U.S. patent application number 13/676132 was filed with the patent office on 2013-10-24 for incontinence treatment device including non-porous cuff and extending members.
This patent application is currently assigned to COLOPLAST A/S. The applicant listed for this patent is COLOPLAST A/S. Invention is credited to Christopher Deegan, Steven McClurg, Mark A. Moschel.
Application Number | 20130281767 13/676132 |
Document ID | / |
Family ID | 49380728 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130281767 |
Kind Code |
A1 |
Deegan; Christopher ; et
al. |
October 24, 2013 |
INCONTINENCE TREATMENT DEVICE INCLUDING NON-POROUS CUFF AND
EXTENDING MEMBERS
Abstract
An incontinence treatment device includes a non-porous support
and an extending member. The non-porous support has a first end
portion provided with a slot and a second end portion. The second
end portion is insertable through the slot to form a cuff that is
configured for placement around a urethra of a user. The extending
member is attached to the support at a junction located between the
first end portion and the second end portion. Tension applied to
the second end portion is adapted to draw the junction toward the
slot to tighten the cuff and thus provide the user with a continent
state. Tension applied to the extending member is adapted to draw
the juncture away from the slot and expand the cuff and thus allow
the user to urinate.
Inventors: |
Deegan; Christopher; (North
St. Paul, MN) ; McClurg; Steven; (Brooklyn Park,
MN) ; Moschel; Mark A.; (New Hope, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COLOPLAST A/S |
Humlebaek |
|
DK |
|
|
Assignee: |
COLOPLAST A/S
Humlebaek
DK
|
Family ID: |
49380728 |
Appl. No.: |
13/676132 |
Filed: |
November 14, 2012 |
Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61F 2002/047 20130101;
A61F 2/042 20130101; A61F 2/0045 20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 20, 2012 |
DK |
PA 2012 70202 |
Claims
1. An incontinence treatment device configured to be implanted in a
body of a user, the incontinence treatment device comprising: a
biocompatible non-porous support configured for implantation in the
body of the user and having a first end portion provided with a
slot and a second end portion, the second end portion is insertable
through the slot to form a cuff that is configured for placement
around a urethra of the user; and a biocompatible extending member
configured for implantation in the body of the user and attached to
the support at a junction located between the first end portion and
the second end portion; wherein tension applied to the second end
portion is adapted to draw the junction toward the slot to tighten
the cuff and thus provide the user with a continent state; wherein
tension applied to the extending member is adapted to draw the
junction away from the slot and expand the cuff and thus allow the
user to urinate.
2. The incontinence treatment device of claim 1, wherein the
support has a height extending between a first side and a second
side of the support, and the second end portion and the extending
member both taper from a first width that is substantially equal to
the height of the support to a second width that is narrower than
the height of the support.
3. The incontinence treatment device of claim 1, wherein the slot
has a slot width and the second end portion has a stop width that
is larger than the slot width and is so configured to prevent the
junction from passing through the slot.
4. The incontinence treatment device of claim 1, wherein the
support is not inflatable.
5. The incontinence treatment device of claim 1, wherein the
support is not a mesh.
6. The incontinence treatment device of claim 1, wherein the
support has a thickness and is fabricated from a film having
substantially uniform density through the thickness.
7. The incontinence treatment device of claim 1, wherein the cuff
is user-activated with each of the second end portion and the
extending member being accessible to the user such that
user-applied tension applied to the second end portion is adapted
to coapt the urethra and provide the user with a continent state,
and user-applied tension to the extending member is adapted to
relieve coaptation of the urethra and allow the user to
urinate.
8. The incontinence treatment device of claim 1, wherein the
non-porous support has three arms including the first end portion
provided with the slot, the second end portion, and the extending
member that is attached to the support at the junction.
9. The incontinence treatment device of claim 1, wherein the
extending member is attached at a substantially orthogonal angle to
the support.
10. The incontinence treatment device of claim 1, wherein the cuff
is coated with a substance that is configured to prevent tissue
attachment to the cuff.
11. The incontinence treatment device of claim 1, wherein the
non-porous support includes a first side spaced apart from a second
side by a sheet width, and the first end portion has a width that
is approximately equal to the sheet width and the second end
portion tapers to a tapered width that is less than the sheet
width.
