U.S. patent application number 15/097470 was filed with the patent office on 2016-08-11 for disposable inserter for use with a medical device.
The applicant listed for this patent is Roche Diagnostics International AG. Invention is credited to Ofer Arnold, Illai J. Gescheit, Avraham Neta.
Application Number | 20160228635 15/097470 |
Document ID | / |
Family ID | 48741037 |
Filed Date | 2016-08-11 |
United States Patent
Application |
20160228635 |
Kind Code |
A1 |
Arnold; Ofer ; et
al. |
August 11, 2016 |
DISPOSABLE INSERTER FOR USE WITH A MEDICAL DEVICE
Abstract
An inserter and methods of using embodiments of the inserter are
described. The inserter includes a housing having a cannula
assembly and an insertion mechanism. Two buttons are located on the
inserter and are concomitantly actionable for actuation of the
insertion mechanism, wherein the insertion mechanism is configured
to place a cannula assembly in a well that is disposed on the
cradle. The inserter also includes a first parts and second part,
whereby the first part includes a handle and the second part
comprises the entire insertion mechanism, whereby the first and
second part are connected via an indentation.
Inventors: |
Arnold; Ofer; (Ha'movil,
IL) ; Gescheit; Illai J.; (Tel Aviv, IL) ;
Neta; Avraham; (Gilon, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Roche Diagnostics International AG |
Rotkreuz |
|
CH |
|
|
Family ID: |
48741037 |
Appl. No.: |
15/097470 |
Filed: |
April 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14562881 |
Dec 8, 2014 |
9333296 |
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15097470 |
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PCT/EP2013/001685 |
Jun 8, 2013 |
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14562881 |
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61657771 |
Jun 9, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/1416 20130101;
A61M 5/5086 20130101; A61M 2005/1585 20130101; A61M 2005/1588
20130101; A61M 5/14244 20130101; A61M 5/158 20130101; A61M 5/1415
20130101; A61M 2005/1586 20130101 |
International
Class: |
A61M 5/158 20060101
A61M005/158; A61M 5/142 20060101 A61M005/142; A61M 5/50 20060101
A61M005/50; A61M 5/14 20060101 A61M005/14 |
Claims
1. A disposable inserter configured to be received by a skin
adherable cradle for supporting an insulin pump, the disposable
inserter comprising: a cannula assembly; an insertion mechanism
configured to place the cannula assembly in a well disposed on the
skin adherable cradle; and an inserter base having a first part and
second part, whereby the first part includes a handle and the
second part comprises the insertion mechanism, whereby the first
and second part are connected via an indentation, and the first
part and second part fold about the indentation when the handle is
pulled to release the inserter base from the skin adherable
cradle.
2. The disposable inserter of claim 1, comprising a protective ring
which is put on a cylindrical portion of the insertion
mechanism.
3. The disposable inserter of claim 1, comprising feedback elements
indicating the status of the insertion mechanism whereby a visible
green protective ring indicates the insertion mechanism is unused
and a visible red slider or parts of it indicate the insertion
mechanism is used.
4. The disposable inserter of claim 1, wherein the handle protrudes
from the first part.
5. The disposable inserter of claim 1, wherein ends of inserter
base are configured to engage snaps of the cradle.
6. The disposable inserter of claim 1, wherein the inserter base
has four points of contact by which to engage the skin adherable
cradle.
7. The disposable inserter of claim 1, wherein the indentation is
geometrically designed to allow the inserter to release from the
cradle only when the handle is pulled away from the cradle to both
deflect upwards and fold the first and second parts of the inserter
base.
8. The disposable inserter of claim 1, wherein the indentation is
geometrically designed to allow the inserter to release from the
cradle only when the handle is pulled away from the cradle to both
deflect upwards and fold the first and second parts of the inserter
base which releases both ends of the inserter base from snaps of
the cradle.
9. The disposable inserter of claim 1, wherein a septum of the
cannula assembly is configured to be placed parallel to an upper
plane of the well when the cannula assembly is placed in the well
by the insertion mechanism.
10. The disposable inserter of claim 1, wherein the insertion
mechanism comprises insertion and retraction springs.
11. The disposable inserter of claim 10, comprising a housing that
comprises the cannula assembly and a protective ring which is put
on a cylindrical portion of the insertion mechanism, wherein the
springs are maintained in the housing by two latches aligned with
holes disposed in the housing, and the protective ring configured
to cover the entire surface area of the two buttons.
