U.S. patent application number 12/492865 was filed with the patent office on 2012-01-26 for extra-corporeally portable infusion device.
This patent application is currently assigned to Roche Diagnostics International AG. Invention is credited to Marco De Polo.
Application Number | 20120022450 12/492865 |
Document ID | / |
Family ID | 39092722 |
Filed Date | 2012-01-26 |
United States Patent
Application |
20120022450 |
Kind Code |
A2 |
De Polo; Marco |
January 26, 2012 |
EXTRA-CORPOREALLY PORTABLE INFUSION DEVICE
Abstract
A portable medical apparatus for administering a fluid drug in
doses, including a first housing including a reservoir unit with an
outlet into a fluid path for conducting the drug, a second housing
including a conveying unit for dispensing the drug from the
reservoir unit in doses and a suitable controller for controlling
the conveying unit, an adaptor including a coupling structure for
receiving the first housing and the second housing and an attaching
structure for extra-corporeally carrying the adaptor on a patient,
wherein the conveying unit and the reservoir unit can be joined
together to form an integrated mechanical and fluidic unit, and
coupled to and decoupled from at least two differently configured
adaptors, wherein at least one of the adaptors is configured to be
directly attached to the surface of the skin and at least one of
the adaptors is configured to be worn on or carried by an article
of clothing or a wearing system (e.g., a belt).
Inventors: |
De Polo; Marco; (San Mateo,
CA) |
Assignee: |
Roche Diagnostics International
AG
Hinterbergstrasse 22
Steinhausen
CH
6312
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20100004596 A1 |
January 7, 2010 |
|
|
Family ID: |
39092722 |
Appl. No.: |
12/492865 |
Filed: |
June 26, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
PCT/EP2007/64645 |
Dec 28, 2007 |
|
|
|
Current U.S.
Class: |
604/131 ;
604/174; 604/180 |
Current CPC
Class: |
A61M 2005/14268
20130101; A61M 2005/14264 20130101; A61M 5/1413 20130101; A61M
5/14248 20130101; A61M 39/02 20130101 |
Class at
Publication: |
604/131 ;
604/174; 604/180 |
International
Class: |
A61M 5/14 20060101
A61M005/14 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 29, 2006 |
CH |
02126/06 |
Claims
1. A portable medical apparatus for administering a fluid drug in
doses, comprising: a first housing including a reservoir unit with
an outlet into a fluid path for conducting the drug; a second
housing including a conveying unit for dispensing the drug from the
reservoir unit in doses and a suitable controller for controlling
the conveying unit; and an adaptor including a coupling structure
for receiving the first housing and the second housing and an
attaching structure for extra-corporeally attaching the adaptor to
a patient; wherein the conveying unit and the reservoir unit can be
joined together to form an integrated mechanical and fluidic unit,
and coupled to and decoupled from at least two differently
configured adaptors, wherein at least one of the adaptors is
configured to be directly attached to the surface of the skin of
the patient and at least one of the adaptors is configured to be
worn on or carried by article of clothing or an accessory used by
the patient.
2. A portable medical apparatus for administering a fluid drug in
doses, comprising: a) a first housing comprising a reservoir unit
including an outlet into a fluid path located downstream of the
reservoir unit for conducting the drug; b) a second housing
comprising a conveying unit for dispensing the drug from the
reservoir unit in doses and means for controlling the conveying
unit; c) an adaptor comprising coupling means for receiving the
first housing together with the reservoir unit and the second
housing together with the conveying unit, said adaptor being
provided in at least two configurations; and d) attaching means for
extra-corporeally carrying the adaptor on the patient; wherein e)
the conveying unit and the reservoir unit can be joined together to
form a mechanical and fluidic overall unit, without using tools,
and coupled to and decoupled from at least two differently embodied
adaptors and can thus be joined together with the respective
adaptor to form a mechanical and fluidic overall unit, without
using tools, and wherein at least one of the adaptors is provided
for direct attaching to the surface of the skin and at least one of
the other adaptors can be worn on an item of clothing or carried by
a wearing system.
