Blood sampling apparatus and method

• US 20050101979A1
• Filed: 06/12/2002
• Published: 05/12/2005
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Lum, Paul, Alden, Don, Freeman, Dominique M., Drbal, Vladimir
• Granted Patent: US 7,682,318 B2
• Time in Patent Office: Days
• 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 5/150152 by an adequate mechanical impact on the puncturing location
• 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 5/15019 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 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150435 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• 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

Abstract

Blood samples can be collected without substantial contamination from ambient air, such that the blood sample may be analysed accurately for gaseous components such as oxygen and carbon dioxide. An embodiment of th device has integrated actuation, lancing, and sample acquisition components, which in some embodiments are miniaturized and/or disposable.

Claims

1. A device for collecting blood from the skin of a patient, the device comprising

a housing having a sampling site, the sampling site defining an opening,

a sample reservoir in fluid communication with the opening,

a lancet maintained within the housing, the lancet having a lancet tip adjacent the opening, and

a lancet driver operably disposed to the lancet to drive the lancet tip through the opening to lance the skin when the lancet driver is actuated,

the device being configured to allow actuation of the lancet driver, lancing of the skin, collection of the blood, and movement of the blood to the sample reservoir to be integrated,

the device further being configured to allow the blood to be collected seamlessly.

2. The device of claim 1, wherein the sampling site is adapted to conform to the skin of the patient to form a substantially airtight seal at the opening when the skin is firmly pressed against the sampling site.

3. The device of claim 1, further comprising a sampling port and a pierceable membrane, the sampling port having a first end contiguous with the opening and a second end opposite the first end relatively nearer to the lancet tip than the first end, the pierceable membrane adjacent to the second end between the lancet tip and the opening.

4. The device of claim 3, wherein the membrane is resealable.

5. The device of claim 3, wherein the sampling port has a surface, wherein at least a portion of the sampling port surface is hydrophilic.

6. The device of claim 3, wherein the membrane has a surface, wherein at least a portion of the membrane surface is hydrophobic.

7. The device of claim 1, further comprising at least one capillary channel in fluid communication with the opening and the sample reservoir, the capillary channel having a surface, at least a portion of the capillary channel surface being hydrophilic.

8. The device of claim 7, having at least two capillary channels, wherein at least one of the capillary channels is a primary capillary channel and at least one of the capillary channels is a supplemental capillary channel, each capillary channel having a cross-sectional area, wherein the cross-sectional area of the at least one primary capillary channel is at least twice the cross sectional area of the at least one supplemental capillary channel.

9. The device of claim 7, wherein the sample reservoir comprises a chamber in fluid communication with the opening, the chamber having a perimeter, and a flexible diaphragm attached to the perimeter of the chamber, the flexible diaphragm capable of moving within the chamber under the influence of a pressure source, said movement of the diaphragm serving to facilitate transport of the blood through the at least one capillary channel.

10. The device of claim 1, wherein the device further comprises testing means in fluid communication with the opening.

11. The device of claim 1, further comprising a depth selector in operable relation to the lancet and a preload adjustment means in operable relation to the lancet driver.

12. The device of claim 1, wherein the device has dimensions smaller than about 80 mm by 30 mm by 10 mm.

13. The device of claim 1, further comprising a backup lancet operably disposed to the sampling site.

14. The device of claim 1, further comprising a backup lancet having a backup lancet tip, the backup lancet maintained within the housing, the sampling site defining a backup opening adjacent the backup lancet tip, the backup opening in fluid communication with the sample reservoir.

15. The device of claim 1, further comprising a backup reservoir in fluid communication with the sampling site.

16. The device of claim 1, further comprising a backup lancet having a backup lancet tip, the backup lancet maintained within the housing, the sampling site defining a backup opening adjacent the backup lancet tip, the sample acquisition module further comprising a backup reservoir in fluid communication with the backup opening.

