U.S. patent application number 10/158977 was filed with the patent office on 2002-10-03 for fluid delivery system and an aseptic connector for use therewith.
Invention is credited to Hirschman, Alan D., Jaecklein, William J., Pomaybo, Amy, Trombley, Frederick W. III.
Application Number | 20020143300 10/158977 |
Document ID | / |
Family ID | 21769922 |
Filed Date | 2002-10-03 |
United States Patent
Application |
20020143300 |
Kind Code |
A1 |
Trombley, Frederick W. III ;
et al. |
October 3, 2002 |
Fluid delivery system and an aseptic connector for use
therewith
Abstract
A fluid delivery system includes a valve device, a pump system
operable to pressurize a fluid and a patient interface. The valve
device includes a sealing element and defines at least a first
outlet and a second outlet. The first outlet includes a first
member of a connector. The pump system is operably associated with
the second outlet of the valve device. The patient interface
includes a second member of the connector and a tube in fluid
connection with the second member. The second member of the
connector is adapted to be removably connected to the first member
of the connector. The first member preferably includes a resilient
septum, and the second member preferably includes a penetrating
member. The connector further comprises a resilient sealing element
that contacts the penetrating member and one of an inner wall of
the first member and an inner wall of the second member to create a
seal between the penetrating member and one of the inner wall of
the first member and the inner wall of the second member.
Inventors: |
Trombley, Frederick W. III;
(Gibsonia, PA) ; Pomaybo, Amy; (Natron Heights,
PA) ; Hirschman, Alan D.; (Glenshaw, PA) ;
Jaecklein, William J.; (Pittsburgh, PA) |
Correspondence
Address: |
GREGORY L BRADLEY
MEDRAD INC
ONE MEDRAD DRIVE
INDIANOLA
PA
15051
|
Family ID: |
21769922 |
Appl. No.: |
10/158977 |
Filed: |
May 30, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10158977 |
May 30, 2002 |
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09507274 |
Feb 18, 2000 |
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09507274 |
Feb 18, 2000 |
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09015175 |
Jan 29, 1998 |
|
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6096011 |
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Current U.S.
Class: |
604/247 ;
604/244 |
Current CPC
Class: |
A61M 39/14 20130101;
Y10S 604/905 20130101; A61M 2039/1033 20130101; A61M 2039/1072
20130101 |
Class at
Publication: |
604/247 ;
604/244 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A fluid delivery system comprising: a valve device comprising a
sealing element and defining at least a first outlet and a second
outlet, the first outlet comprising a first member of a connector;
at least one pump system operably associated with the second outlet
of the valve device, the at least one pump system operable to
pressurize a fluid; and a patient interface comprising a second
member of the connector and a tubing in fluid connection with the
second member, the second member of the connector adapted to be
removably connected to the first member of the connector.
2. The fluid delivery system of claim 1 wherein the patient
interface further comprises a unidirectional flow device in fluid
connection with the tubing between the second member and the
patient.
3. The fluid delivery system of claim 2 wherein the unidirectional
flow device comprises a check valve.
4. The fluid delivery system of claim 1 wherein the valve device is
a dual check valve.
5. The fluid delivery system of claim 1 wherein the valve device
further defines a first inlet.
6. The fluid delivery system of claim 5, further comprising a
source of fluid in fluid connection with the first inlet of the
valve device.
7. The fluid delivery system of claim 6 wherein the source of fluid
comprises a fluid container and a conduit in fluid connection with
the fluid container.
8. The fluid delivery system of claim 7 wherein the source of fluid
is adapted to be removably connected to the first inlet.
9. The fluid delivery system of claim 8 wherein the first inlet
comprises a first member of a second connector and the conduit
comprises a second member of the second connector, the first member
and the second member of the second connector adapted to be
removably connected to one another to removably connect the source
of fluid to the valve device.
10. The fluid delivery system of claim 9 wherein the first member
of the second connector comprises a resilient septum and the second
member of the second connector comprises a penetrating member
adapted to penetrate the resilient septum.