3. The portable medical apparatus in accordance with claim 2,
wherein the coupling means which enables the conveying unit and the
reservoir unit to be mechanically and functionally coupled is
substantially formed by the conveying unit and the reservoir
unit.
4. The portable medical apparatus in accordance with claim 2,
wherein the conveying unit, the reservoir unit and the respective
adaptor can be connected to each other via a force-fit or
positive-fit connection which can be established without using
tools.
5. The portable medical apparatus in accordance with claim 2,
wherein the adaptor comprises an adaptor plate for resting on the
skin or clothing and a connector for a mechanical and fluidic
connection between the reservoir unit and the conveying unit.
6. The portable medical apparatus in accordance with claim 2,
wherein the conveying unit and the reservoir unit can be attached
to a fluidic-mechanical connector of the respective adaptor and
fluidically connected to an outlet of the adaptor.
7. The portable medical apparatus in accordance with claim 2,
wherein the conveying unit and the reservoir unit can be joined
together in a positive fit or in a force fit on a
fluidic-mechanical connector of the respective adaptor.
8. The portable medical apparatus in accordance with claim 2,
wherein either the conveying unit or the reservoir unit can be
joined together with a fluidic-mechanical connector of the adaptor
in a force fit or in a positive fit.
9. The portable medical apparatus in accordance with claim 2,
wherein one of the adaptor or an adaptor plate associated with the
adaptor can be attached to the surface of the skin via one of a
releasable adhesive connection or a skin plaster.
10. The portable medical apparatus in accordance with claim 2,
wherein one of the adaptor or an adaptor plate of the adaptor
comprises means for connecting to a wearing system or an item of
clothing.
11. The portable medical apparatus in accordance with the claim 10,
wherein the means for connecting comprise means for securing
against being unintentionally separated from the wearing
system.
12. The portable medical apparatus in accordance with claim 10,
wherein the adaptor or adaptor plate is connected to a catheter
head which can be disconnected via a catheter line to infuse the
drug.
13. The portable medical apparatus in accordance with claim 2,
further comprising means for bringing about a secured resting state
of the infusion device before separation of the conveying and
reservoir units, wherein said means for bringing about is
automatically actuated by separation and enables administering
automatically after the conveying and reservoir units are joined
together.
14. The portable medical apparatus in accordance with claim 2,
wherein the conveying unit is for one of a single use or repeated
use.
15. The portable medical apparatus in accordance with claim 2,
wherein the reservoir unit is for a single use.
16. The portable medical apparatus in accordance with claim 2,
wherein at least the adaptor which can be attached to the skin is
for a single use.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of International Patent
Application No. PCT/EP2007/064645, filed on Mar. 7, 2007, which
claims priority to Swiss Patent Application No. 02126/06, filed on
Dec. 29, 2006, the entire contents of both of which are
incorporated herein by reference.
BACKGROUND
[0002] The present invention relates to devices for delivering,
injecting, infusing, administering or dispensing a substance, and
to methods of making and using such devices. More particularly, it
relates to a portable medical device or apparatus for dispensing a
fluid drug and, in some embodiments, for automatically dispensing
the fluid drug.
[0003] Devices for automatically and continuously dispensing fluid
drugs are often used with patients who continuously require a drug
which can be exclusively administered subcutaneously, wherein the
requirement varies throughout the day. Specific application
scenarios include, for example, certain pain therapies and the
treatment of diabetes mellitus, in which computer-controlled
administering devices which can be worn on the body are used,
wherein there is a fundamental need for the administering device to
have a low weight and a minimum volume to enable it to be worn
comfortably and discreetly.
[0004] Conventional, extra-corporeal infusion devices for
therapeutic use which are carried on the body or in clothing by a
wearing system are common in the prior art. While the patient is
sleeping, they are in most cases placed on or in a storage location
next to the bed and remain connected to the body via a catheter
supply line, thus maintaining the administering of fluid.
