U.S. patent application number 09/974312 was filed with the patent office on 2002-11-21 for reservoir connector.
Invention is credited to Adair, Randy W., McConnell, Susan, Moberg, Sheldon, Srisathapat, Chad.
Application Number | 20020173748 09/974312 |
Document ID | / |
Family ID | 26803448 |
Filed Date | 2002-11-21 |
United States Patent
Application |
20020173748 |
Kind Code |
A1 |
McConnell, Susan ; et
al. |
November 21, 2002 |
Reservoir connector
Abstract
Apparatuses and methods for a connection interface between a
reservoir or syringe, infusion set tubing, and an infusion pump are
provided. A base is provided which is adapted to receive a
reservoir and engage a cap. A piercing member, such as a needle, is
disposed in the interior of the cap in such a manner that the
needle is separated from the reservoir septum when the base is in a
first detent position, and the needle pierces a reservoir septum
when the base is in a second detent position. When the reservoir,
the base and the cap are connected to form an integrated unit, this
unit is then capable of being inserted and secured in the infusion
pump housing. In some embodiments, an integral connector couples
directly to the reservoir.
Inventors: |
McConnell, Susan; (Woodland
Hills, CA) ; Adair, Randy W.; (Valencia, CA) ;
Moberg, Sheldon; (Granada Hills, CA) ; Srisathapat,
Chad; (Sun Valley, CA) |
Correspondence
Address: |
GATES & COOPER LLP
HOWARD HUGHES CENTER
6701 CENTER DRIVE WEST, SUITE 1050
LOS ANGELES
CA
90045
US
|
Family ID: |
26803448 |
Appl. No.: |
09/974312 |
Filed: |
October 10, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09974312 |
Oct 10, 2001 |
|
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09428818 |
Oct 28, 1999 |
|
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60106237 |
Oct 29, 1998 |
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Current U.S.
Class: |
604/167.02 ;
604/533 |
Current CPC
Class: |
A61M 39/10 20130101;
A61M 39/14 20130101; A61J 1/2089 20130101; A61M 5/162 20130101;
A61M 2205/581 20130101; A61J 1/14 20130101; A61M 2205/582 20130101;
A61M 39/04 20130101; A61J 1/201 20150501; A61M 2005/1623 20130101;
A61J 1/2082 20150501; A61J 1/2051 20150501; A61J 1/2096 20130101;
A61J 1/2075 20150501; A61J 1/2055 20150501 |
Class at
Publication: |
604/167.02 ;
604/533 |
International
Class: |
A61M 005/178 |
Claims
What is claimed is:
1. An apparatus for connecting a reservoir having a septum to a
conduit, the apparatus comprising: a conduit portion; a piercing
member coupled to the conduit portion and adapted to pierce the
septum; and a reservoir connector portion coupled to the conduit
portion and comprising an open-ended cylindrical member; wherein
the open-ended cylindrical member is releasably coupleable to the
reservoir and the piercing member pierces the septum when so
coupled such that the piercing member and the conduit portion can
conduct a fluid.
2. The apparatus of claim 1, wherein the conduit portion comprises
a luer connector.
3. The apparatus of claim 1, wherein the open-ended cylindrical
member includes a base which closes one end of the open-ended
cylindrical member and the piercing member extends from the base
and is enclosed by the open-ended cylindrical member.
4. The apparatus of claim 1, wherein the open-ended cylindrical
member has at least one inwardly protruding tab which engages an
annular shoulder of the reservoir in a snap-fit.
5. The apparatus of claim 1, wherein the open-ended cylindrical
member comprises a plurality of arms, each arm having an inwardly
protruding tab which engages an annular shoulder of the reservoir
in a snap-fit.
6. The apparatus of claim 1, wherein the reservoir connector
portion is coupled to the conduit portion by a neck portion
comprising at least one opening for gripping the piercing
member.
7. The apparatus of claim 1, wherein the reservoir connector
portion is coupled to the conduit portion by a neck portion adapted
to secure the apparatus in a housing.
8. The apparatus of claim 1, wherein the open-ended cylindrical
member comprises a plurality of seating tabs for securing the
apparatus in a housing.
9. A method of connecting a reservoir having a septum to a conduit,
comprising the steps of: releasably coupling a reservoir connector
portion comprising an open-ended cylindrical member to the
reservoir, wherein the reservoir connector portion is coupled to a
conduit portion and the conduit portion is coupled to a piercing
member; and piercing the septum with the piercing member when
releasably coupling such that the piercing member and the conduit
portion can conduct a fluid.
10. The method of claim 9, wherein the conduit portion comprises a
luer connector.
11. The method of claim 9, wherein the open-ended cylindrical
member includes a base which closes one end of the open-ended
cylindrical member and the piercing member extends from the base
and is enclosed by the open-ended cylindrical member.
12. The method of claim 9, wherein the open-ended cylindrical
member has at least one inwardly protruding tab which engages an
annular shoulder of the reservoir in a snap-fit.
13. The method of claim 9, wherein the open-ended cylindrical
member comprises a plurality of arms, each arm having an inwardly
protruding tab which engages an annular shoulder of the reservoir
in a snap-fit.
14. The method of claim 9, wherein the reservoir connector portion
is coupled to the conduit portion by a neck portion comprising at
least one opening for gripping the piercing member.
15. The method of claim 9, wherein the reservoir connector portion
is coupled to the conduit portion by a neck portion adapted to
secure the apparatus in a housing.
16. The method of claim 9, wherein the open-ended cylindrical
member comprises a plurality of seating tabs for securing the
apparatus in a housing.
