U.S. patent application number 11/813433 was filed with the patent office on 2009-03-19 for medical device with protected transcutaneous device.
This patent application is currently assigned to Nova Nordisk A/S. Invention is credited to Simon Rorvig, Claude Teisen-Simony.
Application Number | 20090076451 11/813433 |
Document ID | / |
Family ID | 35976719 |
Filed Date | 2009-03-19 |
United States Patent
Application |
20090076451 |
Kind Code |
A1 |
Teisen-Simony; Claude ; et
al. |
March 19, 2009 |
Medical Device with Protected Transcutaneous Device
Abstract
A medical device is provided comprising a first a second units,
the first unit comprising a housing with a skin-mountable surface,
and a transcutaneous device having a distal portion adapted to be
arranged through the skin of the subject in a situation of use in
which the housing has been applied on a skin surface. The second
unit is adapted to be releasably coupled to the first unit thereby,
in a situation of use, substantially covering an introduction site
of the transcutaneous device through the skin, whereby at least
partial removal of the second unit from the first unit at least
partially uncovers the introduction site. In this way the
transcutaneous device can be protected during use, yet it allows
the user to inspect the introduction site.
Inventors: |
Teisen-Simony; Claude;
(Frederiskberg, DK) ; Rorvig; Simon; (Copenhagen,
DK) |
Correspondence
Address: |
NOVO NORDISK, INC.;INTELLECTUAL PROPERTY DEPARTMENT
100 COLLEGE ROAD WEST
PRINCETON
NJ
08540
US
|
Assignee: |
Nova Nordisk A/S
Bagsvaerd
DK
|
Family ID: |
35976719 |
Appl. No.: |
11/813433 |
Filed: |
January 24, 2006 |
PCT Filed: |
January 24, 2006 |
PCT NO: |
PCT/EP06/50410 |
371 Date: |
April 30, 2008 |
Current U.S.
Class: |
604/131 |
Current CPC
Class: |
A61M 5/158 20130101;
A61M 5/1413 20130101; A61M 2005/1426 20130101; A61M 5/1483
20130101; A61M 2005/1587 20130101; A61M 2005/14252 20130101; A61M
5/14248 20130101; A61M 2005/1585 20130101; A61M 2005/1581
20130101 |
Class at
Publication: |
604/131 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 24, 2005 |
DK |
PA 2005 00115 |
Claims
1. A medical device comprising a first unit (1010) and a second
unit (1050), the first unit being a transcutaneous device unit
comprising: a housing (1015) comprising a mounting surface (1020)
adapted for application towards a skin surface of a subject, and a
transcutaneous device (1017) having a distal portion adapted to be
arranged through the skin of the subject in a situation of use in
which the housing has been applied towards a skin surface of the
subject, the second unit being adapted to be releasably coupled to
the first unit thereby, in a situation of use, substantially
covering an introduction site of the transcutaneous device through
the skin, wherein at least partial removal of the second unit from
the first unit at least partially uncovers the introduction
site.
2. A medical device as in claim 1, wherein the distal portion is
adapted to be arranged through the skin of the subject at an
inclined angle relative to the mounting surface.
3. A medical device as in claim 1, wherein the distal portion is
inclined towards the second unit when the first and second units
are coupled to each other.
4. A medical device as in claim 1, wherein the transcutaneous
device has a retracted position relative to the mounting surface,
and an extended position in which the distal portion projects
relative to the mounting surface.
5. A medical device as in claim 4, wherein the transcutaneous
device unit comprises actuation means (960) for moving the distal
portion of the transcutaneous device between the retracted and the
extended position when the actuation means is actuated by a
subject.
6. A medical device as in claim 1, wherein the second unit is a
process unit comprising a process assembly adapted to cooperate
with the transcutaneous device.
7. A medical device as in claim 6, wherein the transcutaneous
device is in the form of a transcutaneous sensor device, and the
process assembly comprises a processor adapted to transmit and/or
process data acquired via the sensor device.
8. A medical device as in claim 6, wherein the transcutaneous
device is in the form of a transcutaneous access device, and the
process assembly comprises a reservoir (760) adapted to contain a
fluid drug, an expelling assembly (300, 580) adapted for
cooperation with the reservoir to expel fluid drug out of the
reservoir and through the skin of the subject via the
transcutaneous access device, and a processor for controlling the
expelling assembly.
9. A medical device as in claim 8, wherein the transcutaneous
access device is a flexible polymeric cannula.
10. A medical device unit (1010) adapted to be releasably coupled
to a second unit, the medical device unit being a transcutaneous
device unit comprising: a housing adapted for application towards a
skin surface of a subject, the housing comprising a coupling
portion adapted to engage the second unit, and a transcutaneous
device (1017) having a distal portion adapted to be arranged
through the skin of the subject, the distal portion projecting from
the housing in the vicinity of the coupling portion.
11. A medical device comprising a first unit (1010) and a second
unit (1050) adapted to be releasably coupled to the first unit
corresponding to a coupling zone, the first unit being a
transcutaneous device unit comprising: a housing adapted for
application towards a skin surface of a subject, and a
transcutaneous device (1017) having a distal portion adapted to be
arranged through the skin of the subject, the distal portion
projecting from the medical device corresponding to the coupling
zone.
12. A medical device comprising a first unit (1010) and a second
unit (1050) adapted to be releasably coupled to the first unit, the
first unit being a transcutaneous device unit comprising: a housing
adapted for application towards a skin surface of a subject, and a
transcutaneous device having a distal portion adapted to be
arranged through the skin of the subject in a situation of use in
which the housing has been applied towards a skin surface of the
subject, the distal portion projecting from the housing thereby
allowing, in a situation of use, inspection of an introduction site
of the transcutaneous device through the skin when the second unit
is not coupled to the first unit, whereby the second unit when it
is coupled to the first unit fully or partly covers the
introduction site.
13. A method comprising the steps of: (a) providing a
transcutaneous device unit (1010) comprising a transcutaneous
device and a mounting surface, the transcutaneous device having
retracted position relative to the mounting surface, and an
extended position in which a distal portion projects relative to
the mounting surface, (b) providing a process unit (1050)
comprising a process assembly adapted to cooperate with the
transcutaneous device, (c) mounting the mounting surface to a skin
surface of a subject, (d) inserting the transcutaneous device into
the subject by moving the transcutaneous device from the retracted
position to the extended position, the configuration of the
transcutaneous device unit allowing a subject to inspect the
introduction site through the skin, (e) assembling the
transcutaneous device unit and the process unit to provide a
functional communication between the process assembly and the
inserted transcutaneous device, the process unit thereby fully or
partly covering the introduction site.
14. A medical device comprising: a housing comprising a mounting
surface adapted for application towards a skin surface of a
subject, a transcutaneous device having a distal portion adapted to
be arranged through the skin of the subject in a situation of use
in which the housing has been applied towards a skin surface of the
subject, the distal portion being adapted to be arranged through
the skin of the subject at an inclined angle relative to the
mounting surface, the cannula being directed towards a central
portion of medical device, the medical device thereby, in a
situation of use, substantially covering an introduction site of
the transcutaneous device through the skin, and an opening formed
in the housing allowing the introduction site to be inspected.
Description
[0001] The present invention generally relates to a device which is
adapted for application to a skin surface of a subject and
comprises a transcutaneous device. The transcutaneous device may be
in the form of a cannula or a sensor.
BACKGROUND OF THE INVENTION
[0002] In the disclosure 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.
[0003] 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 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.
[0004] Basically, infusion pumps can be divided into two classes.
The first class comprises 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.
[0005] 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 inconveniences, 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. Pat.
No. 5,814,020 (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. U.S. Pat. No. 6,364,865 discloses a
manually held infusion device allowing two vial-type containers to
be connected and a pressure to be build up in one of the containers
to thereby expel a drug contained in that container.
[0006] 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 subject, whereby the place where
the needle penetrates the skin is covered while the appliance is in
use. 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, this as
disclosed in U.S. Pat. Nos. 2,605,765, 4,340,048 and in EP 1 177
802, or the needle may be supplied with the device 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,
this as disclosed in U.S. Pat. Nos. 5,858,001 and 5,814,020.
[0007] As an alternative to a needle, a cannula in combination with
an insertion needle which is withdrawn after insertion thereof may
be used. Typically, the cannula is in the form of a relatively soft
infusion cannula (e.g. a Teflon.RTM. cannula) and a there through
arranged removable insertion needle. This type of cannula and
needle arrangement is well known from so-called infusion sets, such
infusion sets typically being used to provide an infusion site in
combination with (durable) infusion pumps. However, recently a
disposable pump has been disclosed comprising an insertable soft
cannula in combination with an insertion needle. More specifically,
WO 03/090509 shows a skin mountable drug delivery device comprising
an initially concealed soft cannula through which an insertion
needle is arranged. With the device mounted on a skin surface the
cannula can be released and inserted angled through the skin, the
pointed distal end of the insertion needle projecting from the
distal end of the cannula. When the cannula is fully inserted the
insertion needle is withdrawn.