12. An incontinence treatment device configured to be implanted in
a user, the incontinence treatment device comprising: a
biocompatible non-porous sheet having a first side spaced apart
from a second side by a sheet width, a first end portion having a
width that is approximately equal to the sheet width with a slot
formed in the first end portion, and a second end portion that
tapers to a tapered width that is less than the sheet width; a
biocompatible extending member having a first end that is attached
to the sheet at a junction located between the first end portion
and the second end portion, the extending member including a second
end that has a width that is less than the sheet width; wherein the
tapered width of the second end portion of the sheet is insertable
through the slot in the first end portion to form a cuff from the
non-porous sheet that is sized for placement around a human
urethra; wherein the slot has a slot width that prevents the
junction from passing through the slot.
13. The incontinence treatment device of claim 12, wherein the
extending member is attached at a substantially orthogonal angle to
the sheet.
14. The incontinence treatment device of claim 1, wherein the
non-porous support comprises a flexible material.
15. The incontinence treatment device of claim 12, wherein the
non-porous sheet comprises a flexible material.
16. The incontinence treatment device of claim 1, wherein the
second end portion of the non-porous support defines a
substantially smooth outer surface that is configured to slide
through the slot in the first end portion in at least two opposite
directions.
17. The incontinence treatment device of claim 12, wherein the
second end portion of the non-porous sheet defines a substantially
smooth outer surface that is configured to slide through the slot
in the first end portion in two opposite directions.
18. The incontinence treatment device of claim 12 configured such
that the cuff is releasable restrained at a first diameter and upon
application of sufficient tension to the extending member the cuff
is released and expands in diameter.
19. The incontinence treatment device of claim 12 configured to
permit expansion of the cuff upon application of sufficient tension
to the extending member.
20. The incontinence treatment device of claim 1 configured to
permit expansion of the cuff upon application of sufficient tension
to the extending member.
Description
BACKGROUND
[0001] Devices for treating urinary incontinence include slings,
supports, artificial urinary sphincters and other devices that are
implanted in a user to support and/or coapt the urethra.
[0002] A sling is a device that is surgically implanted to support
the urethra and inhibit urine from undesirably leaking from the
urethra. Slings are typically fabricated from mesh and are
implanted through one or more incisions. The sling is secured to
supporting tissue(s) and the tissue eventually grows through the
mesh to support the urethra. The surgeon will peri-operatively
determine and achieve the appropriate level of tension in the sling
relative to the urethra that will post-operatively provide the user
with a continent state.
[0003] An artificial urinary sphincter is generally provided as an
inflatable ring or "donut" that is surgically implanted around the
urethra. Some people become incontinent after having a portion or
all of the prostate gland removed, which can result in a loss of
some or all of the function of the prostatic urinary sphincter. An
artificial urinary sphincter implanted around the compromised
prostatic urinary sphincter can provide the patient with improved
control of urinary function.
[0004] Improved incontinence treatment devices would be welcomed by
both the patient and the surgical staff.
SUMMARY
[0005] One aspect provides an incontinence treatment device
including a non-porous support and an extending member. The
non-porous support has a first end portion provided with a slot and
a second end portion. The second end portion is insertable through
the slot to form a cuff that is configured for placement around a
urethra of a user. The extending member is attached to the support
at a junction located between the first end portion and the second
end portion. Tension applied to the second end portion is adapted
to draw the junction toward the slot to tighten the cuff and thus
provide the user with a continent state. Tension applied to the
extending member is adapted to draw the juncture away from the slot
and expand the cuff and thus allow the user to urinate.
[0006] One aspect provides an incontinence treatment device
including a non-porous sheet and an extending member attached to
the non-porous sheet. The non-porous sheet has a first side spaced
apart from a second side by a sheet width, a first end portion
having a width that is approximately equal to the sheet width with
a slot formed in the first end portion, and a second end portion
that tapers to a tapered width that is less than the sheet width.
The extending member has a first end that is attached to the sheet
at a junction located between the first end portion and the second
end portion. The extending member includes a second end that has a
width that is less than the sheet width. The tapered width of the
second end portion of the sheet is insertable through the slot in
the first end portion to form a cuff from the non-porous sheet that
is sized for placement around a human urethra. The slot has a slot
width that prevents the junction from passing through the slot.