17. An apparatus for connecting a reservoir having a septum to a
conduit, comprising: a conduit means; a piercing means for piercing
the septum coupled to the conduit means; and a reservoir connector
means coupled to the conduit portion and comprising an open-ended
cylindrical member; wherein the open-ended cylindrical member is
releasably coupleable to the reservoir and the piercing means
pierces the septum when so coupled such that the piercing means and
the conduit means can conduct a fluid.
18. The apparatus of claim 17, wherein the conduit means comprises
a luer connector.
19. The apparatus of claim 17, wherein the open-ended cylindrical
member includes a base which closes one end of the open-ended
cylindrical member and the piercing means extends from the base and
is enclosed by the open-ended cylindrical member.
20. The apparatus of claim 17, wherein the open-ended cylindrical
member has at least one inwardly protruding tab which engages an
annular shoulder of the reservoir in a snap-fit.
21. The apparatus of claim 17, wherein the open-ended cylindrical
member comprises a plurality of arms, each arm having an inwardly
protruding tab which engages an annular shoulder of the reservoir
in a snap-fit.
22. The apparatus of claim 17, wherein the reservoir connector
portion is coupled to the conduit means by a neck portion
comprising at least one opening for gripping the piercing
member.
23. The apparatus of claim 17, wherein the reservoir connector
means is coupled to the conduit means by a neck portion adapted to
secure the apparatus in a housing.
24. The apparatus of claim 17, wherein the open-ended cylindrical
member comprises a plurality of seating tabs for securing the
apparatus in a housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This continuation-in-part application claims priority under
35 U.S.C. .sctn.120 from U.S. patent application Ser. No.
09/428,818, filed Oct. 28, 1999, and entitled "RESERVOIR CONNECTOR"
which in turn claims priority from U.S. Provisional Patent
Application No. 60/106,237, filed on Oct. 29, 1998, both of which
are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates generally to improvements in syringe
or reservoir interfaces for use in infusion pumps such as those
used for controlled delivery of medication to a patient. More
specifically, this invention relates to an improved connection
interface between a reservoir or syringe and infusion set tubing or
a standard luer connector.
[0004] 2. Description of the Related Art
[0005] Infusion pump devices and systems are relatively well-known
in the medical arts, for use in delivering or dispensing a
prescribed medication such as insulin to a patient. In one form,
such devices comprise a relatively compact pump housing adapted to
receive a syringe or reservoir carrying a prescribed medication for
administration to the patient through infusion tubing and an
associated catheter.
[0006] The infusion pump includes a small drive motor connected via
a lead screw assembly for motor-driven advancement of a reservoir
piston to administer the medication to the user. Programmable
controls are normally provided for operating the drive motor
continuously or at periodic intervals to obtain a closely
controlled and accurate delivery of the medication over an extended
period of time. Such infusion pumps are utilized to administer
insulin and other medications, with exemplary pump constructions
being shown and described in U.S. Pat. Nos. 4,562,751; 4,678,408;
4,685,903; 5,080,653 and 5,097,122, which are all incorporated by
reference herein.
[0007] Infusion pumps of the general type described above have
provided significant advantages and benefits with respect to
accurate delivery of medication or other fluids over an extended
period of time. The infusion pump can be designed to be relatively
compact as well as water resistant, and may thus be adapted to be
carried by the user, for example, by means of a belt clip. As a
result, important medication can be delivered to the user with
precision and in an automated manner, without significant
restriction on the user's mobility or life-style, including the
ability to participate in water sports.
[0008] Infusion sets refer to the tubing and connection apparatus
which provide a path for the medication to flow to the user from
the reservoir or syringe located in the pump. The connectors for
attaching the infusion set tubing to the reservoirs can take
various forms. A luer connection is a commonly used connection
method. Nevertheless, it remains desirable to develop improved
designs of connection methods to facilitate infusion procedures and
to provide suitable interface connections which are water resistant
so as to permit a user to participate in water sports.
SUMMARY OF THE INVENTION
[0009] The invention disclosed herein has a number of embodiments.
A typical embodiment of the invention is an apparatus for
connecting a reservoir having a septum and a base to a conduit,
such as infusion set tubing. In certain aspects of the present
invention, the apparatus comprises a cap and a releasable coupler
which is adapted to releasably couple the base to the cap in one of
two positions. A piercing member, such as a needle, is coupled to
the conduit. The needle is disposed in the cap in a position other
than the interior of the reservoir when the base is in the first
position. The needle is further disposed to pierce the reservoir
septum when the base is in the second position.
[0010] In another embodiment, the apparatus is used for connecting
a reservoir having a septum and a base to a housing as well as to a
conduit. The housing has a housing engagement member, such as a
thread. The apparatus comprises a cap and a releasable coupler
which is adapted to releasably couple the base to the cap in one of
two positions. A piercing member, such as a needle, is releasably
coupled to the conduit. The needle is disposed in the cap in a
position other than the interior of the reservoir when the base is
in the first position. The needle is further disposed to pierce the
reservoir septum when the base is in the second position. The cap
further includes an engagement member, such as a thread, which is
adapted to engage with the housing engagement member.
[0011] In another embodiment, the cap further includes a vent port
which is covered with hydrophobic material. This permits air to
pass through the cap while preventing water from doing so.
