Vacuum assisted lancing system with controlled rate and method for blood extraction with minimal pain

• US 8,460,210 B2
• Filed: 01/19/2010
• Issued: 06/11/2013
• Est. Priority Date: 01/19/2010
• Status: Active Grant

• Current Assignee: Christopher A. Jacobs
• Original Assignee: Christopher A. Jacobs
• Inventors: Jacobs, Christopher A.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/689,608
• Publication Number:
  US 20110178430A1
• Time in Patent Office: 1,239 Days
• Field of Search: 600/573, 600/576, 600/578, 600/579, 600/583, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150099 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 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15101 Details
• CPC Class Codes: A61B 5/15103 Piercing procedure
• 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 lancing system can include a first device body having a lancing end and a free end, the lancing end including a sealing device, a lancing assembly having a lance coupler slideably coupled with the lancing end, a main shaft slideably coupled with the body, a first piston disposed within the body, wherein the lancing assembly is adapted to create a vacuum prior to lancing and dissipate the vacuum at a controlled rate. The system can include a second device body fluidicly coupled to the first device body and having a second shaft and a second piston. A method of extracting blood can include coupling the sealing device to a surface, creating a vacuum, lancing the surface, and dissipating the vacuum at a controlled rate.

Claims

1. A lancing system for blood extraction, comprising:

a first tubular body having a central longitudinal axis, a lancing end and a longitudinally opposite free end, the lancing end including a sealing device for sealingly engaging a surface to be lanced;

a lancing assembly coupled to the body, the lancing assembly having a lance coupler slideably coupled with the lancing end of the body;

a main shaft slideably coupled with the body along the longitudinal axis, the main shaft having an actuating end disposed inside the body;

a first piston coupled to the main shaft and slideably and sealably disposed within the body, the first piston being biased toward a rest position;

wherein the body forms at least a portion of a vacuum chamber when the sealing device engages the surface to be lanced, the vacuum chamber being in fluid communication with the surface;

a valveless opening through a wall of the tubular body that allows fluid communication between the vacuum chamber and an atmosphere surrounding the lancing system when the first piston is in the rest position, the rest position being between the valveless opening and the free end of the tubular body; and

wherein the lancing assembly is adapted to create a vacuum prior to lancing and dissipate the vacuum at a controlled rate by allowing air to flow into the vacuum chamber from the atmosphere through the opening.

2. The lancing system of claim 1, further comprising:

wherein the first piston is adapted to form a vacuum in the vacuum chamber at a predetermined vacuum generation rate; and

wherein the opening is adapted to dissipate the vacuum by allowing air to flow into the vacuum chamber from the atmosphere at a predetermined vacuum dissipation rate, the vacuum dissipation rate being less than the vacuum generation rate.

3. The lancing system of claim 1, further comprising a vacuum release indicator adapted to indicate whether a vacuum is present in the system.

4. The lancing system of claim 3, wherein the vacuum release indicator is a visible indicator and wherein at least a portion of the visible indicator is visible either outside the body or through the body when no vacuum exists in the vacuum chamber.

5. The lancing system of claim 3, wherein the vacuum release indicator is an external indicator fluidicly coupled to the vacuum chamber.

6. The lancing system of claim 1, the lancing assembly further comprising:

a second tubular body disposed outside of the first tubular body, the second tubular body having a first end fluidicly coupled to the vacuum chamber and a longitudinally opposite second end;

a second shaft slideably coupled with the second tubular body; and

a second piston coupled to the second shaft and disposed within the second tubular body.

7. The lancing system of claim 6, further comprising:

a spring coupled to the second piston; and

a release mechanism coupled to the second tubular body and adapted to selectively couple with the second shaft.

8. The lancing system of claim 6, wherein at least one of the first and second pistons further comprises an opening that allows fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber.

9. The lancing system of claim 8, wherein the first and second pistons are adapted to form a vacuum in the vacuum chamber at a predetermined vacuum generation rate, and wherein the opening is adapted to allow air to flow into the vacuum chamber from the atmosphere at a predetermined vacuum dissipation rate, the vacuum dissipation rate being less than the vacuum generation rate.

10. The lancing system of claim 6, wherein one of the first and second pistons is adapted to form a first portion of the vacuum in the vacuum chamber, and wherein the other of the first and second pistons is adapted to form a remaining second portion of the vacuum in the vacuum chamber.

11. The lancing system of claim 10, wherein the first portion of the vacuum is between about 30% and about 70% of the vacuum.

12. The lancing system of claim 10, wherein the first portion of the vacuum is between about 40% and about 60% of the vacuum.

13. The lancing system of claim 1, further comprising:

a lance coupled to the lance coupler; and

wherein the lancing assembly is adapted to lance the surface.