[0008] When a needle or cannula or other transcutaneous device is
introduced through the skin of a subject, problems may arise, e.g.
incorrect insertion or infection, for which reason it is desirable
to be able to inspect the site of insertion. On the other hand, it
is also desirable to protect the transcutaneous device from
influences from the outside, e.g. from water, dirt and mechanical
influence. The latter is especially an issue for obliquely inserted
soft cannulas as these normally projects a distance between a skin
mountable device and the skin surface, this making the cannula very
exposed.
DISCLOSURE OF THE INVENTION
[0009] Having regard to the above-identified problems, it is an
object of the present invention to provide a skin mountable medical
device or system as well as components therefore, which allow such
a device or system to be used in a convenient and cost-effective
manner, yet allowing safe and reliable treatment of a medical
condition.
[0010] In the disclosure of the present invention, embodiments and
aspects will be described which will address one or more of the
above objects or which will address objects apparent from the below
disclosure as well as from the description of exemplary
embodiments.
[0011] Thus, a medical device is provided comprising a first unit
and a second unit, the first unit being a transcutaneous device
unit comprising a housing adapted for application towards a skin
surface of a subject, and a transcutaneous device having a distal
portion adapted to be arranged through the skin of the subject in a
situation of use in which the housing has been applied towards a
skin surface of the subject. The second unit is adapted to be
releasably coupled to the first unit, whereby, in a situation of
use, it substantially covers an introduction site of the
transcutaneous device through the skin. The other way round, at
least partial removal of the second unit from the first unit will
at least partially uncover the introduction site, this improving
inspectability of the insertion site. In this way the
transcutaneous device can be protected during use, yet it allows
the user to inspect the introduction site. To allow a certain
degree of inspection without having to fully or partly remove the
second unit, one or both units may be provided with openings or
transparent areas.
[0012] The term "housing" merely denotes a supporting structure for
supporting the different elements as described. The housing may be
a traditional partially or fully closed structure, however, it may
also be in the form of an open structure, e.g. a platform. The
mounting surface may be provided by a sheet or foil member attached
to the housing and comprising an adhesive lower surface, i.e. the
mounting surface of the relatively rigid housing does not
necessarily come in direct contact with a skin surface.
[0013] The distal portion of the transcutaneous device may be
adapted to be arranged through the skin of the subject
perpendicularly thereto or at an inclined angle relative to the
skin surface. In the latter case, the distal portion may be
inclined away from the first unit and towards the second unit when
the first and second units are coupled to each other.
[0014] The transcutaneous device may be permanently projecting from
the first unit, and thus introduced through the skin simultaneously
with the first unit being placed on a the skin surface, or it may
be provided in an initially retracted position relative to the
mounting surface, thereby allowing it to be moved to an extended
(and thus inserted) position in which the distal portion projects
relative to the mounting surface. Such a unit may comprise
actuation means for moving the distal portion of the transcutaneous
device between the initial and the extended position when the
actuation means is actuated by a subject.
[0015] In an exemplary embodiment the second unit is a process unit
comprising a process assembly adapted to cooperate with the
transcutaneous device. The transcutaneous device may be in the form
of a transcutaneous sensor device, and the process assembly may
comprise a processor adapted to transmit and/or process data
acquired via the sensor device. Alternatively, the transcutaneous
device may be in the form of a transcutaneous access device, and
the process assembly may comprise a reservoir adapted to contain a
fluid drug, an expelling assembly adapted for cooperation with the
reservoir to expel fluid drug out of the reservoir and through the
skin of the subject via the transcutaneous access device, and a
processor for controlling the expelling assembly. In such a device
the transcutaneous access device may be a flexible polymeric
cannula.
[0016] In a further embodiment a medical device unit adapted to be
releasably coupled to a second unit is provided, the medical device
unit being a transcutaneous device unit comprising a housing
adapted for application towards a skin surface of a subject, the
housing comprising a coupling portion adapted to engage the second
unit, and a transcutaneous device having a distal portion adapted
to be arranged through the skin of the subject, the distal portion
projecting from the housing in the vicinity of the coupling
portion.
[0017] In a yet further embodiment a medical device is provided
comprising a first unit and a second unit adapted to be releasably
coupled to the first unit corresponding to a coupling zone, the
first unit being a transcutaneous device unit comprising a housing
adapted for application towards a skin surface of a subject, and a
transcutaneous device having a distal portion adapted to be
arranged through the skin of the subject, the distal portion
projecting from the medical device corresponding to the coupling
zone.
[0018] In a further embodiment a medical device is provided
comprising a first unit and a second unit adapted to be releasably
coupled to the first unit. The first unit is a transcutaneous
device unit comprising a housing adapted for application towards a
skin surface of a subject, and a transcutaneous device having a
distal portion adapted to be arranged through the skin of the
subject in a situation of use in which the housing has been applied
towards a skin surface of the subject, the distal portion
projecting from the housing thereby allowing, in a situation of
use, inspection of an introduction site of the transcutaneous
device through the skin when the second unit is not coupled to the
first unit, whereby the second unit when it is coupled to the first
unit fully or partly covers the introduction site.
[0019] Also a method is provided comprising the steps of (a)
providing a transcutaneous device unit comprising a transcutaneous
device and a mounting surface, the transcutaneous device having
retracted position relative to the mounting surface, and an
extended position in which a distal portion projects relative to
the mounting surface, (b) providing a process unit comprising a
process assembly adapted to cooperate with the transcutaneous
device, (c) mounting the mounting surface to a skin surface of a
subject, (d) inserting the transcutaneous device into the subject
by moving the transcutaneous device from the retracted position to
the extended position, the configuration of the transcutaneous
device unit allowing a subject to inspect the introduction site
through the skin, and (e) assembling the transcutaneous device unit
and the process unit to provide a functional communication between
the process assembly and the inserted transcutaneous device, the
process unit thereby fully or partly covering and/or fully or
partly preventing inspection of the introduction site.
[0020] As described above, a divided device may be provided with
openings allowing the transcutaneous device to a certain degree.
Thus, in an alternative embodiment, a medical device is provided
comprising a housing comprising a mounting surface adapted for
application towards a skin surface of a subject, and a
transcutaneous device having a distal portion adapted to be
arranged through the skin of the subject in a situation of use in
which the housing has been applied towards a skin surface of the
subject. The distal portion is adapted to be arranged through the
skin of the subject at an inclined angle relative to the mounting
surface, with the cannula being directed towards a central portion
of the medical device, the medical device thereby, in a situation
of use, substantially covering an introduction site of the
transcutaneous device through the skin, however, an opening is
formed in the housing allowing the introduction site to be
inspected by a user from the outside.
[0021] 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 adapted to penetrate the skin of a subject.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] In the following the invention will be further described
with reference to the drawings, wherein FIGS. 1-3 shows in
perspective views sequences of use for a first embodiment of a drug
delivery device,
[0023] FIG. 4 shows in a non-assembled state a needle unit and a
reservoir unit for a further embodiment of a drug delivery
device,
[0024] FIG. 5 shows an exploded view of the needle unit of FIG.
4,
[0025] FIG. 6 shows a perspective view of the needle unit of FIG. 4
in a first state,
[0026] FIG. 7 shows a perspective view of the needle carrier of
FIG. 5,
[0027] FIG. 8 shows a perspective view of the needle unit of FIG. 4
in a second state,
[0028] FIG. 9 shows a side view of the needle unit of FIG. 4,
[0029] FIG. 10 shows a further perspective view of the needle unit
of FIG. 4,
[0030] FIG. 11 shows perspective view of the interior of the
reservoir unit of FIG. 4,
[0031] FIG. 12 shows an exploded view of a further reservoir
unit,
[0032] FIGS. 13A and 13B show in a schematic representation a
transcutaneous device in the form of a cannula and insertion needle
combination,
[0033] FIG. 14 shows a side view of a medical device mounted on a
curved skin surface,
[0034] FIG. 15 shows medical device comprising a patch unit and an
inserter unit,
[0035] FIG. 16 shows an exploded view of the device of FIG. 15,
[0036] FIG. 17 shows the device of FIG. 16 from below,
[0037] FIGS. 18A-18F show different states of use of the device of
FIG. 15,
[0038] FIG. 19 shows an exploded view of a patch unit comprising an
inserter assembly,
[0039] FIG. 20A shows in an exploded view details of the inserter
assembly of FIG. 19,
[0040] FIG. 20B shows the details of FIG. 20A in an assembled
state,
[0041] FIGS. 21A-21D show different states of use of the device of
FIG. 19,
[0042] FIG. 22 shows in an exploded view a schematic representation
of a transcutaneous device unit,
[0043] FIGS. 23A-23D show in different actuation states a mechanism
for insertion of a cannula,
[0044] FIG. 24 shows an exploded view of an inserter,
[0045] FIGS. 25A-25C show the relationship between the needle
holder, the cannula holder, and the spring corresponding to the
states shown in FIGS. 23A-23C,
[0046] FIGS. 26A and 26B show in a non-assembled respectively
assembled state a cannula unit and a reservoir unit for a further
embodiment of a drug delivery device, and
[0047] FIG. 27 shows an alternative configuration for the device of
FIG. 21A.