[0012] In another embodiment, an integral apparatus is used for
connecting a reservoir having a septum and an annular shoulder and
a conduit. This embodiment includes a conduit portion, a piercing
member coupled to the conduit and adapted to pierce the septum and
a reservoir connector portion coupled to the conduit portion and
comprising an open-ended cylindrical member. The open-ended
cylindrical member is releasably coupleable to the reservoir and
the piercing member pierces the septum when so coupled. Typically,
the conduit is a luer connector.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Referring now to the drawings in which like reference
numbers represent corresponding parts throughout:
[0014] FIG. 1 is an exploded, perspective view of a medication
reservoir connection interface apparatus;
[0015] FIG. 2 is a perspective view of a cap used as a medication
reservoir connection interface apparatus;
[0016] FIG. 3 is an exploded, perspective view of an alternative
embodiment of a medication reservoir connection interface
apparatus;
[0017] FIG. 4 is a side, cut-away view of a cap used as a
medication reservoir connection interface apparatus;
[0018] FIG. 5 is a side, plan cut-away view of a medication
reservoir connection interface apparatus with a needle inserted
into a reservoir;
[0019] FIG. 6 is a side, plan cut-away view of a medication
reservoir connection interface apparatus which is inserted into a
pump housing;
[0020] FIG. 7 is a perspective view of an alternative embodiment of
a medication reservoir connection interface apparatus;
[0021] FIG. 8 is a perspective top view of an alternative
embodiment of a medication reservoir connection interface apparatus
which is secured into a pump housing;
[0022] FIG. 9 is a perspective view of an alternative embodiment of
a medication reservoir connection interface apparatus;
[0023] FIG. 10 is an exploded, perspective view of a cap used as a
medication reservoir connection interface apparatus;
[0024] FIG. 11 is a perspective view of a medication reservoir
connection interface adapter;
[0025] FIG. 12 is a cross-sectional view of a medication reservoir
connection interface adapter;
[0026] FIG. 13 is a perspective view of an alternative embodiment
of a cap used as a medication reservoir connection interface
apparatus;
[0027] FIGS. 14A-14C are cross-sectional views of various
embodiments of venting ports for use with a reservoir connection
interface apparatus or adapter;
[0028] FIG. 15 is an exploded, perspective view of an embodiment of
an integral medication reservoir connection apparatus and a
reservoir;
[0029] FIGS. 16A-16C are views of an integral medication reservoir
connection embodiment;
[0030] FIGS. 17A-17D are views of another embodiment of an integral
medication reservoir connection embodiment;
[0031] FIGS. 18A-18C are views of an another embodiment of an
integral medication reservoir connection embodiment without a neck
portion.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0032] In the following description, reference is made to the
accompanying drawings which form a part hereof and which illustrate
several embodiments of the present invention. It is understood that
other embodiments may be utilized and structural and operational
changes may be made without departing from the scope of the present
invention.
[0033] As shown in the drawings for purposes of illustration, the
invention is embodied in an interface for connecting a syringe or a
medication reservoir to a conduit, such as infusion set tubing or
an external needle, as well as to an infusion pump. In one
embodiment, a base is provided which is adapted to receive a
reservoir. A cap is provided which is adapted to be releasably
coupled to the base in one of two positions. The releasable coupler
comprises a pair of detents projecting from the base and two pairs
of detent openings in the cap which are adapted to removably engage
the base detents.
[0034] A piercing member, such as a needle, is disposed in the
interior of the cap in such a manner that the needle is separated
from the reservoir septum when the base detents are in the first
pair of cap detent openings, and the needle pierces the reservoir
septum when the base detents are in the second pair of cap detent
openings. When the reservoir, the base and the cap are connected,
an integrated unit is formed which is then capable of being
inserted in the infusion pump housing. Engagement members, such as
threads, for the cap and the pump housing are used to secure the
integrated unit in the housing.
[0035] In another embodiment, an integral apparatus is used for
connecting a reservoir having a septum and an annular shoulder and
a conduit. The apparatus comprises a conduit portion, a piercing
member coupled to the conduit and adapted to pierce the septum and
a reservoir connector portion coupled to the conduit portion and
comprising an open-ended cylindrical member. The open-ended
cylindrical member is releasably coupleable to the reservoir and
the piercing member pierces the septum when so coupled. Typically,
the conduit is a luer connector.
[0036] FIGS. 1 and 2 show an infusion set connector interface for
attachment to a medication reservoir. The connector interface is
comprised of a base 2 and a cap 4. The cap 4 includes a needle 9
located internal to the cap housing. FIG. 1 is an exploded view,
and therefore, the base 2 would normally be fixedly attached to a
reservoir 1 by securing it around the swage 3, which holds the
reservoir septum. However, alternative embodiments of the present
invention include a removable base so that the connector interface
could be used with standard reservoirs, cartridges or syringes
which were not initially manufactured with the base attached.
[0037] The cap 4 portion of the connector interface is removably
attached to the base 2 with a releasable coupler. In one
embodiment, the releasable coupler is comprised of detents formed
on the base 2 and detent openings disposed in the cap 4. Two
detents 8 are disposed on the sides of the base 2 and are spaced
180.degree. radially apart. Only one detent 8 is shown in FIG. 1.
The detents 8 are sized to fit in the two lower detent openings 6,
or alternatively, in the two upper detent openings 7 which are
formed in the cap 4. As with the pair of detents 8, each of the
lower detent openings 6 and each of the upper detent openings 7,
respectively, are radially spaced apart by 180.degree..
