U.S. patent application number 14/160577 was filed with the patent office on 2014-07-10 for method of treating incontinence.
This patent application is currently assigned to Coloplast A/S. The applicant listed for this patent is Coloplast A/S. Invention is credited to Craig Comiter, Kapri Ellenson, Bryon L. Merade, Victor Nitti, Raymond Rackley, Eugene Rhee, Sandip Vasavada.
Application Number | 20140194675 14/160577 |
Document ID | / |
Family ID | 37235367 |
Filed Date | 2014-07-10 |
United States Patent
Application |
20140194675 |
Kind Code |
A1 |
Merade; Bryon L. ; et
al. |
July 10, 2014 |
Method of treating incontinence
Abstract
An implant for use in the treatment of urinary incontinence
includes a suburethral support and an anchor portion extending from
the support portion. The support portion is operatively
positionable at or distal to the bulbar urethral complex and the
anchor portion is operatively extensible through the obturator
foramen.
Inventors: |
Merade; Bryon L.; (Thousand
Oaks, CA) ; Comiter; Craig; (Palo Alto, CA) ;
Nitti; Victor; (Wyckoff, NJ) ; Rackley; Raymond;
(Shaker Heights, OH) ; Rhee; Eugene; (San Diego,
CA) ; Vasavada; Sandip; (Westlake, OH) ;
Ellenson; Kapri; (Los Alamitos, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Coloplast A/S |
Humlebaek |
|
DK |
|
|
Assignee: |
Coloplast A/S
Humblebaek
DK
|
Family ID: |
37235367 |
Appl. No.: |
14/160577 |
Filed: |
January 22, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11552484 |
Oct 24, 2006 |
|
|
|
14160577 |
|
|
|
|
11119446 |
Apr 30, 2005 |
7431690 |
|
|
11552484 |
|
|
|
|
Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61F 2250/0078 20130101;
A61F 2/0045 20130101 |
Class at
Publication: |
600/30 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. (canceled)
2. A method for treating urinary incontinence in a male patient,
the method comprising: providing an implant having a support
portion, a first arm extending from the support portion and a
second arm extending from the support portion; making an incision
in the male patient; placing the first arm of the implant through
the incision, through a first obturator foramen of the patient, and
adjacent a first descending ramus of the male patient; placing the
second arm of the implant through the incision and extending the
second arm toward a second obturator foramen of the patient
adjacent to a second descending ramus of the male patient; and
positioning the support portion of the implant through the incision
such that the support portion of the implant is located under the
bulbar urethral complex and extends upwardly to a pubic bone of the
male patient.
3. The method of claim 2, further comprising attaching the support
portion of the implant to the pubic bone of the patient.
4. The method of claim 2, further comprising suturing the support
portion of the implant to tissue of the pubic bone.
5. The method of claim 2, further comprising tacking the support
portion of the implant to the pubic bone.
6. The method of claim 2, further comprising attaching the support
portion to periosteum tissue of the pubic bone.
7. The method of claim 2, wherein the first and second arms and the
support portion of the implant are implanted through a single
incision.
8. The method of claim 2, wherein the incision is a incision.
9. The method of claim 2, further comprising dissecting tissue and
exposing the bulbar urethra through the incision.
10. The method of claim 2, wherein the implant as provided includes
the first arm extending substantially parallel to the second
arm.
11. An implant for treating male urinary incontinence, the implant
comprising: a support portion having a first side and a second side
opposite the first side, the support portion being configured to
support the bulbar urethral of a male patient; a first pair of
parallel arm portions extending in a first direction from the first
side of the support portion; a second pair of parallel arm portions
extending in a second direction from the second side of the support
portion that is opposite to the first direction in which the first
pair of parallel arm portions extend.
12. The implant of claim 11, wherein the support portion of the
implant is substantially rectangular.
13. The implant of claim 11, wherein one of the first pair of
parallel arm portions is formed as a single piece with one of the
second pair of parallel arm portions.
14. The implant of claim 11, wherein one of the first pair of
parallel arm portions is the same length as one of the second pair
of parallel arm portions.
15. The implant of claim 11, wherein one of the first pair of
parallel arm portions is adapted to extend through a first
obturator of the male patient and one of the second pair of
parallel arm portions is adapted to extend through a second
obturator of the male patient.
16. The implant of claim 11, wherein the implant forms an
H-shape.
17. The implant of claim 11, wherein the support portion defines a
first side having a common, parallel edge with one of the first
pair of arm portions and one of the second pair of arm
portions.