11. The fluid delivery system of claim 10 wherein the second
connector further comprises a resilient sealing element that
contacts the penetrating member and one of an inner wall of the
first member and an inner wall of the second member to create a
seal between the penetrating member and one of the inner wall of
the first member and the inner wall of the second member.
12. The fluid delivery system of claim 11 wherein the resilient
sealing element comprises an elastomeric member that is compressed
when the first member and the second member are brought together to
form the seal between the penetrating member and one of the inner
wall of the first member and the inner wall of the second
member.
13. The fluid delivery system of claim 1 wherein the first member
of the connector comprises a resilient septum and the second member
of the connector comprises a penetrating member adapted to
penetrate the resilient septum.
14. The fluid delivery system of claim 13 wherein the connector
further comprises a resilient sealing element that contacts the
penetrating member and one of an inner wall of the first member and
an inner wall of the second member to create a seal between the
penetrating member and one of the inner wall of the first member
and the inner wall of the second member.
15. The fluid delivery system of claim 14 wherein the resilient
sealing element comprises an elastomeric member that is compressed
when the first member and the second member are brought together to
form the seal between the penetrating member and one of the inner
wall of the first member and the inner wall of the second
member.
16. The fluid delivery system of claim 1 wherein the first member
of the connector comprises a first threaded section and the second
member of the connector comprises a second threaded section, the
first threaded section and the second threaded section being
adapted to cooperate to releasably connect the first member to the
second member.
17. The fluid delivery system of claim 1 wherein the at least one
pump system comprises a first member of a luer connection and the
second outlet of the valve device comprises a second member of the
luer connection, the first and second members of the luer
connection being adapted to cooperate to removably connect the at
least one pump system to the valve device.
18. The fluid delivery system of claim 1 wherein the at least one
pump system comprises a syringe.
19. The fluid delivery system of claim 1 wherein the patient
interface is discarded after an injection procedure for a patient
is completed to prevent cross-contamination between patients.
20. The fluid delivery system of claim 1 wherein one or both of the
at least one pump system and the valve device can be reused for a
number of injection procedures.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
09/507,274, filed on Feb. 18, 2000, which is a continuation of
application Ser. No. 09/015,175, filed on Jan. 29, 1998, now U.S.
Pat. No. 6,096,011, the contents of which are hereby incorporated
by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to an aseptic connector or
coupler and to a fluid delivery system using such an aseptic
connector, and, more particularly, to an aseptic connector and
fluid delivery system for use in medical procedures in which a
fluid is delivered at a relatively high pressure.
[0003] Aseptic connectors are commonly used in the medical arts,
but most aseptic connectors are limited to use at relatively low
pressures. In some medical procedures, however, it is desirable to
deliver a liquid under relatively high pressures. In radiological
procedures such as computer tomography (CT), for example, a liquid
contrast medium is injected into a patient at pressures of
approximately 300 psi. Although, there are connectors currently
used at high pressures in the medical arts, such "high-pressure"
connectors generally rely upon a friction fit to create a
high-pressure seal and are not aseptic.
[0004] As a result, it is very desirable to develop aseptic
connectors and delivery systems incorporating such aseptic
connectors that are suitable for use at relatively high
pressures.
SUMMARY OF THE INVENTION
[0005] The present invention provides generally an aseptic
connector comprising a first member and a second member. The first
member preferably includes a resilient septum, and the second
member preferably includes a penetrating member. Preferably, the
septum is formed from an elastomeric material such as a silicone
elastomer. The penetrating member preferably includes an extending
penetrating element to penetrate the resilient septum. The aseptic
connector further comprises a resilient sealing element that
contacts the penetrating member and one of an inner wall of the
first member and an inner wall of the second member to create a
seal between the penetrating member and one of the inner wall of
the first member and the inner wall of the second member.
[0006] The seal formed between the penetrating member and the inner
wall of the first member or the inner wall of the second member is
suitable for use at relatively high pressures. In that regard, the
seal is preferably suitable for use (that is, will maintain a seal
and not leak) at pressures of at least 100 psi. More preferably,
the seal is suitable for use at pressures of at least 150 psi. Most
preferably, the seal is suitable for use at pressures of at least
300 psi.
