Note: Descriptions are shown in the official language in which they were submitted.
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INSERTER DEVICE WITH CONTROLLED ACCELERATION
Technical field of the invention
The invention concerns an inserter device for inserting a medical device into
the
subcutaneous or intramuscular area of a patient. More specifically, this
invention relates to an inserter device comprising means for providing a con-
trolled and defined acceleration and deceleration of a penetrating member.
Background of the invention
Inserter devices, also called injectors, are commonly used in the medical
field
for inserting medical devices such as infusion sets and the like, in a semi-
automated fashion through the skin of a patient.
It is known that most patients, especially children, are afraid of sharp
objects,
such as injection needles and other penetrating devices, commonly used for
medical treatment and therapy. This fear is often irrational, and it may
hamper
an appropriate medical treatment.
A further issue related to insertion of medical devices is the risk of contami-
nation of the penetrating member before or during application. This can easily
lead to the introduction of an infection to a patient, e.g. through a
contaminated
insertion needle. The longer such a needle is exposed, the higher the risk of
accidental contamination, e.g. by touching the needle with a finger, bringing
the
needle in contact with an unclean surface, or by airborne contamination,
aerosol
contamination and the like. Depending on the nature of the contamination (e.g.
comprising virus, bacteria, fungus, yeast and/or prion) combined with the
general health status of the patient, the resulting infection can rapidly turn
into a
life threatening situation.
It is well known that contact with an infected, used needle especially in
hospital
environments can be life-threatening, and the risk of accidental exposure to
contaminated material must be minimized.
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Inserter devices and the like are known in the art. EP 1 011 785 relates to an
injector for a subcutaneous infusion set, EP 1 044 028 concerns an inserter
device for an insertion set.
Commonly, insertion of e.g. a cannula or injection needle provides discomfort
and pain. An objective of the present invention is to reduce discomfort and
pain
to a minimum.
Penetration of the skin with a medical device results in tissue damage. It is
an
object of the invention to reduce tissue damage.
Medical devices can be sensitive; it is thus an object of the invention to
provide
an inserter device that protects sensitive medical devices before and during
insertion into a patient.
Known devices do not provide a defined and controlled insertion and retraction
speed, combined with defined and controlled acceleration and deceleration of
the penetrating member to be inserted into a patient.
As none of the known devices solve the problems and issues listed above,
there is an obvious need in the art for an insertion device, which addresses
the
issues discussed above, and which provides a controlled insertion of a
penetrating member through defined acceleration and deceleration.
Summary of the invention
The current invention provides an insertion device, where a controlled accel-
eration and deceleration of a penetrating member is provided. In the present
application a penetrating member is defined as a part that passes through or
penetrates the skin surface of a patient, i.e. the penetrating member can be
an
insertion needle combined with a soft cannula, a hard self-penetrating
cannula,
a self-penetrating sensor or a sensor combined with an insertion needle.
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A first aspect of the invention concerns an inserter device, where a
rotational
movement is transformed into a longitudinal insertion movement, wherein the
axis of said rotational movement and the axis of said longitudinal insertion
movement are essentially parallel and/or aligned with each other.
A second aspect of the invention relates to an inserter device, where a rota-
tional movement is transformed into a longitudinal insertion movement, wherein
the axis of said rotational movement and the axis of said longitudinal
insertion
movement are essentially perpendicular to each other.
Thus, the present invention provides an inserter device as defined by claim 1.
This inserter device comprises a housing encompassing a penetration member,
and the inserter device comprises means for providing a defined acceleration
and deceleration of said penetration member. The defined acceleration and
deceleration is achieved as a result of applying an essentially constant force
and not by varying the applied force.
According to one embodiment the inserter device comprises a housing en-
compassing said penetrating member, a rotating member and driving means for
rotating the rotating member around a rotating axis, the rotating member
comprises transformation means which means transforms the rotational
movement into a longitudinal movement of the penetrating member in the
direction of insertion wherein the transformation means comprises controlling
means providing a controlled variation of the velocity of the penetrating
member
in the direction of insertion.
According to one embodiment the rotating member's rotation axis is parallel to
the direction of insertion of the penetrating member. In one case the rotating
member's rotation axis is aligned with the axis of insertion of the
penetrating
member.
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According to one embodiment the transformation means comprises a groove on
a surface of a body part of the rotating member corresponding to a protruding
part connected to the penetrating member. According to this embodiment the
controlling means can comprise the slope of the groove as the groove extent in
a direction which is not parallel to the direction of insertion, The
transformation
could comprise any corresponding parts on respectively the rotating member
and the penetrating member which corresponding parts can provide a slidable
fit.). The groove can be continuous and the slope of the groove can be defined
in a system of coordinates having an ordinate axis parallel to the rotation
axis of
the rotation member. At least a part of the groove can have a negative slope
or
a constant negative slope in the whole length of the groove when providing a
movement where the longitudinal moving member is moving towards the skin of
the patient. The negative slope of the groove can be decreasing as the
longitudinal moving member moves toward the skin of the patient. The groove
can be continuous and at least a part of the groove can have a positive slope
or
the groove can have a constant positive slope in the whole length of the
groove
in a system of coordinates having an ordinate axis parallel to the rotation
axis of
the rotation member, when providing a movement where the longitudinal
moving member is moving away from the skin of the patient. The positive slope
of the groove can be decreasing as the longitudinal moving member moves
away from the skin of the patient.
According to one embodiment the body part of the rotating member is
cylindrical
and the groove is formed in the outer surface of the body part, means
corresponding to the groove are formed as at least one inward protruding part
on an inner surface of the longitudinal moving member.
According to one embodiment the rotating member's rotation axis is not
parallel
to the direction of insertion of the penetrating member, e.g. the rotating
member's rotation axis can be orthogonal to the direction of insertion of the
penetrating member. If the angle of the rotation axis deviates a few degrees
from orthogonal it will still be considered "orthogonal" according to this
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invention. Also the rotating member can be a shaft, which shaft can be
provided
with one or more discs protruding in relation to the shaft.
Such a shaft can be a crank shaft provided with two discs that are attached
5 orthogonally and concentrically onto said crank shaft, so that crank shaft
and
discs share the same rotation axis.
According to one embodiment the direction of insertion of the penetrating
member is either essentially perpendicular to the patient's skin surface, i.e.
insertion is provided at an insertion angle ains around 900 where the surface
of
the patients skin is considered to constitute the base line of 0 , or 0 <
ains <_ 20 ,
or 20 < ains <_ 40 , or 40 < ains <_ 60 , or 60 < ains <_ 80 .