17. A sample acquisition module for use in collecting blood from the skin of a patient, the sample acquisition module comprising

a housing,

a sampling site on the housing defining an opening, the sampling site shaped to conform to the skin and to form a substantially airtight seal with the skin,

a lancet maintained within the housing, the lancet having a lancet tip adjacent the opening, wherein the lancet is operable to send the lancet tip through the opening to lance the skin of the patient, and

a sample reservoir in fluid communication with the opening, the sample acquisition module configured to allow

seamless sampling of the blood, and

a) integrated lancing of the skin, collection of the blood through the opening, and movement of the blood to the sample reservoir.

18. The sample acquisition module of claim 17, wherein the housing further comprises an attachment site for attaching a lancet driver.

19. The sample acquisition module of claim 17, wherein the sample acquisition module further comprises a lancet driver within the housing, the lancet driver operably disposed to the lancet.

20. The sample acquisition module of claim 17, further comprising a sampling port and a pierceable membrane, the sampling port having a first end contiguous with the opening and a second end opposite the first end relatively nearer to the lancet tip than the first end, the pierceable membrane adjacent to the second end between the lancet tip and the opening.

21. The sample acquisition module of claim 20, wherein the membrane is resealable.

22. The sample acquisition module of claim 20, wherein the sampling port has a surface, wherein at least a portion of the sampling port surface is hydrophilic.

23. The sample acquisition module of claim 20, wherein the membrane has a surface, wherein at least a portion of the membrane surface is hydrophobic.

24. The sample acquisition module of claim 17, further comprising at least one capillary channel in fluid communication with the opening and the sample reservoir, the capillary channel having a surface, at least a portion of the capillary channel surface being hydrophilic.

25. The sample acquisition module of claim 24, having at least two capillary channels, wherein at least one of the capillary channels is a primary capillary channel and at least one of the capillary channels is a supplemental capillary channel, each capillary channel having a cross-sectional area, wherein the cross-sectional area of the at least one primary capillary channel is at least twice the cross-sectional area of the at least one supplemental capillary channel.

26. The sample acquisition module of claim 24, wherein the sample reservoir comprises a chamber in fluid communication with the opening, the chamber having a perimeter, and a flexible diaphragm attached to the perimeter of the chamber, the flexible diaphragm capable of moving within the chamber under the influence of a pressure source, said movement of the diaphragm serving to facilitate transport of the blood through the at least one capillary channel.

27. The sample acquisition module of claim 17, further comprising testing means in fluid communication with the opening.

28. The sample acquisition module of claim 17, wherein the sample acquisition module has dimensions smaller than about 15 mm long, about 10 mm wide, and about 10 mm thick.

29. The sample acquisition module of claim 17, further comprising a backup lancet operably disposed to the sampling site.

30. The sample acquisition module of claim 17, further comprising a backup lancet having a backup lancet tip, the backup lancet maintained within the housing, the sampling site defining a backup opening adjacent the backup lancet tip, the backup opening in fluid communication with the sample reservoir.

31. The sample acquisition module of claim 17, further comprising a backup reservoir in fluid communication with the sampling site.

32. The sample acquisition module of claim 17, further comprising a backup lancet having a backup lancet tip, the backup lancet tip maintained within the housing, the sampling site defining a backup opening adjacent the backup lancet tip, the sample acquisition module further comprising a backup reservoir in fluid communication with the backup sample opening.

33. A method of collecting blood from the skin of a patient, the method comprising

a) contacting the skin of the patient with a blood sampling device,

b) performing a single initiating act resulting in the blood sampling device lancing the skin, collecting blood from the skin, and moving blood to a storage reservoir within the sampling device.

34. The method of claim 33, wherein the single initiating act also results in analysis of the blood.

35. The method of claim 34, wherein the single initiating act also results in display of information obtained from the analysis of the blood.

36. The method of claim 33, wherein the blood is collected and stored seamlessly.

37. The method of claim 33, wherein the single initiating act also results in verification that sufficient blood has been collected and, if insufficient blood has been collected, a backup lancing cycle is initiated.

38. The method of claim 33, wherein the single initiating act also results in verification that sufficient blood has been collected and, if sufficient blood has been collected, signaling that the blood sampling device may be removed from contact with the skin of the patient.