U.S. patent application number 14/092532 was filed with the patent office on 2014-03-27 for infusion pump system.
This patent application is currently assigned to Asante Solutions, Inc.. The applicant listed for this patent is Asante Solutions, Inc.. Invention is credited to James Causey, Mark Estes, Morten Mernoe, Mitchell Wenger.
Application Number | 20140088557 14/092532 |
Document ID | / |
Family ID | 37793979 |
Filed Date | 2014-03-27 |
United States Patent
Application |
20140088557 |
Kind Code |
A1 |
Mernoe; Morten ; et
al. |
March 27, 2014 |
Infusion Pump System
Abstract
An infusion pump system is described that increases patient
comfort and convenience. The infusion pump system includes an
infusion site interface that is releasably connected to an infusion
pump body, and has no tubing associated between the infusion site
interface and the pump body. The infusion pump body may include a
carrier frame that may be adhered to the skin of a user.
Inventors: |
Mernoe; Morten; (Sunnyvale,
CA) ; Causey; James; (Simi Valley, CA) ;
Wenger; Mitchell; (Sunnyvale, CA) ; Estes; Mark;
(Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Asante Solutions, Inc. |
Sunnyvale |
CA |
US |
|
|
Assignee: |
Asante Solutions, Inc.
Sunnyvale
CA
|
Family ID: |
37793979 |
Appl. No.: |
14/092532 |
Filed: |
November 27, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12817031 |
Jun 16, 2010 |
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14092532 |
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|
11557910 |
Nov 8, 2006 |
8475408 |
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12817031 |
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60771496 |
Feb 8, 2006 |
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60758955 |
Jan 13, 2006 |
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60734382 |
Nov 8, 2005 |
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Current U.S.
Class: |
604/506 |
Current CPC
Class: |
A61M 2005/1587 20130101;
A61M 2005/1581 20130101; A61M 5/14248 20130101; A61M 5/158
20130101; A61M 5/14566 20130101; A61M 5/16854 20130101 |
Class at
Publication: |
604/506 |
International
Class: |
A61M 5/142 20060101
A61M005/142; A61M 5/158 20060101 A61M005/158 |
Claims
1.-11. (canceled)
12. A method of operating an infusion pump system, comprising:
adhering an infusion site interface structure to a skin surface,
the infusion site interface structure comprising: a frame with a
lower surface facing toward the skin surface and an upward facing
surface that is opposite the lower surface, a soft cannula coupled
to the frame and extending below the lower surface of the frame for
insertion subcutaneously through the skin surface to at least
partially define a fluid path, and a septum arranged in the fluid
path and coupled to the frame in a position above the upward facing
surface of the frame; and releasably connecting an infusion pump
device to the frame of the infusion site interface structure
adhered to the skin such that the infusion pump device is
mechanically coupled to the frame of the infusion site interface
structure and a piercing member of the infusion pump device
penetrates the septum of the infusion pump device, through the
penetrated septum of the infusion site interface structure, and
through the soft cannula inserted subcutaneously through the skin
surface; causing the infusion pump device to dispense medicine into
a user's body via the fluid path from the medicine reservoir housed
in the infusion pump device, through the penetrated septum of the
infusion site interface structure, and through the soft cannula
inserted subcutaneously through the skin surface; disconnecting and
reconnecting the infusion pump device to the infusion site
interface structure so that the fluid path is broken and
re-established without replacement of the infusion site interface
structure.
13.-23. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 11/557,910 filed on Nov. 8, 2006, which claims the benefit
of U.S. Provisional Application 60/734,382, filed Nov. 8, 2005,
U.S. Provisional Application 60/758,955, filed Jan. 13, 2006, and
U.S. Provisional Application 60/771,496, filed Feb. 8, 2006. The
disclosures of the prior applications are considered part of and
are hereby incorporated in their entirety by reference in the
disclosure of this application.
TECHNICAL FIELD
[0002] This invention relates to infusion pump systems.
BACKGROUND
[0003] An infusion pump may be used to infuse fluids, medication,
or nutrients into a patient's body or circulatory system. An
infusion pump is generally used intravenously, although
subcutaneous, arterial and epidural infusions are occasionally
used. Infusion pumps can reliably administer fluids in ways that
would be impractically expensive or unreliable if performed
manually by nursing staff. For example, infusion pumps can
administer 1 mL per hour injections (too small for a drip),
injections every minute, injections with repeated boluses requested
by the patient up to the maximum number per hour allowed (e.g. in
patient-controlled analgesia), or fluids whose volumes vary by the
time of day.
