Title: Tissue anchoring devices, biological vessel suspending devices and systems and methods utilizing same
Abstract: An elastic suspension device is disclosed. The elastic suspension device includes an element including an elastic connector and at least one anchor at an end portion of the connector, the at least one anchor is designed for anchoring the elastic connector to a tissue.
Patent Number: 6,908,473 Issued on 06/21/2005 to Skiba, et al.
| Inventors:
|
Skiba; Jeffry B. (1990 E. Mt. Lemmon Hwy., Oracle, AZ 85623);
Crisp; William E. (6051 Cactus Wren Dr., Paradise Valley, AZ 85253);
Oren; Ran (Kibbutz Gaaton, 25 130 Doar Na Oshrat, IL)
|
| Appl. No.:
|
815003 |
| Filed:
|
March 23, 2001 |
| Current U.S. Class: |
606/198; 600/29; 606/151 |
| Intern'l Class: |
A61B 017/04 |
| Field of Search: |
600/29
|
References Cited [Referenced By]
U.S. Patent Documents
| 3903894 | Sep., 1975 | Rosen et al.
| |
| 3909894 | Oct., 1975 | Muller.
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| 4556050 | Dec., 1985 | Hodgson et al.
| |
| 4708140 | Nov., 1987 | Baron.
| |
| 5019032 | May., 1991 | Robertson.
| |
| 5041093 | Aug., 1991 | Chu.
| |
| 5041129 | Aug., 1991 | Hayhurst et al.
| |
| 5112344 | May., 1992 | Petros.
| |
| 5114398 | May., 1992 | Trick et al.
| |
| 5183464 | Feb., 1993 | Dubrul et al.
| |
| 5269809 | Dec., 1993 | Hayhurst et al.
| |
| 5707357 | Jan., 1998 | Mikhail et al.
| |
| 5792042 | Aug., 1998 | Cohen et al.
| |
| 5899909 | May., 1999 | Claren et al.
| |
Primary Examiner: Jackson; Gary
Attorney, Agent or Firm: G. E. Ehrlich (1995) Ltd.
Parent Case Text
This application claims priority from now abandoned U.S. Provisional Patent
Application No. 60/197,099, filed Apr. 14, 2000.
Claims
1. A tissue anchoring system comprising:
(a) at least one tissue anchoring device including an element having a connector
and at least one inflatable anchor at an end portion of said connector, when inflated
said at least one inflatable anchor is designed for anchoring said connector to
a tissue; and
(b) a biological vessel suspending device being connectable to said at least
one tissue anchoring device; said biological vessel suspending device including
a generally U-shaped element for engaging a biological vessel therein, said U-shaped
element having inner walls being designed and constructed for preventing disengagement
of said biological vessel from said U-shaped element.
2. The tissue anchoring system of claim 1, wherein said inner walls of said biological
vessel suspending device include inflatable elements.
3. The tissue anchoring system of claim 1, wherein said inner walls of said biological
vessel suspending device are formed with ridges and grooves.
4. A tissue anchoring system comprising:
(a) at least one tissue anchoring device including an element having a connector
and at least one anchor being designed for engaging a tissue at an end portion
of said connector, at least a portion of said element being designed and constructed
for dampening a pulling force exerted thereon; and
(b) a biological vessel suspending device being connectable to said at least
one tissue anchoring device; wherein said biological vessel suspending device including
a generally U-shaped element for engaging a vessel therein, said U-shaped element
having inner walls being designed and constructed for preventing disengagement
of said biological vessel from said U-shaped element.
5. The tissue anchoring system of claim 4, wherein said at least one anchor is
an inflatable anchor designed for anchoring said connector to said tissue when inflated.
6. The tissue anchoring system of claim 4, wherein at least a portion of said
connector is constructed of an elastic material capable of elastically complying
to said pulling force.
7. The tissue anchoring system of claim 4, wherein said connector includes a
spring capable of elastically complying to said pulling force.
8. The tissue anchoring system of claim 4, wherein said inner walls of said biological
vessel suspending device include inflatable elements.
9. The tissue anchoring system of claim 4, wherein said inner walls of said biological
vessel suspending device are formed with ridges and grooves.
10. A method of suspending a biological vessel, the method comprising:
(a) anchoring at least one tissue anchoring device within a tissue, said at least
one tissue anchoring device including an element having at least one anchor at
an end portion of said connector, said at least one anchor being designed for anchoring
said connector to a tissue;
(b) engaging the biological vessel within a biological vessel suspending device
being designed and constructed for preventing disengagement of said biological
vessel therefrom; and
(c) connecting said biological vessel suspending device to said at least one
tissue anchoring device thereby suspending the biological vessel.
11. The method of claim 10, wherein said at least one anchor of said at least
one tissue anchoring device is an inflatable anchor designed for anchoring said
connector to a tissue when inflated.