According to one embodiment the central axis of the inserter device is es-
sentially perpendicular to the patient's skin surface when the inserter device
is
placed in a position ready for insertion, i.e. the inserter device has a
central axis
angle a,entre around 90 where the surface of the patients skin is considered
to
constitute the base line of 0 , or 00 < acentre ~ 20 , or 20 < acentre ~ 40 ,
or 40 <
acentre ~ 60 , or 60 < acentre ~ 80 =
According to one embodiment the direction of insertion of the penetrating
member is parallel to the central axis of the inserter device, i.e. has a
deflection
angle adef,ecti n = 0 from the central axis, or 0 < adeflection < 90 , or 10
< adeflection
< 80 , or 30 < adeflection < 60 =
According to one embodiment the transformation means transform a rotation of
the rotating member of more than approximately 180 , where approximately
means 10 , into a longitudinal movement, said longitudinal movement
providing an insertion of the penetrating member. Especially the
transformation
means can transform a rotation of more than 360 , or more than 1.5
revolutions,
or more than 2 revolutions, of the rotating member into a longitudinal
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movement, said longitudinal movement providing an insertion of said
penetrating member.
According to one embodiment the penetrating member comprises a soft can-
nula and an introducer needle. E.g. the introducer needle can be part of the
inserter device, and the introducer needle can then be removed from a medical
device comprising a soft cannula after insertion of the penetrating member.
According to this embodiment continued rotation of the rotating member in the
same direction of rotation can provide insertion of the penetrating member
followed by retraction of the introducer needle or rotation of the rotating
member
in the opposite direction of rotation after insertion of the penetrating
member
can provide retraction of the introducer needle.
E.g. a rotation of the rotating member of approximately 180 , where approxi-
mately means 10 , can provide retraction of said introducer needle or a ro-
tation of the rotating member of less than 180 , or less than 150 , or less
than
120 , or less than 90 , or less than 60 , or less than 30 provides retraction
of
the introducer needle.
Brief description of the drawings
A detailed description of embodiments of the current invention will be made
with
reference to the accompanying figures, wherein like numerals may designate
corresponding parts in different figures.
Figure 1: A medical device comprising a penetrating member, a body part and
a mounting pad.
Figure 2: Embodiment of an inserter device and its main components.
Figure 3: Alternative embodiment of an inserter device and its main compo-
nents.
Figure 4: An embodiment of an inserter device with activation means, including
close-up of top section.
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Figure 5: Embodiment of a rotating member and a piston with introducer
needle.
Figure 6: Alternative embodiments of rotating means.
Figure 7: Detailed view of an embodiment of a piston with transformation
means (protrusion).
Figure 8: Cross section of an embodiment of an inserter device with medical
device before insertion.
Figure 9: Cross sections of an embodiment of an inserter device with medical
device at positions before insertion (A), inserted (B) and retracted (C).
Figure 10: Different views of embodiments of an inserter device and a medical
device.
Figure 11: Alternative embodiments of transformation means comprising spiral
spring, rotating means and piston.
Figure 12: Embodiment of an inserter device with activation means.
Figure 13: Illustration of the mode of action of an embodiment of an inserter
device with transformation means.
Figure 14: Schematic representation of embodiments of inserter devices with
external activation means.
Figure 15: Two principles of providing controlled variations of insertion
speed
and acceleration/deceleration as a function of angular velocity.
Figure 16: Semi-transparent view of an embodiment of an insertion device with
cran kshaft
Figure 17: An embodiment of an insertion device with crankshaft with partial
cross section through the lower section including medical device with pene-
trating member.
Figure 18: An embodiment of an insertion device with crankshaft with partial
cross section through the top section.
Figure 19: Illustration of the mode of action of an insertion device with
crank-
shaft.
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Detailed description of the invention
According to the invention, different medical devices can be inserted into the
subcutaneous or intramuscular region of a patient. Such medical devices may
comprise e.g. infusion sets or the infusion part of an infusion set, sensor
devices comprising one or more inserted sensors, port devices which only
comprise a body with a restricted access for replacing repeated injections
with
syringes, or any other device having a penetrating member inserted into the
subcutaneous area or intramuscular area of a patient.
It is one of the objects of the present invention to provide an inserter
device that
allows for a controlled, defined and adjustable insertion of a medical device
into
a patient. Such a controlled, defined and adjustable insertion can be achieved
by controlling the speed of insertion, and optionally, also the speed of
retraction
of parts of the inserter device, such as insertion needles commonly used to
insert a medical device with for example a soft cannula, which cannot be
inserted directly. However, the inventors not only provide an inserter device
with
a controlled speed of insertion, but a novel and inventive inserter device,
where
speed as well as acceleration and deceleration of insertion can be controlled.
Thereby, significantly improved reliability, ease of operation, and user
friendliness are provided due to controlled insertion characteristics and
features.
Figure 1 shows different embodiments of a medical device 100 that can be
inserted according to the invention. The medical device shown in Figure 1A
comprises a cannula holding part 101, a body 102 and a mounting pad 103, as
depicted in Figure 1 A.
Figure 1 B shows an embodiment of a cannula holding part 101 comprising a
top section 104 and a cannula 105. The top section 104 comprises an opening
106, closed by a sealing device 107. Towards the bottom of top section 104,
locking means 108 are provided. An internal chamber (not shown) is defined
within top section 104; said internal chamber is in connection with cannula
105.
As seen in Figure 1 A, the body 102 of the medical device 100 comprises an
opening 109 encompassing at least a part of the cannula holding part 101.
Likewise, the mounting pad 103 comprises an opening 110, which is at least as
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wide as or wider than the cannula 105 or cannula holding part 101. In another
embodiment, one or more penetrating member(s), such as an injection needle,
inserter needle or cannula, are injected across the mounting pad 103, said
mounting pad having no opening 110.
Often, a mounting pad 103 is used to ensure the appropriate contact of the
medical device 100 with the skin of the patient. This mounting pad 103 may be
attached to the underside of the body 102 of the medical device 100. Al-
ternatively, the mounting pad 103 is attached to the skin of the patient, and
the
medical device 100 is inserted through the mounting pad 103 or through an
opening 110 in the mounting pad 103.
Figure 1 C illustrates another view of the medical device 100 shown in Figure
1A and B. Figures 1 D and E illustrate other embodiments of a medical device
100. As seen in Figure 1 E, the mounting pad comprises a release liner
comprising a flap 112, in order to remove the release liner before application
of
the medical device.