[0004] As infusion pumps can also produce quite high but controlled
pressures, the pumps can inject controlled amounts of fluids
subcutaneously (beneath the skin), or epidurally (just within the
surface of the central nervous system--a very popular local spinal
anesthesia for childbirth).
[0005] Conventional infusion pumps rely on disposable infusion sets
to link the pump system to an infusion site. These sets generally
have a length of tubing between both ends to accommodate the
patient's changes to wear position, pump maintenance and
programming and to facilitate changing of the catheter system. As
pump systems gradually reduce in size and complexity, the tubing
becomes tangled as a result of its length making the pumps
difficult to use and uncomfortable for the patient.
SUMMARY
[0006] A disconnectable, body-worn infusion pump system allows a
more convenient attachment method for the user of a body-attached
or body-worn pump. The device described herein may adhere to the
skin of a wearer. The infusion pump system maintains a fluid path
between the wearer and a pump. This path can be intermittently
broken and re-established without replacement of the catheter
within the body of the user.
[0007] An infusion pump system is described that includes an
infusion site interface including a soft cannula for penetration of
the skin when the interface is installed, and a hub that rises
above the upper surface of the interface when the interface is
installed, wherein the infusion site interface lacks tubing above
the upper surface of the interface, and an infusion pump body,
wherein the infusion pump body can be releasably connected to the
infusion site interface to form a direct connection between the
infusion pump body and the infusion site interface.
[0008] The system may include an infusion site interface adhesively
attached to the infusion site on a body. The infusion site
interface may include a carrier frame having an adhesive on the
upper surface, enabling temporary adhesion of the pump body to the
upper surface of the carrier frame. The infusion site interface may
include a carrier frame, wherein the carrier frame is adhesively
connected to a body near an infusion site location, and the carrier
frame is connected to the hub. The carrier frame may be connected
to the hub via structural supports between the hub and an outer
frame. The carrier frame may include a webbing.
[0009] The system may include an adhesive on the pump body that
enables temporary adhesion of the pump body to another surface. The
exit port of the infusion pump body may connect directly to an
entry port on the infusion site interface.
[0010] The pump body may releasably connect to the infusion site
interface using a locking mechanism on the hub of the infusion site
interface, or may releasably connect to the infusion site interface
using a guide on the hub of the infusion site interface, or may
releasably connect to the infusion site interface using the
penetration of a pump body exit port through an infusion site
interface septum. The pump body exit port may include a needle.
[0011] The infusion pump body may include a control system. The
infusion site interface may have no tubing external to the skin of
a user after installation of the infusion site interface.
[0012] A method of operating an infusion pump system is described
that includes dispensing medicament from a medicament reservoir in
a pump body through a pump body exit port into an infusion site
interface, wherein there is a direct connection between the
infusion pump body and the infusion site interface during the
dispensing, and wherein the pump body is releasably connected to
the infusion site interface.
[0013] The pump body exit port may include a catheter that
penetrates a septum of the infusion site interface. The catheter
may include a needle. The pump body exit port may connect directly
to an entry port on the infusion site interface. The pump body may
releasably connect to the infusion site interface using a locking
mechanism, or may releasably connect to the infusion site interface
using a guide on the infusion site interface, or may releasably
connect to the infusion site interface using only the penetration
of the pump body exit port through an infusion site interface
septum.
[0014] The infusion site interface may be adhesively attached to
the infusion site on a body. The pump body may be adhesively
attached near the infusion site. The pump body may be adhesively
attached to an upper surface of the infusion site interface. The
pump body may be adhesively attached using a single layer
adhesive.
[0015] An infusion pump system is described that includes an
infusion site interface including a soft cannula for penetration of
the skin when the interface is installed, a carrier frame that can
be adhesively attached to a body surface, and a hub that is
connected to the carrier frame and rises above the carrier frame
when the interface is installed, and an infusion pump body, wherein
the infusion pump body can be connected, detached, and re-connected
to the infusion site interface as desired to form a direct
connection between the infusion pump body and the infusion site
interface.
[0016] An infusion pump system is described that includes an
infusion site interface including a soft cannula for penetration of
the skin when the interface is installed, a carrier frame that can
be adhesively attached to a body surface, and a hub that is
connected to the carrier frame and rises above the carrier frame
when the interface is installed, and an infusion pump body that can
be releasably connected to the infusion site interface, forming a
direct connection between the infusion pump body and the infusion
site interface, and an adhesive surface on the infusion pump
body.
