U.S. patent application number 10/254314 was filed with the patent office on 2004-12-30 for method and apparatus for sampling bodily fluid.
Invention is credited to Perez, Edward.
Application Number | 20040267160 10/254314 |
Document ID | / |
Family ID | 23263927 |
Filed Date | 2004-12-30 |
United States Patent
Application |
20040267160 |
Kind Code |
A9 |
Perez, Edward |
December 30, 2004 |
Method and apparatus for sampling bodily fluid
Abstract
Bodily fluid is sampled by causing a syringe mounted in a
housing to be displaced toward a skin surface. A suction element
disposed on the housing is utilized to creates a suction in the
area to be incised causing bodily fluid to pool. Additionally, the
suction mechanism may be utilized to create a suction in the tube
for drawing in bodily fluid through the piercing element and into
the tube. The syringe remains in the resulting incision while the
surrounding body tissue is stimulated by a stimulator ring to urge
bodily fluid toward the incision. Simultaneously, the syringe may
be moved relative to the incision to keep the incision open. Such
movement of the syringe may comprise reciprocation in the
longitudinal or lateral directions, or both. Alternatively, the
movement of the syringe may comprise rotation about a longitudinal
center line of the syringe, with the pointed end of the syringe
being in the shape of one-half of a cone segment. The suction may
then be applied to the area being incised to promote further
pooling of bodily fluid. After the bodily fluid has been pooled,
suction may be created in a collection tube disposed in
communication with the syringe, to draw bodily fluid inwardly
through the syringe.
Inventors: |
Perez, Edward; (Menlo Park,
CA) |
Correspondence
Address: |
Woodard, Emhardt, Naughton, Moriarty and McNett
Bank One Center/Tower
Suite 3700
111 Monument Circle
Indianapolis
IN
46204-5137
US
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 0059256 A1 |
March 25, 2004 |
|
|
Family ID: |
23263927 |
Appl. No.: |
10/254314 |
Filed: |
September 25, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60324514 |
Sep 26, 2001 |
|
|
|
Current U.S.
Class: |
600/583 |
Current CPC
Class: |
A61B 5/150083 20130101;
A61B 5/150236 20130101; A61B 5/15113 20130101; A61B 5/150099
20130101; A61B 5/150396 20130101; A61B 5/150022 20130101; A61B
5/150068 20130101; A61B 2010/008 20130101; A61B 5/150244 20130101;
A61B 5/1519 20130101; A61B 5/150503 20130101; A61B 5/15194
20130101; A61B 5/15117 20130101; A61B 5/157 20130101; A61B 10/0045
20130101 |
Class at
Publication: |
600/583 |
International
Class: |
A61B 005/00 |
Claims
What is claimed is:
1. A method of expressing bodily fluid from an incision in the
skin, the method comprising: disposing a testing device against the
skin at a location from which the bodily fluid sample is to be
taken, the testing device including a distal end portion forming a
seal with the skin; activating a vacuum source communicating with
the distal end portion of the testing device and drawing the skin
in the area into the distal end portion of the testing device;
deactivating the vacuum source; forming an incision in the skin
with a hollow piercing element; and collecting the bodily fluid for
testing using the hollow piercing element.
2. The method according to claim 1, wherein the testing device
includes the vacuum source.
3. The method according to claim 1, wherein the vacuum source is
applied before forming the incision.
4. The method according to claim 1, wherein the vacuum source is
applied after the forming the incision.
5. The method according to claim 1, wherein the vacuum source is
applied before and after the forming the incision.
6. The method according to claim 1, wherein the step of
deactivating the vacuum source further includes releasing the
vacuum between the testing device and the area of the skin to be
lanced.
7. The method according to claim 1, wherein the testing device
further includes a hollow fluid transport member having one end in
fluid communication with the hollow piercing element and a second
end in fluid communication with a test strip.
8. The method according to claim 7, wherein the vacuum source
creates a vacuum in the hollow fluid transport member.
9. The method according to claim 7, wherein the test strip is
chemical based.
10. The method according to claim 7, wherein the test strip is
electrochemical.
11. The method according to claim 1, wherein the method further
includes drawing the sample of bodily fluid from the incision to a
test strip, determining the level of glucose in the bodily fluid,
and displaying the level on a display included on the testing
device.
12. The method according to claim 1, wherein the testing device
further includes a stimulating device disposed about the distal end
of the testing device, the method further including stimulating the
area of the skin to be lanced with the stimulating device to pucker
the skin.
