A number of surgical procedures are well-known in the arts for affixing tissues to each other, thereby repairing their abnormal pathophysiologies. As an example, tissues that have become inordinately lax or stretched or torn can allow structures or organs to become malpositioned, so that their physiologic functions are altered. In certain body areas, the malposition of a structure due to loss of regional support is referred to as “ptosis,” although this term may not be generally used to refer to malposition in certain other body areas, such as the female pelvis. A situation of tissue or organ malposition due to loss of regional support is seen in pelvic conditions such as cystoceles and rectoceles, as well as in frank uterine prolapse or vaginal vault prolapse. Repairing lax, torn or stretched tissues in general may be termed a “pexy.” As another example wherein tissues are affixed to each other to repair their abnormal physiologies, a surgeon may attach two tissues to each other in a non-anatomic relationship to repair an organ's abnormal physiology, as is seen in a Nissen fundoplication for esophageal reflux.
There are many devices found in the patent literature which describe a variety of surgical instruments and fasteners used in the fixation of tissue. The following U.S. patents are examples of the art of vaginal reconstructive surgery: U.S. Pat. No. 4,196,836 to Becht, U.S. Pat. No. 4,261,244 to Becht and Rothfuss, U.S. Pat. No. 4,424,810 to Jewusiak, U.S. Pat. No. 4,934,364 to Green, U.S. Pat. No. 5,125,553 to Oddsen and Ger, and U.S. Pat. No. 5,217,472 to Green, et al. All patents, patent applications and publications referenced herein are hereby incorporated by reference.
Procedures to manipulate soft tissues, thereby to repair laxities or correct other physiological abnormalities, may be performed using either open techniques, wherein a skin incision is made and dissection is carried into the deeper layers of the body until the relevant organs are reached, or using laparoscopy or other minimally invasive techniques, wherein small skin incisions are used for the insertion of various visualizing, manipulating, cutting and suturing tools to reach the involved organs. In all these cases, extensive dissection and manipulation may be required to identify, free up and suture together the tissues, with the accompanying scarring, devascularization, denervation and risk of prolonged anesthesia and possible blood loss.
Laxities in the female pelvic floor provide an example of an anatomic situation where tissue stretch, tearing or relaxation can lead to physiological abnormalities. Defects in this area may be related to past pregnancies and childbearing, or may be related to loss of soft tissue tone after menopause or with aging. Whatever their etiologies, these defects may result in a variety of urogenital abnormalities, such as cystoceles, rectoceles, vaginal prolapse and genuine stress urinary incontinence. Surgical treatment of this condition may be necessary in up to 11% of the female population; there is presently about a 30% failure rate to such surgery, leading either to further surgery or to alternative treatment with appliances such as vaginal pessaries. Either a vaginal, an open or a laparoscopic approach can be used to perform soft tissue reconstruction in this area. When traditional surgical techniques are used to treat laxities in the female pelvic area, incisions may need to be made in the vaginal mucosa and dissection may need to be carried into the spaces between adjacent organs such as the bladder and rectum, which may lead to blood loss, scarring, denervation, and an unacceptably high failure rate. Laparoscopic procedures directed to this anatomic region have both advantages and disadvantages: advantages include improved visualization of particular areas of the pelvic anatomy, shortened hospitalization, decreased postoperative pain and more rapid recovery; disadvantages include the technical difficulties of the dissection, increased operating time and increased hospital cost due to the length of surgery. (MF Paraiso, T Falcone and MD Walters, “Laparoscopic surgery for genuine stress incontinence,” Int. Urogynecol J. 10:237–247, 1999).
Whether surgery is performed using a vaginal, an open or a laparoscopic approach, identification of the anatomic defects to be repaired is crucial. As an example, those laxities of female pelvic area leading to genuine stress urinary incontinence may involve the various suspensory and supporting elements of the vagina, bladder, urethra and neighboring structures. (A Ostrzenski, “Laparoscopic paravaginal repair for genuine stress urinary incontinence,” The Female Patient 22: 31–35, 1997) One of these structures, the pubocervical fascia, can have four types of damage: lateral superior paravaginal, transverse, distal and central. (A C Richardson, J B Lyon, N L Williams, “A new look at pelvic relaxation,” A . J. Obstet. Gynecol. 126:568, 1976).
Vaginal repair of laxity of the anterior vaginal wall (or cystocele) has traditionally involved a procedure called an anterior colporrhaphy (or anterior repair). This technique involves opening the space between the vaginal mucosa and bladder, plicating the tissue under the bladder to create support, trimming off the excess vaginal mucosa, and the reapproximating the mucosal edges. This technique, however, assumes that the anatomic defect is an attenuation of the tissues under the bladder, the endopelvic fascia. Anatomic studies have demonstrated, however, that in most cases, the true anatomic defect is actually a paravaginal defect, that is, a loss of attachment of the superior lateral sulci of the vagina to the pelvic sidewall, at the level of the arcus tendineous fascia pelvis, or “white line”. (A C Richardson, “Paravaginal repair,” pp. 73–80 in Urogynecological Surgery, ed. W G Hurt, Aspen Medical Publishers, Gaithersburg, Md., 1992) It is estimated that over 80% of cystoceles are caused by this defect.
A suitable operation for such a defect is a paravaginal repair. This technique was originally described via a vaginal route by George White, in 1909, but today is more commonly performed abdominally, through a laparotomy incision. The procedure, whether performed via an abdominal, laparoscopic or transvaginal route is technically demanding and has therefore not gained widespread acceptance in the gynecologic community. There remains a need in the art, therefore, for tools and methods that would facilitate this type of soft tissue repair within the female pelvis.
There exists further in the art a need for systems and methods to facilitate soft tissue repair by the affixation of adjacent or related structures, thereby to treat the variety of physiological disorders related to soft tissue laxity and the variety of physiological disorders treatable by buttressing an abnormal structure with adjacent soft tissues. There remains a further need in the art for devices that may be used to coapt soft tissues tightly enough to hold them in place but not so tightly as to cause damage thereto. It is particularly desirable that a device applied to affix soft tissues be removable without causing significant local trauma, in case the device is initially malpositioned or in case the device needs to be removed during a later surgical revision.
A number of tools and methods are known in the art that relate to the repair of soft tissues that have been disrupted by surgery or trauma, for example for the repair of incisions or lacerations. These tools and methods may not be well adapted for addressing the abovementioned clinical problems, where intact soft tissue structures are to be affixed to each other. There remains a need in the art for a system of soft tissue coaptation suitable for holding intact structures to each other, where significant wound healing processes would not be triggered by the specific defect being repaired. Where the anatomic defect being repaired does not trigger wound healing processes, the physician cannot rely upon those natural processes to add strength to tissue coaptation. Therefore, a system to hold intact soft tissue structures together would advantageously provide sufficient force to hold the intact structures together and thereby to overcome the regional laxity, and would furthermore provide a repair of sufficient duration that the previously lax tissues would remain in their repaired positions.