Patent Application
20080091058
The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are meant to be illustrative rather than limiting. In the drawings:
a and 1b depict a STRATASIS® sling useful in embodiments of the present invention;
a-6b depict cross sections of alternative sheath embodiments;
While the invention will be described in connection with certain preferred embodiments, there is no intent to limit it to those embodiments. The intent is to cover all alternatives, modifications and equivalents as included within the spirit and scope of the invention as defined by the appended claims.
Embodiments of the present invention preferably use a sling made from porcine small intestine submucosa (SIS), although other slings or supports for the urethra may also be used. One sling useful in kit embodiments is depicted in
Embodiments of the slings preferably include features for ameliorating potential causes of pull-out or roll-over of a sling, or a combination of pull-out and roll-over. In some cases, the problem of roll-over may be related to the support portion of the sling, since the primary consideration of this portion in most cases is to provide support for about 1-2 cm of the urethra, spreading the mechanical load and avoiding a stress concentration whereby the sling could damage the urethra. At least one contributor to roll-over forces and roll-over may be the endopelvic fascia, running near the urethra and roughly perpendicular to the sling. The sling may be implanted near the fascia, where the bulk and stiffness of the endopelvic fascia may interfere with a flat, planar installation of the sling by compressing the sling where the fascia pass through the sling. The sling may then be rolled or bunched into a narrow band under the urethra, depriving the urethra of broader, less stressful support.
To address this problem, the sling provides relief features near the support portion of the sling. The relief features provide relief for any endopelvic fascia passing transversely to the orientation of the sling when implanted. Narrowing transitions for providing relief are preferably gently radiused so that the sling continues to provide maximum support for the urethra. The transitions are preferably narrower than the adjacent support portion and the left or right side “tail” or supporting portion of the sling. In addition to or as an alternative to narrower portions, relief may be effectively provided by modifying any material in the relief area to render it less resistant to deformation or displacement by surrounding patient tissues. For example, material in the relief area may be windowed, sliced, perforated or otherwise sufficiently weakened or otherwise modified to facilitate the passage of endopelvic fascia without curling or rolling the intermediate portion of the sling device.
Other features may be added to the sling to increase resistance to pull out, for example anchors that provide convoluted surfaces, surfaces that interfere with movement of the sling, thus increasing resistance to pullout or movement. The features or anchors may be protuberances such as barbs, whereby the sling is provided with a plurality of small anchors to prevent movement once the sling is placed into a patient. In addition, or instead of barbs or protuberances, the sling may be provided with serrations on its edges, as shown in
Processes for making multi-layer laminates from a plurality of individual layers of material are disclosed in U.S. Pat. Nos. 5,885,619 and 5,711,969, hereby incorporated by reference in their entirety. Additional teachings as to processing and layering the materials are disclosed in U.S. Pat. Nos. 5,733,337, 5,995,110, 5,993,844, 5,997,575, and 6,206,931, all of which are hereby incorporated by reference in their entirety. These patents teach the harvesting, cleansing, sterilizing and processing the submucosa from a variety of sources, including the alimentary, respiratory, urinary or genital tracts from bovine, ovine and porcine sources. Included in the processing are processes to dehydrate and compress the submucosal tissues. Processes may include vacuum drying, dead-weight pressing or other pressing, lyophilizing, room temperature or heat pressing, perforating, layering, and so on. Slings made from submucosal tissues by these and other processes are meant to be used in the present invention.
The multiple-layer embodiments may contain two laminate to eight or even more laminate of collagenous material. A preferred embodiment is a four-layer or an eight-layer material made from porcine SIS, and vacuum pressed to bind the layer in the thickness dimension. Any numbers of methods may be used to produce laminates, including the processing described above, mechanical reinforcements in the third (thickness) dimension, and the like. One preferred embodiment is a central portion having eight layers and arms or tails having four layers. The central portion may be prepared using a vacuum pressing process, resulting in a product that is relatively clear or translucent, i.e., allowing some light to pass through but in which objects on the other side are not at all clear or easily discernable. The arms may be prepared by a lyophilizing process, resulting in arms that are opaque, i.e., allowing the passage of no or almost no light. In preferred embodiments, the thickness of the central portion with eight layers is about the same thickness as the four-layer arms.