12. The method of claim 10, wherein at least a portion of said element of said
at least one tissue anchoring device is designed and constructed for dampening
a pulling force exerted thereon by said biological vessel suspending device connected thereto.
13. The method of claim 10, wherein at least a portion of said element of said
at least one tissue anchoring device is composed of an elastic material capable
of complying to a pulling force exerted on said element by said biological vessel
suspending device connected thereto.
14. The method of claim 10, wherein said biological vessel suspending device
is further designed and constructed capable of partially obstructing a flow through
said biological vessel when engaged within said biological vessel suspending device.
15. The method of claim 10, wherein said biological vessel suspending device
includes a generally U-shaped element having inner walls being designed and constructed
for preventing disengagement of said biological vessel from said U-shaped element.
16. The method of claim 10, wherein the biological vessel is the urethra.
17. The method of claim 10, wherein said inner wails include inflatable elements.
18. The method of claim 17, wherein a degree of inflation of said inflatable
elements determines a flow through said biological vessel.
19. The method of claim 10, wherein said inner walls are formed with ridges and grooves.
20. An assembly useful for accurately positioning a bladder neck and/or urethra
prior to a surgical suspension thereof, the assembly comprising:
(a) at least one target marker positionable at an abdominal skin region;
(b) a saddle shaped element for engaging the bladder neck or urethra; and
(c) at least one connecting element being for attaching said saddle shaped element
to said at least one target marker thereby positioning said saddle shaped element
relative to said at least one target marker and enabling accurate positioning of
the bladder neck and/or urethra when engaged by said saddle shaped element.
21. The assembly of claim 20, wherein said at least one connecting element is
designed and constructed to enable modifying a distance between said at least one
target marker and said saddle shaped element when interconnected thereby.
Description
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to tissue anchoring devices and biological vessel
suspending devices and to systems and methods utilizing same, which can be used,
for example, in treating urinary incontinence associated with abnormal bladder positioning.
Urinary incontinence is characterized by the involuntary loss of urine in
individuals. Urinary incontinence affects approximately 13 million people in the
United States alone, 85% of them women. Urinary incontinence can be caused by physical
stress (stress incontinence) typically brought on by heavy object lifting, coughing,
laughing or sneezing, an overactive bladder (typically referred to as urge incontinence)
or by an uncontrollable slow leak which is termed flow incontinence, and which
is often experienced when complete bladder emptying can not be achieved by an individual.
Additional but less common types of urinary incontinence include functional incontinence
and unconscious or reflex incontinence.
Of the above causes for urinary incontinence, stress incontinence and urge incontinence
are considered the most prevalent. Stress incontinence can be caused by anatomic
abnormalities in the positioning of the bladder or bladder neck or by sphincter
dysfunction. Urine loss occurs when the intravesical pressure (i.e., the pressure
within the urinary bladder) exceeds, even by a small amount, the maximum urethral
pressure (i.e., the pressure on the urethra to maintain closure). While the problem
of stress incontinence occurs in both men and women, it predominantly occurs in
women of childbearing age and beyond.
There are several methods and devices which can be used to alleviate involuntary
loss of urine in people suffering from incontinence. Surgery is perhaps the most
desirable method in cases of severe incontinence in younger patients. The surgical
alternative often involves a procedure whereby the bladder neck is suspended such
that the bladder assumes a normal position.
For severe cases of stress incontinence, the surgeon may secure the bladder with
a wide sling positioned under the urethra. Such a sling supports the bladder and
in addition compresses the bottom of the bladder and the top of the urethra, further
preventing leakage.
Abdominal Suspension Procedures
One abdominal suspension procedure is the Marshall Marchetti Krantz (MMK) procedure
which is still offered in many medical centers throughout the United States although
it is no longer the method of choice.
In the MMK procedure, the bladder neck and urethra are separated from the back
surface of the pubic bone. Sutures are placed on either side of the urethra and
bladder neck, which are then elevated to a functional position. The free ends of
the sutures are anchored to the surrounding cartilage and pubic bone.
The Burch procedure, also known as Burch colposuspension (vaginal suspension),
is often performed in conjunction with an invasive surgical procedure such as abdominal
hysterectomy (removal of the uterus). During the suspension procedure, sutures
are placed laterally (sideways), thus avoiding urethral obstruction and allowing
the physician to repair any small cystoceles that may be present. The bladder neck
and urethra are separated from the back surface of the pubic bone and the bladder
neck is then elevated via lateral sutures that pass through the vagina and Cooper's
(pubic) ligaments. The vaginal wall and ligaments are brought together without
tension, and the sutures are tied.
Needle Suspension
Needle suspension procedures are simpler to perform and are less invasive
than abdominal suspension procedures. Numerous types of transvaginal (through the
vagina) needle suspension procedures are known in the art.
In transvaginal needle suspension procedures, sutures are placed blindly through
the pubic skin or via a vaginal incision into the anchoring tissues on each side
of the bladder neck. The bladder neck is then supported by the sutures, which are
tied to the fascia (fibrous tissue) or the pubic bone. Operative times and recovery
periods are typically shorter in needle suspension techniques as compared to abdominal
suspension procedures.