[0038] In operation, the base 2 and the reservoir 1 form an
integrated unit which in turn is to be connected to the cap 4. In
connecting this integrated base/reservoir unit to the cap 4, the
base 2 is inserted into the lower end of the cap 4 until the
detents 8 snap into the lower detent openings 6. This is
accomplished by moving the detents 8 over internal cam surfaces 10
toward the lower detent openings 6. The cam surfaces act as ramps
which compress the detents 8 sufficiently to permit them to snap
into the lower detent openings 6. Internal threads 10a guide the
detents 8 into position.
[0039] When the base/reservoir unit is in this first, lower
position, the needle 9 is positioned apart from the septum (not
shown) of the reservoir 1. Thus the needle does not pierce the
septum while the base/reservoir unit is in this first position.
When the base/reservoir unit is connected to the cap in this
fashion, an integrated cap/base/reservoir unit is thereby formed.
Conveniently, such an integrated cap/base/reservoir unit can be
sold or stored for long periods of time in this fashion.
Alternatively the end user can assemble this unit shortly prior to
placing it in the pump for use.
[0040] When the user desires to insert the cap/base/reservoir unit
in the pump housing and commence dispensing the medication through
a conduit, such as insertion set tubing 5, the base 2 is moved to
the second position within the cap 4. This is accomplished by
twisting the base/reservoir unit while pushing it further into the
cap 4. The detents 8 disengage from the lower detent openings 6 and
engage into the upper detent openings 7. Additional internal
threads 10a of the cap 4 serve to guide the detents 8 over
additional cam surfaces 10 from their first position in the lower
detent openings 6 to the second position in the upper detent
openings 7.
[0041] In one embodiment, the threads and the spacing between the
lower detents 6 and the upper detents 7 is such that a one quarter
(1/4) turn of the base will cause the base/reservoir unit to travel
from the first to the second position. The needle 9 is disposed so
that when the base/reservoir unit is in the second position, the
needle pierces the septum of the reservoir 1. Thus the movement of
the base/reservoir unit from the first to the second position
within the cap serves to cause the needle to pierce the reservoir's
septum, thus permitting the fluid in the reservoir to flow into the
needle 9 and the insertion set tubing 5.
[0042] After this connection is made, the reservoir, base and cap
form a unit which can be releasably secured in the housing of a
medication infusion pump (not shown). Detents 4a extend radially
from the exterior of the cap and are adapted to engage into detent
openings (not shown) in the pump housing. In an alternative
embodiment, the cap 4 can include external threads (not shown)
which are used to engage the threads of the pump housing in order
to secure the reservoir/base/cap unit into the housing.
[0043] FIGS. 3 and 4 show an alternative embodiment of the infusion
set connector interface. The connector interface is comprised of a
base 11 and a cap 12. The cap 12 includes a needle 18 located
internal to the cap housing (FIG. 4). The base 11 would normally be
fixedly attached to the reservoir 1 by securing it around the swage
3. However, alternative embodiments of the present invention
include a removable base so that the connector interface could be
used with standard reservoirs, cartridges or syringes which were
not initially manufactured with the base attached.
[0044] The cap 12 portion of the connector interface is removably
attached to the base 11 with a releasable coupler. In this
embodiment, the releasable coupler is comprised of detents 15
formed on the base 11 and detent openings disposed in the cap 12.
Two detents 13 are disposed on the sides of the base 11 and are
spaced 180.degree. radially apart. Only one detent 13 is shown in
FIG. 3. The detents 13 are sized to fit in two detent openings 14
which are formed in the cap 12. As with the pair of detents 13,
each of the detent openings 14 are radially spaced apart by
180.degree..
[0045] In operation, the base 11 and the reservoir 1 form an
integrated unit which in turn is to be connected to the cap 12. In
connecting this integrated base/reservoir unit to the cap 12, the
base 11 is inserted into the lower end of the cap 12. The detents
13 slide into matingly shaped and longitudinally open entry slots
15 formed within the interior walls of the cap 12. When the base 11
is fully inserted in the cap 12, the leading edges of the detents
13 abut an annular stop shoulder 16 formed within the cap 12. After
the detents 13 are in this position, the base 11 is rotated within
the cap 12 toward a locked position. Referring to FIG. 4, this
rotation displaces the detents 13 in a rotational direction for
engagement with cam surfaces 17 formed within the cap 12. The
rotational force on the detents 13 over the cam surfaces 17
provides a compression force on the detents 13. Continued rotation
of the base 11 displaces the detents 13 past the cam surfaces 17
and into alignment with the detent openings 14. The detents 13
enter the detent openings 14 with a snap-action. Thus, the detents
13 are effectively locked within the detent openings 14 to prevent
longitudinal separation of the base 11 from the cap 12.
[0046] In the preferred embodiment, the internal needle 18 of the
cap 12 is disposed so that when the base/reservoir unit is fully
inserted in the cap 12, the needle pierces the septum (not shown)
of the reservoir 1. Thus the insertion force of the base/reservoir
unit to the point where the detents 13 abut the annular stop
shoulder 16 causes the needle 18 to pierce the septum, thus
permitting the fluid in the reservoir to flow into the needle 18
and the insertion set tubing (not shown).
[0047] After this connection is made, the reservoir, base and cap
form a unit which can be releasably secured in the housing of a
medication infusion pump. (not shown) The cap 12 includes external
threads 19 which are used to engage the threads of the pump housing
in order to secure the reservoir/base/cap unit into the housing. In
the preferred embodiment, the threads 19 have an eight threads per
inch ("TPI"), 2 start profile. Moreover, they have a square shaped
cross section which maximizes their holding strength. Other thread
profiles and cross-sections may be used however.