[0007] One aspect provides a method of treating urinary
incontinence that includes making an incision and exposing tissue
of a urethra, and inserting a non-porous sheet into the incision
and forming a cuff around the urethra with the non-porous sheet by
directing a first end of the non-porous sheet through a slot formed
in a second end of the non-porous sheet. The method further
includes directing an extending member that is attached to the
non-porous sheet to a location outside of the pelvis. The method
additionally includes configuring the cuff to tighten around the
urethra when pulling on the first end of the non-porous sheet, and
configuring the cuff to be loosely positioned around the urethra
when pulling on the extending member.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings are included to provide a further
understanding of embodiments and are incorporated in and constitute
a part of this specification. The drawings illustrate embodiments
and together with the description serve to explain principles of
embodiments. Other embodiments and many of the intended advantages
of embodiments will be readily appreciated as they become better
understood by reference to the following detailed description. The
elements of the drawings are not necessarily to scale relative to
each other. Like reference numerals designate corresponding similar
parts.
[0009] FIG. 1 is a top view of one embodiment of an incontinence
treatment device.
[0010] FIG. 2 is a perspective view of the incontinence treatment
device illustrated in FIG. 1 as assembled to provide a cuff.
[0011] FIG. 3 is a top view of the incontinence treatment device
illustrated in FIG. 2.
[0012] FIG. 4A is a top view and FIG. 4B is an expanded view of the
incontinence treatment device illustrated in FIG. 3 with tension
applied to tighten the cuff of the device.
[0013] FIG. 4C is a top view of the incontinence treatment device
illustrated in FIG. 4A with tension applied to a second extending
member to loosen the cuff of the device.
[0014] FIG. 5 is a schematic view of one embodiment of an
incontinence treatment device with a cuff implanted around the
urethra and extending members directed behind a pubic symphysis and
through a wall of an abdomen.
[0015] FIG. 6 is a schematic view of one embodiment of an
incontinence treatment device with a cuff implanted around the
urethra and extending members directed through obturator foramina
and through a groin of a user.
[0016] FIG. 7A is a schematic view of one embodiment of an
incontinence treatment device with a cuff loosely implanted around
the urethra and extending members implanted in a scrotum.
[0017] FIG. 7B is a schematic view of one embodiment of the
incontinence treatment device illustrated in FIG. 7A with the cuff
tightened around the urethra to provide the user with a continent
state.
DETAILED DESCRIPTION
[0018] In the following Detailed Description, reference is made to
the accompanying drawings, which form a part hereof, and in which
is shown by way of illustration specific embodiments in which the
invention may be practiced. In this regard, directional
terminology, such as "top," "bottom," "front," "back," "leading,"
"trailing," etc., is used with reference to the orientation of the
Figure(s) being described. Because components of embodiments can be
positioned in a number of different orientations, the directional
terminology is used for purposes of illustration and is in no way
limiting. It is to be understood that other embodiments may be
utilized and structural or logical changes may be made without
departing from the scope of the present invention. The following
detailed description, therefore, is not to be taken in a limiting
sense, and the scope of the present invention is defined by the
appended claims.
[0019] It is to be understood that the features of the various
exemplary embodiments described herein may be combined with each
other, unless specifically noted otherwise.
[0020] Tissue includes soft tissue, which includes dermal tissue,
sub-dermal tissue, ligaments, tendons, or membranes. As employed in
this specification, the term "tissue" does not include bone.
[0021] In this specification the word "coapt" means to close or to
substantially close. To coapt an opening is to bring two surfaces
together in close approximation such that the gap between the two
surfaces is reduced or eliminated. To coapt a urethra means to
substantially yet reversibly close the urethra to impede the
passage of urine and provide a person with a continent state.
[0022] In this specification permanent means for as long as an
incontinence treatment device is implanted into a patient. Thus, an
incontinence treatment device having a permanent external portion
outside of an abdominal wall of the patient provides the external
portion outside of the patient for as long as the device is
implanted in the patient.
[0023] In this specification a "user" is one into whom an
incontinence treatment device has been implanted.