12. The disposable inserter of claim 10, comprising a housing that
comprises the cannula assembly and two buttons designed as torsion
snap fit, whereby a torsion bar is a part of the housing, wherein
upon actuation of the two buttons the buttons are tilted and the
insertion spring is allowed to expand and to push the insertion
mechanism downwards to insert the cannula into the skin and the
cannula assembly into the cradle well.
13. The disposable inserter of claim 10, wherein the springs are
preloaded.
14. A method of disconnecting from a skin adherable cradle, which
is adapted to receive a micropump and fluidly connect the micropump
to a cannula, an inserter that comprises an inserter base that has
a first part and second part, whereby the first part includes a
handle and the second part comprises an insertion mechanism that
places a cannula assembly that comprises the cannula in a well of
the skin adherable cradle, whereby the first and second part are
connected via an indentation, and the first part and second part
fold about the indentation when the handle is pulled to release the
inserter base from the skin adherable cradle, said method
comprising: pulling the handle and causing the first part and
second part to fold about the indentation which releases the
inserter base from the skin adherable cradle.
15. The method of claim 14, further comprising indicating status of
the insertion mechanism via feedback elements of the inserter.
16. The method of claim 14, wherein disconnecting the inserter from
the cradle is via pulling the handle away from the cradle to both
deflect upwards and fold the first and second parts of the inserter
base, thereby releasing ends of the inserter base from snaps of the
cradle.
17. The method of claim 14, wherein the pulling of the handling
occurs after triggering the insertion mechanism to place the
cannula assembly in the well.
18. The method of claim 17, wherein after triggering of the
insertion mechanism to place the cannula assembly in the well, said
method further comprises automatically retracting a needle assembly
of the insertion mechanism into a cylindrical portion of the
inserter.
19. The method of claim 17, wherein the triggering of the insertion
mechanism occurs by removing a protective ring that prevents the
unintentional pressing of buttons on the inserter, the buttons
being configured to trigger the insertion mechanism, and by
pressing concomitantly the buttons.
20. The method of claim 19, wherein the triggering of the buttons
tilts the buttons which causes an insertion spring to expand and
push the insertion mechanism downwards to place the cannula
assembly into the well.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 14/562,881, filed on Dec. 8, 2014,
which is a continuation application of PCT patent application no.
PCT/EP2013/001685, which has an international filing date of Jun.
8, 2013 and claims priority to U.S. Provisional Patent Application
No. 61/657771, filed on Jun. 9, 2012. The present application
incorporates herein by reference the disclosure of each of the
above-referenced applications in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to inserters, and more
particularly to systems and methods for use with a medical
device.
BACKGROUND
[0003] Medical treatment of several illnesses/conditions requires
drug infusion into various body compartments, for example, through
subcutaneous and/or intra-venous injections. Patients suffering
from Diabetes Mellitus (DM), for example, require the
administration of varying amounts of therapeutic fluid, e.g.,
insulin, throughout the day to control their blood glucose levels.
In recent years, ambulatory portable insulin infusion pumps have
emerged as an alternative to multiple daily syringe injections of
insulin for Type 1 diabetes patients (see, for example, Diabetes
Medicine 2006; 23(2) 141-7) and subsequently for Type 2 diabetes
patients (see, for example, Diabetes Metab 2007 Apr. 30 and
Diabetes Obes Metab 2007 Jun. 26). Such pumps, which deliver
insulin at a continuous and/or periodic basal rate as well as in
bolus volumes, were developed to liberate patients from having to
perform repeated self-administered injections, and to enable them
to maintain a near-normal daily routine. Both basal and bolus
volumes/doses have to be delivered in substantially precise doses,
according to individual prescription, because an overdose or under
dose of insulin could prove fatal.
SUMMARY
[0004] According to at least one embodiment of the present
disclosure, a disposable inserter and method of use are disclosed.
The disposable inserter in at least one embodiment is configured to
be received by a skin adherable cradle for supporting an insulin
pump. The exemplary disposable inserter comprises a housing
comprising a cannula assembly and an insertion mechanism, two
buttons concomitantly actionable for actuation of the insertion
mechanism, wherein the insertion mechanism is configured to place a
cannula assembly in a well disposed on the cradle; and a first part
and second part, whereby the first part includes a handle and the
second part comprises the entire insertion mechanism, whereby the
first and second part are connected via an indentation.