To enhance tissue anchoring, some needle suspension techniques employ bone anchors
such as those provided by the Vesica™ and Intac/Infast™ bladder suspension kits.
Sling Procedures
Patients with severe stress incontinence and intrinsic sphincter deficiency
(Type III SUI or weakening of the urethra muscle) may not be treatable via the
suspension procedures described hereinabove. Such individuals are good candidates
for a pubovaginal sling procedure, which can create the urethral compression necessary
to achieve bladder control.
This technique involves the creation of a sling from a strip of tissue taken
from the patient's abdominal fascia (fibrous tissue); occasionally, surgeons use
a synthetic sling, although urethral erosion appears to be more common when synthetic
slings are used.
The strip of fascia is obtained via an incision above the pubic bone. Another
incision is made in the front of the vaginal wall, through which the surgeon can
grasp the sling and adjust its tension around the bladder neck. The sling is secured
in place by sutures which are loosely tied to each other above the incision in
the pubic fascia, thus providing a hammock for the bladder neck to rest in.
The pubovaginal sling procedure generally results in high success rates, with
bladder control lasting more than 10 years, although complications such as accidental
bladder injury, wound infections and prolonged urinary retention severely limit
the effectiveness of this technique.
The Vesica™ sling procedure employs two small anchors which are secured
into the pubic bone in order to provide stable fixation for a synthetic or natural
tissue sling which functions in supporting the urethra, bladder neck and sphincter.
The Precision Tack™ transvaginal anchor system also employs bone anchors
which are secured into the backside of the pubic bone via a minimally invasive
procedure. These anchors are connected to a sling via sutures, which sling then
functions like a hammock, to support the bladder in a functional position.
Although the above described surgical procedures provide solutions to individuals
suffering from urinary incontinence, such procedures suffer from several inherent
limitations as follows: (i) the use of pubic bone anchors creates a potential for
osteitis-pubis; (ii) the use of slings and anchors oftentimes does not improve
the intra-urethral pressure differential and as such does not address voiding problems;
(iii) suspensions may create the potential for residual urine in the bladder; (iv)
improper tensioning of supporting sutures may cause urethral obstruction thus making
self-catheterization or additional surgical intervention necessary; (v) most of
these procedures require hospitalization; and (vi) surgical procedures which utilize
sutures/anchors which are secured to soft tissue or bone do not stretch as the
bladder neck angle changes during voiding thus not allowing a correct bladder neck
angle when voiding and in addition create a strain upon the supported tissue which
can lead to tissue damage and/or support failure.
These limitations of prior art suspension techniques are the major causes underlying
a reported 50 to 60% failure rate which is observed therewith following 3 years
of service.
In addition, limitations inherent to bladder neck/urethra positioning techniques
used by surgeons prior to or during a surgical suspension technique often lead
to bladder neck mis-positioning and reduced bladder function.
There is thus a widely recognized need for, and it would be highly advantageous
to have, a tissue anchoring device and a biological vessel suspending device which
can be utilized for bladder suspension while being devoid of the above limitations.
In addition, there is also a widely recognized need for, and it would be also highly
advantageous to have, a bladder positioning assembly and a method utilizing same
which can be used to correctly position the bladder neck and/or urethra prior to
a surgical suspension thereof.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a tissue
anchoring device, comprising an element including a connector and at least one
inflatable anchor at an end portion of the connector, when inflated the at least
one inflatable anchor is designed for anchoring the connector to a tissue.
According to another aspect of the present invention there is provided
a tissue anchoring system comprising: (a) a tissue anchoring device including an
element having a connector and at least one inflatable anchor at an end portion
of the connector, when inflated the at least one inflatable anchor is designed
for anchoring the connector to a tissue; and (b) a guide being detachably attached
to the tissue anchoring device, the guide being for inserting and positioning the
tissue anchoring device within the tissue.
According to yet another aspect of the present invention there is provided
a tissue anchoring system comprising: (a) at least one tissue anchoring device
including an element having a connector and at least one inflatable anchor at an
end portion of the connector, when inflated the at least one inflatable anchor
is designed for anchoring the connector to a tissue; and (b) a biological vessel
suspending device being connectable to the at least one tissue anchoring device.
According to further features in preferred embodiments of the invention
described below, at least a portion of the element is designed and constructed
for dampening a pulling force exerted thereon.
According to still further features in the described preferred embodiments
the inflatable anchor is designed and constructed for dampening a pulling force
exerted on the element.
According to still another aspect of the present invention there is provided
a tissue anchoring device, comprising an element including a connector and at least
one anchor being designed for engaging a tissue at an end portion of the connector,
at least a portion of the element being designed and constructed for dampening
a pulling force exerted thereon.