Figure 1 F and G show a side view and a cross section of the medical device
100. In Figure G, the interlocking means 111, which provide a connection
between the locking means 108 and the body 102, can be seen.
Rotation axis and insertion axis are parallel
In a first aspect, the invention concerns an inserter device, where a
rotational
movement is transformed into a longitudinal insertion movement, wherein the
axis of said rotational movement and the axis of said longitudinal insertion
movement are essentially parallel to each other. The following section
describes
such embodiments, where said axis of said rotational movement and the axis of
insertion are essentially in alignment.
Figure 2 shows an exploded view of the main components of an inserter
device 200 according to one embodiment of the invention. The inserter com-
prises (i) a top section 201; (ii) rotating means 202 comprising a spiral
spring
203 and a rotating member 204; (iii) a middle section 221; (iv) longitudinally
moving means 241; and (v) a bottom section 251. Said sections 201, 221 and
251 define essentially the outer dimensions of the inserter device 200, as
well
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as an inner cavity (not shown). Within said inner cavity the rotating means
202
as well as the longitudinally moving means 241 are provided.
Figure 2 reveals that the different sections and means are predominantly
aligned and oriented in or around the central axis of the inserter device, and
the
5 axis of insertion is essentially the same as the central axis of the
inserter
device.
The following section provides a detailed, top to bottom description of the
components illustrated in Figure 2.
Ad (i) The top section 201 comprises a top part 209 and a body part 210. At
10 the centre of the top part 209 attachment means 207 are provided for at-
tachment of part (shaft 208, see below) of the rotating member 204. Such
attachment means 207 can comprise an opening or a bearing. The top part 209
is essentially flat and formed like a disk. The diameter of the top part 209
exceeds the diameter of the body part 210, thus forming a protrusion 211. The
body part 210 is essentially shaped like a hollow cylinder, and the inner
diameter of body part 210 exceeds the outer diameter of the spiral spring 203
upon assembly of the inserter device 200. One or more attachment means (not
shown) for the spiral spring 203, such as for the outer section 206, can be
provided within top part 209 and/or body part 210 of the top section 201.
Ad (ii) the rotating means 202, comprising a spiral spring 203 and a rotating
member 204. Said spiral spring 203 comprises an inner end 205 positioned
towards the centre of said spring 203, and an outer end 206 positioned at the
periphery. Both inner 205 and outer end 206 can be shaped individually and
independently, for example forming a flap, such as by bending the spiral
member in an inwards or outward fashion. As depicted in this embodiment, the
outer end 206 is formed by bending a section of the spiral member outwards.
Likewise, the inner end 205 of the spiral spring 203 can also be shaped in a
corresponding fashion. The spiral spring 203 rests between the top section 201
and the rotating member 204. The outer diameter of the spiral spring 203 is of
similar size or smaller than the inner cavity of top section 201, at least
during
assembly of the inserter device 200.
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The rotating member 204 comprises a body part 212, a top part 213, and a
shaft 208. The top part 213 is essentially flat and formed like a disk, and it
can
comprise one or more openings 214. The diameter of the top part 213 exceeds
the diameter of the body part 212, thus forming a protrusion 215. The body
part
212 is of cylindrical shape, and it can comprise one or more openings (not
shown), said openings being in connection with the one or more opening 214,
thus forming one or more channels from the top part 213 to the bottom end (not
shown) of the body part 212. One or more grooves 216 formed in the outer
surface of the body part 212 extend from the upper end 217, i.e. the distal
end
which is farthest away from the patient during insertion, to the lower end
218,
i.e. the proximal end which is closest to the patient during insertion, of the
rotating member 204. Furthermore, the rotating member 204 comprises a shaft
208, said shaft 208 protruding upwards, and being aligned with the rotating
axis
of the rotating member 204. The length of the shaft 208 exceeds the height of
the spiral spring 203. In order to accommodate the spiral spring 203, the
diameter and shape of the shaft 208, as well as the inner section of the
spiral
spring 203 are dimensioned in such a way that - upon assembly of the inserter
device 200 - a major part of the spiral spring 203 - such as the whole spiral
spring 203 minus a part of the inner section 205 - surrounds the shaft 208,
upon assembly of the inserter device 200.
Ad (iii) the middle section 221 is the largest component of the inserter
device
200, defining essentially the outside dimensions of the inserter device 200.
The
middle section 221 is essentially of hollow-cylindrical shape, and can
comprise
a top part 222 and a body part 223. Top part 222 and body part 223 can be to
different units that are joined together, e.g. by melding or gluing, or they
are part
of the same (work) piece. Both top part 222 and body part comprise openings at
both end, i.e. top opening 224 and bottom opening 225, respectively. Middle
section 221 thus defines the central cavity of the insertion device, which is
wide
enough to encompass a major part of the above-mentioned rotating means 202,
as well as the longitudinally moving means 241, and the medical device 100 to
be inserted. The top part 222 can be rounded, as depicted in Figure 2, and can
comprise a recess (not shown) in order to encompass at least a part of the
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protrusion 211 of the top section 201. Furthermore, body part 223 and
optionally
top part 222 comprise inner guiding means (not shown), such as one or more
slots (not shown), in order to govern the longitudinal movement of the
longitudinal moving means 241. The outer shape of the inserter device 200 is
predominantly defined by the shape of the middle section 221, which can be
round, elliptical, square, symmetric across one line, rotational symmetric, or
even asymmetric, e.g. in order to provide a better grip for left-handed versus
right-handed persons, as well as for people with small hands compared to
people with larger hands, or prostheses. Thereto, special grip-means (not
shown) can be provided.
Ad (iv) The longitudinal moving means 241 comprise a piston 242, an in-
sertion needle 243, longitudinal guiding means 244, and an inner cavity 245,
which extends from the top of the piston downwards. Said piston 242 is of
essentially hollow-cylindrical shape. The inner diameter of the piston 242 is
smaller than the outer diameter of the body part 212 of the rotating member
204, but it can be smaller than the diameter of the top part 209 of the
rotating
member 204. The height of the piston 242 can be essentially the same, smaller
or larger than the height of the body part 212 of the rotating member 204. At
least a major portion of the rotating member 204, such as a major part of the
body part 212 fit into the inner cavity 245. One or more transformation means
(not shown) can be provided, which are attached and protruding from the inner
wall of the piston 242, said transformation means fit into the groove 216,
thus
transforming a rotational movement of the rotating member 204 into a
longitudinal movement of the piston 242. At the bottom of the piston 243, such
as at the centre or off centre of said bottom, an insertion needle 243 is
attached
via attachment means (not shown). The insertion needle extends perpendicular
to the bottom of the piston 243, and is aligned in the orientation of
insertion. In
the depicted embodiment in Figure 2, the insertion needle 243 is at least
partially inserted into the cannula holding part 101, comprising a body part
101
and a soft cannula 105. Thus, cannula holding part 101 and piston 242 are
connected via the insertion needle 243.