13. The method according to claim 1, wherein the method further
includes vibrating the hollow piercing element after forming the
incision.
14. The method according to claim 1, wherein the method further
includes rotating the hollow piercing element after forming the
incision.
15. The method according to claim 5, wherein the testing device
further includes a stimulating device disposed about the distal end
of the testing device, wherein the method further includes
oscillating the stimulating to cause the area of the skin to be
lanced to pucker, said method further including oscillating the
hollow piercing element after forming the incision.
16. A hand-held apparatus for extracting bodily fluid from an
incision in the skin, comprising: a body having a distal end, the
distal end being positionable against the skin surrounding an
incision location; a suction means coupled with said body for
applying a suction to the distal end of said body; a cutting member
connected with said body and movable between a first position
displaced from the skin and a second position extending into the
skin at an incision location; and a fluid extraction member
positioned to receive bodily fluid from the incision location.
17. The invention of claim 16 wherein said suction means is for
applying the suction prior to said cutting member contacting the
skin.
18. The invention of claim 17 wherein said suction means is further
for releasing the suction prior to said cutting member contacting
the skin.
19. The invention of claim 16 wherein said suction means is for
applying the suction after said cutting member contacts the
skin.
20. The invention of claim 19 wherein said suction member is for
first applying the suction and then subsequently releasing the
suction.
21. The invention of claim 16 wherein said body further includes
means for vibrating said cutting member after contacting the
skin.
22. The invention of claim 16 wherein said body includes means for
rotating said cutting member after contacting the skin.
23. The invention of claim 16 wherein said suction means is for
applying the suction to said fluid extraction member.
24. The invention of claim 16 in which said body further includes a
testing member wherein said fluid extraction member is configured
to deposit extracted fluid onto said testing member.
25. The invention of claim 16 wherein said cutting member is
hollow.
26. The invention of claim 16 wherein said body further includes
means for oscillating the distal end.
27. The invention of claim 21 in which said body further includes a
testing member, said fluid extraction member being configured to
deposit extracted fluid onto said testing member, said body further
including means for oscillating the distal end.
28. The invention of claim 21 wherein said cutting member is hollow
and is in fluid communication with said fluid extraction member,
said suction means being for applying suction to said fluid
extraction member, said body further including means for
oscillating the distal end.
Description
PRIOR APPLICATIONS
[0001] This application claims benefit to U.S. Provisional
Applications: Ser. No. 60/296,950, 60/297,045, and 60/297,098 each
filed Jun. 8, 2001; No. 60/263,533 filed Jan. 22, 2001; and U.S.
patent application Ser. No. 09/528,097 filed Mar. 17, 2000;
US97/08401 file May 16, 1997; US97/08400 filed May 16, 1997; Ser.
No. 09/887,574 filed Jun. 21, 2001; Ser. No. 09/586,969 filed Jun.
5, 2000; Ser. No. 09/180,839 filed Nov. 16, 1998; Ser. No.
09/542,040 filed Mar. 31, 2000; Ser. No. 09/567,054 filed May 8,
2000; The entireties of each of which are herein incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates to lancing devices and methods
for obtaining samples of blood and other fluids from a body for
analysis or processing.
BACKGROUND OF THE INVENTION
[0003] Many medical procedures in use today require a relatively
small sample of blood, in the range of 3-50 milliliters. It is more
cost effective and less traumatic to the patient to obtain such a
sample by lancing or piercing the skin at a selected location, such
as the finger, to enable the collection of 1 or 2 drops of blood,
than by using a phlebotomist to draw a tube of venous blood. With
the advent of home use tests such as self monitoring of blood
glucose, there is a requirement for a simple procedure which can be
performed in any setting by a person needing to test.
[0004] Lancets in conventional use generally have a rigid body and
a sterile needle which protrudes from one end. The lancet may be
used to pierce the skin, thereby enabling the collection of a blood
sample from the opening created. The blood is transferred to a test
device or collection device. Blood is most commonly taken from the
fingertips, where the supply is generally excellent. However,
because the patient must perform multiple tests daily, the
fingertips become sensitive or calloused thereby making it
difficult to obtain a sample. Additionally, the nerve density in
this region causes significant pain in many patients. Therefore
alternate sampling sites, such as earlobes and limbs, is sometimes
practiced to access a bodily fluid sample.
[0005] To reduce the anxiety of piercing the skin and the
associated pain, many spring loaded devices have been developed.