[0017] The adhesive surface may be used to attach the infusion pump
body to the infusion site interface. The adhesive surface may be
used to attach the infusion pump body near an infusion site.
[0018] As used herein, the term "direct connection" refers to a
connection that does not include any tubing or similar intermediary
between the two endpoints of the direct connection.
[0019] As used herein, the term "medicament" generally refers to
all fluids, medication, drugs, nutrients, biomaterials, chemicals,
or other materials that may be dispensed by an infusion pump.
[0020] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
[0021] FIG. 1 is an illustration of an assembled and connected
infusion pump system attached to a human torso.
[0022] FIG. 2 is an illustration of an example of an infusion pump
system, including an infusion pump body detached from an infusion
site interface.
[0023] FIG. 3 is a cross-sectional illustration of an assembled and
connected infusion pump system.
[0024] FIG. 4 shows an assembled view of one example of an infusion
site interface.
[0025] FIG. 5 shows a component view of one example of an infusion
site interface.
[0026] FIG. 6 is an illustration of one example of an infusion site
interface.
[0027] FIG. 7 is a cross-section view of the infusion site
interface shown in FIG. 6.
[0028] FIG. 8 is a top view illustration of another example of an
infusion site interface.
[0029] FIG. 9A is an illustration of another example of an infusion
site interface having an access port.
[0030] FIG. 9B is an illustration of another example of an infusion
site interface having an access port and a septum.
[0031] FIG. 10 is an illustration of another example of an infusion
site interface.
[0032] FIG. 11 is an illustration of another example of an infusion
site interface.
[0033] FIG. 12A illustrates an infusion pump system 1200 which may
be used with an infusion site interface such as the ones shown in
FIG. 6.
[0034] FIGS. 12B-D are illustrations of examples of infusion pump
systems with adhesives for affixing near an infusion site.
[0035] FIGS. 13A-C are illustrations depicting steps of one method
that can be used to attach an infusion pump system to an infusion
site interface.
[0036] FIGS. 13D-F are illustrations depicting steps of one method
that can be used to attach an infusion pump system to an infusion
site system.
[0037] FIG. 14 depicts an alternate embodiment of an infusion pump
system 1400 with a flexible neck for use with an infusion site
interface.
[0038] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0039] An infusion pump system is described that increases patient
comfort and convenience. The infusion pump system includes an
infusion pump body and an infusion site interface. The infusion
pump body is releasably connected to the infusion site interface,
and therefore there is no associated tubing between the infusion
pump body and the infusion site interface. The infusion pump body
also includes a housing that may be adhered to the skin of a
user.
[0040] FIG. 1 shows a view of an assembled infusion pump system 100
attached to a human torso. The infusion pump system 100 may be used
to infuse a medicament directly into an infusion site. A complete
flow path is formed from a medicament reservoir within the infusion
pump system 100 to the infusion site.
[0041] FIGS. 2-3 are illustrations of a self-contained infusion
pump system including an infusion site interface. FIG. 2 shows a
disassembled view of the infusion pump system 100, including a pump
body 102 and an infusion site interface 104. FIG. 3 shows a
cut-away cross-section view of the assembled infusion pump system
100. The component parts illustrated in these views create a
complete, self contained medicine infusion pump system when
assembled.
[0042] Returning to FIG. 2, the infusion pump body has an upper
housing 111 and a lower housing 112 which define a periphery in
which the pump mechanisms reside. The lower housing 112 may be
adhered to a user's skin by means of an adhesive system. The upper
and lower housings 111, 112 may include openings or penetrations
114 for attachment and guidance of the infusion site interface 104
to the pump body 102. Additionally, the openings 114 may allow for
installation of a reservoir contained within the pump body 102. One
or more buttons 113 may be used to enter user requests into the
pump system.
[0043] As can be seen in FIG. 3, mechanisms that are contained in
the pump body 102 may include a reservoir 118, a drive mechanism
124, and a control system. The reservoir 118 includes a distal end
128 and a proximal end 130. The reservoir 118 may be cylindrical in
geometry with the distal end 128 sealed by a moveable plunger 131
of matching geometry as the reservoir 118. The proximal end 130 of
the reservoir 118 may be closed by a reservoir septum 132. In some
embodiments, the reservoir septum 132 may be formed of a
self-sealing material, such as silicone or rubber. In other
embodiments the proximal end 130 of the reservoir 118 may be closed
by a valve or other device. The drive mechanism 124 may be actuated
to apply pressure internal to the reservoir so that a medicament
contained within the reservoir 118 may be dispensed out of the
reservoir 118. In one embodiment, the medicament may be pushed
through a device that pierces the reservoir septum 132. In other
embodiments, the medicament may be pushed through a valve or other
device at the proximal end 130 of the reservoir 118. The actuation
of the drive mechanism 124 may be governed by the control
mechanism. The geometry of the reservoir 118 has been shown as
cylindrical for illustrative purposes only and the reservoir 118 is
geometry independent.