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Ad (v) The bottom section 251 of the inserter device 200 comprises a bottom
part 252 and a ring-shaped part 253. Bottom part is essentially shaped like a
disk, and can have a larger diameter than the ring shaped part 253. In the
depicted embodiment (Figure 2), the bottom part 252 can actually be provided
by the mounting pad 103 of the medical device 100 (see Figure 1 for details).
Thus, the bottom part 252 may comprise a disposable liner and a flap 105. As
depicted and if appropriate, the body 102 of a medical device 100 rests on the
bottom part 252, and is held in an suitable position, such as with the central
cavity of the body 102 of the medical device being aligned with the cannula
holding part 101 and the insertion needle 243. The outer diameter of the ring-
shaped part 253 is the same or smaller than the inner diameter of the bottom
opening 225 of the middle section 221, and the ring-shaped part 253 fits into
the
body part 223 of the middle section 221. In an alternative embodiment of the
invention, the ring-shaped part 253 is omitted, and the bottom opening 225 of
the middle section is sealed by the mounting pad 103 of the medical device 100
to be inserted.
Generally, the mounting pad's adhesive strength is sufficiently strong to
ensure
that the medical device remains on the skin of the patient after insertion,
and
only the insertion needle 243 is removed through the cannula 105, while the
remaining parts of the medical device 100 remain in place. In an alternative
embodiment of the current invention, the medical device 100 is inserted
through
a further medical device.
Figure 3 shows an exploding view of an alternative embodiment of the current
invention. Please refer to Figure 2 for explanation and numbering of the
relevant
components and features are depicted in Figure 3 as in Figure 2.
Several additional and/or different features become apparent, when rotating
the
inserter device 200 by approximately 90 in anti-clockwise direction:
(i) The inserter device 200 comprises activation means 261, situated off-
center
of the top part 209 of the section 201. The activation means comprise a button
262, one or more apertures 263, 264 across the top part 209, and a notch 269,
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situated towards the upper end of the shaft 208, slightly off-center of the
rotating
element 204.
(ii) An embodiment of attachment means 219 for the inner end 205 of the for
spiral spring 203 on the shaft 208 of the rotating member 204 are shown.
(iii) An embodiment of body part 212 of the rotating member 204 is shown,
revealing an embodiment of the groove 216, showing essentially the first and
last quarters oft the groove 216. It is seen that the groove 216 is not
continuous.
(iv) An embodiment of inner guiding means 226, residing within the central
cavity of the middle section 221 is shown. In this embodiment, the guiding
means form a longitudinal groove, extending essentially from the top part 222
to
body part 223 (not shown). The height of the guiding means 226 equals
approximately half the difference between the diameter of the bottom opening
225 minus diameter of top opening 224.
Ad (i): According to one embodiment of the invention, the inserter device 200
is
activated by actuated the button 262 by pushing and/or sliding and/or rotating
and/or pivoting from a position 1, where the rotating member 204 is impeded
from rotating around its rotating axis, to a position 2, where the rotating
member
204 can rotate around its rotating axis. According to the depicted embodiment,
the button 262 - which has a rod-like shape - fits into the notch 269 of the
shaft
208 in position 1, thereby impeding the rotating member 204 from rotating.
Upon actuation of the button 262 - such as sliding or pushing the button 262
outwards, i.e. from a position, where the button 262 resides essentially
within
aperture 263 towards a position, where the button 262 resides essentially
within
aperture 264 - the spiral spring 203, which is in an activated state, is
allowed to
reach a less activated, more relaxed state, whereupon a rotating movement of
the rotating member 204 is provided.
In an alternative embodiment, the button 262 is lifted upwards upon actuation,
thereby leaving notch 269, thereby allowing for rotation of the rotating
member
204.
In order to provide energy for rotating the rotating member 204, the spiral
spring
203 has to be converted from an essentially relaxed state to an activated
state.
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This activated or loaded state can be provided by preventing either the inner
end 205 or the outer end 206 from moving, and rotating either inner end 205 or
outer end 206, either in a direction, where the spiral spring 203 becomes more
closely packed towards the center 205 of the spring, or where the spiral
spring
5 203 becomes more closely packed towards its outer end 206. Relaxation of the
spiral spring 203 occurs in the opposite direction of rotation than its
activation.
In the depicted embodiment in Figure 3, the inner end 205 of the spiral spring
203 is situated within a groove 219 of the shaft 208. The length of the groove
219 is essentially the same or shorter than the length of the shaft 208. The
10 width of the groove 219 is essentially the same or wider than the width of
the
leaf of the spiral spring 203. Upon relaxation of the spiral spring, the inner
end
205 rotates, and relays this rotating movement to the shaft 208 and thus to
the
rotating member 204.
Attachment means for the outer end 206 of the spiral spring, residing within
the
15 upper section 201 are not shown.
According to one embodiment of the invention, the inserter device 200 is pro-
vided in a loaded state to the user.
In a further embodiment, securing means are provided in order to prevent
unintentional activation of the inserter device. Such securing means can
comprise mechanical, electromechanical or electronic means, or a combination
of mechanical, electromechanical or electronic means.
Figure 4 shows an embodiment of an assembled inserter device 200 according
to the current invention, with activation means 261 situated off center on the
top
section 201 (figure 4 A). Top section 201, middle section and bottom section
251 are indicated. A close-up of the activation means 261, comprising a button
262, and a cavity 265 and optional retention means 266 are shown in Figure
4B. The cavity 265 extends radially, starting from a near-centre position 263,
to
a position 264 further away from the centre, but still well within the top
section
201. The cavity 265 is rounded at inner most position 263 and outer most
position 264, with a radius exceeding the radius of the button 262. The
inserter
device 200 can be activated by manipulating button 262 as described above. In
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one embodiment of the invention, the insertion device is activated by bringing
button 262 from a position at or near the near-centre position 263 to a
position
264 further away from the centre of the top section 201. The button 262
extends
across top section 201 and fits into the notch 269 of the shaft 208 of the
rotating
member 204, for example in an activated position. Retention means 266
provides a resistance against unintentional activation of the device. In one
embodiment of the invention, retention means 266 comprise an elastic member,
such as a spring.