The following two patents are representative of the devices which
were developed in the 1980's for use with home diagnostic test
products.
[0006] U.S. Pat. No. 4,503,856, Cornell et al., describes a spring
loaded lancet injector. The reusable device interfaces with a
disposable lancet. The lancet holder may be latched in a retracted
position. When the user contacts a release, a spring causes the
lancet to pierce the skin at high speed and then retract. The speed
is important to reduce the pain associated with the puncture.
[0007] Levin et al. U.S. Pat. No. 4,517,978 describes a blood
sampling instrument. This device, which is also spring loaded, uses
a standard disposable lancet. The design enables easy and accurate
positioning against a fingertip so the impact site can be readily
determined. After the lancet pierces the skin, a bounce back spring
retracts the lancet to a safe position within the device.
[0008] In institutional settings, it is often desirable to collect
the sample from the patient and then introduce the sample to a test
device in a controlled fashion. Some blood glucose monitoring
systems, for example, require that the blood sample be applied to a
test device which is in contact with a test instrument. In such
situations, bringing the finger of a patient directly to the test
device poses some risk of contamination from blood of a previous
patient. With such systems, particularly in hospital settings, it
is common to lance a patient, collect a sample in a micropipette
via capillary action and then deliver the sample from the pipette
to the test device.
[0009] Haynes U.S. Pat. No. 4,920,977 describes a blood collection
assembly with lancet and microcollection tube. This device
incorporates a lancet and collection container in a single device.
The lancing and collection are two separate activities, but the
device is a convenient single disposable unit for situations when
sample collection prior to use is desirable. Similar devices are
disclosed in Sarrine U.S. Pat. No. 4,360,016, and O'Brien U.S. Pat.
No. 4,924,879.
[0010] Jordan et al. U.S. Pat. No. 4,850,973 and No. 4,858,607,
disclose a combination device which may be alternatively used as a
syringe-type injection device and a lancing device with disposable
solid needle lancet, depending on configuration.
[0011] Lange et al. U.S. Pat. No. 5,318,584 describes a blood
lancet device for withdrawing blood for diagnostic purposes. This
invention uses a rotary/sliding transmission system to reduce the
pain of lancing. The puncture depth is easily and precisely
adjustable by the user.
[0012] Suzuki et al. U.S. Pat. No. 5,368,047, Dombrowski U.S. Pat.
No. 4,654,513 and Ishibashi et al. U.S. Pat. No. 5,320,607 each
describe suction-type blood samplers. These devices develop suction
between the lancing site and the end of the device when the lancet
holding mechanism withdraws after piercing the skin. A flexible
gasket around the end of the device helps seal the end around the
puncture site until adequate sample is drawn from the puncture site
or the user pulls back on the device.
[0013] Garcia et al. U.S. Pat. No. 4,637,403 and Haber et al. U.S.
Pat. No. 5,217,480, disclose combination lancing and blood
collection devices which use a diaphragm to create a vacuum over
the wound site.
[0014] Erickson et al. U.S. Pat. No. 5,582,184 describes a means of
collecting and measuring bodily fluids. This system uses a coaxial
syringe and capillary tube disposed within a spacer member. The
spacer member limits the depth of syringe penetration, and
compresses body tissue around the syringe while the syringe is in
the skin, for improving the flow of interstitial fluid to the
syringe. A suction device draws bodily fluid through the syringe
and into the capillary tube.
[0015] Single use devices have also been developed for single use
tests, i.e. home cholesterol testing, and for institutional use to
eliminate cross-patient contamination multi-patient use. Crossman
et al. U.S. Pat. No. 4,869,249, and Swierczek U.S. Pat. No.
5,402,798, also disclose disposable, single use lancing devices.
U.S. Pat. Nos. 5,421,816; 5,445,611; and 5,458,140 disclose, as a
replacement for invasive sampling, the use of ultrasound to act as
a pump for expressing interstitial fluid directly through intact
(non-lanced) skin. The amount of fluid which can be obtained in
that way is very limited, however.
[0016] The disclosures of the above patents are incorporated herein
by reference.
[0017] Even with the many improvements which have been made, the
pain associated with lancing remains a significant issue for many
patients. The need for blood sampling and the fear of the
associated pain is also a major obstacle for the millions of
diagnosed diabetics, who do not adequately monitor their blood
glucose due to'the pain involved. Moreover, lancing to obtain a
blood sample for other diagnostic applications is becoming more
commonplace, and a less painful, minimally invasive device is
needed to enhance those applications and make those technologies
more acceptable.
