U.S. patent application number 12/029234 was filed with the patent office on 2008-08-14 for automated insertion assembly.
Invention is credited to Richard J. Lanigan.
Application Number | 20080195045 12/029234 |
Document ID | / |
Family ID | 39530661 |
Filed Date | 2008-08-14 |
United States Patent
Application |
20080195045 |
Kind Code |
A1 |
Lanigan; Richard J. |
August 14, 2008 |
AUTOMATED INSERTION ASSEMBLY
Abstract
An automated insertion assembly includes a first dermal
perforation assembly configured to releasably engage a first
subdermal device. A first actuation assembly is configured to drive
the first dermal perforation assembly into a user's skin to a first
depth and drive the first subdermal device into the user's skin to
a second depth. The second depth is greater than the first
depth.
Inventors: |
Lanigan; Richard J.;
(Concord, NH) |
Correspondence
Address: |
HOLLAND & KNIGHT LLP
10 ST. JAMES AVENUE
BOSTON
MA
02116
US
|
Family ID: |
39530661 |
Appl. No.: |
12/029234 |
Filed: |
February 11, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60889007 |
Feb 9, 2007 |
|
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|
Current U.S.
Class: |
604/117 ;
604/157 |
Current CPC
Class: |
A61M 2005/1585 20130101;
A61M 2005/1581 20130101; A61B 5/1427 20130101; A61B 5/150022
20130101; A61B 5/15107 20130101; A61B 5/150389 20130101; A61B
5/15186 20130101; A61M 5/14244 20130101; A61B 5/150358 20130101;
A61M 5/148 20130101; A61M 5/158 20130101; A61B 5/15117 20130101;
A61B 5/15123 20130101; A61B 5/15119 20130101; A61M 5/14232
20130101; A61M 2005/1583 20130101; A61B 5/15125 20130101; A61B
5/150503 20130101; A61B 5/150175 20130101; A61B 5/15121 20130101;
A61M 5/142 20130101; A61M 2207/00 20130101 |
Class at
Publication: |
604/117 ;
604/157 |
International
Class: |
A61M 5/48 20060101
A61M005/48; A61M 5/46 20060101 A61M005/46 |
Claims
1. An automated insertion assembly comprising: a first dermal
perforation assembly configured to releasably engage a first
subdermal device; and a first actuation assembly configured to
drive the first dermal perforation assembly into a user's skin to a
first depth and drive the first subdermal device into the user's
skin to a second depth, wherein the second depth is greater than
the first depth.
2. The automated insertion assembly of claim 1 wherein the first
subdermal device is chosen from the group consisting of a cannula
assembly and a probe.
3. The automated insertion assembly of claim 1 wherein the first
dermal perforation assembly includes: a first insertion needle
assembly for at least partially encapsulating at least a portion of
the first subdermal device.
4. The automated insertion assembly of claim 1 wherein the first
actuation assembly includes: a first actuator for providing
mechanical energy sufficient to drive the first dermal perforation
assembly into the user's skin to the first depth and drive the
first subdermal device into the user's skin to the second
depth.
5. The automated insertion assembly of claim 4 wherein the first
actuator is a spring-based actuator.
6. The automated insertion assembly of claim 4 wherein the first
actuation assembly includes: one or more gear assemblies for at
least partially coupling the first actuator to the first dermal
perforation assembly.
7. The automated insertion assembly of claim 4 wherein the first
actuation assembly includes: one or more linkage assemblies for at
least partially coupling the first actuator to the first dermal
perforation assembly.
8. The automated insertion assembly of claim 1 further comprising:
a second dermal perforation assembly configured to releasably
engage a second subdermal device; and a second actuation assembly
configured to drive the second dermal perforation assembly into the
user's skin to a third depth and drive the second subdermal device
into the user's skin to a fourth depth.
9. The automated insertion assembly of claim 8 wherein the fourth
depth is greater than the third depth.
10. The automated insertion assembly of claim 8 wherein the fourth
depth is less than/equal to the third depth.
11. The automated insertion assembly of claim 8 wherein the second
subdermal device is chosen from the group consisting of a canular
assembly and a probe.
12. The automated insertion assembly of claim 8 wherein the second
dermal perforation assembly includes: a second insertion needle
assembly for at least partially encapsulating at least a portion of
the second subdermal device.
13. The automated insertion assembly of claim 8 wherein the second
actuation assembly includes: a second actuator for providing
mechanical energy sufficient to drive the second dermal perforation
assembly into the user's skin to the third depth and drive the
second subdermal device into the user's skin to the fourth
depth.
14. The automated insertion assembly of claim 13 wherein the second
actuator is a spring-based actuator.
15. The automated insertion assembly of claim 13 wherein the second
actuation assembly includes: one or more gear assemblies for at
least partially coupling the second actuator to the second dermal
perforation assembly.
16. The automated insertion assembly of claim 13 wherein the second
actuation assembly includes: one or more linkage assemblies for at
least partially coupling the second actuator to the second dermal
perforation assembly.
17. The automated insertion assembly of claim 8 wherein the first
actuation assembly and the second actuation assembly are a single
actuation assembly.
18. An automated insertion assembly comprising: a first dermal
perforation assembly configured to releasably engage a first
subdermal device; a second dermal perforation assembly configured
to releasably engage a second subdermal device; and an actuation
assembly configured to: drive the first dermal perforation assembly
into a user's skin to a first depth, drive the first subdermal
device into the user's skin to a second depth, drive the second
dermal perforation assembly into the user's skin to a third depth,
and drive the second subdermal device into the user's skin to a
fourth depth, wherein the second depth is greater than the first
depth.
19. The automated insertion assembly of claim 18 wherein the fourth
depth is greater than the third depth.
20. The automated insertion assembly of claim 18 wherein the fourth
depth is less than/equal to the third depth.
21. The automated insertion assembly of claim 18 wherein the first
subdermal device and the second subdermal device are chosen from
the group consisting of a cannula assembly and a probe.
22. The automated insertion assembly of claim 18 wherein the first
dermal perforation assembly includes: a first insertion needle
assembly for at least partially encapsulating at least a portion of
the first subdermal device.
23. The automated insertion assembly of claim 18 wherein the second
dermal perforation assembly includes: a second insertion needle
assembly for at least partially encapsulating at least a portion of
the second subdermal device.
24. The automated insertion assembly of claim 18 wherein the
actuation assembly includes: an actuator for providing mechanical
energy sufficient to drive the first dermal perforation assembly
into a user's skin to a first depth, drive the first subdermal
device into the user's skin to a second depth, drive the second
dermal perforation assembly into the user's skin to a third depth,
and drive the second subdermal device into the user's skin to a
fourth depth.