In an alternative embodiment, activation of the inserter device 200 is
achieved
by activating button 262, which activates a rocking mechanism (not shown),
which comprises a blocking member (not shown) that is removed from a
position within notch 269 of the activated or loaded rotating member 204.
Thereby, the rotating member is no longer restricted from rotating.
Figure 5 shows a detailed view of rotation member 204 and a piston 241 ac-
cording to an embodiment of the invention, such as the one illustrated in
Figure
3. Compared to Figure 3, rotation member 204 and a piston 241 are rotated
approximately 45 in anti-clockwise direction. In this view, the upper end 217
of
the rotating member 204 is seen; this is where groove 216 starts and ends. In
one embodiment, the groove is not continuous. In another embodiment, the
groove is continuous, i.e. without a start and/or endpoint.
In the current embodiment, approximately half a rotation of the rotating
member
204, i.e. approximately 180 , are converted into a longitudinal movement of
the
piston 241, where the length of said longitudinal movement is essentially
defined by the lead, i.e. the distance parallel to the axis between the start
position of the groove 216 at the upper end 217 and at the lower end 218. At
the bottom of the piston 242, an insertion needle 243 is attached.
Figure 6 shows different embodiments of rotating members 204 according to
the invention. Figure 6 A presents a further view of the rotating member 204,
similar to Figures 3 and 5, but with an additional rotation of approximately
45
compared to Figure 5. A notch 220 is seen at the lower end of rotating member
204, where the groove 206 reaches the lowest position. In one embodiment of
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the invention, notch 220 has no practical function during application of the
device, but has a function during assembly and/or manufacturing of the
inserter
device 200, where it facilitates assembly or makes assembly possible. In
another embodiment, notch 220 is not present.
Figures 6B and 6C show alternative embodiments of the rotating member 204.
In these embodiments, the rotating member 204 does not comprise a top part
213, and no protrusion 215. The shaft 219 can vary in form and shape, and in
the depicted embodiments, the shaft is of essentially round diameter, though
wider at the bottom than at the top, i.e. wider towards the body part 212 of
the
rotational member 204. The top surface of the shaft 219 is essentially flat.
In
another embodiment of the invention, the top surface of the shaft 219 is
concave. In a further embodiment of the invention, the top surface of the
shaft
219 is convex.
In the embodiments depicted in Figure 6 A, B and C, different positions of the
respective grooves 216 on the rotating member 204 are provided. An inserter
device according to the present invention will reveal different speeds and di-
rections of the longitudinal movement of the piston 241 during one rotation,
depending on the position and track of the groove 216. These speed differences
can also be expressed in differences in acceleration (positive or negative).
Commonly, a negative acceleration is also termed deceleration.
Upon anti-clockwise rotation of the rotating member 204, an inserter device
with
a rotating member 204 similar to the one depicted in Figure 6B, will show a
higher acceleration and higher speed of insertion of the piston 241 within the
first -90 rotation than an inserter device with a rotating member 204 similar
to
the one depicted in Figure 6C. This is due to the steeper track of the groove
216
(Figure 6B) compared to the track's slope seen in Figure 6C. However, during
the remaining -90 rotation, the insertion speed will be opposite. But with
similar
rotation speeds, similar height of the rotating member and similar lead, the
total
time needed for insertion will be similar, though the respective speeds of
insertion, and also the respective accelerations and decelerations will be
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different. These are directly proportional the slope of the groove 216 of the
rotating member 204.
Figure 7 shows a semi-transparent view of the longitudinal moving means 241,
comprising a piston 242, an insertion needle 243, one or more longitudinal
guiding means 244, positioned symmetrically and diametrically towards each
other, and transformation means 246. In the depicted embodiment, the
transformation means 246 are provided in essentially the shape of a small
cylinder or rod, protruding radially inwards from the inner wall of the piston
242,
positioned close to the top of the piston 242, opposite the guiding means 244.
The transformation means 246 are provided with a diameter, length and shape
that allows said transformation means 246 to fit and remain in the grove 216
of
the rotating member 204, and to transform the rotation of the rotating member
204 into a longitudinal movement of the longitudinal moving means 241.
The longitudinal guiding means 244 can be of essentially rectangular shape ,
and they fit into the groove of the guiding means 226, provided within the
central cavity of the middle section 221 (see e.g. Figure 3). In one
embodiment,
the longitudinal guiding means 244 are approximately of the same length as the
height of the piston 242. In another embodiment, the length of the
longitudinal
guiding means 244 are longer than the length of the longitudinal movement. In
a
further embodiment, the length of the longitudinal guiding means 244 exceeds
the height of the rotating member 204. In yet another embodiment, the length
of
the piston 242 is greater than the height of the rotating member 204.
Figure 8 reveals an embodiment of an inserter device 200 according to the
invention. For clarity, some sections or part of sections are either removed
and/or shown as cross-sections. Figure 8 gives an impression of the different
dimensions and shapes of the major constituents of an inserter device ac-
cording to the invention.
The activation means 261 are not visible in Figure 8.
Figure 9 presents 3 design drawings showing cross sections of an embodiment
of an inserter device 200 according to the invention. The relative positions,
proportions and interaction of the major constituents are illustrated. The
inserter
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device has several features in common with the inserter devices 200 presented
in the previous Figures (Figures 2-8). The respective views are indicated by
letters and arrows. The numbering of the different constituents of the
inserter
device is indicated, and coherent with the sections above.
In Figure 9A, the inserter device 200 is loaded/activated/energized and ready
for insertion. This view reveals the shape of the longitudinal channels or
cavities
or openings 214, which extend across the rotating member 204. A central cavity
becomes apparent, which is located towards the lower section of the rotating
member 214. It is positioned in continuation of the shaft 218, and
approximately
as wide as the diameter of the shaft.
Figure 9B, the inserter device 200 is presented after an approximate 180
rotation of the rotating member 204. The diameter of the spiral spring 203 has
increased, and cannula holding part 101 has been brought in position within
the
body 102 of the medical device, and cannula 105 and the tip of the insertion
needle 243 protrude the bottom plane and bottom part 252.
Figure 9C shows the inserter device 200 after insertion of the medical device
100. The insertion needle 243 retracted, and the inserted device is ready for
removing from the patient.