[0005] Miniaturised infusion devices have recently become available
which are attached directly to the surface of the skin. The
administering device is attached to the surface of the skin and the
administering cannula is inserted into the body tissue by the
patient personally.
[0006] Once such an infusion device has been attached to the
surface of the skin, it generally adheres to the body for 4 to 5
days and is then completely or partially disposed of.
[0007] Both infusion devices which are attached to the surface of
the skin and conventional infusion devices exhibit
situation-dependent advantages and disadvantages specific to their
type. Thus, for example, it is desirable during daily use by the
patient for the infusion device to be temporarily removable, at
least partially, to, for example, pursue a sporting activity
without hindrance or to not expose precision parts or electronic
components of the administering device to undesirable contact with
water in the course of showering or bathing.
[0008] A conventional administering device can be temporarily
removed by temporarily disconnecting the catheter tube and suitably
sealing the coupling locations. Single-use auxiliary devices or
features, for example insulin ampoules, batteries and/or catheters,
can also be replaced or exchanged without any problems in the
conventional administering devices, since the devices are designed
for a long service life.
[0009] By contrast, administering devices which are worn on the
surface of the skin typically may not be temporarily disconnected
nor can parts of the device be exchanged due to their design which
is consistently oriented toward single use and low production
costs. Temporarily disconnecting them from the body in a way
suitable for the patient, for physical activities such as, for
example, sports, swimming or cleaning the body, is not possible.
Even if administering devices which are worn on the surface of the
skin are significantly miniaturised, the patient remains restricted
in their freedom of movement, since a certain component volume is
still arranged on the body, and a static imbalance limits the
wearing comfort. There is also the danger of the apparatus
detaching from the body because it is insufficiently adhered to the
body, for example when attached by means of a plaster, or of the
apparatus being torn from the body by sudden movements. The
injection locations and wearing locations are also limited for this
design. Nonetheless, such devices provide an inconspicuous,
discreet way of being worn and short fluid connections which may be
cited as advantages of administering devices which are worn on the
surface of the skin.
[0010] EP 1527792 A1 describes an administering device which can be
attached on the surface of the skin, but which cannot be
temporarily disconnected.
SUMMARY
[0011] It is an object of the present invention to provide a
portable medical device or apparatus for administering a fluid drug
in doses, which optionally can be worn directly on a surface of the
body and/or can be carried by the patient in a conventional way,
depending on what is desired and/or suitable.
[0012] In one embodiment, the present invention comprises an
extra-corporeally portable infusion device which comprises: a
reservoir unit comprising a reservoir for a fluid drug and a
conveying unit for dispensing the drug in doses. The conveying unit
comprises a suitable mechanism or mechanisms for conveying the drug
and delivering it in doses.
[0013] The present invention is not restricted to administering
insulin, but rather generally encompasses administering products
which can be administered by infusion or injection. Comparable
apparatus can be used not only for self-administering but also in
an in-patient environment, for example under the constant
supervision of a physician in clinics, for example during recovery
or other aftercare, in which they are worn by the patient.
[0014] In one embodiment, the present invention comprises a
portable medical apparatus for administering a fluid drug in doses,
including a first housing including a reservoir unit with an outlet
into a fluid path located downstream of the reservoir unit for
conducting the drug, a second housing including a conveying unit
for dispensing the drug from the reservoir unit in doses and a
suitable controller for controlling the conveying unit, an adaptor
including a coupling structure for receiving the first housing
together with the reservoir unit and the second housing together
with the conveying unit, and an attaching structure for
extra-corporeally carrying the adaptor on the patient, wherein the
conveying unit and the reservoir unit can be joined together to
form a mechanical and fluidic overall unit, and coupled to and
decoupled from at least two differently configured adaptors to form
a mechanical and fluidic whole, and wherein at least one of the
adaptors is provided for being directly attached to the surface of
the skin and at least one of the adaptors can be worn on or carried
by an article of clothing or an accessory or wearing system (e.g.,
a belt, suspenders, etc.).