[0005] In at least one embodiment of the inserter, the insertion
mechanism comprises insertion and retraction springs, the springs
being maintained in the housing by two latches aligned with holes
disposed in the housing.
[0006] In at least one embodiment of the inserter, the inserter
further comprises a protective ring which is put on the cylindrical
portion of the inserter, the protective ring configured to cover
the entire surface area of the two buttons. The two buttons, in at
least one embodiment, are designed as torsion snap fit, whereby the
torsion bar is a part of the housing. Upon actuation of the two
buttons, in at least one embodiment, the buttons are tilted and the
insertion spring is allowed to expand and pushes the entire
mechanism assembly downwards to insert the cannula into the skin
and the cannula assembly into the cradle well.
[0007] In at least one embodiment of the inserter, the springs are
preloaded.
[0008] In at least one embodiment of the inserter, the inserter
comprises feedback elements indicating the status of the inserter
whereby a visible green protective ring indicates the inserter is
unused and a visible red slider or parts of it indicate the
inserter is used.
[0009] In at least one embodiment of the present disclosure, a
method of inserting a cannula into a body is disclosed. The method,
in at least one embodiment, comprises: placing an inserter base of
an inserter on a skin adherable cradle adapted to receive a
micropump, the inserter comprising a cannula assembly comprising a
cannula; removing a protective ring preventing unintentional
pressing of buttons on the inserter, the buttons configured to
trigger an insertion mechanism; triggering the insertion mechanism
by pressing concomitantly the buttons, the buttons being located on
the two sides of the cylindrical portion of the inserter, the
insertion mechanism inserting the cannula assembly into a well
located in the cradle and further inserting the cannula of the
cannula assembly into the body; and disconnecting the inserter from
the cradle after insertion of the cannula
[0010] In at least one embodiment of the method, the method further
comprises connecting a pump to the cradle, the connecting step
comprising pricking a septum of the cannula assembly with a
connecting lumen provided with the micropump.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the present
disclosure may be carried out in a variety of other ways, including
those not necessarily depicted in the drawings. The accompanying
drawings incorporated in and forming a part of the specification
illustrate several aspects of embodiments of the present
disclosure, and together with the description serve to explain the
principles of the present disclosure; it being understood, however,
that this invention is not limited to the precise arrangements
shown.
[0012] FIG. 1a illustrates the placing of the inserter and cradle
on the user's skin in a chosen insertion site (e.g., lower abdomen,
lower back, thigh or upper arm), according to at least one
embodiment of the present disclosure.
[0013] FIG. 1b illustrates the removal of a protective ring before
insertion, according to at least one embodiment of the present
disclosure.
[0014] FIG. 1c illustrates the initiation of the insertion of a
cannula via pressing on two buttons, according to at least one
embodiment of the present disclosure.
[0015] FIG. 1d illustrates the disconnection of the inserter from
the cradle after cannula insertion, according to at least one
embodiment of the present disclosure.
[0016] FIG. 1e illustrates disposal of the inserter after cannula
insertion is completed, according to at least one embodiment of the
present disclosure.
[0017] FIG. 2 illustrates an exploded view of the inserter,
according to at least one embodiment of the present disclosure.
[0018] FIG. 3a illustrates a perspective view of the mechanism
assembly, according to at least one embodiment of the present
disclosure.
[0019] FIG. 3b illustrates an exploded view of the mechanism
assembly, according to at least one embodiment of the present
disclosure.
[0020] FIGS. 4a and 4b illustrate perspective views of a slider
part, including its various features/elements, according to at
least one embodiment of the present disclosure.
[0021] FIG. 5a illustrate a cross section view of the inserter in a
loaded position (e.g., upon initiation of insertion), according to
at least one embodiment of the present disclosure.
[0022] FIG. 5b illustrates an enlarged view of the pressing of the
buttons and showing the support and release of the slider,
according to at least one embodiment of the present disclosure.
[0023] FIG. 5c illustrates the inserter when the cannula is
inserted and the slider latches are fixed/engaged in the housing
holes/grooves, according to at least one embodiment of the present
disclosure.
[0024] FIG. 5d illustrates the retraction of the needle assembly,
while the slider is fixed/in place, according to at least one
embodiment of the present disclosure.