[0044] In one embodiment, a reservoir 118 containing a medicament
may be installed in the pump body 102 via an opening in the pump
body 114. The infusion pump body may be prepared for use after
installation of the infusion site interface 104 at a body location.
In some embodiments, the infusion pump body may be prepared for use
by inserting a reservoir 118 of medicament in the infusion pump
body 102. For example, a generally cylindrical and geometrically
matched medicament reservoir 118 is inserted into the vacant pump
cavity. In another embodiment, the reservoir might be installed by
separating the pump body, such as by separating upper and lower
housings. In another embodiment, the reservoir might be pre-loaded
into the pump body, and require no user loading. Examples of
medicaments that may be contained in the medicament reservoir 188
may include insulin, pain relief drugs, hormone therapy, blood
pressure treatments, anti-emetics, osteoporosis treatments, or
other injectable medicines or liquids.
[0045] FIGS. 4 and 5 show assembled and component views of one
example of an infusion site interface 104. The infusion site
interface may also be referred to as a catheter head system. The
infusion site interface 104 provides for continuous or intermittent
subcutaneous fluid infusion and is comprised of an upper housing
140, a lower housing 142, a hub 144 having a hollow chamber, an
infusion site interface septum 146, a catheter of biocompatible
material 149, and an O-ring 152 for sealing the exterior surface
155 of the hub 144 against the interior surface of the pump body
102 associated with the opening 114 of the pump body. The catheter
149 may be used for indwelling in a user after installation of the
infusion site interface 104 at a location on the body. The catheter
149 also defines a through passage for passing a medicament from
the infusion pump system into a body. The infusion site interface
104 provides for the continuous fluid path between the reservoir
118 and the user.
[0046] A continuous fluid path may be formed by connecting one side
of the hub 144 to the pump body. One side of the hub 144 may be
equipped with a septum piercing device 162 that penetrates the
reservoir septum 132 (shown in FIG. 3), enabling medicament to
enter the hub. In one embodiment, the medicament may enter a
chamber or junction within the hub 144. Medicament may flow from
the hub 144 through the catheter 149 and into the user. Typically,
the infusion site interface 104 is equipped on a side generally
tangent to the septum piercing device 162 and coplanar to a user's
skin. The biocompatible catheter 149 may be used for subcutaneous
infusion of medicine to a user. Thus, the septum piercing device
162 of the infusion site interface 104 may initiate a pathway for
medicament by penetration of the reservoir septum 132 during
attachment of the pump body 102 to the infusion site interface 104.
During treatment, medicament may traverse from the reservoir 118
through the septum piercing device 162, through the hub 144 and
catheter 149, and into the user.
[0047] Referring again to FIG. 2, the infusion site interface 104
may be attached to the pump system 102 by insertion of the
generally cylindrical exterior surface 155 of the hub 144 of the
catheter head system 104 into the geometrically matched opening 114
of the pump body 102. In some embodiments, the exterior surface of
infusion site interface 104 may contain alignment features of
geometry such that the infusion site interface 104 may be attached
in a single orientation or discreet set of orientations into
matching mating features in the pump body 102. The alignment
feature(s) on the exterior surface of the hub 144 may allow the
infusion site interface 104 to be securely attached to the pump
body 102, preventing unintended separation of the two systems.
[0048] In another embodiment, the pump system 102 may attach to the
infusion site interface 104 using another method or device which
allows for the secure attachment of the infusion site interface 104
to the pump body 102. In one approach, the secure attachment may be
in the form of a locking ring which securely and releasably locks
the infusion site interface 104 to the pump system 102. In another
approach, the secure attachment may be in the form of a Luer-lock
connection. In another approach, the secure attachment may be
created by a mechanism or method which is detachable from the
completed system, such as flexible connector. In another approach,
the secure attachment may be in the form of replaceable locking
tabs on the upper housing 111, the lower housing 112 or infusion
site interface 104. When locked, the tabs on the infusion site
interface 104 may engage features on the pump body 102 to prevent
the accidental release of the infusion site interface 104.
Alternatively, locking tabs on the pump body 102 may engage
features on the infusion site interface 104 to prevent accidental
releases. The infusion pump body may be directly connected to the
infusion site interface, such that there is no tubing or other
intermediate between the pump body and the infusion site
interface.
