U.S. patent application number 10/165102 was filed with the patent office on 2002-12-12 for devices and methods for the expression of bodily fluids from an incision.
Invention is credited to Patel, Paul, Perez, Edward, Raney, Charles C..
Application Number | 20020188223 10/165102 |
Document ID | / |
Family ID | 27538721 |
Filed Date | 2002-12-12 |
United States Patent
Application |
20020188223 |
Kind Code |
A1 |
Perez, Edward ; et
al. |
December 12, 2002 |
Devices and methods for the expression of bodily fluids from an
incision
Abstract
Systems and methods for the expression of bodily fluid from an
incision in the skin include devices which bear against the skin in
a manner to retain the fluid adjacent the incision site and urge
the fluid inwardly toward the incision. One system utilizes a
constricting member which engages the skin at initial, outer
positions, and moves to draw the skin into an inner position
forming a bulged, pinch of skin containing the incision site. The
constricting member comprises flexible or non-flexible components,
and is formed as a single, continuous member or as a plurality of
discrete elements. A second system includes a bi-stable expression
member including a skin-engaging portion having a first, outwardly
bulged condition, and a second, inverted condition the skin is
drawn into and retained within the member. The exterior surface of
the expression member is optionally configured or treated to
enhance the grasping of the skin. A third system involves a
pressing member including deformable portions defining opposed,
skin-engaging surfaces which are displaced upon pressing the member
against the skin a sufficient amount. The deformable portions
comprise flexible or non-flexible components, and are formed as a
single, continuous member or as a plurality of discrete elements.
The present invention further encompasses the combination of the
foregoing expression systems with each other, as well as with other
expression devices known in the art. Moreover, the invention
includes the combination of the expression systems with incising,
sampling and/or testing systems, particularly in a single,
integrated device. The present invention also contemplates the
associated methods for expressing bodily fluid from an incision,
including in combination with methods for incising, sampling and/or
testing of the bodily fluid.
Inventors: |
Perez, Edward; (Menlo Park,
CA) ; Raney, Charles C.; (Scotts Valley, CA) ;
Patel, Paul; (Sunnyvale, CA) |
Correspondence
Address: |
Woodard, Emhardt, Naughton, Moriarty and McNett
Bank One Center/Tower
Suite 3700
111 Monument Circle
Indianapolis
IN
46204-5137
US
|
Family ID: |
27538721 |
Appl. No.: |
10/165102 |
Filed: |
June 7, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60296949 |
Jun 8, 2001 |
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60296950 |
Jun 8, 2001 |
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60315873 |
Aug 29, 2001 |
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60315968 |
Aug 29, 2001 |
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Current U.S.
Class: |
600/573 |
Current CPC
Class: |
A61B 5/150503 20130101;
A61B 5/150358 20130101; A61B 5/14532 20130101; A61B 5/150213
20130101; A61B 5/1519 20130101; A61B 5/15113 20130101; A61B
5/150022 20130101; A61B 5/150068 20130101; A61B 5/15117 20130101;
A61B 5/150412 20130101; A61B 5/14514 20130101; A61B 5/15194
20130101; A61B 5/15128 20130101 |
Class at
Publication: |
600/573 |
International
Class: |
A61B 005/00 |
Claims
What is claimed is:
1. A device for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the device
comprising: a body; and a member connected with said body and
defining opposed, skin-engaging surfaces, said member having a
first condition with the skin-engaging surfaces contacting the skin
and located at initial, outer positions, said member having a
second condition with the skin-engaging surfaces engaging the skin
and located at constricting, inner positions, the skin being drawn
inward as the skin-engaging surfaces move from the outer positions
to the inner positions, the skin being constricted by the
skin-engaging surfaces in the inner positions.
2. The device of claim 1 in which said member comprises a member
deformable between the first and second conditions.
3. The device of claim 2 in which said member is flexible and
reversibly flexes between the first and second conditions.
4. The device of claim 3 in which said member is comprised of a
material selected from the group consisting of silicone, urethane,
polyvinyl chloride, and delrin.
5. The device of claim 2 in which said member is deformable in a
manner that is at least partially irreversible.
6. The device of claim 2 in which said member is configured to
deform to move the skin-engaging surfaces from the first positions
to the second positions upon pressing the member against the
skin.
7. The device of claim 2 in which said member comprises a single,
continuous member defining at least two opposed, skin-engaging
surfaces.
8. The device of claim 7 in which said member comprises a
continuous, perimetric surface defining the opposed, skin-engaging
surfaces.
9. The device of claim 8 in which said member comprises a circular
surface defining the skin-engaging surfaces.
10. The device of claim 8 in which said member comprises a
plurality of separate, contiguous elements defining the continuous,
perimetric skin-engaging surfaces.
11. The device of claim 7 in which said member is flexible and
reversibly flexes between the first and second positions.
12. The device of claim 11 in which said member is comprised of a
material selected from the group consisting of silicone, urethane,
polyvinyl chloride, and delrin.
13. The device of claim 11 in which said member is configured to
deform to move the skin-engaging surfaces from the first positions
to the second positions upon pressing the member against the
skin.
14. The device of claim 2 in which said member comprises a
plurality of separate elements, each element defining a
skin-engaging surface.
15. The device of claim 14 in which the separate elements are
spaced apart.
16. The device of claim 1 in which said member comprises a
plurality of separate, rigid elements, each element defining a
skin-engaging surface and being movable between the first and
second conditions.
17. The device of claim 16 in which the separate elements are
spaced apart.
18. The device of claim 17 in which the separate elements are
movable to move the skin-engaging surfaces in a radially-inward
direction from the first positions to the second positions.
19. The device of claim 18 in which the separate elements are
arranged to have the skin-engaging surfaces fall within a circular
pattern in the first positions.
20. The device of claim 16 in which the separate elements pivot to
move the skin-engaging surfaces from the first positions to the
second positions.
21. The device of claim 20 in which the separate elements are
arranged to have the skin-engaging surfaces fall within a circular
pattern in the first positions, and in which the separate elements
are pivotable to move the skin-engaging surfaces in a
radially-inward direction from the first positions to the second
positions.
22. The device of claim 1 and which further includes a second
expression member positioned to express the bodily fluid from the
incision.
23. The device of claim 1 and which further includes a sealing ring
attached to said body and positioned interior of said member, the
sealing ring being positioned to be in contact with the skin when
the skin is drawn inward with the skin-engaging surfaces in the
inner positions.
24. The device of claim 1 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
25. The device of claim 24 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
26. The device of claim 25 in which said lancing device comprises
an annular capillary lancet, the annular capillary lancet including
a capillary tube and a lancet received within the capillary
tube.
27. The device of claim 25 in which said body comprises a test
strip.
28. The device of claim 1 and which further includes a sampling
device connected to said body.
29. The device of claim 28 in which said sampling device includes
an inlet, said sampling device having a fluid-receiving position
for receiving the bodily fluid expressed from the incision.
30. The device of claim 29 in which said sampling device is
retained in the fluid-receiving position when the skin-engaging
surfaces move from the outer positions to the inner positions.
31. The device of claim 29 in which said sampling device further
includes a second position displaced from the fluid-receiving
position, said sampling device being movable from the second
position to the fluid-receiving position with the skin-engaging
surfaces in the inner positions.
32. The device of claim 28 in which said sampling device includes a
capillary tube defining a passageway communicating with the inlet
opening.
33. The device of claim 28 in which said sampling device includes a
test strip.
34. The device of claim 28 and which further includes a test system
connected with said body and in fluid communication with said
sampling device.
35. The device of claim 28 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
36. The device of claim 35 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
37. The device of claim 35 and which further includes a test system
connected with said body and in fluid communication with said
sampling device.
38. A device for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the device
comprising: a body defining a cavity; and a bi-stable expression
member connected with said body adjacent to the interior cavity and
including a portion having first and second stable conditions, said
portion in the first stable condition being outwardly bulged
relative to said body, said portion in the second stable condition
being inverted and received within the cavity of said body, said
portion including an exterior skin-engaging surface and defining an
aperture communicating between the exterior skin-engaging surface
and the cavity of said body, the skin-engaging surface engaging the
skin and drawing the skin into said member as said portion inverts
from the first condition to the second condition.
39. The device of claim 38 in which said member is configured to
automatically invert from the first condition to the second
condition upon pressing said member against the skin.
40. The device of claim 38 in which said body comprises a
cylindrical portion including a ring-shaped end surface, and in
which said member comprises a semi-spherical member including a
circular rim secured to the cylindrical end portion.
41. The device of claim 38 in which the exterior skin-engaging
surface of said member includes a plurality of projections for
engaging the skin as said member inverts from the first condition
to the second condition.
42. The device of claim 38 in which the aperture has a minimum
dimension of at least about 2 mm.
43. The device of claim 42 in which the aperture is round and has a
diameter of at least about 7 mm.
44. The device of claim 38 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
45. The device of claim 44 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
46. The device of claim 45 in which said lancing device comprises a
lancet positioned and operable to incise the skin through the
aperture in said member.
47. The device of claim 38 and which further includes a sampling
device connected to said body.
48. The device of claim 38 and which further includes a test system
connected to said body and in fluid communication with said
sampling device.