[0048] In the figures like structures are mainly identified by like
reference numerals.
DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0049] When in the following terms such 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. The shown figures are schematic
representations for which reason the configuration of the different
structures as well as there relative dimensions are intended to
serve illustrative purposes only.
[0050] Firstly, with reference to FIGS. 1-3 an embodiment of a
medical device for drug delivery will be described focusing
primarily on the directly user-oriented features. The
transcutaneous device unit 2 comprises a transcutaneous device in
the form of a hollow infusion device, e.g. a needle or soft
cannula, and will thus in the following be termed a needle unit,
however, the needle may be replaced with any desirable
transcutaneous device suitable for delivery of a fluid drug or for
sensing a body parameter.
[0051] More specifically, FIG. 1 shows a perspective view of
medical device in the form of a modular skin-mountable drug
delivery device 1 comprising a patch-like needle unit 2 (which may
also be denoted a patch unit) and a reservoir unit 5. When supplied
to the user each of the units are preferably enclosed in its own
sealed package (not shown). The embodiment shown in FIG. 1
comprises a patch unit provided with an insertable steel needle,
however, the embodiment is exemplary of how to use a patch unit
with an insertable transcutaneous device, e.g. needle, cannula or
sensor. In case an actual embodiment requires the patch unit to be
mounted on the skin and the transcutaneous device inserted before a
reservoir or other unit can be attached, it follows that the method
of use would be adopted correspondingly.
[0052] The needle unit comprises a flexible patch portion 10 with a
lower adhesive mounting surface adapted for application to the skin
of a user, and a housing portion 20 in which a hollow infusion
needle (not shown) is arranged. The needle comprises a pointed
distal end adapted to penetrate the skin of a user, and is adapted
to be arranged in fluid communication with the reservoir unit. In
the shown embodiment the pointed end of the needle is moveable
between an initial position in which the pointed end is retracted
relative to the mounting surface, and an extended position in which
the pointed end projects relative to the mounting surface. Further,
the needle is moveable between the extended position in which the
pointed end projects relative to the mounting surface, and a
retracted position in which the pointed end is retracted relative
to the mounting surface. The needle unit further comprises
user-gripable actuation means in the form of a first strip-member
21 for moving the pointed end of the needie between the initial and
the second position when the actuation means is actuated, and
user-gripable retraction in the form of a second strip-member 22
means for moving the pointed end of the needle between the extended
and the retracted position when the retraction means is actuated.
As can be seen, the second strip is initially covered by the first
strip. The housing further comprises user-actuatable male coupling
means 31 in the form of a pair of resiliently arranged hook members
adapted to cooperate with corresponding female coupling means on
the reservoir unit, this allowing the reservoir unit to be
releasable secured to the needle unit in the situation of use. A
flexible ridge formed support member 13 extends from the housing
and is attached to the upper surface of the patch. In use a
peripheral portion 12 of the patch extends from the assembled
device as the reservoir unit covers only a portion 11 of the upper
surface of the patch. The adhesive surface is supplied to the user
with a peelable protective sheet.
[0053] The reservoir unit 5 comprises a pre-filled reservoir
containing a liquid drug formulation (e.g. insulin) and an
expelling assembly for expelling the drug from the reservoir
through the needie in a situation of use. The reservoir unit has a
generally flat lower surface adapted to be mounted onto the upper
surface of the patch portion, and comprises a protruding portion 50
adapted to be received in a corresponding cavity of the housing
portion 20 as well as female coupling means 51 adapted to engage
the corresponding hook members 31 on the needle unit. The
protruding portion provides the interface between the two units and
comprises a pump outlet and contact means (not shown) allowing the
pump to be started as the two units are assembled. The lower
surface also comprises a window (not to be seen) allowing the user
to visually control the contents of the reservoir before the two
units are connected.
[0054] First step in the mounting procedure is to assemble the two
units by simply sliding the reservoir unit into engagement with the
needle unit (FIG. 2). When the hook members properly engage the
reservoir unit a "click" sound is heard (FIG. 3) signalling to the
user that the two units have been properly assembled. If desired, a
visual or audible signal may also be generated. Thereafter the user
removes the peelable sheet 14 to uncover the adhesive surface where
after the device can be attached to a skin surface of the user,
typically the abdomen. Infusion of drug is started by gripping and
pulling away the actuation strip 21 as indicated by the arrow
whereby the needle is inserted followed by automatic start of the
infusion. The needle insertion mechanism may be supplied in a
pre-stressed state and subsequently released by the actuation means
or the needle insertion may be "energized" by the user. A "beep"
signal confirms that the device is operating and drug is infused.
The reservoir unit is preferably provided with signal means and
detection means providing the user with an audible alarm signal in
case of e.g. occlusion, pump failure or end of content.
[0055] After the device has been left in place for the recommended
period of time for use of the needle unit (e.g. 48 hours)--or in
case the reservoir runs empty or for other reasons--it is removed
from the skin by gripping and pulling the retraction strip 22 which
leads to retraction of the needle followed by automatic stop of
drug infusion where after the strip which is attached to the
adhesive patch is used to remove the device from the skin
surface.
[0056] When the device has been removed the two units are
disengaged by simultaneously depressing the two hook members 31
allowing the reservoir unit 5 to be pulled out of engagement with
the needle unit 2 which can then be discarded. Thereafter the
reservoir unit can be used again with fresh needle units until it
has been emptied.
[0057] FIG. 4 shows a further embodiment of medical device 500
substantially corresponding to the embodiment of FIG. 1, the device
comprising a transcutaneous device unit 502 and a process unit 505,
More specifically, the transcutaneous device unit comprises a
flexible patch portion (in the shown embodiment formed by a
perforated sheet member 570) comprising an upper surface and a
lower surface, the lower surface being adapted for application to
the skin of a subject, a first housing 503 comprising a first
coupling with two male coupling elements 511, and a transcutaneous
device arranged in the housing (see below). Two supporting ridge
members 561 extend from the first housing and are attached to the
upper surface of the sheet member. The supports serve as attachment
supports for the first housing, however, they may also serve to
control the distance between the lower surface or the process unit
and the patch. When the second unit is configured to accommodate at
least partially the support members, e.g. in corresponding cut-out
portions or grooves 504 (see FIG. 12), the supports may also serve
to laterally stabilize the connection between the two units. The
process unit comprises a second housing 501 with a lower surface
and a second coupling arranged at a peripheral portion of the
second housing, and a process assembly, e.g. a pump assembly as
will be described below. In the shown embodiment the process unit
has a generally flat rectangular shape with a cut-off end portion
defining the interface with the transcutaneous device unit and also
comprising the coupling in the form of two female coupling elements
506 arranged at each side of the end portion. Corresponding to
FIGS. 1-3, the first and second couplings can be connected to each
other with the upper surface of the patch facing towards the lower
surface of the second housing. Due to the peripheral arrangement of
the second coupling the flexible patch portion facing towards the
lower surface of the second housing is free to move relative
thereto, the degree of freedom being determined by the flexibility
of the patch and supports if so provided and, of course, the
surface to which the transcutaneous device unit is mounted.
[0058] In the shown embodiment the patch portion has the same
general shape as the combined device albeit somewhat larger. In
alternative embodiments the patch may comprise openings or cut-out
portions. For example, an area between the two support legs may be
cut out allowing the underlying skin to better breath.
[0059] FIG. 14 shows a side view of the assembled device 500
mounted on a curving skin surface 590. As appears, the flexible
patch portion with its support members is allowed to follow the
curvature of the skin, this creating a ventilation space between
the process unit and the patch portion.
[0060] FIG. 5 shows an exploded perspective view of the needle unit
comprising an upper housing portion 510, a needle carrier 520 and a
thereto mounted infusion needle 530, an actuation member 540, a
release member 550, a lower housing portion 560 and a sheet member
570 with a lower adhesive mounting surface 571. The actuation
member comprises a user gripable portion 541 and a needle actuation
portion 542, and the release member comprises a user gripable
portion 551 and a needle retraction portion 552. In the assembled
state as shown in FIG. 6, the upper and lower housing portions form
a housing 503 in which the needle and the needle carrier is
mounted, the actuation and release members being operatable
connected to the needle carrier with the user gripable portions
arranged outside the housing. The sheet member further comprises an
opening 572 arranged in register with a lower protrusion 565
provided around the exit aperture for the transcutaneous device,
just as the sheet is provided with a large number of small
perforations to improve breathability through the sheet. The
housing 503 is provided with user actuatable coupling means 511
allowing a reservoir unit to be attached to and released from the
needle unit 505, the reservoir unit comprising corresponding mating
coupling means 506 as well as a display 587. The display may
indicate e.g. proper function of the unit, the amount of drug in
the reservoir or different error conditions.