[0018] An object of the present invention therefore, is to provide
a device and a method for obtaining a sample of bodily fluid
through the skin which is virtually pain free and minimally
invasive.
[0019] Therefore, it is another object of the invention to provide
a lancet carrier which eliminates the above-mentioned
shortcomings.
[0020] Another object of this invention is to provide a method
which can result in a sample of either blood or interstitial fluid,
depending on the sample site and the penetration depth utilized.
While there are no commercially available devices utilizing
interstitial fluid (ISF) at this time, there are active efforts to
establish the correlation of analytes, such as glucose, in ISF
compared to whole blood. If ISF could be readily obtained and
correlation is established, ISF may be preferable as a sample since
there is no interference of red blood cells or hematocrit
adjustment required.
[0021] Another object of this invention is to provide a method
which can draw a small but adjustable sample, i.e. 3 microliters
for one test device and 8 microliters for another test device, as
appropriate.
[0022] Another object of this invention is to provide a method by
which the drawn sample is collected and may be easily presented to
a testing device, regardless of the location of the sample site on
the body. This approach helps with infection control in that
multiple patients are not brought in contact with a single test
instrument; only the sampling device with a disposable
patient-contact portion is brought to the test instrument.
Alternatively, the disposable portion of a test device may be
physically coupled with the sampler so the sample can be brought
directly into the test device during sampling. The test device may
then be read in a test instrument if appropriate or the testing
system can be integrated into the sampler and the test device can
provide direct results displayed for the patient.
[0023] It is a further object of the invention is to provide a
device for minimally invasive sampling comprising a reusable
sampler and disposable sample collection.
[0024] Yet another object of the present invention is to provide a
method of increasing the amount of bodily fluid available for
sampling.
SUMMARY OF THE INVENTION
[0025] These and other objects are achieved by the present
invention, one aspect of which relates to a method for sampling
blood comprising the steps of placing a forward end of a housing
against a skin surface, advancing a hollow piercing element
forwardly to cut an incision through the skin surface, and
depressing a ring of body tissue in surrounding relationship to the
incision to spread apart sides of the incision while urging bodily
fluid toward and into the incision. Simultaneously, the piercing
element is moved within the incision to keep the incision open. A
suction may be applied to the skin to aid the pooling of bodily
fluid in the area of the incision. Additionally, a suction may be
applied to the piercing element to draw in bodily fluid from the
incision and into a tube communicating with the piercing
element.
[0026] Another aspect of the present invention relates to a
sampling device for sampling bodily fluid. The sampling device
comprises a housing, a piercing element carrier mounted in the
housing and carrying a hollow piercing element. A tube communicates
with the piercing element. A driver mechanism mounted in the
housing drives the syringe carrier forwardly to cut an incision in
the skin and maintain and end of the piercing element in the
incision. A stimulator mechanism disposed on the housing depresses
a ring of body tissue in surrounding relationship to the incision
to spread apart sides of the incision while urging bodily fluid
toward the incision. A syringe-moving mechanism disposed on the
housing moves the end of the piercing element relative to the
incision to maintain the incision open while the stimulator
mechanism urges bodily fluid thereto. A suction mechanism disposed
on the housing creates a suction to cause bodily fluid to pool in
the area to be incised, as will be described in greater detail
below. Additionally, the suction element may be applied to the tube
and utilized for drawing in bodily fluid through the piercing
element and into the tube.