[0024] In this specification "non-porous" means a material with no
through-holes. For example, a non-porous material is characterized
by the absence of multiple holes that extend through the material
from one surface to the other surface. Non-porous, as employed in
this specification, means a material that is configured to prevent
tissue growth through the implanted material.
[0025] Embodiments provide an incontinence treatment device
implantable into a user and including extending members that allow
the user to selectively move from a state of continence (free from
urine leakage) to a state that allows urination. Tension applied to
a first extending member is adapted to draw the junction toward the
slot to tighten the cuff and coapt the urethra to provide the user
with a continent state. Tension applied to the second extending
member is adapted to draw the juncture away from the slot and
loosen the cuff to relieve coaptation of the urethra and allow the
user to urinate.
[0026] FIG. 1 is a top view of one embodiment of an incontinence
treatment device 20. The incontinence treatment device 20 (device
20) includes a support 22 in the form of a sheet or a band that
extends between a first end 24 and a second end 26, with a first
end portion 28 adjacent to the first end 24 and a second end
portion 30 adjacent to the second end 26. An extending member 32 is
attached to the support 22 at a junction 34 that is located between
the first end portion 28 and the second end portion 30. The support
22 is fabricated to be non-porous such that after implantation the
non-porous support 22 discourages or prevents tissue from growing
onto or through the non-porous support 22.
[0027] One of the end portions 28, 30 is provided with a slot 36.
For example, the first end portion 28 is provided with a slot 36
that is sized to receive the second end portion 30. Inserting the
second end portion 30 through the slot 36, for example along a path
38, forms the support 22 into a cuff (40 in FIG. 2) with the second
end portion 30 extending in a different direction from the
extending member 32.
[0028] Prior to assembly, the device 20 provides three segments or
arms: a first arm A1 that is provided by the first end portion 28
having the slot 36, a second arm A2 that is provided by the second
end portion 30, and a third arm A3 that is provided by the second
extending member 32.
[0029] In one embodiment, the second extending member 32 is
attached at a substantially orthogonal angle to the support 22. In
one embodiment, the second extending member 32 is attached to the
support 22 at an angle other than 90 degrees.
[0030] FIG. 2 is a perspective view and FIG. 3 is a top view of the
support 22 providing a cuff 40. The cuff 40 has two adjustment
arms, a tightening arm provided by the second end portion 30 and a
loosening arm provided by extending member 32.
[0031] During implantation, the support 22 is placed on a first
side of the urethra and the second end portion 30 is inserted
through the slot 36 to form the cuff 40 around the urethra of a
user. The assembled cuff 40 thus has two extending members: a first
extending member 42 provided by the second end portion 30 and the
second extending member 32 attached to the support 22 between the
first end portion 28 and the second end portion 30.
[0032] In one embodiment, the slot 36 is formed to have a slot
width W (FIG. 2). In one embodiment, the junction 34 between the
member 32 and the support 22 includes a stopper 44 with a stop
width S that is larger than the slot width W. The stop width S of
the stopper 44 is configured to prevent the junction 34 from
passing through the slot 36. In one embodiment, the slot width W is
sized to prevent passage of the extending member 32 through the
slot 36.
[0033] In one embodiment, the support 22 has a height H extending
between opposing sides of the support 22, and each of the first
extending member 42 and the second extending member 32 tapers from
a first width L that is substantially equal to the height H of the
support 22 to a second width D that is narrower than the height H
of the support.
[0034] The support 22 is non-porous and is preferably fabricated
from a synthetic material such as rubber, silicone, thermoplastic
polymer, thermoset polymer, or blends of polymers or copolymers.
One suitable material for fabricating the support 22 is silicone
rubber. The support 22 is fabricated to be non-porous to discourage
tissue growth through the surface of the support 22.
[0035] In one embodiment, at least the cuff 40 portion of the
device 20 is coated with a substance that prevents tissue from
attaching to or growing on a surface of the cuff 40. Tissue growth
into or through the support 22 would undesirably fixate the support
22 into the patient after it is implanted. The support 22 is
fabricated from materials that are non-porous and are selected to
reduce or prevent the likelihood of tissue growth into or through
the support 22. Although not bound to this theory, tissue is
expected to grow around the cuff 40 and envelop the cuff 40 in a
pocket of tissue that allows the cuff 40 to move (tighten and
loosen) relative to the urethra.
