U.S. patent application number 11/266904 was filed with the patent office on 2008-01-10 for integrated package.
This patent application is currently assigned to Novo Nordisk A/S. Invention is credited to Erik Winkel Ethelfeld.
Application Number | 20080009805 11/266904 |
Document ID | / |
Family ID | 33436005 |
Filed Date | 2008-01-10 |
United States Patent
Application |
20080009805 |
Kind Code |
A1 |
Ethelfeld; Erik Winkel |
January 10, 2008 |
Integrated package
Abstract
The present invention generally relates to skin-mountable
devices. A device in accordance with the invention comprises a
first skin-mountable unit having a mounting surface comprising
adhesive means for adhering the unit to the skin of a subject, and
a second handling unit releasably attached to the skin-mountable
unit. The handling unit comprises an interior space at least
partially accommodating the skin-mountable unit and has an opening
through which the skin-mountable member can be moved when detached
from the handling unit, the handling unit having a portion
surrounding the opening. The device further comprises a seal member
releasably attached to the circumferential portion, thereby
providing a closed space for the skin-mountable unit. In this way a
device is provided allowing for easy handling as a user can use the
handling unit to grip and handle the combined device during
operation thereof, just as the second unit can be designed and
optimized for ease of use during manipulation of the skin-mountable
unit.
Inventors: |
Ethelfeld; Erik Winkel;
(Copenhagen, DK) |
Correspondence
Address: |
NOVO NORDISK, INC.;PATENT DEPARTMENT
100 COLLEGE ROAD WEST
PRINCETON
NJ
08540
US
|
Assignee: |
Novo Nordisk A/S
Bagsvaerd
DK
DK-2880
|
Family ID: |
33436005 |
Appl. No.: |
11/266904 |
Filed: |
November 4, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/DK04/00334 |
May 10, 2004 |
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11266904 |
Nov 4, 2005 |
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60471196 |
May 16, 2003 |
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Current U.S.
Class: |
604/180 ;
604/93.01 |
Current CPC
Class: |
A61M 5/14248 20130101;
A61M 2005/1585 20130101; A61M 5/158 20130101; A61M 2005/14252
20130101 |
Class at
Publication: |
604/180 ;
604/093.01 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
May 8, 2003 |
DK |
PA 2003 00698 |
Claims
1. A device comprising: a skin-mountable unit having a mounting
surface comprising adhesive means for adhering the unit to the skin
of a subject, the adhesive means being covered by thereto
releasably attached protective means, a handling unit releasably
attached to the skin-mountable unit and comprising an interior
space at least partially accommodating the skin-mountable unit and
having an opening through which the skin-mountable member can be
moved when detached from the handling unit, the handling unit
having a portion surrounding the opening, and a seal member
releasably attached to the surrounding portion, thereby providing a
sealed space for the skin-mountable unit, wherein removal of the
seal member results in the protective means being removed from the
adhesive means.
2. A device as defined in claim 1, wherein the handling unit
comprises a circumferential portion surrounding the opening.
3. A device as defined in claim 2, wherein the circumferential
portion defines a general plane.
4. A device as defined in claim 3, wherein the mounting surface is
generally planar and arranged substantially corresponding to the
general plane defined by the surrounding portion of the handling
unit
5. A device as defined in claim 4, wherein the seal member is
releasably attached to the adhesive means, the seal member thereby
providing the protective means.
6. A device as defined in claim 4, wherein the mounting surface is
arranged in a retracted position relative to the general plane.
7. A device as defined in any of the previous claims, the
skin-mountable unit further comprising a transcutaneous device
having a distal pointed end adapted to penetrate the skin of the
subject, the transcutaneous device having a first position in which
the distal end is retracted relative to the mounting surface, and a
second position in which the distal end projects relative to the
mounting surface.
8. A device as defined in claim 7, further comprising actuatable
driving means associated with the handling unit and adapted to move
the transcutaneous device from the first position to the second
position when the driving means is actuated with the handling unit
attached to the skin-mountable unit.
9. A device as defined in claim 8, wherein the driving means
comprises spring means, the handling unit further comprising:
actuation means actuatable from a first condition through an
intermediate condition to a second condition in which the
transcutaneous device is moved to its second position, whereby
actuation of the actuation means from the first to the intermediate
condition causes activation of the driving means, and actuation of
the actuation means from the intermediate to the second condition
causes release of the activated spring means thereby moving the
transcutaneous device from the first position to the second
position.
10. A device as defined in claim 9, wherein the actuation means
comprises an actuating element which is moved from a first position
through an intermediate position to a second position, preferably
corresponding to a substantially non-composite movement.
11. A device as defined in claim 9, wherein actuation of the
actuation means from the first through the intermediate to the
second condition is accomplished by moving two actuation elements
against each other.
12. A device as defined in claims 8, wherein the driving means can
be locked in its activated state.
13. A device as defined in claim 8, wherein the driving means
comprises spring means (540) which is or can be arranged in an
activated state, the second unit comprising trigger means (542) for
releasably retaining the spring means in the actuated state, the
trigger means being operable to release the spring means for moving
the transcutaneous device from the first position to the second
position.
14. A device as defined in claim 8, wherein the handling unit
comprises a housing defining the interior space, the skin-mountable
unit comprising an upper portion facing towards the interior space,
the driving means being arranged within the interior space between
the upper portion and the housing.
15. A device as defined in claim 7 in combination with an inserter
(610), the inserter comprising: means (611) for releasably receive
and support the handling unit, actuatable driving means (640), the
handling unit comprising a portion (657) moveable by the driving
means when the latter is actuated, the moveable portion of the
handling unit being arranged to engage the skin-mountable unit to
thereby move the transcutaneous device from its first to its second
position.
16. A device as defined in claim 7, wherein the transcutaneous
device is a hollow infusion needle, the skin-mountable unit further
comprising: a reservoir adapted to contain a liquid drug and
comprising in a situation of use an outlet in fluid communication
with the infusion needle, and expelling means for expelling a drug
out of the reservoir and through the skin of the subject via the
infusion needle.
17. A medical device as defined in claim 8, wherein the
transcutaneous device is a cannula (860) in combination with a
pointed insertion needle (880) accommodated at least partially
within the cannula, the cannula having a distal opening, the
cannula and insertion needle being arranged to be simultaneously
moved by the driving means from their respective first position to
their respective second position when the driving means is
actuated, wherein the insertion needle is arranged to be moveable
away from the distal opening when the cannula and the insertion
needle have been moved to their second position.
18. A medical device as defined in claim 17, wherein the cannula
comprises a needle-penetratable septum (861) through which the
insertion needle is arranged when the cannula and the insertion
needle is moved from their respective first position to their
19. A medical device as defined claim 8, wherein the transcutaneous
device is a longitudinal sensor device (760) in combination with a
pointed insertion needle (770) arranged to support a distal portion
of the sensor device, the sensor device and insertion needle being
arranged to be simultaneously moved by the driving means from their
respective first position to their respective second position when
the driving means is actuated, wherein the insertion needle is
arranged to be moveable away from the distal portion when the
sensor device and the insertion needle have been moved to their
second position.
20. A medical device as defined claim 17, wherein the insertion
needle in its second position is attached to the second unit,
whereby removal of the second unit from the first unit withdraws
the insertion needle therefrom.