[0048] When disconnection of the base 11 from the cap 12 is
desired, the base 11 must be reverse-rotated within the cap 12, to
move the detents 13 past the cam surfaces 17 into re-alignment with
the entry slots 15. Such reverse-rotation of the coupler can be
performed relatively easily, but essentially requires an
affirmative intent by the user to disconnect the coupling. When the
detents 13 are re-aligned with the entry slots 15, the cap 12 and
base 11 can be separated easily with minimal longitudinal
force.
[0049] FIG. 5 shows a cross sectional view of the
reservoir/base/cap integrated unit in accordance with the
embodiment of FIGS. 3 and 4. The reservoir 1 includes a crimp seal
swage 3 which encloses the outer periphery of the rubber septum 20
in order to secure the septum 20 to the reservoir 1 and form a
water tight seal. With the base 11 in the locked position as shown,
the detents 13 of the base 11 are locked into the detent openings
14 to securely attach the base/reservoir unit into the cap 12. The
needle 18 pierces the rubber septum 20, thus permitting the flow of
liquid through the needle 18 and into the infusion set tubing
cavity 22. Infusion set tubing (not shown) is secured into the
cavity 22 to allow the liquid to continue its flow to the user.
[0050] In the preferred embodiment, the conduit from the cap 12 is
infusion set tubing. However in an alternative embodiment, the
conduit comprises a second needle (not shown). This is secured into
the cavity 22 with the point of the second needle extending
outward. With this arrangement, the connector serves as an
apparatus for permitting the refilling of the reservoir 1. The
second, external needle would pierce the septum of a supply vial of
fluid. The fluid could then be drawn into the cap in a reverse flow
and into the reservoir 1 via the internal needle 18.
[0051] In the embodiment shown in FIG. 5, infusion set tubing is
secured to the cavity 22 to allow liquid to flow to the user. The
cavity 22 is disposed in the raised portion of the cap 12. In an
alternative embodiment, however, the raised portion of the cap 12
can be in the shape of a standard luer fitting 47 shown in FIG.
13.
[0052] Referring to FIG. 5, in one embodiment the base 11 is formed
around and fixedly attached to the crimp seal swage 3 portion of
the reservoir 1. In an alternative embodiment, however, the base 11
is not fixedly attached to the reservoir. Rather, the base 11 is a
separate unit which is adapted to be releasably secured to the
reservoir via a friction fit. This arrangement permits the
connector apparatus to be used with standard reservoirs.
[0053] Still referring to FIG. 5, the cap 12 includes threads 19
for securing the assembly into the pump housing (not shown). A
shoulder 23 is formed as part of the cap 12 and is adapted to seat
against the pump housing to form a water tight seal. This prevents
any water which is exterior to the housing from entering, thus
permitting the user to engage in water sports.
[0054] The construction of these pumps to be water resistant can
give rise to operational problems. As the user engages in
activities which expose the pump to varying atmospheric pressures,
such as for example, swimming or traveling in an airplane,
differential pressures can arise between the interior of the air
tight/water-resistant housing and the atmosphere. Should the
pressure in the housing exceed external atmospheric pressure, the
resulting forces could cause the reservoir piston to be driven
inward thus delivering unwanted medication. Alternatively, should
the pressure in the housing be less than the external pressure, the
resulting forces could cause the infusion pump motor to work harder
to advance the reservoir piston.
[0055] To address this problem, a preferred embodiment of the
invention includes a vent which permits water resistant housing
construction. The cap 12 includes a plurality of vent ports 24,
only one of which is shown in FIG. 5. The vent ports 24 permit
equalization of pump housing pressure to atmospheric pressure.
Hydrophobic material (not shown) covers the interior openings of
the vent ports 24. Hydrophobic material permits air to pass through
the material while preventing water or other liquids from doing so,
thus permitting water resistant venting. The preferred embodiment
uses a hydrophobic material such as Gore-Tex.RTM., PTFE, HDPE, or
UHMW polymers from sources such as W. I. Gore & Associates,
Flagstaff, Ariz., Porex Technologies, Fairburn, Ga., DeWAL
Industries, Saunderstown, R.I., or Pall Specialty Materials, Port
Washington, N.Y.
[0056] These materials are available in sheet form or molded (press
and sintered) in a geometry of choice. Referring to FIGS. 14A-14C,
preferred methods to attach this material to the cap 12 include
molding the hydrophobic material into a sphere 50 (FIG. 14A) or a
cylinder 51 (FIG. 14B) and pressing it into a cavity in the
pre-molded plastic housing. Alternatively, a label 52 (FIG. 14C) of
this material could be made with either a transfer adhesive or heat
bond material 53 so that the label could be applied over the vent
port 24. Alternatively, the label could be sonically welded to the
housing. In either method, air will be able to pass freely, but
water will not.
[0057] In an alternative embodiment which is not shown, the venting
is accomplished through a vent port located in the pump housing.
This is described in greater detail in copending U.S. patent
application Ser. No. 09/429,352, filed Oct. 28, 1999, which
application is incorporated by reference in its entirety.
Alternatively, vent ports can be placed both in the cap 12 as well
as the pump housing.
[0058] An advantage of placing the vent port and hydrophobic
material in the cap 12, as opposed to in the pump housing only, is
that the infusion set and its related connectors are disposable and
are replaced frequently with each new reservoir or vial of
medication. Thus, new hydrophobic material is frequently placed
into service. This provides enhanced ventilation as compared with
the placement of hydrophobic material in only the pump housing.
Material in this location will not be replaced as often and thus is
subject to dirt or oil build up which will retard ventilation.
