TITLE OF THE INVENTION

NEEDLE DRIVER AND ASSEMBLY BACKGROUND OF THE INVENTION FIELD OF THE INVENTION [0001] This invention relates to urogenital surgery.

DESCRIPTION OF THE RELATED ART

[0002] Female genital prolapse has long plagued women. It is estimated by the U.S. National Center for Health Statistics that 247,000 operations for genital prolapse were performed in 1998. With the increasing age of the U.S. population, these problems will likely assume additional importance.

[0003] The common clinical symptoms of vaginal prolapse are related to the fact that, following hysterectomy, the vagina is inappropriately serving the role of a structural layer between intra-abdominal pressure and atmospheric pressure. This pressure differential puts tension on the supporting structures of the vagina, causing a "dragging feeling" where the tissues connect to the pelvic wall or a sacral backache due to traction on the uterosacral ligaments. Exposure of the moist vaginal walls leads to a feeling of perineal wetness and can lead to ulceration of the exposed vaginal wall. Vaginal prolapse may also result in loss of urethral support due to displacement of the normal structural relationship, resulting in stress urinary incontinence. Certain disruptions of the normal structural relationships can result in urinary retention, as well. Stretching of the bladder base is associated with vaginal prolapse and can result in complaints of increased urinary urgency and frequency. Other symptoms, such as anal incontinence and related bowel symptoms, and sexual dysfunction are also frequently seen with vaginal prolapse.

[0004] Anterior vaginal wall prolapse causes the vaginal wall to fail to hold the bladder in place. This condition, in which the bladder sags or drops into the vagina, is termed a cystocele. There are two types of cystocele caused by anterior vaginal wall prolapse. Paravaginal defect is caused by weakness in the lateral supports (pubourethral ligaments and attachment of the bladder to the endopelvic fascia); central defect is caused by weakness in the central supports. There may also be a transverse defect, causing cystocele across the vagina.

[0005] Posterior vaginal wall prolapse results in descent of the rectum into the vagina, often termed a rectocele, or the presence of small intestine in a hernia sac between the rectum and vagina, called an enterocele. Broadly, there are four types based on suspected etiology. Congenital enteroceles are thought to occur because of failure of fusion or reopening of the fused peritoneal leaves down to the perineal body. Posthysterectomy vault prolapses may be "pulsion" types that are caused by pushing with increased intra-abdominal pressure. They may occur because of failure to reapproximate the superior aspects of the pubocervical fascia and the rectovaginal fascia at the time of surgery. Enteroceles that are associated with cystocele and rectocele may be from "traction" or pulling down of the vaginal vault by the prolapsing organs. Finally, iatrogenic prolapses may occur after a surgical procedure that changes the vaginal axis, such as certain surgical procedures for treatment of incontinence. With regard to rectoceles, low rectoceles may result from disruption of connective tissue supports in the distal posterior vaginal wall, perineal membrane, and perineal body. Jvlid- vaginal and high rectoceles may result from loss of lateral supports or defects in the rectovaginal septum. High rectoceles may result from loss of apical vaginal supports. Posterior or posthysterectomy enteroceles may accompany rectoceles. [0006] Several factors have been implicated as being involved in genital prolapse in women. It is thought that individual women have differing inherent strength of the relevant connective

tissue. Further, loss of connective tissue strength might be associated with damage at childbirth, deterioration with age, poor collagen repair mechanisms, and poor nutrition. Loss of muscle strength might be associated with neuromuscular damage during childbirth, neural damage from chronic straining, and metabolic diseases that affect muscle function. Other factors involved in prolapse include increased loads on the supportive system, as seen in prolonged lifting or chronic coughing from chronic pulmonary disease, or some disturbance in the balance of the structural support of the genital organs. Obesity, constipation, and a history of hysterectomy have also been implicated as possible factors. [0007] As noted, vaginal prolapse and the concomitant anterior cystocele can lead to discomfort, urinary incontinence, and incomplete emptying of the bladder. Posterior vaginal prolapse may additionally cause defecatory problems, such as tenesmus and constipation. Furthermore, apart from the physical symptoms, vaginal prolapse has been shown to result in a lower quality of life for its sufferers, including feeling less attractive, less feminine, and less sexually attractive.