21. A method of applying a device to a skin surface of a subject,
comprising the steps: a) providing a device having a first unit and
a releasably attached second unit, the first unit comprising: a
generally planar mounting surface comprising adhesive means for
adhering the first unit to the skin of the subject, the adhesive
means being covered by thereto releasably attached protective
means, the second unit comprising: an interior space accommodating
the first unit and having an opening through which the first unit
can be moved when detached from the second unit, the second unit
having a circumferential portion defining a general plane and
surrounding the opening, the mounting surface being arranged
interiorly in respect of the general plane or substantially
corresponding to the general plane, a seal member releasably
attached to the circumferential portion, thereby providing a sealed
space for the first unit, wherein removal of the seal member
results in the protective means being removed from the adhesive
means, b) removing the seal member thereby exposing the adhesive
means, c) arranging the adhesive means in contact with the skin of
the subject and d) removing the second unit from the first
unit.
22. A method as defined in claim 21, wherein the seal member is
releasably attached to the adhesive means, the seal member thereby
providing the protective means,
23. A device as defined in claim 1, wherein the protecting means is
provided by a peelable sheet member (351) attached to the adhesive
means, the sheet member being connected to the seal member.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of international
application no. PCT/DK2004/000334 filed May 10, 2004 and claims
priority of Danish application no. PA 2003 00698 filed May 8, 2003
and U.S. provisional application Ser. No. 60/471,196 filed May 16,
2003, all of which are hereby incorporated by reference.
[0002] The present invention generally relates to skin-mountable
devices. Especially, the invention relates to such devices which
are supplied to the user in a package from which the device has to
be removed prior to use.
BACKGROUND OF THE INVENTION
[0003] In the disclosure and discussion of the present invention
reference is mostly made to the treatment of diabetes by injection
or infusion of insulin, however, this is only an exemplary use of
the present invention.
[0004] Portable drug delivery devices for delivering a drug to a
patient are well known and generally comprise a reservoir adapted
to contain a liquid drug and having an outlet in fluid
communication with a transcutaneous access device such as a hollow
infusion needle, as well as expelling means for expelling a drug
out of the reservoir and through the skin of the subject via the
hollow needle. Such devices are often termed infusion pumps.
[0005] Basically, infusion pumps can be divided into two classes.
The first class comprises durable infusion pumps which are
relatively expensive pumps intended for 3-4 years use, for which
reason the initial cost for such a pump often is a barrier to this
type of therapy. Although more complex than traditional syringes
and pens, the pump offer the advantages of continuous infusion of
insulin, precision in dosing and optionally programmable delivery
profiles and user actuated bolus infusions in connections with
meals.
[0006] Addressing the above problem, several attempts have been
made to provide a second class of drug infusion devices that are
low in cost and convenient to use. Some of these devices are
intended to be partially or entirely disposable and may provide
many of the advantages associated with an infusion pump without the
attendant cost and inconveniencies, e.g. the pump may be prefilled
thus avoiding the need for filling or refilling a drug reservoir.
Examples of this type of infusion devices are known from U.S. Pat.
Nos. 4,340,048 and 4,552,561 (based on osmotic pumps), U.S. Pat.
No. 5,858,001 (based on a piston pump), U.S. Pat. No. 6,280,148
(based on a membrane pump), U.S. Pat. No. 5,957,895 (based on a
flow restrictor pump (also know as a bleeding hole pump), U.S. Pat.
No. 5,527,288 (based on a gas generating pump), or U.S. patent
(based on a swellable gel) which all in the last decades have been
proposed for use in inexpensive, primarily disposable drug infusion
devices, the cited documents being incorporated by reference.
[0007] The disposable pumps generally comprises a skin-contacting
mounting surface adapted for application to the skin of a subject
by adhesive means, and with the infusion needle arranged such that
in a situation of use it projects from the mounting surface to
thereby penetrate the skin of the user, whereby the place where the
needle penetrates the skin is covered while the appliance is in
use.
[0008] The infusion needle may be arranged to permanently project
from the mounting surface such that the needle is inserted
simultaneously with the application of the infusion pump. Examples
of this configuration can be found in U.S. Pat. Nos. 2,605,765,
4,340,048 and in EP 1 177 802. Although this configuration provides
a simple and cost-effective solution, the actual user-performed
piercing of the tissue with the needle is often problematic as
people who are not experts in medicine are usually insufficiently
practised to place such a needle correctly and they often suffer
from a fear of the likely pain.
[0009] Addressing the above problem, infusion pump devices have
been proposed in which the pump device is supplied to the user with
the needle in a retracted state, i.e. with the distal pointed end
of the needle "hidden" inside the pump device, this allowing the
user to place the pump device on the skin without the possibility
of observing the needle. When first the needle is hidden, at least
some of the fear is overcome making the introduction of the needle
in a second step less problematic. U.S. Pat. Nos. 5,858,001 and
5,814,020 disclose infusion devices of this type in which an
infusion needle is arranged in an upper housing portion pivotably
arranged relative to a base plate portion. In this way the user can
introduce the needle by pressing the upper portion into engagement
with the base plate portion.
[0010] To further reduce the fear and pain associated with the
introduction of the needle, many recent pump devices have been
provided with actuatable needle insertion means, which just has to
be released by the user after which e.g. spring means quickly will
advance the needle through the skin.
[0011] For example, U.S. Pat. No. 5,957,895 discloses a liquid drug
delivery device comprising a bent injection needle which is adapted
to project through a needle aperture in the bottom surface of the
housing in a situation of use. A movable needle carrier is disposed
in the housing for carrying the injection needle and for causing
the injection end of the needle to project through the needle
aperture upon movement of the needle carrier.
[0012] U.S. Pat. No. 5,931,814 discloses an infusion device having
a housing with a drug reservoir, an infusion needle (or cannula)
communicating with the reservoir, means for inserting the needle,
and pump means for discharging the reservoir contents through the
needle. The needle is fixed relative to the housing and projects
beyond the lower skin-contacting surface of the housing to the
depth required for injection. The needle is surrounded by a
protective element which is moved by spring means from a first end
position in which the protective device projects beyond the lower
surface of the housing and beyond the needle to a second end
position in which the protective device does not project beyond the
underside of the casing. An advantage of this design is that the
needle is arranged in a fixed position relative to the reservoir.
WO 02/15965 discloses a similar infusion device in which a base
plate member acts as a protecting element until an upper part of
the device, to which the needle is fixed, is moved down into
engagement with the base plate member.
[0013] In the devices disclosed in U.S. Pat. Nos. 5,957,895 and
5,931,814 the needle is automatically inserted by the release of
pre-tensioned spring means arranged within the devices, whereas in
the device known from WO 02/15965 the needle is inserted by the
user actively moving the hidden needle. Although the automatic
needle insertion means adds convenience for the user and may serve
to overcome needle fear, such means also adds to the complexity and
bulkiness of the device, the first issue adding to the cost of the
device, the latter issue making the device less attractive and
convenient to wear.
[0014] As the above-described infusion devices all comprise a
subcutaneous needle, the devices have to be supplied to the user in
a sterile state, i.e. in a sterile package.
[0015] Before turning to the disclosure of the present invention, a
different type of device relying on the insertion of a needle or
needle-like structure will be described.
[0016] Although drug infusion pumps, either disposable or durable,
may provide convenience of use and improved treatment control, it
has long been an object to provide a drug infusion system for the
treatment of e.g. diabetes which would rely on closed loop control,
i.e. being more or less fully automatic, such a system being based
on the measurement of a value indicative of the condition treated,
e.g. the blood glucose level in case of insulin treatment of
diabetes.