[0036] In one embodiment, since the non-porous support 22 is not a
mesh. In one embodiment, the non-porous support 22 has a thickness
and is fabricated from, for example, a solid film having
substantially uniform density through the thickness. Thus, in one
embodiment, the support 22 and the resulting assembled cuff 40 are
not inflatable.
[0037] FIG. 4A is a top view and FIG. 4B is an expanded view of the
cuff 40. Tension T1 illustrates a pulling force applied to the
first extending member 42. The tension T1 will draw the junction 34
up to the slot 36 and reduce the diameter of the cuff 40, which is
useful to coapt the urethra to provide the user with a continent
state. With reference to FIG. 4B, the tension T1 applied to the
first extending member 42 tightens the cuff 40 until a stopper 44
is caught by the slot 36, which prevents further collapse of the
cuff 40.
[0038] The arc length of the support 22 extending from the junction
34 to the slot 36 (See FIG. 1) is selected such that the cuff 40
provides an inside diameter that is sufficient to collapse or coapt
a human urethra without over compressing or eroding the urethra.
The stopper 44 thus provides a feature that prevents the cuff 40
from being collapsed too tightly against the urethra.
[0039] FIG. 4C is a top view illustrating a second tension T2
applied to the second extending member 32 to draw the stopper 44
away from the slot 36, which expands the cuff 40 to relieve
coaptation of the urethra to allow the user to urinate.
[0040] When implanted, the cuff 40 provides the user with the
ability to pull on the first extending member 42 to achieve a
continent state, and to subsequently pull on the second extending
member 32 to transition the user into a state that allows urine to
pass through the urethra.
[0041] In one embodiment, the cuff 40 is user-activated with each
of the first and second extending members 42, 32, respectively,
implanted to be accessible to the user such that user-applied
tension T1 applied to the first extending member 42 will coapt the
urethra to provide the user with a continent state, and
user-applied tension T2 applied to the second extending member 32
will relieve the coaptation of the urethra and allow the user to
urinate.
[0042] FIG. 5 is a schematic view of one embodiment of the device
20 after implantation. The cuff 40 is implanted around the urethra
U and the extending members 32, 42 are tunneled behind the pubic
bone PB and project through a wall of the abdomen. The extending
members 32, 42 are located in a user-accessible location outside
the body. Tension applied by the user to the first extending member
42 tightens the cuff 40 to coapt the urethra and provide the user
with a continent state. Tension applied by the user to the second
extending member 32 loosens the cuff 40 to relieve the coaptation
of the urethra and allow the user to urinate.
[0043] In one embodiment, the device 20 is implanted into the
patient such that the cuff 40 surrounds the urethra U and the
extending members 32, 42 exit through the skin of the abdomen of
the user. In one the suitable implantation approach, a perineal
incision (male) or a vaginal incision (female) is made, and tissue
surrounding the urethra U is dissected to gain access to the
urethra U. A portion of the device 20 is inserted into the
incision. With reference to FIG. 1, the second end portion 30 is
subsequently maneuvered around the urethra U and inserted through
the slot 36 in the first end portion 28 to form the cuff 40 around
the urethra U. A suitable tunneling device, such as a pointed
introducer 50 or needle-like device, is inserted through the skin
of the abdomen at an access point in an abdominal location that is
superior to the pubic symphysis PS. The introducer 50 is tunneled
downward toward the urethra U and exits the incision formed in the
patient. One of the extending members 32, 42 is engaged with a
T-slot 52 formed in an end portion 54 of the introducer 50, and the
introducer 50 is retracted upwards behind the pubic bone PB and out
of the access point formed in the abdominal location. This maneuver
is repeated on the contralateral side, in which the pointed
introducer 50 is inserted through the skin and into the abdomen at
a second access point that is superior to the pubic symphysis PS
and again tunneled downward to exit the incision formed in the
patient. The other of the extending members 32, 42 is engaged with
the slot 52 of the introducer 50, and the introducer 50 is
retracted upwards behind the pubic bone PB and out of the second
access point formed in the abdomen.