25. The automated insertion assembly of claim 24 wherein the
actuator is a spring-based actuator.
26. An automated insertion assembly comprising: a first dermal
perforation assembly configured to releasably engage a first
subdermal device; a second subdermal device; and an actuation
assembly configured to: drive the first dermal perforation assembly
into a user's skin to a first depth, drive the first subdermal
device into the user's skin to a second depth, and drive the second
subdermal device into the user's skin to a third depth, wherein the
second depth is greater than the first depth.
27. The automated insertion assembly of claim 26 wherein the second
subdermal device is a cannula assembly.
28. The automated insertion assembly of claim 26 wherein the first
dermal perforation assembly includes: a first insertion needle
assembly for at least partially encapsulating at least a portion of
the first subdermal device.
29. The automated insertion assembly of claim 26 wherein the
actuation assembly includes: an actuator for providing mechanical
energy sufficient to drive the first dermal perforation assembly
into a user's skin to a first depth, drive the first subdermal
device into the user's skin to a second depth, and drive the second
subdermal device into the user's skin to a third depth.
Description
RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Ser.
No. 60/889,007, filed 9 Feb. 2007, and entitled: TWO-STAGE
TRANSCUTANEOUS INSERTER, which is herein incorporated by reference
in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates to insertion assemblies and, more
particularly, to automated insertion assemblies.
BACKGROUND
[0003] Numerous devices (e.g., drug delivery systems, analyte
monitoring systems, including but not limited to blood glucose
monitoring systems or any system monitoring any patient condition
from any patient fluid or physiological characteristic) require
that the skin of the user being tested be perforated to allow for
e.g., the supplying of drug to the user and/or the monitoring of
various bodily/physiological conditions (e.g., blood conditions,
i.e., glucose levels or other analyte levels whether in the blood
or other fluid or indicative by another physical condition, i.e.,
temperature). The difficulty with these devices is compounded where
two or more are used.
[0004] Unfortunately, such systems may require the user to manually
insert the various cannulas and/or probes into or onto their skin,
often resulting in incorrect insertions and discomfort/pain. This
problem is compounded when the user is using multiple devices e.g.,
an insulin delivery system and a blood glucose monitoring
system.
SUMMARY OF DISCLOSURE
[0005] In a first implementation, an automated insertion assembly
includes a first dermal perforation assembly configured to
releasably engage a first subdermal device. A first actuation
assembly is configured to drive the first dermal perforation
assembly into a user's skin to a first depth and drive the first
subdermal device into the user's skin to a second depth. The second
depth is greater than the first depth.
[0006] One or more of the following features may be included. The
first subdermal device may be chosen from the group consisting of a
cannula assembly and a probe. The first dermal perforation assembly
may include a first insertion needle assembly for at least
partially encapsulating at least a portion of the first subdermal
device. The first actuation assembly may include a first actuator
for providing mechanical energy sufficient to drive the first
dermal perforation assembly into the user's skin to the first depth
and drive the first subdermal device into the user's skin to the
second depth. The first actuator may be a spring-based
actuator.
[0007] The first actuation assembly may include one or more gear
assemblies for at least partially coupling the first actuator to
the first dermal perforation assembly. The first actuation assembly
may include one or more linkage assemblies for at least partially
coupling the first actuator to the first dermal perforation
assembly.
[0008] A second dermal perforation assembly may be configured to
releasably engage a second subdermal device. A second actuation
assembly may be configured to drive the second dermal perforation
assembly into the user's skin to a third depth and drive the second
subdermal device into the user's skin to a fourth depth. The fourth
depth may be greater than the third depth. The fourth depth may be
less than/equal to the third depth.
[0009] The second subdermal device may be chosen from the group
consisting of a cannula assembly and a probe. The second dermal
perforation assembly may include a second insertion needle assembly
for at least partially encapsulating at least a portion of the
second subdermal device. The second actuation assembly may include
a second actuator for providing mechanical energy sufficient to
drive the second dermal perforation assembly into the user's skin
to the third depth and drive the second subdermal device into the
user's skin to the fourth depth.
[0010] The second actuator may be a spring-based actuator. The
second actuation assembly may include one or more gear assemblies
for at least partially coupling the second actuator to the second
dermal perforation assembly. The second actuation assembly may
include one or more linkage assemblies for at least partially
coupling the second actuator to the second dermal perforation
assembly. The first actuation assembly and the second actuation
assembly may be a single actuation assembly.
[0011] In another implementation, an automated insertion assembly
includes a first dermal perforation assembly configured to
releasably engage a first subdermal device. A second dermal
perforation assembly is configured to releasably engage a second
subdermal device. An actuation assembly is configured to: drive the
first dermal perforation assembly into a user's skin to a first
depth, drive the first subdermal device into the user's skin to a
second depth, drive the second dermal perforation assembly into the
user's skin to a third depth, and drive the second subdermal device
into the user's skin to a fourth depth. The second depth is greater
than the first depth.
[0012] One or more of the following features may be included. The
fourth depth may be greater than the third depth. The fourth depth
may be less than/equal to the third depth. The first subdermal
device and the second subdermal device may be chosen from the group
consisting of a canular assembly and a probe.
[0013] The first dermal perforation assembly may include a first
insertion needle assembly for at least partially encapsulating at
least a portion of the first subdermal device. The second dermal
perforation assembly may include a second insertion needle assembly
for at least partially encapsulating at least a portion of the
second subdermal device. The actuation assembly may include an
actuator for providing mechanical energy sufficient to drive the
first dermal perforation assembly into a user's skin to a first
depth, drive the first subdermal device into the user's skin to a
second depth, drive the second dermal perforation assembly into the
user's skin to a third depth, and drive the second subdermal device
into the user's skin to a fourth depth. The actuator may be a
spring-based actuator.
[0014] In another implementation, an automated insertion assembly
includes a first dermal perforation assembly configured to
releasably engage a first subdermal device, a second subdermal
device, and an actuation assembly. The actuation assembly is
configured to: drive the first dermal perforation assembly into a
user's skin to a first depth, drive the first subdermal device into
the user's skin to a second depth, and drive the second subdermal
device into the user's skin to a third depth. The second depth is
greater than the first depth.
[0015] One or more of the following features may be included. The
second subdermal device may be a cannula assembly. The first dermal
perforation assembly may include a first insertion needle assembly
for at least partially encapsulating at least a portion of the
first subdermal device. The actuation assembly may include an
actuator for providing mechanical energy sufficient to drive the
first dermal perforation assembly into a user's skin to a first
depth, drive the first subdermal device into the user's skin to a
second depth, and drive the second subdermal device into the user's
skin to a third depth.