18. The implant of claim 17, wherein the support portion defines a
second side that is substantially parallel to and opposite the
first side, the second side having a common, parallel edge with one
of the first pair of arm portions and one of the second pair of arm
portions.
19. The implant of claim 11, wherein the support portion is a
central support portion.
20. A method for treating male urinary incontinence in a male
patient, the method comprising: making an incision and exposing a
bulbar urethra of the patient; inserting an implant through the
incision, the implant including a support portion, a first pair of
arm portions, and a second pair of arm portions, the support
portion including a front, a back, a first side and a second side
opposite the first side, the first pair of arm portions extending
from the first side of the support portion and the second pair of
arms extending from the second side of the support portion and in
an opposite direction to the first pair of arms; extending the
support portion of the implant under the bulbar urethral complex;
and tensioning the first and second pairs of arm portions to
achieve suburethral compression.
21. A method for treating urinary incontinence in a male patient,
the method comprising: providing an H-shaped implantable device
having a central support portion; making a non-scrotal incision in
a human patient; placing arm portions of the implant through the
incision and extending the arm portions toward first and second
obturator foramen, respectively, of the patient; positioning a
central support portion of the implant through the incision and
under the bulbar urethral complex of the male patient; and
tensioning the implant to achieve suburethral compression.
Description
STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
[0001] Not Applicable
BACKGROUND
[0002] The present invention is directed to surgical implants for
the treatment of male incontinence, and in particular, implantable
slings that are operative to provide sling-type support at or
distal to the bulbar urethral region of a patient and operatively
anchored into position via fixation about the patient's descending
rami.
[0003] Of the estimated 19 million North American adults who have
urinary incontinence, 20% are estimated to be men. Such condition
can range in severity from partial to complete loss of bladder
control and patients afflicted with urinary incontinence can
experience varying degrees of urine loss. In addition, it is known
that urinary incontinence may change over time and that men with
light incontinence, for example, may experience minimal leakage
during the occurrence of a provocative event, such as laughing or
coughing, whereas men with heavy incontinence may experience
continuous urine leakage.
[0004] Generally, male urinary incontinence is not considered a
disease, but rather a symptom or side effect of another medical
condition. Among the causes known to cause urinary incontinence
include prostate surgery, and in particular total prostatectomy,
head and spinal cord injury, infection, certain toxins, such as too
much alcohol consumption, certain medications, such as sedating
medications, and certain diseases, such as cancer, Parkinson's
disease and multiple sclerosis. Indeed, male incontinence can be
caused simply by virtue of the aging process or emotional
distress.
[0005] Each case of male incontinence, however, is unique and no
two men are affected by incontinence in the same way. There are,
however, well-recognized types of incontinence and various ways to
treat the same. Stress incontinence, which is the most common type
of incontinence, wherein urine leakage occurs during the occurrence
of a provocative event, such as sneezing, laughing, lifting heavy
objects, or when the patient engages in any type of exercise that
puts pressure on the bladder. Urge incontinence occurs when the
patient wants to urinate but is incapable of exercising restraint
until reaching a restroom. Additional types of incontinence include
overflow incontinence, which occurs when the quantity of urine
exceeds the capacity of the patient's bladder, and functional
incontinence, which occurs when the patient has knowledge of the
need to urinate but simply cannot access a restroom quickly enough
due to a physical obstruction or debilitation.
[0006] To treat male urinary incontinence, several options are
available. Among the more effective types of recognized treatment
include behavioral techniques, such as biofeedback, bladder
training, and pelvic muscle exercises, and modifications of the
patient's diet and fluid intake. With respect to the latter, it is
known that eliminating or cutting back on certain types of
substances, such as caffeine and alcohol, can help alleviate
incontinence. There are additionally medications available, such as
dicyclomine (Bentyl), flavoxate (Urispas), hyoscyamine sulfate
(Anaspaz), imipramine (Tofranil), oxybutynin (Ditropan),
tolterodine (Detrol), and propantheline (Pro-Banthine),
phenylpropanolamine (Dexatrim), and pseudoephedrine (Sudafed) that
are helpful in controlling urinary incontinence.
[0007] Surgery may additionally be an option to treat male urinary
incontinence. Along these lines, surgical implants, such as the
In-Vance, produced by American Medical Systems, Inc., of
Minneapolis, Minn., is a commercially available surgical implant
that is operative to provide structural support to the urethra for
the treatment of stress incontinence. In this regard, the implant
is operative to provide structural support to the urethra such that
during a provocative event, the implant will provide structural
support to the urethra thus causing the urine to be retained within
the bladder and not leak through the urethra.