[0027] Still another aspect of the invention relates to a device
for obtaining a sampling of a bodily fluid through the skin
comprising a housing member containing a hollow piercing element
for piercing the skin. A first spring member disposed in the
housing urges the piercing element to protrude from a forward end
of the housing sufficient to cut an incision through the skin. A
stop member defines a maximum penetration depth of the piercing
element. A second spring disposed in the housing partially retracts
the piercing element while maintaining a front end of the piercing
element in the incision. A tube communicates with a rear end of the
piercing element. A suction mechanism creates a suction in the tube
for drawing in bodily fluid through the piercing element.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] The objects and advantages of the invention will become
apparent from the following detailed description of preferred
embodiments thereof in connection with the accompanying drawings in
which like numerals designate like elements and in which:
[0029] FIG. 1 is a longitudinal sectional view taken through a
sampling device according to the present invention, with a syringe
thereof in an armed state;
[0030] FIG. 2 is a view similar to FIG. 1 after the syringe has
been triggered and forms an incision in a skin surface;
[0031] FIG. 3 is a view similar to FIG. 2 after a suction mechanism
has been actuated to draw in bodily fluid through the syringe;
[0032] FIG. 3A is a sectional view taken along the line 3A-3A in
FIG. 3;
[0033] FIG. 4 is a schematic view of a syringe being reciprocated
longitudinally within an incision according to the present
invention;
[0034] FIG. 5 is a schematic view of a syringe being reciprocated
laterally within an incision according to the present
invention;
[0035] FIG. 6 is a schematic view of a syringe being oscillated in
an elliptical direction according to the present invention;
[0036] FIG. 7 is a schematic view of a syringe being rotated within
an incision according to the present invention;
[0037] FIG. 8 is a longitudinal sectional view of a lower portion
of a modified sampling device according to the present invention,
with a syringe disposed in a retracted state;
[0038] FIG. 9 is a view similar to FIG. 8 after the syringe has
been urged forwardly;
[0039] FIG. 10 is a side elevational view of a lower end of a
syringe having a stop member fixed thereto according to the present
invention; and
[0040] FIG. 11 is a sectional view taken along the line 11-11 in
FIG. 10;
[0041] FIG. 12 is a top view of a integrated testing/lancing
apparatus according to one embodiment of the present invention;
[0042] FIG. 13 is a cross-sectional side view illustrating an
integrated lancet and test strip holder according to the present
invention; and
[0043] FIG. 14 is a side view illustrating the anti-coring needle
in accordance with a lancing device of the present invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0044] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated 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, modifications, and further applications of the
principles of the invention being contemplated as would normally
occur to one skilled in the art to which the invention relates.
[0045] Depicted in FIGS. 1-3 is a bodily fluid sampling device 10
comprising an outer cylindrical housing 12. Screwed into an upper
end of the housing 12 is a fixing sleeve 14 in which are formed
upper and lower recesses 16, 18. The upper recess 16 has an
internal screw thread connected to an externally threaded stop ring
20 which can be adjusted to a selected vertical position relative
to the housing.
[0046] Slidably disposed for longitudinal movement within the
fixing sleeve 14 is a hollow drive rod 22. Screwed onto a lower end
of the drive rod 22 is a syringe carrier 24. Mounted in a lower end
of the carrier 24 is a syringe 26 of the type which includes a
longitudinal capillary passage 28 (see FIG. 4). That passage is
preferably offset laterally with respect to a center axis of the
syringe. In lieu of a syringe, any suitable type of hollow piercing
element can be employed, such as a needle or sharp cannula, for
example. An upper end of the syringe communicates with a sampling
tube 30, an upper end of the tube fitting into a lower recess 32
formed in the drive rod 22.
[0047] Intermediate its upper and lower ends, the drive rod 22
includes a radial enlargement 33 in which an outwardly open,
annular groove 34 is formed that is sized to receive a pin 36 of a
first trigger 38.
[0048] Slidably mounted within the sampling tube 30 is a plunger 40
having a soft tip 42 that snugly (sealingly) engages an inner
surface of the tube 30. An upper end of the plunger 40 is fixed to
the lower end of a drawbar 46 which slides within a center bore of
the drive rod 22.
[0049] Screwed to an upper end of the drive rod 22 is a mounting
sleeve 48 in which a second trigger 50 is mounted for lateral
sliding movement. Formed in the second trigger 50 is a center hole
52 that is larger than the outer diameter of the drawbar 46. The
drawbar 46 has a recess 54 sized to receive respective sides of the
hole 52.
[0050] A drive spring 56 in the form of a coil compression spring
acts between the enlargement 33 and the fixing sleeve 14. Resting
on the fixing sleeve 14 is a retraction spring 58 in the form of a
coil compression spring. Acting between the enlargement 33 and the
top of the plunger 40 is a suction spring 60 in the form of a coil
compression spring.
[0051] Mounted on the syringe carrier 24 is a piezoelectric
transducer 66 which is electrically connected to a battery 68.
Piezoelectric transducers are conventional types of vibrators which
can be oriented to produce vibrations in any desired direction. A
lower end of the piezoelectric transducer 66 is in contact with the
syringe for vibrating the syringe, i.e., either vertically
(longitudinally), laterally, or elliptically (a combination of
vertical and lateral vibrations).