[0008] Vaginal prolapse develops when intra-abdominal pressure pushes the vagina outside the body. In a normal situation, the levator ani muscles close the pelvic floor. This results in little force being applied to the fascia and ligaments that support the genital organs. Increases in abdominal pressure, failure of the muscles to keep the pelvic floor closed, and damage to the ligaments and fascia all contribute to the development of prolapse. In addition, if a woman has a hysterectomy, the vaginal angle may be altered, causing increased pressure at a more acute angle, accelerating the prolapse.

[0009] There are generally two different types of tissue that make up the supportive structure of the vagina and uterus. First, there are fibrous connective tissues that attach these organs to the pelvic walls (cardinal and uterosacral ligaments; pubocervical and rectovaginal fascia). Second, the levator ani muscles close the pelvic floor so the organs can rest on the muscular

shelf thereby provided. It is when damage to the muscles opens the pelvic floor or during the trauma of childbirth that the fascia and ligaments are strained. Breaks in the fascia allow the wall of the vagina or cervix to prolapse downward.

[0010] As noted above, the levator ani muscles close the pelvic floor so the organs can rest on the muscular shelf thereby provided. The levator ani muscles arise from the pubis, the pelvic fascia, and the ischial spine. They insert on the pelvic viscera, coccyx, and the fibrous raphe of the perineum.

[0011] When damage has occurred in the levator muscle, most commonly as a result of obstetric injury, the anatomical defect is noted as a tendency towards a vertical elongation of the levator plate. This downward sagging of the levator plate results in the longitudinal enlargement of the levator hiatus with secondary placement of the cervix and upper vagina upon the levator hiatus. With increased intra-abdominal pressure the defective levator plate is no longer supportive of the downward movement of the uterus, cervix and upper vagina, which are resting upon the levator hiatus, and genital prolapse develops. Over a period of time elongation of the uterosacral and cardinal ligaments will result.

[0012] The cardinal and uterosacral ligaments form a suspensory mechanism that suspends the vaginal apex but allows for some vertical mobility. In the normal woman the cervix will descend to but not below the plane of the ischial spines. Damage to the cardinal uterosacral ligament complex permits the uterus and upper vagina to telescope downwards, like an inverted sock. Complete failure of the cardinal uterosacral ligament complex will result in a "cervix-first" prolapse.

[0013] Anteriorly, the continence mechanism is maintained by the integrity of the suburethral hammock and the insertion of pubo-urethral ligaments into the mid urethra. Posteriorly, the perineal body needs to be firm and substantial in size to allow stretching and

angulation of the vagina around it. Levator muscle distension can have a significant effect on perineal body descent and future pelvic prolape, as well as prolapse recurrence. [0014] Treatment of vaginal prolapse is uncertain, and generally based on the symptoms of the prolapse. If symptoms are more severe, treatment is commonly by either surgery or pessary. Surgical options might include hysterectomy or by uterus-saving procedures. Such procedures may include abdominal or vaginal access routes. Sacralcolpopexy or sacrospinous fixation may be used. Anterior colporrhaphy is often utilized for treatment of anterior vaginal prolapse. In addition, methods of surgical repair using mesh or biological implants, or a combination thereof, to support the prolapsed organ in its appropriate position, have been developed, and may use either a transobturator or vaginal approach. Examples of such methods include those described in U.S. Patent No. 6,911,003, U.S. Patent No. 6,612,977, U.S. Patent No. 6,652,450, U.S. Patent No. 6,802,807, U.S. Publication 2005/0245787 and in U.S. Publication 2005/0245787, herein expressly incorporated by reference.