[0016] The details of one or more implementations are set forth in
the accompanying drawings and the description below. Other features
and advantages will become apparent from the description, the
drawings, and the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a diagrammatic view of an automated insertion
assembly;
[0018] FIG. 2 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0019] FIG. 3 is a diagrammatic view of an insertion needle
assembly of the automated insertion assembly of FIG. 1;
[0020] FIG. 4 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0021] FIG. 5 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0022] FIG. 6 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0023] FIG. 7 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0024] FIG. 8 is another diagrammatic view of the automated
insertion assembly of FIG. 1;
[0025] FIG. 9A is a diagrammatic view of a crank assembly of the
automated insertion assembly of FIG. 1;
[0026] FIG. 9B is a diagrammatic view of an alternative embodiment
of the crank assembly of FIG. 9A;
[0027] FIG. 9C is a diagrammatic view of an alternative embodiment
of the crank assembly of FIG. 9A;
[0028] FIG. 10 is a diagrammatic view of a spring-based actuator of
the automated insertion assembly of FIG. 1;
[0029] FIGS. 11A-11B are front and back views of a sharps cartridge
of automated insertion assembly of FIG. 1;
[0030] FIG. 12 is an isometric view of a cartridge assembly for
housing the sharps cartridge of FIGS. 11A-11B;
[0031] FIGS. 13A-13B are various isometric views of the automated
insertion assembly of FIG. 1;
[0032] FIG. 14A is a series of views of a dermal perforation
assembly of the automated insertion assembly of FIG. 1;
[0033] FIG. 14B is an isometric view of the dermal perforation
assembly of FIG. 14A;
[0034] FIGS. 15A-15L are a series of views of an alternative
embodiment of the automated insertion assembly of FIG. 1; and
[0035] FIGS. 16-18 are isometric views of a gear assembly/actuator
of the automated insertion assembly of FIG. 1.
[0036] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0037] The following description describes various embodiments of
an automated insertion assembly. The device is a mechanical device
capable of automatically inserting or introducing one or more
probes or sensors. In one embodiment, the device includes
automatically inserting at least one probe into a patient's skin by
first inserting an introduction needle that at least partially
encapsulates the probe. The insertion needle reaches a
predetermined first depth in the skin and is withdrawn by the
device, leaving the probe behind. The device additionally includes
a pusher device that automatically and mechanically pushes the
probes to a second depth, deeper than the first depth. The pusher
device is then mechanically and automatically retracted.
[0038] In another embodiment, in addition to the probe insertion
capabilities described above, the inerter apparatus additionally
includes a cannula or other drug delivery insertion device. The
cannula insertion device includes an automatic and mechanical
inserter that inserts a cannula using an introduction needle. The
insertion needle is automatically and mechanically retracted.
[0039] In one embodiment of the apparatus, both the cannula and
probe are inserted simultaneously. The probe inserter includes a
pusher where the cannula inserter does not. However, the
introduction needles perforate the skin simultaneously.
[0040] Inserting two devices at the same time has many advantages,
including but not limited to, convenience and less pain and/or less
number of painful events for the patient. Additionally, because
both devices are inserted using the same apparatus, the spacing
between the two devices in the patient can be predetermined and
thus, may increase accuracy, efficiency and safety in the use of
the devices. For example, in some applications, the inserter is
used to insert two or more probes or other devices; at appropriate
distances one from another. However, in other applications where a
probe and delivery device are inserted together, the probes or
probe and delivery device should be spaced apart a minimum distance
for accuracy. Inserting both devices using the same inserter
assures the patient inserts both devices at the minimum recommended
distance. Additionally, in some embodiments, the inserter may apply
two or more sensors or probes at a predetermined distance, where
the readings between the sensors or probes are indicative. In these
embodiments, the distance between the probes or sensors is
maintained for accuracy and/or to eliminate or minimize
interference. Thus, again, in this instance, the inserter assures
the correct distance.
[0041] In another embodiment, the inserter inserts two or more
probes, two or more sensors or two or more cannulas or drug
delivery devices simultaneously. In still further embodiments, the
inserter may insert a variety of sensors or probes or all the same
sensors or probes and/or drug delivery paths, cannulas or
needles.
[0042] Referring to FIGS. 1, 2, 3, 3L, 3R & 3T, there is shown
automated insertion assembly 10 that may include first dermal
perforation assembly 12 that may be configured to releasably engage
first subdermal device 14. First actuation assembly 16 may be
configured to drive first dermal perforation assembly 12 into a
user's skin 18 to a first depth and drive first subdermal device 14
into user's skin 18 to a second depth. The manner in which
automated insertion assembly 10 drives first dermal perforation
assembly 12 to a first depth and drives first subdermal device 14
to a second depth is described below in greater detail. Typically,
the second depth (i.e. the depth to which first subdermal device 14
is driven) is greater than the first depth (i.e. the depth to which
first dermal perforation assembly 12 is driven), thus allowing
first subdermal device 14 to penetrate skin that was not previously
penetrated/damaged by first dermal perforation assembly 12.
However, the second depth in some embodiments may be equal or less
than the first depth.
[0043] Examples of first subdermal device 14 may include but are
not limited to a cannula assembly, a needle assembly, an infusion
assembly, a glucose monitoring probe, a potassium or any
electrolyte and/or analyte monitoring probe, or any type of probe
that monitors any chemical, analyte or physiological characteristic
including, but not limited to, hydration and/or temperature and/or
conductivity/electrical pulses. In still other embodiments, the
probes may impart an electrical stimulation. Additionally, in some
embodiments, the device may include an RF transmitter or compounds.
In one embodiment, the compound is any therapeutic compound, and
dissolves into the dermal layer over a period of time. In still
other embodiments, the device may include, but is not limited to, a
bedside IV or other patient monitoring assembly, or any other
device used to monitor physiological conditions.
[0044] Automated insertion assembly 10 may be included within (or a
portion of) various other devices (e.g., device 22), examples of
which may include but are not limited to an infusion pump assembly,
a glucose monitoring system, a potassium or any electrolyte
monitoring system, an analyte monitoring system or any type of
system or device that monitors any chemical or physiological
characteristic including, but not limited to, hydration and/or
temperature and/or conductivity. In still other embodiments, the
probes may impart an electrical stimulation and may be part of an
electrical stimulation device. Additionally, in some embodiments,
the device may include an RF transmitter or compounds. In one
embodiment, the compound is any therapeutic compound system, and in
one embodiment, the system provides for a compound that dissolves
into the dermal layer over a period of time. In still other
embodiments, the device may include, but is not limited to, a
bedside IV or other patient monitoring assembly, or any other
device used to monitor physiological conditions. Further, automated
insertion assembly 10 may be separate from (but tethered to)
various other devices (e.g. device 24), examples of which may
include but are not limited to an infusion pump assembly, a glucose
monitoring system or probe, a potassium or any electrolyte
monitoring system or probe, or any type of probe or system that
monitors any chemical, analyte or physiological characteristic
including, but not limited to, hydration and/or temperature.