[0052] Disposed at a lower end of the housing 12 is a stimulator
sleeve 70. That sleeve has an annular lower face 72 of
frusto-conical shape, and is screwed into a sleeve carrier 74.
Projecting from diametrically opposite positions of the sleeve
carrier 74 are pins 76 which are slidably disposed in respective
vertical slots 78 formed in the housing 12.
[0053] Rotatably mounted on diametrically opposite sides of the
housing 12 are a pair of identical drive gears 80 (see also FIG.
3A). Formed in an inner surface of each drive gear 80 is a cam
groove 82 in which a respective pin 76 projects. Mounted above the
drive gear for rotation about a central longitudinal axis of the
housing is a ring gear 84 which is rotated by an output pinion 86
of an electric motor 88. The underside of the ring gear 84 is
formed with teeth that mesh with teeth formed around the outer
peripheries of the drive gears 80. Therefore, rotation of the
pinion gear 86 is transmitted to the drive gears 80 to rotate the
drive gears. The accompanying rotation of the eccentric grooves 82
of the drive gears causes the pins 76, and thus the sleeve carrier
74, to reciprocate vertically, along with the stimulator
sleeve.
[0054] The operation of the sampling device 10 will now be
explained. To arm the device, the mounting sleeve 48 is pulled
upwardly by a user until a beveled face 90 of the enlargement 33 of
the drive rod 22 cams the first trigger 38 laterally outwardly.
When the groove 34 of the enlargement becomes aligned with the
cammed-out first trigger 38, the first trigger is urged inwardly by
a spring (not shown) to insert the pin 36 into the groove 34 for
retaining the drive rod 22 in the armed state (FIG. 1).
Simultaneously, the drive spring 56 is compressed from a relaxed
state, and the syringe carrier 24, together with the syringe 26, is
raised. The drawbar 46 is retained by the second trigger 50, with
the suction spring 60 disposed in a compressed state.
[0055] The lower end 72 of the housing 12 is placed against the
skin surface S, preferably at a portion of the body having fewer
nerve endings than, say the fingertip. A forearm would be a
suitable location. Suction may be applied to the skin surface S at
this time. The suction may be applied and held, or applied and
released prior to the syringe cutting the skin. The trigger 38 is
then pulled out against a spring bias to release the drive rod 22
and the compressed drive spring 56. As a result, the drive rod 22,
the syringe carrier 24, and syringe 26 are driven downwardly, so
that the syringe cuts an incision I through the skin surface S, as
shown in FIG. 2.
[0056] During downward movement of the drive rod 22, the mounting
sleeve 48 engages an upper end of the retraction spring 58 and then
abuts the stop ring 20, thereby limiting the incision depth and
slightly compressing the retraction spring 58. The retraction
spring 58 then moves the drive rod 22 slightly upwardly, but not
enough to completely remove the syringe 26 from the incision I.
Then, the motor 88 is actuated, either manually, or automatically
in response to the firing of the syringe, to vertically reciprocate
the stimulator sleeve 70. Consequently, the lower face 72
repeatedly depresses a ring of skin and body tissue which surrounds
the incision. Each depression of that ring causes the incision to
bulge and the sides of the incision to be spread apart, and urges
bodily fluid such as blood or interstitial fluid toward and
outwardly through the incision I, as explained also in commonly
assigned U.S Pat. Nos. 5,879,311, and 5,591,493.
[0057] In order to enable the inwardly urged bodily fluid to pool
at the incision (for subsequent sampling), the syringe 26 is
vibrated relatively slowly by the piezoelectric transducer 66 to
keep the incision open. As noted earlier, the direction of
vibration can be determined by the particular orientation of the
transducer 66. In one embodiment, the direction of vibration is
longitudinal or vertical (FIG. 4); in another embodiment the
vibration is lateral (FIG. 5); in another embodiment the vibration
is a combination of lateral and vertical, i.e., generally
elliptical oscillation (FIG. 6).
[0058] It will be appreciated that if the syringe were not moved
within the incision, the presence of a stationary syringe within
the incision could result in a closing of the incision by collagen
in the skin, whereby bodily fluid could not pool at the
incision.
[0059] After a short period, sufficient to allow an ample amount of
bodily fluid to pool at the incision, the second trigger 50 is
manually actuated to release the drawbar 46, causing the spring 60
to raise the plunger 40 within the tube 30. That produces a suction
in the tube 30 below the plunger 40, which draws in a sample 91 of
bodily fluid through the syringe 26 (FIG. 3).
