DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The present invention has been made in view of the above circumstances, one aspect of which is the provision of a device for supporting the male bladder to prevent incontinence. A further aspect of the invention is providing a bioabsorbable device for treating male incontinence. Yet another aspect of the present invention is the provision of bulk between the bladder and the sphincter. Still another aspect the provision of an implant for allowing various sphincters found in the human body to function normally. A further aspect of the present invention is the minimization of the amount of incision and dissection of bodily structure needed when administering to urinary incontinence. Still another aspect of the present invention is altering the male post-radical prostatectomy anatomy.

[0028] The invention relates to a spacer for relieving excess pressure exerted on a sphincter muscle by an anatomical structure. A preferred embodiment relates to a urethral spacer. The urethral spacer is a disk-like element formed of an absorbable, biodegradable material, and includes a slot through a portion of the device which permits the disk to be opened up and positioned around the urethra. The urethral spacer is sutured in place around the urethra adjacent to or around the urinary sphincter, preferably after a radical prostatectomy.

[0029] A first exemplary embodiment of the present invention is shown in FIGS. 1 a and 1 b . The post-radical prostatectomy implant of the present invention includes a spacer 10 , preferably having a round, disc-like shape. The spacer 10 includes a circular opening 12 and, in some embodiments, a slot 14 . The opening 12 is sized to fit snugly around a urethra. The slot 14 extends from an outer edge 16 of the spacer 10 to an inner edge 18 of the spacer, terminating at the opening 12 . Portions of the implant 20 , 22 , are located on each side of the slot 14 . The implant is opened up by pushing or pulling the portions 20 , 22 on each side of the slot 14 away from each other, thus, providing an open path 24 to the opening 12 . The open spacer 10 can be positioned around a urethra 42 (not shown in FIG. 1 ), as further described below. Once positioned, the portions 20 , 22 on each side of the slot 14 are released and meet at the slot 14 , thus closing the spacer 10 around the urethra 42 (not shown in FIG. 1 ).

[0030] The spacer 10 has an outer diameter of approximately 2.0 to 5.0 centimeters. The opening 12 measures between 0.4 centimeters to 1.0 centimeter in diameter, with 0.5 to 0.7 centimeters being, preferably, appropriately sized for typical pediatric use. The spacer 10 has a cylindrical height ranging from approximately 2 millimeters to 1 centimeter.

[0031] The spacer 10 is preferably made from a bioabsorbale material, including but not limited to, fascia, dermis, or collagen, further optionally cross-linked, and may further optionally include a material for providing more rigidity, e.g., Dacron. Other suitable bioabsorbable materials that may be used include, but are not limited to, Polydiaxonone Suture (PDS), or Vicryl. The implant primarily provides support, and need only be sufficiently pliable for proper positioning about the urethra 42 . The use of a bioabsorbable is preferred for two reasons. First, the material greatly reduces the risk of foreign body reactions, for example, the formation of stones. Second, bioabsorbable material is favored because it promotes natural tissue growth, re-structuring the anatomy. Over time, the body connective tissue grows over the spacer 10 , providing reinforcing structure to the bladder 40 and urethra 42 (not shown in FIG. 1 ). The bioabsorbable material decreases as natural tissue increases, leaving natural tissue in place of the spacer 10 .

[0032] Bioabsorbable materials come from a wide variety of sources. It will be appreciated by those skilled in the art that such materials with sufficient rigidity and flexibility characteristics may be used without departing from the scope of the present invention. It will be further appreciated by one skilled in the art that while bioabsorbable material is preferred, biocompatible, nonabsorbable materials, such as polymers, nylon, silicon, nitinol, surgical stainless steel, and the like may be used without departing from the scope of the present invention.

[0033] The present invention is further described in light of the anatomy with which it is used. FIG. 2 a illustrates the pre-radical prostatectomy anatomy. The bladder 40 holds urine. The urethra 42 allows urine to drain from the bladder 40 . The bladder neck 43 is a funnel-shaped, s tissue leading from the bladder 40 to the urethra 42 . The urinary sphincter 44 is a muscular ring that controls the opening and closing of the bladder 40 . The prostate gland 46 lies underneath the bladder 40 and adjacent to the urethra 42 , just above the urinary sphincter 44 . The urogenital diaphragm 48 is a thin musculo-fascial sheet providing support to the immediate structures, including the prostate 46 , urethra 42 , and urinary sphincter 44 . The rectum 60 lies anterior to the bladder 40 and urethra 42 . The anal sphincter muscle 62 controls the opening and closing of the rectum 60 .

[0034] FIG. 2 b illustrates the post-radical prostatectomy anatomy of a patient after the prostate has been removed. With the prostate removed, the bladder 40 is surgically joined to the urethra 42 and the sphincter 44 , asserting added pressure on the urinary sphincter 44 and urogenital diaphragm 48 .

[0035] FIG. 3 illustrates an exemplary embodiment of a urethral spacer 10 implanted in a post-radical prostatectomy anatomy, in a midsagittal sectional view of the male pelvic area.

[0036] FIGS. 4 a through 4 e illustrate an exemplary process of inserting a spacer 10 into the post-radical prostatectomy anatomy of a patient. Referring to FIGS. 4 a and 4 b , a catheter 80 , e.g., a Foley-type catheter is extended through the urethra 42 and into the bladder neck 43 . The prostate gland 46 is removed, leaving the urethra 42 exposed between the urinary sphincter 44 and bladder neck 43 . Portions of the urethra 42 , bladder neck 43 , urethral sphincter 44 , and diaphragm 48 may be damaged during the procedure, potentially causing incontinence, are removed, either with the prostate gland 46 , or thereafter. A small portion of the urethra 42 directly above the urinary sphincter 44 usually remains. The remaining portion of the urethra 42 and remaining portion of the bladder neck 43 are pulled together along the arrows A and B, and joined together, e.g. by suturing, to form the anastomosis.