[0044] The perineal or the vaginal incision is closed. The
extending members 32, 42 project outward from the abdomen through
the access points formed in the abdominal locations. A suitable
barrier is provided to prevent the transmission of bacteria into
the abdominal locations. In other approaches, a prophylactic
antibiotic is employed to reduce infection at the abdominal
locations.
[0045] The first and second extending members 42, 32, respectively,
are thus accessible to the user. Tension applied to the first
extending member 42 will tighten the cuff 40 to coapt the urethra
U. Tension applied to the second extending member 32 will expand
the cuff 40 to allow the user to pass urine through the urethra
U.
[0046] FIG. 6 is a schematic view of one embodiment of the cuff 40
implanted around the urethra U with each of the extending members
32, 42 directed through one of the obturator foramina OF and out of
the groin to a user-accessible location.
[0047] In one embodiment, the device 20 is implanted into the
patient such that the cuff 40 surrounds the urethra U and the
extending members 32, 42 extend through an obturator foramen and
out of the skin of the groin. In one suitable implantation
approach, a perineal incision (male) or a vaginal incision (female)
is made, and tissue surrounding urethra is dissected to gain access
to the urethra U. With reference to FIG. 1, the second end portion
30 is maneuvered around the urethra U and inserted through the slot
36 in the first end portion 28 to form the cuff 40 around the
urethra U. The ends of the extending members 32, 42 are suitably
tunneled through each of the obturator foramen OF and out of the
skin in the region of the groin.
[0048] In one embodiment, an introducer 60A is employed in an
"inside out" approach to tunnel the ends of the extending members
32, 42 out of the skin of the groin. For example, an end of the
second extending member 32 is engaged with a tip 62 of the
introducer 60A at a location outside of the incision (perineal for
male or vaginal for female). The introducer 60A is suitable curved
to allow the end of the extending member 32 to be directed behind
the descending pubic ramus PR, through one of the obturator foramen
OF, and out of the skin in the region of the groin. A similar
maneuver is repeated on the contralateral side with a suitably
formed second introducer 60B to direct the end of the extending
member 42 through the other obturator foramen OF.
[0049] Another suitable approach directs an introducer through an
"outside in" approach in which the introducer enters the skin in
the groin region, penetrates the obturator foramen OF, and is
directed around the descending pubic ramus PR until a tip of the
introducer exits the incision. The tip of the introducer is coupled
with an end of one of the extending members 32, 42, and the
introducer is retrieved back through the incision, the obturator
foramen OF, and the skin in the groin region. A similar maneuver is
repeated on the contralateral side to place the other of the
extending members 32, 42.
[0050] Thus, as illustrated in FIG. 6, each of the first and second
extending members 42, 32, respectively, is implanted through one of
the obturator foramen and extends to the skin to a user-accessible
location.
[0051] FIG. 7A is a schematic view of one embodiment of an open
cuff 40 implanted around the urethra U and FIG. 7B is a schematic
view of the cuff 40 coapting the urethra U.
[0052] In one embodiment, the extending members 32, 42 are
implanted in a scrotum of a male user, and although implanted
internal to the user, are accessible for selectively altering the
user between a continent state and a urination state.
[0053] Similar to the approaches described above, an incision is
made, and tissue surrounding urethra is dissected to gain access to
the urethra U. The non-porous sheet 22 is maneuvered around the
urethra U to form the cuff 40 around the urethra U. The ends of the
extending members 32, 42 are directed into the scrotum Sc and the
incision is closed.
[0054] The user pulls on the extending members 32, 42 through the
skin of the scrotum to adjust the cuff 40 between the tightened and
coapted state and the loosened and open states. FIG. 7A illustrates
the second extending member 32 activated or pulled to open the cuff
40. In this configuration, the user is provided with an opened cuff
40 that allows the user to pass urine through the urethra U.
[0055] FIG. 7B illustrates the first extending member 42 tensioned
or otherwise pulled to collapse the cuff 40 around the urethra U,
which provides the user with a continent state.
[0056] Although specific embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that a variety of alternate and/or equivalent
implementations may be substituted for the specific embodiments
shown and described without departing from the scope of the present
invention. This application is intended to cover any adaptations or
variations of medical devices as discussed herein. Therefore, it is
intended that this invention be limited only by the claims and the
equivalents thereof.
* * * * *