According to an additional aspect of the present invention there is provided
a tissue anchoring system comprising: (a) a tissue anchoring device including an
element having a connector and at least one anchor being designed for engaging
a tissue at an end portion of the connector, at least a portion of the element
being designed and constructed for dampening a pulling force exerted thereon; and
(b) a guide being detachably attached to the tissue anchoring device, the guide
being for inserting and positioning the tissue anchoring device within the tissue.
According to yet an additional aspect of the present invention there is
provided a tissue anchoring system comprising: (a) at least one tissue anchoring
device including an element having a connector and at least one anchor being designed
for engaging a tissue at an end portion of the connector, at least a portion of
the element being designed and constructed for dampening a pulling force exerted
thereon; and (b) a biological vessel suspending device being connectable to the
at least one tissue anchoring device.
According to still further features in the described preferred embodiments
the at least one anchor is an inflatable anchor designed for anchoring the connector
to the tissue when inflated.
According to still further features in the described preferred embodiments
at least a portion of the connector is composed of an elastic material capable
of elastically complying to a pulling force exerted upon the element.
According to still further features in the described preferred embodiments
the connector includes a spring capable of elastically complying to a pulling force
exerted upon the element.
According to still an additional aspect of the present invention there
is provided a biological vessel suspending device comprising a generally U-shaped
element for engaging a biological vessel therein, the U-shaped element having inner
walls being designed and constructed for preventing disengagement of the biological
vessel from the U-shaped element.
According to still further features in the described preferred embodiments
the inner walls include inflatable elements.
According to still further features in the described preferred embodiments
the inner walls are formed with ridges and grooves.
According to still further features in the described preferred embodiments
the inner walls are further designed and constructed capable of at least partially
obstructing a flow through the biological vessel when engaged in the generally
U shaped element.
According to still further features in the described preferred embodiments
the biological vessel suspending device further comprising at least one connector
forming a part of, or being attached to, the generally U-shaped element, the at
least one connector being for connecting the biological vessel suspending device
with a tissue anchoring device.
According to still further features in the described preferred embodiments
a degree of inflation of the inflatable elements determines a flow through the
biological vessel.
According to a further aspect of the present invention there is provided
a method of suspending a biological vessel, the method comprising the step of:
(a) anchoring at least one tissue anchoring device within a tissue, the at least
one tissue anchoring device including an element having at least one anchor at
an end portion of the connector, the at least one anchor being designed for anchoring
the connector to a tissue; (b) engaging the biological vessel within a biological
vessel suspending device being designed and constructed for preventing disengagement
of said biological vessel therefrom; and (c) connecting the biological vessel suspending
device to the at least one tissue anchoring device thereby suspending the biological vessel.
According to still further features in the described preferred embodiments
the at least one anchor of the at least one tissue anchoring device is an inflatable
anchor designed for anchoring the connector to a tissue when inflated.
According to still further features in the described preferred embodiments
at least a portion of the element of the at least one tissue anchoring device is
designed and constructed for dampening a pulling force exerted on the element by
said biological vessel suspending device connected thereto.
According to still further features in the described preferred embodiments
at least a portion of the element of the at least one tissue anchoring device is
composed of an elastic material capable of complying to a pulling force exerted
on the element by the biological vessel suspending device connected thereto.
According to still further features in the described preferred embodiments
the element of the at least one tissue anchoring device includes a spring capable
of complying to a pulling force exerted on the element by the biological vessel
suspending device connected thereto.
According to still further features in the described preferred embodiments
the inner walls of the biological vessel suspending device are further designed
and constructed capable of partially obstructing a flow through the biological
vessel when engaged within the generally U shaped element.
According to still further features in the described preferred embodiments
the biological vessel is the urethra or the bladder neck.
According to still further features in the described preferred embodiments
the inner walls include inflatable elements.
According to still further features in the described preferred embodiments
the inner walls are formed with ridges and grooves.
According to still further features in the described preferred embodiments
a degree of inflation of the inflatable elements determines a flow through the
biological vessel.
According to a further aspect of the present invention there is provided
an assembly useful for accurately positioning a bladder neck and/or urethra prior
to a surgical suspension thereof, the assembly comprising: (a) at least one target
marker positionable at an abdominal skin region; (b) a saddle shaped element for
engaging the bladder neck or urethra; and (c) at least one connecting element being
for attaching the saddle shaped element to the at least one target marker thereby
positioning the saddle shaped element relative to the at least one target marker
and enabling accurate positioning of the bladder neck and/or urethra when engaged
by the saddle shaped element.
According to still further features in the described preferred embodiments
the at least one connecting element is designed and constructed to enable modifying
a distance between the at least one target marker and the saddle shaped element
when interconnected thereby.