[0049] FIG. 6 shows one example of an infusion site interface 600.
FIG. 7 shows a cross-section view of the infusion site interface
600 shown in FIG. 6.
[0050] The infusion site interface 600 includes a soft cannula 602
of biocompatible material that may be inserted into the body of a
user. The cannula 602 is attached at its upper or proximal end to
an annular sealing flange 607 that forms the center of a carrier
frame 640. The cannula 602 also defines a central channel 620. The
annular sealing flange 607 may be attached coaxially to the lower
or distal surface of an inner ring or hub 614. Together, these
elements provide for the creation of a continuous fluid flow path
from the orifice of the hub 614 through to the cannula 602. These
elements may also form the confines of an intermediate chamber in
the hub 614 that connects to the channel 320 in the cannula 602.
The hub 614 defines a central orifice that may be closed by a
septum 630 that seals the fluid path of the hub 614 and cannula 602
from the outside world.
[0051] The infusion site interface 600 may also include a carrier
frame 640. The carrier frame 640 may include as components an outer
frame member 621 and one or more structural supports 624. The outer
frame 621 may be attached to the hub 614 by one or more structural
supports 624. The structural supports 624 may be configured to be
radial spokes, curved supporting members, or other configurations.
In various embodiments, there may be zero, one, or multiple
structural supports 624. The components forming the carrier frame
640 may be made of a rigid, semi-rigid, or flexible material which
may be adhered to the body by a skin adhesive system. The carrier
frame may also include a flexible mesh or other material between
the hub 614, outer frame member 621 and structural supports 624.
When present, the flexible mesh or other material may improve the
adhesion of the infusion site interface 600 to a treatment location
on a body. The flexible mesh may also assist in attaching,
detaching, or handling the infusion site interface 600.
[0052] The outer frame member 621 may be of size and shape to
permit convenient placement on the body. The outer frame member 621
may be of sufficient rigidity to maintain secure location of the
cannula 602 in the body of the wearer, and act to prevent the
infusion site interface 600 from changing position or detaching
from the desired location. The outer frame member 621 may be of
sufficient flexibility to maintain wearer comfort, and maintain
attachment of the cannula to the wearer during the normal wear
duration.
[0053] The cannula 602 may be a biocompatible plastic tube inserted
subcutaneously in the body of the wearer to create a fluid path
from a pump device to a location within the body of the wearer. The
cannula 602 may be rigidly or flexibly attached to the hub 614 of
the frame. Generally, the cannula 602 is maintained at a location
within the body of the wearer by the adhesion of the carrier frame
of the adhesion site interface 600 to the body of the wearer. The
infusion site interface may be designed such that there is no
tubing that extends external of the body after the infusion site
interface is in place. Thus, the infusion site interface may be
located on a surface of a body, with a soft cannula descending to a
tissue location. The infusion site interface may also include a
carrier frame that is adhesively attached to the body, holding the
infusion site interface in place, and a hub that extends above the
surface of the of the carrier frame for attachment of a pump
body.
[0054] The septum 630 provides a penetrable barrier or seal from
the inserted cannula 602 to the outside world. The septum 630 may
be of a size sufficient to allow the insertion of a drug delivery
needle (as described below) or a similar drug delivery conduit. The
entry of the drug delivery conduit into the cannula 602 may be
perpendicular to the skin surface or at a suitably convenient
angle. The septum 630 may be formed of a self-sealing material such
as rubber or silicone.
[0055] The infusion site interface 600 may also include a leak
detection mechanism, whereby positive indication is provided to the
wearer of the infusion site system 600 that a compromise in the
fluid path has occurred. This indication can be by visual or
tactile means either through color change or a means for dermal
stimulation at the site.
[0056] FIG. 8 shows a top view of one embodiment of an infusion
site interface 800. The infusion site interface 800 shown is
similar to infusion site interface 600 in FIGS. 6 and 7, with the
exception that the hub 814 is attached to the outer frame member
821 by a plurality of structural supports 824 that are curved
radial spokes. In some embodiments, the carrier frame may also
include a flexible mesh or other material between the hub 814,
outer frame member 821 and structural supports 824.
