Method and apparatus for sampling and analysis of fluids

• US 8,092,394 B2
• Filed: 09/13/2005
• Issued: 01/10/2012
• Est. Priority Date: 09/13/2004
• Status: Active Grant

• Current Assignee: Microsample Ltd.
• Original Assignee: Microsample Ltd.
• Inventors: Harman, Anthony David, Cassells, John Maclaren
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Danega, Renee
• Application Number:
  US11/574,919
• Publication Number:
  US 20070232956A1
• Time in Patent Office: 2,310 Days
• Field of Search: 600/573
• US Class Current: 600/573
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/1519 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
• CPC Class Codes: A61B 5/411 : Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/441 : Skin evaluation, e.g. for skin disorder diagnosis

Abstract

A medical device having a housing (2) with a bore (3) and a lancet (1) slidably fitting in the bore. The lancet operates as a positive displacement piston. In a retracted position, in which the lancet is rearwardly displaced along the bore to define a fluid-containing space in the bore forwardly on the lancet tip, the fluid-containing space has a cross-section dimension to allow fluid to be retained therein by surface tension. The device has a seal (6) operable substantially to prevent flow of fluid from the fluid-containing space past the seal means on movement of the lancet. Displacement of the lancet between the puncture and retracted positions provides suction for drawing fluid into and along the fluid-containing space from the forward end of the bore, and/or pressure for expelling fluid from the fluid-containing space via the forward end of the bore. Also disclosed are methods for operating the device.

Claims

1. An allergy-testing device, the device having a housing with a bore and a lancet slidably fitting in the bore, the lancet being a penetrating component and being movable between a puncture position, in which a sharpened tip of the lancet is exposed from a forward end of the bore for a puncture operation, and a retracted position, in which the lancet is rearwardly displaced along the bore to a safe position to protect users from needle-stick injuries, the device having seal means in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet during forward and rearward displacement of the lancet, wherein in the retracted position a liquid-containing space is defined in the bore forwardly of the lancet tip, an aqueous liquid contained in the liquid-containing space comprising an aqueous solution of allergen or a suspension of allergen particles in a carrier liquid, the liquid-containing space having a cross-sectional diameter of 3 mm or less to allow aqueous liquid to fully bridge across the diameter of the forward end of the bore and wet the full circumference of the forward end of the bore and be aspirated into the liquid-containing space, and be retained in the liquid-containing space by surface tension forces and by the seal means, wherein the seal means is operable substantially to prevent flow of the aqueous liquid from the liquid-containing space past the seal means on forwards, and rearwards displacement of the lancet and to oppose dripping of the aqueous liquid from the forward end of the bore under the influence of gravity so that:

(i) displacement of the lancet from the puncture position to the retracted position provides suction for drawing aqueous liquid into and along the liquid-containing space from the forward end of the bore, and

(ii) displacement of the lancet from the retracted position to the puncture position provides pressure for expelling aqueous liquid from the liquid-containing space via the forward end of the bore;

wherein the device further includes a spacer member located forwardly of the forward end of the bore, the spacer member being for contact with the skin of a subject, the spacer member including a vent which vents the spacer member and the forward end of the bore when the sealing means is in sealing engagement with the sealing surface and the spacer member is pressed against the skin of the subject;

wherein the seal means is formed by the outer surface of the lancet, the sealing surface being an internal surface of the bore.

2. A device according to claim 1 wherein the outer surface of the lancet is profiled to provide the seal means as a surrounding projection.

3. A device according to claim 1 wherein the seal means is disposed adjacent the lancet tip, at least when the lancet is in the retracted position.

4. A device according to claim 1 having cooperating means for providing an intermediate delay position for the lancet between the puncture position and the retracted position.

5. A device according to claim 1 having at least one stop member for limiting the forward and/or rearward travel of the lancet.

6. A device according to claim 4 wherein, during retraction from the puncture position, the contacting or increased contacting of the seal means with the sealing surface provides the intermediate delay position.

7. A device according to claim 1 wherein the bore includes a region of increased cross-section dimension for location of the seal means or the sealing surface at the puncture position of the lancet.

8. A device according to claim 1 wherein the seal means or sealing surface is disposed beyond the forward end of the bore at the puncture position of the lancet.

9. A device according to claim 1 wherein the seal means is a sealing member disposed rearwardly in the device from the forward tip of the lancet and movable with the lancet tip and the sealing surface is formed by the internal surface of a sealing region of the bore.