Additionally, in some embodiments, the device may include an RF
transmitter or compounds. In one embodiment, the compound is any
therapeutic compound, and dissolves into the dermal layer over a
period of time. In still other embodiments, the device may include,
but is not limited to, a bedside IV or other patient monitoring
assembly, or any other device used to monitor physiological
conditions.
[0045] First dermal perforation assembly 12 may include first
insertion needle assembly 28 that may be configured to at least
partially encapsulate at least a portion of first subdermal device
14. However, in some embodiments, an insertion needle assembly is
not included.
[0046] First actuation assembly 16 may include first actuator 30
for providing mechanical energy sufficient to drive first dermal
perforation assembly 12 into user's skin 18 to the first depth and
drive first subdermal device 14 into user's skin 18 to the second
depth. Examples of first actuator 30 may include but are not
limited to a spring-based actuator (not shown), a motor-based
actuator (not shown), a pneumatic-based actuator (not shown), and a
shape memory wire-based actuator (not shown).
[0047] First actuation assembly 16 may include one or more gear
assemblies (to be discussed below in greater detail) for at least
partially coupling first actuator 30 to first dermal perforation
assembly 12. Additionally/alternatively, first actuation assembly
16 may include one or more linkage assemblies (to be discussed
below in greater detail) for at least partially coupling first
actuator 30 to first dermal perforation assembly 12.
[0048] First insertion needle assembly 28 of first dermal
perforation assembly 12 may be configured to allow first subdermal
device 14 to exit from first insertion needle assembly 28. For
example, first insertion needle assembly 28 may include
longitudinal slot 32 through which first subdermal device 14 may
exit from first insertion needle assembly 28. Specifically, first
insertion needle assembly 28 may be a traditional hypodermic-type
(i.e. hollow core) needle assembly. As shown in FIG. 3T (which is a
cross-sectional view of FIG. 3 along section line AA), first
insertion needle assembly 28 may include interior passage 34 which
may be sized to receive first subdermal device 14. As shown in FIG.
3R (i.e. a right-side view of first insertion needle assembly 28 in
the direction of arrow 36) and FIG. 3L (i.e. a left-side view of
first insertion needle assembly 28 in the direction of arrow 38),
longitudinal slot 32 may extend the entire length of first
insertion needle assembly 28. Alternatively, longitudinal slot 32
may extend a partial length of first insertion needle assembly 28,
wherein the partial length is positioned to allow first subdermal
device 14 to exit first insertion needle assembly 28 at the
appropriate position along the length of first insertion needle
assembly 28.
[0049] Referring to FIG. 4, automated insertion assembly 10 may
include second dermal perforation assembly 50. Second dermal
perforation assembly 50 may be configured to releasably engage
second subdermal device 52. A second actuation assembly (not shown)
may be configured to drive second dermal perforation assembly 50
into user's skin 18 to a third depth and drive second subdermal
device 52 into user's skin 18 to a fourth depth. This second
actuation assembly (not shown) may include a second actuator for
providing the mechanical energy sufficient to drive second dermal
perforation assembly 50 into user's skin 18 to the third depth and
drive second subdermal device 52 into user's skin 18 to the fourth
depth. Examples of this second actuator (not shown) may include but
are not limited to a spring-based actuator (not shown), a
motor-based actuator (not shown), a pneumatic-based actuator (not
shown), and a shape memory wire-based actuator (not shown).
[0050] In alternate embodiments of automated insertion assembly 10,
the various dermal perforation assemblies may be configured such
that one or more are driven to equal depths. In one embodiment, all
of the assemblies are driven to equal depths.
[0051] In a fashion similar to that of first actuation assembly 16,
the second actuation assembly (not shown) may include one or more
gear assemblies (to be discussed below in greater detail) for at
least partially coupling the second actuator (not shown) to second
dermal perforation assembly 50. Additionally/alternatively, the
second actuation assembly (not shown) may include one or more
linkage assemblies (to be discussed below in greater detail) for at
least partially coupling the second actuator (not shown) to second
dermal perforation assembly 50.
[0052] Alternatively, first dermal perforation assembly 12 and
second dermal perforation assembly 50 may be driven by a common
actuation assembly (e.g. first actuation assembly 16) and/or a
common actuator (e.g. first actuator 30).
[0053] Typically, the fourth depth (i.e. the depth to which second
subdermal device 52 is driven) is greater than the third depth
(i.e. the depth to which second dermal perforation assembly 50 is
driven), thus allowing a second subdermal device 52 to penetrate
skin that was not previously penetrated/damaged by second dermal
perforation assembly 50.
[0054] The third depth (i.e. the depth to which second dermal
perforation assembly 50 is driven) may be the same as or different
from the first depth (i.e. the depth to which first dermal
perforation assembly 12 is driven). Further, the fourth depth (i.e.
the depth to which second subdermal device 52 is driven) may be the
same as or different from the first depth (i.e. the depth to which
first subdermal device 14 is driven).
[0055] In a fashion similar to that of first subdermal device 14,
examples of second subdermal device 52 may include but are not
limited to a cannula assembly, a glucose monitoring probe, a
potassium or any electrolyte monitoring probe, or any type of probe
that monitors any chemical, analyte or physiological characteristic
including, but not limited to, hydration and/or temperature.
Additionally, in some embodiments, the device may include an RF
transmitter or compounds. In one embodiment, the compound is any
therapeutic compound, and dissolves into the dermal layer over a
period of time. In still other embodiments, the device may include,
but is not limited to, a bedside IV or other patient monitoring
assembly, or any other device used to monitor physiological
conditions.
[0056] In a fashion similar to that of first dermal perforation
assembly 12, second dermal perforation assembly 50 may include
second insertion needle assembly 54 that may be configured to at
least partially encapsulate at least a portion of second subdermal
device 52. Second insertion needle assembly 54 of second dermal
perforation assembly 50 may be configured to allow second subdermal
device 52 to exit second insertion needle assembly 54. For example,
second insertion needle assembly 54 may include a longitudinal slot
(similar to that of first insertion needle assembly 28) through
which second subdermal device 52 may exit second insertion needle
assembly 54.
