VACUUM ASSISTED LANCING SYSTEM WITH DEPTH CONTROLLER AND METHOD FOR BLOOD EXTRACTION WITH MINIMAL PAIN

• US 20110178431A1
• Filed: 01/19/2010
• Published: 07/21/2011
• Est. Priority Date: 01/19/2010
• Status: Active Grant

• Current Assignee: Christopher A. Jacobs
• Original Assignee: Christopher A. Jacobs
• Inventors: Jacobs, Christopher A.
• Granted Patent: US 8,485,990 B2
• Time in Patent Office: Days
• 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 lancing end, a lancing mechanism including a lancing shaft slideably coupled with the lancing end of the body, a main shaft slideably coupled with the body and having an actuating end disposed inside the body, a piston coupled to the main shaft and disposed within the body, a spring coupled to the piston, a release mechanism adapted to selectively couple with the main shaft, and a depth controller removably coupled to the lancing end of the body. A method can include coupling a lance having a needle and a base to the lancing shaft, choosing to use a depth controller having a spacer with a top surface and an opening, engaging a lancing surface with the depth controller, actuating the lancing mechanism, penetrating the lancing surface, and contacting the top surface of the spacer with the base.

Claims

1. A lancing system for blood extraction, comprising:

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

a lancing mechanism coupled to the lancing end of the body, the lancing mechanism including a lancing shaft having a lance coupling end and an actuating end, the lancing shaft being slideably coupled along the longitudinal axis 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 and a free end disposed outside the body;

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

a spring coupled to the piston so that the piston is biased toward the free end of the body;

a release mechanism coupled to the body and adapted to selectively couple with the main shaft; and

a depth controller removably coupled to the lancing end of the body, the depth controller having a calibrated spacer with a top surface, a predetermined thickness and an opening adapted to allow at least a portion of a lance to pass there through.

2. The lancing system of claim 1, wherein the depth controller is adapted to be optionally replaced by a user.

3. The lancing system of claim 1, further comprising an at least partially transparent viewing tube coupled between the spacer and the lancing end of the body.

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

a lance coupled to the lance coupling end of the lancing shaft, the lance having a needle and a base supporting the needle; and

wherein the top surface of the spacer is adapted to prevent the base of the lance from passing through the central opening, thereby limiting a depth to which the needle can penetrate a lancing surface.

5. The lancing system of claim 4, wherein the central opening of the spacer has a cross-sectional area that is smaller in at least one dimension than a cross-sectional area of the base of the lance.

6. The lancing system of claim 1, further comprising a plurality of interchangeable depth controllers adapted to be removably coupled to the lancing end of the body, each depth controller having a calibrated spacer.

7. The lancing system of claim 6, wherein the plurality of depth controllers comprises a set of depth controllers in a container.

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

at least two depth controllers having differently calibrated spacers;

wherein each spacer is incrementally calibrated to limit to a different depth an extent to which a lance may penetrate a lancing surface; and

wherein each of the at least two depth controllers is adapted to be optionally coupled to and uncoupled from the body by a user.

9. The lancing system of claim 1, further comprising a bottom surface of the spacer adapted to sealingly engage a lancing surface, thereby forming a vacuum chamber between the surface and the piston.

10. The lancing system of claim 9, further comprising:

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

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 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.

11. The lancing system of claim 9, further comprising

a lance coupled to the lance coupling end of the lancing shaft;

and

wherein the system is adapted to create a first portion of a vacuum in the vacuum chamber, lance the surface during the first portion of the vacuum, and create a remaining second portion of the vacuum.

12. The lancing system of claim 9, further comprising a vacuum release indicator adapted to indicate whether a vacuum is present in the system.

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

a shaft coupler having at least two separable portions for removably coupling the lancing shaft to the main shaft, 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; and

wherein the first and second portions are adapted to be removably coupled together having a coupler force there between.

14. The lancing system of claim 13, further comprising a stop adapted to overcome the coupler force when the shaft coupler is in a predetermined position, thereby uncoupling the at least two separable portions.

15. The lancing system of claim 13, wherein the stop is adapted to prevent the lancing shaft from further moving in a first direction, thereby causing a vibration.

16. The lancing system of claim 14, further comprising at least one lancing spring coupled to the lancing shaft and adapted to move the actuating end of the lancing shaft toward the lancing end of the body after the coupling force is overcome.

17. A method of extracting blood from a lancing surface with a lancing system including a tubular body having a central longitudinal axis, a lancing end and a longitudinally opposite free end, a lancing mechanism coupled to the lancing end of the body, the lancing mechanism including a lancing shaft having a lance coupling end and an actuating end, the lancing shaft being slideably coupled along the longitudinal axis to 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 and a free end disposed outside the body, a piston coupled to the main shaft and disposed within the body, a spring coupled to the piston so that the piston is biased toward the free end of the body, a release mechanism coupled to the body and adapted to selectively couple with the main shaft, and at least a first depth controller, the method comprising:

coupling a lance to the lance coupling end of the lancing shaft, the lance having a needle and a base supporting the needle;

choosing to use the first depth controller, the first depth controller having a calibrated first spacer with a top surface, a predetermined thickness and an opening adapted to allow at least a portion of the lance to pass there through;

engaging the lancing surface with the depth controller;

actuating the lancing mechanism so that the lance moves toward the lancing surface;

allowing at least a portion of the needle to pass through the opening of the first spacer;

penetrating the surface with the needle; and

contacting the top surface of the first spacer with the base, thereby limiting to a first depth the extent to which the needle can penetrate the lancing surface.

18. The method of claim 17, wherein choosing to use the first depth controller comprises removably coupling the first depth controller to the lancing end of the body.

19. The method of claim 17, wherein the system further comprises a second depth controller having a calibrated second spacer, the first and second depth controllers being interchangeable, the method further comprising:

uncoupling the first depth controller from the body; and

coupling the second depth controller to the body in place of the first depth controller.

20. The method of claim 19, wherein the first and second spacers are each incrementally calibrated to limit to a different depth an extent to which the lance may penetrate the surface, the method further comprising contacting a top surface of the second spacer with the base, thereby limiting to a second depth the extent to which the needle can penetrate the lancing surface.

21. The method of claim 17, further comprising uncoupling the first depth controller from the body and uncoupling the lance from the lancing shaft.

22. 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 coupled thereto;

a lancing shaft having a lance coupling end and an actuating end, the lancing shaft being slideably coupled along the longitudinal axis to the lancing end of the body;

at least one lancing spring coupled to the lancing shaft;

a release mechanism coupled to the free end of the body;

a main shaft having an actuating end, a free end and a release coupler there between, wherein the main shaft is slideably coupled with the free end of the body along the longitudinal axis 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, and wherein the free end of the main shaft is disposed outside 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;

a shaft coupler having at least two separable portions for removably coupling the lancing shaft to the main shaft, 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; and

a plurality of user interchangeable depth controllers, each depth controller adapted to be removably coupled to the lancing end of the body and having a calibrated spacer with a top surface, a predetermined thickness and an opening adapted to allow at least a portion of a lance to pass through the spacer.

23. The system of claim 22, wherein at least two of the plurality of depth controllers have spacers calibrated to limit to a predetermined depth an extent to which a lance may penetrate a surface.

24. The system of claim 22, wherein at least two of the plurality of depth controllers have spacers incrementally calibrated to limit to different depths an extent to which a lance may penetrate a surface.

25. The system of claim 22, further comprising a lance coupled to the lance coupling end of the lancing shaft.