[0017] A given monitor system for measuring the concentration of a
given substance may be based on invasive or non-invasive measuring
principles. An example of the latter would be a non-invasive
glucose monitor arranged on the skin surface of a patient and using
near-IR spectroscopy, however, the present invention is concerned
with the introduction of a transcutaneous device such as a
needle-formed sensor element.
[0018] The sensor may be placed subcutaneously being connected to
external equipment by wiring or the substance (fluid) to be
analysed may be transported to an external sensor element, both
arrangements requiring the placement of a subcutaneous component,
the present invention addressing both arrangements. However, for
simplicity the term "sensor" is used in the following for both
types of sensor elements.
[0019] Turning to the sensor elements per se, relatively small and
flexible electrochemical sensors have been developed for
subcutaneous placement of sensor electrodes in direct contact with
patient blood or other extra-cellular fluid (see for example U.S.
Pat. No. 5,482,473), wherein such sensors can be used to obtain
periodic or continuous readings over a period of time. Insertion
devices for this type of sensors are described in, among others,
U.S. Pat. Nos. 5,390,671, 5,391,950, 5,568,806 and 5,954,643 which
hereby are incorporated by reference.
[0020] More specifically, U.S. Pat. No. 5,954,643 discloses an
insertion set comprising a mounting base supporting a proximal end
of a flexible thin film sensor, the sensor including a distal
segment with sensor electrodes thereon which protrudes from the
mounting base for transcutaneous placement, wherein the sensor
distal segment is slidably carried by a slotted insertion needle
fitted through the assembled base. Placement of the insertion set
against the patient's skin causes the insertion needle to pierce
the skin to carry the sensor electrodes to the desired subcutaneous
site, after which the insertion needle can be slidably withdrawn
from the insertion set. A similar arrangement is known from U.S.
Pat. No. 5,568,806.
DISCLOSURE OF THE INVENTION
[0021] Having regard to the above-identified problems, it is an
object of the present invention to provide a skin-mountable device
which can be supplied to the user in a sealed enclosure, which is
convenient to handle and use, and which can be manufactured cost
effectively.
[0022] Thus, in a general aspect a device is provided, comprising a
first skin-mountable unit having a mounting surface comprising
adhesive means for adhering the unit to the skin of a subject, a
second handling unit releasably attached to the skin-mountable unit
and comprising an interior space at least partially accommodating
the skin-mountable unit and having an opening through which the
skin-mountable member can be moved when detached from the handling
unit, the handling unit having a portion surrounding the opening,
the device further comprising a seal member releasably attached to
the surrounding portion, thereby providing a closed space for the
skin-mountable unit. By the term partially is defined that a
portion of the first unit may project from the opening.
[0023] In this way a device is provided allowing for easy handling
as a user can use the handling unit to grip and handle the combined
device during operation thereof, just as the second unit may be
designed and optimized for ease of use during manipulation (e.g.
activation) of the skin-mountable unit.
[0024] In exemplary embodiments the handling unit comprises a
circumferential portion surrounding the opening. Advantageously,
the circumferential portion defines a general plane, this allowing
e.g. foil-, film- or paper-like materials to be used as sealing
members. In exemplary embodiments when it is desirable to sterilize
the entire first unit, the seal member may be penetratable for
sterilizing gases (e.g. ethylene oxide or dry steam), yet being
non-penetratable for germs. By this arrangement the first unit can
serve as a packaging for the second unit, this further reducing
costs as well as overall size.
[0025] In exemplary embodiments the handling unit comprises a
unitary housing portion defining an interior space which in
combination with the seal member provides the closed space. The
housing portion may be provided by a thermo-formed or injection
moulded unitary structure.
[0026] In a further aspect a device is provided, comprising a first
unit and a releasably attached second unit. The first unit
comprises a mounting surface adapted for application to the skin of
a subject, and a transcutaneous access device (in the following
also termed a transcutaneous device) comprising a distal pointed
end adapted to penetrate the skin of the subject, and the second
unit comprises a portion (e.g. a flange defining the general plane)
adapted to engage the skin of the subject. The transcutaneous
device has a first position in which the distal end is retracted
relative to the skin-engaging portion and a second position in
which the distal end projects relative to the skin-engaging
portion. The second unit comprises actuatable driving means adapted
to move the transcutaneous device from the first position to the
second position when the driving means is actuated with the second
unit attached to the first unit. By this arrangement the second
unit can be brought in engagement with the skin of the subject
where after the driving means can be actuated for insertion of the
transcutaneous device. In an exemplary embodiment of this
arrangement the transcutaneous device is fixedly attached to the
first unit, the first unit having a first position in which the
mounting surface is retracted relative to the skin-engaging
portion, and a second position in which the mounting surface has
been moved to a plane defined by the skin-engaging portion, whereby
the mounting surface engages the skin of the user and the
transcutaneous device penetrates the skin when the driving means is
actuated. The first unit may be arranged in an inclined position,
this allowing the infusion device to be pivoted into its second
skin-contacting position in a well controlled way.
[0027] In a yet further aspect a device is provided, comprising a
first unit and a releasably attached second unit. The first unit
comprises a mounting surface adapted for application to the skin of
a subject, and a transcutaneous device comprising a distal pointed
end adapted to penetrate the skin of the subject, wherein the
transcutaneous device has a first position in which the distal end
is retracted relative to the mounting surface, and a second
position in which the distal end projects relative to the mounting
surface. The second unit comprises actuatable driving means adapted
to move the transcutaneous device from the first position to the
second position when the driving means is actuated with the second
unit attached to the first unit. By this arrangement the first unit
can be applied to the skin of the subject where after the driving
means can be actuated for insertion of the transcutaneous
device.
[0028] The transcutaneous device may be in the form of a pointed
hollow infusion needle, a micro needle array, a pointed needle
sensor, or a combination of a relatively flexible per se blunt
cannula or sensor device with a pointed insertion needle may
provide a pointed transcutaneous device, the insertion needle being
retractable after insertion of the blunt portion of the
transcutaneous device. The cannula is advantageously soft and
flexible relative to the insertion needle which typically is a
solid steel needle. In the disclosure of the present invention as
well as in the description of the exemplary embodiments, reference
will mostly be made to a transcutaneous device in the form of an
infusion needle.
[0029] The first and second units may be releasably attached to
each other by any suitable means allowing the device initially to
be handled and applied against the skin as a unitary device, yet
allowing the units to be separated by the user, e.g. by a
frictional fit, releasable gripping means with or without locking
means, or by breakable attachment means such as adhesives or
welding. The mounting surface may be held in contact with the skin
surface by use of additional means (e.g. adhesive bandages),
however, preferably the mounting surface comprises adhesive means
for attaching the first unit directly to the skin of the
subject.
[0030] For each of the above aspects, the driving means may in the
form of spring means which is arranged in an activated state when
supplied to the user or can be arranged in an activated state by
the user, the second unit comprising trigger means for releasably
retaining the spring means in the actuated state (e.g. compressed
or bend), wherein the trigger means is operable to release the
spring means for moving the needle from the first position to the
second position. It should be emphasized that the actuated state
not necessarily is a stable state in which the spring means can be
left, but a state which may require that an actuation input (e.g. a
force applied by the user) is upheld, i.e. the spring means may
resume an initial state if the actuation input is removed. The
spring means may be any elastically compressible or deformable
driving means.