[0015] In one preferred embodiment of an administering device in
accordance with the present invention, the device is designed such
that the conveying unit and the reservoir unit can be mechanically
and functionally joined together and/or separated by a suitable
coupling mechanism or structure, wherein the conveying unit, the
reservoir unit and an adaptor, which can comprise a flexible or--as
applicable--rigid adaptor plate for resting on clothing or directly
on the body, are combined to form an integrated unit.
[0016] In some preferred embodiments, one or more coupling means
is/are formed on the conveying unit and one or more coupling means
is/are formed on the reservoir unit, each such that it cannot be
removed without a tool, for example by being integrally molded to
the respective housing or connected to it in a material fit or
otherwise fixedly joined, for example screwed, to it. This provides
the advantage that the coupling means are molded or connected to
the respectively assigned unit of the two units such that they
cannot be lost, and are therefore available at any time.
[0017] In one preferred embodiment, the reservoir unit and the
conveying units of the administering device (e.g., a pump) are
coupled to a fluidic-mechanical connector of the adaptor which both
fixes the units relative to the adaptor or the adaptor plate, and
ensures a fluidic connection between the reservoir unit and a
cannula which infuses the body, for e.g., a subcutaneous
administering. The connector may be advantageously arranged in the
middle of the adaptor plate. The mechanical coupling to the
connector can be a force-fit coupling achieved by clamping onto the
connector or a positive-fit coupling achieved by forming a counter
contour using the connected housing parts of the reservoir unit and
conveying unit.
[0018] In another preferred embodiment, a device in accordance with
the present invention comprises a coupling means embodied such that
the reservoir unit and the conveying unit can be joined together by
moving them relative to each other, for example along rigid guides,
e.g. by being pushed together along linear guides such as linear
dovetail guides, or by a bayonet lock formed by the two units. This
type of coupling enables the two units to be positioned precisely
with respect to each other and also facilitates personally joining
together the reservoir unit and conveying unit at inaccessible or
difficult-to-view locations, for example at an adaptor plate which
is laterally attached to a persons belt.
[0019] In some preferred embodiments, the coupling means is
embodied such that the conveying unit and the reservoir unit can be
joined together by latch or snap-in, complementary latching
elements. Such coupling means generally manage without additional
securing means.
[0020] In yet another preferred embodiment, the coupling means is
embodied such that the reservoir unit and the conveying unit are
joined together in a force fit, e.g. by being clamped or
temporarily adhered by a magnetic force or via a Velcro coupling.
The coupling means can likewise be embodied such that the reservoir
unit and the conveying unit are joined together by expanding one or
more rubbery or elastic positive elements formed by the unit,
which--when the reservoir unit and the conveying unit are joined
together--form(s) an elastically biased positive fit with assigned,
rigid positive elements of the complementary unit by enclosing or
engaging with one or more counter contours. This enables a
zero-clearance coupling to be realized in a cost-effective and
simple way.
[0021] In one preferred embodiment, the units are attached to the
surface of the skin by an adaptor comprising one adaptor plate
which remains on the surface of the skin while the administering
device is temporarily disconnected and forms a so-called retained
part, via a releasable adhesive connection or a skin plaster. This
embodiment combines the advantages of the ability to discreetly
wear the extra-corporeal infusion devices which are attached to the
body with the patient-friendly ability to be temporarily
disconnected.
[0022] In another preferred alternative embodiment, the pump parts
are coupled to a wearing system of the patient, via an adaptor
comprising one adaptor plate, to be carried. Such an adaptor plate
is embodied such that means for connecting it to a wearing system,
e.g. a pendant strap, a belt strap encircling the body, a belt clip
or a way of being attached to an item of clothing, are available.
This enables the infusion device to be simply adapted to different
everyday situations and/or uses by exchanging the wearing system.
The device, comprising the pump parts and the adaptor plate, can be
worn as a whole on a belt. For this purpose, a lateral cannula
connector on the adaptor plate is needed. One or more attaching
clips or a belt strap can be attached to the plane underside of the
adaptor plate thus created.