The present invention successfully addresses the shortcomings of the presently
known configurations by providing a tissue anchoring device and a biological vessel
supporting device, and systems and methods utilizing same for effecting tissue
to tissue anchoring.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to
the accompanying drawings. With specific reference now to the drawings in detail,
it is stressed that the particulars shown are by way of example and for purposes
of illustrative discussion of the preferred embodiments of the present invention
only, and are presented in the cause of providing what is believed to be the most
useful and readily understood description of the principles and conceptual aspects
of the invention. In this regard, no attempt is made to show structural details
of the invention in more detail than is necessary for a fundamental understanding
of the invention, the description taken with the drawings making apparent to those
skilled in the art how the several forms of the invention may be embodied in practice.
In the drawings:
FIG. 1 illustrates a tissue anchoring device according to one embodiment of
the present invention;
FIGS. 2
a-b illustrate positioning (FIG. 2
a) and anchoring (FIG.
2
b) of the tissue anchoring device of FIG. 1;
FIG. 3 illustrates the tissue anchoring device of FIG. 1 attached to a positioning
guide according to the present invention;
FIGS. 4
a and 4
b illustrate various connector ends of the
tissue anchoring device of the present invention;
FIG. 5
a illustrates a biological vessel supporting device according to
one embodiment of the present invention;
FIGS. 5
b-c illustrate a biological vessel supporting device according
to another embodiment of the present invention showing the inflatable vessel engagement
elements in a deflated (FIG. 5
b) and an inflated (FIG. 5
c) configuration;
FIG. 6 is a perspective view of an assembly for positioning the bladder neck
and/or urethra in preparation for a surgical suspension procedure according to
the present invention as positioned in relation to the bladder, pubis and surrounding
tissue; and
FIGS. 7-8 illustrate tissue piercing (FIG. 7) and anchor positioning (FIG.
8) as guided by the saddle shaped element of the assembly illustrated in FIG. 6.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is of a tissue anchoring device and a biological vessel
supporting device and of systems and methods utilizing same. Specifically, the
present invention can be used to anchor tissue to tissue while allowing tissue
compliance and reducing forces applied to the tissue, thus reducing the risk of
tissue damage and/or anchoring failure.
The principles and operation of the present invention may be better understood
with reference to the drawings and accompanying descriptions.
Before explaining at least one embodiment of the invention in detail, it is
to be understood that the invention is not limited in its application to the details
of construction and the arrangement of the components set forth in the following
description or illustrated in the drawings. The invention is capable of other embodiments
or of being practiced or carried out in various ways. Also, it is to be understood
that the phraseology and terminology employed herein is for the purpose of description
and should not be regarded as limiting.
Referring now to the drawings, FIG. 1 illustrates a tissue anchoring device
in accordance with the teachings of the present invention, which is referred to
hereinbelow as anchoring device
10.
Device
10 includes an element
12 which includes a connector
14 and at least one inflatable anchor
16 which is attached to, or
form a part of a distal portion
18 of connector
14. Preferably connector
14 is tubular in shape having a diameter ranging from several millimeters
to several centimeters and having a length of several centimeters or more depending
on the application of anchoring device
10 and the tissue into which it is anchored.
Anchoring device
10 is typically constructed from one or more biocompatible
polymer such as that utilized in catheters or other intrabody devices and/or any
biocompatible material suitable for use in implants. Preferably, the biocompatible
polymer is selected so as to minimize tissue growth around anchoring device
10,
since, as described in detail hereinbelow, anchoring device
10 is preferably
utilized for predetermined time periods following which removal thereof is preferred.
Inflatable anchor
16 is designed for anchoring connector
14
to a tissue region
20 when inflated. Tissue region
20 can include,
for example, bone or cartilage tissue, muscle tissue and/or connective tissue.
As is shown in FIGS. 2
a-b, inflatable anchor
16, is inflated following
insertion and positioning of anchoring device
10 into tissue region
20.
As is shown in FIG. 3 such insertion and positioning can be facilitated by a
guide
25, which is detachably attached to anchoring device
10 at a proximal
portion
24 thereof.
Preferably, tissue region
20 is pierced prior to insertion of
anchoring device
10 by either guide
24 which in this case includes
a distal end portion adapted for this purpose, or alternatively by a medical device
such as a tissue piercer, a syringe needle or the like.
Alternatively, a distal end
33 of anchoring device
10
can be designed and configured so as to facilitate self insertion thereof into
tissue region
20 without a need for first piercing the tissue.
Once anchoring device
10 is positioned within tissue region
20,
inflatable anchor
16 is inflated via a fluid such as air, gas, or saline,
provided under pressure from, for example, via a syringe
26 (shown in FIG.
1) which, in some configurations, forms a part of guide
25.
The fluid provided from syringe
26 can be utilized to directly inflate
inflatable anchor
16, or alternatively it can be utilized to drive a piston
provided within distal portion
18 of anchoring device
10, which in
turn forces a fluid stored within reservoir
30 into inflatable anchor
16.
In any case, upon inflation, anchor
16 assumes a protruded configuration
(as shown, for example, in FIG. 2
b) which prevents anchoring device
10
from being pulled out of tissue region
20.
