising:

(a) a housing; and

(b) a lancet size blade structure retractably connected in the housing, the blade structure having at least two blades each including a cutting edge, the blades abutting one another to form one or more rigid joints such that the cutting edges are remote from the corresponding one or more rigid joints, the blade structure having a distal portion in which for each blade the distance from the rigid joint to the cutting edge associated with the blade decreases towards a distal end of the blade structure, to terminate at a sharp point, such that a plane that passes through the mid-line of a blade (center plane) forms an angle less than 180 degree with at least one neighboring center plane of the neighboring blades neighboring thereto, thereby decreasing the tendency of the blade structure to flex as the distal end of the blade structure is driven into the skin to yield blood therefrom.

21. The blood sampling device according to claim 20, wherein each blade in the blade structure has a thickness that is less than 100 microns near the distal portion.

22. A blood sampling device for penetrating skin to sample blood therefrom, comprising:

(a) a housing; and

(b) a blade structure retractably connected in the housing, the blade structure having at least two blades each including a cutting edge, the blades abutting one another to form one or more rigid joints such that the cutting edges are remote from the corresponding one or more rigid joints, the blade structure having a distal portion in which for each blade the distance from the rigid joint to the cutting edge associated with the blade decreases towards a distal end of the blade structure, to terminate at a sharp point, such that a plane that passes through the mid-line of a blade (center plane) forms an angle less than 180 degree with at least one neighboring center plane of blades neighboring thereto, thereby decreasing the tendency of the blade structure to flex as the distal end of the blade structure is driven into the skin to yield blood therefrom;

wherein the blades are generally planar and extend radially from the rigid joint; and

(c) at least one capillary, the capillary extending along the rigid joint at the distal portion of the blade structure and being cradled between two blades that abut at an angle less than 180 degrees, the capillary having a distal opening proximate to the distal end of the blade structure.