[0007] The resilient sealing element preferably comprises an
annular, elastomeric member that is axially compressed when the
first member and the second member are brought together. The axial
compression of the annular, elastomeric member causes a radial
expansion which exerts radial pressure upon the penetrating member
and the inner wall of the first member or the inner wall of the
second member to form the seal between the penetrating member and
the inner wall of the first member or the inner wall of the second
member.
[0008] In one embodiment, the resilient septum preferably has at
least one generally circular enclosed end, which is attached to the
annular, elastomeric member. The generally circular enclosed end is
preferably fabricated from an elastomer such as a silicone
elastomer that is preferably suitable for repeated penetration by
the penetrating element. Preferably, the circular enclosed end of
the septum and the annular, elastomeric member are formed
integrally from such a material. The annular, elastomeric member is
preferably seated in a generally cylindrical seating chamber formed
in the first member. This seating chamber preferably has an inner
wall having a diameter slightly greater than an outside diameter of
the annular, elastomeric member. The annular, elastomeric member
preferably has an inner diameter slightly greater than the outer
diameter of the penetrating element. Upon axial compression of the
annular, elastomeric member, a seal is formed between the
penetrating element and the inner wall of the seating chamber.
Preferably, the annular, elastomeric member is extended in length
to have a generally cylindrical shape.
[0009] In the embodiment of the previous paragraph, the penetrating
member preferably includes an abutment shoulder that axially
compresses the annular, elastomeric member when the first member
and the second member are brought together. This abutment shoulder
is preferably a radially outward extending shoulder on the
penetrating member.
[0010] The first member of the aseptic connector preferably further
includes a first threaded section and the second member of the
aseptic connector preferably includes a second threaded section.
The first threaded section and the second threaded section are
adapted to cooperate to securely and releasably connect the first
member to the second member. The first threaded connection and the
second threaded connection also assist in enabling the user to
axially compress the annular, elastomeric member as the first
member and the second member are brought into releasable
connection.
[0011] The present invention also provides a fluid delivery system
comprising at least a first aseptic connector as described above.
The fluid delivery system further comprises a pump system in fluid
connection with one of the first member and the second member of
the aseptic connector. The other of the first member and the second
member is in fluid connection with the patient.
[0012] The fluid delivery system preferably further comprises a
dual check valve. The other of the first member and the second
member is connected to a first outlet of the dual check valve. The
pump system is connected to a second outlet of the dual check
valve, and a source of the fluid is connected to the inlet of the
dual check valve. The fluid delivery system preferably further
comprises a check valve in fluid connection between the patient and
the other of the first member and the second member.
[0013] The fluid delivery system preferably further comprises a
second aseptic connector in which one of a first member of the
second aseptic connector and a second member of the second aseptic
is connected to the inlet of the dual check valve. The other of the
first member of the second aseptic connector and the second member
of the second aseptic connector is connected to the source of the
fluid. Preferably, the second aseptic connector is designed as
described above.
[0014] The aseptic coupler or connector of the present invention is
suitable for use at relatively high pressures while being
relatively simple in design and operation. The aseptic connector of
the present invention is also inexpensive to fabricate, making it
(or one of its first and second members) suitable for disposal
after only a single use, if desired. However, the unique design of
the aseptic connector of the present invention also makes it
suitable for repeated use at relatively high pressures. The aseptic
connector of the present invention maintains a leak proof seal at
high pressures after many such uses.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a cross-sectional view of one embodiment of a
female member of an aseptic connector of the present invention.
[0016] FIG. 2 is a cross-sectional view of one embodiment of a male
member of an aseptic connector of the present invention.
[0017] FIGS. 3A through 3D illustrated the cooperation of the
female member of FIG. 1 and the male member of FIG. 2 to form a
releasable aseptic connection.
[0018] FIG. 4 is a cross-sectional view of another embodiment of an
aseptic connector in which the male and female members are in a
disconnected state.
[0019] FIG. 5 is a cross-sectional view of the embodiment of the
aseptic connector of FIG. 4 in which the male and female members
are in a connected state.
[0020] FIGS. 6A and 6B illustrate an embodiment of a fluid delivery
system incorporating the aseptic connector of FIGS. 1 through
3D.