The needle is preferably made from stainless steel or any other medically-acceptable material, and preferably has a uniform diameter of about 2-3 mm, although other diameters may be used. The distal and proximal ends of the needle may be flattened for easier insertion into handle 21, and for ease of attachment of hook 28 into an aperture of a sling. The handle may be made from stainless steel or from molded plastic. The ligature carriers or needles and the sheaths may be inserted via a suprapubic route, from incisions in the patient's lower abdomen to one or more incisions in the patient's vagina. Alternately, the needles and sheaths may be inserted via a vaginal route, that is, from one or more incisions in the patient's vagina, upwards on either side of the urethra, to incisions in the patient's lower abdomen.
A thin, flexible sheath for use in the kit is depicted in
At the end of the procedure, when the sheath is removed from the patient, the sheath may be extracted beginning with the wider end, and will pull out a little more easily if there is a slight taper. About 1-2 degrees of taper is sufficient; more or less may be used. The sheath should have a slightly larger diameter than the needle. In one embodiment, the sheath is about 10 Fr diameter (about 3.33 mm, 0.131 inches) and the needle is about 9 Fr diameter (about 3 mm, about 0.118 inches). This provides a clearance on each side between the needle and sheath of about 0.15 mm or about 0.006 inches.
In addition to the taper, the sheath may be coated on its inside, its outside, or both. The coating 46 on the inside will be in contact with the sling as the sling is pulled through the sheath. The coating may be a thin layer of polyethylene or fluoro-polymer, or it may be a lubricious coating, such as a hydrophilic coating, to ease the passage of the sling and the needle as they are drawn through the sheath. The coating on the outside preferably makes the sheath very lubricious as the sheath is inserted into the patient. This coating may be a lubricious coating, such as a hydrophilic coating, or it may simply be a very thin, slick coating of PTFE-type material, or polyethylene. The outer coating may also include a local anesthetic, such as lidocaine or bupivacaine, to ease the sensation of the sheath and needle being implanted into the patient. There are many ways to coat sheaths, needles or other objects with a small, desired, and controlled amount of an anesthetic.
In one embodiment, the sheath may be tapered on at least one end, the distal end, for ease of insertion into the patient.
Alternative embodiments of the needles or ligature carriers are depicted in
A physician using the ligature carriers, sheaths, and a sling as described above, may implant the sling in a patient, as described in the flowchart of
Holding the sheaths in place, preferably from a suprapubic position, the physician then draws 94 the sling into the sheaths using the ligature carriers, on both sides of the patient. After this step, the physician gently removes 95 the sheaths from the pathways, leaving the sling in place. The physician then adjust 96 the sling to remove wrinkles and tension from the sling. The physician should then trim 97 the ends of the sling, using a sling cutter, to the level of the rectus fascia. The sling cutter is described in co-pending application Ser. No. 11/399,781 titled “Percutaneous and Endoscopic Cutters,” filed on Apr. 7, 2006, which is assigned to the assignee of this patent. The abdominal and vaginal incisions are then closed.
This procedure is preferably accomplished with an antegrade placement technique, although a retrograde technique may also be used. In this technique, an appropriate amount of anesthesia may be used, and two small (0.5 to 1.0 cm) abdominal skin incisions are made, one on each side of the midline, and just above the pubic symphysis. A vaginal incision is made approximately 1 cm from the outer urethral meatus, a midline vertical anterior vaginal incision of approximately 2 cm toward the bladder neck. A small paraurethral space is made by dissecting the vaginal wall from the periurethral fascia, which are preferably left adjacent the urethra and as intact as possible.
In the antegrade placement technique, the ligature carriers extend through the sheaths and each is brought from one of the abdominal skin incisions, along the posterior of the pubic bone, and guided through the vaginal incision. Once the ligature carriers and sheaths are in place, the procedure described above is accomplished. A similar technique is followed for the retrograde placement method.
All references, including publications, patent applications, and patents cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) is to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.
The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
Preferred embodiments are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. Skilled artisans will use such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
This application claims priority from U.S. Provisional Application No. 60/829,582, titled “Urethral Sling Implantation Using Needle Sheaths,” filed on Oct. 16, 2006, the entirety of which is fully incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 60829582 | Oct 2006 | US |