49. The device of claim 38 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
50. The device of claim 49 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
51. The device of claim 50 and which further includes a test system
connected to said body and in fluid communication with said
sampling device.
52. A device for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the device
comprising: a body; and a member connected with said body and
including deformable portions defining opposed, skin-engaging
surfaces, said member having a first condition with the
skin-engaging surfaces contacting the skin and located at first
positions, said member having a second condition with the
skin-engaging surfaces engaging the skin and at second positions
displaced from the first positions, the deformable portions being
configured to deform from the first positions to the second
positions upon pressing of said member against the skin, the first
condition of said member corresponding to said member being in
contact with the skin and the second condition of said member
corresponding to said member being pressed against the skin a
sufficient amount to deform the portions from the first positions
to the second positions.
53. The device of claim 52 in which the deformable portions are
flexible and reversibly flex between the first positions and the
second positions.
54. The device of claim 52 in which said member comprises a single,
continuous member defining the opposed skin-engaging surfaces.
55. The device of claim 52 in which said member comprises a
plurality of separate, contiguous elements defining the opposed,
skin-engaging surfaces.
56. The device of claim 52 in which said member comprises a
plurality of separate, spaced-apart elements defining the opposed,
skin-engaging surfaces.
57. The device of claim 56 in which the separate elements are
arranged to have the skin-engaging surfaces fall within a circular
pattern in the first and second positions.
58. The device of claim 52 in which the skin-engaging surfaces
include outer contact areas and inner contact areas, the deformable
portions being configured to provide resistance to deformation
which is greater at the outer contact areas than at the inner
contact areas, said device thereby applying greater pressure to the
skin at the outer areas as compared to the inner areas when said
device is pressed against the skin.
59. The device of claim 52 in which the skin-engaging surfaces
include outer contact areas and inner contact areas, the inner
contact areas being recessed inwardly of the outer contact areas,
said device thereby applying pressure to the skin first at the
outer areas and second at the inner areas when said device is
pressed against the skin.
60. The device of claim 52 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
61. The device of claim 60 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
62. The device of claim 61 in which said lancing device comprises a
lancet positioned and operable to incise the skin through the
aperture in said member.
63. The device of claim 52 and which further includes a sampling
device connected to said body.
64. The device of claim 52 and which further includes a test system
connected to said body and in fluid communication with said
sampling device.
65. The device of claim 52 and which further includes an incising
mechanism connected to said body and positioned to incise a
person's skin at a location interior of said member.
66. The device of claim 65 in which said incising mechanism
comprises a lancing device positioned to lance the person's
skin.
67. The device of claim 66 and which further includes a test system
connected to said body and in fluid communication with said
sampling device.
68. A method for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the method
comprising: providing an expression device including a body and a
member connected with the body and defining opposed, skin-engaging
surfaces, the member having a first condition with the
skin-engaging surfaces contacting the skin and located at initial,
outer positions, the member having a second condition with the
skin-engaging surfaces engaging the skin and located at
constricting, inner positions, the skin being drawn inward as the
skin-engaging surfaces move from the outer positions to the inner
positions, the skin being constricted by the skin-engaging surfaces
in the inner positions; contacting the skin with the skin-engaging
surfaces with the skin-engaging surfaces at the initial, outer
positions; and moving the skin-engaging surfaces to the
constricting, inner positions to draw the skin inward and to
constrict the skin with the skin-engaging surfaces.
69. The method of claim 68 in which the member is deformable
between the first and second conditions, and said moving comprises
deforming the member.
70. The method of claim 68 in which the member is flexible and
reversibly flexes between the first and second conditions, and said
moving comprises flexing the member.
71. The method of claim 68 in which the member comprises a single,
continuous member defining at least two opposed, skin-engaging
surfaces.
72. The method of claim 68 in which the member comprises a
plurality of separate elements, each element defining a
skin-engaging surface, and said moving comprises moving each of the
plurality of elements.
73. The method of claim 68 and which further includes incising the
skin.
74. The method of claim 68 and which further includes collecting
the bodily fluid.
75. The method of claim 74 and which further includes incising the
skin.
76. The method of claim 74 and which further includes testing the
bodily fluid.
77. The method of claim 76 and which further includes incising the
skin.
78. A method for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the method
comprising: providing an expression device including a body
defining a cavity and a bi-stable expression member connected with
the body adjacent to the interior cavity and including a portion
having first and second stable conditions, the portion in the first
stable condition being outwardly bulged relative to the body, the
portion in the second stable condition being inverted and received
within the cavity of the body, the portion including an exterior
skin-engaging surface and defining an aperture communicating
between the exterior skin-engaging surface and the cavity of the
body, the skin-engaging surface engaging the skin and drawing the
skin into the member as the portion inverts from the first
condition to the second condition; contacting the skin with the
skin-engaging surface at the first, outwardly bulged condition; and
inverting the portion with the skin-engaging surface in contact
with the skin to draw the skin into the member.
79. The method of claim 78 and which further includes incising the
skin.
80. The method of claim 78 and which further includes collecting
the bodily fluid.
81. The method of claim 80 and which further includes incising the
skin.
82. The method of claim 80 and which further includes testing the
bodily fluid.
83. The method of claim 82 and which further includes incising the
skin.
84. A method for expressing bodily fluid from an incision in the
skin, the incision being formed at an incision site, the method
comprising: providing an expression device including a body and a
member connected with the body and including deformable portions
defining opposed, skin-engaging surfaces, the member having a first
condition with the skin-engaging surfaces contacting the skin and
located at first positions, the member having a second condition
with the skin-engaging surfaces engaging the skin and at second
positions displaced from the first positions, the deformable
portions being configured to deform from the first positions to the
second positions upon pressing of the member against the skin, the
first condition of the member corresponding to the member being in
contact with the skin and the second condition of the member
corresponding to the member being pressed against the skin a
sufficient amount to deform the portions from the first positions
to the second positions; contacting the skin with the skin-engaging
surfaces with the skin-engaging surfaces in the first positions;
and pressing the expression device against the skin and deforming
the member to move the skin-engaging surfaces from the first
positions to the second positions.
85. The method of claim 84 in which the deformable portions are
flexible, and said deforming comprises flexing the deformable
portions.
86. The method of claim 84 in which the skin-engaging surfaces
include outer contact areas and inner contact areas, the deformable
portions being configured to provide resistance to deformation
which is greater at the outer contact areas than at the inner
contact areas, the device thereby applying greater pressure to the
skin at the outer areas as compared to the inner areas when the
device is pressed against the skin.
87. The method of claim 84 in which the skin-engaging surfaces
include outer contact areas and inner contact areas, the inner
contact areas being recessed inwardly of the outer contact areas,
the device thereby applying pressure to the skin first at the outer
areas and second at the inner areas when the device is pressed
against the skin.
88. The method of claim 84 and which further includes incising the
skin.
89. The method of claim 84 and which further includes collecting
the bodily fluid.
90. The method of claim 89 and which further includes incising the
skin.
91. The method of claim 89 and which further includes testing the
bodily fluid.
92. The method of claim 91 and which further includes incising the
skin.
Description
REFERENCE TO RELATED APPLICATIONS/PATENTS
[0001] This application is related to and claims priority from the
following U.S. patent applications, Ser. Nos. 09/879,991, filed by
Perez et al. on Jun. 14, 2001 (Atty Docket 1104); 60/296,949, filed
by Perez on Jun. 8, 2001 (Atty Docket 1106); 60/296,950, filed by
Perez on Jun. 8, 2001 (Atty Docket 1139); 60/315,873, filed by
Perez et al. on Aug. 29, 2001 (Atty Docket 1107); and 60/315,968,
filed by Perez et al. on Aug. 29, 2001 (Atty Docket 1125). The
disclosures in the foregoing applications are hereby incorporated
by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to the sampling of a bodily
fluid obtained from an incision in the skin, and more particularly
to acquiring the fluid by capillary action. The invention also may
include the combination of such sampling devices and methods with
incising, expressing, and/or testing systems.
[0004] 2. Description of the Prior Art
[0005] The acquisition and testing of bodily fluids is useful for
many purposes, and continues to grow in importance for use in
medical diagnosis and treatment, and in other diverse applications.
In the medical field, it is desirable for lay operators to perform
tests routinely, quickly and reproducibly outside of a laboratory
setting, with rapid results and a readout of the resulting test
information. Testing can be performed on various bodily fluids, and
for certain applications is particularly related to the testing of
blood and/or interstitial fluid. Such fluids can be tested for a
variety of characteristics of the fluid, or analytes contained in
the fluid, in order to identify a medical condition, determine
therapeutic responses, assess the progress of treatment, and the
like.
[0006] The testing of bodily fluids basically involves the steps of
obtaining the fluid sample, transferring the sample to a test
device, conducting a test on the fluid sample, and displaying the
results. These steps are generally performed by a plurality of
separate instruments or devices.
[0007] One method of acquiring the fluid sample involves inserting
a hollow needle or syringe into a vein or artery in order to
withdraw a blood sample. However, such direct vascular blood
sampling can have several limitations, including pain, infection,
and hematoma and other bleeding complications. In addition, direct
vascular blood sampling is not suitable for repeating on a routine
basis, can be extremely difficult and is not advised for patients
to perform on themselves.