[0060] Then, the device can be removed from the skin, and the
sample delivered to a suitable test site. Alternatively, the device
may contain a test device in conjunction with the sampling device
described above. Suitable test devices which may be incorporated
with the sampler described above are shown and described in
co-pending U.S. patent application No. (Insert)
[0061] As an alternative to the reciprocation of the syringe, the
syringe can be rotated about its own center axis while disposed in
the incision I. In that regard, a rotatable syringe 92 as shown in
FIG. 7 can be utilized in a device 10' shown in FIGS. 8 and 9. That
device 10' is similar to that depicted in FIGS. 1-3 with the
addition of a rotary gear 94 that is driven by a pinion 95 of a
second motor 96. The gear 94 includes an upwardly open recess 98
sized to receive, with a snug fit, a lower end 100 of the tube 30
in which the syringe 92 is disposed. Thus, when the syringe carrier
24' is driven toward the skin, the lower portion 100 of the tube 30
enters the recess 98 to create a frictional engagement between the
tube 30 and the gear 94 (see FIG. 9). By then rotating the pinion
95, the gear 94, the tube 30, and the syringe 92 are rotated
relative to the carrier 24' about an axis coinciding with a center
axis of the syringe 92. The syringe 92 includes a pointed end 102
in the form of one-half of a cone. As the syringe rotates about its
own axis, the semi-conical segment 102 cuts a conical recess 104 in
the incision and keeps the incision open as the stimulator sleeve
70 reciprocates.
[0062] Any of the syringes described thus far can be provided with
a stop which would replace the stop ring 20. Such a stop 110 is
shown in FIGS. 10 and 11 in connection with the syringe 92. The
stop 110 comprises a disc fixed to the syringe. When the disc
contacts the skin surface, no further entry of the syringe into the
skin can occur. The stop ring 20 could also be used to open and
close the incision to promote bodily fluid pooling.
[0063] It will be appreciated that the present invention minimizes
the pain experienced by a user, because it can be used to provide a
sample of bodily fluid at an area of the body which contains fewer
nerve endings than in an area such as the finger tips. By
stimulating the body tissue surrounding the incision, while moving
the syringe relative to the incision, bodily fluid is caused to
pool in the incision, thereby providing an ample sample to be
sucked through the syringe and into a collection tube. Thus, an
area of the body less sensitive to pain can be used as a source of
bodily fluid.
[0064] Although the stimulator member 70 is disclosed as having a
generally annular skin contacting surface, i.e., a surface which is
symmetric about the center axis thereof, the member 70 could
instead have an elliptical or polygonal end face whereby the ring
of body tissue depressed thereby would have a corresponding
shape.
[0065] An alternative method according to the present invention
includes the use of a suction device prior to use of the lancing
device. The lower end of the housing 12 is placed against the skin
surface S, preferably at a portion of the body where the sample is
to be taken from. For example, a forearm would be a suitable
location. A vacuum source is activated whereupon the skin S
adjacent the lower end of the housing 12 is drawn into the
frusto-conical shaped distal tip. The suction causes bodily fluid
beneath the skin to pool in the area of skin S in contact with the
testing device 10. The vacuum is released thereby releasing the
skin. The trigger 38 is then pulled out against a spring bias to
release the drive rod 22 and the compressed drive spring 56. As a
result, the drive rod 22, the syringe carrier 24, and syringe 26
are driven downwardly, so that he syringe cuts an incision I
through the skin surface S. During the downward movement of the
drive rod 22, the mounting sleeve 48 engages an upper end of the
retraction spring 58 and then abuts the stop ring 20, thereby
limiting the incision depth and slightly compressing the retraction
spring 58. The retraction spring 58 then moves the drive rod 22
slightly upwardly, but not enough to completely remove the syringe
26 from the incision I. Then, the motor 88 is actuated, either
manually, or automatically in response to the firing of the
syringe, to vertically reciprocate the stimulator sleeve 70.
Consequently, the lower face 72 repeatably depresses a ring of skin
and body tissue which surrounds the incision. The depression of the
ring causes the skin adjacent the incision to bulge and the sides
of the incision spread apart, such that bodily fluid is urged from
the incision in response to the applied force.