[0023] In another preferred embodiment using an adaptor plate for
carrying on a wearing system, a catheter head which can be
disconnected--comprising a cannula for inserting into the body
tissue--is connected to the adaptor plate via a short catheter
line. Catheter heads which can be disconnected are known in the
prior art and are routinely used in pump therapy. In such an
embodiment, a septum on the fluidic-mechanical connector of the
adaptor plate is unnecessary.
[0024] In yet another preferred embodiment of a portable medical
device in accordance with the present invention, the coupling means
comprise securing means by which the reservoir unit and the
conveying unit can be secured against being unintentionally
separated, when they are properly joined together, wherein the
securing means requires a manipulation to release their lock or
connection, which is different than the manipulation required for
separating them, e.g. pressing a release button if a rotational
movement is required for separating. This enables an optimal degree
of security against unintentional separation and loss.
[0025] In another preferred embodiment, means--e.g. electronic
means--are provided on the device which bring about a secured
resting state of the infusion device before separation and enable
administering to be continued as planned after joining
together.
[0026] In some embodiments of the present invention, the conveying
unit optionally consists of a conveying unit for single use or for
repeated use, the reservoir unit optionally consists of a reservoir
unit for single use or for repeated use, and the adaptor plates are
optionally embodied for single use or for repeated use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 depicts an embodiment of the present invention
comprising a reservoir unit, a conveying unit and an adaptor plate
for directly attaching to the surface of the skin;
[0028] FIG. 2 depicts an adaptor plate for carrying on a wearing
system in the form of a belt encircling the body, wherein a short
catheter tube piece is attached to the adaptor plate and spans the
distance between the wearing position and the cannula injection
position;
[0029] FIG. 3 depicts an adaptor plate for directly attaching to
the surface of the skin, wherein the fluid supply line runs in the
adaptor plate; and
[0030] FIG. 4 depicts an adaptor plate for carrying on a wearing
system, wherein the fluid supply line runs in the adaptor
plate.
DETAILED DESCRIPTION
[0031] With regard to fastening, mounting, attaching or connecting
components of the present invention, unless specifically described
as otherwise, conventional mechanical fasteners and methods may be
used. Other appropriate fastening or attachment methods include
adhesives, welding and soldering, the latter particularly with
regard to the electrical system of the invention, if any. In
embodiments with electrical features or components, suitable
electrical components and circuitry, wires, wireless components,
chips, boards, microprocessors, inputs, outputs, displays, control
components, etc. may be used. Generally, unless otherwise
indicated, the materials for making the invention and/or its
components may be selected from appropriate materials such as
metal, metallic alloys, ceramics, plastics, etc.
[0032] FIG. 1 shows an infusion device in accordance with the
present invention, comprising a conveying unit (2) which can be
coupled to a reservoir unit (1) which is attached to the surface of
the skin (7) by an adaptor plate (3a). Because the infusion device
is completely attached to the surface of the body, large
gravitational and acceleration forces may arise in certain
circumstances. Accordingly, a suitably strongly adhesive plaster
(6) has to be selected which adheres well, but at the same time is
simple to remove.