10. A device according to claim 9 wherein a cross-sectional dimension of the sealing member is greater than a cross-sectional dimension of the liquid-containing space but less than or equal to 10 times the cross-sectional dimension of the liquid-containing space.

11. A device according to claim 1 wherein the lancet tip is sharpened to have a radius of curvature in at least one dimension of one quarter or less of the narrowest cross-sectional dimension of a non-tip region of the lancet.

12. A device according to claim 1 wherein, in use, the liquid-containing space presents means for measuring or testing a characteristic of the liquid to liquid contained in the liquid-containing space.

13. A device according to claim 1 having a secondary conduit from the bore, communicating with the liquid-containing space.

14. A device according to claim 1 having a closure member located forwardly of the lancet tip, sealing at least a part of the liquid-containing space.

15. A device according to claim 1 wherein the spacer member is dimensioned to provide an accumulation space between a puncture in the skin of the subject and the forward end of the bore.

19. A device according to claim 1 including sensing means for sensing the presence and/or amount of liquid along the liquid-containing space.

20. An allergy-testing device according to claim 1 wherein the liquid-containing space is pre-filled and sealed, the liquid-containing space being pre-filled with said aqueous liquid.

16. A device according to claim l including sensing means for sensing the presence or absence of liquid at the forward end of the bore.

17. A device according to claim 16 wherein the sensing means includes at least two electrodes, at least one of which is located at the forward end of the bore to detect the presence or absence of liquid at the forward end of the bore by measurement of the resistance between the electrodes.

18. A device according to claim 17 wherein the lancet provides one of the electrodes.

21. An allergy-testing device, the device having a housing with a bore and a lancet slidably fitting in the bore, the lancet being a penetrating component and being movable between a puncture position, in which a sharpened tip of the lancet is exposed from a forward end of the bore for a puncture operation, and a retracted position, in which the lancet is rearwardly displaced along the bore to a safe position to protect users from needle-stick injuries, the device having seal means in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet during forward and rearward displacement of the lancet, wherein in the retracted position a liquid-containing space is defined in the bore forwardly of the lancet tip, an aqueous liquid contained in the liquid-containing space comprising an aqueous solution of allergen or a suspension of allergen particles in a carrier liquid, the liquid-containing space having a cross-sectional diameter of 3 mm or less to allow aqueous liquid to fully bridge across the diameter of the forward end of the bore and wet the full circumference of the forward end of the bore and be aspirated into the liquid-containing space, and be retained in the liquid-containing space by surface tension forces and by the seal means, wherein the seal means is operable substantially to prevent flow of the aqueous liquid from the liquid-containing space past the seal means on forwards and rearwards displacement of the lancet and to oppose dripping of the aqueous liquid from the forward end of the bore under the influence of gravity so that:

(i) displacement of the lancet from the puncture position to the retracted position provides suction for drawing aqueous liquid into and along the liquid-containing space from the forward end of the bore, and

(ii) displacement of the lancet from the retracted position to the puncture position provides pressure for expelling aqueous liquid from the liquid-containing space via the forward end of the bore;

wherein the device further includes a spacer member located forwardly of the forward end of the bore, the spacer member being for contact with the skin of a subject, the spacer member including a vent which vents the spacer member and the forward end of the bore when the sealing means is in sealing engagement with the sealing surface and the spacer member is pressed against the skin of the subject;

wherein the seal means is a sealing member disposed around the lancet, the sealing surface being an internal surface of the bore.

22. An allergy-testing device, the device having a housing with a bore and a lancet slidably fitting in the bore, the lancet being a penetrating component and being movable between apuncture position, in which a sharpened tip of the lancet is exposed from a forward end of the bore for a puncture operation, and a retracted position, in which the lancet is rearwardly displaced along the bore to a safe position to protect users from needle-stick injuries, the device having seal means in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet during forward and rearward displacement of the lancet, wherein in the retracted position a liquid-containing space is defined in the bore forwardly of the lancet tip, an aqueous liquid contained in the liquid-containing space comprising an aqueous solution of allergen or a suspension of allergen particles in a carrier liquid, the liquid-containing space having a cross-sectional diameter of 3 mm or less to allow aqueous liquid to fully bridge across the diameter of the forward end of the bore and wet the full circumference of the forward end of the bore and be aspirated into the liquid-containing space, and be retained in the liquid-containing space by surface tension forces and by the seal means, wherein the seal means is operable substantially to prevent flow of the aqueous liquid from the liquid-containing space past the seal means on forwards and rearwards displacement of the lancet and to oppose dripping of the aqueous liquid from the forward end of the bore under the influence of gravity so that:

(i) displacement of the lancet from the puncture position to the retracted position provides suction for drawing aqueous liquid into and along the liquid-containing space from the forward end of the bore, and

(ii) displacement of the lancet from the retracted position to the puncture position provides pressure for expelling aqueous liquid from the liquid-containing space via the forward end of the bore;

wherein the device further includes a spacer member located forwardly of the forward end of the bore, the spacer member being for contact with the skin of a subject, the spacer member including a vent which vents the spacer member and the forward end of the bore when the sealing means is in sealing engagement with the sealing surface and the spacer member is pressed against the skin of the subject;

wherein the seal means is a sealing member disposed at the internal surface of the bore, the sealing surface being an outer surface of the lancet.

23. A device according to claim 22 wherein the seal means is a rod seal.

24. A method of operating an allergy-testing device, the device having a housing with a bore and a lancet slidably fitting in the bore, the lancet being a penetrating component and being movable between a puncture position, in which a sharpened tip of the lancet is exposed from a forward end of the bore for a puncture operation, and a retracted position, in which the lancet is rearwardly displaced along the bore to a safe position to protect users from needle-stick injuries, the device having seal means in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet during forward and rearward displacement of the lancet, wherein in the retracted position, a liquid-containing space is defined in the bore forwardly of the lancet tip, the liquid-containing space having a cross-sectional diameter of 3 mm or less so that aqueous liquid fully bridges across the diameter of the forward end of the bore and wets the full circumference of the forward end of the bore and is aspirated into the liquid-containing space, and is retained in the liquid containing space by surface tension forces and by the seal means, wherein the seal means substantially prevents flow of the aqueous liquid from the liquid-containing space past the seal means on forward and rearwards displacement of the lancet and opposes dripping of the aqueous liquid from the forward end of the bore under the influence of gravity, the method including displacing the lancet between the puncture and retracted positions to carry out the following steps in sequence:

(i) drawing aqueous liquid into and along the liquid-containing space from the forward end of the bore by suction, the aqueous liquid comprising an aqueous solution of allergen or a suspension of allergen particles in a carrier liquid,

(ii) before puncturing the skin of a subject, expelling said aqueous liquid from the liquid-containing space via the forward end of the bore onto the skin of the subject at a skin location to be punctured, and

(iii) puncturing the skin of the subject at the skin location to be punctured;

wherein the device further includes a spacer member located forwardly of the forward end of the bore, the spacer member including a vent, wherein in steps (ii) and (iii) the spacer member is pressed in contact with the skin of the subject and the vent vents the spacer member and the forward end of the bore when the sealing means is in sealing engagement with the sealing surface.

25. A method of operating an allergy-testing device, the device having a housing with a bore and a lancet slidably fitting in the bore, the lancet being a penetrating component and being moveable between a puncture position, in which a sharpened tip of the lancet is exposed from a forward end of the bore for a puncture operation, and a retracted position, in which the lancet is rearwardly displaced along the bore to a safe position to protect users from needle-stick injuries, the device having seal means in sliding engagement with a sealing surface, one of the seal means and the sealing surface being fixedly movable with the lancet during forward and rearward displacement of the lancet, wherein in the retracted position, a liquid-containing space is defined in the bore forwardly of the lancet tip, wherein an aqueous liquid is contained in the liquid-containing space comprising an aqueous solution of allergen or a suspension of allergen particles in a carrier liquid, the liquid-containing space having a cross-sectional diameter of 3 mm or less so that aqueous liquid fully bridges across the diameter of the forward end of the bore and wets the full circumference of the forward end of the bore and is retained in the liquid-containing space by surface tension forces and by the seal means, wherein the seal means substantially prevents flow of said aqueous liquid from the liquid-containing space past the seal means on forward and rearwards displacement of the lancet and opposes dripping of the aqueous liquid from the forward end of the bore under the influence of gravity, the method including displacing the lancet between the puncture and retracted positions to carry out the following steps in sequence:

(i) before puncturing the skin of a subject, expelling said aqueous liquid from the liquid-containing space via the forward end of the bore onto the skin of the subject at a skin location to be punctured, and

(ii) puncturing the skin of the subject at the skin location to be punctured;

wherein the device further includes a spacer member located forwardly of the forward end of the bore, the spacer member including a vent, wherein in steps (i) and (ii) the spacer member is pressed in contact with the skin of the subject and the vent vents the spacer member and the forward end of the bore when the sealing means is in sealing engagement with the sealing surface.