Figure 10 shows further embodiments of an inserter device 200 according to
the invention. Figure 10A reveals the bottom section 251, where in this em-
bodiment the release liner has been removed from the mounting pad 103, re-
vealing the bottom surface of the release liner. Commonly, this surface will
have
a sufficient adhesive strength to provide sufficient adhesion to the skin of
the
patient in order to keep mounting pad, medical device and cannula in the
desired position. When appropriate, said adhesive strength is also sufficient
to
allow the inserter device to be removed safely, while still keeping the
medical
device at the desired position.
Figure 10 B provides a top view of an inserter device 200 with activation
means
261. To the right, an embodiment of a medical device 100 is seen, comprising
mounting pad, release liner with flap 112.
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The diameter of the mounting pad 103 is of similar size or smaller than the
outer
diameter of the inserter device 200. In another embodiment of the invention,
the
diameter of the mounting pad 103 is larger than the outer diameter of the
inserter device 200.
5 Figure 11 shows alternative embodiments of an inserter device according to
the
invention. Figure 11 A shows an embodiment of rotating means 202, comprising
a spiral spring 205 and a rotating member 204, and a piston 242. In this
embodiment, the shaft 208 is longer than the width of the spiral spring 203.
The
longitudinal guiding means 244 are slightly rounded. In this embodiment, the
10 longitudinal guiding means 244 shorter than the height of the piston 242.
Note
that the rotating member 204 does not comprise a top part 213 and no
opening(s) 214.
Figure 11 B shows an embodiment of a rotating member 204 with a groove a
shaft 208 and a groove 216. Also this embodiment of a rotating member does
15 not comprise a top part 213, and has no opening 214. The track of the
groove
216 is very step (high lead), going from the upper end 217 to the lower end
218
of the rotating member 204 within approximately 90 . An inserter device 200
according to the invention with a rotating member 204 will provide insertion
and
or retraction of a medical device to be inserted into a patient with less
rotation
20 than for example an inserter device 200 comprising a rotating member 204 as
shown in Figures 2, 3, 5, 6, 8 or 9. In these embodiments, a rotation of
approximately 180 of a rotating member 204 is converted or transformed into a
complete insertion movement in longitudinal direction of a longitudinally
moving
member 241.
However, in another embodiment of the invention, a groove 216 is provided with
a track requiring more than 180 for insertion or retraction or both, such as
181
to 360 , or more than 1 rotation, turn or revolution, i.e. more than 360 ,
such as
361- 540, or more than 1,5 rotations, or more than 2 rotations.
In a further embodiment, the degree of rotation required of the rotating
member
204 for insertion and/or retraction is less than 180 , such as 10 to 170 , or
20
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to 1600, or 30 to 1600, or 40 to 1500, or 50 to 1400, or 60 to 1300, or 60
to
120 , or 70 to 1100, or 80 to 1000 or around 90 .
In yet a further embodiment, the degree of rotation required for insertion is
essentially the same as the degree of rotation required for retraction.
In yet another embodiment, the degree of rotation required for insertion is
different from the degree of rotation required for retraction, such as more
than
+/- 50, more than +/-100, more than +/ 20, more than +/-45 , more than +/-90 ,
more than +/-135 , more than +/-180 , more than +/- 270 , or more than +/-360
.
In still another embodiment, the groove 216 crosses itself, i.e. the track for
the
downward movement and the following upwards movement. This can be
required when rotations of more than 360 are required for a complete
insertion
and retraction.
In an alternative embodiment, the longitudinal retraction movement is achieved
by rotating the rotating member in the opposite direction.
Figure 11 C shows an embodiment of a piston 242 according to the invention.
The longitudinal guiding means 244 possess a rounded cross section, and
extend from the top of the guiding means almost to the bottom of the piston
242.
Figure 12 shows an embodiment of an inserter device 200 according to the
invention, and in this view, the middle section 221 can be seen, as well as
activation means 261, comprising a button 262, provided of centre of the top
section 201. It becomes apparent that the mechanical layout of the inserter
device with the dominating middle section 221 opens up for a variety of design
and feature possibilities.
Although depicted essentially flat in Figure 12 and previous Figures, top
section
201 can also be rounded, of symmetrical or asymmetrical shape. Thus, top
section 201 may also comprise one or more protrusions or one or more notches
or grooves.
Figure 13 A, B, C and D summarizes the first aspect of the invention, con-
cerning an inserter device, where a rotational movement is transformed into a
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longitudinal insertion movement, wherein the axis of said rotational movement
and the axis of said longitudinal insertion movement are essentially parallel
and
overlapping. The drawings are not to scale.
Figure 13 A shows an embodiment of an activated, tense and compacted spiral
spring 203, the spring 203 is fastened to the shaft 208 at the centre 205 and
to
the not shown housing 223 at the periphery 206. Figure 13 B shows a partial
cross-section of an inserter device according the invention where the energy
providing means comprises a spiral spring 203, before, or at the onset of
insertion. Figure 13 C shows the same embodiment of a spiral spring 203 as
shown in fig. 13 A but in fig. 13 C the spring 203 is in a relaxed, expanded
state.
Figure 13 D shows a partial cross-section of the same embodiment of an
inserter device as shown in fig. 13 B, during, or at towards the end of
insertion.
The diameter of the spiral spring 203 which is shown in fig. 13 A, B, C and D
increases during relaxation. In another embodiment of the invention, the dia-
meter of the spiral spring decreases, when moving from the activated state to
the relaxed state. The control of insertion speed is provided by the strength
or
amount of energy released by the energy providing means per time interval,
together with technical features for controlling the amount of energy released
per time interval. Further, the speed and changes of speed and direction can
be
controlled by the lean, i.e. slope of the groove 216 of the rotating member
204,
which is directly transformed to a longitudinal movement of a longitudinally
moving member 242.
In one embodiment of the invention, the energy providing means for providing
energy for insertion of the medical device 100 comprises a clockwork. In a
further embodiment, the clockwork comprises controlling means for providing a
controlled release of energy. Release of energy can be constant or essentially
constant. Alternatively, the release of energy can be varying during insertion
of
the medical device 100. Furthermore, if required, the energy provided for
retraction an insertion needle 243 can be different from the energy for
inserting
the medical device 100.
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Figure 14 shows two alternative possibilities for activating an inserter
device
according to the present invention. Figure 14 shows an inserter device 200,
comprising energizing means. Said energizing means comprise interacting
means 281, which interacting means 281 are connected to the shaft 208 of the
inserter device, and a key 282 comprising a handle 284 and connecting means
283, said connecting means 283 can interact with the interacting means 281, in
order to energize or activate an energy storage device, such as a spiral
spring
203.