[0057] FIG. 9A shows another example of an embodiment of an
infusion site interface 900. The infusion site interface 900
includes a central hub 904 and a cannula 902. The cannula 902 may
be formed of a soft biocompatible material, and is designed for
insertion into the body of a user. The central hub 904 includes an
access port 917 and locking features 921. The access port 917
connects to the cannula 902 such that medicaments that pass through
the access port 917 pass through and into the cannula 902 for
infusion into a user. The locking features 921 may be used to affix
an infusion pump body to the infusion site Interface. A covering
which normally seals against the access port 917 to prevent foreign
materials from entering the infusion site system 900 opens when an
infusion pump body is attached to allow medicaments pumped from the
infusion pump body to pass into the infusion site interface.
[0058] The infusion site interface 900 may also include a carrier
frame 907. The carrier frame 907 may include an outer frame member
908 and a flexible material 911. The central hub 904 may be
connected to the outer frame member 908 by the flexible material
911. The flexible material 911 may be formed of a mesh or other
material. The carrier frame 907 formed by the outer frame member
908 and flexible material 911 may adhere to the body by a
conventional adhesive system.
[0059] FIG. 9B shows another example embodiment of an infusion site
interface 950, similar to the infusion site interface of FIG. 9A.
The infusion site interface 950 shown in FIG. 9B also includes a
septum 975 located on the top surface of the hub 954. In this
embodiment, the access port 967 or the septum 975 may be used to
supply a medicament from an infusion pump body to the cannula 952
for infusion into a user.
[0060] FIG. 10 shows another example embodiment of an infusion site
interface 1000. Infusion site interface 1000 includes a hub 1004
and a carrier frame 1005. The carrier frame 1005 includes an outer
frame member 1008 and a flexible mesh 1006. The outer frame member
1008 is affixed to the hub 1004 by the flexible mesh 1006. The
carrier frame 1008 may be in a rectangular shape, as shown in FIG.
10, or may have alternate shapes, such as a circle, square, o
ellipse, or may have other regular or irregular shapes. Adhesive
may be applied to the bottom surface of the carrier frame,
including the flexible mesh 1006 and the outer frame 1008, and may
be used to affix the infusion site system to a user's body.
[0061] The hub 1004 includes an access port 1017, a septum 1025,
and locking features 1021. The locking features 1021 may be used to
affix an infusion pump system to the infusion site system 1000. The
access port 1017 and septum 1025 connect to a cannula (not shown)
such that medicaments from an infusion pump body which pass through
the access port 1017 or septum 1025 pass through and into the
cannula for infusion into a user.
[0062] FIG. 11 shows another example embodiment of an infusion site
interface 1100. Infusion site interface 1100 includes a cannula
1103, a central body hub 1105, and a carrier frame 1113. The
cannula 1103 is attached to the central body hub 1105, and may be
accessed by an infusion pump body via a septum 1106. A locking
mechanism 1107 may be incorporated into the central body hub 1105
and may be used to attach an infusion pump body to the infusion
site interface 1100. The carrier frame 1113 may include an outer
frame member 1008 which is connected to the central body hub 1105
by a structural support 1115. In this embodiment, the structural
support is configured as webbing. The webbing may be rigid,
semi-rigid, or flexible. In some embodiments, the carrier frame
1113 may also include a flexible mesh or other material between the
central body hub 1105, outer frame member 1008, and webbing 1115.
The carrier frame 1113 may be adhered to a user's body via the
outer frame member 1117, webbing 1115, and if present, the optional
mesh or other material. In other embodiments, the central body hub
1105 may have one or more guiding members to guide an infusion pump
body for attachment to the infusion pump interface 1100.
[0063] The skin adhesive system used with the infusion site systems
described above may include a variety of systems, methods, and
materials. In one embodiment, the skin adhesive system may be a
flexible membrane with skin compatible adhesive capable of
removably securing an infusion site interface to the skin of a
user. In another embodiment, a flexible membrane may have a skin
compatible adhesive on a first surface and a device compatible
adhesive on a second surface. In other embodiments, the skin
adhesive system may include an adhesive composed of a single layer
material that is adhesive to both the user's skin surface and the
infusion site interface. Variously, the adhesive material may be a
gel layer, a liquid layer that dries after contact, or other
material. The precise size and placement of adhesive may be
dependant on the application. Typically, the adhesion of the
infusion site interface to a user's skin may also include adhesion
of a carrier frame to the user's skin.
[0064] FIGS. 12A-12D illustrate how adhesives may be used with an
infusion pump body 1200 to establish a fluid path from the infusion
pump system 1200 to an infusion site system without direct
mechanical coupling, thereby creating a "floating" fit wherein the
flexibility of the infusion pump system including the infusion pump
body and the infusion site interface is greatly increased.