[0008] With respect to utilizing sling implants to treat male
incontinence, however, such approach has numerous drawbacks. Due to
the differences between male and female anatomy, to secure sub
urethral sling implants into position typically requires the use of
bone screws, which are well-known in the art to be difficult and
time consuming to deploy, and can result in significant patient
discomfort, especially within the first couple of weeks following
the surgical implantation. In addition, implanting suburethral
slings are often times difficult to secure into position with the
optimal degree of tension. Indeed, the implantation of suburethral
slings for the treatment of male incontinence is well-recognized as
complex, time consuming and can produce suboptimal clinical
outcomes. Moreover, it is well recognized among urologists
performing such implant procedures that sutures attached to bone
anchors and or bone screws utilized to secure the sling into
position frequently break and that often times additional bone
screws must be secured into position. In fact, each suture attached
to bone anchors and or bone screws must typically be retensioned
two to three times before optimal sling positioning and structural
support to the urethra is achieved.
[0009] Accordingly, there is a substantial need in the art for a
suburethral sling implant for the treatment of male incontinence
that is substantially easier to surgically secure into position and
that can further provide an optimal degree of urethral support to
thus effectively treat male urinary incontinence. There is
additionally a need in the art for an implant that is of simple
construction, easy to surgically manipulate, and can be
manufactured at relative low cost utilizing known implant
materials, whether it be synthetic materials, natural tissues, or
combinations thereof. There is yet a further need in the art for
such an implant that can be secured into position such that the
implant defines a suburethral sling portion operatively positioned
at or distal to the bulbar urethra of the patient that remains
anchored into position via the use of an anchoring portion that
extends through the obturator foramen and remain secured at or near
the descending rami of the patient's pelvis without the use of bone
anchors. With respect to the latter, it would be exceptionally
advantageous for such a surgical implant that could be anchored to
the pubis through the obturator foramen preferably via the
descending rami thereof.
BRIEF SUMMARY
[0010] The present invention specifically addresses and alleviates
the above-identified deficiencies in the art. In this regard, the
present invention is directed to sub urethral sling implants and
methods of deploying the same that are effective and substantially
easier to deploy than prior art implants and implantation
techniques for treating male incontinence. The implant comprises
the combination of a urethral support portion and at least one
anchoring portion. The support portion is operatively positioned at
or distal to the bulbar urethra. Per conventional sub urethral
slings, the support portion is operative to provide structural
support to the urethra such that during the occurrence of a
provocative event, the sling is operative to compressively engage
the urethra to prevent urine leaking therefrom. The support portion
will have a surface area that is at least 2 cm long by 1 cm wide to
8 cm long by 8 cm wide.
[0011] The anchor portion extends from the support portion. The
anchor portion, which may take a variety of configurations, is
operative to extend through the obturator foramen of the patient
and become secured at a locus preferably at or near the descending
ramus. To effectuate such attachment, it is contemplated that one
or more sutures may be utilized to ensure that the anchor portion
becomes secured about the ramus and that the support portion
remains operatively positioned at or distal to the bulbar urethra.
In a preferred embodiment, the implant will have at least two
anchor portions extending from the support portion with each
respective anchor portion extending through the obturator foramen
and attachable about respective ones of the patient's rami. The
anchor portions will have a width ranging from between 0.5-4 cm and
the length ranging from at least 5.0 cm to 45.0 cm. To the extent
necessary, both the support and anchor portions of the implant may
be surgically fashioned as necessary to optimize sizing and
configuration of the implant to suit the needs of a specific
patient.
[0012] In certain embodiments of the implant of the present
invention, the same may take the form of implants having a central
support structure with anchoring portions extending therefrom in
opposed directions or may be fashioned to have generally "H",
inverted "U", or "X" shapes. The implants may further be provided
as generally rectangular, square or trapezoidal shapes and may
further be provided with one or more apertures to accommodate the
attachment of sutures, surgical tacks and the like. The implants of
the present invention may further be fabricated such that sutures
are pre-attached thereto, per the teachings of Applicants' co-owned
pending U.S. patent application Ser. No. 10/947,182, entitled
READILY IMPLANTABLE SLING, filed Sep. 22, 2004, the teachings of
which are expressly incorporated by reference. The implants of the
present invention may further be fabricated from any of a variety
of surgically compatible materials well-known in the art, including
synthetic materials, such as synthetic mesh and the like, as well
as natural materials, such as harvested tissues from sources such
as animals, cadavers or the patient himself. The implants may
further be fabricated such that the same are formed from
combinations of materials, including but not limited to
combinations of different types of synthetic materials,
combinations of different types of natural tissues and/or
combinations of both synthetic and natural tissues.