[0057] As discussed above, in one embodiment, first dermal
perforation assembly 12 may be driven into user's skin 18 to a
first depth; first subdermal device 14 may be driven into user's
skin 18 to a second depth; second dermal perforation assembly 50
may be driven into user's skin 18 to a third depth; and second
subdermal device 52 may be driven into user's skin 18 to a fourth
depth. However, in other embodiments, first dermal perforation
assembly 12 and/or any one or more of the subdermal devices 14, 52
may be ultimately driven to the same depths. Thus, herein, the
terms first depth, second depth, etc., may mean different depths or
the same depth, depending on the embodiment. However, it should be
appreciated that automated insertion assembly 10 allows one or more
devices to be inserted at the same or different depth.
[0058] Thus, automated insertion assembly 10 may be configured to
drive first dermal perforation assembly 12 to a first depth; drive
first subdermal device 20 to a second depth; drive second dermal
perforation assembly 50 to a third depth; and drive second
subdermal device 52 to a fourth depth, in a variety of different
ways, each of which is considered to be within the scope of this
disclosure.
[0059] Accordingly and for illustrative purposes only, a first
configuration is illustrated in FIGS. 4-8. As shown in FIG. 4,
first actuation assembly 16 (and/or a second actuation assembly,
not shown) may displace linkage assembly 100 and/or linkage
assembly 102 in the direction of arrows 104, 106 (respectively).
Linkage assemblies 100, 102 may be coupled to one or more gear
assemblies coupled to e.g., first actuator 30. For example, if
actuator 30 is a motor, an output shaft (not shown) of actuator 30
may include a gear assembly (not shown) to e.g., mesh with a rack
gear assembly (not shown) included within e.g., linkage assembly
100, thus allowing for the conversion of rotational energy into
linear displacement.
[0060] The displacement of linkage assembly 100 and/or linkage
assembly 102 may result in first dermal perforation assembly 12
(and first insertion needle assembly 28) and/or second dermal
perforation assembly 50 (and second insertion needle assembly 54)
moving toward user's skin 18. Automated insertion assembly 10 may
include one or more depth stops (e.g., depth stops 108, 110) for
controlling the total displacement experienced by first dermal
perforation assembly 12 and/or second dermal perforation assembly
50.
[0061] The positioning of depth stops 108, 110 is for illustrative
purposes only and is not intended to be a limitation of this
disclosure. For example, depth stops 108, 110 may be positioned
lower or higher within automated insertion assembly 10, or first
dermal perforation assembly 12 and/or second dermal perforation
assembly 50 may be configured to "bottom out" on the surface of
user's skin 18.
[0062] Referring also to FIG. 5, first dermal perforation assembly
12 and/or second dermal perforation assembly 50 may continue to
move downward until (in this particular example) first dermal
perforation assembly 12 contacts depth stop 108 and/or second
dermal perforation assembly 50 contacts depth stop 110. Once depth
stop 108 and/or depth stop 110 contacts first dermal perforation
assembly 12 and/or second dermal perforation assembly 50, one or
more spring assemblies (e.g. spring assembly 112 and/or spring
assembly 114) may begin to compress. Specifically, spring assembly
112 and/or spring assembly 114 may be sized to provide a mechanical
resistance that is sufficient to drive first insertion needle
assembly 28 (included within first dermal perforation assembly 12)
and/or second insertion needle assembly 54 (included within second
dermal perforation assembly 50) into user's skin 18.
[0063] The positioning of spring assemblies 112, 114 is for
illustrative purposes only and is not intended to be a limitation
of this disclosure. For example, spring assemblies 112, 114 may be
positioned lower within automated insertion assembly 10 to reduce
the overall height of automated insertion assembly 10.
[0064] Referring also to FIG. 6, spring assembly 112 and/or spring
assembly 114 may continue to compress. Further, in this particular
example, linkage assembly 100 is shown to be directly coupled to a
portion (e.g., portion 116) of first subdermal device 14. Depth
stop 108 may be positioned to allow linkage assembly 100 to drive
first dermal perforation assembly 12 to the above-described first
depth.
[0065] Accordingly, once depth stop 108 is encountered by first
dermal perforation assembly 12, all downward movement of first
dermal perforation assembly 12 may cease. However, as spring
assembly 112 compresses, linkage assembly 100 may continue to move
in a downward direction. Further, as first subdermal device 14 is
(in this particular example) directly coupled to linkage assembly
100 (via portion 116), first subdermal device 14 may continue to
move in a downward direction, continuing to penetrate user's skin
18 to a depth (e.g., the above-described second depth) that is
deeper than the depth of first insertion needle assembly 28 of
first dermal perforation assembly 12 (e.g., the above-described
first depth).
[0066] Portion 116 of first subdermal device 14 may e.g. contain
electronic circuitry and/or sensing devices that process the data
obtained by first subdermal device 14. Alternatively, portion 116
of first subdermal device 14 may simply be a rigid device upon
which linkage assembly 100 may provide downward pressure to drive
first subdermal device 14 to the above-described second depth.
[0067] At least a portion of first subdermal device 14 (e.g. the
portion penetrating user's skin 18) may be constructed of a
material that is sufficiently rigid to penetrate user's skin 18.
Examples of such a material may include but are not limited to
steel, stainless steel, titanium, or plastic. Accordingly, when
linkage assembly 100 continues to provide downward force (in the
direction of arrow 104), first subdermal device 14 may continue to
penetrate user's skin 18 until the desired depth (e.g., the
above-described second depth) is achieved. While the
above-described first depth (i.e., the depth of first insertion
needle 28 of first dermal perforation assembly 12) may be adjusted
by adjusting (in this example) the position of depth stop 108), the
above-described second depth (i.e., the depth of first subdermal
device 14) may be adjusted by adjusting the total travel of linkage
assembly 100.
[0068] Additionally and in this particular example, linkage
assembly 102 is shown to be directly coupled to a portion (e.g.,
portion 118) of second subdermal device 52. Depth stop 110 may be
positioned to allow linkage assembly 102 to drive second dermal
perforation assembly 50 to the above-described third depth.
[0069] Accordingly, once depth stop 110 is encountered by second
dermal perforation assembly 50, all downward movement of second
dermal perforation assembly 50 may cease. However, as spring
assembly 114 compresses, linkage assembly 102 may continue to move
in a downward direction. Further, as second subdermal device 52 is
(in this particular example) directly coupled to linkage assembly
102 (via portion 118), second subdermal device 52 may continue to
move in a downward direction, continuing to penetrate user's skin
18 to a depth (e.g., the above-described fourth depth) that is
deeper than the depth of second insertion needle assembly 54 of
second dermal perforation assembly 50 (e.g., the above-described
third depth).