[0066] After a short period, sufficient to allow an ample amount of
bodily fluid to pool at the incision, the second trigger 50 is
manually actuate to release the drawbar 46, causing the spring 60
to raise the plunger 40 within the tube 30. This produces suction
in the tube 30 below the plunger 40, which draws in a sample 91 of
bodily fluid through the syringe. The sample may then be delivered
to an appropriate test media or testing device as described
above.
[0067] Additionally, as described above, the vacuum may be
repeatedly applied to the skin prior to deployment of the needle to
form the incision I. By repeatably applying a vacuum source to the
skin S this encourages bodily fluid to pool in the location
adjacent to where the incision is to be made. Because bodily fluid
is pooled in this area prior to formation of the incision I, once
the incision I is formed the a sample is bodily fluid is easily
collected because of the large volume of fluid available within the
area.
[0068] It is further contemplated that the vacuum mechanism may be
activated after the incision is formed to further express fluid
from the incision. In addition to the vacuum source, it is also
contemplated that a vibratory force, a heat force, and/or an
ultrasonic force may be applied to the area to be lanced to further
the expression of bodily fluid. Additionally, the vacuum may be
repeatedly applied to the skin after the formation of incision I.
Repeated application of a vacuum after the incision is formed
encourages bodily fluid to continue to pool in the area adjacent to
the incision, thereby aiding collection of the bodily fluid.
[0069] Referring now to FIG. 12 there is shown yet another
alternative embodiment of the present invention. As shown in FIG.
12 the test device 100 comprises a main body 120, a test strip
holder/tip assembly 130, and a lancing device 150. The functions of
the testing device 100 are similar to that as described above with
reference to testing device 10. The testing device 100 is prepared
for use by first inserting a disposable lancet/test strip holder
and test strip into the lancing device 150. The lancing device 150
is then prepared for use by pulling up on a driving mechanism (not
shown) thereby compressing a driving spring (not shown). The device
100 is placed over an area to be lanced, wherein a vacuum mechanism
disposed within the main body 120 and in communication with the tip
assembly 130 is then activated. Skin S is drawn into the distal end
of the device 100. The vacuum mechanism may then be deactivated
thereby releasing the vacuum force on the skin, or repeatedly
activated and deactivated.
[0070] After the vacuum device has been utilized, device 100
releases the driving spring, wherein a lancet is advanced through
the patient's skin to form an incision I therein. The lancet may
then be retracted from the incision I. Alternatively, it may be
desirable to leave the lancet within or directly adjacent the
incision for the reasons described above. Additionally, the vacuum
device may be activated, activated and deactivated, or repeatedly
activated and deactivated after forming the incision. Furthermore,
a vibratory force may be applied to the lancet, the vibratory force
may be applied vertically, horizontally, or any combination
thereof.
[0071] A sample of bodily fluid may then be withdrawn from the
incision and transported to a test area. The sample may be
withdrawn from the incision through a capillary tube having one end
disposed within the end of the test device 100 and the other end in
communication with a chemical pad of a test strip and or
electrochemical measuring device. Alternatively, the test strip may
include capillary means such as a capillary tube or a cascading
capillary. In yet another alternative embodiment, the test strip
may be disposed adjacent to the distal end of the testing device
wherein the lancet passes through an aperture in the test strip.
The test strip may further include a gasket and/or a deep dermal
constriction device. Furthermore, by placing the strip against the
patient's skin and lancing there through this eliminates the need
for a capillary to transport the bodily fluid from the incision to
the test strip. This may lead to shorter sample times and/or lessen
the likelihood of a failed test due to inadequate sample
delivery.
[0072] In yet an additional alternative embodiment as shown in
FIGS. 13 and 14, the test device 200 may include a test strip (not
pictured) and lancet 220 which may be formed as an integrated unit.
The lancet 220 may be embodied in the form of an anti-coring needle
having a pre-bent radius of curvature R and a fluid inlet 223 such
as that described in co-pending provisional patent application No.
60/297,098 filed on Jun. 8, 2001, the entirety of which is herein
incorporated by reference. In this embodiment, the test device is
placed over the area to be lanced, a vacuum is drawn on the skin
thereby increasing the amount of bodily fluid adjacent the test
device. The vacuum is release and the lancet is advanced thereby
forming an incision within the patient's skin. Bodily fluid may
then be withdrawn from the incision. The bodily fluid is then
collected using one of the devices described above. After a
sufficiently sized sample has been collected, the test device may
be removed from the patient's skin, this may be prompted by a
audible and/or visual marker. The test device will then deliver to
the patient a visual indication of the test results.
[0073] 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.
* * * * *