[0008] The other common technique for collecting a bodily fluid
sample is to form an incision in the skin to bring the fluid to the
skin surface. A lancet, knife or other cutting instrument is used
to form the incision in the skin. The resulting blood or
interstitial fluid specimen is then collected in a small tube or
other container, or is placed directly in contact with a test
strip. The fingertip is frequently used as the fluid source because
it is highly vascularized and therefore produces a good quantity of
blood. However, the fingertip also has a large concentration of
nerve endings, and lancing the fingertip can therefore be painful.
Alternate sampling sites, such as the palm of the hand, forearm,
earlobe and the like, may be useful for sampling, and are less
painful. However, they also produce lesser amounts of blood. These
alternate sites therefore are generally appropriate for use only
for test systems requiring relatively small amounts of fluid, or if
steps are taken to facilitate the expression of the bodily fluid
from the incision site. Various methods and systems for incising
the skin are known in the art. Exemplary lancing devices are shown,
for example, in U.S. Pat. Nos. Re 35,803, issued to Lange, et al.
on May 19, 1998.; U.S. Pat. No. 4,924,879, issued to O'Brien on May
15, 1990; U.S. Pat. No. 5,879,311, issued to Duchon et al. on Feb.
16, 1999; U.S. Pat. No. 5,857,983, issued to Douglas on Jan. 12,
1999; U.S. Pat. No. 6,183,489, issued to Douglas et al. on Feb. 6,
2001; U.S. Pat. No. 6,332,871, issued to Douglas et al. on Dec. 25,
2001; and U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct.
12, 1999. A representative commercial lancing device is the
Accu-Chek Softclix lancet.
[0009] Patients are frequently advised to urge fluid to the
incision site, such as by applying pressure to the area surrounding
the incision to milk or pump the fluid from the incision.
Mechanical devices are also known to facilitate the expression of
bodily fluid from an incision. Such devices are shown, for example,
in U.S. Pat. Nos. 5,879,311, issued to Duchon et al. on Feb. 16,
1999; U.S. Pat. No. 5,857,983, issued to Douglas on Jan. 12, 1999;
U.S. Pat. No. 6,183,489, issued to Douglas et al. on Feb. 6, 2001;
U.S. Pat. No. 5,951,492, issued to Douglas et al. on Sep. 14, 1999;
U.S. Pat. No. 5,951,493, issued to Douglas et al. on Sep. 14, 1999;
U.S. Pat. No. 5,964,718, issued to Duchon et al. on Oct. 12, 1999;
and U.S. Pat. No. 6,086,545, issued to Roe et al. on Jul. 11, 2000.
A representative commercial product that promotes the expression of
bodily fluid from an incision is the Amira AtLast blood glucose
system.
[0010] The acquisition of the produced bodily fluid, hereafter
referred to as the "sampling" of the fluid, can take various forms.
Once the fluid specimen comes to the skin surface at the incision,
a sampling device is placed into contact with the fluid. Such
devices may include, for example, systems in which a tube or test
strip is either located adjacent the incision site prior to forming
the incision, or is moved to the incision site shortly after the
incision has been formed. A sampling tube may acquire the fluid by
suction or by capillary action. Such sampling systems may include,
for example, the systems shown in U.S. Pat. Nos. 6,048,352, issued
to Douglas et al. on Apr. 11, 2000; U.S. Pat. No. 6,099,484, issued
to Douglas et al. on Aug. 8, 2000; and U.S. Pat. No. 6,332,871,
issued to Douglas et al. on Dec. 25, 2001. Examples of commercial
sampling devices include the Roche Compact, Amira AtLast,
Glucometer Elite and Therasense FreeStyle test strips.
[0011] The bodily fluid sample may be analyzed for a variety of
properties or components, as is well known in the art. For example,
such analysis may be directed to hematocrit, blood glucose,
coagulation, lead, iron, etc. Testing systems include such means as
optical (e.g., reflectance, absorption, fluorescence, Raman, etc.),
electrochemical, and magnetic means for analyzing the sampled
fluid. Examples of such test systems include those in U.S. Pat.
Nos. 5,824,491, issued to Priest et al. on Oct. 20, 1998; U.S. Pat.
No. 5,962,215, issued to Douglas et al. on Oct. 5, 1999; and U.S.
Pat. No. 5,776,719, issued to Douglas et al. on Jul. 7, 1998.
[0012] Typically, a test system takes advantage of a reaction
between the bodily fluid to be tested and a reagent present in the
test system. For example, an optical test strip will generally rely
upon a color change, i.e., a change in the wavelength absorbed or
reflected by dye formed by the reagent system used. See, e.g., U.S.
Pat. Nos. 3,802,842; 4,061,468; and 4,490,465.
[0013] A common medical test is the measurement of blood glucose
level. The glucose level can be determined directly by analysis of
the blood, or indirectly by analysis of other fluids such as
interstitial fluid. Diabetics are generally instructed to measure
their blood glucose level several times a day, depending on the
nature and severity of their diabetes. Based upon the observed
pattern in the measured glucose levels, the patient and physician
determine the appropriate level of insulin to be administered, also
taking into account such issues as diet, exercise and other
factors.
[0014] In testing for the presence of an analyte such as glucose in
a bodily fluid, test systems are commonly used which take advantage
of an oxidation/reduction reaction which occurs using an
oxidase/peroxidase detection chemistry. The test reagent is exposed
to a sample of the bodily fluid for a suitable period of time, and
there is a color change if the analyte (glucose) is present.
Typically, the intensity of this change is proportional to the
concentration of analyte in the sample. The color of the reagent is
then compared to a known standard which enables one to determine
the amount of analyte present in the sample. This determination can
be made, for example, by a visual check or by an instrument, such
as a reflectance spectrophotometer at a selected wavelength, or a
blood glucose meter. Electrochemical and other systems are also
well known for testing bodily fluids for properties on
constituents.
[0015] The present invention provides for enhancing the fluid
sampling and testing by assisting in the expression of the fluid
from the incision. Expression of the fluid is always useful in
order to increase the quantity of bodily fluid available for
acquisition by a sampling device. Such larger quantities make it
easier to quickly and reliably acquire the fluid, and reduce the
potential that there will be an insufficient quantity of fluid
acquired for testing to be performed. When used at the fingertip,
expression results in an even larger quantity of fluid being
produced in a shorter period of time, thereby providing a suitable
amount of fluid for tests requiring relatively larger quantities.
When used at alternate sites, the fluid expression can be important
to provide a sufficient quantity of fluid to be acquired and tested
by a given system.
SUMMARY OF THE INVENTION
[0016] The present invention provides various systems and methods
for the expression of bodily fluid from an incision in the skin.
The invention encompasses separate expression devices as well as
combination systems including incising, sampling and/or testing
systems.
[0017] In accordance with one aspect of the present invention,
there is provided a device for expressing bodily fluid from an
incision site which includes a body and a constricting member
connected to the body and defining opposed, skin-engaging surfaces.
The constricting member has a first condition with the
skin-engaging surfaces contacting the skin at initial, outer
positions, and a second condition with the skin-engaging surfaces
engaging and drawing the skin into an inner position forming a
bulged, pinch of skin containing the incision site. The
constricting member deforms or moves between the first and second
conditions, and may comprise flexible or non-flexible components.
The constricting member may also be formed as a single, continuous
member or as a plurality of discrete elements.
[0018] In accordance with a second aspect of the present invention,
there is provided a device for expressing bodily fluid from an
incision site including a body defining a cavity and a bi-stable
expression member connected to the body adjacent to the interior
cavity. The expression member includes a skin-engaging portion
having first and second stable conditions, with the portion in the
first stable condition being outwardly bulged relative to the body,
and the portion in the second stable condition being inverted and
received within the cavity of the body. The exterior of the
skin-engaging portion includes an exterior surface and defines an
aperture communicating between the exterior surface and the cavity.
The skin-engaging portion engages the skin and draws the skin into
the member as the skin-engaging portion inverts from the first
condition to the second condition. The exterior surface of the
skin-engaging portion is optionally configured or treated to
enhance the grasping of the skin, such as by providing projections
or a sticky coating.
[0019] In a third aspect, the present invention provides a device
for expressing bodily fluid from an incision site which includes a
body and a pressing member connected with the body and including
deformable portions defining opposed, skin-engaging surfaces. The
deformable portions having first positions contacting the skin and
second positions engaging the skin and displaced from the first
positions. The deformable portions are configured to deform from
the first positions to the second positions upon pressing the
member against the skin a sufficient amount. The deformable
portions of the pressing member may comprise flexible or
non-flexible components, and may also be formed as a single,
continuous member or as a plurality of discrete elements.
[0020] The present invention further encompasses the combination of
the foregoing expression systems with each other, as well as with
other expression devices known in the art. Moreover, the invention
includes the combination of the expression systems with incising,
sampling and/or testing systems, particularly in a single,
integrated device. The present invention also contemplates the
associated methods for expressing bodily fluid from an incision,
including in combination with methods for incising, sampling and/or
testing of the bodily fluid.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a front, elevational view of a fluid testing
device including an expression system in accordance with an
embodiment of the present invention.
[0022] FIG. 2 is a cross-sectional view of the testing device of
FIG. 1.
[0023] FIG. 3 is a distal end, plan view of the testing device of
FIG. 1.
