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

• US 8,480,596 B2
• Filed: 01/19/2010
• Issued: 07/09/2013
• 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:
  US12/689,570
• Publication Number:
  US 20110178429A1
• Time in Patent Office: 1,267 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 device body having a sealing device coupled to a lancing end, a lancing shaft slideably coupled to the lancing end, a lancing spring coupled to the lancing shaft, a release mechanism, a main shaft slideably coupled with a free end of the device body in communication with the release mechanism, a piston coupled to the main shaft, a vacuum spring coupled to the piston, and a shaft coupler having at least two separable portions for removably coupling the lancing shaft to the main shaft. The system can include a lance tool having an insertion portion and a removal portion. A method can include creating a first portion of a vacuum, lancing a surface, and creating a second portion of a vacuum.

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, the lancing end having a sealing device for contacting a surface for blood extraction;

a lancing shaft having a lance coupling end configured to couple with a lance and an actuating end, the lancing shaft being slideably coupled along the longitudinal axis to the lancing end of the body with the actuating end disposed within the body facing toward the free end of the body;

at least one lancing spring coupled to the lancing shaft;

a release mechanism coupled to the body;

a main shaft having an actuating end, a free end and a release coupler, wherein the main shaft is slideably coupled with the free end of the body along the longitudinal axis so that the release coupler can communicate with the release mechanism, and wherein the actuating end of the main shaft is disposed inside the body facing toward the actuating end of the lancing shaft, and wherein the free end of the main shaft is disposed proximate to the free end of the body;

a piston coupled to the main shaft and disposed within the body so that a vacuum chamber is formed between the sealing device and the piston;

an opening that allows fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber;

a vacuum spring coupled within the body so that the piston is biased toward the free end of the body and away from the actuating end of the lancing shaft; and

a shaft coupler having at least two separable portions that, when coupled, removably couple the actuating end of the lancing shaft and the actuating end of the main shaft to one another, wherein a first portion of the at least two separable portions is coupled to the actuating end of the lancing shaft and a second portion of the at least two separable portions is coupled to the actuating end of the main shaft.

2. The lancing system of claim 1, wherein the opening is in the piston.

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 1, wherein the sealing device further comprises a transparent viewing tube having one end coupled to the lancing end of the body and a longitudinally opposite end having an annular seal coupled thereto.

6. The lancing system of claim 5, wherein the annular seal is selected from the group consisting of a suction cup, a rubber coating and an integral contoured edge.

7. The lancing system of claim 1, further comprising a lance coupled to the lance coupling end of the lancing shaft.

8. The lancing system of claim 7, wherein the lance includes a base and a needle, and wherein the sealing device further comprises an adjustable depth controller having a central opening there through, the central opening being large enough for the needle to pass at least partially there through.

9. The lancing system of claim 8, wherein the depth controller is interchangeable.

10. The lancing system of claim 8, wherein the central opening of the depth controller has a cross-sectional area that is smaller in at least one dimension than a cross-sectional area of the base of the lance.

11. The lancing system of claim 7, further comprising a lance tool removably coupled to the lance, the lance tool comprising:

a lance insertion portion and a lance removal portion, wherein the lance insertion portion forms a clearance fit with the lance and the lance removal portion forms an interference fit with the lance; and

wherein the lance insertion portion is adapted to insert the lance into the lance coupling end of the lancing shaft so that the lance is retained in the lance coupling end, and the lance removal portion is adapted to remove the lance from the lance coupling end of the lancing shaft so that the lance is retained in the lance removal portion of the lance tool.

12. The lancing system of claim 1, wherein the piston is 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.

13. The lancing system of claim 1, wherein the shaft coupler further comprises a coupling force between the first and second portions that exceeds a force of the at least one lancing spring.

14. The lancing system of claim 13, further comprising a stop coupled to the body between the lance coupling end and the actuating end of the lancing shaft, the stop having a top side toward the actuating end of the lancing shaft and a bottom side toward the lance coupling end of the lancing shaft.

15. The lancing system of claim 14, wherein the vacuum spring is adapted to move the actuating ends of the lancing shaft and the main shaft toward the free end of the body until the stop prevents further movement of the lancing shaft thereby overcoming the coupling force.