[0070] Portion 118 of second subdermal device 52 may e.g. contain
electronic circuitry and/or sensing devices that process the data
obtained by second subdermal device 52. Alternatively, portion 118
of second subdermal device 52 may simply be a rigid device upon
which linkage assembly 102 may provide downward pressure to drive
second subdermal device 52 to the above-described fourth depth.
[0071] At least a portion of second subdermal device 52 (e.g. the
portion penetrating user's skin 18) may be constructed of a
material that is sufficiently rigid to penetrate user's skin 18.
Examples of such a material may include but are not limited to
steel, stainless steel, titanium, or plastic. Accordingly, when
linkage assembly 102 continues to provide downward force (in the
direction of arrow 106), second subdermal device 52 may continue to
penetrate user's skin 18 until the desired depth (e.g., the
above-described fourth depth) is achieved. While the
above-described third depth (i.e., the depth of second insertion
needle 54 of second dermal perforation assembly 50) may be adjusted
by adjusting (in this example) the position of depth stop 110), the
above-described fourth depth (i.e., the depth of second subdermal
device 52) may be adjusted by adjusting the total travel of linkage
assembly 102.
[0072] Continuing with the above-stated example and referring also
to FIG. 7, upon achieving the desired depth (i.e. the
above-described second depth for first subdermal device 14 and/or
the above-described fourth depth for second subdermal device 52),
linkage assembly 100 and/or linkage assembly 102 may begin to move
upward in the direction of arrow 200 and/or arrow 202. Accordingly,
spring assembly 112 and/or spring assembly 114 may decompress. As
linkage assembly 100 and/or linkage assembly 102 move in an upward
direction, linkage assembly 100 and/or linkage assembly 102 may
move away from portion 116 of first subdermal device 14 and/or
portion 118 of second subdermal device 52. Accordingly, while
linkage assembly 100 and/or linkage assembly 102 move upward, first
subdermal device 14 and or second subdermal device 52 may remain
within user skin 18.
[0073] Referring also to FIG. 8, once spring assembly 112 and/or
spring assembly 114 are fully decompressed, first dermal
perforation assembly 12 and/or second dermal perforation assembly
50 may begin to move upward (i.e. away from depth stops 108, 110
respectively). Accordingly, first insertion needle assembly 28 of
first dermal perforation assembly 12 may also move upward and may
be removed from user's skin 18. Further, second insertion needle
assembly 54 of second dermal perforation assembly 50 may also move
upward and may be removed from user's skin 18.
[0074] As discussed above, automated insertion assembly 10 may be
configured to drive first dermal perforation assembly 12 to a first
depth; drive first subdermal device 14 to a second depth; drive
second dermal perforation assembly 50 to a third depth; and drive
second subdermal device 52 to a fourth depth, in a variety of
different ways, each of which is considered to be within the scope
of this disclosure. Accordingly, while FIGS. 4-8 illustrates a
single linkage assembly (e.g. linkage assembly 100), wherein each
linkage assembly utilizes a spring assembly (e.g. spring assembly
112) to allow e.g. first subdermal device 14 to be inserted into
user's skin 18 at a depth greater than that of first insertion
needle assembly 28 of first dermal perforation assembly 12, other
configurations are possible and are considered to be within the
scope of this disclosure.
[0075] For example and referring also to FIG. 9A, an actuator (e.g.
actuator 30) included within an actuation assembly (e.g. actuation
assembly 16) may be configured to rotate crank assembly 300, which
rotates about centerline 302. Crank assembly 300 may be configured
as a variable stroke crank assembly. For example, first rod journal
304 may be offset (with respect to main journal 306) by a distance
of 50% of the second depth and second rod journal 308 may be offset
(with respect to main journal 306) by a distance of 50% of the
first depth. Linkage assembly 310 (e.g., a connecting rod) may be
coupled to rod journal 304 and configured to drive first subdermal
device 14 and linkage assembly 312 (e.g., a connecting rod) may be
coupled to rod journal 308 and configured to drive first dermal
perforation assembly 12. Accordingly, as crank assembly 300 rotates
about centerline 302, linkage assembly 310 is linearly displaced
the distance required to achieve the above-described second depth
and linkage assembly 312 is linearly displaced the distance
required to achieve the above-described first depth.
[0076] Referring also to FIG. 9B, an alternative crank assembly
300' is shown. As with crank assembly 300, crank assembly 300' may
be configured as a variable stroke crank assembly. Accordingly, as
crank assembly 300' rotates, linkage assembly 310 is linearly
displaced the distance required to achieve the above-described
second depth and linkage assembly 312 is linearly displaced the
distance required to achieve the above-described first depth.
[0077] Referring also to FIG. 9C, an alternative crank assembly
300'' is shown that utilizes a single linkage assembly (e.g.,
linkage assembly 310'). Other alternative embodiments may utilize a
plurality of crank assemblies (not shown).
[0078] As discussed above, first actuator 30 (and/or the second
actuator, not shown) may be a spring-based actuator. Referring also
to FIG. 10A-10D, an example of such a spring-based actuator is
shown. Spring-based actuator 400 may be configured to drive first
dermal perforation assembly 12 and/or second dermal perforation
assembly 50 (and first insertion needle assembly 28 and/or second
insertion needle assembly 54, respectively) downward (as shown in
FIGS. 10B-10C) and subsequently upward (as shown in FIGS.
10D-10E).
[0079] Referring also to FIGS. 11A (front view) and 11B (back
view), there is shown first dermal perforation assembly 12' (i.e.,
an alternative embodiment of first dermal perforation assembly 12)
and second dermal perforation assembly 50' (i.e., an alternative
embodiment of second dermal perforation assembly 50). Together, the
combination of first dermal perforation assembly 12' and second
dermal perforation assembly 50' may be referred to as a "sharps
cartridge" 450.
[0080] As with the above-described system, first dermal perforation
assembly 12' may include first insertion needle assembly 28' and
second dermal perforation assembly 50' may include second insertion
needle assembly 54'. For illustrative purposes and in this
particular embodiment, first dermal perforation assembly 12' is
shown to be configured to effectuate the insertion of a glucose
monitoring probe (i.e., first subdermal device 14') and second
dermal perforation assembly 50' is shown to be configured to
effectuate the insertion of a cannula assembly (i.e., second
subdermal device 52'). Depending on the manner in which the cannula
assembly (i.e., second subdermal device 52') is configured, the
cannula assembly may or may not include a septum assembly (i.e., a
self-sealing and piercable member for establishing fluid
communication with a medical device, such as a fluid delivery
device).