[0031] When the driving means comprises spring means, the second
unit may comprise actuation means actuatable from a first condition
through an intermediate condition to a second condition, whereby
actuation of the actuation means from the first to the intermediate
condition causes activation of the driving means, and actuation of
the actuation means from the intermediate to the second condition
causes release of the activated spring means thereby moving the
needle from the first position to the second position. By this
arrangement the actuation means may serve as a user interface such
that the user will not have to directly engage the spring means
just as the user input may be transformed, e.g. from one type of
movement to another.
[0032] Advantageously the actuation means comprises an actuating
element (e.g. an element which can be gripped or actuated by the
user) which is moved from a first position through an intermediate
position to a second position, preferably corresponding to a
substantially non-composite movement (e.g. a unidirectional linear
or rotational movement, without intermediate lockable state). In an
alternative arrangement actuation of the actuation means from the
first through the intermediate to the second condition is
accomplished by moving two actuation elements against each.
[0033] Advantageously, the handling unit comprises a housing
defining the interior space, the skin-mountable unit comprising an
upper portion (i.e. opposite the mounting surface) facing towards
the interior space, the driving means being arranged within the
interior space between the upper portion and the housing. In this
configuration the housing may serve as the user interface providing
the above-discussed actuation means for the driving means.
[0034] For embodiments in accordance with the above yet further
aspect, the mounting surface is advantageously generally planar and
arranged substantially corresponding to the general plane. When
such a mounting surface comprises adhesive means for attaching the
first unit to the skin of the subject, the seal member may
advantageously be releasably attached to the adhesive means, this
arrangement avoiding the use of a separate releasable protecting
means such as a liner (e.g. a foil or sheet member) on the
adhesive. In case a separate liner is provided, the liner and the
seal member may be arranged such that pealing off the seal member
automatically result in the liner being peeled of, this
irrespective of the position of the mounting surface.
[0035] As indicated above, the present invention may be utilized in
combination with a number of different types of devices.
[0036] For example, for a needle device as described above the
needle may be in the form of a hollow infusion needle, the first
unit further comprising a reservoir adapted to contain a liquid
drug and comprising in a situation of use an outlet in fluid
communication with the infusion needle, as well as expelling means
for expelling a drug out of the reservoir and through the skin of
the subject via the hollow needle. The reservoir and the expelling
means may be of any suitable type, e.g. of any of the types
described in the above-referred documents.
[0037] In a further embodiment the first unit comprises a
transcutaneous device comprising a transcutaneous member (e.g. a
soft cannula or a sensor) in combination with a co-axially or
co-linearly arranged pointed insertion needle, the insertion needle
and the transcutaneous member being arranged to be simultaneously
moved by the driving means from their respective first position to
their respective second position when the driving means is
actuated, the insertion needle being removable from the
transcutaneous member after insertion. Advantageously the insertion
needle is attached to or gripped by the driving means, this
allowing the insertion needle to be removed from the first unit
together with the second unit.
[0038] Corresponding to the above-described aspects the insertion
needle may be fixed or moveable relative to the mounting surface.
The insertion needle may have any desirable configuration such as
solid or grooved.
[0039] The above-described embodiments have all been provided with
a transcutaneous device adapted to penetrate the skin of a subject,
however, the present invention may also be used in combination with
skin-mountable devices not comprising a transcutaneous device.
[0040] In a further aspect of the invention, a method of applying a
device to a skin surface of a subject is provided, the method
comprising the steps of: (a) providing a device having a first unit
and a releasably attached second unit, wherein the first unit
comprises a generally planar mounting surface comprising adhesive
means for adhering the first unit to the skin of the subject. The
second unit comprises an interior space accommodating the first
unit and having an opening through which the first unit can be
moved when detached from the second unit, the second unit having a
circumferential portion defining a general plane and surrounding
the opening, the mounting surface being arranged interiorly in
respect of the general plane or substantially corresponding to the
general plane, a seal member releasably attached to the
circumferential portion, thereby providing a closed space for the
first unit. The method comprises the further steps of (b) removing
the seal member, (c) arranging the device in contact with the skin
of the subject, and (d) removing the second unit from the first
unit.
[0041] Depending on whether the mounting surface initially is
positioned interiorly in respect of the general plane or
substantially corresponding to the general plane, the adhesive
surface may be placed in contact with the skin surface either when
the device is subsequently moved towards the skin (e.g. by
actuation means) or when the device is initially placed on the skin
surface.
[0042] As used herein, the term "drug" is meant to encompass any
drug-containing flowable medicine capable of being passed through a
delivery means such as a hollow needle in a controlled manner, such
as a liquid, solution, gel or fine suspension. Representative drugs
include pharmaceuticals such as peptides, proteins, and hormones,
biologically derived or active agents, hormonal and gene based
agents, nutritional formulas and other substances in both solid
(dispensed) or liquid form. In the description of the exemplary
embodiments reference will be made to the use of insulin.
Correspondingly, the term "subcutaneous" infusion is meant to
encompass any method of transcutaneous delivery to a subject.
Further, the term needle (when not otherwise specified) defines a
piercing member (including an array of micro needles) adapted to
penetrate the skin of a subject.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] In the following the invention will be further described
with references to the drawings, wherein
[0044] FIG. 1 shows in a perspective view a first embodiment of a
medical device gripped by a user corresponding to a first state of
use,
[0045] FIG. 2A shows in a perspective view the medical device of
FIG. 1 gripped by the user corresponding to a second state of
use,
[0046] FIG. 2B shows the needle device of FIG. 1A with an outer
portion cut away,
[0047] FIG. 2C shows the first unit of the needle device of FIG.
1A,
[0048] FIGS. 3A-3C shows a third state of use corresponding to
FIGS. 2A-2C,
[0049] FIGS. 4A-4C shows a fourth state of use corresponding to
FIGS. 2A-2C,
[0050] FIG. 5 shows in a perspective view the medical device of
FIG. 1 gripped by the user corresponding to a fifth state of
use,
[0051] FIG. 6 shows in cross-section a second embodiment of a
medical device,
[0052] FIG. 7 shows in cross-section a third embodiment of a
medical device,
[0053] FIG. 8 shows in cross-section a fourth embodiment of a
medical device,
[0054] FIG. 9 shows in cross-section a fifth embodiment of a
medical device,
[0055] FIG. 10 shows in cross-section a sixth embodiment of a
medical device, and
[0056] FIGS. 11A-11D shows different expelling means suitable for
use with the invention, FIG. 12A shows an exploded view of a drug
infusion device seen from above, FIG. 12B shows an exploded view of
the infusion device seen of FIG. 12A from below, FIGS. 12C and 12D
shows the infusion device comprising two sub-assemblies, FIG. 12E
shows the infusion device in an assembled initial state,
[0057] FIG. 12F shows the infusion device in an assembled actuated
state,
[0058] FIG. 12G shows the infusion device in its delivery
package,
[0059] FIGS. 13A-13C shows different states of use for a sensor
device, and
[0060] FIGS. 14A-14C show in cross-sections a further embodiment of
a medical device.
[0061] In the figures like structures are identified by like
reference numerals.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0062] When in the following terms as "upper" and "lower", "right"
and "left", "horizontal" and "vertical" or similar relative
expressions are used, these only refer to the appended figures and
not to an actual situation of use.
[0063] FIGS. 1-4 show in schematic representations perspective
views of different states of use of a medical device in accordance
with the invention. Correspondingly, the configuration of the
different structures as well as there relative dimensions are
intended to serve illustrative purposes only.
[0064] More specifically, FIG. 1 shows a first embodiment of a
medical device 100 gripped by a user. The medical device comprises
a second unit 110 with a housing defining an interior space 115,
and a first unit 150 releasably attached within the interior space.