[0024] FIG. 4 is a partial, cross-sectional view of the testing
device of FIG. 1.
[0025] FIG. 5 is a partial cross-sectional view of the device,
showing the expression member in the constricting position.
[0026] FIG. 6 is a partial cross-sectional view of the device,
showing the incising of the skin.
[0027] FIG. 7 is a partial cross-sectional view of the device
showing the acquisition of the bodily fluid by a sampling
system.
[0028] FIGS. 8-10 are partial, cross-sectional views showing
alternate configurations of the expression member.
[0029] FIG. 11 is a side, cross-sectional view of a test strip
including an expression system in accordance with an alternate
embodiment of the present invention.
[0030] FIG. 12 is a bottom, plan view of the test strip of FIG. 11,
partially in cross section.
[0031] FIG. 13 is a side, cross-sectional view of the test strip of
FIG. 11, showing the expression system in the constricting
position.
[0032] FIG. 14 is a side, cross-sectional view of the test strip of
FIG. 11, showing the bodily fluid being acquired by the capillary
passageway in the test strip.
[0033] FIG. 15 is a side, elevational view, partially in
cross-section, showing a further embodiment of the present
invention including movable, rigid constricting elements.
[0034] FIG. 16 is a side, elevational view, partially in
cross-section, showing the device of FIG. 15 with the elements in
the constricting position.
[0035] FIG. 17 is a partial, side view of the device of FIG. 15,
showing the attachment of the constricting elements.
[0036] FIG. 18 is a side, elevational view of another embodiment of
an expression system in accordance with the present invention.
[0037] FIG. 19 is a side, cross-sectional view of the device of
FIG. 18.
[0038] FIG. 20 is a side, cross-sectional view of the device of
FIG. 18, showing the expression member in the inverted
position.
[0039] FIG. 21 is a side, cross-sectional view of an additional
embodiment of an expression system according to the present
invention.
[0040] FIG. 22 is a side, cross-sectional view of the device of
FIG. 21, showing the expression elements in the deformed
condition.
[0041] FIG. 23 is a side, cross-sectional view of an alternate
embodiment of the expression system of FIG. 21.
[0042] FIG. 24 is a distal end, elevational view of the expression
system of FIG. 23.
[0043] FIG. 25 is a partial, cross-sectional view of a fluid
sampling device including a combined expression system in
accordance with one embodiment of the present invention.
[0044] FIG. 26 is a side, cross-sectional view of a lancing device
further incorporating an expression system of the present
invention.
[0045] FIG. 27 is a side, elevational view of a lancet holder
useful in the device of FIG. 26.
[0046] FIG. 28 is a partial, cross-sectional view of the
skin-engaging portion of the device of FIG. 26, and further showing
a test strip mounted therein.
[0047] FIG. 29 is a cross-sectional view of the device of FIG. 26
taken along the line 26-26 and viewed in the direction of the
arrows.
[0048] FIG. 30 is a side, elevational view of an alternate
embodiment of an integrated fluid testing device according to an
embodiment of the present invention.
[0049] FIGS. 31 and 32 are partial, cross-sectional views of the
fluid testing device of FIG. 30, showing in particular the
expression of fluid from the skin and movement of the fluid up to
the test area.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0050] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended, such alterations and further modifications in the
illustrated devices and methods, and such further applications of
the principles of the invention as illustrated therein being
contemplated as would normally occur to one skilled in the art to
which the invention relates.
[0051] The present invention provides a variety of devices and
methods which separately or in combination are useful in enhancing
the expression of fluid from an incision in the skin. This
expression of the fluid results in a fluid sample that is larger,
and/or produced more quickly, than would otherwise result.
Expression of a bodily fluid from an incision is desirable in many
instances. The lancing of the skin may produce a sufficient
quantity of blood or interstitial fluid, but expression of the
fluid from the incision will provide greater assurance that a
sufficient quantity has been produced, and that the sample may be
successfully and readily acquired. Also, expression of the bodily
fluid is advantageous in the use of alternate test sites, such as
the palm or forearm, because the quantity of fluid produced without
expression can be significantly less than the amount produced at
the fingertip. While some test devices will operate with greatly
reduced fluid volumes, a greater volume of fluid makes it easier to
acquire the fluid for testing. The present invention provides
devices and methods that greatly enhance the expression of fluid
from an incision.
[0052] The expression of fluid is also important when used in
combination devices. The expression of fluid in the context of an
integrated lancing and sampling device, for example, is
advantageous since it is more difficult to view the fluid sample
and it is therefore more important that the sample is sufficient
for sampling and testing purposes. The present invention is readily
combined in a single, integrated unit with incising, sampling
and/or testing devices.
[0053] The fluid is obtained from an incision formed in the surface
of the skin. The incising of the skin may be accomplished by any
suitable means, including cutting with a mechanical instrument,
laser, high speed fluid stream, etc. Of these, lancing the skin is
most common and is preferred, and specific descriptions herein use
lancing for purposes of example. It will be appreciated, however,
that lancing is only exemplary, and all forms of making an incision
in the skin are included.
[0054] The depth of penetration generally controls the fluid
produced, particularly in combination with the characteristics of
the incision site. The present invention is useful with various
bodily fluids, including blood or interstitial fluid. The incising
device may be configured for production of either blood or
interstitial fluid, for example, by controlling the distance which
the incising device extends into the user's skin. For example, a
depth of 0.25 mm to 4 mm will typically produce blood from the
dermis, while a depth of 0.05 mm to 0.5 mm will produce
interstitial fluid from the epidermis.
[0055] The present invention encompasses the concept that bodily
fluid can be expressed from an incision by a variety of methods and
devices that retain the fluid adjacent the incision and/or urge the
fluid toward the incision. One concept involves constricting the
area surrounding the incision, thereby retaining the bodily fluid
within the constricted location and at the same time urging the
fluid toward the incision. A second concept involves pressing the
skin surrounding the incision, thereby increasing the pressure on
the fluid and forcing it to move toward and out of the incision. A
third concept involves the "kneading" of the skin by moving a
device along the skin in the direction of the incision, thereby
pushing the fluid toward and out of the incision. The present
invention further contemplates the combination of any two or all
three of these modes of expression.
[0056] The fluid expression functions to facilitate the production
of fluid at the site of an incision. As used herein, the term
"incision" is intended to cover any opening in the skin that
permits direct access to the bodily fluid. Unless indicated
otherwise, the expression systems can be used before and/or after
the incision is formed. Therefore the term "incision site" is
intended to include the site where an incision either has been or
will be formed, unless from the context or express language it is
clear otherwise.
[0057] One of the approaches to expression in accordance with the
present invention is the constriction of the skin surrounding the
site of the incision. The constriction may occur before, during
and/or after the incision is formed. The term constriction is
intended herein to refer to contacting the skin at locations
outward of the incision site and then moving a portion of the skin
inward toward the incision site and holding the skin in that
position. The initial engagement of the skin and the subsequent
movement inwardly of the skin essentially grasps the skin at the
surface and pinches the skin in a manner to retain it in the
constricted position. This provides a portion of skin around the
incision site that is engaged by the constriction device and is
retained in this position for a period of time, typically while the
incising and sampling take place. The skin will have the appearance
of a raised pucker or pinch of skin which includes the incision
site. This constriction of the skin is distinguished from mere
pressing against the skin. The bodily fluid is held within the
region of the constriction and is also urged toward the incision by
pressure generated by the constricting device.
[0058] In one embodiment, the constriction device comprises a
deformable member positioned at the end of a support housing. The
deformable member engages the skin as the device is initially
pressed against the skin. As the device is further pressed against
the skin, the member deforms such that the engaging surface grasps
the skin and moves it inwardly toward the incision site. In this
embodiment, the deformed member is preferably configured such that
pressing the member against the skin automatically causes the
member to deform in a manner that constricts the skin. In a
preferred embodiment, the deformation of the member comprises
non-permanent flexing of the member between the outer and inner
positions. However, the invention also contemplates the use of a
member that deforms in a manner that is permanent, or at least not
fully reversible. The deforming member may be constructed from a
variety of pliable, biocompatible materials suitable to produce
such flexing or other deformation, including for example silicone,
urethane, polyvinyl chloride, delrin, and various other natural and
synthetic materials having the requisite physical properties.
[0059] Referring in particular to the drawings, there is shown a
fluid expression device 10 constructed in accordance with a first
embodiment of the present invention. Device 10 (FIG. 1) includes a
housing 11 having a deformable expression member 12 at the end
thereof. For purposes of illustration, the deformable member is
described hereafter with respect to a flexible member. Housing 11
is typically an elongated, cylindrical member which is readily
grasped by the user, but the housing may have a variety of other
shapes. The material used for the housing is not critical, and may
comprise, for example, various metals and plastics. The housing
typically will contain other systems for incising, sampling and/or
testing the bodily fluid.
[0060] The expression member 12 is connected to or integral with
the housing and defines a plurality of distal end, skin-engaging
surfaces, for example, 13a and 13b. In the embodiment shown, the
expression member comprises a continuous, perimetric surface 13
defining the opposed, skin-engaging surfaces. The surfaces are
"opposed" in the sense that movement of the surfaces will result in
the constriction of the skin as previously described. The surfaces
move from a first, skin-contacting position (FIG. 4) to a second,
skin-constricting position (FIG. 5). The surfaces may move directly
toward each other, or simply in a direction sufficient to constrict
the skin. For example, one set of skin-engaging surfaces could move
in parallel toward a second set of opposed, skin-engaging surfaces.
