Sampling devices and methods involving relatively little pain

• US 9,033,898 B2
• Filed: 06/22/2011
• Issued: 05/19/2015
• Est. Priority Date: 06/23/2010
• Status: Active Grant

• Current Assignee: Yourbio Health Incorporated
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Chickering, Donald E. III, Bernstein, Howard, Davis, Shawn, Haghgooie, Ramin, Levinson, Douglas A., Michelman, Mark, Gong, Ping
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US13/166,451
• Publication Number:
  US 20120010529A1
• Time in Patent Office: 1,427 Days
• Field of Search: 600/573, 600/576, 606/181, 606/182
• US Class Current: 600/573
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150091 by electricity
• 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 5/150106 Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
• CPC Class Codes: A61B 5/150129 by cooling
• CPC Class Codes: A61B 5/150145 by negative pressure, e.g. suction, vacuum
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/15105 : Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15119 : comprising shape memory alloys
• CPC Class Codes: A61B 5/15125 : comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15134 : Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/15136 : by use of radiation, e.g. laser
• CPC Class Codes: A61B 5/1514 : by use of gaseous agents, e.g. using suction aspiration or pressurized gas
• 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
• CPC Class Codes: A61B 5/154 : Devices using pre-evacuated means
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 : having a lumen
• CPC Class Codes: A61M 2037/0046 : Solid microneedles
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

Systems and methods for delivering and/or receiving a substance or substances, such as blood, from subjects. In one embodiment, devices and methods for receiving blood from a subject employ devices including a substance transfer component (such as one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, for example, using pain scales such as the WONG BAKER FACES Pain Scale. The device may be self-contained, applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may be processed to determine the blood and/or an analyte within the blood using sensors or agents in the device or an external apparatus. Other aspects of the present invention are directed at other devices for receiving bodily fluids kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Claims

1. A device for receiving blood or other substance from the skin of a subject, the device comprising:

a housing;

a device actuator;

a substance transfer component including an opening for receiving blood from the skin of the subject, the substance transfer component also including at least three needles having a length of 500-1500 microns, the needles being moveable relative to the housing such that actuation of the device actuator moves the needles relative to the housing;

a self-contained, sealed vacuum chamber containing a vacuum prior to movement of any component of the device relative to the housing during use of the device for receiving blood or other substance from the subject;

a flow path between the vacuum chamber and the at least three needles of the substance transfer component;

a flow controller to control fluid communication along the flow path; and

a vacuum actuation component configured to open the flow controller to enable fluid communication through the flow path, the vacuum actuation component being distinct from the at least three needles,

wherein the device actuator is positioned at least partially in the vacuum chamber,

wherein the device is constructed and arranged to insert at least a portion of the needles into the skin, and to apply vacuum from the vacuum chamber to the skin to receive blood from the subject,

and wherein an average pain indication experienced from a 10 microliter blood sampling using the device is less than an average pain indication experienced from a 10 microliter blood sampling using a standard spring-loaded 21-gauge retractable finger lancet, wherein both average pain indications are measured from at least 10 subjects using the WONG-BAKER FACES Pain Scale.

2. The device of claim 1, wherein the device is constructed and arranged to insert at least a portion of the substance transfer component into the skin, and to receive blood from the subject, with an average pain indication over at least 10 subjects, from prior to insertion into the skin of the subject through receiving of at least 10 microliters of blood from the subject, of significantly less than the pain experienced from a blood sampling using a standard spring-loaded 23-gauge retractable finger lancet.

3. The device of claim 1, wherein the device is constructed and arranged to insert at least a portion of the substance transfer component into the skin, and to receive blood from the subject, with an average pain indication over at least 10 subjects, from prior to insertion into the skin of the subject through receiving of at least 10 microliters of blood from the subject, of significantly less than the pain experienced from a blood sampling using a standard spring-loaded 25-gauge retractable finger lancet.

4. The device of claim 1, wherein the device is constructed and arranged to insert at least a portion of substance transfer component into the skin, and to receive blood from the subject, with an average pain indication over at least 10 subjects, from prior to insertion into the skin of the subject through receiving of at least 10 microliters of blood from the subject, of significantly less than the pain experienced from a blood sampling using a standard spring-loaded 28-gauge retractable finger lancet.

5. The device of claim 4, wherein an average pain indication experienced from a 1-microliter blood sampling using the device is at least 70% less painful than an average pain indication experienced from a blood sampling using the standard 28-gauge retractable finger lancet, wherein both average pain indications are measured from at least 10 subjects using the WONG-BAKER FACES Pain Scale.

6. The device of claim 1, wherein the device is constructed and arranged to insert at least a portion of substance transfer component into the skin, and to receive blood from the subject, with an average pain indication over at least 10 subjects, from prior to insertion into the skin of the subject through receiving of at least 10 microliters of blood from the subject, of significantly less than the pain experienced from a blood sampling using a standard spring-loaded 33-gauge retractable finger lancet.