In the following the second unit will also be termed the
"inserter". The housing comprises a main portion with a lower
opening surrounded by a circumferential flange 111 extending away
from the housing, the flange having a lower surface 112 defining a
general plane for the medical device. The housing further comprises
first and second upwardly protruding actuation members (or handling
members) 120, 130 arranged on the upper portion of the housing
opposite the opening, the actuation members comprising ribbed
portions 121, 131 allowing for easy gripping by a user, e.g. using
the first and second fingers as shown. The first unit is in the
form of a needle device (e.g. an infusion device or a sensor
device) comprising an adhesive mounting surface 151 adapted for
application to the skin of a subject, the mounting surface being
generally planar and arranged substantially corresponding to the
general plane. The needle device further comprises a needle (not
shown) having a distal pointed end adapted to penetrate the skin of
the subject, the needle having a first position in which the distal
end is retracted relative to the mounting surface, and a second
position device 100 can be placed on a skin portion of the user
(see FIG. 2A), the needle device thereby adhesively engaging the
skin.
[0065] Corresponding to the invention, the inserter further
comprises actuatable driving means adapted to move the needle from
the first position to the second position when the driving means is
actuated with the second unit attached to the first unit. As best
seen in FIG. 2B the driving means is in the form of an angularly
bend leaf spring 140 comprising an upper portion 142 extending into
the interior of the first actuation member 120 and a lower portion
141 with a distal end which in an initial state rests on a shelf
member 144 protruding inwardly from the housing. In the initial
state as supplied to the user, the spring is preferably in a
relaxed condition and the spring may be held in place merely in
cooperation with the first actuation member and the shelf, however,
to prevent the spring from disengaging after actuation (see below)
the upper portion may be attached to the first actuation member.
The first actuation member is pivotably attached to the main
portion by an integrally formed hinge 122. To prevent unintentional
movement of the first actuation member and serving as tamper
evidence, breakable locking means 123 is provided between the first
actuation member and the main portion.
[0066] As best seen in FIG. 2C, the needle device comprises a lower
base portion 155 defining the mounting surface, and an upper
housing portion 156 pivotably attached to the base portion by hinge
means 157. The needle is fixedly attached to the housing portion,
the mounting surface comprising an opening (not shown) through
which the needle can be advanced from its first to its second
position when the housing portion is moved from an initial upper
position to a lower engagement position. Between the two portions
is arranged locking means (not shown) allowing the housing portion
to be locked to the base plate when moved into engagement
therewith.
[0067] After having placed the medical device on a skin portion,
the user presses the actuation members towards each other to
activate the driving means, thereby breaking the locking means as
shown in FIG. 3A. In an alternative embodiment (not shown) the
locking means may be collapsible. During this action the first
actuation member is moved from a first (initial) position (or
condition) through an intermediate position to a second position,
during which movement of the first actuation member from the first
to the intermediate position causes activation of the spring, and
actuation of the first actuation member from the intermediate to
the second position causes release of the activated spring thereby
moving the needle from the first position to the second position.
More specifically, corresponding to the intermediate condition, the
leaf spring has been bent but the lower portion 141 is still
resting on the shelf 144 (see FIG. 3B) whereby energy is
elastically stored in the spring. Corresponding to the second
condition the spring is released from the shelf, the lower portion
of the spring thereby being forced downwardly engaging the upper
surface of the housing portion 156, whereby the latter is pivoted
downwardly into locking engagement with the base portion 155 as
shown in FIGS. 4B and 4C. During this action the needle is moved
from its first to its second position, the pointed distal end
thereby being introduced through the skin of the user. As seen in
FIG. 3B the inserter comprises a protrusion 145 which in the
initial state is in engagement with a corresponding depression on
the housing portion 156 thereby serving (in combination with
similar opposed means (not shown)) as a releasably attachment means
between the two units.
[0068] When the needle has been introduced the inserter can be
removed as shown in FIG. 4A. FIG. 5 shows the same situation seen
from the perspective of the user when the needle device has been
placed on the abdomen.
[0069] In the first embodiment the needle was attached to an upper
housing portion which was moveably arranged relative to the
mounting surface, thereby providing the relative movement between
the needle and the mounting surface. In FIG. 6 is shown a second
embodiment of a medical device 200 substantially corresponding to
the first embodiment, the device comprising an inserter 210,
defining an interior space 215 with a leaf spring 240, frictionally
coupled to an infusion device 250 comprising a hollow infusion
needle 260, a drug-containing cartridge 270 as well as expelling
means (not shown) arranged therewithin. However, in contrast to the
first embodiment, merely the needle is moveable relative to the
mounting surface. In the shown schematic embodiment the needle is
bent in a U-form with the U-portion protruding through an upper
surface of the infusion device, the needle further comprising a
pointed distal end adapted to penetrate the skin of the user and a
pointed proximal end adapted to penetrate a needle-penetratable
sealing member 271 of the cartridge. In alternative embodiments the
needle may be arranged within the infusion device, additional means
being adapted to transfer the movement of the spring to the needle
(see FIG. 9). In respect of use and actuation of the medical
device, the second embodiment corresponds to the above-described
first embodiment.
[0070] In FIG. 7 is shown a third embodiment of a medical device
300 substantially corresponding to the first embodiment, the device
comprising an inserter 310 coupled to an infusion device 350
comprising a hollow infusion needle 360 protruding from a mounting
surface of the infusion device, a drug-containing cartridge 370 as
well as expelling means (not shown) arranged therewithin. However,
in contrast to the first embodiment, the mounting surface is
initially arranged in a retracted position relative to the general
plane defined by the lower surface 312 of the flange. As appears,
the infusion device is arranged in an inclined position, this
allowing the infusion device to be pivoted into its second
skin-contacting position in a well controlled way. When comparing
the first and third embodiment, it appears that the infusion device
350 corresponds to the upper housing portion 156, both members
being arranged in an inclined position and comprising a fixedly
attached needle. The inserter comprises gripping means 345, 346 in
engagement with corresponding areas on the housing portion of the
needle device thereby serving as a releasably attachment means
between the two units.
[0071] The protruding portion of the needle is preferably supplied
to the user with a protecting member (not shown). When the device
is to be used, the user removes the sealing foil member 313, the
protecting means, e.g. a peelable liner or foil member 351 covering
the adhesive on the mounting surface as well as the needle
protecting member, after which the medical device can be placed
against the skin of the user corresponding to the situation shown
in FIG. 2A. The liner may as shown be coupled to the foil allowing
the two members to be removed in one operation. In respect of
actuation of the medical device, the third embodiment substantially
corresponds to the above-described first embodiment, the main
difference being that the base portion (and thereby the mounting
surface) initially is attached to the housing portion forming a
unitary infusion device.
[0072] In FIG. 8 is shown a fourth embodiment of a medical device
400 substantially corresponding to the first embodiment, the device
comprising an inserter 410 coupled to an infusion device 450, the
infusion device comprising a hollow infusion needle 460 mounted in
an upper housing portion 456 and arranged in a retracted position
relative to a base portion 455, and a drug-containing cartridge 470
proximally provided with a conduit 471 in communication with gas
generating expelling means (not shown) arranged therewithin.
[0073] Whereas the inserter of the first embodiment is suitable for
manufacture using injection molding, the inserter of the forth
embodiment has been adapted for thermoforming, i.e. corresponding
to the method often used for cost effective manufacture of
packaging materials.