DETAILED DESCRIPTION OF THE INVENTION
[0021] As illustrated in FIG. 1, a first or female member 10
preferably comprises a generally cylindrical base member 15 having
a passage 20 therethrough. Passage 20 is preferably in fluid
connection with a seating area or chamber 25 formed within base
member 15. Seating chamber 25 preferably comprises a generally
cylindrical passage having a diameter larger than the diameter of
passage 20. Seating chamber 25 is adapted to seat a flexible or
resilient septum 50 therein. Septum 50 preferably comprises a
generally cylindrical side portion 55 and a generally circular end
portion 60. Generally cylindrical side portion 55 and generally
circular end portion 60 are preferably formed integrally from an
elastomeric material, such as a silicone elastomer. The outer
diameter of side portion 55 is preferably slightly less than the
diameter of seating chamber 25. Base member 15 preferably further
includes a retention member 70 to retain septum 50 within seating
chamber 25. In the embodiment of FIG. 1, retention member 70
extends radially inward (with respect to axis A) around the
perimeter of seating chamber 25.
[0022] Base member 15 also preferably includes a mechanism, such as
threaded portion 75, on an outside wall thereof to form a
releasable connection with a second member 100. Base member 15
preferably also comprises an extending member 80 in fluid
connection with passage 20 to which a conduit or connector (not
shown), such as flexible tubing or a luer connector, can be
attached. Base member 15 is preferably fabricated from a relatively
rigid polymeric material.
[0023] As illustrated in FIG. 2, the connector of the present
invention also comprises second or male member 100. Second member
100 comprises a penetrating member 110. Penetrating member 110
comprises a generally cylindrical penetrating element 115 extending
from a first end thereof. A passage 120 is formed through
penetrating element 115 and the remainder of penetrating member
110. The second end of penetrating member 110 preferably forms an
extending member 122 in fluid connection with passage 120 to which
a conduit or connector (not shown), such as flexible tubing or a
luer connector, can be attached.
[0024] Second member 100 also preferably includes a swivel member
125 rotatably connected to penetrating member 110. In the
embodiment of FIG. 2, swivel member 125 comprises a passage 130
through which penetrating member 110 passes. In the embodiment of
FIG. 2, penetrating member 110 is rotatably connected to swivel
member 125 through the cooperation of an annular depression 135
formed in penetrating member 110 and a radially inward extending
flange 140 on swivel member 125. Swivel member 125 preferably
further includes a threaded portion 145 on an interior surface
thereof to cooperate with threaded portion 75 of first member 10.
Preferably, penetrating member 110 and swivel member 125 are
fabricated from a relatively rigid polymeric material.
[0025] The cooperation of first element 10 and second element 100
to form an aseptic connection is illustrated in FIGS. 3A through
3D. First member 10 and second member 100 are first drawn axially
together as illustrated in FIG. 3A. As penetrating element 115
pierces flexible septum 50 (see FIG. 3B), swivel member 125 is
rotated relative to base member 15 to engage threaded portions 145
and 75. As threaded portions 145 and 75 are tightened, bringing
first member 10 and second member 100 in closer contact, an
abutment shoulder 150 of penetrating member 110 exerts axial force
upon septum 50. Generally cylindrical side portion 55 of septum 50
(which preferably has an inner diameter slightly greater than the
outer diameter of penetrating element 115) is thereby compressed
and exerts force generally symmetrically around penetrating element
115 and against the inner wall of seating chamber 25 to create a
tight and substantially leak proof seal therebetween. The
substantial axial and radial forces upon septum 50 (and the
resultant seal) enable use of the aseptic connector at relatively
high pressures.
[0026] Upon connection of first member 10 and second member 100,
passage 20 and passage 120 are in fluid connection to allow flow of
a fluid through the aseptic connector. As best illustrated in FIG.
3C, penetrating element 115 is preferably sized such that it does
not directly contact any portion of first member 10 other than
septum 50. As penetrating element 115 has been exposed to the
exterior environment, contact of penetrating element 115 only with
septum 50 assists in preventing cross contamination between first
member 10 and second member 100. Penetrating element 115 must also
be of sufficient length to extend beyond septum 50 to ensure
unobstructed flow through passage 120.