[0081] In this particular embodiment, the cannula assembly (i.e.,
second subdermal device 52') may be constructed of a
semi-rigid/rigid material and therefore may be capable of
penetrating user's skin 18 (FIG. 2) without the use of second
insertion needle assembly 54' of second dermal perforation assembly
50'. Accordingly and when configured in such a manner, second
insertion needle assembly 54' may not be required and, therefore,
may not be included within second dermal perforation assembly
50'.
[0082] Alternatively, the cannula assembly (i.e., second subdermal
device 52') may be constructed of a non-rigid material and,
therefore, may be incapable of penetrating user's skin 18 (FIG. 2)
without the use of second insertion needle assembly 54'.
Accordingly and when configured in such a manner, second insertion
needle assembly 54' may be required and, therefore, may be included
within second dermal perforation assembly 50'.
[0083] Further and in this particular embodiment, the glucose
monitoring probe (i.e., first subdermal device 14') may be
constructed of a non-rigid material and, therefore, may be
incapable of penetrating user's skin 18 (FIG. 2) without the use of
first insertion needle assembly 28' and, therefore, may be included
within first dermal perforation assembly 12'.
[0084] As discussed above, one or more spring assemblies (e.g.,
spring assemblies 112, 114) may be included within automated
insertion assembly 10 to allow for the insertion of one or more of
the subdermal devices to a depth (i.e., within user's skin 18) that
is deeper than that of the corresponding insertion needle assembly.
Accordingly and in this particular embodiment, first dermal
perforation assembly 12' is shown to include an alternative
embodiment spring assembly (i.e., spring assembly 112'). In this
particular example, spring assembly 112' may be a portion of and
molded within first dermal perforation assembly 12'. Spring
assembly 112' may be sized to provide a mechanical resistance that
is sufficient to drive first insertion needle assembly 28'
(included within first dermal perforation assembly 12') into user's
skin 18.
[0085] Once all downward movement of first dermal perforation
assembly 12' ceases (due to e.g., encountering a depth stop, as
described above), spring assembly 112' may compress and the
above-described linkage assembly (e.g., linkage assembly 100) may
continue to drive first subdermal device 14' in a downward
direction and further into user's skin 18 to a depth (e.g., the
above-described second depth) that is deeper than the depth of
first insertion needle assembly 28' of first dermal perforation
assembly 12' (e.g., the above-described first depth).
[0086] In this particular embodiment, sharps cartridge 450 is shown
to include slots 452, 454 within which tabs 456, 458 may be
positioned. Tabs 456, 458 maybe coupled to the above-described
linkage assembly (e.g., linkage assembly 100).
[0087] Referring also to FIG. 12, there is shown cartridge assembly
500 for carrying sharps cartridge 450, thus protecting the user of
sharps cartridge 450 from being accidentally punctured by the
glucose monitoring probe (i.e., first subdermal device 14') and/or
the cannula assembly (i.e., second subdermal device 52').
[0088] Referring also to FIGS. 13A-13C, there is shown an
illustrative and exemplary process for loading cartridge assembly
500 into automated insertion assembly 10. For example and in this
embodiment, when loading cartridge assembly 500 into automated
insertion assembly 10, the user may pivot cover assembly 502 of
automated insertion assembly 10 to expose slot 504 into which
cartridge assembly 500 may be placed (as shown in FIG. 13A).
Cartridge assembly 500 may include a toothed track 506 for
releasably engaging one of the above-described gear assemblies.
[0089] Once cover assembly 502 is pivoted, the user may align
cartridge 500 with slot 504 in automated insertion assembly 10 (as
shown in FIG. 13B) and insert cartridge 500 into automated
insertion assembly 10.
[0090] In this particular embodiment, insertion of cartridge
assembly 500 into slot 504 of automated insertion assembly 10 may
result in the "cocking" of the automated insertion assembly 10 to
prepare automated insertion assembly 10 to deliver cartridge
assembly 500. For example and as discussed above, automated
insertion assembly 10 may include first actuation assembly 16 (FIG.
2), which may include first actuator 30 (FIG. 2). As discussed
above, examples of first actuator 30 may include but are not
limited to a spring-based actuator (not shown), a motor-based
actuator (not shown), a pneumatic-based actuator (not shown), and a
shape memory wire-based actuator (not shown). Assuming that first
actuator 30 is a spring-based actuator, upon the user inserting
cartridge assembly 500 into slot 504 of automated insertion
assembly 10, first actuator 30 (i.e., a spring-based actuator in
this example) may be wound. Alternatively, other "cocking"
procedures may be employed, which may include but are not limited
to a "cocking" lever (not shown) that winds the above-described
spring-based actuator (e.g., first actuator 30).
[0091] Once cartridge assembly 500 is fully inserted into slot 504,
the user may reverse pivot cover assembly 502 (as shown in FIG.
13C).
[0092] As discussed above, when inserting e.g., first subdermal
device 14' into user's skin 18, first subdermal device 14' may be
inserted to a depth that is greater than the depth to which first
insertion needle assembly 28' (included within first dermal
perforation assembly 12') is inserted into user's skin 18.
[0093] For example and referring also to FIGS. 14A-14B, first
dermal perforation assembly 12' may be driven toward user's skin
18. Upon contact with user's skin 18, first insertion needle
assembly 28' (included within first dermal perforation assembly
12') may be inserted into user's skin 18. Additionally, first
dermal perforation assembly 12' (e.g., a glucose monitoring probe
in this example) may also be inserted into user's skin 18.
Additional downward force may be applied to first dermal
perforation assembly 12' and, for the reasons discussed above,
first dermal perforation assembly 12' (e.g., a glucose monitoring
probe in this example) may continue to be driven downward (i.e.,
into user's skin 18).
[0094] In this particular embodiment, base 550 of automated
insertion assembly 10 may include a recess configured to receive
first subdermal device 14', thus allowing first subdermal device
14' to be driven further downward into user's skin 18 to a level
that is deeper than that of first insertion needle assembly 28'.
Once first subdermal device 14' is positioned at the appropriate
depth, first dermal perforation assembly 12' may move upwardly to
extract first insertion needle assembly 28' from user's skin 18,
resulting in first subdermal device 14' disconnecting from first
dermal perforation assembly 12', thus allowing first dermal
perforation assembly 12' to remain within user's skin 18.
