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

• US 8,485,991 B2
• Filed: 01/19/2010
• Issued: 07/16/2013
• 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:
  US12/689,657
• Publication Number:
  US 20110178434A1
• Time in Patent Office: 1,274 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 method of masking pain resulting from a lancing system can include moving a first portion and a second portion of a lancing assembly in a first direction, stopping the first portion from further moving in the first direction, thereby causing a first vibration, allowing the first portion to move in a second direction while the second portion continues moving in the first direction, and lancing a surface with the first portion while the first vibration is occurring. A system for lancing a surface and masking resulting pain may include a device body having an end adapted to sealingly engage the surface, structure for creating a first portion of a vacuum, structure for causing a vibration, and a lancing mechanism adapted to lance the surface while the first portion of the vacuum and the vibration are acting on the surface.

Claims

1. A method of masking pain resulting from a lancing system for blood extraction, the system comprising a tubular body having a longitudinal axis, a lancing end and a longitudinally opposite free end, and a lancing assembly coupled to the body, the lancing assembly having a lance coupler with a lance coupled thereto for penetrating a surface from which the blood is to be extracted, the method comprising:

simultaneously moving a first portion and a second portion of the lancing assembly in a first direction along the longitudinal axis toward the free end;

contacting a component of the lancing assembly with the first portion, thereby stopping the first portion of the lancing assembly from further moving in the first direction and causing a first vibration;

thereafter moving the first portion in a second direction opposite the first direction while the second portion continues moving in the first direction, the second direction being along the longitudinal axis toward the lancing end; and

lancing the surface with the first portion while the first vibration is occurring.

2. The method of claim 1, further comprising returning the first portion of the lancing assembly to a state of rest.

3. The method of claim 1, further comprising causing a second vibration by stopping the first portion of the lancing assembly from further moving in the second direction.

4. The method of claim 3, wherein the second vibration occurs while the first vibration is occurring.

5. The method of claim 3, wherein the second vibration occurs concurrent with the lancing of the surface.

6. The method of claim 3, wherein the second vibration occurs after the lance penetrates the surface.

7. The method of claim 1, wherein the lancing assembly includes a lancing shaft slideably coupled with the lancing end of the body, the lancing shaft having an actuating end disposed inside the body and a longitudinally opposite lance coupling end coupled to the lance coupler, a main shaft slideably coupled with the free end of the body, the main shaft having an actuating end disposed inside the body, 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, the method further comprising:

coupling the lancing shaft to the main shaft by coupling the at least two separable portions of the shaft coupler together; and

moving the lancing shaft and the main shaft in the first direction while the shafts are coupled together.

8. The method of claim 7, wherein the system includes a stop coupled to the lancing end of the body between the lance coupling end and the actuating end of the lancing shaft, the method further comprising:

stopping the lancing shaft from further moving in the first direction with the stop;

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

allowing the lancing shaft to move in the second direction while the main shaft continues moving in the first direction.

9. The method of claim 7, wherein the system includes a piston coupled to the main shaft and slideably and sealably disposed inside 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.

10. The method of claim 9, 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.

11. A method of masking pain resulting from a lancing system for blood extraction, the system comprising a tubular body having a 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, 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 there between, wherein the main shaft is slideably coupled with 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 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, thereby moving the at least two separable portions of the shaft coupler in a first direction along the longitudinal axis toward the free end of the body;

contacting a component of the system with the first portion, thereby stopping the first portion of the shaft coupler from further moving in the first direction and causing a first vibration;

uncoupling the at least two separable portions of the shaft coupler to allow the at least two separable portions to move independently from one another within the body;

allowing the piston to travel in the first direction;

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

thereafter moving the first portion of the shaft coupler in a second direction opposite the first direction while the second portion of the shaft coupler continues moving in the first direction, the second direction being along the longitudinal axis toward the lancing end of the body; and

lancing the surface while the surface is subjected to the vacuum and while the first vibration is occurring.

12. The method of claim 11, further comprising returning the first portion of the shaft coupler to a state of rest.

13. The method of claim 11, further comprising causing a second vibration by stopping the first portion of the shaft coupler from further moving in the second direction.

14. The method of claim 13, wherein the second vibration occurs while the first vibration is occurring.

15. The method of claim 13, wherein the second vibration occurs concurrent with the lancing of the surface.

16. The method of claim 13, wherein the second vibration occurs after the lance penetrates the surface.

17. The method of claim 11, wherein the system includes a stop coupled to the lancing end of the body between the lance coupling end and the actuating end of the lancing shaft, the method further comprising stopping the lancing shaft from further moving in the first direction with the stop.

18. The method of claim 11, further comprising:

creating a first portion of the vacuum;

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

creating a remaining second portion of the vacuum.

19. The method of claim 11, 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.