Anchoring device
10 of the present invention can be used in tissue
to tissue anchoring including for example, bone to bone, bone to soft tissue and
soft tissue to soft tissue anchoring.
For example, anchoring device
10 of the present invention can be utilized
in a system designed for suspending and positioning a urinary bladder, the abnormal
positioning of which (descended) leads to urinary incontinence in affected individuals.
As such, connector
14 of anchoring device
10 can be adapted for
directly or indirectly connecting to an intrabody organ such as a bladder or to
a biological vessel connected thereto. As is specifically shown in FIGS. 4
a
and
4b for this purpose, proximal portion
24 of connector
14 is configured with holes, ridges and groves and/or various other elements
which facilitate direct or indirect connection to, for example, slings designed
for suspending a urinary bladder.
It will be appreciated that during service, especially when utilized for suspending
a urinary bladder, anchoring device
10 of the present invention is subjected
to considerable pulling forces resultant from movement of the suspended bladder.
Thus, according to another preferred embodiment of the present invention, connector
14 and/or inflatable anchor
16 are designed and constructed for elastically
complying to a pulling force exerted on anchoring device
10 (indicated by
22 in FIG. 2
b). Such elastic compliance results in dampening of the
pulling force as well accommodation, features which are particularly advantageous
as is further detailed hereinbelow.
As used herein, the term "elastically complying" refers to the ability to absorb
(dampen) a force via an elastic structural change.
To enable such elastic compliance, at least a portion of connector
14
is
fabricated from an elastic material such as silicon rubber, PEEK, ultra high molecular
weigh polyethylene (UHMWPE) or Nitinol. Thus, in this case, a pulling force applied
to proximal end
32 of connector
14 would be absorbed, at least in
part, by elastic stretching of at least a portion of connector
14.
The elastic portion of connector
14 can be selected of a material or configuration
allowing for a controlled (e.g., slow) contraction following elastic stretching.
Such controlled contraction can be useful in cases where rapid contraction of the
elastic portion of connector
14 can be damaging to tissues or organs.
Alternatively, such elastic compliance can be effected by a spring
of a shape and composition specifically designed for body tissue implantation.
Such a spring can be fabricated in a cone-like shape such that the wider end can
serve as a tissue anchor while the narrower end can serve as a direct or indirect
point of attachment to a sling.
Additionally or alternatively, inflatable anchor
16 can be configured
such that a pulling force applied to proximal end
32 would be, at least
in part, absorbed by directional and elastic compression of inflatable anchor
16
which at the same time would not substantially reduce the anchoring capabilities thereof.
In any case, such compliance/dampening features provide two important advantages.
A first advantage is the considerable reduction of a force applied upon the anchoring
device
10 and as such a reduced risk of tissue damage and/or anchoring failure.
A second advantage lies with the directional compliance of anchoring device
10
which enables anchoring device
10 to elastically stretch. Such elastic stretching
is especially important in cases where anchoring device
10 is used for suspending
a bladder which requires a certain degree of accommodation to assure correct bladder
neck positioning and thus function at all times.
It will be appreciated that although the use of an inflatable anchor
16
provides several inherent advantages over other anchor configurations, an anchoring
device
10 employing anchors such as, but not limited to, deployable mushroom-like
devices in place of inflatable anchor
16 are also envisaged by the present
invention. Preferably, such anchors are configured capable of dampening a pulling
force applied upon anchoring device
10.
In many surgical cases tissue such as a tendon or ligament needs to be firmly
reattached to a bone from which it was detached. A typical prior art reconstruction
of the area may involve the use of sutures and implantable anchors which are driven
into bone providing an eyelet for reattachment of the detached tissue. Such devices
are commercially available through Johnson & Johnson's Mitek division, Zimmer's
Statac Product Line, and numerous other manufacturers. While these devices may
provide approximation of tissue, they do not address the original compliance of
the tissue and as such surgical repairs are stiff and inflexible. Surgeons opt
to use absorbable sutures which are absorbed over time leaving the compliance of
the site much the same as before the procedure.
Thus, anchoring device
10 of the present invention is also advantageous
for use in cases where some motion in the repaired site is desired.
According to another aspect of the present invention and as specifically
shown in FIGS. 5
a-b there is provided a biological vessel suspending device
which is referred to herein as suspending device
50.
Suspending device
50 includes a generally U-shaped element
52
which acts as a sling for engaging a biological vessel, such as a blood vessel
or a urethra. Inner walls
54 of element
52 are designed and constructed
for preventing disengagement of a biological vessel therefrom.
According to one preferred embodiment of this aspect of the present invention
and as specifically shown in FIG. 5
a, inner walls
54 include grooves
56 and ridges
58 which serve for grasping the biological vessel,
thus preventing disengagement of the biological vessel from suspending device
50.
According to another preferred embodiment of this aspect of the present
invention, and as specifically shown in FIGS. 5
b-c, inner walls
54
include one or preferably several inflatable elements
60. Inflatable elements
60 are designed to forcibly engage the biological vessel when inflated,
thus preventing disengagement of the biological vessel from suspending device
50.