[0013] Regardless of the embodiment, in all procedures involving
the implantation of the implants of the present invention, such
procedures are performed with the patient assuming a lithotomy
position. A vertical perineal incision is made in the midline
dissecting to expose the bulbar urethra and the inferior aspect of
the descending rami bilaterally. A surgical introducer is utilized
to introduce the implant into position, typically through the
obturator foramen, in manner that is substantially easier and less
traumatic than conventional surgical procedures utilized to access
and implant slings for the treatment of male incontinence. Once the
surgical site is accessed and the anchoring portion will preferably
be positioned through the obturator foramen and anchored into
position. Surgical sutures and the like may be deployed to
facilitate anchoring of the anchor portions of the implant. Minor
variations well-known to those skilled in the art may necessarily
be made to effectuate optimal attachment and positioning of the
support portion of the implant, as may be necessary for a given
patient. In all cases, however, the surgical procedures and
implants of the present invention provide a radically more
efficient, effective and less traumatic surgical approach to the
treatment of male incontinence.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] These and other features and advantages of the various
embodiments disclosed herein will be better understood with respect
to the following description and drawings, in which like numbers
refer to like parts throughout.
[0015] FIG. 1 is a frontal perspective view of a pelvis, a bladder
and a urethra extending therefrom with a sling-type implant shown
operatively secured into position, the implant having a support
portion aligned at or distal to the bulbar urethra and anchoring
portions, the latter shown extending through the obturator foramen
and secured about dedicated ones of the rami of each hip bone.
[0016] FIG. 2 is a side perspective view of the pelvis and implant
of FIG. 1 showing a respective one of the anchor portions of the
implant secured about the ramus.
[0017] FIG. 3 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with the
present invention.
[0018] FIG. 4 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
[0019] FIG. 5 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
[0020] FIG. 6 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
[0021] FIG. 7 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
[0022] FIG. 8 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
[0023] FIG. 9 is a frontal view of an implant for the treatment of
male urinary incontinence as constructed in accordance with another
embodiment of the present invention.
DETAILED DESCRIPTION
[0024] The above description is given by way of example, and not
limitation. Given the above disclosure, one skilled in the art
could devise variations that are within the scope and spirit of the
invention disclosed herein, including various ways of making and
surgically implanting the implants described herein. Further, the
various features of the embodiments disclosed herein can be used
alone, or in varying combinations with each other and are not
intended to be limited to the specific combination described
herein. Thus, the scope of the claims is not to be limited by the
illustrated embodiments.
[0025] Referring now to the drawings, initially to FIG. 1, there is
shown an implant 10 for the treatment of male incontinence that is
operative to provide suburethral support to thus prevent the
leakage of urine, particularly when the patient experiences a
provocative event. In this respect, the implant 10 is operative to
act as a sub urethral sling, as is known in the art, but is
advantageously operative to be more easily secured into position
than prior art sling implants. The implants of the present
invention are further capable of being deployed in a manner that is
far less traumatic than prior art sling implants and methods of
surgically implanting the same, and further utilizing novel
attachment approach that provides for optimal suburethral
positioning of the sling 10 in an exceptionally secure manner
without the use of bone anchors.
[0026] In its broadest sense, the implants of the present invention
comprise the combination of a urethral support portion and at least
one anchoring portion. The support portion is operatively
positioned at or distal to the bulbar urethra. The anchoring
portion is operative to secure the support portion into position to
thus provide structural support to the urethra, and particularly so
during the occurrence of a provocative event. To achieve that end,
the anchoring member is generally operative to extend through the
obturator foramen and become secured at at least one and preferably
both of the patient's rami. In preferred embodiments of the
invention, discussed more fully below, the anchor portion will be
operatively interconnectable with the descending ramus of one of
the patient's pelvis. Advantageously, the positioning of the anchor
portion against the descending ramus will be accomplished without
the use of bone screws, which are well-known in the art to be
problematic to deploy and utilized as an attachment point for
sutures and the like.
[0027] The implants of the present invention further may take a
variety of embodiments. In certain of the embodiments depicted, the
implant will include first and second attachment portions extending
from the support portion with each attachment portion being
operatively extensible through the obturator foramen and attachable
to respective ones of the patient's descending rami. Such
attachment portions may be operative to extend in opposed
directions from the support portion or, alternatively, extend in
generally parallel relation to one another from the support
portion. In certain other embodiments, the support portion
anchoring portion may be formed as a continuous segment or
otherwise formed to have a generally rectangular or trapezoidal
shape. Moreover, in certain embodiments, the implants of the
present invention may incorporate the use of sutures or with other
types of surgically implantable structures and the like to
facilitate attachment of the same into position. Specifically, it
is contemplated that such embodiments may rely upon a combination
of structures in combination with certain portions of the implant
to facilitate attachment and positioning thereof.
