SAMPLING DEVICES AND METHODS INVOLVING RELATIVELY LITTLE PAIN

• US 20120010529A1
• Filed: 06/22/2011
• Published: 01/12/2012
• 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
• Granted Patent: US 9,033,898 B2
• Time in Patent Office: Days
• US Class Current: 600/576
• 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

The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., to the skin and/or from the skin. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, 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, to for example, using pain scales such as the Wong-Baker FACES Pain Scale. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus. For example, blood may be received from the device, and/or the device may contain sensors or agents able to determine the blood and/or an analyte suspected of being contained in the blood. Other aspects of the present invention are directed at other devices for receiving blood (or other bodily fluids, e.g., interstitial fluid), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Claims

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

a substance transfer component for receiving blood from the skin of the subject,

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 21-gauge retractable finger lancet.

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.

5. 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.

6. The device of claim 5, 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.

9. 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.

4. (canceled)

7-8. -8. (canceled)

10. A device for essentially pain-free receiving of blood or other substance from the skin of a subject, the device comprising:

a substance transfer component for receiving blood or other substance from the skin of the subject, 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 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.

13. The device of claim 10, wherein the substance transfer component includes at least one microneedle for insertion into the skin of the subject, wherein at full insertion into the skin, the at least one 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.

11-12. -12. (canceled)

14-16. -16. (canceled)

17. A device for receiving a substance from the skin of a subject, and/or for delivering a substance to the skin of a subject, the device comprising:

a substance transfer component for insertion into the skin of a subject, having a pre-deployed position and a deployed position; and

a deployment actuator, operably linkable to the substance transfer component, the deployment actuator switchable from a first stable configuration, through an unstable configuration, to a second stable configuration, wherein in the first stable configuration, the substance transfer component is not contactable with the skin of the subject, and in the second stable configuration, the substance transfer component is insertable in the skin of the subject,

and wherein the substance transfer component is constructed and arranged to deliver, to the skin of the subject, a substance selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

18. The device of claim 17, wherein the substance transfer component includes a plurality of skin insertion objects.

20. The device of claim 18, wherein at least some of the skin insertion objects comprise microneedles.

21. The device of claim 18, wherein at least some of the skin insertion objects are at least partially coated with a substance arranged to be delivered to the subject when the skin insertion objects are inserted into the skin.

22. The device of claim 21, wherein the substance arranged to be delivered to the subject is selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

23. The device of claim 21, wherein the substance is an analgesic.

24. The device of claim 23, wherein the analgesic comprises one or more of lidocaine, bupivacaine, and tetracaine.

25. The device of claim 18, wherein at least some of the skin insertion objects are hollow.

19. (canceled)

26-29. -29. (canceled)

30. A device for receiving a substance from the skin of a subject, and/or for delivering a substance to the skin of a subject, the device comprising:

a substance transfer component for insertion into the skin of a subject, having a pre-deployed position and a deployed position; and

a deployment actuator able to move the substance transfer component from the pre-deployed position to the deployed position in a period of time of less than 0.002 seconds, and/or at a velocity of at least 6 meters/second when the substance transfer component is positioned to first contact the skin during deployment,

and wherein the substance transfer component is constructed and arranged to deliver, to the skin of the subject, a substance selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

31. The device of claim 30, wherein the substance transfer component includes a plurality of skin insertion objects.

33. The device of claim 31, wherein at least some of the skin insertion objects comprise microneedles.

34. The device of claim 31, wherein at least some of the skin insertion objects are at least partially coated with a substance arranged to be delivered to the subject when the skin insertion objects are inserted into the skin.

36. The device of claim 34, wherein the substance is an analgesic.

37. The device of claim 36, wherein the analgesic comprises one or more of lidocaine, bupivacaine, and tetracaine.

32. (canceled)

35. (canceled)

38-59. -59. (canceled)

60. A device for receiving a substance from the skin of a subject, and/or for delivering a substance to the skin of a subject, the device comprising:

a substance transfer component for insertion into the skin of a subject, having a pre-deployed position and a deployed position; and

a deployment actuator able to move the substance transfer component from the pre-deployed position to the deployed position at an average acceleration of at least 60,000 meters/second.

61. The device of claim 60, wherein the substance transfer component is constructed and arranged to deliver, to the skin of the subject, a substance selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

62-80. -80. (canceled)

81. A device for receiving a substance from the skin of a subject, and/or for delivering a substance to the skin of a subject, the device comprising:

a substance transfer component including a plurality of skin insertion objects for insertion into the skin of a subject, having a pre-deployed position and a deployed position, each of the skin insertion objects protruding from a base and defining a length from the base, and the plurality of skin insertion objects defining an average length of no more than 1,500 microns; and

a deployment actuator able to move the skin insertion objects from a fully pre-deployed position to a fully deployed position with a force sufficient to insert the plurality of skin insertion objects into or through the skin to an average insertion depth of at least 60% the average length of the plurality of skin insertion objects,

and wherein the substance transfer component is constructed and arranged to deliver, to the skin of the subject, a substance selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

82. The device of claim 81, wherein at least some of the skin insertion objects comprise needles.

83. The device of claim 81, wherein at least some of the skin insertion objects comprise microneedles.

84-105. -105. (canceled)

106. A device for delivering a substance to the skin of a subject, the device comprising:

a substance transfer component for insertion into the skin of a subject, having a pre-deployed position and a deployed position; and

a deployment actuator, operably linkable to the substance transfer component, the deployment actuator switchable from a first stable configuration, through an unstable configuration, to a second stable configuration, wherein in the first stable configuration, the substance transfer component is not contactable with the skin of the subject, and in the second stable configuration, the substance transfer component is insertable in the skin of the subject,

and wherein the substance transfer component is constructed and arranged to deliver, to the skin of the subject, a substance selected from the group consisting of a peptide, a protein, a carbohydrate, a nucleoprotein, a mucoprotein, a lipoprotein, a glycoprotein, a nucleic acid, a nucleotide, nucleoside, a lipid, and a biologically active organic molecule.

107-115. -115. (canceled)