[0061] As seen is the user gripable portion 551 of the release
member initially covered by a portion of the actuation member, this
reducing the probability that the user erroneously uses the release
member instead of the actuation member. Further, the actuation and
release members (or portion thereof) may be colour coded to further
assist the user to correctly use the device. For example, the
actuation member may be green to indicate "start" whereas the
release member may be red to indicate "stop".
[0062] FIG. 7 shows in perspective the needle carrier 520 with the
needle 530 and the needle actuation portion 542 of the actuation
member 540. The needle actuation portion comprises two legs 543
allowing it to slide relative to the housing, the legs being
arranged through respective openings 563 in the housing. The needle
carrier is adapted to be connected to a hinge member 562 of the
lower housing portion to thereby allow the needle carrier and
thereby the needle to pivot corresponding to a pivoting axis
defined by a hinge. In the shown embodiment is the needle carrier
in the form a bent sheet metal member, the carrier comprising an
upper arm 521 and a lower arm 522 connected to each other by a
hinge portion 523 allowing the lower arm to pivot relative to the
upper arm and corresponding to the pivoting axis. The lower arm
forms a tray in which the hollow infusion needle 530 is mounted
(e.g. by welding or adhesive), the needle having a distal pointed
portion 531 adapted to penetrate the skin of the subject, the
distal portion extending generally perpendicular to the mounting
surface of the needle unit, and a proximal portion 532 arranged
substantially corresponding to the pivoting axis and adapted to
engage a fluid supply. Thus, when a portion of the upper arm is
mounted in the housing, the lower arm can pivot between a first
retracted position in which the distal portion of the needle is
retracted within the housing, and a second extended position in
which the distal portion projects relative to the mounting surface.
In the shown embodiment the needle carrier provides the drive means
for moving the lower arm between the two positions. This may as in
the present embodiment be provided by the elastic properties of the
sheet material per se corresponding to the hinge portion, or
alternatively an additional spring may be provided between the two
arms to thereby urge them apart. To lock the lower part in an
energized, releasable first position, the upper arm is provided
with a flexible release arm 526 comprising a catch 527 supporting
and arresting the lower arm in its first downwardly biased
position, as well as a release portion 528 engaging a ramp surface
544 of the needle actuation portion 542, the catch further
comprising an inclined edge portion 529 adapted to engage the lower
arm when the lafter is moved from its extended to its retracted
position as will be described in greater detail below.
[0063] To actuate the needle the user grips the flexible strip
forming the user gripable portion 541 (which preferably comprises
adhesive portions to hold it in its shown folded initial position)
and pulls the needle actuation portion 542 out of the housing, the
actuation member 540 thereby fully disengaging the housing. More
specifically, when the ramp surface 544 is moved it forces the
latch 527 away from the lower arm to thereby release it, after
which the release portion 528 disengages the ramp allowing the two
legs to be pulled out of the housing. As seen in FIG. 8, when the
actuation member is removed the user gripable portion 551 of the
release member is exposed. As for the actuation member, the user
gripable portion of the release member preferably comprises
adhesive portions to hold it in its shown folded initial
position.
[0064] In the shown embodiment the release member is in the form of
a strip formed from a flexible material and having an inner and an
outer end, the strip being threaded through an opening 512 in the
housing, the strip thereby forming the user gripable portion 551
and the needle retraction portion 552, the inner end of the strip
being attached to the housing and the outer end of the strip being
attached to a peripheral portion of the sheet member 570 or,
alternatively, a peripheral portion of the housing. In the
projection shown in FIG. 9 the release member is shown in its
initial position, the retraction portion forming a loop 555
arranged below the lower arm of the needle carrier, this position
allowing the lower arm to be moved to its actuated position and
thereby the needle to its extended position.
[0065] When the user decides to remove the needle unit from the
skin, the user grips the user gripable portion 551, lifts it away
from the housing and pulls it upwardly whereby the loop shortens
thereby forcing the lower arm upwardly, this position corresponding
to an intermediate release state. By this action the lower arm
engages the inclined edge portion 529 of the catch 527 thereby
forcing it outwardly until it snaps back under the lower arm
corresponding to the position shown in FIG. 7. As the actuation
member 540 has been removed from the needle unit, the needle
carrier is irreversibly locked in its retracted position. When the
user further pulls in the release member, the peripheral portion of
the sheet member to which the release member is attached will be
lifted off the skin, whereby the needle unit with its attached
reservoir unit can be removed from the skin, this as described
above.
[0066] Advantageously, the actuation and release members may be
formed and arranged to communicate with the reservoir unit (not
shown). For example, one of the legs of the actuation member may in
its initial position protrude through the housing to thereby engage
a corresponding contact on the reservoir unit, this indicating to
the reservoir unit that the needle unit has been attached, whereas
removal of the actuation member will indicate that the needle has
been inserted and thus that drug infusion can be started.
Correspondingly, actuation of the release member can be used to
stop the pump.
[0067] In FIG. 10 the side of the needle unit 502 which connects to
the reservoir unit is shown. In addition to the two ridge members
561 and the user actuatable coupling means 511 the needle unit
comprises further structures which connects to and/or engages the
reservoir unit to provide a functional interface with the reservoir
unit. More specifically, the needle unit comprises a fluid inlet
provided by the pointed proximal portion 532 of the needle
projecting from the needle unit and adapted to engage a fluid
outlet of the reservoir unit, an actuator 515 projecting from the
needle unit and adapted to engage and actuate a fluid connector in
the reservoir unit (see below), and first and second contact
actuators 548, 558 adapted to engage corresponding contacts on the
reservoir unit. The first contact actuator is provided by the
distal end of one of the legs 543 of the needle actuator projecting
through an opening in the housing, and the second contact actuator
is provided by a hinged portion of the housing connected to the
needle retraction portion 552 of the release member 550. When the
needle unit is first connected to the reservoir unit both contact
actuators will protrude from the housing and engage the
corresponding contacts on the reservoir unit thereby indicating
that that a needle unit has been connected. When the needle is
actuated the first contact actuator will be withdrawn and thereby
disengage the corresponding contact on the reservoir unit to start
pump actuation. When the needle is retracted the second contact
actuator will pivot and disengage the corresponding contact on the
reservoir unit to stop pump actuation.
[0068] FIG. 11 shows the reservoir unit with an upper portion of
the housing removed. The reservoir unit comprises a reservoir 760
and an expelling assembly comprising a pump assembly 300 and
control and actuation means 580, 581 therefore. The pump assembly
comprises an outlet 322 for connection to a transcutaneous access
device (e.g. the needle 530) and an opening 323 allowing an
internal fluid connector to be actuated, see below. The reservoir
560 is in the form of prefilled, flexible and collapsible pouch
comprising a needle-penetrable septum adapted to be arranged in
fluid communication with the pump assembly, see below. The shown
pump assembly is a mechanically actuated membrane pump, however,
the reservoir and expelling means may be of any suitable
configuration.
[0069] The control and actuation means comprises a pump actuating
member in the form of a coil actuator 581 arranged to actuate a
piston of the membrane pump, a PCB or flex-print to which are
connected a microprocessor 583 for controlling, among other, the
pump actuation, contacts 588, 589 cooperating with the contact
actuators on the needle unit, signal generating means 585 for
generating an audible and/or tactile signal, a display (not shown)
and an energy source 586. The contacts are preferably protected by
membranes which may be formed by flexible portions of the
housing.
[0070] In FIG. 12 an exploded view of the reservoir unit 505 of
FIG. 4 is shown, the unit comprising an upper housing member 507, a
lower housing member 508 with a transparent area 509 and grooves
504 to receive the ridge members 561 extending from the needle
unit, a flexible reservoir 760 with a rounded edge portion 762 on
which a septum member 761 is mounted, a pump assembly 300 with
actuator and a circuit board (not shown) arranged above the
reservoir and comprising electronic components for controlling
actuation of the pump. The upper and lower housing members comprise
reservoir mounting means in the form of opposed upper and lower
ridge portions 780 (the lower not seen) adapted to engage and mount
the reservoir in the housing. Each ridge portion comprises a
central cut-out portion 781 adapted to engage the septum member on
its opposed surfaces when the housing members are assemble thereby
locking the reservoir in place within the housing. The degree of
locking will be determined by the pressure exerted on the septum
member, the elastic properties of the septum member and the
friction between the ridge and the septum member. On each side of
the cut-out portion the ridge portions comprise a straight portion
782 which may aid in mounting the reservoir in the housing. The
straight portions may engage the initially prefilled reservoir to
help lock it in place, however, as the reservoir is emptied and
flattens this grip may lessen. In contrast, the engagement with the
septum is adapted to properly hold the reservoir in place as the
reservoir is emptied. The straight portions may also be adapted to
pinch and fully flatten the reservoir thus serving as an additional
mounting means. Additional mounting means (not shown) may engage
and grip the reservoir at other locations, e.g. along the welded
edges 765.
