WO2007018520A1

WO2007018520A1 - Bladder saver retropubic ligature carrier device

Info

Publication number: WO2007018520A1
Application number: PCT/US2005/026991
Authority: WO
Inventors: M.D. Darius Samimi
Original assignee: Samimi M D Darius
Priority date: 2005-07-28
Filing date: 2005-07-28
Publication date: 2007-02-15

Abstract

A retropubic ligature carrier apparatus (10) for use in performing an operation through bodily tissues, especially in the treatment of female urinary incontinence. The apparatus (10) comprises a trocar (30) and a stand (20), serving as a bridge for the trocar (30). The stand (20) has a vertically extending passageway (22) for receiving the trocar (30) and has a base portion (21) with two triangular-shaped sides and a planar member (25) extending past the base portion (21) between the two triangular-shaped sides at an angle from the plane of the trocar (30) when resident in said passageway (22). In use, the physician places his fingers above and below said planar member (25) to gently and accurately guide the trocar (30) into bodily tissue.

Description

D E S C E I E 1 I Q N

BLADDER SAVER RETROPUBIC LIGATURE CARRIER DEVICE

Priority is claimed to U.S. Provisional Patent Application Ser. No. 60/035,603 filed on March 24, 1997, the disclosure of which is herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgery apparatuses and devices which a physician utilizes to perform an operation through bodily tissues, especially in the treatment of female urinary incontinence.

More specifically, the present invention is directed to a bladder saver retropubic ligature carrier device having a stand or base and a trocar or needle with a cutting tip for cutting into bodily tissue. The bladder saver retropubic ligature carrier device of this invention is compact, easily adaptable to a variety of surgical procedures, and represents a cutting-edge surgical tool capable of being used in traditional as well as newly pioneered operations for treating female urinary incontinence disorders.

BACKGROUND OF THE INVENTION

Treatment of female urinary incontinence has been attempted by various methods and devices throughout the decades. Generally, physicians have endeavored to exercise various puncture techniques wherein the wall of the vagina is undesirably disturbed and damaged.

Typically, female urinary incontinence is remedied by tying the urethro-vesical junction to the back of the symphysis pubis. With existing surgical devices, physicians have had few options to conduct alternative medical procedures. Moreover, traditional medical procedures have always involved application of general anesthesia because of the invasive nature of the remedial action.

One of the most famous treatments for female urinary incontinence is the Perayra technique. The original Pereyra technique used No.30 stainless wire, which was looped through the vagina without a vaginal incision, by the blind passage of a specially designed needle through a suprapubic incision.

In a modified Pereyra procedure, the superior wall of the vagina is sutured to the abdominal wall rather than sutured in the retropubic region. The modified Pereyra procedure involves the use of a ligature carrier having a brace to guide a retractable needle for extension and retraction. The brace includes a generally flat serrated or striated brace handle from which parallel guides extend back, away from the needle tip. The needle's end is angulated and has an eye at its tip. The needle slides through a hole in the brace handle. As has been recounted in prior art of record, there exist numerous explanations for high failure rates of the Pereyra procedure. In another treatment, known as the "Burch Procedure", the vaginal fascia used to elevate the urethro-vesical angle and the vaginal fascia near the urethra are sutured to Cooper's ligament and the ilecpectineal ligament after dissection in retzius space.

Endoscopic suspension was first described in 1973 by Stamey. The innovation was to emphasize the use of the cystoscope to control accurate placement of the suspending sutures. In his technique, a T-shaped vaginal incision is made in the anterior vaginal wall and the periurethral tissue exposed. Then, through a short suprapubic incision, the specially designed Stamey needle is introduced through the rectus fascia. With the needle in place, Cystoscopic inspection is performed with movement of the needle. Small dacron buttresses are used to prevent suture pull through. Dacron tubes are used to buttress the endopelvic fascia.

Gitte and Laughlin, in 1988, modified the Stamey procedure by making no vaginal incision at all. Instead, they insert the monofilament nylon suture through the vaginal epithelium. In this technique, permanent sutures are withdrawn by a long suspension needle retropubically to the stab incision, where they are secured to fat. It is suggested that over time, the sutures pull through the subcutaneous tissues and then become attached to the rectus fascia with appropriate tension. Vaginal repithelization occurs over these sutures.

None of the previous tools, in combination with any of the aforementioned techniques for treating female urinary incontinence, has been suitable for conducting a procedure which can be performed without an incision on the vaginal wall. Furthermore, none of these tools, in combination with any procedures, has featured an absence of anchoring of the bladder neck suspension and suture to the anterior rectus fascia.

In a new approach, to avert postoperative pain syndrome due to nerve entrapment, the present invention is utilized to anchor the bladder neck with suspending sutures to the edge of pubic bone on the Scarpa fascia and rectus abdominus tendinous plus Cooper ligament. It is recognized that the present invention has been specially adapted to serve as a necessary apparatus for successfully performing the new procedure. As a result of employing the present invention in combination with the new procedure, a surgeon should expect patients to exhibit increased support and remarkable scarification after the operations.