[0059] As an alternative to the use of hydrophobic material, water
can be prevented from flowing through the vent port by other
apparatuses, such as the use of relief valves.
[0060] FIG. 6 shows a cross-sectional view of the
reservoir/base/cap unit in accordance with the embodiment of FIGS.
3 and 4 which is secured into a pump housing 30. The threads 19 of
the cap 12 engage the pump housing threads. Rather than the use of
threads, an alternative embodiment (not shown) of the cap 12 could
include detents extending radially from the exterior of the cap 12
which are adapted to engage detent openings in the pump
housing.
[0061] The shoulder 23 portion of the cap 12 seats against the pump
housing 30 to permit water tight construction. Further aiding in
the watertight construction is an O-ring seal 31 which is disposed
in the pump housing 30 and located just above the shoulder 23. In
the preferred embodiment, the vent material 32 is comprised of
hydrophobic material and is sonic welded to the upper interior
surface of the cap 12. Alternatively, the vent material 32 could be
attached to the cap 12 with an adhesive. The vent ports are not
shown in FIG. 6.
[0062] Although the foregoing description of the venting was in
connection with the embodiment of FIGS. 3-6, this feature is also
applicable to the embodiment of FIGS. 1-2.
[0063] FIGS. 7 and 8 show an alternative embodiment of the cap 12.
Referring to FIG. 7, a cap engagement member consists of a detent
arm 34 which is formed in the upper portion of the cap 12. The
purpose of the detent arm 34 is to securely engage the cap 12 into
the pump housing. FIG. 8 shows a top view of the cap 12 positioned
in the pump housing 30. The pump housing 30 has two case lock
recesses 35 disposed in the circular rim of the housing. The detent
arm 34 snaps into either of the case lock recesses 35. This
engagement results in a "click" when the cap 12 is appropriately
seated, thus providing both tactile and audible feedback to the
user that the cap is securely engaged in the pump housing.
Moreover, the detent arm 34 aligning with the recess 35 also serves
as a visual indicator that the cap 12 is appropriately seated.
[0064] FIG. 9 shows an alternative embodiment of the cap 12 which
contains a child safety feature. The cap 12 includes a locking
member which consists of a safety tab 36 disposed in a groove 37.
The safety tab 36 is sized such that it is able to slide along the
length of the groove 37. When the safety tab 36 is in the position
shown in FIG. 9, the detent arm 34 is unable to retract from its
engaged position. Thus when the cap 12 is seated into the pump
housing 30 (not shown) and the detent arm is seated into the case
lock recess 35 (not shown), the safety tab 36 will prevent the
detent arm 34 from disengaging from the case lock recess 35 thus
more securely locking the cap 12 in the pump housing.
[0065] Thus for example, a parent could slide the safety tab 36
from the unlocked location in the groove 37 to the locked location
shown in FIG. 9 so that it would be more difficult for a young
child or infant to inadvertently remove the cap/base/reservoir unit
from the pump housing. On the other hand, when the safety tab 36 is
moved to the opposite end of the groove 37, the detent arm 34 is
able to retract thus permitting removal of the cap 12 from the pump
housing.
[0066] Although the foregoing description of the cap engagement
member and child safety tab was in connection with the embodiment
of FIGS. 3-9, this feature is also applicable to the embodiment of
FIGS. 1-2.
[0067] FIG. 10 shows an exploded view of the cap 12 and the vent
material 32. In the preferred embodiment, the vent material is made
of hydrophobic material and is formed in a circular shape with a
circular hole in the center. The vent material 32 is attached to
the upper interior surface 38 of the cap 12 via sonic welding or an
adhesive. When it is so attached, the needle 18 protrudes through
the center hole of the vent material 32 but the interior openings
of the vent ports 24 (not shown) are covered.
[0068] FIGS. 11 and 12 show an embodiment of the present invention
where an adapter 40 is provided to allow a standard style syringe
41 with an integrated luer fitting 42 to be mounted and sealed in
the pump housing. The syringe 41 is inserted through the center of
the adapter 40 and held into place by a friction fit. The O-ring
seal 43 in the adapter 40 seats against the syringe wall in order
to prevent water and dirt from entering the pump housing.
[0069] A shoulder 45 is formed as part of the adapter 40 and is
adapted to seat against the interior of the pump housing to form a
water tight seal. Two tabs 44 are formed on the top surface of the
adapter 40 and provide a surface for the user to grip the adapter
40 and twist it so that the adapter threads 19 engage the threads
(not shown) of the pump housing. A detent arm 34 is formed in the
upper portion of the adapter 40. Its purpose is to securely lock
the adapter 40 into the pump housing (not shown) in the same manner
as is shown in FIG. 8. Although not shown in FIGS. 11 and 12, the
adapter 40 can further contain vent ports covered with hydrophobic
material or a relief valve in order to permit water resistant
venting of the pump housing in the same manner as previously
described with other embodiments.
[0070] FIG. 13 shows another embodiment of the present invention
where an interface is provided to connect a reservoir to a conduit,
such as tubing, via a standard luer fitting connection. This allows
a luer style disposable infusion set to connect to the pump housing
(not shown). A cap 46 is formed with a luer fitting 47 portion as
an integral part thereof. Except for the shape of the luer fitting
47 portion, the cap 46 has all of the other features of the cap 12
shown in FIG. 5. Thus referring to FIG. 13, the cap 46 is comprised
of, among other things, threads 19, detent openings 14, a shoulder
23, vent ports 24, a detent arm 34, and a needle (not shown)
disposed in the interior of the cap 46.