[0071] In the above described embodiments, the transcutaneous
device has been in the form of a unitary needle device (e.g. an
infusion needle as shown or a needle sensor (not shown), however,
the transcutaneous device may also be in the form of a cannula or a
sensor in combination with an insertion needle which is withdrawn
after insertion thereof. For example, the first needle portion may
be in the form of a (relatively soft) infusion cannula (e.g. a
Teflon.RTM. cannula) and a there through arranged removable
insertion needle. This type of cannula needle arrangement is well
known from so-called infusion sets, such infusion sets typically
being used to provide an infusion site in combination with
(durable) infusion pumps.
[0072] Thus, FIGS. 13A and 13B show in a schematic representation
how a cannula and insertion needle combination can be arranged
within a housing 601 of in a given medical device 600 (partly
shown), e.g. an infusion device or an infusion set. More
specifically, the medical device comprises a transcutaneous
assembly 650 comprising a combination of a relatively soft cannula
651 (which e.g. may be of the soft "Teflon.RTM." type) carried by a
lower member 653 and a pointed insertion needle 661 (e.g. made from
medical grade stainless steel) slidably arranged within the cannula
and carried by an upper member 663, both members being mounted to
allow axial displacement of the cannula respectively the insertion
needle. The cannula comprises a proximal inlet (not shown) allowing
it to be or to be arranged in fluid communication with a fluid
source. The medical device further comprises a base plate 620 with
an opening 621 for the cannula as well as a release member 622. The
lower member comprises an elastomeric seal 652 through which the
insertion needle is arranged. The cannula and the insertion needle
may be straight or curved dependent upon how the two members are
mounted in the device, e.g. arcuate corresponding to a pivoting
axis or straight corresponding to linear movement as illustrated.
The upper member comprises a coupling member 667 locking the
members together in an initial position with distal end of the
insertion needle extending from the distal opening of the cannula
as shown in FIG. 13A, and the base plate comprises coupling member
657 for locking the lower member in an extended position with
distal end of the cannula extending through the opening in the base
plate (see FIG. 13B). Between the housing of the device and the
upper member a first spring 668 is arranged biasing the upper
member upwards. Correspondingly, the device also comprises a second
spring 658 biasing the lower member upwardly. The medical device
further comprises a gripping tab 676 and a pulling member 677
corresponding to the embodiment shown in FIG. 1.
[0073] In a situation of use the assembly is moved downwardly,
either manually or by a releasable insertion aid, e.g. a spring
loaded member acting through an opening in the housing (not shown)
whereby the cannula with the projecting insertion needle is
inserted through the skin of a subject. In this position the lower
member engages the coupling member 657 to thereby lock the cannula
in its extended position, just as the coupling member 667 is
released by the release member 622 thereby allowing the upper
member to return to its initial position by means of the first
spring.
[0074] When the user intends to remove the delivery device from the
skin surface, the user grips the gripping portion of the tab and
pulls it in a first direction substantially in parallel with the
skin surface, by which action the flexible strip 677 releases the
coupling member 657 from the lower member whereby the lower member
and thereby the cannula is retracted by means of the second spring.
When the cannula has been withdrawn from the skin, the user uses
the now unfolded tab to pull off the entire delivery device from
the skin surface, for example by pulling the tab in a direction
away from the skin surface.
[0075] With reference to FIGS. 15-18 a medical device 700 will be
described comprising a cannula and an insertion needle (in the
following also "needle" for short). The cannula may be in the form
of what is traditionally referred to as a "soft catheter" or a
"Teflon.RTM. catheter". The device comprises two portions, a patch
unit 710 comprising a housing mounted on a patch of flexible sheet
material, and an inserter unit 720 removeably coupled to the patch
housing. The inserter housing initially comprises the entire
insertion mechanism including the cannula. When actuated the
cannula becomes attached to the patch housing where after the
inserter housing with the remaining inserter mechanism can be
detached and discarded.
[0076] More specifically, the patch unit comprises a flexible sheet
721 with a lower adhesive surface and an opening 722 for the
cannula, a patch housing with top 723 and base 724 portions, the
base portion being attached to the upper surface of the sheet. The
patch housing comprises an opening 725 for the cannula arranged
just above the opening in the sheet, as well as a coupling in the
form of two flexible arms 726 allowing the inserter to be
attached.
[0077] The inserter unit comprises an inserter housing with top 733
and base 734 portions, the base portion comprising two walls 735
with upper inclined edges serving as a ramp 736 for an inserter
assembly 740. The inserter assembly comprises an inserter 750, a
needle holder 760 comprising a needle 761 protruding there from, a
cannula holder 770 with a cannula 771 protruding there from, the
cannula comprising a proximal needle penetrable septum, two springs
751 mounted on respective spring guides 752 on the inserter, and a
release and retraction strip 780 (see FIG. 18A). The strip
comprises a proximal end projecting from the housing and a distal
end attached to the needle holder, the strip forming a loop portion
attached to the inserter. The inserter and the cannula holder are
each provided with pairs of grooves 755, 775 allowing the inserter
and the cannula to slide on the ramp. The inserter comprises an
opening 753, an inclined ramp member 754 and a locking projection
757 adapted to engage a corresponding opening 737 in the housing.
The needle holder comprises a flexible release arm 763 with an
upwardly protruding catch 762, and the cannula holder comprises a
pair of coupling elements 772 for engagement with the patch
housing. In an initial assembled state (see FIG. 17) the cannula
holder is arranged in front of the inserter and the needle holder
is arranged below the inserter with the needle positioned through
the septum and within the cannula and projecting there from, and
with the catch 762 protruding through the opening 753. As an
example, the cannula may be a soft catheter with an OD of 0.7 mm
and an ID of 0.4 mm and the needle may have an OD of 0.4 mm (G27).
The inner surface of the inserter housing comprises a ramp 738 and
a hold 739 adapted to engage the inserter assembly as described
below. In a fully assembled initial state the inserter assembly is
locked in place by the locking projections 757 engaging the opening
737 in the inserter housing, the springs being arranged in a
compressed state between the inserter and the inserter housing.
Upper guides 731 in the inserter housing secures that the inserter
assembly can move only along the inclined ramp.
[0078] Next, with reference to FIGS. 18A-18F operation of a medical
device of the above-outlined construction for insertion of a soft
catheter will be described. The user first removes a protective
sheet covering the adhesive surface of the patch and arranges the
patch on a suitable skin portion of a subject, e.g. the abdomen. In
the start position (see FIG. 18A) the soft catheter holder with a
soft catheter is placed in front of the inserter. The needle holder
is connected to the inserter, which is loaded with springs (see
FIG. 15), all integrated in the inserter housing. The inserter
needle is arranged inside the soft catheter with its pointed needle
tip e.g. 2 mm in front of the soft catheter. Next the user pulls
the strip which releases the inserter from the housing, this
allowing the inserter assembly with soft catheter and needle holder
to start move forwards pushed by the springs. As appears, by this
action the strip is released from the needle holder. By the initial
travel of the inserter assembly the inserter needle with soft
catheter penetrates dermis 2-4 mm. During this movement the catch
of the release arm on the needle-holder engages the ramp placed on
the inserter-housing (see FIG. 18B). The ramp depresses the release
arm in relation to its engagement with the inserter, and finally
arrests the release arm as it engages the hold at the end of the
ramp, this temporary halting movement of the needle holder. After
needle movement has come to a halt, the inserter and the soft
catheter holder continue forward movement driven by the springs,
thereby moving the soft catheter ahead of the needle an into
sub-cutis. The needle holder is stopped until the soft catheter tip
is e.g. 1-5 mm in front of needle tip. During this movement the
release arm on the needle holder is stopped by the hold in the
housing, however, at the same time the flexible arm is engaged by
the ramp member on the inserter. This ramp depresses the release
arm until it is lifted free of the hold where after it again
engages the inserter (see FIG. 18C). After the needle holder has
re-engaged the inserter, the needle now follows the soft catheters
movement through sub-cutis to a final position, and the needle can
therefore act as guide for the soft catheter, with the tip of the
needle e.g. 1-5 mm behind the tip of the soft catheter. When the
cannula reaches its final fully extended position the soft catheter
holder is positioned in the patch-housing where it is locked in
place (see FIG. 18D). As appears, the above-described actions all
take place automatically driven by the springs and in a very short
time, this providing minimum discomfort to the subject.