16. The lancing system of claim 15, wherein the at least one lancing spring is adapted to move the actuating end of the lancing shaft in the direction longitudinally opposite from the actuating end of the main shaft after the coupling force is overcome.

17. The lancing system of claim 15, wherein the system is adapted to cause a vibration when the stop prevents further movement of the lancing shaft.

18. The lancing system of claim 1, wherein the first and second portions of the shaft coupler are adapted to be coupled together until a predetermined separation force is applied to the shaft coupler.

19. A method of extracting blood with a vacuum assisted lancing system including a tubular body having a lancing end and a free end, the lancing end having a sealing device coupled thereto, a lancing shaft having a lance coupling end and an actuating end, a lance coupled to the lance coupling end of the lancing shaft, a release mechanism coupled to the body, a main shaft having an actuating end, a free end and a release coupler, wherein the main shaft is slideably coupled with the free end of the body so that the release coupler may communicate with the release mechanism, and wherein the actuating end of the main shaft is disposed inside the body toward the actuating end of the lancing shaft, a piston coupled to the main shaft and disposed within the body so that a vacuum chamber is formed between the sealing device and the piston, an opening that allows fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber, a vacuum spring coupled within the body so that the piston is biased toward the free end of the body and away from the actuating end of the lancing shaft, and a shaft coupler having at least two separable portions, wherein a first portion is coupled to the actuating end of the lancing shaft and a second portion is coupled to the actuating end of the main shaft, the method comprising:

cocking the lancing system by moving the actuating end of the main shaft, energizing the vacuum spring, coupling the at least two separable portions of the shaft coupler together thereby coupling the actuating end of the lancing shaft and the actuating end of the main shaft to one another, and coupling the release coupler to the release mechanism;

coupling the sealing device to a surface for blood extraction and forming at least a partial seal between the sealing device and the surface;

uncoupling the release coupler from the release mechanism;

allowing the vacuum spring to at least partially deenergize;

uncoupling the at least two separable portions of the shaft coupler thereby uncoupling the actuating end of the lancing shaft and the actuating end of the main shaft from one another;

allowing the piston to travel toward the free end of the body;

creating a vacuum between the surface and the piston thereby subjecting the surface to the vacuum; and

lancing the surface while the surface is subjected to the vacuum and while the actuating end of the lancing shaft and the actuating end of the main shaft are uncoupled from one another.

20. The method of claim 19, further comprising:

creating a first portion of the vacuum;

lancing the surface; and

creating a remaining portion of the vacuum after the surface has been lanced.

21. The method of claim 19, further comprising:

creating the vacuum at a predetermined vacuum generation rate; and

dissipating the vacuum by allowing air to flow into the vacuum chamber through the opening at a predetermined vacuum dissipation rate;

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

22. The method of claim 21, further comprising creating the vacuum and dissipating the vacuum simultaneously.

23. The method of claim 19, further comprising:

moving the at least two separable portions of the shaft coupler in a first direction toward the free end of the body;

stopping the first portion of the shaft coupler;

uncoupling the at least two separable portions of the shaft coupler; and

moving the first portion of the shaft coupler in a second direction longitudinally opposite from the first direction.

24. The method of claim 23, further comprising:

moving the second portion of the shaft coupler in the first direction while the first portion of the shaft coupler is moving in the second direction.

25. The method of claim 19, further comprising:

manipulating the surface with at least a portion of the system;

extracting blood from the surface; and

collecting at least a portion of the extracted blood.

26. The method of claim 25, wherein manipulating the surface includes twisting, pumping, increasing contact pressure, decreasing contact pressure, or a combination thereof.

27. The method of claim 19, wherein the system includes a vacuum release indicator, the method further comprising indicating whether a vacuum is present in the system.

28. The method of claim 19, further comprising:

creating a vibration on the surface before the surface is penetrated; and

continuing at least a portion of the vibration until after the surface is penetrated.

29. The method of claim 19, wherein the system includes a depth controller coupled to the lancing end of the body, the method further comprising defining an extent to which the lance can penetrate the surface.