14. The lancing system of claim 13, wherein the lancing assembly is adapted to create a first portion of the vacuum, lance the surface during the first portion of the vacuum, and create a remaining second portion of the vacuum.

15. A method of extracting blood with a vacuum assisted lancing system including a first tubular body having a lancing end and a longitudinally opposite free end, the lancing end including a sealing device for sealingly engaging a surface to be lanced, a lancing assembly coupled to the body, the lancing assembly having a lance coupler slideably coupled with the lancing end of the body, a main shaft slideably coupled with the body, the main shaft having an actuating end disposed inside the body, a first piston coupled to the main shaft and slideably and sealably disposed within the body, the first piston being biased toward a rest position, a valveless opening through a wall of the first tubular body that allows fluid communication between the interior of the first tubular body and an atmosphere surrounding the lancing system when the first piston is in the rest position, the rest position being between the valveless opening and the free end of the first tubular body;

and a lance coupled to the lance coupler, the method comprising;

coupling the sealing device to a surface;

creating a vacuum by moving the first piston toward the free end of the first tubular body;

lancing the surface;

dissipating the vacuum at a controlled rate; and

removing the sealing device from the surface.

16. The method of claim 15, further comprising:

creating a first portion of the vacuum;

lancing the surface during the first portion of the vacuum; and

creating a remaining second portion of the vacuum.

17. The method of claim 16, wherein the first portion of the vacuum is between about 30% and about 70% of the vacuum.

18. The method of claim 16, wherein the first portion of the vacuum is between about 40% and about 60% of the vacuum.

19. The method of claim 15, wherein lancing the surface further comprises lancing the surface before the vacuum is created.

20. The method of claim 15, further comprising:

creating the vacuum at a predetermined vacuum generation rate; and

dissipating the vacuum at a predetermined vacuum dissipation rate;

wherein the vacuum dissipation rate is less than the vacuum generation rate.

21. The method of claim 20, further comprising creating the vacuum and dissipating at least a portion of the vacuum simultaneously.

22. The method of claim 15, wherein the system further includes a vacuum release indicator, the method further comprising indicating at least one state of vacuum in the system.

23. A method of extracting blood with a vacuum assisted lancing system including a first tubular body having a lancing end and a longitudinally opposite free end, the lancing end including a sealing device for sealingly engaging a surface to be lanced, a lancing assembly coupled to the body, the lancing assembly having a lance coupler slideably coupled with the lancing end of the body, a main shaft slideably coupled with the body, the main shaft having an actuating end disposed inside the body, wherein the body forms at least a portion of a vacuum chamber;

a first piston coupled to the main shaft and slideably and sealably disposed within the body, a second tubular body disposed outside of the first tubular body, the second tubular body having a first end fluidicly coupled to the vacuum chamber and a longitudinally opposite second end, a second shaft slideably coupled with the second tubular body, a second piston coupled to the second shaft and disposed within the second tubular body, at least one of the first and second pistons being biased toward a rest position;

a valveless opening through a wall of the first tubular body that allows fluid communication between the vacuum chamber and an atmosphere surrounding the lancing system when the at least one piston is in the rest position, the rest position being between the valveless opening and the free end of the first tubular body; and

a lance coupled to the lance coupler, the method comprising;

coupling the sealing device to a surface;

creating a vacuum;

lancing the surface;

dissipating the vacuum at a controlled rate; and

removing the sealing device from the surface.

24. The method of claim 23, further comprising:

creating a first portion of the vacuum;

lancing the surface during the first portion of the vacuum; and

creating a remaining second portion of the vacuum.

25. The method of claim 24, wherein the first portion of the vacuum is between about 30% and about 70% of the vacuum.

26. The method of claim 24, wherein the first portion of the vacuum is between about 40% and about 60% of the vacuum.

27. The method of claim 23, wherein lancing the surface further comprises lancing the surface before the vacuum is created.

28. The method of claim 23, further comprising:

creating a first portion of the vacuum with one of the first and second pistons; and

creating a remaining second portion of the vacuum with the other of the first and second pistons.

29. The method of claim 23, wherein the system further comprises an opening in at least one of the first and second pistons allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber, and wherein dissipating the vacuum at a controlled rate further comprises allowing air to flow through the opening and into the vacuum chamber.

30. The method of claim 23, wherein dissipating the vacuum at a controlled rate further comprises moving at least one of the first and second pistons and thereby decreasing a volume of the vacuum chamber.

31. The method of claim 23, further comprising:

creating the vacuum at a predetermined vacuum generation rate; and

dissipating the vacuum at a predetermined vacuum dissipation rate;

wherein the vacuum dissipation rate is less than the vacuum generation rate.

32. The method of claim 31, further comprising creating the vacuum and dissipating at least a portion of the vacuum simultaneously.

33. The method of claim 23, wherein the system further includes a vacuum release indicator, the method further comprising indicating at least one state of vacuum in the system.