Also, one or more of the skin-engaging surfaces may be fixed
relative to the housing, while other of the surfaces move relative
to the fixed surfaces. In a preferred embodiment, the skin-engaging
member provides surfaces which fall within a circular pattern and
the surfaces are then preferably diametrically opposed, or
equi-radially spaced about the circular configuration. In
deforming, the circular or other form of the member may reduce in
size or may change shape. In the latter instance, for example, a
circular shape may be changed to an oval or oblong shape such that
the skin is pinched from two opposing sides.
[0061] In use, the surfaces 13 contact the skin surface 14 as the
device 10 is pressed (downwardly in FIG. 4) against the skin. The
device is then pressed further against the skin and the surfaces 13
engage the skin and urge the skin inward as the expression member
flexes (FIG. 5). This action produces an upwardly-bulged, pinch of
skin 15. The inward and upward movements of the skin-engaging
surfaces constrict the skin, holding bodily fluid within the
constricted area and applying a pressure that will urge the fluid
toward and out of an incision.
[0062] The expression member 12 has been described as being a
flexible member. This indicates that releasing the pressure and
removing the device from the skin will result in a return of the
member to the starting shape shown in FIG. 4. The use of a flexible
member is preferable in that the device is thereby available for
repeated use. However, alternatively the deformation of the member
may be permanent or only partially reversible. In that event, the
member will not return to its original shape. Such devices may not
be reusable without replacement of the deforming expression member.
However, this may be suitable in certain applications, such as in a
clinical setting where it would be appropriate to replace the
skin-engaging member after each use. The deforming member can be
readily adapted for replacement on the housing, such as by the use
of a snap, press or threaded fit of the member to the housing.
[0063] The constriction device finds particular advantage in
combination with an incising system constituting a part of an
overall integrated device. As used herein, incising is intended to
mean generally any way to form an incision in the skin to enable
fluid to be accessed directly. Described hereafter is an exemplary
device using a lancet to form the incision.
[0064] As shown in the drawings, the device 10 may include, for
example, a lancing device 16 operable to incise the bulged skin. In
this version, the lancing device 16 includes a capillary tube 17
and a lancet 18 longitudinally movable within the capillary tube.
In accordance with the method depicted in the drawings, the lancing
device 16 is positioned to have its distal end adjacent the pinch
of skin formed by the constriction device (FIG. 5). The lancet 18
is then advanced beyond the end 19 of the capillary tube 17 a
predetermined distance to enter the skin and form an incision 20 of
desired depth (FIG. 6). The lancet 18 is then withdrawn from the
incision and a drop of blood or interstitial fluid 21 exits from
the incision.
[0065] The constriction of the skin adjacent the incision ensures
that fluid within that region will be retained, rather than moving
away from the site. The constriction of the skin further provides a
bulged, pressurized pinch of skin 15 which tends to spread the
incision apart after it is formed. This facilitates the expression
of fluid from the incision since the skin is prevented from
reclosing around the incision. In addition, the pressure maintained
by the constricting member urges fluid to exit the incision once it
is formed.
[0066] The spacing and movement of the skin-engaging surfaces of
the constriction member are selected to provide the desired
expression results. The member 13 moves between a first condition
with the surfaces contacting the skin and located at initial, outer
positions (FIG. 4), and a second condition with the surfaces
engaging the skin and located at constricting, inner positions
(FIG. 5). The skin is drawn inward as the skin-engaging surfaces
move from the outer positions to the inner positions. The initial
and constricted spacings of the skin-engaging surfaces may be
varied depending on the targeted bodily fluid, the incision site,
for example, the finger versus alternate sites, and other
considerations. In a typical device, for example, the outer
contacting dimension 22 (FIG. 4) is about 5 to about 30 mm,
preferably about 15 to about 25 mm, and the inner constricting
dimension 23 (FIG. 5) is about 2 to about 9 mm, preferably about 6
to about 8 mm.
[0067] The particular procedure represented in the drawings
involves the constricting of the skin prior to and during lancing.
It will be appreciated, however, that the constriction may also be
applied simultaneously with or after the formation of the incision.
Further, the constriction device is shown as being combined in a
single device with the lancing system. However, the constricting
device is also applicable for use as a separate device that is
applied to the skin over an incision site.
[0068] The described embodiment further demonstrates the inclusion
of a sampling device useful for acquiring the fluid formed at the
incision site. The capillary tube 17 defines an annular, capillary
passageway 24 between the lancet 18 and the interior wall of the
capillary tube. The capillary tube is positioned to contact the
fluid droplet 21 as it forms (FIG. 7). As the droplet is generated,
it eventually grows to a sufficient size that it contacts the end
opening of the capillary passageway. The fluid is then drawn
upwardly into the annular passageway 24 by capillary action. This
action can be enhanced by using a capillary tube having an interior
passageway which is formed of a material that is naturally
hydrophilic or has been treated to be hydrophilic, or which is
covered, e.g., coated, with a hydrophilic material. The capillary
tube may further be treated or constructed to have a hydrophobic
outer surface 25 to inhibit attraction of the bodily fluid to the
exterior of the capillary.
[0069] The constriction member may assume a variety of particular
shapes and compositions. For example, referring to FIGS. 8-10,
there are shown several expression devices 10a-10c having
alternative configurations for the constriction member 12. As these
drawings demonstrate, the shape of the constriction member may
include such variations as rounded (12a), squared (12b) and bulged
(12c) profiles. The skin-engaging surfaces 13 may be perpendicular
with or angled to the adjacent portion of the constriction member,
the longitudinal axis of the device 10, and/or the skin surface.
The shapes and sizes are selected such that the deformation of the
member provides a desired grasping and constriction of the
skin.
[0070] The constriction member may be formed in a variety of
manners. The member may be a single, unitary material.
Alternatively, the member may be formed from several individual
members that are separately attached to the housing or are joined
together as an integral unit. The member may be uniform in
composition, or it may be constructed of different materials,
including materials having different physical properties, such as
different durometers or other parameters that allow for tailoring
the deformation characteristics of the member. For example, the
flex or other deformation rate of different portions of the
constriction member may be selected to control the rate and shape
in which the member deforms, thereby controlling the manner in
which the skin is constricted.
[0071] The constriction member is generally shown as having a
diameter comparable to that of the housing. However, this should
not be considered as limiting. Instead, the member may also be
formed having a diameter greater or less than the diameter of the
housing or other supporting structure. It is within the scope and
intent of the present invention that the shape, size and other
characteristics may be widely varied in order to provide a desired
constricting of the skin to achieve the purposes set forth
herein.
[0072] In an alternative embodiment, the constriction system
utilizes several discrete members, rather than a single continuous
member, which engage the skin and pinch it inwardly. Referring in
particular to FIGS. 11-14, there is shown an embodiment of the
constriction system in combination with alternative lancing,
sampling and testing systems. In this version, the sampling system
comprises a test strip 26 including a constricting system 27
attached to the underside thereof. The constricting system is shown
as including several discrete, deformable elements 28, each element
defining a surface 29 to engage the skin and move it inwardly to
constrict the skin in the manner described with respect to the
prior embodiments. This embodiment is shown in the drawings as
including several arm-like structures, although various other
shapes of the constricting elements are also suitable.
[0073] In the use of a plurality of discrete elements, the
positioning of such elements is variable. It is preferred that the
elements are selected to be spaced apart and to generally surround
the incision site. The elements are therefore preferably provided
such that at least two elements are positioned to be on opposite
sides of the incision site, but also any additional number of
elements may be included. In a preferred embodiment, the elements
include skin-engaging surfaces 29 positioned to fall within a
circular pattern (FIG. 12). The elements preferably deform in a
manner to move the skin-engaging surfaces in a radially-inward
direction from the first positions to the second positions. In this
embodiment, the elements are then preferably positioned to be
diametrically-opposed, or equi-radially spaced about the incision
site.
[0074] The strip 26 is preferably combined in an integrated unit
which further includes components for the purposes of incising the
skin and collecting the produced fluid sample. The test strip
includes a body 30 defining an opening 31, a capillary passageway
32, and a test area 33. A sealing ring 34 is attached to or formed
integrally with the underside of the body 30 in a position
surrounding the opening 31 and interior of the deformable arms 28.
The sealing ring may be constructed from any material that will
suitably conform to and seal with the skin, including silicon,
urethane, rubber, latex and various other natural and synthetic
materials that are biocompatible. Alternatively, the sealing ring
may be formed from a hard material such as plastics, metal, ceramic
or other materials in order to provide a seal when pressed against
the user's skin.
[0075] The use of the test strip system 26 proceeds as follows. The
test strip 26 is pressed against the skin such that the arms 28
engage the skin and deform inwardly, thereby creating and retaining
a bulged skin area 35. The skin is drawn upward and inward to an
extent that it bears against the sealing ring 34, forming a fluid
tight seal therewith. This assures that any fluid exiting the
incision will be retained within the opening 31, rather than moving
out under the test strip body. The sealing ring further functions
to press against the skin, thereby providing an additional
expression force, and pulling on the skin to open the incision when
formed. Also, the contact of the skin with the sealing ring locates
the skin at a controlled position to facilitate the formation of
the incision at a desired depth and position.