[0079] At this point the soft catheter has been placed at the
desired place and what remains is for the user to withdraw the
needle and remove the remaining inserter assembly and housing. In
the shown embodiment the inserter is locked in place in its
foremost position. The needle holder is released from the inserter
and the needle is retracted by the user pulling the strip attached
to the needle holder until the needle has been locked in its fully
retracted position with the distal pointed end arranged within the
inserter housing (see FIG. 18E). In the shown embodiment the
inserter serves to surround and protect the pointed end of the
needle. Finally the user detaches the inserter housing from the
patch unit which can then be disposed off (see FIG. 18F). The
cannula is now ready to be connected to a fluid source, e.g. a
reservoir unit as shown in FIG. 1 and of the same principal
configuration as described with reference to FIGS. 11 and 12.
Indeed, the interface of the pump assembly 300 will have to be
modified in order to connect to the proximal septum of the soft
catheter or cannula instead of a pointed needle end, i.e. the pump
assembly will be provided with a pointed hollow needle establishing
a fluid communication between the pump assembly and the inserted
cannula.
[0080] With reference to FIGS. 15-18 an embodiment comprising a
separate cannula inserter has been described, however, a
corresponding mechanism may also be incorporated in a unitary patch
unit. Such a design would indeed result in a larger patch housing,
however, the user would not have to detach and discard the
inserter. For such a design the needle may be hollow and comprise a
proximal end, with the distal end of the needle being in sealed
fluid communication with the interior of the cannula when the
needle has been arranged in its retracted position. By this
arrangement a fluid communication can be provided between the
proximal end of the needle and the cannula, this allowing the fluid
communication to be established between the patch unit and the
reservoir unit corresponding to the connection between the units in
the FIGS. 5-12 embodiment. In this case a delivery device would
supply drug to the cannula via the hollow needle.
[0081] With reference to FIGS. 19-21 a further integrated concept
will be disclosed. The concept consists of an introducer needle
surrounding a cannula, e.g. a soft catheter. The 1-2 mm cutis or
derma is penetrated by the needle and only the soft catheter is
inserted into sub-cutis. Once the soft catheter is fully inserted,
the needle is retracted. Since the needle is placed on the outside
of the soft catheter, the soft catheter can be made in a smaller
diameter compared to a concept in which the needle is arranged
inside the needle and trauma in subcutis is thereby minimized,
however, the larger diameter needle may cause larger trauma in the
derma just as the cannula may be more susceptible to kinking and
there may be less control when positioning the soft catheter in the
subcutis. Also clotting during use may be more likely. These issues
have to be considered when deciding on a specific concept and the
specific design parameters for such a concept.
[0082] Turning to an exemplary embodiment, the medical device is in
the form of a unitary patch unit 800 comprising a housing mounted
on a patch of flexible sheet material, the inserter housing
comprising the entire insertion mechanism including the
cannula.
[0083] More specifically, the patch unit comprises a flexible sheet
821 with a lower adhesive surface and an opening 822 for the
cannula (in this embodiment a flexible soft catheter), a patch
housing with top 823 and base 824 portions (823' indicates a top
portion shown upside down), with the base portion being attached to
the upper surface of the sheet, wherein the top portion comprises a
45 degrees guide 825 for the cannula holder (see below). The patch
housing comprises an opening for the cannula and needle arranged
just above the opening in the sheet, as well as a coupling in the
form of two flexible arms 826 allowing a delivery device to be
attached. The base portion comprises two walls 835 with upper
inclined edges serving as a ramp 836 for an inserter assembly 840.
The inserter assembly comprises an inserter 850 with an attached
needle 861 and a cannula holder 870 attached to a cannula 871 and
adapted for moving the cannula relative to the inserter and thereby
the needle (see FIGS. 20A and 20B). The inserter is provided with
pairs of grooves allowing the inserter to slide on the ramp. The
insertion mechanism further comprises a user-releasable spring (not
shown) for moving the inserter and a strip (not shown) for moving
the cannula holder relative to the inserter. As an example, the
soft catheter may have an OD of 0.4 mm and an ID of 0.1 mm and the
needle may have an OD of 0.7 mm and an ID 0.4 mm (G22).
[0084] To save space in the patch housing, the soft catheter
introducing mechanism is placed perpendicular in respect of the
direction of introduction. The soft catheter 871 is placed in a
groove 855 in the inserter that guides the soft catheter, the
groove having a 90 degrees bend to change the direction of the soft
catheter during the introduction. As appears from FIGS. 20A and 20B
when the catheter holder 870 is moved across the inserter the soft
catheter is extended in a perpendicular direction.
[0085] Next, with reference to FIGS. 21A-21D operation of a medical
device of the above-outlined construction for insertion of a soft
catheter will be described. The user first removes a protective
sheet covering the adhesive surface of the patch and arranges the
patch on a suitable skin portion of a subject, e.g. the abdomen. In
the start position (see FIG. 21A) the inserter is arranged in its
retracted position and the cannula holder is arranged in its
initial position. When the inserter is released (e.g. by pulling a
strip to release a spring) the introducer needle with the soft
catheter inside penetrates dermis e.g. 2-4 mm (see FIG. 21B). By
continuous pulling the strip the user starts the introducing of the
soft catheter into sub-cutis by pulling the soft catheter holder
across the inserter until the soft catheter is fully introduced
(see FIG. 21C). After the soft catheter is fully introduced the
user continues the pulling of the strip and pulls the soft catheter
holder further across the inserter, however, as the soft catheter
holder has reached the 45 degrees ramp, the inserter is forced
backwards with the same speed as the soft catheter is moved
forward, the result is that the soft catheter stays in its final
position and the introducer needle on the inserter is removed and
disappears into the patch housing (see FIG. 21D).
[0086] As the proximal end of the soft catheter is stationary, it
may be provided with a pointed hollow needle which would allow a
reservoir unit basically as shown in FIGS. 11 and 12 to be
connected thereto.
[0087] FIG. 22 shows in an upper exploded view a drawing of a
schematic representation of a transcutaneous device unit (here a
cannula unit) comprising a mechanism for inserting a soft cannula.
The mechanism is similar to the mechanism described with reference
to FIGS. 19-21. More specifically, the unit comprises a bottom part
910 onto which is mounted a chassis part 920 thereby creating an
interior in which the different parts of the mechanism are
arranged. In addition to the functional portions of the bottom and
chassis part the mechanism comprises a needle holder 930 with a
needle mount 931 to which a needle 932 is mounted, a cannula holder
940 comprising first and second gripping portions 941, 942 adapted
to engage the needle holder, and a hollow cannula assembly
comprising a soft, flexible cannula with a distal portion 951, an
intermediate portion 952, and a proximal portion 953, the cannula
assembly further comprising a tubular housing member 955 adapted to
engage an opening 922 in the chassis portion, an elastomeric
tubular member 956 in which the proximal end of the cannula is
mounted, and a needle pierceable elastomeric septum, the tubular
member and the septum being arranged in the housing member thereby
providing a fluid inlet port for the hollow cannula. The mechanism
further comprises a coil-formed torsion spring 960 comprising an
actuator arm 961 with a curved distal end 962, the spring being
arranged in a spring holder 970 comprising a catch 971 allowing the
spring to be mounted in a pre-tensioned state. A release member 975
is provided comprising an outer end portion 976 adapted to engage
e.g. a pump unit when the latter is mounted, and an inner end
portion 977 adapted to engage and release the actuator arm from the
spring holder. The bottom part comprises an inclined surface 911
with a guide 912 comprising a first guide groove 913 arranged
corresponding to a longitudinal axis of the unit, and a second
guide groove 914 arranged at an angle of 45 degrees relative to the
first guide groove.
[0088] In the assembled state the cannula holder is mounted on the
needle holder with the gripping portions 941, 942 arranged on each
side of the needle mount 931, this allowing the cannula holder to
slide along the length of the needle holder, the two holders
thereby forming an inserter. In an initial state the distal portion
of the cannula is positioned in the needle and the intermediate
portion is positioned in a channel formed between the needle holder
and the cannula holder, the cannula being mounted to the cannula
holder by means of a flexible member on the first gripping
portion.
[0089] In the assembled state the needle holder with the cannula
holder mounted is arranged on the inclined surface and is allowed
to slide up and down, with the guide grooves adapted to engage a
guide member arranged on the lower surface of the cannula holder
(not shown, see e.g. FIG. 24). To control movement of the needle
holder the needle mount comprises a guide portion 933 with two
opposed grooves adapted to engage a corresponding guide member 921
arranged on an interior surface of the chassis part. As appears, in
the shown schematic drawing the inclined surface 911 is shown
without cut-out portions allowing the release member 975 and the
spring holder 970 to be mounted (see below).
