Vacuum assisted lancing system with elective vacuum release and method for blood extraction with minimal pain

• US 8,657,763 B2
• Filed: 02/07/2012
• Issued: 02/25/2014
• 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): Hoekstra, Jeffrey G
• Assistant Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/367,953
• Publication Number:
  US 20120143086A1
• Time in Patent Office: 749 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 5/15003 for venous or arterial blood
• 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 5/150083 by vibration, e.g. ultrasound
• 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 5/150114 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/150145 by negative pressure, e.g. suction, vacuum
• 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 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means

Abstract

A vacuum assisted lancing system for blood extraction can include a tubular body having a vacuum chamber, a lancing mechanism configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body, a release mechanism for selectively holding the vacuum mechanism in an energized state, and an opening for allowing fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber. The system can include structure for selectively commencing dissipation of the vacuum and a fixed or adjustable depth controller. A method of manipulating a surface for blood extraction can include coupling the lancing system to the surface, blocking the opening, creating a vacuum, moving the lance coupler from a first position distal from the surface to a second position proximal to the surface, maintaining the vacuum for a period of time, and commencing dissipation of the vacuum by unblocking the opening.

Claims

1. A vacuum assisted lancing system for blood extraction, comprising:

a tubular body having a central longitudinal axis, a lancing end and a free end;

a lancing mechanism coupled with the body and including a lance coupler configured to removably couple with a lance;

a vacuum mechanism coupled with the body and including a piston slideably coupled within the body so that a vacuum chamber is formed between the piston and the lancing end of the body;

a release mechanism configured to selectively hold the vacuum mechanism in an energized state;

an opening through a wall of the body between the piston and the lancing end of the body that allows fluid communication back and forth between the vacuum chamber and an atmosphere surrounding the body; and

at least one spring configured to

simultaneously move both the lance coupler and the piston in an initial direction toward the free end of the body upon the release mechanism being activated to release the vacuum mechanism from the energized state and create a vacuum in the vacuum chamber, and

thereafter move the lance coupler in a second direction toward the lancing end of the body.

2. The lancing system of claim 1, wherein the opening is configured to be sealingly engaged by a user so that the user can selectively block and unblock the opening.

3. The lancing system of claim 1, wherein the release mechanism further comprises a release, and wherein the opening is disposed in the release.

4. The lancing system of claim 3, wherein the release has an activated position, and wherein the opening is configured to be at least partially blocked when the release is in the activated position.

5. The lancing system of claim 1, further comprising a valve coupled to the opening.

6. The lancing system of claim 1, further comprising a depth controller having one end removably coupled to the lancing end of the body and a longitudinally opposite end configured to sealingly engage a surface to be lanced.

7. The lancing system of claim 6, wherein the depth controller is adjustable.

8. The lancing system of claim 6, wherein the depth controller further comprises a spacer having a variable thickness.

9. The lancing system of claim 1, further comprising a lance coupled to the lancing mechanism.

10. A vacuum assisted lancing system for blood extraction, comprising:

a body having a first end adapted to sealingly engage a surface to be lanced, a longitudinally opposite second end, a vacuum chamber between the first and second ends, an opening through a wall of the body that allows fluid communication back and forth between the vacuum chamber and an atmosphere surrounding the vacuum chamber, and a lance coupler slideablv disposed within the vacuum chamber;

means for selectively holding the lance coupler in a cocked position and releasing the lance coupler from the cocked position;

means for creating a vacuum in the vacuum chamber and acting on the surface to be lanced;

means for moving a lance initially in a first direction toward the second end of the body upon release of the lance coupler from the cocked position, stopping the lance, moving the lance in a longitudinally opposite second direction toward the surface to be lanced, and thereafter disposing the lance in contact with the surface while the vacuum is acting on the surface; and

means for selectively commencing dissipation of the vacuum after the vacuum has acted on the surface for a period of time.

11. The lancing system of claim 10, wherein the opening through the body is disposed through a release.

12. The lancing system of claim 10, further comprising means for simultaneously initiating creation of the vacuum and at least partially blocking the opening through the body.

13. The lancing system of claim 10, further comprising means for dissipating the vacuum at a controlled rate.

14. The lancing system of claim 10, further comprising a lance coupled to the means for disposing a lance in contact with the surface.

15. A method of manipulating a surface for blood extraction with a vacuum assisted lancing system including a tubular body having a lancing end and a free end, a lancing mechanism coupled with the body and having a lance coupler configured to removably couple with a lance, a vacuum mechanism including a piston slideably coupled within the body so that a vacuum chamber is formed between the piston and the lancing end of the body, a release mechanism configured to selectively hold the vacuum mechanism in an energized state, and an opening through a wall of the body between the piston and the lancing end of the body that allows fluid communication back and forth between the vacuum chamber and an atmosphere surrounding the vacuum chamber, the method comprising:

coupling the lancing system to the surface;

blocking the opening;

activating the lancing system by actuating the release mechanism, thereby

creating a vacuum and subjecting the surface to the vacuum, and

simultaneously moving both the lance coupler and the piston in an initial direction toward the free end of the body until the lance coupler reaches a first position distal from the surface and thereafter moving the lance coupler from the first position distal from the surface to a second position proximal to the surface;

maintaining the vacuum for a period of time; and

commencing dissipation of the vacuum by unblocking the opening, thereby allowing the surface to fluidicly communicate with an atmosphere surrounding the lancing system while the lancing system is coupled to the surface.

16. The method of claim 15, wherein the lancing system includes a release coupled with the opening, and wherein the blocking and activating steps are accomplished simultaneously by engaging and holding the release.

17. The method of claim 16, wherein commencing dissipation of the vacuum further comprises disengaging the release.

18. The method of claim 15, wherein blocking the opening further comprises sealingly engaging the opening with a finger, and wherein unblocking the opening further comprises disengaging the opening and the finger.

19. The method of claim 15, wherein the lancing system includes a lance removably coupled to the lance coupler, and wherein the method further comprises lancing the surface.

20. The method of claim 19, further comprising maintaining the vacuum for a period of time after the surface has been lanced.