Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-04-27
2001-12-11
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S096010
Reexamination Certificate
active
06328729
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to surgical methods. More particularly, this invention relates to a colporrhaphy method using balloon dissection.
BACKGROUND OF THE INVENTION
As a result of overdistention during childbirth, infection or other trauma, damage to the female pelvic anatomy may occur, manifesting in vaginal prolapse, or in less severe instance, in either cystocele or rectocele, or their combination. Cystocele results when the bladder herniates into the anterior vaginal wall. Similarly, rectocele results when the rectum herniates into the posterior vaginal wall.
The vagina lies between the rectum and the bladder. Normally, there are planes of cleavage or potential spaces occurring between the vagina and these structures whereby the vagina, the rectum and the bladder may function and move independently of one another. The potential space between the bladder and the vagina is denoted the vesicovaginal space whereas the potential space between the vagina and the rectum is denoted the rectovaginal space. These “spaces” are generally filled with adipose tissue, providing little connectivity so that the structures are relatively independent of one another.
Both cystocele and rectocele are often accompanied by “loss” of the vesicovaginal space or the rectovaginal space, or their combination. Such “loss” is manifested in an increase of adhesions between the adjacent structures, often holding them in an unnatural anatomical position. For example, a symptom of cystocele is an unnatural protrusion or bulge of the anterior vaginal wall that is aggravated by gravity and accompanied by urinary incontinence. Because of these adhesions within these spaces, impaired or potential mobility of one related structure necessarily involves the adjacent structure, and independent function is compromised. Therefore, any surgical repair tending to return the pelvic anatomy to normalcy advantageously includes restoration of independent mobility of these fused structures. This can usually be accomplished, at least in part, by dissection of the adhesions within these pelvic spaces.
Release of these adhesions through conventional colporrhaphy entails extensive incisions within the vagina, followed by manual dissection to the anatomic limits of the spaces. (see, e.g., Mastery of Surgery, 2
nd
Ed., Vol. II, pp. 1532-1549). This approach is tedious, requires cautery to control bleeding, and causes extensive trauma to tissue adjacent to the spaces, which may result in additional subsequent adhesions. Thus there is a need in the art for improved methods of dissecting the vesicovaginal and rectovaginal spaces which reduce trauma to the patient and are less time consuming.
Compared to manual dissection, a less traumatic form of dissection is that accomplished by inflation of a balloon. Balloon dissection is blunt by nature, and tends to minimize bleeding, particularly if the balloon is left in place briefly after inflation as a tamponade. Additionally, the balloon will tend naturally to find the extremes of the anatomic space. Thus, balloon dissection of the vesicovaginal space (VVS) and rectovaginal space (RVS) will provide a less traumatic form of dissection. In, e.g., U.S. Pat. Nos. 5,496,345, 5,814,060, and 5,514,153, a variety of balloon dissection apparatus and methods of surgical procedures using such apparatus are disclosed, which disclosures are hereby incorporated by reference. Despite the advances disclosed by these references, a need exists for a balloon dissection apparatus adapted for dissecting the VVS and RVS, particularly wherein the balloon dissection apparatus enters these spaces through an incision within the vagina.
SUMMARY OF THE INVENTION
In one innovative aspect of the invention, a balloon apparatus adapted for dissection of the VVS and the RVS is provided. The balloon apparatus comprises a tubular member connected to a proximal housing having a stop wherein a lumen extends through the proximal housing and tubular member. A flattened substantially rectangular balloon constructed from a non-elastomeric material seals about the tubular member. A tunneling member attached to a proximal handle having a stop is slidably disposed within the lumen of the tubular member and proximal housing wherein a seat on the proximal housing may engage the stop located on the proximal handle. The tunneling member may be hollow to accommodate a laparoscope inserted in a port located on the proximal handle. When deflated, the balloon is disposed in a generally cylindrical roll or gathered about the tunneling member. A longitudinally extending sleeve surrounds the deflated balloon to retain the balloon in the generally cylindrical roll about the tunneling member. A weakened region of the sleeve permits the sleeve to separate from the deflated balloon. The weakened region may comprise a series of longitudinally extending co-linear perforations of the sleeve. A balloon inflation tube in fluid communication with the interior of the balloon is provided for connection to an inflation source. When the stop of the handle and the seat of the proximal housing are engaged and the sleeve surrounds the deflated balloon, the distal end of the tunneling member is adjacent the distal end of balloon wherein the tunneling member, the balloon, and the sleeve form a blunt-tipped tunneling assembly.
In a preferred embodiment, the balloon comprises a distal portion and a substantially heel-shaped portion extending proximally at an oblique angle from the distal end of the tubular member. The heel-shaped portion is inverted into the balloon when the balloon is deflated. A retainer prevents the heel-shaped portion from everting. The retainer may comprise a number of alternate embodiments. In one embodiment, the retainer comprises a modification of the longitudinal perforations wherein the perforations comprise a proximal portion and a distal portion. The proximal portion of the longitudinal perforations, which is located adjacent the heel-shaped portion of the balloon, contains perforations spaced apart a first predetermined distance. The perforations of the distal portion are spaced apart a second predetermined distance, wherein the first predetermined distance is greater than the second predetermined distance, thereby inhibiting separation of the perforations in the proximal portion relative to the distal portion. In another embodiment, the retainer may comprise a ring-shaped member disposed about the tunneling member. The distal end of the inverted heel-shaped portion is attached to the ring-shaped member. Displacing the tunneling member proximal to the ring-shaped member releases the heel-shaped portion of the balloon. In yet another embodiment, the retainer may comprise an external ring-shaped member disposed about the sleeve surrounding the deflated balloon. The external ring-shaped member overlaps the inverted heel-shaped portion of the balloon. A connector attached to the external ring-shaped member allows a clinician to proximally withdraw the external ring-shaped member, releasing the inverted heel-shaped portion of the balloon. In yet another embodiment, no retainer is necessary; the frictional resistance of the inverted portion to becoming everted acts as a “retainer” for the inverted heel-shaped portion.
In another innovative aspect of the invention, methods of dissecting an anatomical space (either the RVS and VVS) using the balloon apparatus are provided. The clinician makes an incision to provide access to the anatomical space. With the sleeve maintaining the deflated balloon in a generally cylindrical roll about the tunneling member, and with the stop and seat engaged so that the distal end of the tunneling member is adjacent the distal end of balloon wherein the distal ends of the tunneling member, the balloon, and the sleeve form a blunt-tipped tunneling assembly, the clinician inserts the tunneling assembly into the incision in the anatomical space. The clinician then advances the tunneling member for a sufficient distance into the space such that the balloon may access the space, whereupon t
General Surgical Innovations Inc.
Mendez Manuel
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