To understand the setting in which the present invention functions, the new surgical procedure is herein described for reference. First, a special long suspension needle is passed through the anterior Scarpa fascia, then the rectus tendinous abdorninus and the Cooper ligament, toward the undersurface of the symphysis pubis, the retropubic fat pad and the endopelvic fascia and the vaginal wall into the vagina, lateral to the urethrovesical junction, under direct finder guidance. A No.2 monofilament nylon suture is threaded through the needle's eye, withdrawn to a suprapubic port, and tagged with a hemostat clamp.

Next, the vaginal side tail of the nylon suture is loaded with a Mayo or curve needle. The suture is placed in a circular or spiral fashion incorporating full thickness in the vaginal wall 1-1.5 cm. on the lateral side of the urethrovesical level. The suture end is replaced on the long needle eye and withdrawn through the second puncture on the junction of the Scarpa fascia and the edge of the symphysis pubis, 1.0 cm. from the first puncture and tagged with a hemostat.

In this technique, no vaginal incision is necessary because the suture buries itself by gradually penetrating through the vaginal epithelium and then making remarkable scarification on the endopelvic ligament and the retropubic structure, plus on the rectus abdominus tendinous, the Cooper ligament, and the Scarpa fascia on the edge of the pubic bone under subcutaneous fat. At the time that the surgeon passes the suspension needle through the lateral edges of the incision, he leaves a bridge of the Scarpa fascia, the rectus abdominus tendinous, and the Cooper ligament, between the suspending sutures, for suspension at the end of cystoscopy. The cystoscopy is performed to help assure that there has been no injury to the bladder.

The rigid cystoscopy assists in confirming that adequate support has been given to the urethra and bladder neck. If the suspension sutures have unintentionally penetrated the bladder wall, such a case is noticed at the time so the cystoscope and suture can be pulled out and the operation can be repeated. Also, the lateral aspect at 3 and 9 o'clock of the urethrovesical junction and the lower bladder must be seen clearly with no oozing or bleeding and no suture violation. If there is suture violation, the surgeon can pull it out and re-attempt correct placement. A suprapubic catheter with memory must be placed under the supervision of the cystoscopy surgeon. The catheter must be fixed with several sutures for prevention of dislodging or extravasation. Care must be taken to ensure that the catheter functions satisfactorily.

The monofilament sutures are tied over a reinforced 1-1.5 cm. Scarpa fascia and the rectus abdominus tendinous attached to the pubic bone. After pushing or bringing the urethrovesical junction to the retropubic space or normal position, moderate tension is required to furnish the support necessary to treat urinary stress incontinence.

In short, a surgeon utilizing the present invention restores the anatomical and physiological position of the proximal urethra, in such a fashion, as to allow transmission of intra-abdominal pressure. Urethral closure pressure is enhanced at least to the same degree and sometimes to a greater degree than normal.

Accordingly, the need arises for a bladder saver retropubic ligature carrier device with a specially designed tip and main body, which allows a physician to exercise increased dexterity and achieve greater operation success. SUMMARY OF THE INVENTION

By the present invention, a bladder saver retropubic ligature carrier device for the carrying out procedures to treat female urinary incontinence is disclosed. The present invention includes a double-pronged stand and a special trocar.

Accordingly, one of the objects of the present invention is to provide a bladder saver retropubic ligature carrier device for reducing the duration of operation procedures by up to 53 percent, while preventing bladder violation.

Another of the objects of the present invention is to provide a bladder saver retropubic ligature carrier device which is capable of granting the surgeon increased dexterity and greater surgical accuracy.

Yet another of the objects of the present invention is to provide a bladder saver retropubic ligature carrier device which is capable of facilitating the operation's sling procedure.

Still another of the objects of the present invention is to provide a bladder saver retropubic ligature carrier device which provides overall better operational results because less repeat procedures are required.

A further object of the present invention is to a provide bladder saver retropubic ligature carrier device which assists the surgeon in maintaining low morbidity and complications.

Another object of the present invention is to provide a bladder saver retropubic ligature carrier device for the purposes described which has a mechanism to avoid needle stick of the surgeon's fingers.

In view of the above-mentioned and other objects, all of which will become more readily understood as the nature of the present invention is better understood, the invention comprises the novel combination and arrangement of parts hereinafter more fully described, illustrated, and claimed with reference being made to the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational perspective view of one embodiment of the present invention, showing a stand next to a modified trocar.

FIG. 2 is an exploded elevational perspective view of FIG. 1, illustrating one method of handling of the present invention.

Similar reference characters denote corresponding features consistently throughout the attached drawings. DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

The present invention will be seen to relate to a bladder saver retropubic ligature carrier device 10 of unique design. The present invention is comprised primarily of a cast metal stand 20 and one or a plurality of trocar rods 40 or 42.

