Tack device with shield

Surgery – Instruments – Surgical mesh – connector – clip – clamp or band

Reexamination Certificate

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Details

C606S075000

Reexamination Certificate

active

06544273

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to methods and apparatus for treating incontinence, especially by bladder neck support.
BACKGROUND OF THE INVENTION
Urinary incontinence is an unfortunately common medical complaint. Many treatments have been suggested. Recently, a relatively minimally invasive technique has become more common, in which a bladder neck and/or urethra is supported by a sling, so that the urethra is partially compressed and/or has a support below it so that during straining and/or bladder/uretheral descent, pressure is applied between the urethra and the sling, thereby closing its lumen.
Benderev et. al, in U.S. Pat. No. 5,836,314 and Brenneman et al, in PCT publication WO 98/19606, the disclosures of which are incorporated herein by reference, describe exemplary procedures for treating incontinence. Two or more bone anchors are attached to the pubic bone. Each anchor is pre-threaded with a suture. Brenneman suggests attaching a sling to the sutures such that when the sutures are pulled tight and knotted, the sling is urged towards the pubic bone. Benderev suggests integrally molding one end of a suture with a “suture support,” which suture support is provided to prevent damage to the urethra by the sutures.
It should be noted that, prior to the introduction of slings, some earlier procedures, for example the Burch procedure and the M.M.K. procedure, used only sutures without a sling to support the bladder neck. Also the, different, needle bladder neck suspension procedure uses only sutures. The disadvantage of these procedures is that the bare sutures can cut into and damage the urethra. In a sling procedure, described below, a mesh or a wide strip of material contacts the urethra instead of sutures, so that the urethra is not damaged.
FIG. 1
is a schematic side cut-through illustration of a pubic region
20
during such a procedure, before the sutures are tightened. In the figure, a sling
32
is located between a vagina
22
and a bladder neck
26
of a bladder
24
. The sling is threaded by a plurality of sutures
36
, which are attached to a bone anchor
30
, in a pubic bone
28
.
There are two commonly applied methods of bringing sling
32
to a position between vagina
22
and bladder neck
26
. In a first method, an incision is made in the vagina, at an area corresponding to that marked with reference number
34
, perpendicular to the figure plane, thereby forming a flap. The sling is inserted into the incision, under the flap, and after the sling is tightened, the incision is closed. In a second method, only a small hole in the vagina lining is made for each inserted bone anchor and a tunnel is formed between the two holes, for insertion of sling
32
therethrough.
This family of suture-sling techniques has several disadvantages:
(a) the suture is an additional element which may be damaged during the procedure or after it;
(b) knotting the sutures (after they are tightened) takes skill and time; additionally, some patients have complained that the sutures cause discomfort during sexual activity, since such sutures typically have sharp edges and are often bulky as the suture may have to be knotted as many as six times to assure patency;
(c) the sutures add some unwanted leeway between the positioning of the anchors and the positioning of the ends of the sling; and
(d) the sutures may damage the sling by cutting through it (older tissue being more susceptible); if the suture enters the sling at multiple points (to reduce strain at the sling-suture joints) the sling may be deformed by the sutures.
U.S. Pat. No. 3,580,313, to McKnight, the disclosure of which is incorporated herein by reference, suggests using the tissue between the urethra and the vagina as a “sling” and stapling that tissue to the pubic bone. However, this solution may not be suitable for some patients, such as older patients, as their tissue are usually too weak to provide a suitable support. Also, older tissue is more susceptible to cut-through damage from the staples.
SUMMARY OF THE INVENTION
An aspect of some preferred embodiments of the present invention relates to a sutureless method of supporting a bladder neck. In a preferred embodiment of the invention, the bladder neck is supported by a sling, and the sling is directly tacked to a pubic bone, without intermediate sutures. Alternatively or additionally, the sling is directly attached to the bone using other means, for example an adhesive. As used herein “directly attached” means attached without an intermediate suture. In many cases, the sling will not be in direct physical contact with the bone. Generally, but not necessarily, there will be only tissue (if any) between the sling and the bone. However, in a preferred embodiment of the invention, there will not be a suture or other implant between the sling and the bone.
It is noted that by not requiring sutures, the previously required step of tightening and tying the sutures is not required.
An aspect of some embodiments of the invention relates to a tack shield. In an exemplary embodiment of the invention, when a tack is mounted on a tack head, for use in the body, the tack is surrounded by a shield, so that the tack tip and/or other parts of the tack, do not inadvertently damage the body. In an exemplary embodiment of the invention, the shield is retractable. Alternatively or additionally, the shield is flexible or bendable, being pushed back by forceful contact of the shield with a bone, to reveal the tack.
In an exemplary embodiment of the invention, the shield includes at least one slot adapted for receiving a sling from the side of the shield. Thus, the sling can lie flat while it is mounted on the tack and the shield is protecting the body from the tack. Optionally, the shield is rotationally fixed relative to the tack head, so that the sling placement can be known outside the body.
The entire shield need not be flexible, for example, only the part defining the slot(s) may be flexible. However, it may be simpler to manufacture the shield from a single material.
An aspect of some embodiments of the invention relates to a device for assisting in mounting a sling on a tack. In an exemplary embodiment of the invention, the device comprises a peg portion with an aperture formed at a tip thereof, for reversibly receiving the tip of a tack. In operation, a sling is placed between the aperture and the tack tip, and the peg is advanced towards the tack, forcing the tack tip to penetrate the sling. Optionally, the peg includes a finger guard, to protect fingers holding the peg from the tip of the tack, if the peg slips. Alternatively, a peg-like tip may be mounted on a handle, for example a perpendicular bar. Alternatively or additionally, a portion of the peg, near the aperture is slightly tacky, to engage the sling prior to mounting. Alternatively or additionally, the peg near the aperture is slotted, to hold the sling. In an exemplary embodiment of the invention, the peg diameter is larger than the sling width.
In an exemplary embodiment of the invention, the sling mounting device is used in conjunction with a slotted shield. Alternatively or additionally, the sling mounting device can apply enough force to bend back the shield. Optionally, the peg portion is mounted on one jaw of a pliers, with the other jaw adapted to engage the tack head behind the tack, for example, so that a greater contact force can be applied and/or so that the tack head does not inadvertently move.
Alternatively to the aperture reversibly receiving the tack tip, in an exemplary embodiment of the invention, the peg is a one-time device. In one example, the peg must be broken in order to remove it from the tip. Optionally, the peg includes a draw string down its side for splitting the peg.
An aspect of some preferred embodiments of the invention relates to a sling that is preloaded with one or more tacks at one or both ends thereof prior to insertion into a body. In a preferred embodiment of the invention, the pre-loaded sling is mounted on a tacker, for insertion into the body. Alterna

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