7. The device of claim 1, wherein the needles are arranged for an insertion depth into skin of 500 to 1250 micrometers.

8. The device of claim 1, wherein the substance transfer component includes 4 to 28 needles.

9. The device of claim 8, wherein the needles are arranged in an array where no two needles are closer than 0.1 mm.

10. The device of claim 1, wherein the device further comprises a deployment actuator including a snap dome arranged to insert the needles into skin.

11. The device of claim 1, wherein the device is arranged to receive at least 50 microliters of blood.

12. The device of claim 1, wherein the at least 3 needles are arranged in a circular array.

13. The device of claim 1, wherein the device further comprises a storage chamber arranged to receive blood received from the skin.

14. The device of claim 13, wherein the device actuator includes a button which is pressable to cause insertion of the needles into skin.

15. The device of claim 14, wherein the button is pressable to cause the vacuum chamber to evacuate the storage chamber and reduce pressure on skin below the needles.

16. The device of claim 1, further comprising a deployment actuator including a snap dome arranged to insert the needles into skin.

17. The device of claim 1, wherein the flow controller comprises a pierceable seal.

18. The device of claim 1, wherein the flow controller comprises a valve.

34. The device of claim 14, wherein the button is moveable relative to the housing and extends through a wall of the housing and into the vacuum chamber.

19. A device for receiving blood or other substance from the skin of a subject, the device comprising:

a housing;

a device actuator;

a substance transfer component including an opening for receiving blood or other substance from the skin of the subject, the substance transfer component also including at least three needles having a length of 500-1500 microns, the needles being moveable relative to the housing such that actuation of the device actuator moves the needles relative to the housing;

a self-contained, sealed vacuum chamber containing a vacuum prior to movement of any component of the device relative to the housing during use of the device for receiving blood or other substance from the subject;

a flow path between the vacuum chamber and the at least three needles of the substance transfer component; and

a flow controller configured to control fluid communication along the flow path;

wherein the device is constructed and arranged to insert at least a portion of the needles into the skin, and to apply the vacuum from the vacuum chamber to the skin to receive blood from the subject,

and wherein an average pain indication experienced from a 10 microliter blood sampling using the device is no more than 25% of the highest pain indication as measured from the lowest pain indication to the highest pain indication according to at least one of the following pain scales;

the WONG BAKER FACES Pain Scale, the Visual Analog Pain Scale, or the Numerical Pain Rating Scale.

20. The device of claim 19, wherein at least one of the needles comprises a microneedle for insertion into the skin of the subject, wherein at full insertion into the skin, the microneedle has an insertion depth of at least 200 microns and a cross-sectional area, at the surface of the skin, of at least 2500 square microns.

21. The device of claim 19, wherein the needles are arranged for an insertion depth into skin of 500 to 1250 micrometers.

22. The device of claim 19, wherein the substance transfer component includes 4 to 28 needles.

23. The device of claim 22, wherein the needles are arranged in an array where no two needles are closer than 0.1 mm.

24. The device of claim 19, wherein the device further comprises a deployment actuator including a snap dome arranged to insert the needles into skin.

25. The device of claim 19, wherein the device is arranged to receive at least 50 microliters of blood.

26. The device of claim 19, wherein the at least 3 needles are arranged in a circular array.

27. The device of claim 19, wherein the device further comprises a storage chamber arranged to receive blood received from the skin.

28. The device of claim 27, wherein the device actuator includes a button which is pressable to cause insertion of the needles into skin.

29. The device of claim 28, wherein the button is pressable to cause the vacuum chamber to evacuate the storage chamber and reduce pressure on skin below the needles.

30. The device of claim 27, further comprising a deployment actuator including a snap dome arranged to insert the needles into skin.

31. The device of claim 19, wherein the flow controller comprises a pierceable seal.

32. The device of claim 19, wherein the flow controller comprises a valve.

33. A device for receiving blood or other substance from the skin of a subject, the device comprising:

a housing;

a device actuator;

a substance transfer component including an opening for receiving blood from the skin of the subject, the substance transfer component also including at least three needles having a length of 500-1500 microns, the needles being moveable relative to the housing such that actuation of the device actuator moves the needles relative to the housing;

a self-contained, sealed vacuum chamber containing a vacuum prior to movement of any component of the device relative to the housing during use of the device for receiving blood or other substance from the subject;

a flow controller to control flow in a flow path between the opening and the vacuum chamber;

a flexible structure sealingly separating the opening from the vacuum chamber, the at least three needles being mounted on the flexible structure such that movement of the flexible structure relative to the housing causes the needles to move with the flexible structure relative to the housing,

wherein the device is constructed and arranged to insert at least a portion of the needles into the skin, and to apply vacuum from the vacuum chamber to the skin to receive blood from the subject,

and wherein an average pain indication experienced from a 10 microliter blood sampling using the device is no more than 25% of the highest pain indication as measured from the lowest pain indication to the highest pain indication according to at least one of the following pain scales;

the WONG BAKER FACES Pain Scale, the Visual Analog Pain Scale, or the Numerical Pain Rating Scale.