[0028] For purposes of defining the general parameters of implants
of the present invention, it is presently believed that the support
portion of the implant will define a surface area ranging from a 1
cm width by 2 cm length to an 8 cm width by 8.0 cm length. With
respect to the anchor portion, the same will preferably define a
surface area defined by a 0.5 cm width by 5.0 cm length to an area
defined by a 4.0 cm width to a 45.0 cm length. With respect to the
latter, it should further be understood that certain embodiments of
the present invention, discussed more fully below, sutures may be
utilized in operative combination with the anchoring portion or, in
certain embodiments, exclusively with the support portion, to thus
define means for attaching and securing the implant into
position.
[0029] With respect to the fabrication of the implants of the
present invention, the same may be made from either synthetic
materials, such as surgical mesh and the like, natural tissues,
such as tissues harvested from either an animal, cadaverous source
or the patient himself, and/or combinations of synthetic and
natural materials. Along these lines, it is contemplated that the
implants of the present invention can be fabricated consistent with
those methods disclosed in Applicant's co-owned and co-pending U.S.
patent application Ser. No. 10/684,861, the teachings of which are
expressly incorporated herein by reference. Along these lines, it
is further contemplated that in certain embodiments of the present
invention, the implants may be prefabricated with slings or sutures
attached thereto, consistent with the teachings of Applicants'
co-owned pending U.S. patent application Ser. No. 10/947,182,
entitled READILY IMPLANT ABLE SLING, the teachings of which are
likewise incorporated by reference.
[0030] Bearing the foregoing principles in mind, a detailed
explanation is provided herebelow with respect to the structure,
properties and functioning of the implants of the present
invention. Referring again to FIG. 1, the implant 10 is situated
such that the support portion 12 thereof is operatively positioned
over the urethra. The implant 10 as depicted includes first and
second support portions 14, 16 that are shown extending through the
obturator foramen 18 and wrapped about dedicated ones of the
descending rami 20, 22 of hip bones 24, 26, respectively.
[0031] FIG. 2 more clearly depicts such engagement between a
respective one of the anchor portions 14 as extending through the
obturator foramen 18 and engaged with descending ramus 20 of hip
bone 24. In this regard, the implants of the present invention
generally operate on the principle of including attachment of the
implant into position via an anchoring mechanism that extends
through the obturator foramen and becoming secured to at least one,
and preferably both of the descending ramus of the patient;
however, it should be understood that the descending ramus locus is
not to limit the scope of the present invention and that attachment
to any part of the periphery of the pubis and ischium may be
considered suitable areas to which the implants of the present
invention may be attached. Accordingly, fixation of the anchor
portions at the descending rami or any other structure should not
be deemed limiting in any respect.
[0032] Bearing the foregoing principles in mind, and referring now
to remaining FIGS. 3-9, there are shown various embodiments of the
implants of the present invention. Referring initially to FIG. 3,
implant 300 is defined by support portion 302 with anchor portions
304, 306 extending in opposed directions therefrom. According to a
preferred embodiment, support portion will have a width "A" of
approximately 4 cm and a length "B" of approximately 6 cm. Anchor
portions 304, 306 may extend from support portion 302 via a tapered
segment, as shown, and will have a length "C" of approximately 15
cm and a width "D" of approximately 2 cm. As discussed above, the
implant 300 may be fabricated from either synthetic and/or natural
materials. It should be understood, however, that the specific
dimensions provided herein are not absolute, and variations in the
length and width of both the support portion 302 and anchor
portions 304, 306 can be readily made by those skilled in the art.
Along these lines, it should be understood that the specific
dimensions provided herein can vary by 50% or substantially
greater, as discussed above, and retain its ability for use as an
implant.
[0033] With respect to the procedure for implanting the implant 300
depicted in FIG. 3, Applicants believe that the best mode for
performing the same will require the patient to assume a lithotomy
position. A vertical perineal incision will be made in the midline
dissecting to expose the bulbar urethra in the inferior aspect of
the descending rami bilaterally. A suitable introducer is then
passed from inside out or outside in through the upper aspect of
the obturator foramen. A suture that is attached to a respective
one of the anchor portions 304 or 306 is threaded through the
introducer. The introducer is then retracted and the suture is
pulled until a respective one of the ends of the anchor portion 304
or 306 to which the suture is attached can be grasped. The support
portion 302 is then carried over the bulbar urethral complex and,
thereafter, a second introducer is passed from inside out or
outside in on the contra-lateral side to thus enable the second
other respective anchor portion extends through the obturator
foramen. The second introducer is then retracted and a suture
affixed to the respective other anchor portion extends around the
pubic ramus. Once so positioned, tension is introduced to the
implant 300 such that the support portion 302 thereof achieves
optimal suburethral compression. The respective ends of anchor
portions 304, 306 are then secured, preferably via attachment to
support portion 302 at the edge of each pubic ramus. To achieve
that end, it is contemplated that a suture with or without an
additional tensioning disc (not shown) is passed through anchor
portions 304, 306 to effectuate such attachment.