[0027] As set forth above, threaded portions 75 and 145 of first
member and second member, respectively, cooperate to retain first
member and second member together, and to thereby maintain the
tight and substantially leak proof seal of the aseptic connector.
The cooperation of threaded portions 75 and 145 also acts to
maintain the interior of the aseptic connector in an aseptic
condition, until disengagement as illustrated in FIG. 3D. Upon
disengagement, septum 50 substantially prevents leakage of fluid
from first member 10.
[0028] FIGS. 4 and 5 illustrate another embodiment of an aseptic
connector 150 of the present invention. Aseptic connector 150
comprises a first or female member 155 and a second or male member
175. First member 155 is preferably generally cylindrical in shape
and comprises a septum 160 enclosing one end thereof. First member
155 also preferably comprises an extending member 162 to which a
conduit or connector (not shown), such as flexible tubing or a luer
connector, can be attached. Extending member 162 has a passage 164
formed therein, which is in fluid connection with an interior 166
of first member 155. First member 155 also preferably comprises
threading 170 on an exterior wall thereof.
[0029] Second member 175 comprises a penetrating member 180.
Penetrating member 180 comprises a generally cylindrical
penetrating element 182 extending from a first end thereof. A
passage 184 is formed through penetrating element 182 and the
remainder of penetrating member 180. The second end of penetrating
member 180 preferably forms an extending member 186 in fluid
connection with passage 184 to which a conduit or connector (not
shown), such as flexible tubing or a luer connection, can be
attached.
[0030] Second member 180 also preferably includes a swivel member
190 rotatably connected to penetrating member 180 as described
above. Swivel member 190 preferably includes threading 192 on an
interior surface thereof to cooperate with threading 170 on first
member 155. Second member 175 also preferably includes opposing
wing elements 194 extending radially outward therefrom to
facilitate rotation of second member 175 relative to first member
155 to form a threaded connection of first member 155 and second
member 175.
[0031] The cooperation of first member 155 and second member 175 to
form an aseptic connection is illustrated in FIGS. 4 and 5. As
discussed above in connection with first member 10 and second
member 100, first member 155 and second member 175 are first drawn
axially together. As penetrating element 182 pierces flexible
septum 160, swivel member 190 is rotated relative to first member
155 to engage threaded portions 170 and 192. As threaded portions
170 and 192 are tightened, bringing first member 150 and second
member 175 into closer contact, a forward surface 172 of first
member 155 contacts an annular, elastomeric member 196 seated in a
generally cylindrical interior chamber 198 of second member 175.
Annular, elastomeric member 196 is thereby compressed generally
symmetrically around penetrating member 180 and against the inner
wall of swivel member 190 to create a tight and substantially leak
proof seal between penetrating member 180 and the interior wall of
swivel member 190. As discussed above, the substantial axial and
radial forces upon annular, elastomeric member 196 (and the
resultant seal) enable use of aseptic connector 150 at relatively
high pressures.
[0032] FIG. 6A illustrates an embodiment of a fluid (for example,
contrast media) delivery system 200 incorporating an aseptic
connector as described in FIGS. 1 through 3B. As recognized by one
skilled in the art, aseptic connector 150 of FIGS. 4 and 5 is
equally suitable for use in fluid delivery system 200. Other fluid
delivery systems in which the aseptic connector of the present
invention can be used are discussed U.S. Pat. No. 5,569,181, the
disclosure of which is incorporated herein by reference.
[0033] Delivery system 200 preferably includes a disposable patient
interface 300 in releasable fluid connection with an outlet 360 of
a pumping system, such as a manual or injector-powered syringe 350.
An example of a powered injector and syringe suitable for use in
the present invention is described in U.S. Pat. No. 5,383,585, the
disclosure of which is incorporated herein by reference. Other
pumping systems, such as rotary pumps and gear pumps, are also
suitable for use in the present invention.
