Apparatus and method for minimizing pain perception

• US 6,231,531 B1
• Filed: 04/09/1999
• Issued: 05/15/2001
• Est. Priority Date: 04/09/1999
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Agilent Technologies, Inc.
• Inventors: Greenstein, Michael, King, David, Zawadzki, Jerry, Mauze, Ganapati Ramnath, Verdonk, Edward Dennis, Lum, Paul, Freeman, Dominique, Simons, Tad Decatur
• Primary Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US09/289,884
• Time in Patent Office: 767 Days
• Field of Search: 601/46, 601/2, 604/131, 604/148, 604/154, 604/22, 600/583, 600/577, 600/578, 606/181, 606/182, 606/183, 606/185
• US Class Current: 601/46
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• 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 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 23/0218 with alternating magnetic fields producing a translating or oscillating movement
• CPC Class Codes: A61H 23/0263 using rotating unbalanced masses
• CPC Class Codes: A61M 5/422 Desensitising skin

Abstract

An apparatus and method for minimizing a subject'"'"'s pain perception during an invasive medical procedure, such as blood sampling and the like. The apparatus can include a receiving surface constructed to contact a portion of the subject'"'"'s skin and a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject'"'"'s skin. An invasive sharp can be substantially permanently supported and moveably disposed with respect to the receiving surface such that the invasive sharp reciprocates between a first position in which the sharp is spaced from the receiving surface, away from the subject'"'"'s skin, and a second position in which at least a portion of the sharp protrudes through an opening in the receiving surface.

Claims

1. An apparatus for reducing a subject'"'"'s pain perception during a medical procedure, said apparatus comprising:

a receiving surface constructed to contact a portion of the subject'"'"'s skin, said receiving surface having an opening therethrough;

a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject'"'"'s skin, to reduce pain perception, said vibratory mechanism transmitting vibrations having a frequency between about 5 Hz and about 150 Hz; and

an invasive sharp supported with respect to said receiving surface and moveably disposed with respect to said receiving surface, said invasive sharp reciprocating between a first position in which the invasive sharp is spaced from the receiving surface, away from the subject'"'"'s skin, and a second position in which at least a portion of the invasive sharp protrudes through the opening in the receiving surface.

2. The apparatus of claim 1, wherein the vibratory mechanism transmits vibrations having a frequency between about 30 Hz and about 40 Hz.

3. The apparatus of claim 1, further comprising a roller unit moveably disposed relative the invasive sharp such that the roller unit applies a force on the invasive sharp that moves the invasive sharp from the first position to the second position.

4. The apparatus of claim 3, further comprising a resilient member associated with the invasive sharp such that the resilient member moves the invasive sharp from the second position to the first position when the force applied by the roller unit is removed.

5. The apparatus of claim 4, wherein the resilient member is a spring.

6. The apparatus of claim 4, where in the resilient member is an elastomeric sheet.

7. The apparatus of claim 4 wherein said roller unit comprises:

a support arm; and

a rotatable roller mounted on said support arm, said roller being moveable from a first location spaced from the invasive sharp to a second location engaging the sharp, said roller moving in a direction generally perpendicular to a direction of movement of the invasive sharp from the first position to the second position.

8. The apparatus of claim 1, wherein the vibratory mechanism includes a roughened roller unit moveably disposed relative to the receiving surface such that movement of the roller unit transmits vibrations through the receiving surface.

9. A modular system for obtaining a blood sample from a subject with reduced pain perception, said system comprising:

a housing;

a removable module disposed within the housing, said module having a receiving surface constructed to contact a portion of the subject'"'"'s skin, said receiving surface having an opening therethrough;

an invasive sharp moveably disposed within the removable module such that the invasive sharp reciprocates between a first position in which the invasive sharp is withdrawn from the receiving surface within the module and a second position in which at least a portion of the invasive sharp protrudes through the opening in the receiving surface; and

a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject'"'"'s skin to reduce pain perception, the vibratory mechanism transmitting vibrations having a frequency between about 5 Hz and about 150 Hz.

10. The system of claim 9, wherein the removable module includes a channel adapted to receive a body fluid from the subject and to direct the body fluid to a point of use.

11. The system of claim 10, wherein the channel includes a capillary tube.

12. The system of claim 9, wherein the vibratory mechanism transmits vibrations having a frequency between about 30 Hz and about 40 Hz.

13. The system of claim 9, further comprising a roller unit moveably disposed within the housing such that the roller unit is capable of applying a force on the invasive sharp that moves the invasive sharp from the first position to the second position.

14. The system of claim 13, further comprising a resilient member associated with the invasive sharp such that the resilient member moves the invasive sharp from the second position to the first position when the force applied by the roller unit is removed.

15. The system of claim 9, wherein the vibratory mechanism includes a roughened roller unit moveably disposed within the housing such that movement of the roller unit transmits vibrations through the receiving surface.

16. A method of reducing a subject'"'"'s pain perception during a medical procedure, said method comprising the steps of:

a) supporting an invasive sharp with respect to a receiving surface, said receiving surface having an opening therethrough for passage of the invasive sharp;

b) vibrating the receiving surface while contacting at least a portion of the receiving surface with a portion of the subject'"'"'s skin to vibrate the subject'"'"'s skin for a period of time sufficient to reduce the subject'"'"'s pain perception proximate a contact point, said vibrating step comprising the step of vibrating the receiving surface at a frequency between about 5 Hz and about 150 Hz;

c) piercing the subject'"'"'s skin with the sharp while the skin is contacting the receiving surface; and

d) withdrawing the sharp from the subject'"'"'s skin.

17. The method of claim 16, wherein the subject'"'"'s skin is vibrated from about ten seconds to about twenty seconds prior to the piercing step.

18. The method of claim 16, wherein the piercing step comprises the step of actuating a roller unit moveably disposed relative to the invasive sharp such that the roller unit applies a force on the invasive sharp that moves the invasive sharp from a first position to a second position in which the sharp pierces the subject'"'"'s skin.

19. The method of claim 18, wherein the step of withdrawing the invasive sharp from the subject'"'"'s skin comprises the step of releasing the force applied by the roller unit on the sharp to allow a resilient member associated with the invasive sharp to move the invasive sharp from the second position to the first position.

20. An apparatus for reducing a subject'"'"'s pain perception during a medical procedure, said apparatus comprising:

a receiving surface constructed to contact a portion of the subject'"'"'s skin, said receiving surface having an opening therethrough;

a vibratory mechanism associated with the receiving surface such that the vibratory mechanism transmits vibrations through the receiving surface and to the subject'"'"'s skin to reduce pain perception, said vibratory mechanism including a roughened roller unit moveably disposed relative to the receiving surface such that movement of the roller unit transmits vibrations through the receiving surface; and

an invasive sharp supported with respect to said receiving surface and moveably disposed with respect to said receiving surface, said invasive sharp reciprocating between a first position in which the invasive sharp is spaced from the receiving surface, away from the subject'"'"'s skin, and a second position in which at least a portion of the invasive sharp protrudes through the opening in the receiving surface.