[0034] Referring now to FIG. 4, there is shown a further embodiment
400 for use in the surgical treatment of male urinary incontinence.
As depicted, the implant 400 includes a support portion 402 with
first and second anchor portions 404, 406 depending therefrom in
generally parallel relation to one another and additional anchor
portions 404a, 406a, ascending therefrom to define an "H" shape.
The implant 400, as depicted, is preferably formed such that
support portion 402 has a width "F" of approximately 7 cm and a
height "G" of approximately 5 cm. Anchor portions 404, 406
preferably have a length "H" of approximately 30 cm and a width "I"
of 1 cm. Additional anchor portions 404a, 406a will have a width of
approximately 1.5 cm and a height "J" of approximately 14 cm, and
may preferably be formed as extensions of 404 and 406,
respectively. Again, such dimensions can be varied as may be deemed
appropriate by one skilled in the art.
[0035] In the embodiment depicted, anchor portions 404, 406 are
operative to extend through the retropubic space, from posterior to
symphysis, or may extend via a trans obturator route. Anchor
portions 404a, 406a are operative to pass through the rectus fascia
from anterior to symphysis.
[0036] Per the best mode discussed above with respect to implant
300, the surgical procedure for implanting implant 400 will
preferably be conducted with the patient assuming a lithotomy
position whereby a vertical perineal incision will be made in the
midline dissecting to expose the bulbar urethra in the descending
pubic rami bilaterally. The bulbar spongiosis will be left intact.
Thereafter, suprapubic transverse incisions of approximately 1 cm
are made, 3 cm lateral to the midline on either side. A suitable
introducer is then passed from such incisions and tunneled
superficially anterior to the pubic symphysis (not retropubically)
and caused to exit through the initial perineal incision. A
respective one of the ascending anchor portions 404a or 406a is
attached to a suprapubic introducer and pulled through the
suprapubic incisions. This same maneuver is then repeated for the
respective other ascending anchor portion 404a or 406a.
[0037] Hereafter, two new incisions, which are preferably
approximately 1 cm above the pubic symphysis are performed. The
suitable introducer is then passed from above, retropubically, and
out through the initial perineal incision. A respective one of the
descending anchor portions 404 or 406 is then attached to the
introducer and pulled up through such newly formed incision. Such
procedure is repeated with respect to the other descending anchor
portion 404 or 406, which as a consequence creates two sets of
anchor portions, namely, descending anchor portions 404, 406 and
ascending portions 404a, 406a in the suprapubic region. The
ascending anchor portions 404a, 406a are then tunneled into the
retropubic anchor portions 404, 406 beneath the skin and thereafter
ascending portion 404a will be surgically connected with descending
portion 404 and ascending portion 406a surgically attached to
descending anchor portion 406. To achieve such surgical attachment,
it is contemplated that such attachment may be attained via the use
of sutures.
[0038] In a further refinement of such procedure, it is
contemplated that surgical positioning of descending anchor
portions 404, 406 can be accomplished via the use of a suitable
introducer that is passed from outside in or inside out through the
obturator foramen. A suture that is attached to the distal most end
of respective one of anchor portions 404, 406 will be threaded to
the introducer. Once the introducer is advanced through the
obturator foramen, the same is retracted with the suture affixed to
the end of descending anchor portion 404 or 406 is pulled until the
end of the anchor portion 404 or 406 can be grasped. A second
suitable introducer is utilized with respect to the surgical
positioning of the respective other anchor portion 404 or 406 on
the contra-lateral side. Once so positioned, anchor portions 404
and 406 can be affixed to ascending anchor portions 404a, 406a
around the descending rami via the transobturator approach and
secured on itself via a suture line.