[0034] In the embodiment of FIG. 6A, disposable patient interface
300 preferably comprises an IV catheter 310. IV catheter 310 is
preferably in fluid connection with a check valve 320 or other
suitable means to ensure unidirectional flow of the medium into the
patient. Check valve 320 is in fluid connection with flexible
tubing 330. Flexible tubing is preferably in fluid connection with
extending member 122 of male member 100 of the aseptic
connector.
[0035] Female member 10 of the aseptic connector is preferably in
fluid connection with powered syringe 350. In the embodiment of
FIG. 6A, female member 10 is in fluid connection with a first
outlet 410 of dual check valve 400 via extending member 80 of
female member 10. A second outlet 420 of dual check valve 400 is
preferably in releasable fluid connection with syringe 350 via, for
example, a luer connection. Inlet 430 of dual check valve 400 is
preferably in fluid connection with female member 10' of a second
aseptic connector of the present invention via extending member 80'
thereof.
[0036] Female member 10' is preferably in releasable fluid
connection with a disposable source of contrast medium 500. In that
regard, a male member 100' is preferably in fluid connection with a
contrast container 505. In the embodiment of FIGS. 6A and 6B, male
member 100' is in fluid connection with the first end of a length
of conduit 510 via extending member 122'. The second end of conduit
510 is in fluid connection with a spike 520 designed to penetrate a
septum (not shown) of container 505, as known in the art.
[0037] During an injection procedure, plunger 355 of syringe 350 is
first drawn rearward (toward powered injector 360). The negative
pressure created within syringe 355 causes a valve of inlet 430 of
dual check valve 400 to open and contrast medium to flow into
syringe 350 from contrast container 505 via second outlet 420.
Concurrently, the negative pressure within syringe 350 causes a
valve of second outlet 410 to remain closed.
[0038] After a desired amount of contrast medium is drawn into
syringe 350, plunger 355 is advanced forwardly (away from powered
injector 360) to create a positive pressure within syringe 350 and
thereby inject contrast medium into the patient. The positive
pressure within syringe 350 causes the valve of inlet 430 of dual
check valve 400 to close and the valve of second outlet 410 to
open, thereby allowing the contrast medium to be injected into the
patient via disposable patient interface 300.
[0039] As best illustrated in FIG. 6A, the releasable nature of the
aseptic connector of the present invention allows male member 100
to be disconnected from female member 10 so that disposable patient
interface 300 may be discarded, preferably after each injection
procedure. The disposable nature of patient interface 300 assists
in preventing cross contamination between patients.
[0040] Likewise, male member 100' is disconnectable from female
member 10'. Fluid source 500, including contrast container 505,
conduit 510 and male member 100', can thus be discarded when
contrast container 505 is emptied. Dual check valve 400 can be
reused with a new contrast container 505 and a new male member 100'
if so desired.
[0041] Syringe 350 can be released from dual check valve 400 so
that syringe 350, dual check valve 400 and female members 10 and
10' attached thereto can be discarded periodically. For example,
syringe 350, dual check valve 400 and female members 10 and 10' can
be discarded daily or after a certain number of injection
procedures, such as, for example, 6-8 procedures, have been
completed during the day. When more than one injection procedure is
performed before dual check valve 400 and female members 10 and 10'
are discarded, septums 50 and 50' are preferably cleaned using an
aseptic technique between procedures by, for example, wiping
septums 50 and 50' with alcohol to reduce the likelihood of
contamination.
[0042] As also clear to one skilled in the art, configurations
other than set forth in FIGS. 6A and 6B are possible. For example,
conduit 510 can be connected directly to inlet 430 of dual check
valve 400 without an intermediate releasable aseptic connection. In
that embodiment, container 505, conduit 510, dual check valve 400,
and female member 10 are preferably discarded periodically as a
unit. For example, those components may be discarded daily or upon
emptying of container 500. Once again, septum 50 is preferably
cleaned using an aseptic technique between injection
procedures.
[0043] Although the present invention has been described in detail
in connection with the above examples, it is to be understood that
such detail is solely for that purpose and that variations can be
made by those skilled in the art without departing from the spirit
of the invention. The scope of the invention is indicated by the
following claims rather than by the foregoing description. All
changes to the present invention that fall within the meaning and
range of equivalency of the claims are to be embraced within their
scope.
* * * * *