In Figure 14 A shows an embodiment, where external, manual or automated
input, such as rotation of the key 282 is transformed into a rotation which
leads
to activation or inactivation of the spiral spring 203. The rounded arrow
indicates
said rotation of the key 282. The automated input can also comprise one or
more of electric, electronic and electromagnetic input. In one embodiment of
the
invention, an electric/electromagnetic motor provides activation of the spiral
spring 203. In another embodiment of the invention, the external input
comprises compressed gas, such as compressed air, C02, N2 and the like.
In Figure 14 B, the energy storage device (spiral spring 203) is activated by
manual or automated input, said input being in a longitudinal up or down
movement, or a combination of up and down movements, as indicated by the
double arrow. According to one embodiment of the invention, external energy
provides the required energy for insertion of a medical device 100, and
optional
retraction of an insertion needle 243. In another embodiment, external energy
provides the energy required for bringing spiral spring 203 from a relaxed
state
to an activated state.
Rotation axis and insertion axis are perpendicular
A second aspect of the invention relates to an inserter device, where a rota-
tional movement is transformed into a longitudinal insertion movement, wherein
the axis of said rotational movement and the axis of said longitudinal
insertion
movement are essentially perpendicular to each other.
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Figure 15 illustrates two different principles of converting a rotational
movement
into a longitudinal movement. A common feature for both principles is that the
direction of the longitudinal movement is not parallel to the rotation axis of
the
rotating member, in contrast to the first aspect of the invention. Commonly,
the
direction and axis of the longitudinal movement is perpendicular, or
essentially
perpendicular or orthogonal to the rotation axis of the rotating member.
Figure 15A illustrates how the rotation of a rotating member, such as a disk
or
wheel can be converted into a longitudinal movement. Furthermore, the
corresponding functions of translocation (S) and velocity (V) are shown
schematically, each as a function of rotation (cp). It is seen that these
functions
are essentially sine or cosine functions, with a period of 2Tr. Using this
principle
for providing a controlled and defined longitudinal movement, speed and
acceleration are defined by the above mentioned trigonometric functions (sin
and cos) and are dependent on the speed of rotation.
The technical means for providing a longitudinal movement from a rotational
movement comprise:
= a rotating member 300 rotating around an axis 301 - in this embodiment
shown as a rotating disk , however virtually any other rotating body could do
as well.
= a first elongated member 302, such as a connecting rod
= attachment means 303 - connecting the first elongated member to said ro-
tating member 300 and providing a pivoting movement of the first elongated
member 302 as required.
= a second elongated member 304 (piston)
= a joint 305 between first and second elongated member, providing a pivoting
movement between the first 302 and the second elongated member 304 as
required, as well a longitudinal movement in the direction of the second
elongated member 304.
= longitudinal guiding means 306 , which provide and govern the alignment of
the second elongated member 304 in the direction of the desired longitudinal
movement.
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The length of insertion/longitudinal movement is essentially as long as 2 x
the
distance from the centre of rotation to the point of attachment of first
elongated
member.
Figure 15B illustrates a different principle for transforming a rotational
move-
5 ment of a rotating member into a defined linear movement of longitudinally
moving member. In this embodiment, a rotating member, of irregular shape
defines a resulting longitudinal movement. The corresponding graphs of
translocation (S) and velocity (V) are shown schematically, each as a function
of
rotation (cp).
10 The technical means for providing a longitudinal movement from a rotational
movement comprise:
= a rotating member 400 rotating around an rotating axis 401- in this embo-
diment a rotating disk of irregular shape; alternatively, a circular disk, ro-
tating off centre will also provide .
15 = transformation means 402
= an elongated member 403
= longitudinal guiding means 405
= elastic means 404, for example comprising a spiral spring.
The length of insertion/longitudinal movement is defined by the differences in
20 radius, i.e. essentially as long as the difference between the rotating
member's
400 longest radius (R,) and shortest radius (Rs)
The following Figures (Figure 16 to Figure 19) illustrate embodiments of the
current invention, based on the principle of transforming a rotational
movement
into a longitudinal movement, as previously presented in Figure 15A.
25 Figure 16 shows a semi-transparent view of an embodiment of an inserter
device 500 with crank shaft according to the present invention. The inserter
device' 500 comprises a top section 501, a middle section 502 and a body
section 503, which govern the appearance of the inserter device. A central
cavity 505 is provided within top section 501, middle section 502 and body
section 503.
Top section 501 is rounded and of the shape of a half-sphere. Top section 501
and middle section 502 are connected, and can be provided in one piece or as
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separate pieces, which have to be joined. Top section 501 and middle section
502 have similar or matching wall thickness. Middle section 502 is of hollow-
cylindrical shape. Commonly, although depicted semi-transparent, top section
501 and middle section 502 are not transparent.
Bottom section 503 is disk-shaped, and its diameter is larger than the outer
diameter of the middle section 503. The bottom section comprises an inner
extension 504. Middle section 502 overlaps the inner platform 504. The inner
extension 504 comprises a platform 506, pair of guiding means 551, and a ring-
shaped circular part 507.
The inner extension 504 of the bottom section 503 comprises an inner platform
506, which is essentially cylindrical; the outer diameter of said inner
platform
504 is larger than the inner diameter of the middle section 502.
The guiding means 551 are positioned diametrically towards the outside of the
inner extension 504, extending vertically upwards (i.e. orthogonally to the
bottom plane of the inserter device 500) from the inner platform 506, thus
inside
middle section 502 and the central cavity 505.
At the centre of the inner platform 506, there is an opening, where the
cannula
holding part 101 is seen, with the cannula pointing downwards, in the
direction
and axis of insertion.
At the upper end of the guiding means 551, a crank shaft 512 is provided with
bearing means (not shown), allowing for rotation of the crank shaft 512
parallel
to the bottom plane of the inserter device, i.e. horizontally, and
perpendicularly
to the guiding means 551.
On crank shaft 512, within the two guiding means 551, a spiral spring 561 and
two discs 511 a and 511 b are attached orthogonally and concentrically onto
said
crank shaft 512, so that crank shaft 512, spiral spring 561 and discs 511 a
and b
share the same rotation axis. Discs 511 a and b, as well as spiral spring 561
are
of similar diameters. Disc 511 a is mounted near the centre of the crank shaft
512, flanked by disc 511 b and spiral spring 561. Only the inner part 562 of
spiral
spring 561 is attached to the crank shaft 512. Crank shaft 512 can comprise
two
sections, so that on the one section of the crank shaft 512 are mounted spiral
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spring 561 as well as disc 511 a, while disc 511 b is mounted on the other
section of crank shaft 512.