[0090] The bottom part 910 further comprises two opposed leg
portions 918 each with a lobe 919, the lobes providing attachment
points when the bottom part is mounted to a flexible sheet or foil
member 901 comprising an adhesive lower mounting surface 904
allowing the trans-cutaneous unit to be mounted on a skin surface
of a subject. The sheet member comprises a central opening 903
through which the needle and cannula is introduced, as well as a
release liner 902. A cover portion 905 serves to close the interior
thereby forming a substantially closed housing.
[0091] With reference to FIGS. 23A-23D the mechanism described with
reference to FIG. 22 is shown in a partly assembled state, the
chassis part and the proximal portion of the cannula not being
shown. The assembled embodiment differs slightly from the
above-described embodiment, however, as the differences are small
the same reference numerals are used.
[0092] The assembled embodiment primarily differs from the FIG. 23
embodiment in that the inclined surface 911 has been replaced with
a number of wall members, the upper surfaces of these wall members
in combination providing an inclined "surface" on which the needle
holder is arranged, this allowing the spring 960 and release member
975 to be shown functionally correctly arranged.
[0093] FIG. 23A shows the assembly in an initial state with the
needle holder 930 in a first (or initial) retracted position with
the needle correspondingly in its retracted position with the
distal pointed end arranged within the housing. The cannula holder
is positioned in a right-most position on the needle holder
corresponding to its retracted position. The distal portion of the
cannula is positioned in the needle with the distal end just within
the distal end of the needle, and the intermediate portion is
positioned in the channel formed between the needle holder and the
cannula holder (see FIG. 24), the cannula being gripped by a
flexible arm formed as part of the first gripping member 941.
[0094] When a pump unit (not shown) is attached to the cannula unit
the pump unit engages and pushes the outer end portion 976 of the
release member 975, thereby releasing the spring actuator arm 961.
The actuator then starts to turn clockwise (as seen in the figure)
and engages a rear surface of the needle member pushing it forward
to its extended position as seen in FIG. 23B. During this movement
the needle holder is guided linearly by engagement with the guide
member 921 arranged on an interior surface of the chassis part,
whereas the cannula correspondingly is guided linearly to its first
extended position by engagement with the first guide groove 913.
Thus, during this forward movement, the cannula holder does not
move relative to the needle holder.
[0095] In this position the needle holder cannot be moved further
forward, and as the spring actuator arm continues to turn clockwise
it engages the guide member arranged on the lower surface of the
cannula holder (not shown, see FIG. 24) thereby starting to move
the cannula holder to the left, sliding on the needle holder. At
this position the guide member has reached the lower end of the
first guide groove (see FIG. 22) and is now moved into the second
inclined guide groove where it is moved upwards along the guide
groove, thereby being moved further to the left. As the cannula
holder is attached to the needle holder, the needle holder is also
moved upwards, however, it is guided linearly backwards due to the
engagement with the guide member 921. When the cannula holder has
reached the upper end of the second guide groove, it has reached
its second extended position just as the needle holder has reached
its second retracted position (the first and second retracted
positions may be the same), just as the cannula holder has reached
its second extended position.
[0096] As described above, the cannula has a distal portion
initially arranged within the needle, an intermediate portion
arranged in the channel formed between the cannula and needle
holder, and a proximal portion serving as a flexible connection
between the moving inserter and the fluid inlet port. As the
cannula is attached to the cannula holder corresponding to the
proximal end of the intermediate portion, movement to the left of
the cannula holder will push the cannula through the channel,
around the bend connecting the channel and the needle, and down
into the needle. Thus as the cannula holder is moved from its first
to its second extended position, the cannula is pushed out through
the needle, whereas in the meantime the needle holder with the
needle is retracted (see FIG. 23C). In case the cannula and needle
are extended respectively retracted at the same speed (this
corresponding to the second guide groove being straight and
arranged at an angle of 45 degrees relative to the first guide
groove) then the distal portion of the extended cannula will not
move relative to the housing, whereas the needle will be
retracted.
[0097] In order to allow the guide member of the cannula holder to
properly enter the second guide groove, it may be desirable to
connect the two guide grooves with a short groove portion, this
providing that the cannula will be extended a little before the
needle starts to retract, this as shown in FIG. 23D.
Correspondingly, by modifying the configuration of the second guide
groove it is possible to retract the cannula a little from its most
extended position. The latter may be desirable in order to free a
distal cannula opening from any tissue plug formed during
insertion.
[0098] In FIG. 24 is shown an exploded view of the inserter seen
from below, i.e. the needle holder 930 and the cannula holder 940.
In the figure the flexible arm 946 for holding the cannula in
engagement with the first gripping member 941 can be seen, just as
the guide member 945 arranged on the lower surface of the cannula
holder can be seen. The needle holder is provided with a
longitudinal wall portion 935 adapted for engagement with the
spring actuator arm. Between the two holders a channel is formed in
which the intermediate portion of the cannula initially is
arranged.
[0099] In FIGS. 25A-25C are shown the relationship between the
needle holder, the cannula holder, and the spring corresponding to
the states shown in FIGS. 23A-23C. The partial assembly is rotated
180 degrees corresponding to the needle axis, and is thus seen from
below.
[0100] In the initial position the actuator arm 961 is hold in its
pre-stressed position in locking engagement with the needle holder
(see FIG. 25A). When the spring is released the actuator arm start
to turn counter clockwise (as seen in the figure) whereby it
engages the wall portion 935 and start to move the needle holder
930 forwards to its extended position (see FIG. 25B). As appears,
the curved distal end 962 of the actuator arm allows the arm to
slide on the wall. From this position the actuator arm continuous
to turn counter clockwise and subsequently engages the guide member
945 on the cannula holder 940 which is then moved to the right (as
seen in the figure) to its second extended position and up, guided
by the second guide groove, thereby moving the needle holder to its
second retracted position (see FIG. 25C). As appears, during the
latter movement the guide member 945 slides on the actuator arm. As
also appears, during movement of the cannula holder, the free
proximal portion 953 of the flexible cannula provides fluid
communication between the remaining part of the cannula and the
fluid port.
[0101] In the above described embodiment, a cannula is guided
within a hollow needle, however, other arrangements may be used.
For example, the needle may be part-circular (i.e. more than 180
degrees), this providing a smaller cross-sectional area during
insertion. Alternatively, the needle and the cannula may be
arranged side-by-side with corresponding gripping means provided
there between providing that the cannula and needle are only
allowed to move longitudinally relative to each other.
[0102] In traditional infusion sets a pointed needle is arranged
inside a soft cannula, however, although the needle provides the
cutting and columnar strength during insertion, the cannula is
arranged unprotected against compressive forces in its longitudinal
direction, such forces tending to collapse the cannula.
Correspondingly, a typical infusion set cannula thus has a
relatively thick wall with an outer diameter of 0.7 mm and an inner
diameter of 0.4 mm. In contrast, by arranging the soft cannula
inside the needle (which is typically made from medial grade
stainless steel and thus very rigid), the properties of the needle
material can used to provide a much more thin-walled outer tubular
structure. For example, a needle with an outer diameter of 0.5 mm
and an inner diameter of 0.35 mm may be used, this providing less
pain during insertion, just as a thinner soft cannula may be more
comfortable to wear. A corresponding cannula will then have an
outer diameter of close to 0.35 mm and an inner diameter typically
in the 0.15-0.20 mm range. The cannula may be made from e.g. PTFE
or FEP.
[0103] In the shown embodiment the cannula inserter mechanism is
arranged in a cannula unit to be used in combination with a
specific pump coupled directly thereto, however, the principles of
the inserter mechanism may be used also in a conventional-type
infusion set adapted to be connected to an drug delivery pump by a
length of tubing. Further, instead of a flexible hollow cannula, a
flexible sensor may be introduced. Also, instead of inserting the
cannula at an inclined angle relative to a skin surface, a cannula
may be inserted perpendicularly, i.e. inclined 90 degrees.
Correspondingly, the mechanism may also be arranged to insert the
cannula in a direction pointing away from the pump unit to which it
is to be attached. In the shown embodiment the cannula is inclined
30 degrees relative to horizontal, however, a preferred range is
20-45 degrees. The less inclined the cannula is arranged, the
longer the inserted length in the tissue may be, i.e. corresponding
to the protruding length of a transcutaneous device below a plane
defined by the mounting surface. For the shown angle of 30 degrees
a length of 8 mm is selected, this providing a vertical insertion
of approximately 4 mm. For vertical insertion a length of 12 mm or
less is preferred for a steel needle, whereas a length of 9 mm or
less is preferred for a soft cannula. For a relatively "flat"
insertion a length of 20 mm or less is preferred for a soft
cannula, typically less than 17 mm.