DETAILED DESCRIPTION
[0025] Usage of an infusion device (e.g., insulin pump, insulin
micropump) may require the adherence of a cradle to the user's skin
and the insertion of a cannula into the body. The insertion of the
cannula is performed by inserting a cannula assembly into a well
which is located in the cradle. The cradle can be adhered to the
skin via an adhesive layer which is attached to the bottom surface
of the cradle. In order to insert the cannula assembly to the skin
and to snap it into the well, an insertion device may be required.
FIGS. 1a-1e illustrates exemplary steps (e.g., five steps) of
insertion that a pump user may perform in order to prepare the
infusion system for pump connection, and drug (e.g., insulin)
delivery.
[0026] FIG. 1a illustrates a step in which the disposable inserter
300 is placed at the user's skin, when the protective ring 390,
which prevents unintentional pressing of the buttons (not shown)
and undesirable insertion of the cannula, is still placed on the
inserter, as safety means. The adherence of the inserter is done,
while the cradle 20 is firmly fixed to the inserter 300. The user
holds the entire assembly, that is, the disposable inserter and
cradle by the handle 302, protruding from the cradle. The inserter
is pre-loaded, therefore the user does not have to load the cannula
or to insert a cannula into the inserter 300.
[0027] FIG. 1b shows the stage of preparing the inserter for
insertion stage. This stage can be performed either when the
inserter is already adhered to the user skin or prior to adherence.
However, placing the device with the protective ring 390 is
recommended to avoid insertion due to an unintentional press. The
figure shows the user pulling the protective ring 390 upwards
sliding it from the cylindrical portion of the disposable inserter
300.
[0028] FIG. 1c shows the user pressing both buttons 304 located on
the two sides of the cylindrical portion of the inserter 300. The
buttons in additional embodiments can be located at any part of the
inserter 300, or cradle. Pressing both buttons, initiates the
insertion of the cannula into the skin. The user must press both
buttons concomitantly, in order to perform insertion. This is a
safety means, to avoid unintentional insertion, in case only one
button 304 is pressed. The cradle 20 and the inserter fixed to it
300, are adhered to the skin when the user presses the buttons
304.
[0029] FIG. 1d shows the user releasing the disposable inserter
300, after insertion has been performed. The cannula assembly 330
was inserted into the well 22 protruding from the cradle 20. At
this stage the cannula 332 made out of Teflon.RTM., or any other
bio-compatible material, is located within the skin, and the septum
334 is parallel to the upper plane of the well, allowing the
connection of the micropump (not shown), and the receiving of a
connecting lumen to deliver insulin from the pump into the skin via
the cannula 332. The user releases the inserter from the cradle, by
pulling the handle 302, upwards. A geometrical indentation 306, is
designed to allow the inserter release only when the user pull the
inserter up, by having a deflection upwards, folding the two parts
of the inserter base 308, to release both ends of the inserter base
308 from the snaps of the cradle 309 and 309'. At this point, the
entire insertion mechanism resides in the cylindrical portion of
the inserter 300.
[0030] FIG. 1e shows that the user disposes the inserter, which was
released in FIG. 1d into a special can for needle and inserters.
The disposable inserter, when disposed has no loaded mechanisms
within, there for the risk of needle pricking after insertion is
reduced. Disposing the inserter, and using a new inserter, and the
fact that the inserter is pre-loaded, allows the user not to deal
with loading needle, and cannulas. This is a major advantage as far
as risk of needle pricking.
[0031] FIG. 2 shows an exploded view of the disposable insertion
system, that is the disposable inserter 300 and the cradle 20. The
figure shows the assembly of the different parts and subassemblies
of the device. The inserter base 311 is located between the
peripherals of the cradle 20. It is fixed at least 4 points of
contact in order to allow a robust connection. The mechanism
assembly 3000 which includes the needle assembly, retraction
spring, and cannula assembly is assembled together and is put
through the inner diameter of the cylindrical portion of the
inserter 300. In order to allow the mechanism to function properly
as will be explained further the two red slider latches 332 and
332' (not shown) are aligned with the housing holes 308 and
308'(not shown). They will allow the positioning of the red slider
330 after insertion and neutralize the insertion spring, and
release the retraction spring, so that the insertion needle
retraction will take place. The insertion spring 320 is placed on
the upper protrusions of the red slider 338 and on the other end it
is connected to the cork 370. After the inserter is closed by the
cork 370, with all the components of the mechanism within, the
protective ring 390 is put on the cylindrical portion of the
inserter 300, so that it covers the entire surface area of the
pressing buttons.
