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

• US 8,460,211 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:
  US12/689,641
• Publication Number:
  US 20110178432A1
• 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 device body having a lancing end and a free end, a lancing shaft having an actuating end, a stop coupled to the body, a lancing spring coupled to the lancing shaft, a main shaft having an actuating end, and 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. A method of extracting blood can include coupling the actuating end of the main shaft to the actuating end of the lancing shaft, moving the lancing shaft toward the free end of the device body, stopping the lancing shaft, uncoupling the actuating ends, and moving the lancing shaft toward a surface to be lanced.

Claims

1. A lancing system for blood extraction, comprising:

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

a lancing shaft having a lance coupling end and an actuating end wherein the lance coupling end is configured to be removably coupled with a lance having a needle, the lancing shaft being slideably coupled along the longitudinal axis to the lancing end of the body;

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

at least one lancing spring coupled to the lancing shaft;

a main shaft having an actuating end and a free end, wherein the actuating end of the main shaft is disposed inside the body toward the actuating end of the lancing shaft;

a shaft coupler having at least two separable portions that removably engage 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, the first and second portions being removably engageable with one another and having a coupler force there between; and

a biasing device configured to move the shaft coupler toward the free end of the body while the first and second portions are engaged;

wherein the stop is configured to overcome the coupler force when the shaft coupler is moved toward the free end of the body by stopping the first portion of the shaft coupler after the shaft coupler has moved a distance toward the free end of the body, the biasing device and stop thereby cooperating to disengage the at least two separable portions.

2. The lancing system of claim 1, wherein the at least one lancing spring is adapted to move the actuating end of the lancing shaft toward the lancing end of the body after the coupler force is overcome.

3. The lancing system of claim 1, wherein one of the at least two separable portions includes a magnet and the other of the at least two separable portions includes magnetic material.

4. The lancing system of claim 1, wherein the at least one lancing spring is adapted to at least temporarily bias the first portion of the shaft coupler toward the lancing end of the body.

5. The lancing system of claim 1, wherein the at least one lancing spring further comprises:

a first spring coupled between the stop and the actuating end of the lancing shaft; and

a second spring coupled between the stop and the lance coupling end of the lancing shaft.

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

7. The lancing system of claim 6, further comprising a lance tool coupled to the lance, the lance tool including 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 of the lancing shaft, 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.

8. The lancing system of claim 6, wherein the lance includes a base and a needle, and further comprising an interchangeable depth controller coupled to the lancing end of the body, the depth controller having a central opening large enough for the needle to pass at least partially there through.

9. 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.

10. The lancing system of claim 1, further comprising a sealing device coupled to the lancing end of the body and adapted to form at least a partial seal with a surface to be lanced.

11. The lancing system of claim 10, 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.

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

a piston coupled to the main shaft and slideably and sealably disposed inside the body so that a vacuum chamber is formed between the piston and the lancing end of the body; and

wherein the biasing device is coupled to the piston so that the piston is biased toward the free end of the body.

13. The lancing system of claim 12, further comprising:

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

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, the vacuum dissipation rate being less than the vacuum generation rate.

14. The lancing system of claim 12, 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, lance a 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 lancing system including a tubular body having a lancing end and a free end, a lancing shaft having a lance coupling end and an actuating end wherein the lance coupling end is configured to be removably coupled with a lance having a needle, the lancing shaft being slideably coupled with the lancing end of the body, a stop coupled to the lancing end of the body, the stop being disposed between the lance coupling end and the actuating end of the lancing shaft, at least one lancing spring coupled to the lancing shaft, a main shaft having an actuating end and a free end, wherein the actuating end of the main shaft is disposed inside the body toward the actuating end of the lancing shaft, and 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 the first and second portions are adapted to be removably coupled together having a coupler force there between, and a lance coupled to the lance coupling end of the lancing shaft, the method comprising:

engaging the actuating end of the main shaft to the actuating end of the lancing shaft by engaging the first and second portions of the shaft coupler with one another;

contacting a surface with the lancing end of the body;

moving the shaft coupler toward the free end of the body while the first and second portions are engaged;

stopping the first portion of the shaft coupler with the stop after the shaft coupler has moved a distance toward the free end of the body;

uncoupling the actuating end of the lancing shaft from the actuating end of the main shaft by disengaging the first and second portions of the shaft coupler; and

thereafter moving the lancing shaft toward the surface until the lance penetrates the surface.

16. The method of claim 15, further comprising:

energizing the at least one lancing spring; and

wherein moving the lancing shaft toward the surface further comprises at least partially deenergizing the at least one lancing spring.

17. The method of claim 15, further comprising:

moving the first portion of the shaft coupler toward the lancing end of the body; and

simultaneously moving the second portion of the shaft coupler toward the free end of the body.

18. The method of claim 17, further comprising returning the first portion to a state of rest.

19. The method of claim 15, wherein stopping the first portion of the shaft coupler with the stop further comprises causing at least one vibration.

20. The method of claim 19, further comprising allowing the vibration to continue until the lance penetrates the surface.

21. The method of claim 15, 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.

22. The method of claim 15, wherein the system includes a piston coupled to the main shaft and slideably and sealably disposed inside the body and a spring coupled to the piston so that the piston is biased toward the free end of the body, the method further comprising:

creating a first portion of a vacuum;

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

creating a remaining second portion of the vacuum.

23. The method of claim 22, 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.