[0074] More specifically, the inserter comprises a lower opening
surrounded by a circumferential flange 411 to which a seal member
413 is releasably attached, and two upwardly protruding
substantially identical actuation members 420, 430 between which is
provided a number or grooves 425 allowing the two actuation members
to be pressed against each other. The inserter further comprises a
first set of inwardly protruding members 445, 446 adapted to engage
corresponding recesses on the infusion device, and a second set of
inwardly protruding members 422, 432 adapted to hold a spring in
place. The spring is in the form of a bi-staple leaf spring
comprising an initially upwardly curved central portion 441 and two
upwardly protruding leg portions 442, 443 arranged within the
actuation members.
[0075] After having removed the seal member 413 and the liner
protecting the adhesive, the medical device 400 is placed on a skin
portion of the user. The user presses the two actuation members
towards each other to activate the driving means. During this
action the actuation members are moved from a first (initial)
position (or condition) through an intermediate position to a
second position, during which, the spring is activated and
released. More specifically, corresponding to the intermediate
condition, the two leg portions have been moved towards each other
thereby tensioning the curved portion of the spring, however,
corresponding to the second condition the bi-stable spring suddenly
transforms into its second bi-stable state whereby the curved
portion is forced downwardly engaging the upper surface of the
infusion device, whereby the latter is pivoted downwardly into
engagement with the base portion whereby the needle is introduced
through the skin of the user. As the second bi-stable state is only
semi-stable, the spring will return to its initial position as the
user reduces the compression force on the actuation members,
however, this will not influence the infusion device. When the
needle thus has been introduced the inserter can be removed.
[0076] In the above described embodiments the needle (or the member
comprising the needle) has been held in its non-actuated state by
frictional means or gripping means, however, in an alternative
configuration additional releasable locking means (not shown) may
be provided. In advantageous embodiments such locking means is
coupled to the user actuatable actuation means such that the
locking means is released in combination with actuation of the
driving means. Such locking means may be formed as a separate
member or may be formed integrally with either a housing or a
spring member.
[0077] FIG. 9 shows a fifth embodiment of a medical device 500 in
which the driving means is (or can be) arrested in an activated
state before being released by the user. The needle device 550
substantially corresponds to the second embodiment, i.e. merely the
needle is moveable relative to the mounting surface, the needle
being associated with additional transfer means 551 protruding from
the upper surface of the needle device and adapted to be engaged by
the drive means.
[0078] The inserter comprises a drive means in the form of a spring
actuated piston assembly 540, 541 acting on the transfer means. In
the shown embodiment the medical device is supplied to the user as
a sealed unit with the spring in a pre-tensioned state, the
inserter being provided with user actuatable release means 542
allowing the user to release the spring after the device has been
placed on a skin portion of the user as discussed above.
Advantageously, the release means may be designed to allow the
combined device to be provided in a sterilized and sealed condition
(not shown).
[0079] In an alternative embodiment (not show) the inserter may be
supplied with the spring in a nontensioned state, the inserter
comprising means allowing the user to activate and lock the spring
in an activated state. In a further alternative embodiment (not
show) such an inserter may be supplied as a separate unit in which
the needle device is mounted by the user. In this way the inserter
can be provided as a durable unit.
[0080] FIG. 10 shows a sixth embodiment of a medical device 600
substantially corresponds to the fifth embodiment, however, the
inserter is provided as a separate unit adapted to engage a needle
device provided as a sealed unit.
[0081] More specifically, the needle device 650 resembles the
combined device of the fifth embodiment (i.e. comprising a needle
device and a casing therefore), however, the driving means has been
omitted allowing the needle device to be supplied as a compact,
sterilized and sealed unit comprising a needle device 655 and an
outer housing (e.g. in the form of a closed packaging) 656, 613,
the unit being adapted to be mounted in a separate inserter 610.
The inserter comprises a housing 611 adapted to engage the outer
housing of the needle device and comprises a drive means 640, 641,
642 corresponding to the fifth embodiment, i.e. a lockable,
spring-driven piston adapted to engage the transfer means 651
through a deformable portion 657 of the outer housing. The two
units may be provided with releasable gripping means 612 allowing
the inserter to be attached to the needle device prior to arranging
the needle device on a skin portion, this improving handling.
Correspondingly, the user may place the needle device 650 in the
inserter before removing the protective foil 613. The inserter may
be supplied separately as a durable unit or it may be supplied as
part of a kit, e.g. a package containing a plurality of needle
devices and an inserter. Indeed, the transfer means may also be
actuated manually by the user by simply applying pressure with a
finger.
[0082] In the above-described embodiments a medical device has been
described comprising a reservoir, however, for better illustrating
the principles of the present invention, the means for expelling a
drug from the reservoir has been omitted in the figures. Such
expelling means, which as the reservoir does not form part of the
present invention in its basic form, may be of any type which would
be suitable for arrangement within a skin-mountable drug delivery
device. Further, as the needle of the present invention also may be
in the form of a needle sensor, the interior of the medical device
may comprise sensor means adapted to cooperate with the needle
sensor.
[0083] In FIGS. 11A-11D examples of expelling means suitable for
use with the present invention are shown schematically, however,
these are merely examples. More specifically, FIG. 1 1A shows a
pump arrangement comprising a drug-containing cartridge 1010 having
a distal closure member 1011 allowing a needle to be connected, and
a piston 1015 slidingly arranged there within, a flexible toothed
piston rod 1020 (for example as disclosed in U.S. Pat. No.
6,302,869), an electric motor 1030 which via a worm-gear
arrangement 1031 drives the piston rod to expel drug from the
cartridge, the motor being controlled by control means 1040 and the
energy for the control means and the motor being provided by a
battery 1050. The pump may be activated when the needle is inserted
(by means not shown) or by separate user-actuatable means (not
shown) after the inserter has been detached form the delivery
device.
[0084] FIG. 11B shows a pump arrangement comprising a
drug-containing cartridge 1110 having distal and proximal closure
members 1111, 1112, and a piston 1115 slidingly arranged there
within, gas generating means 1120 in fluid communication with the
interior of the cartridge via conduit 1121 for driving the piston
to expel drug from the cartridge, the gas generating means being
controlled by control means 1140 and the energy for the control
means and the gas generation being provided by a battery 1150. The
pump may be activated as indicated above. A detailed disclosure of
such gas generating means for a drug delivery device can be found
in e.g. U.S. Pat. No. 5,858,001.
[0085] FIG. 11C shows a pump arrangement comprising a
drug-containing cartridge 1210 having distal and proximal closure
members 1211, 1212, and a piston slidingly 1215 arranged there
within, an osmotic engine 1220 in fluid communication with the
interior of the cartridge via conduit 1221 for driving the piston
to expel drug from the cartridge. The osmotic engine comprises a
first rigid reservoir 1225 containing a salt-solution and a second
collapsible reservoir 1226 containing water, the two reservoirs
being separated by a semi-permeable membrane 1227. When supplied to
the user, the fluid connection 1228 between the second reservoir
and the membrane is closed by a user-severable membrane (e.g. a
weak weld) which, when severed, will allow the osmotic process to
start as water is drawn from the second reservoir through the
membrane and into the first reservoir. The pump may be activated as
indicated above. A detailed disclosure of the osmotic drive
principle can be found in e.g. U.S. Pat. 5,169,390.