[0076] A lancing device 36 is extended downwardly through opening
31 to lance the skin to the desired, controlled depth. The lancet
is then withdrawn (FIG. 14) and bodily fluid 37 is allowed to form
at the incision site. When the fluid accumulates to a sufficient
extent, it contacts the entrance of the passageway 32 and is drawn
into and through the passageway by capillary action. The fluid
moves to the test area 33, such as by wicking into an absorbent
material 37, and there contacts the test reagent 38 positioned on
top of the wicking material.
[0077] The fluid is thereby presented in the test area and can be
tested by conventional means, such as by reacting the fluid with
the test reagent and analyzing the reaction product by optical or
electrochemical means. For example, shown diagrammatically in FIG.
14 is a light source 39 for directing light against the test
reagent, and a blood glucose meter 40 for receiving light reflected
from the test reagent. In conventional fashion, the meter analyzes
the reflected light to determine the result of the reaction between
the bodily fluid and the test reagent. In this manner, a wide
variety of analytes and properties of the fluid may be determined.
Such test systems are well known in the art and therefore are not
further described herein.
[0078] This embodiment provides another example of an integrated
device which combines the expression system with incising, sampling
and/or testing of the bodily fluid. This embodiment also
demonstrates a device which would be suitable for the use of
deformable expression elements which could be formed to flex, or to
deform in a partially or fully non-reversible manner. A test strip
of this type is preferably used once and then discarded, and it
would therefore be suitable to provide expression elements that
deform in a permanent manner. In use, the test strip is pressed
against the skin to automatically deform the expression arms,
thereby grasping and constricting the skin. Bodily fluid expressed
from the incision is collected and tested, and the test strip is
thereafter disposable.
[0079] In a similar manner, the constriction system may use rigid,
movable, skin-engaging elements. For example, as shown in FIGS.
15-17, the constriction system may include a plurality of
non-deforming arms 41 pivotally attached to the housing 42 by
attachment to support blocks 43 with pins 44. For simplicity of
explanation, two opposed arms 41 are shown in the figures. However,
any larger number of separate arms may also be used, preferably
spaced evenly about the incision site.
[0080] The arms function in the same manner as described with
respect to the deforming members of the prior embodiments. The arms
have a first, radially-outward position (FIG. 15) at which they
initially contact the skin. The arms are pivotable about pins 44 to
a second, radially-inward position (FIG. 16) in which the skin is
pinched and bulges upwardly as previously described.
[0081] The arms may be constructed in various ways to provide the
described functionality. The arms may be curved, angled or
otherwise shaped to allow for movement from the outer position to
the inner position to pinch the skin. The arms may be oriented to
automatically pivot inward when pressed against the skin.
Alternatively, the arms may be biased to the inward position by
springs or other biasing means (not shown), which biasing may be
released manually or automatically to urge the arms to the inner
position. This movement occurs as the device is maintained in
contact with the skin, and may occur automatically as the device is
pressed against the skin. The arms may be constructed of any
materials having suitable strength and rigidity, including various
biocompatible plastics and metals.
[0082] This alternate embodiment is equally useful with the variety
of additional components as described with respect to the previous
embodiment. For example, the constriction members are useful as a
stand-alone expression device, or in combination with various
incising and/or sampling systems, optionally including testing
systems. The expression system is shown in FIG. 16 in combination
with an annular capillary lancet as described with respect to
previous embodiments. In the use of this combination, the capillary
45 or other sampling device may have a recessed position (FIG. 15)
displaced from the position for receiving fluid (FIG. 16). In that
case, the capillary is moved downwardly toward the skin from the
initial, displaced position to the fluid-receiving position to
place the end opening of the capillary passageway at a location
where it will contact the bodily fluid when it appears. The lancet
46 is extended beyond the capillary and incises the skin as
previously described, and the resulting fluid contacts and enters
the capillary passageway.
[0083] A further embodiment within the purview of the present
invention is shown in FIGS. 18-20. The device 47 comprises a
housing 48 having a deformable expression member 49 secured to the
distal end. The expression member may be formed from a variety of
materials as previously described, and may be attached by any
suitable means, including gluing or otherwise fastening the
material to the housing. The expression member 49 is shown as
having a generally rounded shape, although alternative shapes may
be used. The member may include several projections 50 or other
structures designed to engage the skin as described hereafter.
[0084] The expression member 49 is configured to have two stable
positions with the member either extended or inverted, shown
particularly in FIGS. 19 and 20, respectively. The member in the
extended position is located adjacent the skin 51 in the area
intended for fluid sampling. The device is then pressed against the
skin and the member 49 inverts (FIG. 20), and in the process the
skin is engaged and drawn into the cavity thereby formed in the
expression member. This drawing in of the skin is facilitated by
the engagement of the projections 50 with the skin. The member 49
thereby operates, in the manner previously discussed, to retain
bodily fluid within the area and to apply pressure to the skin to
facilitate the expression of fluid from an incision formed
therein.
[0085] Once the bi-stable, dynamic bevel member 49 has been
inverted (FIG. 20), the skin is lanced and the bodily fluid
expressed from the incision. For example, the device 47 includes an
annular capillary lancet system 52 as described and shown with
respect to FIGS. 2-7. The system includes a capillary tube 53
positioned within the housing 48 such that the end of the capillary
will be proximate to the expression member 49 when such member is
in the inverted position retaining the skin. The lancet 54 is
extended beyond the end of the capillary tube and passes through a
central opening 55 in the expression member to lance the skin. The
lancet is then withdrawn and bodily fluid is expressed from the
incision and through the opening 55. As the fluid sample grows it
will make contact with the end of the capillary tube and will be
drawn therein. Alternatively, the incision may be formed prior to
applying the bi-stable member to the skin, but this is not
preferred.
[0086] The opening 55 is sized to allow for the expression of the
fluid from the incision. In one respect, the size of the opening is
not critical, provided that it is large enough to permit the fluid
to pass readily therethrough. In some instances, however, it may be
desirable to provide an opening of a given, minimum dimension in
order to further enhance the expression of the fluid. The opening
may have any desired shape, but it is typically round and
preferably has a minimum dimension of about 2 mm, and more
preferably at least about 7 mm.
[0087] The outer surface of the constriction member 49 may be
configured in a variety of ways to promote engagement of the skin.
In a preferred embodiment, the member 49 includes
outwardly-extending projections 50 that will contact and grasp the
skin as the member inverts. The member may alternatively include
other surface features to promote the engagement of the skin,
including various surface projections or textures, or treatments
such as coatings which stick to the skin.
[0088] The constriction devices of the present invention provide
several advantages for the expression of a bodily fluid from an
incision. As already described, the constriction of the skin
maintains bodily fluid within the area of the incision site, and
also applies a pressure to the skin that will tend to force fluid
toward the incision. The constriction devices in certain
embodiments also apply pressure to the skin in a manner which
increases with the distance from the incision. For example, the
drawing in of the skin by the bi-stable dynamic bevel will result
in the skin being drawn the tightest in the area adjacent to the
perimeter of the member 49, with less tension present toward the
center. This provides a greater force at the perimeter to maintain
the fluid therein, and to urge the fluid toward the center, and at
the same time provides less tension toward the center in order to
allow the fluid to move more freely toward and out of the incision.
Correspondingly, the constriction devices in certain embodiments
provide a pulling force at the center of the constricted space,
thereby urging the incision open to facilitate the expression of
bodily fluid from the incision.
[0089] The present invention also contemplates the use of members
which are pressed against the skin, as distinguished from
constricting the skin, to enhance the expression of bodily fluid
from an incision.
[0090] In the embodiments of FIGS. 21-24, there are provided fluid
expression devices, each of which includes a housing with a
pressing element attached at the distal end thereof. The pressing
element comprises a material having physical properties and a
configuration to provide the desired application of force against
the skin.
[0091] In one aspect of the invention, the element is designed to
press against the skin in a manner to apply pressure in a
predetermined pattern that urges the desired bodily fluid to move
toward the incision site. In one approach, the element is
configured to apply the greatest pressure at the outermost
position, and to provide less pressure inwardly thereof. In a
second approach, the element is configured to apply pressure
initially at the outermost position, and to thereafter apply
pressure at successively inward locations as the element is further
urged against the skin. In addition, both approaches can be
combined in a single design.
[0092] Referring to the drawings, there is shown an expression
device 56 including a housing 57 and a deformable, pressing member
58. The pressing member 58 is depicted as comprising a series of
segments 59 distributed radially about the housing. Each segment is
generally wedge shaped with the taper extending in the direction of
the centerline of the housing. In addition, ridges 60 and 61 extend
upwardly from the wedge-shaped bodies.
[0093] The expression device 56 is used by pressing the device
against the skin 62 at the desired sampling site. In this
embodiment, the segments 59 are deformable, either by flexing, or
in a partially or fully non-reversible manner. For purposes of
illustration, the device is hereafter described with respect to
flexible elements. As the device is pressed into the skin, the
flexible segments 48 are forced upward, and spread apart slightly.