[0071] While the embodiment of FIG. 13 includes a base member (not
shown) to complete the connection of the cap 46 with a reservoir,
other embodiments of the invention perform this function using a
single integrated unit. In an illustrative embodiment shown in FIG.
15 which includes a number of typical elements of the invention, a
luer adapter 51 is provided as a single, integral unit for
connection to a standard prefilled cartridge or medication
reservoir 52. The reservoir 52 is comprised of a watertight
cylinder 53 having a neck 54 with an opening (not shown) at the
proximate end of the cylinder 53. A swage 55 having an annular
shoulder 56 is secured around the neck 54 of the cylinder 53. The
swage 55 secures a rubber septum (not shown) over the opening (not
shown) of the neck 54 thus providing a fluid-tight seal. The luer
adapter 51 is comprised of a reservoir connector portion 57, a neck
portion 58 and a male luer connector portion 59. The reservoir
connector portion 57 includes a piercing member or needle 60 which
is adapted to pierce the septum (not shown) of the reservoir 52
upon attaching it to the luer adapter 51.
[0072] In an illustrative embodiment shown in FIGS. 16A-16C which
includes a number of typical elements of the invention, the
reservoir connector portion 57 further comprises an open-ended
cylindrical member 61 having a base 62 which closes one end of the
cylindrical member 61. The needle 60 is enclosed by the cylindrical
member 61 and projects axially from the base 62. The length of
extension of the needle 60 from the base is shorter than that of
the cylindrical member 61 which serves to protect the needle 60 and
to reduce the likelihood of accidental needle contact with the
hands of users.
[0073] In the embodiment of FIGS. 16A-16C, the cylindrical member
61 has a plurality of generally rectangular-shaped gaps 63
extending from the open end of the member 61 to the base 62 thereby
forming a plurality of arms 64. To secure the luer adapter 51 to
the reservoir 52, the arms 64 can be snapped over the reservoir
swage 55 (FIG. 15). Inwardly protruding tabs 65 are formed on the
end of the arms 64 and are sized to engage the annular shoulder 56
of the reservoir swage 55 thus securing it to the luer adapter 51
in a snap-fit engagement. Moreover, as the luer adapter 51 is
inserted over the swage 55, the needle 60 pierces the reservoir
septum thus providing a fluid path from the reservoir to the luer
fitting.
[0074] The snap fit engagement disclosed herein allows a user to
quickly and conveniently couple a reservoir to a specific
interface, such as a luer, another snap-fit or any other fitting
known in the art that is present on the conduit or device to which
the reservoir is coupled. As used herein, snap-fit as in "snap-fit
engagement" refers to the releasable coupling of a first member
(e.g. the arm 64 of FIG. 16C) to a second member (e.g. the swage 55
in FIG. 15) where a protrusion on the first member (e.g. the tab 65
on the arm 64 of FIG. 16C) typically rides over a portion of the
second member causing the first member to temporarily deflect until
the protrusion on the first member is situated in a receiving space
on the second member (e.g. the annular shoulder 56 of FIG. 15).
Advantageously, this engagement typically results in a "click" when
the first member is appropriately situated, thus providing both
tactile and audible feedback to the user that the first member is
securely engaged with the second member. Additional benefits of
such an engagement include its facilitating a medical
practitioner's ability to quickly and easily assemble an apparatus
in situations where a patient requires immediate medical
intervention.
[0075] Embodiments having a single integral unit comprising a base
and a cap further reduce the amount of time needed to generate a
fully functional medical device because there is no need to
separately couple a base to a reservoir before using the adapter.
In addition, because this embodiment comprises a single integral
unit rather than a composite of multiple subunits, this design
facilites both operator handling as well as the maintainence of
sterility. In addition, manufacturing is simplified because the
device may be produced from a single mold.
[0076] In typical embodiment illustrated in FIGS. 16A-16C, the
cylindrical member 61 is constructed of polyolefin or other
material which has sufficient flexibility to permit the arms 64 to
flex and snap fit over the reservoir swage 55 yet further has
sufficient strength to secure the needle 60 in the luer adapter 51.
Although the illustrative embodiment shown in FIGS. 16A-16C has
arms 64, other embodiments of the present invention include an
open-ended cylinder member which has no gaps in the cylinder wall
and therefore no arms. Utilizing a material of appropriate
flexibility, the cylinder member of such an embodiment is able to
snap-fit over a reservoir swage. Furthermore, a balance may be
struck between the flexibility (or elasticity) of the selected
material and the number and dimensions (e.g. width and wall and tab
thicknesses) of the arms 64 employed to obtain the design
engagement feel. In embodiments for which the open-ended
cylindrical member includes no arms, the wall and tab thicknesses
are selected in consideration of the material elasticity.
[0077] In another typical embodiment of the invention that is
illustrated in FIGS. 16A-16C the male luer connector portion 59 of
the luer adapter 51 is joined to the reservoir connector portion 57
by the neck portion 58. The neck portion 58 is cylindrically-shaped
and has a diameter which is smaller than that of the reservoir
connector portion 57 as well as the male luer connector portion 59
of the luer adapter 51. The neck portion 58 is sized to fit within
a housing of a medication infusion pump or any other apparatus so
that the luer adapter 51 and reservoir 52 assembly can be secured
therein. The male luer connector portion 59 is a standard fitting
comprising a luer collar 66 and a luer taper 67.
[0078] FIGS. 17A-17D show an another typical embodiment of an
integral piece luer adapter 81. In this embodiment, the adapter 81,
operates in essentially the same manner as the embodiment of FIGS.