In addition, inflatable elements
60 also serve for controlling the flow
of biological fluid through the biological vessel. For example, inflatable elements
60 can be configured such that when inflated to a predetermined volume they
compress the biological vessel so as to partially or fully constrict flow therethrough.
Thus, the degree of inflation and the number of inflatable elements employed can
be utilized to regulate flow through the biological vessel.
Inflation of inflatable elements
60 can be effected by direct injection
of fluid, such as air or saline, into inflatable elements
60 or injection
ports thereof, via, for example, a syringe. As such, the number of elements
60
inflated and the degree of inflation of each and thus the degree of constriction
on the biological vessel can be effected even following implantation of suspending
device
50.
By using an imaging modality, a treating physician can locate and inflate inflatable
elements
60 using a mildly invasive procedure. For example, ultrasound imaging
can be utilized to locate saline filled inflatable elements
60 which can
then be inflated or deflated using a syringe and needle.
The use of inflatable elements
60 for engaging a biological vessel is
particularly advantageous since it allows a physician to control the force applied
on the vessel while at the same time control fluid flow therethrough. This is especially
true when engaging a urethra for bladder repositioning in incontinence treatment
since it allows a physician to safely and easily suspend the bladder while at the
same time to determine fluid flow through the urethra which is most suitable for
each case.
Suspending device
50 is preferably utilized in conjunction with
sutures and/or tissue anchors in order to provide support to a descended bladder.
Preferably, suspending device
50 is utilized in conjunction with anchoring
device
10 described hereinabove.
In any case, to enable attachment to sutures or anchors, suspending device
50
includes one or more connecting elements
62 which enable direct connection
to suture threads, tissue anchors and the like.
Preferably, connecting elements
62 are configured connectable
with connector
14 of anchoring device
10 described hereinabove.
Thus, the present invention provides a tissue anchoring device and a biological
vessel supporting device each utilizable in various bladder support techniques.
Anchoring device
10 and or suspending device
50 can be inserted
and positioned using trans-vaginal procedures employing, for example, a dedicated
and minimally invasive procedure.
For example, when utilized for supporting a descended bladder, one or more anchoring
devices
10 are inserted into a tissue pre-pierced via a small incision made
by, for example, a hypodermic needle or a sharpened tube, which can also act as
guide
25 described hereinabove. Once in place, anchoring device
10
is anchored and connected to a sling such as suspending device
50 which
engages a biological vessel of interest, such as the urethra. The connection tension
between anchoring device
10 and the sling is then adjusted such that the
bladder is supported in a natural position. In cases where urethral flow control
is necessary, suspending device
50 which includes inflatable elements
60
is preferably utilized. In this case, inflatable elements
60 are inflated
to a desired volume as described hereinabove to thereby set a predetermined flow rate.
In addition to the above application, suspending device
50 and in particular
anchoring device
10 can be utilized for various other applications.
As a body ages and experiences the effects of gravity, tissue compliance is altered
leading to changes in tissue strength and as such support. In some cases this change
in tissue compliance is cosmetic, while in others it alters normal physiological function.
Thus, restoration of tissue compliance and support is another object of the
present invention. For example, the present invention can be utilized in face lift,
brow lift, breast lift and thigh lift procedures as well as for correcting vaginal
prolapse, cystoceal, recticeal, and the like.
Thus, the present invention provides a tissue anchoring device and a biological
vessel suspending and systems and methods utilizing each or both.
It will be appreciated that when utilized in bladder suspension procedures, the
present invention provides numerous advantages over the prior art.
In urinary incontinence, maintenance of the bladder neck angle alone only solves
a part of the problem. The bladder neck angle was originally designed to move with
increased abdominal pressure which forces the urethra/bladder neck down and allows
voiding of the bladder. With most prior art surgical solutions, the ability of
the angle to change with abdominal pressure is lost since most utilized devices
do not provide for compliance.
By enabling compliance through elastic changes, the present invention allows
the
bladder neck angle to move downward with increased abdominal pressure while reducing
the force on the anchored tissue. This unique approach to conditioned tension closely
simulates the natural function of the tissue surrounding the bladder neck/urethra.
An additional limitation which severely affects the success rate of prior art
surgical suspension techniques is the inability of the surgeon to correctly position
the bladder neck and/or the urethra prior to or during a surgical suspension procedure.
Thus, according to another aspect of the present invention and as specifically
shown in FIG. 6, there is provided an assembly useful for positioning the bladder
neck and/or urethra prior to surgical suspension thereof, which is referred to
herein as assembly
100.
Assembly
100 includes one or more (two are shown in FIG. 6) target
markers
102 which are individually positionable upon an abdominal skin region
104. Such positioning can be effected via adhesive backing, suction or the
like as long as target markers
102 remain securely fastened to skin region
104 while being easily (and preferably painlessly) detachable therefrom
following bladder positioning.