[0086] FIG. 11D shows a pump arrangement comprising a
drug-containing flexible reservoir 1310 arranged within a rigid
fluid-filled secondary reservoir 1311 in fluid communication with a
primary reservoir 1320 through a conduit 1330 comprising a flow
restrictor 1331. The primary reservoir is in the form of a
cartridge with a moveable piston 1321 and contains a viscous drive
fluid. A spring is arranged to act on the piston to drive fluid
from the first to the second reservoir thereby expelling drug from
the flexible reservoir when the latter is connected to an infusion
needle (not shown). The flow rate will be determined by the
pressure generated by the spring in the drive fluid, the viscosity
of the drive fluid and the flow resistance in the flow restrictor
(i.e. bleeding hole principle). The pump may be activated by
straining the spring or by releasing a pre-stressed spring, either
when the needle is inserted (by means not shown) or by separate
user-actuatable means (not shown) after the inserter has been
detached form the delivery device. An example of this principle
used for drug infusion is known from DE 25 52 446. In an
alternative configuration, the drug reservoir may be pressurized
directly to expel the drug via a flow restrictor, e.g. as disclosed
in U.S. Pat. No. 6,074,369.
[0087] In the above described embodiments, the transcutaneous
device has been in the form of a unitary an insertion needle which
is withdrawn fully or partly after insertion thereof.
[0088] With reference to FIGS. 13A-13C an embodiment of a sensor
device will be described, having the same general hinged
configuration as the needle device of the first embodiment, wherein
the transcutaneous device is in the form of a combined needle
sensor and corresponding insertion needle therefore. For improved
clarity, the structures relating to the inserter have been omitted
in the drawings.
[0089] More specifically, the sensor device 750 comprises a lower
base portion 755 defining the mounting surface, and an upper
housing portion 756 pivotably attached to the base portion by hinge
means 757. A relatively flexible needle-formed sensor 760 with a
distal sensor element is fixedly attached to the housing portion
and is in communication with signal receiving means 761. The signal
receiving means may be contact means for connecting the sensor
device to external processor means for evaluating the signals,
transmitting means for wireless transmission to an external
processor, or a processor arranged within the housing. The
needle-sensor is supported by an insertion needle 770, the support
preventing deformation of the needle-sensor during insertion. The
insertion needle is slidably received in the upper housing portion
and comprises a gripping member 771 allowing the insertion needle
to be withdrawn by the user after insertion has taken place. The
mounting surface comprises an opening 758 through which the two
needles can be advanced from its first to its second position when
the housing portion is moved from an initial upper position to a
lower engagement position. Between the two portions is arranged
locking means (not shown) allowing the housing portion to be locked
to the base plate when moved into engagement therewith.
[0090] FIG. 13A shows the sensor device in an initial position,
FIG. 13B shows the sensor device after the two needles 760, 770
have been introduced and the inserter has been removed, and FIG.
13C shows the situation in which the needle-sensor has been
inserted and the insertion needle has been withdrawn. In the shown
embodiment the insertion needle is adapted to be withdrawn by the
user, however, the driving means and the gripping means may be
designed to engage each other such that the insertion needle is
removed from the sensor device together with the inserter.
[0091] In FIG. 14A is shown a schematic representation of a further
embodiment of a medical device 800 substantially corresponding to
the embodiment shown in FIG. 7, the device comprising an inserter
810 coupled to an infusion device 850 comprising a flexible
infusion cannula 860 adapted to cooperate with a pointed insertion
needle 880 mounted on the leaf spring 840 by means of a needle
carrier 881, a drug-containing cartridge 870 as well as expelling
means (not shown) arranged there within. The flexible cannula
(which e.g. may be of the soft "Teflon.RTM." type) comprises a
self-sealing needle-penetratable septum portion 861 through which
the insertion needle is mounted as well a circumferentially
arranged locking means in form of a collar 862. In the initial
position the pointed distal end of the insertion needle is arranged
in a slightly retracted position relative to the distal opening of
the infusion cannula and with the needle carrier positioned a small
distance above the septum. When the inserter is actuated as shown
in FIGS. 2-4, the needle carrier is moved downwardly thereby
engaging the septum, in which position the insertion needle
projects a small distance out through the cannula, and further
forcing the cannula from its retracted to its extended position,
the projecting pointed needle end allowing the cannula to be
introduced through the skin of a subject, see FIG. 14B. In this
position the locking means engages the housing of the medical
device allowing the insertion needle to be removed from the device
together with the inserter as seen in FIG. 14C.
[0092] In an alternative embodiment (not shown) the needle device
is in the form of a so-called infusion set comprising an infusion
cannula and a therethrough arranged removable insertion needle,
such infusion sets typically being used to provide an infusion site
in combination with (durable) infusion pumps.
[0093] In the above-described embodiments the needle has been
arranged primarily for actuation by external driving means
positioned above the needle device, however, with reference to
FIGS. 12A-12G a drug infusion device is shown which is adapted for
manual actuation by moving an actuation member in parallel with the
mounting surface, such a device advantageously being supplied to
the user in a sealed package in accordance with the present
invention.
[0094] More specifically, a drug infusion device 901 comprises a
base plate 910, a first cover member 920 and a second cover member
930, the three elements in combination forming a housing in which a
pump assembly 940 and a flexible drug reservoir 950 are
arranged.
[0095] The base plate comprises a lower generally planar surface
918 serving as a mounting surface comprising adhesive means for
adhering the unit to the skin of a subject, and an upper surface
919 provided with connecting means allowing the first and second
cover members as well as a pump assembly 940 to be mounted on the
base plate. More specifically, the base plate comprises three
upstanding hook-members 911 adapted to engage corresponding hook
structures 921 on the first cover member to thereby lock the two
members to each other in a snap-action manner, as well as a pair of
parallelly arranged opposed members 912 having outwardly open
grooves adapted to engage corresponding flange structures 931 on
the second cover member allowing the two members to be mounted in
sliding engagement with each other. In order to control movement
between the two members, the grooves and the flanges may be
provided with corresponding ratchet or locking means 916, 932. To
help align the second cover member as it is moved towards the first
cover member, the base plate comprises a ridge member 913 adapted
to engage a corresponding groove structure 933 on the second cover
member. The base plate member further comprises an aperture 914, a
part-cylindrical "female" hinge member 915 adapted to engage the
pump assembly, as well as an opening 917 associated with the hinge
member.
[0096] The pump assembly 940 comprises a membrane pump as well as
control means, actuating means (e.g. heating means), contact means
and an energy source for driving the pump. The pump assembly is
configured with a (part) cylindrical hinge body 941 from which
protrudes a pump body 942 wherein the pump and driving means are
arranged. On the lower surface of the hinge body an engagement
member 947 is arranged. The pump inlet is in fluid communication
with an inlet needle 943 protruding axially from an end of the
hinge body and the pump outlet is in fluid communication with an
infusion needle 944 protruding from a lower surface 948 of the pump
body, both needles having a pointed free end. The hinge body is
adapted to be pivotally received in the hinge member 915 with the
engagement member 947 arranged in the opening 917 to prevent axial
displacement of the pump assembly, and with the infusion needle in
alignment with the aperture 914.
[0097] The flexible reservoir 950 is in the form of a pouch- or
bag-like member formed from a pliable material and provided with a
needle penetratable connecting means, e.g. a self-sealing septum
(not shown). The reservoir is easily collapsible allowing the drug
contained therein to be sucked out by the pump without the need for
additional venting means. The reservoir is mounted and hold in
place under the second cover member by appropriate means. In the
shown embodiment the reservoir is prefilled with a drug such as
insulin, however, the reservoir may also be adapted to be filled by
the user prior to user.