[0033] The disadvantages of an apparatus which is permanently
attached to the body can be solved by attaching the reservoir unit
(1) and the conveying unit (2)--which contains the drive unit (12)
and the electronics (13)--to the body via an adaptor. The adaptor
comprises an adaptor plate (3a) which rests on the skin, and a
fluidic-mechanical connector (5) which projects from it. The units
(1) and (2) can be detached from the adaptor plate (3a) via the
connector (5) by simple hand movements, while the adaptor plate
(3a) can remain on the body, and can thus be temporarily removed
from the body to, for example, pursue a sporting activity without
hindrance or to not expose precision parts or electronic components
of the administering device to undesirable contact with water in
the course of showering or bathing. The conveying unit (2), the
reservoir unit (1) and the adaptor (3a, 5) are connected by a
suitable coupling structure or means (4) which act by being
snapped, screwed or by using a quick-release lock (for example
levers and belts, a clasp, etc.). The adaptor (3a, 5), comprising
an integrated cannula (14) for inserting into the body tissue (7),
serves as a connecting and attaching system for the insulin pump
and connects the conveying unit (2) to the reservoir unit (1). A
septum (15) prevents body fluid from exiting the body while the
device is temporarily disconnected. An injection needle (16) which
can be inserted on the fluidic-mechanical connector (5) allows the
body tissue (7) to be penetrated when the cannula (14) is applied,
wherein the reservoir unit can be used as a bearing or carrying
housing part, with the advantage that the apparatus unit as a whole
can be designed to be very compact and flat. An additional ampoule
compartment, such as is used in conventional insulin pumps, is
omitted in this arrangement. Handling is likewise simplified, since
an additional adaptor is not needed to mechanically connect the
reservoir unit (1) and the conveying unit (2) to the cannula (14)
and fluidically connect the reservoir unit (1) to the cannula (14),
wherein the reservoir unit (1) is designed such that additional
conveying as a result of external forces cannot occur due to
reinforcements provided (for example, ribs).
[0034] FIG. 2 shows an embodiment of an adaptor plate (3b) in
accordance with the present invention, the plate 3b for an
administering device which is carried on the patient's body via a
wearing system. As an alternative to being worn attached to the
body by the adaptor plate (3a), the reservoir unit (1) and the
conveying unit (2) can be combined with the adaptor plate (3b)
which enables the fluidic connection to the catheter head (11) via
a short (e.g., <50 cm) catheter (10) and can be carried on the
body by the patient by, e.g., a belt wearing system (8, 9). Since
the forces are largely absorbed via the wearing system, it is
possible to use a smaller plaster (17) for attaching the cannula,
which reduces the danger of skin irritation and can reduce
attaching problems. To enable the infusion device to be temporarily
disconnected, the catheter head is embodied such that it can be
disconnected. Decoupling the reservoir unit (1) and the conveying
unit (2) is not absolutely necessary in this case. The septum in
the connector is also unnecessary in this case.
[0035] FIG. 3 shows another embodiment of an adaptor plate (3c) for
direct attachment to the surface of the skin, in which a catheter
supply line (19) is integrated into the adaptor plate downstream of
the reservoir unit (1) and can be worn directly on the surface of
the skin. The cannula (18) is arranged in the middle of the adaptor
plate (3c) and surrounded by a symmetrically arranged skin plaster
or adhesive. This arrangement means that the forces which act on
the injection location are the same on all sides, thus increasing
the wearing comfort. The reservoir unit (1) and the adaptor unit
(3c) are fluidically connected using a septum/needle connector
(20). The mechanical connection is provided via a mechanical
coupling means (23) arranged on the respectively facing side.
[0036] FIG. 4 shows an embodiment of an adaptor plate (3d) which is
provided for carrying on a wearing system. The reservoir unit and
the adaptor unit (3d) are fluidically connected via a septum/needle
connector (20); the connecting catheter supply line (19) is
integrated into the adaptor plate. The mechanical connection is
provided via mechanical coupling structure (23) arranged on the
respectively facing side. The catheter supply line (22) which leads
downstream is attached, fixedly or releasably, to the adaptor
plate. In a representation which is not shown, the catheter supply
line can also lead laterally away from the adaptor plate, for
example to enable it to be attached to a belt. Suitable attaching
structures (20) for attaching the plate 3d to a wearing system are
attached to or carried by the facing-side ends of the adaptor plate
(3d).
[0037] Embodiments of the present invention, including preferred
embodiments, have been presented for the purpose of illustration
and description. They are not intended to be exhaustive or to limit
the invention to the precise forms and steps disclosed. The
embodiments were chosen and described to provide the best
illustration of the principles of the invention and the practical
application thereof, and to enable one of ordinary skill in the art
to utilize the invention in various embodiments and with various
modifications as are suited to the particular use contemplated. All
such modifications and variations are within the scope of the
invention as determined by the appended claims when interpreted in
accordance with the breadth they are fairly, legally, and equitably
entitled.
* * * * *