16A-16C, and comprises a male luer connector portion 82 at one end,
a reservoir connector portion 83 at the opposite end, and a
connecting neck portion 84. The male luer connector portion 82 is a
standard, known fitting which includes a luer collar 85, a luer
taper 86 and threads 87 which are on the internal surface of the
luer collar 85. As illustrated in FIG. 17B, the connecting neck
portion 84 is generally cylindrical in shape and has a first collar
89 which attached to the male luer connector portion 82 as well as
a second collar 90 which is attached to the reservoir connector
portion 83. A plurality of longitudinally extending ribs 91 connect
the first collar 89 with the second collar 90. A plurality of
openings 92 which are defined by the ribs 91 expose a needle 88
which extends from the male luer connector portion 82, through the
neck portion 84 and to the reservoir connection portion 83. The
openings 92 provide access by external devices which can be used to
grip the needle 88 during the assembly process. The needle 88 can
be held in place while a mold is being filled during this assembly.
Although a plurality of openings is preferred, only one such
opening 92 is included to hold the needle 88.
[0079] In the embodiment of the invention illustrated in FIGS.
17A-17D, the reservoir connector portion 83 comprises an open-ended
cylindrical member 92 having a base 93 which closes one end of the
cylindrical member 92. The needle 88 is enclosed by the cylindrical
member 92 and projects axially from the base 93. The cylindrical
member 92 has a plurality of generally rectangular-shaped gaps 94
extending from the open end of the member 92 to the base 93 thereby
forming a plurality of arms 95. To secure the luer adapter 81 to a
reservoir, the arms 95 can be snapped over a swage of an industry
standard reservoir. As seen in FIG. 17D, inwardly protruding tabs
96 are formed on the end of the arms 95 and are sized to engage an
annular shoulder of a standard reservoir swage thus securing it to
the luer adapter 81 in a snap-fit engagement as previously
described.
[0080] In the embodiment illustrated in FIGS. 17A-17D, the needle
88 projects axially from the base 93 of the cylindrical member 92
and extends for a length which is shorter than the length of the
arms 95. The opposite end of the needle 88 extends to the end of
the luer taper 86 thus providing a fluid flow path from a reservoir
which may be attached to the reservoir connection portion 83 to
infusion set tubing which may be attached to the luer connector
portion 82. In one embodiment (not shown), the end of the needle 88
which extends to the luer taper 86 can be tapered outwardly in
order to more securely seat the needle 88 in the luer adapter 81.
Alternatively the needle 88 can be grit blasted in order to enhance
the bonding to the body of the luer adapter 81, or the needle 88
can be assembled via an insertion molding process or an epoxy
bonding process.
[0081] In another illustrative embodiment (not shown), the needle
88 does not extend to the end of the luer taper 86. Rather, the
needle 88 terminates inside of the luer taper 86 and a cylindrical
cavity (not shown) within the luer taper 86 extends from the end of
the needle 88 to the exterior of the luer taper 86. This cavity can
be sized to receive a needle or other conduit from another device
in order to provide a flow path to refill a cartridge which may be
attached to the reservoir connection portion 83.
[0082] As illustrated in FIGS. 17B and 17C, the arms 95 are wider
and the gaps 94 are narrower than the arms 64 and the gaps 63 shown
in the embodiment of FIGS. 16A-16C. As previously mentioned, the
number and dimensions of the arms which are used to snap over the
swage of a standard reservoir can be adjusted to accommodate the
degree of flexibility of the material used to construct a
cylindrical member portion of a luer adapter.
[0083] FIGS. 18A-18C show yet another embodiment of the present
invention. In this embodiment, a luer adapter 101 is comprised of a
reservoir connection portion 102 and a male luer connection portion
103. In contrast to the embodiments of FIGS. 16A and 17A, the luer
adapter 101 does not have a neck portion since one may not be
needed for those applications where it is not necessary for a luer
adapter to be secured in a medication pump or other device in that
fashion. However the luer adapter 101 does have a plurality of
generally rectangular-shaped seating tabs 104 disposed on the
reservoir connector portion 102. The tabs 104 can be used to secure
the luer adapter 101 in a medication pump or other device housing.
In other respects, the luer adapter 101 operates in the same manner
as the embodiments of FIGS. 16A and 17A.
[0084] Those skilled in the art will appreciate that while the
embodiments of FIGS. 15-18 disclose an adapter for connecting a
standard reservoir to a luer fitting as a typical embodiment of the
invention, the invention disclosed herein is not limited to luer
fittings. Instead, the design of the inventive adapter can be used
for connecting a standard reservoir to one or more of the variety
of other types of fittings know in the art, such a swage or crimp
fitting, threaded or unthreaded fittings, a nipple fitting or any
other fitting known in the art without departing from the scope of
the invention. By utilizing such a design, the invention therefore
serves as a universal adapter for connecting elements such as a
conduit to any one of a wide variety of reservoirs known in the
art.
[0085] While the description above refers to particular embodiments
of the present invention, it will be understood that many
modifications may be made without departing from the spirit
thereof. The accompanying claims are intended to cover such
modifications as would fall within the true scope and spirit of the
present invention. The presently disclosed embodiments are
therefore to be considered in all respects as illustrative and not
restrictive, the scope of the invention being indicated by the
appended claims rather than the foregoing description, and all
changes which come within the meaning and range of equivalency of
the claims are therefore intended to be embraced therein. All
patents, patent application and literature references identified
herein are incorporated herein by reference.
* * * * *