[0098] The above-described components are assembled in two
subassemblies (see FIGS. 12C and 12D), a main assembly 960 and a
reservoir assembly 970, this allowing the assemblies to be
sterilized independently if necessary. More specifically, the main
assembly comprises the base plate member with the first housing
member mounted on top thereof providing a cavity in which the pump
assembly 940 is pivotally arranged in the hinge member 915, and the
reservoir assembly comprises the second housing member with the
reservoir mounted corresponding to a lower surface thereof. The
hinge may be configured to provide an upwardly biasing force
preventing the pump assembly from pivoting downwardly. The second
housing member is provided with an end portion having a grooved
area 934 and an oppositely arranged shroud portion 935 adapted to
slide under the first cover member, as well as a lower ramp member
936 associated with the lower surface of the second housing member,
the function of which will be explained in greater detail below.
The grooved area may in combination with an opposed protruding
ridge 923 on the first cover member serve as engagement means
allowing the infusion device to be releasable locked to
corresponding engagement means on the housing member of the package
(see FIG. 12G).
[0099] The drug infusion device 901 is supplied to the user with
two subassemblies assembled corresponding to an initial state as
shown in FIG. 12E. More specifically, the reservoir assembly is
mounted in sliding engagement with the base plate member by means
of the connecting members 912, 931, a cavity inclosing the
reservoir thereby being formed between the second cover member and
the base plate member, the reservoir connecting means being
arranged in axial alignment with the inlet needle. In the initial
state the reservoir assembly is not fully moved towards the first
cover member, however, the shroud is partially inserted under the
first cover member, this providing a closed cavity. The locking or
ratchet means 916, 932 arranged between the second cover member and
the base plate member may be configured to prevent that the
reservoir assembly can be removed by the user.
[0100] In accordance with the invention and as shown in FIG. 12G,
the infusion device 901 is supplied in an enclosure allowing for
easy handling. More specifically, the device is supplied in a
package housing 990 substantially corresponding to the external
configuration and size of the device in its initial state, the
package housing having engagement means 993, 994 cooperating with
corresponding engagement means (shown simplified) on the infusion
device, and a circumferential flange 991 defining an opening
substantially corresponding to the mounting surface of the device,
the opening being closed by a seal member 992 releasable attached
to the flange and the adhesive on the mounting surface. To improve
handling the package housing comprises opposed raised portions 995,
996 allowing the container to be easily gripped by two fingers. The
package housing is made from a flexible, easily deformable
material.
[0101] To activate the infusion device, the reservoir assembly is
moved towards the pump assembly (see FIG. 12F) whereby a number of
actions takes place. More specifically, the inlet needle 943 will
penetrate the reservoir connecting means providing fluid
communication between the reservoir and the pump, and the ramp 936
on the second cover member will engage the pump assembly to thereby
pivot it downwardly whereby the infusion needle 944 will be moved
through he aperture 914. At the same time contact means arranged on
the pump assembly (e.g. on the lower surface of the pump body) will
be activated, thereby activating the pump control means and
eventually the pump, however, the activated control means may be
adapted to "wait" for a command signal from an external signal
(e.g. supplied from a remote control device) before the pump is
actuated. In an alternative embodiment (not shown) the reservoir
assembly and the pump assembly may be adapted to move linearly,
e.g. in a co-linear fashion when arranged in a "stack". In further
alternative embodiments (not shown) the reservoir may be connected
to the pump, the pump being started, and the needle introduced
partly or fully independently of each other, e.g. by two or three
user actuated actions.
[0102] The drug infusion device 901 may be used in the following
way. After the seal member (and eventually a separate liner) has
been removed the device in its package housing is placed on a
suitable skin portion of the user, e.g. in the abdominal region.
Hereafter the user presses the raised portions of the package
container against each other thereby pushing the reservoir assembly
serving as a button (indicated by the grooved area 934) towards the
main portion until it locks in place, this, as described above,
resulting in activation of the pump and introduction of the needle
through the skin of the user. At the same time the package housing
will disengage from the infusion device. Depending on the
programming of the control means, the pump may start to operate
immediately or it may wait for user activated commands before pump
action is initiated, e.g. commands received from a remote commander
or from input means arranged on the device.
[0103] When the device is to be removed, it may be pulled of the
skin in its active state with the needle protruding from the lower
surface, or the device may be reversed to its initial state before
it is removed. For example, if locking means are arranged between
the shroud and the first cover member, the locking means may be
released by pushing down the upper surface of the first cover
member.
[0104] The above-described embodiments have all been provided with
a subcutaneous device adapted to penetrate the skin of a subject,
however, the present invention may also be used in combination with
skin-mountable devices not comprising a needle or any other
skin-piercing element.
[0105] For example, the skin-mountable device may be in the form of
a sensor device comprising a sensor means adapted to be arranged in
contact with a skin portion of a subject and capable of being
influenced by a body substance or condition and producing a signal
corresponding thereto. The sensor device further comprising control
means adapted to receive signals from the sensor means and generate
command signals in response thereto. The control means may be
adapted for connecting the sensor device to external processor
means for evaluating the signals, transmitting means for wireless
transmission to an external processor, or a processor arranged
within the housing.
[0106] In a further embodiment the skin-mountable device is a
signal device comprising first and second electrodes arranged on
the mounting surface and adapted to be mounted in conductive
contact with the skin of a subject, the first and second electrodes
providing a pair of electrodes, and a voltage source for providing
a voltage between the pair of electrodes. The signal device further
comprises control means for controlling the voltage applied between
the pair of electrodes, the control means being adapted for
identifying a predefined condition or a signal and applying a
voltage between the pair of electrodes in response thereto. Such a
signal device may be provided in combination with any
skin-mountable device, or it may be provided as a separate
skin-mountable signal unit adapted to be in communication with
and/or controlled by one or more primary devices. When provided
with means for receiving externally generated (cordless) command
signals, the signal device may be used in combination with devices
or systems which then do not have to be skin mounted. For example,
such a signal device may be utilized with a separate infusion pump
which may then be carried in a belt or in a pocket. In a different
technical field, people with impaired hearing may use the signal
device as a hearing aid, e.g. to help hear the phone ring, an alarm
clock sound or any other traditionally audible signal. Indeed, for
any given combination of the signal device of the invention and an
external device, the two devices will have to be adapted to
communicate with each other.
[0107] In the above description of the preferred embodiments, the
different structures and means providing the described
functionality for the different components have been described to a
degree to which the concept of the present invention will be
apparent to the skilled reader. The detailed construction and
specification for the different components are considered the
object of a normal design procedure performed by the skilled person
along the lines set out in the present specification.
CITED DOCUMENTS WHICH ARE INCORPORATED BY REFERENCE
[0108] U.S. Pat. No. 4,340,048 [0109] U.S. Pat. No. 4,552,561
[0110] U.S. Pat. No. 5,858,001 [0111] U.S. Pat. No. 6,280,148
[0112] U.S. Pat. No. 5,957,895 [0113] U.S. Pat. No. 5,527,288
[0114] U.S. Pat. No. 2,605,765 [0115] U.S. Pat. No. 4,340,048
[0116] EP 1 177 802 [0117] U.S. Pat. No. 5,814,020 [0118] U.S. Pat.
No. 5,931,814 [0119] WO 02/15965 [0120] U.S. Pat. No. 5,482,473
[0121] U.S. Pat. No. 5,390,671 [0122] U.S. Pat. No. 5,391,950
[0123] U.S. Pat. No. 5,568,806 [0124] U.S. Pat. No. 5,954,643
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