The bladder saver retropubic ligature carrier device 10 has a primary purpose of enabling a surgeon to pass through retropubic anatomy (not shown) without posing a danger of bladder (not shown) and vessel (not shown) injury. The stand 20 is designed to serve as a bridge for the trocar 30 during an operation. hi a preferred embodiment of the present invention, as shown in FIG. 1, the stand 20 is composed of a base portion 21 of a cubical conical configuration with an exaggerated planar member 25. Base portion 21 serves as a holder for the surgeon's fingers 27, as shown in FIG. 2. The surgeon's fingers 27 are placed above and below the planar member 25 to allow a premium of movement for the stand 20.

Apertures or passageways 22 extend downward through base portion 21 for receiving a pair of metal trocar rods 40. Depending through base portion 21, rods 40 emerge from corresponding apertures or outlets (not shown) located on the bottom side of base portion 21. Rods 40 are set parallel to one another and joined together via brace 50 near the upper end of stand 20. Brace 50 is a fixed connection between rods 40, thus forming a stint or stylet in combination with rods 40. During an operation, the surgeon will find it useful to be able to utilize stylets of various lengths within base portion 21. Metal rods 40 have cutting tips 45 disposed below the lower end of stand 20. Each cutting tip 45 comprises a planar angular slash across the lower end of the trocar rod 40 for providing a smooth knife-like shape for enabling the trocar rod 40 to cut directly into bodily tissue.

The planar member 25 extends at approximately a 20 degree angle from the plane of trocar rods 40 when rods 40 are resident in passageways 22 . During operation procedures, the surgeon can reliably manipulate the stand 20 by placing fingers 27 above and below planar member 25 and rods 40 in the manner shown in FIG. 2.

In some surgical procedures, a modified trocar 30 may replace one or both trocar rods 40 in base portion 21, such that modified trocars 30 extend through passageways 22. In this application, a modified trocar 30 can be accurately guided inside a patient's body as the surgeon employs stand 20.

Modified trocar 30 has a cutting tip 60 which has a spiral shape resembling a screw thread for screwing into bodily tissues, as opposed to cutting directly into such tissues. Spiral tip 60 creates a less invasive entrance than a trocar tip having a knife-like shape. Unlike a knife-like trocar, modified trocar 30 can be twisted as it penetrates bodily tissue so that spiral tip 60 makes a gradual entrance. Modified trocar 30 has a striated handle 70 which assists the surgeon in maintaining his grip as modified trocar 30 is twisted or rotated. Striated handle 70 is of general cylindrical shape with a series or parallel ridges 82 running the length of its cylindrical shape for providing improved gripability.

Modified trocar 30 has an eye (passageway)80 located above spiral tip 60 for receiving a suture (not shown). Trocar rods 40 may also be provided with similar eyes located above their cutting tips 45 for receiving sutures (not shown). hi summary, the above described bladder saver retropubic ligature carrier devices provide for ease of use in various application, thus enabling significant advances in surgical operating technique.

It is to be understood that the present invention is not limited to the embodiments described above, but encompasses any and all embodiments as fall within the true spirit and scope of the invention.

Claims

C L A I M SWHAT IS CLAIMED IS:

1. A retropubic ligature carrier apparatus for use with a trocar in performing an operation through bodily tissues, especially in the treatment of female urinary incontinence, comprising: a stand, serving as a bridge for a trocar, said stand having a passageway for receiving the trocar and having a base portion with two triangular-shaped sides and a planar member extending past said base portion between said two triangular-shaped sides in line with the hypotenuses of said two triangular-shaped sides at an angle from the plane of the trocar when resident in said passageway; wherein the user places his fingers above and below said planar member to securely guide the trocar.

2. The apparatus of claim 1, wherein said stand is made of metal.

3. A retropubic ligature carrier apparatus for use in performing an operation through bodily tissues, especially in the treatment of female urinary incontinence, comprising: a trocar; and a stand, serving as a bridge for said trocar, said stand having a passageway for receiving said trocar and having a base portion with two triangular-shaped sides and a planar member extending past said base portion between said two triangular-shaped sides at an angle from the plane of said trocar when resident in said passageway;

wherein the user places his fingers above and below said planar member to securely guide the trocar.

4. The apparatus of claim 3 wherein the stand is made of metal.

5. The apparatus of claim 3 wherein the planar member extends at approximately a twenty-degree angle relative to the plane of said trocar.

6. The apparatus of claim 3 wherein the trocar is a metal rod which extends vertically through the stand, the trocar having a cutting tip at the lower end thereof.

7. The apparatus of claim 6 wherein the cutting tip of the trocar has a spiral shape resembling a screw thread for screwing into bodily tissues.

8. The apparatus of claim 7 wherein the upper end of the trocar rod is provided with a striated handle for enabling rotation of the trocar rod for advancing the cutting tip into bodily tissues.

9. The apparatus of claim 6 wherein the cutting tip of the trocar has a smooth knife- like shape for enabling the trocar rod to cut directly into bodily tissues.

10. The apparatus of claim 6 wherein the cutting tip of the trocar comprises a planar angular slash across the lower end of the trocar rod for enabling the rod to cut smoothly and directly into bodily tissues.

11. The apparatus of claim 6 wherein the trocar rod has an eye near the lower end thereof for receiving a suture.