Patent Application
20160310249
The invention relates generally to surgical devices and methods and, more particularly, to an implant or sling system having overlapping sheath sections that include one or more texture or like release features.
Urinary incontinence is a significant health concern worldwide. Incontinence may occur when the pelvic floor weakens. There are five basic types of incontinence: stress incontinence, urge incontinence, mixed incontinence, overflow incontinence and functional incontinence. There are a large number of surgical interventions and procedures for addressing incontinence.
A variety of surgical procedure options are currently available to treat incontinence. Depending on age, medical condition, and personal preference, surgical procedures can be used to completely restore continence. One type of procedure, found to be an especially successful treatment option for SUI in both men and women, is a sling procedure.
A sling procedure is a surgical method involving the placement of a sling to stabilize or support the bladder neck or urethra. There are a variety of different sling procedures. Descriptions of different sling procedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.
Sling procedures differ in the type of material used for the sling, the method of anchoring the sling material in the body and how the sling material is inserted in the body. The time required for a surgical procedure varies, but is preferably as short as possible.
Many slings include a protective sheath used during insertion of the sling. After the sling is implanted, the sheath is removed and discarded. The protective sheath is generally constructed of a material that affords visual examination of the implantable sling and that affords smooth passage of the sling assembly through tissue of the patient. A two-piece overlapping sheath assembly is disclosed in published U.S. patent application Ser. No. 2002/0156487, which is hereby incorporated by reference fully herein.
In many cases, the sheath is made of polyethylene. Other materials used to construct the sheath include polypropylene, nylon, polyester or Teflon. The sheath material should be flexible and provide sufficient structural integrity to withstand the various forces exerted on the sheath throughout the sling delivery procedure. The sheath can be configured to have sufficient flexibility to facilitate user manipulation and adequate structural strength to withstand the various forces applied to the sheath during delivery and/or positioning of the sling assembly. It should also conveniently separate from the sling material after the sling is implanted without materially changing the position of the sling.
The sheath may comprise two elongate, separable sections. During sheath removal, the first section and the second section of the sheath are slid off the sling by pulling each end of the sheath away from the middle portion of the sling assembly. Removal of the sheath causes separation of the overlapping sheath sections, thereby exposing the sling.
However, with such configurations the first and second sections of the sheath can “stick” to one another or otherwise bind during the removal process due to either friction caused by the respective telescoping sections of the sheath or when a spacer such as a clamp is used under the urethra. This phenomenon can occur much like what occurs with highly polished gage blocks (e.g., which are very flat and can come into close contact across a relatively large surface area). As such, the sheaths can sometimes exhibit resistance to motion relative to one another.
The present invention relates generally to an implant or sling device including one or more sheath sections that are easily removed from a surgical sling after the sling assembly is situated under the patient's urethra or like anatomical structure of the patient. Various embodiments of the present invention can be employed with or by using existing or known incontinence sling materials, devices, or procedures.
In various embodiments of the present invention, a slight texture or surface feature can be provided to the sheath between the materials that interface with each other such that the materials resist or eliminate the behavior of resistance to motion. The texture or feature interferes with the material's surface interactions. The resulting value is that no other device or structural variable of the implant or sheath needs to change, other than the inside surface of the outer overlapping sheath, the outside of the inner overlapping sheath, or both. Because other operations are sometimes performed on the outside of the sheaths (printing, surface-surface bonding, etc.) it may be preferable to provide the surface texture on the inside of the outer overlapping sheath in certain embodiments.
The included release feature can include one or more ribs, nubs, generally linear or arcuate protrusions, longitudinal protrusions, undulations, periodic or spaced coatings, surface disruptions, rough surfaces, and the like.
Referring generally to
Various tools, device structures, implants, components, methods and techniques described and depicted in U.S. Patent Publication Nos. 2002/0156487 and 2005/0043580 are envisioned for use, in whole or in part, with the present invention. As such, the entire disclosures of the above-referenced patents are incorporated herein by reference in their entirety.
Referring to
The length of the sheaths 12a, 12b can vary greatly depending on the particular procedure or application. In certain embodiments the range can be from about 1.0 inches to about 16 inches. The first and second sheaths can be of equal length from their distal ends to proximal ends, or take on different length configurations. Any of the end portions 14, 16, 18, 20 can be tapered, thinner than other portions, or include a reduced inner and/or outer diameter compared to other sheath portions.
The proximal end 18 of sheath section 12b is inserted into the distal end 16 of sheath section 12a to form an overlap region 22 of the first and second sheaths 12a, 12b, as shown in
The overlap region 22 may range in length from about 0.2 inches to about 4.0 inches in various embodiments. In certain embodiments the proximal end 18 is smaller in overall diameter or construct compared to the distal end 16 to further facilitate insertion and the corresponding overlapping at region 22. Other material and dimensional constructs are envisioned as well to accommodate the overall and can be implemented without deviating from the spirit and scope of the present invention.
As shown in
The release feature 24 can be provided with or applied to the target surface or sheath surface via various techniques or procedures. In certain embodiments, the feature 24 can be defined with the target sheath surface via a molding or extrusion process. In other embodiments, the feature 24 can be etched (e.g., via laser, cutting, surface disruption) or otherwise defined in or on the corresponding surface. Further, the feature 24 can be included on or in a separate material (e.g., film) and applied to the applicable target surface of the sheath—e.g., via adhesive, molding, sealing, melting, and the like. In still other embodiments, one or more elements, members, or textures can be formed or provided to the sheath surface by applying a generally viscous polymer or like material, spraying polymer or like material onto the sheath surface, etc.
For instance, sheath 12 portions including ribs can include one or more ribs 24 placed on respective interfacing surfaces of the sheath 12. The ribs 24 (and any of the other feature 24 embodiments) can extend along the longitudinal axis of the sheath surface (
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.
Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.
This Application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/151,540, filed Apr. 23, 2015, and U.S. Provisional Patent Application No. 62/151,467, filed Apr. 23, 2015; with each of the referenced applications being incorporated fully herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62151540 | Apr 2015 | US | |
| 62151467 | Apr 2015 | US |
