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

• US 9,622,695 B2
• Filed: 05/23/2013
• Issued: 04/18/2017
• 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): HENSON, DEVIN B
• Application Number:
  US13/900,872
• Publication Number:
  US 20130261500A1
• Time in Patent Office: 1,426 Days
• 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 lancing system for blood extraction, comprising:

a tubular body having a central longitudinal axis, a lancing end and a longitudinally opposite second end, the lancing end having a first opening adapted to allow at least a portion of a lance to pass there through;

a lancing shaft having a lance coupling end configured to couple with a lance and a longitudinally opposite actuating end, the lancing shaft being slideably coupled relative to the body with the actuating end disposed within the body;

a stop disposed longitudinally between the lance coupling end and the actuating end of the lancing shaft, the lancing shaft being slideably coupled relative to the stop;

a first lancing spring disposed at least partially between the stop and the lance coupling end of the lancing shaft;

a second lancing spring disposed at least partially between the stop and the actuating end of the lancing shaft;

a main shaft having an actuating end and a longitudinally opposite second end, wherein the main shaft is slideably coupled relative to the body and wherein the actuating end of the main shaft is disposed inside the body;

a piston coupled to the main shaft and disposed within the body;

a vacuum chamber formed at least partially between the piston and the first opening;

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

a vacuum spring coupled to the body and configured to bias the piston toward the second 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, further comprising a vacuum release indicator adapted to indicate whether a vacuum is present in the system.

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

4. The lancing system of claim 1, wherein the piston is adapted to form a vacuum in the vacuum chamber at a vacuum generation rate, and wherein the second opening is adapted to allow air to flow into the vacuum chamber from the atmosphere at a vacuum dissipation rate that is less than the vacuum generation rate.

5. 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 first lancing spring.

6. The lancing system of claim 1, wherein the vacuum spring is adapted to move the actuating end of the lancing shaft and the actuating end of the main shaft toward the second end of the body until the stop prevents further movement of the lancing shaft thereby overcoming a coupling force between the first and second portions of the shaft coupler.

7. The lancing system of claim 6, wherein the first lancing spring is adapted to move the actuating end of the lancing shaft in a direction longitudinally opposite from the actuating end of the main shaft after the coupling force is overcome.

8. A method of extracting blood with a lancing system including a tubular body having a central longitudinal axis, a lancing end and a longitudinally opposite second end, the lancing end having a first opening adapted to allow at least a portion of a lance to pass there through, a lancing shaft having a lance coupling end configured to couple with a lance and a longitudinally opposite actuating end, the lancing shaft being slideably coupled relative to the body with the actuating end disposed within the body, a lance coupled to the lance coupling end of the lancing shaft, a stop disposed longitudinally between the lance coupling end and the actuating end of the lancing shaft, the lancing shaft being slideably coupled relative to the stop, a first lancing spring disposed at least partially between the stop and the lance coupling end of the lancing shaft, a second lancing spring disposed at least partially between the stop and the actuating end of the lancing shaft, a main shaft having an actuating end and a longitudinally opposite second end, wherein the main shaft is slideably coupled relative to the body and wherein the actuating end of the main shaft is disposed inside the body, a piston coupled to the main shaft and disposed within the body, a vacuum chamber formed at least partially between the piston and the first opening, a second opening that allows fluid communication between the vacuum chamber and an atmosphere surrounding the vacuum chamber, a vacuum spring coupled to the body and configured to bias the piston toward the second 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, the method comprising:

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

coupling the first opening to a surface for blood extraction and forming at least a partial seal with the surface;

deenergizing the vacuum spring;

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

stopping the first portion of the shaft coupler;

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

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

creating a vacuum in the vacuum chamber; and

lancing the surface while the surface is subjected to the vacuum.

9. The method of claim 8, further comprising:

creating a first portion of the vacuum prior to lancing the surface; and

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

10. The method of claim 8, further comprising:

creating the vacuum at a vacuum generation rate; and

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

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

11. The method of claim 10, further comprising creating the vacuum and dissipating the vacuum simultaneously.

12. The method of claim 8, 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.

13. A lancing system for blood extraction, comprising:

a tubular body having a central longitudinal axis, a lancing end and a longitudinally opposite second end;

a lancing shaft having a lance coupling end configured to couple with a lance and a longitudinally opposite actuating end, the lancing shaft being slideably coupled relative to the body with the actuating end disposed within the body;

a stop disposed longitudinally between the lance coupling end and the actuating end of the lancing shaft, the lancing shaft being slideably coupled relative to the stop;

a first lancing spring disposed at least partially between the stop and the lance coupling end of the lancing shaft;

a second lancing spring disposed at least partially between the stop and the actuating end of the lancing shaft;

a main shaft having an actuating end and a longitudinally opposite second end, wherein the main shaft is slideably coupled relative to the body and wherein the actuating end of the main shaft is disposed inside the body; 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; and

a main spring configured to bias the main shaft, wherein the main spring is adapted to move the actuating end of the lancing shaft and the actuating end of the main shaft toward the second end of the body until the stop prevents further movement of the lancing shaft thereby overcoming a coupling force between the first and second portions of the shaft coupler.

14. The lancing system of claim 13, further comprising a lancing depth controller coupled to the lancing end of the body.

15. The lancing system of claim 13, further comprising a lance coupled to the lance coupling end of the lancing shaft.

16. The lancing system of claim 13, further comprising a vacuum release indicator adapted to indicate whether a vacuum is present in the system.

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

18. The lancing system of claim 13, wherein the first lancing spring is adapted to move the actuating end of the lancing shaft in a direction longitudinally opposite from the actuating end of the main shaft after the coupling force is overcome.

19. The lancing system of claim 13, wherein at least one of the at least two separable portions of the shaft coupler is selected from the group consisting of a magnet, magnetic material, hook material, loop material, a ball, a joint adapted to removably couple with a ball, and a combination thereof.