[0104] In FIG. 26A is shown an embodiment of a medical device 1000
of the type shown in FIG. 1, comprising a cannula unit 1010 and a
thereto mountable pump (or reservoir) unit 1050, however, instead
of a needle insertion mechanism as shown in FIG. 7, a cannula
inserter mechanism as described with reference to FIGS. 22-25 is
used. In the shown embodiment the cannula unit comprises a housing
1015 with a shaft into which a portion 1051 of the pump unit is
inserted. The shaft has a lid portion 1011 with an opening 1012,
the free end of the lid forming a flexible latch member 1013 with a
lower protrusion (not shown) adapted to engage a corresponding
depression 1052 in the pump unit, whereby a snap-action coupling is
provided when the pump unit is inserted into the shaft of the
cannula unit. Also a vent opening 1054 can be seen. The housing
1015 is provided with a pair of opposed legs 1018 and is mounted on
top of a flexible sheet member 1019 with a lower adhesive surface
1020 serving as a mounting surface, the sheet member comprising an
opening 1016 for the cannula 1017.
[0105] As appears, from the housing of the cannula unit extends a
cannula at an inclined angle, the cannula being arranged in such a
way that its insertion site through a skin surface can be inspected
(in the figure the full cannula can be seen), e.g. just after
insertion. In the shown embodiment the opening in the lid provides
improved inspectability of the insertion site. When the pump unit
is connected to the cannula unit it fully covers and protects the
cannula and the insertion site from influences from the outside,
e.g. water, dirt and mechanical forces (see FIG. 26B), however, as
the pump unit is detachable connected to the cannula unit, it can
be released (by lifting the latch member) and withdrawn fully or
partly from the cannula unit, this allowing the insertion site to
be inspected at any desired point of time. By this arrangement a
drug delivery device is provided which has a transcutaneous device,
e.g. a soft cannula as shown, which is very well protected during
normal use, however, which by fully or partly detachment of the
pump unit can be inspected as desired. Indeed, a given device may
be formed in such a way that the insertion site can also be
inspected, at least to a certain degree, during attachment of the
pump, e.g. by corresponding openings or transparent areas, however,
the attached pump provides a high degree of protection during use
irrespective of the insertion site being fully or partly occluded
for inspection during attachment of the pump.
[0106] In the shown embodiment an inclined cannula is used,
however, in an alternative embodiment a needle mechanism of the
type shown in FIG. 7 may be used if the point of insertion was
moved closer to the coupling portion of the needle unit, this
allowing also such a perpendicularly inserted to be inspected by
detaching the pump unit.
[0107] FIG. 27 shows an alternative configuration for the device
disclosed in FIG. 21A. As the former embodiment the patch unit 1901
comprises a flexible sheet 1921 with a lower adhesive surface and
an opening for the cannula, a patch housing 1923 attached to the
upper surface of the sheet and comprising an opening for the
cannula, as well as a coupling in the form of two flexible arms
1926 allowing a delivery device unit 1902 to be attached. However,
in contrast to the former embodiment the orientation of the angled
cannula 1971 has been reversed so that it points essentially in the
opposite direction, i.e. towards the attached delivery device unit
instead of away from the patch unit. Correspondingly, the opening
in the flexible sheet is not peripherally but more centrally
located (as indicated with dotted lines 1922 in FIG. 21A). As
appears, this arrangement allows the point of insertion of the
cannula through the skin to be hidden and thus protected by the
attached delivery device during normal operation of the assembled
device, yet allows the cannula insertion site to be inspected by
simply detaching and reattaching the delivery device unit. Further,
as the modified inserter is moved towards the delivery device unit
this movement may be used to connect the fluid inlet of the cannula
with the fluid outlet from the delivery device unit, e.g. by means
of a pointed needle connector and a needle penetratable septum
arranged on either of the units. As appears, such a reversed
arrangement may also be provided for a cannula inserter of the type
disclosed with reference to FIGS. 15-18.
[0108] Indeed, the concept of a medical device comprising an angled
insertable cannula which in its inserted position is covered by a
detachable portion of the device can be used in combination with
any type of cannula-needle arrangement, not only the embodiments
disclosed above. The assembly may also be provided as a unitary
device in which an opening may be formed allowing the insertion
site to be inspected during use.
[0109] Although it is believed that the above-disclosed medical
devices can be manufactured in a cost-effective manner, frequent
changes of cannula or needle devices, e.g. infusion sets, is one of
the cost drivers and poor convenience factors in CSII (continuous
subcutaneous insulin infusion) treatment. It is today generally not
recommended to wear an infusion set for more than 2 days before
changing it, but in practice pump users wear them for a longer
time--on average 3.3 days. One of the limiting factors in wear time
is that the risk of bacterial growth at the infusion site increases
with longer wear times. The preservatives in insulin are
anti-bacterial, but since they don't get in touch with the outside
of the infusion needle they have no effect on this bacterial
growth.
[0110] With a porous infusion needle or cannula having a pore size
between the molecular size of the preservatives (typically small
molecules like meta-cresol and phenol) and the molecular size of
insulin (rather large molecules), some of the preservatives will
move to the outside of needle where they can reduce bacterial
growth and potentially increase the safe wear time of the infusion
needle. For a polymeric cannula the entire tube or portions thereof
thus can advantageously be made from a polymeric material allowing
the preservatives to diffuse from the cannula and into the
subcutis. A cannula may also be made from a fibrous material as
used in micro tubes for dialysis. For a steel needle laser drilling
of micro side openings would allow preservatives together with
insulin to diffuse out in the subcutis along the needle (unless the
side openings are made so small that they would be an effective
barrier to the insulin molecules). The porous portion of the needle
may be uniformly porous or it may be adapted to cause weeping at a
non-uniform flow rate along the length of the porous portion. A
porous portion may e.g. be located at the portion of the needle or
cannula intended to cross the skin barrier. US 2004-0220536, which
is hereby incorporated by reference, discloses a surgical needle
with a porous distal portion from which a liquid injectate will
weep or ooze multidirectionally under injection pressure while the
porous distal portion of the needle is inserted into a body
surface. More specifically, it is disclosed how a needle or cannula
can be provided with pores from which a liquid will ooze. For
example, the porous portion of the needle can be fabricated from
any of a number of different "open cell" porous materials (i.e.,
materials in which the pores are interconnecting). For example, a
distal portion can be fabricated from a porous sintered metal, such
as forms a non-woven matrix of metal fibers selected from such
metals as stainless steel, tantalum, elgiloy, nitinol, and the
like, and suitable combinations of any two or more thereof.
Generally, the metal fibers will have a diameter in the range from
about 1.0 micrometer to about 25 micrometer. A non-woven matrix of
metal fibers having these desired properties that can be used in
manufacture of the porous distal portion of the invention needle is
available from the Bekaeart Corporation (Marietta, Ga.), and is
sold under the trademark, BEKIPOR RTM filter medium. A porous
portion of the needle can also be fabricated from such porous
materials as a porous polymer, such as a porous polyimide,
polyethylene, polypropylene, polytetrafluroethylene, and the like.
Such porous polymers are disclosed, for example, in U.S. Pat. No.
5,913,856, which is hereby incorporated by reference in its
entirety. Alternatively, a porous ceramic can be used, such as is
known in the art for use in ceramic filters and separation
membranes, or a porous metal (also known as an expanded metal) or
carbon, such as is known in the art for use in filters or bone
grafts. For example, Mott Corporation (Farmington, Conn.)
manufactures porous metals for use in various types of filters. If
the porous filter medium is flexible, a porous portion of a needle
can be fabricated by wrapping the filter medium, which is available
commercially as a flat sheet, one or more times around an axis
while creating a hollow central core. The porous portion of the
needle can then be fused in fluid-tight fashion (e.g. welded) to a
non-porous hollow needle shaft using methods known in the art. To
create a porous portion of the needle having decreasing impedance
to fluid flow, a porous filter medium or metal mesh having an
appropriate porosity gradient can be employed in fabrication of the
porous portion. Alternatively, a porous portion can be created from
a non-porous material (e.g., a metal) using a cutting laser and
techniques known in the art to punch pores into the needle segment
(i.e. by a process of laser etching). For example, the nonporous
hollow shaft, porous portion, and point of a needle can be
fabricated of metal in a single piece, for example, from a
conventional hypotube. In this scenario, a metal-cutting laser is
used to create a segment of the needle that has appropriate
porosity, for example, a porosity gradient within a portion of the
needle to equalize fluid impedance along the length of the porous
portion of the needle.
[0111] The direct advantage of the above principle is a reduced
bacterial growth at the infusion site compared with standard
infusion needles. This increases user convenience, since an
infusion set can be worn longer before it needs to be replaced--a
replacement that can be painful especially for soft infusion
needles where a large diameter steel needle is used to guide the
soft infusion needle into the skin. Since infusion sets are
typically rather expensive, increased wear time will furthermore be
cost-attractive to pump users.
[0112] 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.
* * * * *