The wedge shape of the segments causes the pressing members to
provide greater resistance nearer the perimeter of the housing 57,
and lesser resistance in the direction toward the center of the
device. The ridges 60 and 61 further provide flexing
characteristics of the segments, thereby varying the resistance to
flexing afforded by such segments. The result is that the skin 64
extends upwardly into the open end of the housing, with the applied
pressure against the skin being greatest at the radially-outermost
positions, and lesser in the direction of the center of the housing
(FIG. 22). This produces a pressure gradient in which the pressure
on the skin decreases in the direction from the perimeter to the
incision site. This urges bodily fluid along the gradient in the
direction of the incision. An incision 63 is formed generally at
the center of the pressing segments, such as by use of an annular
capillary lancet system 64, as described with respect to previous
embodiments. The produced fluid 65 contacts the capillary
passageway and is drawn therein.
[0094] As previously described, another aspect of the present
invention is the fact that the pressing elements will tend to open
the incision by pulling the skin in the radially-outward direction.
As the device is pressed into the skin, the greater pressure
applied at the outer portions will more firmly engage the skin and
will apply this radially-outward force to the skin. Therefore, a
stretching force is imparted to the skin, which will cause the
incision to pull apart. In addition, the skin-engaging surfaces 66
of the flexible members 59 may be configured to increase the
friction with the skin in order to further produce this stretching
force. For example, projections such as shown in FIG. 18, or other
surface features, may be provided on the surfaces 66 to cause the
members to further grasp the skin as the device is pressed into the
skin.
[0095] It will be appreciated that the shape, size, material and
other parameters for the pressing member can be varied in order to
achieve the desired effects. For example, the pressing member 58 is
shown as comprising several separate, but contiguous, members.
Alternatively, the member 58 may be formed from several
spaced-apart members, or may comprise a unitary, continuous member.
While shown as having a wedge shape with upwardly extending ridges,
the member may also have varying configurations with regard to
cross-section, projections and the like. The pressing member may be
formed from a single material or from a combination of materials,
and a wide variety of materials may be used to obtain the desired
physical characteristics. Such materials include, for example,
various natural and synthetic materials, including polyvinyl
chloride, silicon, urethane, and the like.
[0096] The pressing member may also be configured to first apply
pressure at radially outer locations, followed by pressure
application radially-inward thereof. This can be accomplished in a
variety of ways. For example, the pressing member may be positioned
such that the skin-engaging surface is inwardly and rearwardly
angled such that contact with the skin first occurs at the radially
outermost locations and moves progressively inwardly therefrom.
Alternatively, the skin-engaging surface may be provided with
projections which extend further in the radially-outermost
locations.
[0097] Referring to FIGS. 23-24, there is shown another embodiment
of an expression device including a deformable pressing member
constructed in accordance with the present invention. The device 67
includes a housing 68 and a pressing member 69 attached thereto.
This embodiment demonstrates the use of varying length projections
70-72 extending outwardly from the skin-engaging surface 73 of the
pressing member 69. The outermost ring 70 extends the farthest and
will therefore engage the skin first as the device is pressed
against the skin. The second ring 71 will next engage the skin,
followed by the third ring 72, as the device is moved further
against the skin. In this manner, a force will first be applied by
the outer ring 70, and this force will be the greatest applied
against the skin as the device is advanced. The result is that the
expression device 67 will apply compressive forces against the skin
which move progressively inward, and which reduce in amount in the
same, radially-inward direction. Each of these conditions will urge
bodily fluid toward the centerline of the device, thereby promoting
the expression of the fluid from a centered incision. It will be
appreciated that this effect may be accomplished whether the
pressing member is deformable, e.g., flexible, or not, although a
flexible pressing member is preferred.
[0098] The embodiments of FIGS. 21-24 further demonstrate that the
pressing member may be mounted to the housings in various ways. In
the embodiment of FIG. 21, for example, the pressing member is
mounted within the supporting housing 56. The pressing member may
alternatively be mounted at the end edge of the housing, on the
exterior of the housing as shown in FIG. 23, or in any other manner
that positions the skin in the desired location relative to the
overall device, for example to enable lancing and/or sampling.
[0099] A variety of other expression systems utilizing members
specially configured or operable to press the skin to express
bodily fluid are also known in the art, and are useful in
accordance with the present invention. In one embodiment, the
expression device includes a fixed pressing surface, typically
annular in shape and preferably including an internal aperture
having a minimum diameter, such as 6 mm. In particular respects,
the pressing surface includes a surface which tapers inwardly and
rearwardly, providing a frusto-conical shape that bears against the
skin. Examples of such fixed, pressing surfaces are described in
U.S. Pat. Nos. 5,964,718 and 6,066,103. Alternatively, combination,
rigid pressing members have also been disclosed in the art. For
example, disclosed in U.S. Pat. Nos. 5,951,493, 6,071,250, and
6,319,210 are expression devices which include a first, outer
pressing member and a second, inner pressing member. The pressing
members are generally coaxial, and may be pressed against the skin
either separately or at the same time. In one aspect, the members
are pressed against the skin in a particular pattern, such as by
first pressing the outer member against the skin and then pressing
the inner member against the skin to urge the bodily fluid to move
toward a central incision site. In another aspect, the members are
pressed in an alternating pattern to knead the skin and form a
peristaltic pumping of the fluid.
[0100] Other pressing systems have also been identified for urging
bodily fluid toward an incision site. For example, in U.S. Pat.
Nos. 5,951,493, 6,071,250, and 6,319,210 there are described
expression systems that include a coil spring that is pressed
against the skin. The use of rollers that press against the skin
and are then moved radially inward to push fluid toward the center
are described in U.S. Pat. Nos. 5,951,493 and 6,332,871.
[0101] The present invention further contemplates the combination
of the foregoing expression systems. It will be apparent from the
drawings that the expression systems are directly combinable to
provide the advantages of the separate systems in a single device.
For purposes of further illustration, exemplary combinations of the
expression systems are provided hereafter. For example, referring
to FIG. 25, there is shown a testing device 74 including a housing
75 and a combination expression system 76 secured thereto. The
expression system includes a constriction member 77 shown in the
inner, constricting position forming the bulged pinch of skin 78.
In addition, a deformable pressing member 79 is mounted in the
interior of the housing 75 and is positioned to also bear on the
pinch of skin 78.
[0102] As this embodiment demonstrates, the combination of the
different expression systems provides a device that achieves
expression in ways, and to an extent, which may not be available
from the individual systems. In one sense, the combination such as
shown in FIG. 25 provides the constricting function of the
constriction member 76, and the pressing function of the deformable
pressing member 79. In addition, it will be noted that the
combination causes each system to operate somewhat differently from
what might occur separately. For example, the addition of the
pressing system provides additional pressure for expressing fluid,
and also provides additional forces to help pull and maintain the
incision open after it has formed. On the other hand, the addition
of the constricting member to the deformable pressing system helps
to retain fluid in the area of the skin where the pressing member
is bearing against the skin. The application of a pressing member
alone is accomplished by pushing the member against the skin, which
may exclude fluid that is not within the perimeter of the pressing
member, and further may force some fluid out of the pressing area
as the device is pressed against the skin. However, in accordance
with the combined system, the pressing member does not bear against
the skin until the skin has already been engaged by and pulled
inward by the constricting system. The skin is actually pulled up
against the pressing member. Therefore, the pressing member will
not exclude or force out bodily fluid in the same manner that may
otherwise occur without the constricting member, and the result is
that additional fluid may be available at the incision site.
[0103] The following embodiments further demonstrate that the
expression systems are readily adapted for use with various
incising, sampling and/or testing devices. Referring in particular
to FIGS. 26-29, a typical lancing device is shown except that it
has been modified to include an exemplary expression system in
accordance with the present invention. The basic lancing device,
absent the expression system, is further described in U.S. Pat. No.
Re 35,803, the disclosure of which is hereby incorporated by
reference. Therefore, for illustrative purposes, only the major
components of said device are shown in the drawings and described
herein.
[0104] The lancing device 201 includes a housing 202 which contains
a lancet drive mechanism 203 and a lancet holder 204. The drive
mechanism includes a rotatable sleeve 205 and a spirally-wound,
coiled spring 206 coupled between the housing and the rotatable
sleeve. The lancet holder 204 is longitudinally slidable within the
sleeve 205 and includes arms 207 with end lugs 208 that are
receivable within recesses formed in a lancet component. The lancet
component 209 includes a body 210 and a lancet tip 211. The lancet
body defines a circumferential recess 212 which receives the end
lugs 208 of the arms of the lancet holder 204. The lancet 209 is
thereby longitudinally movable inside of the sleeve 205 in concert
with the movement of the lancet holder 204.
[0105] The rotatable sleeve 205 includes a drive pin 213, and the
lancet holder 204 defines a driver cam 214. The driver cam includes
a first cam segment 215 to allow for cocking of the mechanism. The
driver cam further includes a second, symmetrical, arcuate cam
segment 216 to provide for projection and withdrawal of the lancet
tip relative to the housing opening 217 formed in the pressing
member 218 of the housing. An outer ring 219 connects with the
rotatable sleeve 205 and upon rotation of the outer ring the sleeve
is also rotated to tension the spring 206 as the drive pin 213
moves within the first cam segment 215. The rotatable sleeve
automatically locks once in the fully tensioned position.