[0032] FIG. 3a shows the mechanism assembly 3000 after assembly.
The needle insertion 336 goes through the cannula 322 and picks
outside, so that insertion will be flawless. The entire cannula
assembly 3300 is in contact with the red slider 330. The cannula
cover and septum, which define the upper plane of the cannula
assembly 3300 are tangent to the lower plane of the red slider 330.
The cannula assembly 330 is held on the insertion needle 336 due to
friction forces. During assembly, and when resides in the housing
prior to insertion, the two red slider latches must be pushed
inwards, as shown by the arrows in the figure , in order to hold
the needle assembly (not shown) and the retraction spring (not
shown) which are in a loaded position within the red slider
330.
[0033] FIG. 3b shows an exploded view of the mechanism assembly
3000. The mechanism assembly includes the cannula assembly 3300,
needle assembly 338 and retraction spring. The needle assembly
composing the needle hub 337 and the insertion needle 336 is
sliding through the red slider 330, while the retraction spring
340, is concentric to the needle assembly 338 symmetric axis. When
assembled, the red slider latches must be in an opened position to
allow the needle hub 337 to go through the inner diameter of the
red slider until the red slider latches 332 and 332' can hold the
insertion assembly 338 in the indent diameter 337' of the needle
hub 337. In this position the retraction spring 340 is connected on
one end to the bottom surface of the red slider 330 and to the
bottom surface of the needle hub 337, and it is in a loaded
position wanting to expand and retract the needle.
[0034] FIG. 4a shows the red slider part 330 with its features. The
red slider latches 332 and 332' are the ones which are holding the
needle assembly 338 and the insertion spring 340 loaded during the
insertion. This is done by a force exerted inwards. The red slider
latches retract and deflected outwards when they arrive to the
height where the housing holes (not shown) are located. This fixes
the red slider 330 in place and holding the insertion spring in a
free state. And allows the retraction spring 340 to retract and
pull the needle assembly 338 from the user's skin. The deflection
of the red slider latches 332 and 332' is allowed due to the
through hole 339 of the red slider 330. The bulges 333 and 333' are
aiding the grip of the red slider latches in the housing holes when
insertion ended and cannula assembly is in the well. The
protrusions of the red slider 383, are supports for the insertion
spring 320. The indent 331 is to allow the press buttons 304 to be
deflected with no interference.
[0035] FIG. 4b shows the inner volume of the red slider 330. The
insertion needle 336 can go through the red slider through a hole
342 and then the cannula assembly 3300 can be connected. Indent 341
is a dedicated support for the retraction needle 340 in the red
slider 330 while in a loaded state.
[0036] FIG. 5a shows a cross section view of the inserter 300 in a
loaded position. This state is prior to insertion initiation. The
user presses both buttons 304 and 304' in order to insert the
cannula into the skin. Exerting force on the buttons, will tilt the
buttons. The buttons 304 and 304' are designed as torsion snap fit,
which its torsion bar is a part of the housing 380. Before the user
press the buttons, the mechanism assembly and the red slider 300 in
particular rests on the two protrusion snaps 3041 as shown in FIG.
5b. When the user exert force, the buttons tilt and allow the
insertion spring 320 to expand and to push the entire mechanism
assembly downwards to insert the cannula into the skin and the snap
the cannula assembly 3300 into the cradle well 22. In order to
prevent interference of the buttons with the mechanism, more
specifically, to contact the insertion spring 320, a protective
wall 371 was design in the cork 370 to limit the motion and
deflection of the buttons 304 and 304'.
[0037] FIG. 5c shows the inserter 300, in the insertion phase. The
cannula assembly 3300 is inserted into the cradle well 20. The
buttons 304 and 304' were pressed and the red slider 330 moved
downwards due to the insertion spring 430 which pushed the
mechanism assembly down. The red slider latches 332 and 332' are
fixed in the housing holes 308 and 308' using the bulges 333 and
333' we described in FIG. 4a. In this state, both the cannula 322
and the insertion needle 336 are inserted to the skin. The design
determines that in this state the insertion spring is in its free
state and it is neutralized both by the red slider latches 332 and
332' fixed in the housing holes 308 and 308, and due to the design
of spring selection.