[0039] Referring now to FIG. 5, there is shown a further embodiment
of an implant 500 falling within the scope of the present
invention. As depicted, the implant includes a support portion 502
and first and second support portions 504, 506 depending therefrom
in generally parallel relation to define an inverted U-shape. The
support portion 502 further includes first and second apertures
508, 510 formed thereon through which dedicated sutures 512, 514
extend therethrough. The implant 500 is preferably fashioned such
that the support portion 502 has a length "K" of approximately 8 cm
and a height "L" of approximately 4 cm. Each respective anchor
portion 504 will preferably have a length "M" of approximately 45
cm in length and a width "N" of approximately 1 cm in length.
Again, the dimensions of such implant can vary as will be
understood by those skilled in the art.
[0040] With respect to the implantation of the implant 500, the
same is again performed with the patient assuming lithotomy
position. A vertical perineal incision is made in the midline
dissecting to expose the bulbar urethra and the descending rami
bilaterally leaving the bulbar spongiosis intact. One centimeter
suprapubic transverse incisions are made 3 cm laterally to the
midline on either side. A suitable introducer is then passed from
this "stab wound" and tunneled superficially anterior to the pubic
symphysis (not retropubically) that exits through the initial
perineal incision. A respective one of the sutures 512 or 514 is
attached to the introducer and pulled through the upper "stab"
incision. This same procedure is repeated on the respective other
side with respective other suture 512 or 514. Respective ones of
the sutures 512, 514 are tied down to the rectus fascia in the
suprapubic area.
[0041] A suitable introducer is then passed from outside in or
inside out through the obturator foramen. A suture that is attached
to a respective one of the anchor portions 504 or 506 on one side
is threaded through such introducer. The introducer is retracted
and the suture is pulled until the respective one of the ends of
either 504, 506 (depending on which portion is attached) can be
grasped. The same procedure is repeated with respect to the other
anchor portion 504 or 506 whereby a second introducer is passed
from outside in or inside out on the contra-lateral side. Both free
ends of anchor portions 504 or 506 will be overlapped and secured.
Along these lines, such anchor portions 504, 506 will be tied
around the descending rami via a trans obturator approach and thus
secured to itself via a suture.
[0042] In a variation of the embodiment and procedure discussed
above with respect to implant 500, it is contemplated that as
opposed to the use of apertures 508, 510 with dedicated suture
lines 512 and 514 affixed thereto, the implant 500 may utilize
thumb tack-like anchors (not shown) in the positions of 508 and
510, respectively. Such embodiment will further preferably include
a support portion 502 that has a width "K" of 7 cm as opposed to 8
cm.
[0043] To implant such embodiment, the patient will assume a
lithotomy position and a vertical perineal incision will be made in
the midline dissecting to expose the bulbar urethra and descending
rami bilaterally leaving the bulbar spongiosis intact. The support
portion 502 will be attached via these thumb tacks positioned where
apertures 508 and 510 are depicted, respectively, on each side of
the upper aspect of the descending rami close to the pubic
symphysis.
[0044] A suitable introducer is then passed from outside in or
inside out through the obturator foramen. A suture that is attached
to a respective distal-most end of one of the anchor portions 504
or 506 is threaded through the introducer. The introducer is then
retracted and the suture is pulled until the distal-most end of a
respective one of one of the anchor portions 504 or 506 can be
grasped. This portion of a respective one of the anchor portions is
wrapped around the ramus and tied down to the support portion. A
second introducer is passed from outside in or inside out on the
contra-lateral side and the process is repeated with respect to the
respective other anchor portion 504 or 506. The support portion 502
is then tacked down at the upper aspect of the descending rami. The
anchor portions 504, 506 are then tied around the descending rami
via the trans obturator approach and then secured on itself via
suture attachment.
[0045] Referring now to FIG. 6, a further implant 600 is depicted.
As illustrated, the implant 600 comprises a generally rectangular
implant defining a middle support portion 602 with anchor portions
604, 606 formed integral therewith and defining first and second
opposed ends. According to such implant, the same will preferably
be formed to have a length "O" of approximately 45 cm and a width
"P" of approximately 3 cm.
[0046] To implant such embodiment 600, a vertical perineal incision
is made in the midline dissecting to expose the bulbar urethra and
the inferior aspect of the descending rami bilaterally while the
patient assumes a lithotomy position. A suitable introducer is
passed from outside in or inside out through a 3 cm groin incision
that is chosen with the finger in the initial perineal incision to
pass through the obturator foramen. A respective end 604 or 606
that is attached to the introducer tip and advanced within the
perineal incision. The introducer is retracted through the
obturator foramen with the respective other end 604 or 606 being
grasped at the lateral groin incision site and cut at skin level.
The opposite end 604 or 606 is carried over the bulbar urethral
complex. A second suitable introducer is passed from outside in or
inside out through another 3 cm groin incision on the
contra-lateral side and the process is repeated. The respective
ends 604 and 606 of the implant 600 are cut at the level of the
skin at the groin incisions.