[0095] Referring also to FIG. 15A-15L, there is shown a series of
illustrations of another embodiment of automated insertion assembly
10 (i.e., automated insertion assembly 10'). In this particular
embodiment, automated insertion assembly 10' may includes actuator
platform 600 that is slidably seated upon one or more carriage
guides (e.g., carriage guide 602) that may be driven by e.g., first
actuator 30 included within actuation assembly 16. As discussed
above, examples of first actuator 30 may include but are not
limited to a spring-based actuator (not shown), a motor-based
actuator (not shown), a pneumatic-based actuator (not shown), and a
shape memory wire-based actuator (not shown).
[0096] First dermal perforation assembly 12', second dermal
perforation assembly 50' and/or cartridge assembly 500 (which was
described above as including first dermal perforation assembly 12',
and second dermal perforation assembly 50') may be releasably
attached to (e.g., clipped to) actuator platform 600 via one or
more clip regions/assemblies (not shown). One or more tabs (e.g.,
tabs 456, 458) may protrude through slots 452, 454 (FIG. 11) within
e.g., first dermal perforation assembly 12', second dermal
perforation assembly 50' and/or cartridge assembly 500. As actuator
platform 600 travels toward user's skin 18 (FIG. 2), the various
insertion needle assemblies may penetrate user's skin 18. When (for
the reasons discussed above), first dermal perforation assembly
12', second dermal perforation assembly 50' and/or cartridge
assembly 500 can no longer travel in a downward direction (i.e.,
toward user's skin 18), first subdermal device 14' and/or second
subdermal device 52' may continue to be driven downward (i.e., into
user's skin 18) until the desired depth is achieved (which e.g.,
may be greater than the depth of first insertion needle assembly
28' and/or second insertion needle assembly 54'). Once properly
inserted, actuator platform 600 may begin traveling upward,
extracting first dermal perforation assembly 12', second dermal
perforation assembly 50' and/or cartridge assembly 500.
[0097] As discussed above, automated insertion assembly 10 may
include one or more gear assemblies that may be configured to at
least partially couple the actuators (e.g., first actuator 30)
included within automated insertion assembly 10 to the dermal
perforation assemblies (e.g., first dermal perforation assembly 12)
included within automated insertion assembly 10.
[0098] Referring also to FIGS. 16-17, there is shown one embodiment
of the above-described gear assemblies coupled to one embodiment of
an actuator (e.g., first actuator 30). In this particular
embodiment, automated insertion assembly 10 is shown in the
above-described "cocked" position, as cartridge assembly 500 is
shown in a position that is indicative of being inserted within
automated insertion assembly 10. As discussed above, when in the
"cocked" position, the various insertion needle assemblies included
within cartridge assembly 500 are ready to be inserted into user's
skin 18. When inserting cartridge assembly 500 into automated
insertion assembly 10, toothed track 506 within cartridge assembly
500 may releasably engage the uppermost gear of drive gear set 650,
resulting in the uppermost gear rotating clockwise, raising
actuator 652, and winding torsion spring 654 (i.e., the actuator),
thus "cocking" automated insertion assembly 10 with sufficient
potential energy to insert the various insertion needle assemblies
and subdermal devices into user's skin 18.
[0099] Once "cocked", torsion spring 654 may also have enough
stored energy to remove the various insertion needle assemblies,
while leaving the subdermal devices within user's skin 18. After
full insertion of cartridge assembly 500 into automated insertion
assembly 10, the uppermost gear within drive gear set 650 may be
seated in a toothless groove and, therefore, may spin freely upon
actuation without moving cartridge assembly 500.
[0100] Prior to closing cover assembly 502 (FIGS. 13A-13C),
actuator 652 may be placed into a retracted position by rotating
retraction gears 656. The process of retracting actuator 652 may be
accomplished via e.g., cover assembly 502. Accordingly, when
closing cover assembly 502, retraction gears 656 may rotate in the
opposite direction, inserting e.g., tabs 456, 458 (FIGS. 11A-11B)
into slots 452, 454 (FIGS. 11A-11B). Safety catch 658 may be used
to prevent the untimely "firing" of cartridge assembly 500 into
user's skin 18.
[0101] To activate this particular embodiment of automated
insertion assembly 10, the upper portion of release lever 660 may
be pushed forward, causing release lever 660 to pivot about fulcrum
662 and disengage trigger catch 664 from a cooperatively shaped
recess in drive wheel 666. Torsion spring 654 may then cause drive
gear set 650 to rotate, turning drive wheel 666 and lowering
actuator 652. As actuator 652 is lowered, teeth 668 within actuator
652 will slide through the longitudinal grooves in retraction gear
656. The use of drive wheel 666 and the connecting rod assemblies
(e.g., connecting rod 670) may result in a sinusoidal insertion
velocity (with respect to the various insertion needle assemblies
included within sharps cartridge 500). Other insertion velocity
profiles may be created by e.g., replacing drive wheel 666 with a
cam assembly (not shown).
[0102] Referring also to FIG. 18, there is shown the
above-described gear assembly/actuator (i.e., of FIGS. 16-17) after
"firing", that is after insertion of insertion needle assemblies
28'. 54' into user's skin 18. Typically, drive wheel 666 is
configured so that after insertion of insertion needle assemblies
28' 54' (and the associated subdermal devices), drive wheel 666 has
sufficient momentum to continue to rotate, thus extracting
insertion needle assemblies 28' 54' from user's skin 18. Depending
upon the design of drive wheel 666 and the connecting rod(s), the
kinetic profile of insertion and withdrawal may approximate a
sine-wave, i.e., starting slowly, accelerating and then slowing
down again.
[0103] If retraction gear shaft 672 is coupled to cover assembly
502, the opening of cover assembly 502 may actuate the retraction
by disengaging tabs 456, 458 (FIGS. 11A-11B) from slots 452, 454
(FIGS. 11A-11B), thus allowing removal of cartridge assembly 500
from automated insertion assembly 10. Automated insertion assembly
10 may then be ready for reuse with a replacement sharps cartridge.
One or more spring assemblies may cause cartridge assembly 500 to
pop up out of slot 504 to simplify removal.
[0104] In one embodiment of automated insertion assembly 10, drive
wheel 666 may not rotate a full 360.degree., but a lesser amount,
e.g., 330.degree.. In this particular embodiment, actuator 652 may
"top-out" prior to the complete 360.degree. rotation of drive wheel
666, thus resulting in e.g., cartridge assembly 500 being partially
pushed out of slot 504 (thus facilitating easy removal from
automated insertion assembly 10).
[0105] A number of implementations have been described.
Nevertheless, it will be understood that various modifications may
be made. Accordingly, other implementations are within the scope of
the following claims.
* * * * *