[0106] Upon pressing a lock release button 220, the sleeve rotates
back to its original position. During this return rotation, the
drive pin 213 moves within the second cam segment 216, causing the
lancet holder and lancet initially to translate longitudinally of
the sleeve 205 and housing 202 in a direction to drive the lancet
tip to incise the skin. The lancet tip 211 is immediately
thereafter withdrawn by operation of the second cam segment 216 of
the lancet holder.
[0107] The pressing member extends to an annular surface 221 and
defines slots 222 and 223 adjacent thereto. Three pivoting
expression arms 224 are secured to the housing in equi-radially
spaced positions by means of yokes 225 and pins 226. Each arm 224
has a first, spread position (FIG. 26), and is movable from this
initial position to the second, constricting position (FIG.
28).
[0108] A test strip 227 is received within the slots 222-223 and
includes an aperture 228 which is thereby positioned in line with
the lancet 211. The test strip includes a capillary passageway (not
shown) that extends from an inlet opening which communicates with
the aperture 228 to a test region 229. The test region includes
suitable reagent to interact with the bodily fluid which is
received in the test region. An optical test device 230 is mounted
to the housing and is positioned to evaluate the results of the
reaction in the test region.
[0109] In accordance with the present invention, the integrated
device 201 is operable as follows. The device is pressed against
the skin and the arms 224 are manipulated from the open position to
the constricting position (FIG. 28). The skin 231 is thereby drawn
in to form a raised pinch of skin that bears against the annular
surface 221. The lancet 211 is then advanced through the aperture
228 in the test strip and incises the skin. As a fluid droplet
forms, it contacts the capillary passageway of the test strip 227
and is transported to the test region 229. The fluid then reacts
with the reagent provided in the test region, and the results are
read by the test device 230.
[0110] The foregoing description provides a representative sample
of a lancing device useful in accordance with the present
invention. It will be appreciated, however, that the particular
lancing device and method are not limiting to the present
invention, which finds utility with innumerable lancing systems. By
way of further example, other representative lancing mechanisms
include those shown in U.S. Pat. Nos. 4,924,879, issued to O'Brien
on May 15, 1990; U.S. Pat. No. 5,879,311, issued to Duchon et al.
on Mar. 9, 1999; U.S. Pat. No. 5,857,983, issued to Douglas et al.
on Jan. 12, 1999; U.S. Pat. No. 6,015,392, issued to Douglas et al.
on Jan. 18, 2000; U.S. Pat. No. 6,048,352, issued to Douglas et al.
on Apr. 11, 2000; U.S. Pat. No. 6,183,489, issued to Douglas et al.
on Feb. 6, 2001; U.S. Pat. No. 5,951,492, issued to Douglas et al.
on Sep. 14, 1999; U.S. Pat. No. 5,951,493, issued to Douglas et al.
on Sep. 14, 1999; U.S. Pat. No. 6,332,871, issued to Douglas et al.
on Dec. 25, 2001; U.S. Pat. No. 5,964,718, issued to Duchon et al.
on Oct. 12, 1999; U.S. Pat. No. 6,066,103, issued to Duchon et al.
on May 23, 2000; and U.S. Pat. No. 6,086,545, issued to Roe et al.
on Jul. 11, 2000.
[0111] An alternate, totally integrated fluid monitoring device is
shown in FIG. 30. The integrated device 301 includes a housing 302
which includes or supports components operable to lance, express,
sample and test bodily fluids. The housing includes a first member
303, a cylindrical extension member 304, and an expression system
305. The device 301 is shown in FIG. 30 as being contacted against
the skin 306 in the position prior to expression of bodily
fluid.
[0112] The components of the integrated device 301 are shown in
detail beginning in FIG. 31. The cylindrical member 304 is mounted
within a cavity 307 defined by the first member 303, and is secured
therein, such as by a press fit or by gluing. The cylindrical
member 304 defines an interior passageway 308, and a lancet 309 is
received therein. The space between the lancet and the cylindrical
member therefore defines an annular passageway, which is sized to
provide a capillary attraction to the desired bodily fluid, as
later described.
[0113] The lancet 309 is mounted to a lancet carrier 310 which
includes an extension 311. The extension passes through an aperture
312 formed in an interior wall 313 of the member 302. The member
302 further defines a chamber 314 in which the extension 311 is
received. A lancet button 315 is received through an aperture 316
in the member 302 and includes a mounting yoke 317 which is
connected with the lancet carrier extension 311. A coil spring 318
is positioned around the extension 311 and is bears at one end on
the yoke 317, and at the other end on the wall 313. In this manner,
pressure applied against the button 315 will urge the lancet beyond
the distal end 319 of the cylindrical member 304 for lancing the
skin. Upon release of the downward pressure, the spring 318 will
withdraw the lancet back into the cylindrical member 304, thereby
removing the lancet from the incision formed in the skin.
[0114] The device 301 further includes an expression system 305
attached to the cylindrical member 304. In particular, the
expression system includes a cylindrical expressing member 320
secured to a support 321 which is in turn attached to or formed
integrally with the cylindrical member 304. The expressing member
320 is deformable to facilitate the expression of fluid from an
incision positioned interior of the member. The expressing member
has an initial condition in which the skin-engaging surface 322
contacts the skin at a radially-outward position (FIG. 31). Upon
further pressing the device 301 against the skin, the member 320
deforms inwardly, thereby grasping and moving the skin upward and
inward to a constricted position (FIG. 32). This movement applies
pressure against the skin to hold bodily fluid within the
constricted area and to urge the fluid toward the center.
[0115] A test strip 323 is received through an aperture 324 in the
wall of the cylindrical member 304. The test strip extends within
the annular passageway between the lancet 309 and the interior of
the cylindrical member 304, and therefore is in position to be
contacted by fluid received in the passageway. A window 325 is
located in the side of the cylindrical member 304 at a position to
allow the test strip to be viewed from the exterior of the device.
Therefore, the results of a reaction between the bodily fluid and
the test strip can be observed through the window 325. Alternative
test systems, including optical and electrochemical systems for
example, are equally useful in accordance with the present
invention.
[0116] The integrated device is operable to provide complete
lancing, expressing, sampling and testing of a bodily fluid as
follows. As shown in the drawings, the device 301 is initially
positioned against the skin at the locating desired for fluid
acquisition. The device is then pressed against the skin
sufficiently to deform the expressing member 320, as shown in FIG.
32. This results in the creation of a raised pinch of skin 326. A
force is then applied to the button 315 to move the lancet
downwardly into the skin to form an incision 327. The force is
immediately released from the button and the lancet retracts from
the incision into the cylindrical member, as shown in FIG. 32. A
droplet of bodily fluid will begin to form at the incision site,
facilitated by the expressive forces applied to the skin by the
expressing member 320.
[0117] As the droplet grows in size, it contacts the end opening of
the passageway 308 and is drawn in by capillary action. The fluid
sample continues to be drawn into the passageway until it contacts
the test strip 323. The test strip is selected to provide a test of
the desired constituent or property of the bodily fluid being
sampled. The results are obtained by optical detection of the
reaction through the window 325.
[0118] It will be appreciated from the foregoing descriptions that
the several forms of expression comprising the present invention
are useful independently of the presence or type of incising,
sampling or testing systems. In certain embodiments, however, the
expression mechanisms and methods are combined with incising,
sampling and/or testing systems. It will be appreciated by those
skilled in the art that the function of the expression system is
achieved independent of the incising and sampling systems, and
therefore is useful with a variety of such systems as are known in
the art. However, the expression systems are advantageously
combined with incising and sampling systems in a single, integrated
device. Because the expression is achieved essentially
independently of these other systems, the expression system is
readily adapted as an additional component of such devices. It will
similarly be appreciated that the integrated device may also
combine testing means to test desired constituents or
characteristics of the fluid sample that has been acquired.
Further, this integrated operation is available for all of the
expression systems described herein. For example, the expression
systems are useful in combination with a wide range of incising,
sampling and testing systems, including those herein described in
the description of the prior art and elsewhere, and the disclosures
of such patents are hereby incorporated by reference.
[0119] As shown in the drawings, such an integrated device
preferably operates such that the device does not have to be
repositioned at any time during the process of incising,
expressing, and/or sampling. More specifically, the device
preferably carries incising, expressing, sampling and testing
systems to perform a complete, integrated monitoring of the bodily
fluid. In accordance with this approach, the device is moved
against the skin and is maintained in this position while the
incision is formed, and also while the resulting fluid droplet
develops and is carried into the sampling device. The fluid is then
analyzed by the test system and the result of the analysis is
provided to the user. All of these actions therefore may be
accomplished by a single, integrated unit, providing a simple,
quick and reliable method for acquiring and testing a bodily
fluid.
[0120] Moreover, the combination of the various systems in a single
unit assures that the separate systems will be properly coordinated
in use. The timing for the formation of the constricted pinch of
skin and the lancing of the skin can be controlled automatically,
or by manual operation by the user. The positions of the incision
site and of the sampling capillary tube are predetermined to
optimize the acquisition of the fluid formed at the incision site.
This reduces the potential for a user to fail to successfully
collect the fluid that is produced.
[0121] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only the preferred embodiment has been shown
and described and that all changes and modifications that come
within the spirit of the invention are desired to be protected.
* * * * *