Assembly
100 further includes a saddle shaped element
106
(hereinafter saddle
106) for engaging the bladder neck
108 or urethra
110. Such engagement can be effected via an engagement groove
111
optionally provided with the inflatable elements described hereinabove. Groove
111 is constructed so as to securely engage the bladder neck and/or urethra
while being easily detachable therefrom when desired.
Assembly
100 also includes at least one connecting element
112
which serves for attaching saddle
106 to target marker(s)
102. Such
attachment enables to position saddle
106 relative to target marker(s)
102
thus enabling accurate positioning of the bladder neck and/or urethra when engaged
by the saddle shaped element.
Connecting element
112 is designed and constructed so as to enable
modification/adjustment of a distance between the at least one target marker and
the saddle shaped element when interconnected thereby.
For example, a target marker end
114 of connecting element
112
can be configured with an adjustment mechanism
115 (such as a screw) which
can be utilized to adjust the length of connecting element
112 and as such
to adjust the distance between target marker
102 and saddle
106 interconnected thereby.
Alternatively, the saddle attachment end
116 of connecting
element
112 can include a plurality of saddle attachment sites
118
which enable accurate and indexed positioning of saddle
106 relative to
target markers
102, thus enabling accurate positioning of the bladder neck
and/or urethra.
As shown in FIG. 6, assembly
100 of the present invention can be used
to
position the bladder and/or urethra in the following manner.
One or more target marker(s)
102, are fixed to abdominal skin region
104
which lies directly above the pubic bone, and small abdominal incisions (indicated
at
120) are made with, for example, a scalpel.
A No. 16-18 French catheter is placed in the urethra to stabilize it and to allow
manipulation thereof. With a speculum
122 inserted, a small incision is
made in the vaginal wall in order to expose the urethra. The incision is forced
open with a retractor, the urethra is separated from the vaginal wall and saddle
106 is positioned such that the urethra is engaged by saddle
106.
Connecting element
112 is inserted via the vaginal incision and
used to attach saddle
106 to target marker(s)
102 by threading end
114 of connecting element
112 through the abdominal incision (indicated
at
120).
Using adjustment mechanism
115, saddle
106 and bladder neck/urethra
engaged thereby are pulled towards the pubic bone (pubis) until a desired position
is achieved and connecting element
112 is locked in place thus suspending
the bladder/urethra at the desirable position.
Thus, assembly
100 of the present invention enables positioning of the
bladder neck/urethra prior to suspension surgery, thus freeing the surgeon from
having to keep the bladder neck/urethra in the correct position during a surgical procedure.
It will be appreciated that assembly
100 and the above described method
of utilizing same can be used prior to any prior art surgical suspension procedure.
Preferably, the above described method is utilized with tissue anchoring
device
10 and/or suspending device
50 of the present invention.
Thus, as shown in FIGS. 7-8, following bladder positioning, a guide
128
can be inserted into one of the guide bores
130 provided in saddle
106
and advanced until the urogenital diaphragm is reached (resistance of fibrous tissue
is felt). The guide or a sharp piercer
132 is used to perforate the diaphragm
and with the guide re-inserted or the sharp point of the guide withdrawn, tissue
anchoring device
10 and preferably an attached suspending device
50
are advanced along the lower surface of the pubic bone in the retro-pubic space,
until the rectus fascia (Fascia) which serves as a site for tissue anchoring is reached.
As specifically shown in FIG. 8, guide
128 (or piercer
132) is
used
to drive tissue anchoring device
10 (inflatable anchor) into the rectus
fascia tissue and to deploy an anchor element, such as an inflatable anchor element
via a syringe
136 which is connected to guide
128. Following anchoring,
suspending device
50 is attached to the bladder neck or urethra and if necessary
connected to anchoring device
10. It will be appreciated, that saddle
106
can be designed to also function as suspending device
50, thus negating
the need to position suspending device
50 and to remove saddle
106.
Following removal of assembly
100, the elastic compliance feature
of tissue anchoring device
10 and/or attached suspending device
50
ensure that correct bladder neck position is maintained at all times. In addition,
such elastic compliance dampens forces applied to anchored tissues thus reducing
or preventing tissue damage.
It is appreciated that certain features of the invention, which are, for clarity,
described in the context of separate embodiments, may also be provided in combination
in a single embodiment. Conversely, various features of the invention which are,
for brevity, described in the context of a single embodiment, may also be provided
separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments
thereof, it is evident that many alternatives, modifications and variations will
be apparent to those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall within the spirit
and broad scope of the appended claims. All publications, patents and patent applications
mentioned in this specification are herein incorporated in their entirety by reference
into the specification, to the same extent as if each individual publication, patent
or patent application was specifically and individually indicated to be incorporated
herein by reference. In addition, citation or identification of any reference in
this application shall not be construed as an admission that such reference is
available as prior art to the present invention.
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