[0038] FIG. 5c shows the retraction phase. The cannula 322 is
inserted and the cannula assembly 3300 is fixed in the cradle well
22. However the needle assembly 338 is retracted automatically. The
fixation of the two red slider latches 332 and 332' in the housing
holes 308 and 308' due to their aspiration to return to their
initial state and shape in which they were manufactured, releases
the grip the two red slider latches 332 and 332' held to the needle
hub 337. Therefore, the retraction spring 340 expands and pushes
the needle assembly 338 upwards, retracting the needle from the
user's skin and cannula volume 22. The design will take a safety
factor to the retraction displacement to make sure that a full
retraction was operated. In this state both the retraction spring
340 and insertion spring 320 are in a free state. After this
operating step of retraction, the user can disconnect the inserter
300 from the cradle 20 and continue according to FIG. 1d-1e, as
depicted.
[0039] There is disclosed a disposable inserter adapted to be
received by a skin adherable cradle for supporting an insulin pump,
the disposable inserter comprising: a housing comprising a cannula
assembly and an insertion mechanism; two buttons concomitantly
actionable for actuation of the insertion mechanism, wherein the
insertion mechanism is adapted to place a cannula assembly in a
well disposed on the cradle.
[0040] In at least one embodiment, the insertion mechanism
comprises insertion and retraction springs, the springs being
maintained in the housing by two latches aligned with holes
disposed in the housing.
[0041] In at least one embodiment, the disposable inserter further
comprises a protective ring 390 which is put on the cylindrical
portion of the inserter 300, so that to cover the entire surface
area of the two buttons.
[0042] In at least one embodiment, the buttons are designed as
torsion snap fit, whereby the torsion bar is a part of the
housing.
[0043] In at least one embodiment, upon actuation of the buttons
the buttons are tilted and the insertion spring 320 is allowed to
expand and to push the entire mechanism assembly downwards to
insert the cannula into the skin and the cannula assembly 3300 into
the cradle well 22.
[0044] In at least one embodiment, the springs are preloaded.
[0045] In at least one embodiment, the disposable inserter
comprises two parts whereby the first part includes a handle and
the second part comprising the entire insertion mechanism whereby
the first and the second part are connected via an indentation
[0046] In at least one embodiment, the disposable inserter
comprises feedback elements indicating the status of the inserter
whereby a visible green protective ring indicates the inserter is
unused and a visible red slider or parts of it indicate the
inserter is used.
[0047] There is disclosed a method of inserting a cannula into a
body, comprising the steps of: placing an inserter base 308 of an
inserter 300 on a skin adherable cradle adapted to receive a
micropump, the inserter comprising a cannula assembly comprising a
cannula ; removing a protective ring 390 preventing unintentional
pressing of buttons triggering a insertion mechanism ; triggering
the insertion mechanism by pressing concomitantly two buttons 304
and 304', the buttons being preferably located on the two sides of
the cylindrical portion of the inserter 300, the insertion
mechanism inserting the cannula assembly into a well located in the
cradle and further inserting the cannula of the cannula assembly
into the body ; disconnecting the inserter 300 from the cradle 20
after insertion of the cannula (by pulling upwards a handle
302).
[0048] In at least one embodiment, the method further comprises the
step of connecting a pump to the cradle, the connection pricking a
septum 334 of the cannula assembly with a connecting lumen 102
provided with the micropump.
[0049] There is disclosed an inserter comprising two parts whereby
the first part includes a handle and the second part comprising the
entire insertion mechanism whereby the first and the second part
are connected via an indentation
[0050] There is disclosed an inserter comprising feedback elements
indicating the status of the inserter whereby a visible green
protective ring indicates the inserter is unused and a visible red
slider or parts of it indicate the inserter is used. [0051] 336
Insertion needle [0052] 337 Needle hub [0053] 338 Needle assembly
[0054] 330 Red slider [0055] 311 inserter base [0056] 3000
Mechanism assembly [0057] 370 Cork [0058] 332 and 332' Red slider
latches [0059] 308 and 308' Housing holes [0060] 383 Protrusions of
red slider [0061] 304 Pressing buttons [0062] 322 Cannula [0063]
3300 Cannula assembly [0064] 337' Indent diameter of needle hub
[0065] 340 Retraction spring
* * * * *