[0065] FIG.12A illustrates an infusion pump body 1200 which may be
used with various infusion site interfaces, such as the ones shown
in FIG. 6. The infusion pump body 1200 includes a casing 1210 which
contains a reservoir and pumping mechanism. The infusion body 1200
also includes an infusion site docking area 1212 with a septum
piercing device 1220 that may provide a direct fluid path from the
reservoir to the infusion site interface. The septum piercing
device 1220 also serves as the exit port of the infusion pump body.
The pumping mechanism including the pump housing 1210 may cause a
medicament in the reservoir to flow through the septum piercing
device 1220 and pass into an infusion site interface.
[0066] A connection between the infusion pump body and an infusion
site interface may be created by the septum piercing device
penetrating a septum of the infusion site interface. This may be
accomplished without the direct attachment of the infusion pump
housing 1210 to the infusion pump interface. The infusion pump body
would then be able to move relative to the infusion site interface,
and move as the user moved. The infusion pump body may use manual
or automatic methods to establish the fluid connection after
placement of the infusion pump system 1200 on the body. In some
embodiments the infusion site interface and the infusion site
docking area 1212 may include corresponding guiding members, such
that the pump casing 1210 may be guided onto the infusion site
interface. This embodiment would allow for vertical flexibility,
while restricting horizontal motion between the pump body 1200 and
the infusion site interface.
[0067] The adhesive system described above may be sufficient size
and capability to adhere the infusion site interface to the skin of
the user. In some embodiments, the adhesive system may also have
sufficient size and capability to also adhere the infusion pump
body to the skin of the wearer or to the infusion site interface. A
release liner may be used with the adhesive system. Prior to
application of an adhesive, a release liner may cover exposed
adhesives to prevent unintentional adhesion. Immediately before or
during application, the release liner may be removed to expose the
adhesive layer for use.
[0068] FIG. 12B shows one embodiment of an adhesive system. In this
adhesive system, the adhesive 1240 covers a portion of the bottom
of the infusion pump body 1200.
[0069] FIG. 12C shows another embodiment of an adhesive system, in
which adhesive 1250 covers the entire bottom of the infusion pump
body 1200.
[0070] FIG. 12D shows another embodiment of an adhesive system, in
which adhesive 1260 extends past the edges of the infusion pump
system 1200.
[0071] In some embodiments, the adhesive may be formed as a planar
substrate of material to which adhesive may be applied to one or
both sides. A first adhesive, such as hydrocolloid or synthetic
rubber, may be applied to the skin contacting surface for extended
adhesion to human skin in all conditions. A second adhesive, such
as acrylic, synthetic rubber or any other type of adhesive that is
appropriate for the characteristics of the adhesive system, may be
applied to the device contacting surface. In some embodiments, the
adhesive system may include a flexible agent with a skin compatible
adhesive on a first surface and a device compatible adhesive on a
second surface.
[0072] The variation in thickness of the carrier across the surface
of adhesion is dependant on the material selected for the carrier
and the mechanical properties desired. In some embodiments, the
carrier thickness will be in the range of 0.1 mm to 1 mm. For
example, a carrier frame including an adhesive patch designed to
extend 2.5 cm from the periphery of an infusion site hub may, for
example, have an adhesive thickness of 0.5 mm at region of contact
with the infusion site interface hub, and a thickness that
decreases to a thickness of 0.2 mm at the edges. In some
embodiments, the carrier frame of an infusion site interface may be
designed to stretch, allowing greater comfort for the user and
better adhesion for the device. Both linear and non-linear adhesive
thickness changes are possible.
[0073] In some embodiments, a single adhesive layer or coating may
be applied directly to skin-contacting surfaces of the infusion
pump body. Suitable adhesives include hydrocolloid, acrylic,
synthetic rubber or other type of adhesive that is appropriate for
the characteristics of the device and user skin.
[0074] In various embodiments, the adhesive system may also include
compounds to reduce or modify the discomfort associated with
attachment of the infusion site interface, or the pump body to the
skin. These compounds include, but are not limited to, compounds
intended to reduce irritation, inflammation and itching. The
compounds may be included in the manufacture of the adhesive or the
carrier material, or subsequently an adhesive that is manufactured
with these properties specifically integrated into the chemical
composition may be applied to the device after manufacturing.
[0075] FIGS. 13A-C depict an example of an infusion pump body 1300
with a locking attachment mechanism being attached to the infusion
site interface 1000. In FIG. 13A, the infusion pump body 1300 is
aligned with a locking collar in the infusion pump body 1300 such
that locking features 1021 match up with corresponding features in
the locking collar. Pressing the infusion pump system down onto the
infusion site system causes a septum piercing device to pierce the
septum 1025. In some embodiments, the attachment mechanism
connecting the infusion pump body 1300 to the infusion site
interface 1000 may be a Luer lock.