Attachment means 522 are provided between the two discs 511 a and b, said
attachment means 522 connecting rod 521 with the discs 511 a and b, and
allowing for a pivoting movement of the connecting rod 521. The connecting rod
521 is attached off-centre of the discs 511 a and b. The attachment means 522
comprise of a second shaft, mounted parallel to said crank shaft 512 via a
through-going opening, near the top end 523 of the connecting rod, and the
second shaft protruding said connecting rod on both sides of the trough-going
opening.
Apart from providing a point of attachment of the connecting rod 521, the at-
tachment means 522 provide a stable connection between discs 511 a and b, so
that a rotation of the crank shaft 512 is carried on from on disc 511 to the
other,
also in the absence of a section of the crank shaft 512. This provides the
necessary space for the connection rod 521 to transform a rotation of discs
511 a and b into a pivoting and up-and downwards movement, which would
otherwise be partially restrained or interfere, if crank shaft 512 would be an
ordinary by shaft, such as a rotating rod or cylinder.
Near the bottom end 524 of the connection rod 521, a flexible joint 541 is
provided for connecting the bottom end 524 of connecting rod 521 with piston
531. In the depicted embodiment, the pivoting movement of the connecting rod
521 is transformed into a longitudinal movement of the piston via said
flexible
joint 541. Flexible joint 541 comprises a traversal bar 542, onto which piston
531 is attached in the centre of the traversal bar 542. The traversal bar 542
is
parallel to the crank shaft 512, and remains parallel to shaft 542 while
moving
up and down as required, guided by the guiding means 551. Said guiding
means 551 prevent the transversal bar from pivoting or twisting, for example
around the axis of insertion.
The piston 531 is solidly attached to the transversal bar 542, and in this em-
bodiment, the piston 531 is positioned in the centre of the transversal bar
542,
aligned in direction of insertion and aligned with the centre axis of the
insertion
device 500.
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At the bottom end of the piston 531, an introducer needle 243 is attached (tip
pointing down), and said introducer needle being aligned with the centre axis
of
the insertion device 500. The tip of the introducer needle 243 is not visible,
and
in the depicted embodiment, it is introduced into the cannula holding part 101
of
a medical device.
Another feature of the traversal bar 542 is that it provides attachment means
563 in the form of a fixing point of the outer end of the spiral spring 561,
re-
sulting in the outer end of the spiral spring 561 resting against the
traversal bar
542.
Figure 17 is a partial cross section of the embodiment of an inserter device
500
with crank shaft 512 as presented in Figure 16, before or ready for insertion.
For
clarity, top section 501 and middle section 502 are removed. Furthermore,
spiral
spring 562 is not shown, whereupon spring attachment means 563 are seen,
which in this embodiment comprise a longitudinal groove in crank shaft 512.
The partial cross section through bottom section 503 and inner extension 504
reveal a bottom cavity 572, which provides room for the body 102 of a medical
device to be inserted. The top of bottom cavity 572 is defined by the bottom
surface of platform 506, the sides of the bottom cavity 572 is defined by the
inner surface of the inner extension 504, the bottom of the bottom cavity 572
is
defined by the body 102 of the medical device to be inserted, and the central
section of the bottom cavity 572 is defined by the outer surface of cannula
holding part guiding means 571. The function of said cannula holding part
guiding means is to maintain the cannula holding part oriented in the
direction of
insertion before and during at least a part of its insertion.
Figure 18 show the embodiment of an inserter device 500 with crank shaft, as
previously presented in Figures 16 and 17 in an inserted (A) and in a
retracted
(B) state. The numbering corresponds to the numbers and nomenclatures
presented earlier, and the direction of rotation is indicated. In this
embodiment,
the direction of rotation for insertion and retraction are the same. In
another
embodiment, direction of rotation and insertion are different. This figure
illustrates how the different moving parts interact in order to transform
rotation
into a translatory, longitudinal movement, resulting in the insertion of a
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penetrating member, followed by retraction of an inserter needle 243. The
similarities between the depicted embodiment, and the general principle
outlined an introduced in Figure 15A become obvious in the following Table I:
Table 1: Comparison between Figure 15A and Figure 18
Figure 15A Figure 18
Rotating member 300 Discs 511 a and b, crank shaft 512
Axis 301 Rotation axis of crank shaft 512
and discs 511 a and b
First elongated member 302 Connecting rod 521
Attachment means 303 Attachment means 522
Second elongated member 304 Piston 531
Joint 305 Joint 541, transversal bar 542
Longitudinal guiding means 306 Guiding means 551, cannula
holding part guiding means 571
Figure 19 illustrates another embodiment of an insertion device according to
the invention with crankshaft. In Figure 19A the top section 501 and a part of
middle section 502 are removed, revealing following features: A toothed wheel
582 is provided with a cover 583 surrounding the spiral spring 561.
Furthermore, activation means 581 are seen. In this embodiment, the activation
means are situated externally, and protrude middle section 502.
Activation means 581 comprise a button and a shaft. Figure 19B shows a
detailed view of an embodiment of the activation means 581. The activation
means 581 comprise a button situated on a shaft protruding from a rocking
leaver 590. In the depicted position of the activation means 583, the tip of
the
rocking leaver 590 fits into a groove between two neighbouring teeth of the
toothed wheel 582. An integrated spring 591 is provided on said rocking leaver
590. The integrated spring is positioned between the inner wall of middle
section 502 and the teeth of toothed wheel 582. In the depicted position in
Figure 19B, the toothed wheel 582 cannot turn. Upon application of a
downwards force on said button in direction of said shaft, the rocking leaver
pivotes, and as a result the tip of the rocking leaver 590 is no longer
situated
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between the teeth of the teethed wheel 582. Thereby, the insertion device 500
is activated and insertion is initiated.
An inserter device according to the present application commonly comprise an
opening at the bottom, which is sufficiently wide to allow a medical device
100
5 to leave the inserter device through said opening.
In another embodiment of the invention, the opening can be sealed with a
detachable sealing foil, which may comprise a flap in order to facilitate the
removal process before use of the inserter device. Such a detachable sealing
foil is not necessarily a part of the mounting pad 103 of a medical device
100.
10 The detachable sealing foil, or a mounting pad 103 with release liner can
en-
sure an appropriate hygiene standard, by maintaining appropriate levels of
disinfection or sterility. Furthermore, the sealing foil may act as an
indicator for
integrity of the inserter device and/or medical device 100, thereby improving
safety standards, as use of potentially compromised and thus no longer sterile
15 device can be avoided.