[0037] Referring to FIG. 4 c , to insert the spacer 10 , the implant is opened up by forcing the portions 20 , 22 on each side of the slot 14 away from each other, thus, providing an open path 24 to the opening 12 . The spacer 10 is moved toward point C, with the urethra 42 in the open path, until the urethra 42 is located in the opening 12 , with the spacer 10 surrounding the urethra 42 . Once positioned, the portions 20 , 22 on each side of the slot 14 are released and at least partially close the slot 14 , thus closing the spacer 10 around the urethra 42 . The spacer 10 is placed between the bladder 40 and the urinary sphincter 44 , preferably in approximately the same position as that previously occupied by the prostate gland 46 . The spacer 10 then absorbs pressure exerted by the bladder 40 .

[0038] Referring to FIG. 4 d , once the spacer 10 is in place, sutures, surgical glue, or the like (not shown) may further optionally be used to secure the spacer 10 and relieve absorbed pressure from the bladder 40 . Sutures may be secured to the bladder 40 , urethra 42 , or urogenital diaphragm 48 . In FIG. 4 d , four suture points 50 are shown. However, it will be appreciated by one skilled in the art that at least two suture points 50 are sufficient to secure the spacer 10 . Further, the location of the suture points 50 are illustrative, as suture points 50 can be placed in a variety of locations on the spacer 10 without departing from the scope of the present invention. Additionally, surgical glue or biocompatible staples may be used to secure the spacer 10 .

[0039] It will be appreciated by one skilled in the art that the spacer 10 may be inserted during the same procedure as the radical prostatectomy. However, the spacer 10 may also be inserted during another procedure, some time after the radical prostatectomy has been performed.

[0040] As described with the preferred embodiment, alternative embodiments of devices in accordance with the present invention are preferably made from bioabsorbable material. However, it will be appreciated by one skilled in the art that biocompatible material may be used without departing from the scope of the present invention.

[0041] Although the spacer 10 of the present invention has been described as having a disc-like shape, it will be appreciated by one skilled in the art that the over-all shape of the spacer 10 can take a variety of forms. Further, it will also be appreciated by one skilled in the art that the shape of the opening 12 is designed to accommodate a human urethra without squeezing the urethra, and though a generally circular or elliptical shape is preferred, a variety of shapes can serve this purpose.

[0042] Although the spacer 10 of the present invention have been described as being a closed disc, it will be appreciated by one skilled in the art that the spacer 10 may extend partially around the urethra 42 . Referring to FIG. 5 a , an alternative embodiment of the present invention, which extends partially around the urethra 42 , is illustrated. In this embodiment, the slot 14 ′ is wider than in the embodiment illustrated in FIGS. 1 a , 1 b , up to approximately one-half (½), preferably one-third (⅓), of the circumference of the spacer 10 ′, always leaving an open path. In other words, the spacer 10 ′ encircles approximately at least one-half (½), and preferably two-third (⅔) of the circumference of the urethra 42 .

[0043] Referring to FIG. 5 b , the alternative embodiment of FIG. 5 a is illustrated implanted in the post-radical prostatectomy male anatomy. This embodiment is particularly useful when the spacer 10 ′ is inserted in a later procedure performed sometime after the radical prostatectomy, i.e., at a time after the surgical opening used to perform the radical prostatectomy has been closed. Particularly, scar tissue may develop after a radical prostatectomy, and usually does so between the urethra and the rectum 60 . Thus, the spacer 10 ′ may vary in thickness, with thicker portions located on the urethral side of the spacer 10 ′ opposite the slot 14 ′.

[0044] It will also be appreciated by one skilled in the art that the spacer 10 of the present invention may be used to support anatomy preventing the proper function of a sphincter in other parts of the body. Referring to FIG. 6, a midsagittal section view of the female pelvic area is illustrated. Particularly, a rectum 60 is opened and closed by an anal sphincter muscle 62 . Fecal incontinence is caused by prolapse of the rectum 60 putting pressure on the anal sphincter 62 , causing it to open. A spacer in accordance with the present invention, such as spacer 10 or 10 ′, may be implanted between the rectum 60 and the anal sphincter muscle 62 to support the rectum 60 and relieve pressure on the anal sphincter muscle 62 . Still referring to FIG. 6 , the spacer 10 of the present invention may also be used in cases where bladder or pouch neobladder reconstruction is performed. Similar to procedures previously described herein, a spacer in accordance with the present invention, such as spacer 10 or 10 ′, is placed around the urethra 70 between the bladder or pouch neobladder 72 and the sphincter urethra muscle 74 . Generally, the spacer 10 of the present invention is appropriately used whenever anatomical structures are exerting pressure on a sphincter which otherwise operates normally. The spacer 10 is placed above a sphincter and between the sphincter and whichever anatomical structure is exerting excess pressure on the sphincter.

[0045] An alternative embodiment of the spacer 10 of the present invention does not include the slot 14 when manufactured. However, at the time of performing the method of implanting the spacer 10 , the physician may cut the spacer to form the slot extending from the outer edge 16 of the spacer to the inner edge 18 , terminating at the opening 12 . For this purpose, the spacer is preferably formed of a material and of a thickness that can be easily cut by the practitioner with surgical scissors or a scalpel. In this manner, the spacer 10 may be custom cut to fit the anatomy as the differences from one patient to another may dictate, and may be formed as a spacer 10 , 10 ′, or similar shape.

[0046] The foregoing description of the preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiment was chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto, and their equivalents.