[0047] The implant in embodiment 700 depicted in FIG. 7 assumes a
generally rectangular configuration having a width "Q" of 4 cm and
a height "R" of 3 cm. Per the other embodiments, the implant is
preferably secured into position by making a vertical perineal
incision to the midline dissecting to expose the bulbar urethra and
the inferior aspect of the descending rami bilaterally while the
patient assumes a lithotomy position. A suture secured on a UR-6
needle is then used to bite into the periosteum of the descending
rami bilaterally. Although not shown, there will be four sutures
altogether on each side for a total of 8 secured knots to fix the
implant 700 into position. The lower three sutures on one side are
threaded through the implant, which is placed as high as possible
on the bulbar urethral complex. Such lower three sutures are
loosely held to stabilize the sling and the top apical suture is
then placed, one on each side at the junction of the descending
rami to the pubic symphysis. The apical sutures are tied down as
tight as possible. The three lower sutures are then tied down
accordingly on each side.
[0048] In the further embodiment depicted in FIG. 8, the implant
800 assumes a generally trapezoidal having an upper length "S" of
approximately 4 cm, a lower length "T" of approximately 6 cm and a
height "U" of approximately 3 cm. Such implant is secured in
position via the initial formation of a vertical perineal incision
that is made in the midline dissecting to expose the bulbar urethra
and the descending rami bilaterally leaving the bulbar spongiosis
intact. The implant 800, which will further preferably have access
holes 804 formed thereon, is then placed over the bulbar urethra
complex. A fine drill, such as many of a variety well-known to
those skilled in the art, is then advanced through each of the
holes 804 to secure a preloaded suture. The four sutures that will
extend through dedicated ones of the apertures 804 are tied along
side of the lateral aspects of the implant 802 to create two knots
on each side. The support portion 802 will then be operative to
provide the necessary degree of suburethral support.
[0049] In FIG. 9, there is depicted yet a further embodiment of an
implant 900 useful in the surgical treatment of male urinary
incontinence and falling within the scope of the present invention.
Such implant will preferably have the dimensions of a height "V" of
3 cm and a width of 4 cm, as the same pertains to the urethral
support portion 902. Each anchor portion 904, 906 will preferably
have a length "X" of approximately 20 cm and a width "Y" of 1 cm.
Similar to the embodiment depicted in FIG. 3, such embodiment 900
includes a urethral support portion 902 with two anchor portions
904, 906 extending therefrom in opposed directions. With regard to
the best mode by which Applicants would suggest securing such
implant 900 into position, such surgical procedure would involve
the patient assuming a lithotomy position and, per the other
embodiments discussed above, a vertical perineal incision would be
made in the midline dissecting to expose the bulbar urethral and
the inferior aspect of the descending rami bilaterally. A suitable
introducer would then be passed from inside out or outside in
through the upper aspect of the obturator foramen. An end portion
of a respective one of the anchor portions 904 or 906 is attached
through the introducer. The introducer is retracted and the
respective other end of the respective other anchor portion 904 or
906 is grasped and a ratchet closure is done, as will be understood
by those skilled in the art. Support portion 902 is carried over
the bulbar urethral complex. Thereafter, a second suitable
introducer is passed from inside out or outside in on the
contra-lateral side and the process repeated with respect to the
other respective anchor portion 904, 906. The ends of the sling are
then secured to a square-like portions of the urethral support
portion 902 at the edge of the pubic ramus with a ratchet
closure.
[0050] Additional modifications and improvements of the present
invention may also be apparent to those of ordinary skill in the
art. Thus, the particular combination of parts and steps described
and illustrated herein is intended to represent only certain
embodiments of the present invention, and is not intended to serve
as limitations of alternative devices and methods within the spirit
and scope of the invention. Along these lines, the suggested
surgical implantation techniques with respect to each of the
depicted embodiments simply represents the Applicants' best mode
for practicing the invention. It should be understood, however,
that different surgical approaches may be readily known and
understood by those skilled in the art. In addition, it is
contemplated that future advances in medicine can and will be made
that will facilitate the ability of the implants of the present
invention to be more easily, quickly and accurately secured into
position and operative to achieve the highest degree of favorable
patient outcome. In addition, it is emphasized again that although
dimensions are provided herein with respect to the implants of the
present invention, as well as the choice of materials that may be
utilized as to fabricate the same, it should be understood that any
suitable material useful for fabricating an implant, whether known
now or later developed, should be deemed to fall within the scope
of the present invention.
* * * * *