[0076] FIG. 13B shows a twisting motion used to lock the infusion
pump body 1300 onto the infusion site interface 1000. FIG. 13C
shows the complete infusion pump system including the infusion pump
body 1300 locked to the infusion site interface 1000 via the
locking features 1021. In some embodiments, the infusion site
interface 1000 includes an adhesive on the top surface of the
infusion site interface. In such a case, the pump body 1300 would
also be adhesively attached to the infusion site interface,
creating a tighter connection between the components of the
infusion pump system. In other embodiments, the top surface of the
infusion site interface 1000 and the bottom surface of the infusion
pump body 1300 may include a mechanical adhesion system. In such a
system, the pump body 1300 would be mechanically adhered to the
infusion site interface 1000, also creating a tighter connection.
An example of a mechanical adhesion system that may be used
includes a Velcro adhesive system, or other mechanical
adhesion.
[0077] FIGS. 13D-E depict another example of an infusion pump body
1300 with a locking attachment mechanism being attached to the
infusion site interface 1000. Similar steps to FIGS. 13A-C are
shown, with a different infusion site interface. In this example,
infusion site interface 900 is used to affix the infusion pump body
1300 to the user's body. In addition, an additional mesh 1305 is
used to secure the infusion pump body 1300 to the user's body after
attachment to the infusion site interface. In various embodiments,
the additional mesh 1305 may include an adhesive on the top surface
for attachment to the pump body 1300, or may include a mechanical
adhesion system used in conjunction with other components on the
infusion pump body 1300.
[0078] In some embodiments, an infusion pump system may be attached
to an infusion site system with an insert and twist method, or
alternately a detent fit or user activated locking lever or
securing mechanism whereby the frame of the infusion site system is
mechanically coupled to the body of the infusion pump system.
[0079] In other embodiments, the alignment method may use guide
features to connect a pump body with an infusion site interface.
These guide features may employ geometries or shapes for the
infusion site interface in which complimentary geometries and
shapes are provided on the infusion pump body to maintain
alignment.
[0080] In other embodiments, the mechanical attachment of infusion
pump body to the infusion site interface 600 may be effected
without mechanical locking The infusion site interface may include
a mechanism for the alignment of the infusion pump body, with
adhesion of the pump body to the skin being the only method
employed to retain the exit port of the infusion pump body within
the infusion site interface to maintain fluid path continuity.
[0081] FIG. 14 depicts an alternate embodiment of an infusion pump
body for use with an infusion site system. The infusion pump body
1400 includes a pump body reservoir section 1410, a flexible neck
1414, and an infusion pump head 1412. The infusion pump head 1412
is used to connect to an infusion site interface, such as those
described earlier. The flexible neck 1414 allows the pump body 1410
and infusion site interface to move semi-independently relative to
each other when attached together. The pump body reservoir section
1410 includes a pumping mechanism 1420 and a reservoir 1430
containing a medicament to be infused. The reservoir 1430 is
connected to an exit port 1431 on the infusion pump head 1412 such
that a medicament in the reservoir may flow directly from the
reservoir to an attached infusion site interface. The exit port
1431 may be formed of a septum piercing device.
[0082] In some embodiments, the infusion pump body 1400 may have a
window 1421 which may be used to access the infusion site. Such a
window may allow for inspection or care of the infusion site
without removing the infusion pump body 1400. In some embodiments,
the window 1421 may be able to be opened or moved aside, allowing
for access to the infusion site or infusion site interface. For
example, this might allow for injection of an additional or
different medicament using the same infusion site interface.
[0083] While several specific embodiments and variations have been
described herein, it will be appreciated that other variations and
modifications may be encompassed within the scope of the present
invention, and that structural and functional equivalents to the
various components and structures described herein will occur to
those skilled in the pertinent arts. For example, the physical
shape and size of the individual component parts, as described
herein, are exemplary only, and other shapes and configurations
will readily suggest themselves. Likewise, various ways may be
found to attach the infusion site system to the pump and or to
provide a separate locking mechanism. Furthermore, the
configurations of the mechanisms and elements described herein are
likewise exemplary only. The extent of this document should be
deemed to include any device that exemplifies the concepts
described herein and these and other variations and modifications
that may suggest themselves to those skilled in the pertinent arts
are considered to be within the spirit and scope of the present
invention. Accordingly, other embodiments are within the scope of
the following claims.
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