[0015] Methods of pelvic floor reconstruction that utilize a single incision have been developed. These techniques require anchoring an implant to some tissue of the patient . This tissue may include bone, but bone anchors have not met mass acceptance because of risks (real or perceived) of osteomyelitis and the difficulty in removal. Placement of bone anchors also requires significantly more dissection than most pelvis surgeons desire, and certainly would not be viewed as minimally invasive. The implant may alternatively be anchored to fascia. This is the foundation for most attachment sites, with attachment to Cooper's ligament and the white line (arcus tendineus fasciae) being used most often. The implant may also be anchored to a site on the muscle. Both the obturator and iliococcygeus muscle are relatively easy to access and of the appropriate dimension to serve as anchoring sites. Appropriate locations for anchoring include the pubis, the sacrum, the ischial

tuberosity, Cooper's ligament, the white line, the obturator membrane, the levator muscle, and the sacrospinous ligament. Appropriate devices for anchoring include bone anchors, needles, and needle suspensions. Other techniques, such as staples, toggle bolt-like systems, and other types of screws are also possible. Bone anchoring techniques are disfavored. Accordingly, the fundamental requirements for universal application of improved techniques include that the surgery be minimally invasive for the patient as appealing to the surgeon. Thus, it should be easy to use, applicable to all pelvis sizes and architecture, safe for staff and patient, able to attach to all soft tissues, of an ergonomic design, and capable of ambidextrous use.

[0016] Several problems have been associated with such methods of pelvic floor reconstruction. The instrumentation is perceived to be brutal, and the surgery is perceived to be difficult. Surgeons perceive that the distance from the incision to the anchoring site is too great, or that the approach is otherwise undesirable. For example, if the approach involves a skin to obturator membrane pathway, a stab wound in the skin is necessitated a stab wound in skin, along with an additional small incision. If the approach involves a pathway from the skin at the buttocks to the "white line" (Arcus tendineus fasciae), the problems are the same, with the additional concern of potential buttock pain post procedure. Further, there remain concerns regarding potential migration of needle to vital structures, and possibly imprecise placement of anchoring point to desired site.

[0017] The newer approaches to pelvic floor reconstruction also often require reaching the tip of a needle to attach a connector. This, too, is perceived to be difficult. Surgeon's express frustration in gaining adequate exposure to the site of attachment. Surgeon's may have a tendency to use less than optimum technique to avoid this exposure problem. For example, in certain surgical procedures, an arm of an implant must penetrate the pelvic floor from laterally to medially to create an anchoring site high up in the pelvis. Surgeons may

compromise correct attachment by their tendency to "bring the needle out" for connection purposes, resulting in loss of the desired attachment location. Surgeons also experience difficulty in establishing an angle of attachment of a needle tip to connector. [0018] Consequently, there is a need for tools to improve the acceptability of improved methods of repair of pelvic organ prolapse and pelvic floor reconstruction. Particularly needed are methods and tools for assisting the surgeon in connecting an implant to its appropriate anchoring site. The key features of such improved methods include use of a single incision, a flexible device to accommodate all pelvis architectures, single hand application allowing the surgeon to control the procedure, safety for the staff in placing an implant, intuitive application for both surgeon and patient. Such a technique would enjoy a broad opportunity to use in a myriad of surgical applications.

SUMMARY OF THE INVENTION

[0019] The present invention is directed to improved methods and devices for repair of pelvic organ prolapse and reconstruction of pelvic floor of a patient in need thereof. The invention is a system. The system allows for the safe placement of attachment between the implant and the selected anchor site. The system comprises spiral tissue anchors with attached suture, an anchoring system comprising an inner core and an outer sheath. The system may also include a cutting/crimping device for attaching the mesh implant to the attachment sutures, and may include grafts or implants labeled for each compartment i.e. anterior mesh, sling, and posterior mesh systems. The system may also include a needle driver for placing the implant.

BRIEF DESCRIPTION OF THE'DRAWINGS

[0020] A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the

following detailed description when considered in connection with the accompanying drawings, wherein:

[0021] Fig. 1 is a depiction of the spiral anchor of the present invention.

[0022] Fig. 2 is a depiction of the inner core of the present invention.

[0023] Fig. 3 is a depiction of the outer sheath of the present invention.

[0024] Fig. 4 is a depiction of the plastic cap covering the spiral anchor of the present invention.

[0025] Fig. 5 shows another view of the plastic cap covering the spiral anchor of the present invention.

[0026] Fig. 6 shows a slot end of the inner core of the present invention.

[0027] Fig. 7 shows a handle of the inner core of the present invention.

[0028] Fig. 8 shows an end of the inner core of the present invention.

[0029] Fig. 9 shows a disposable clip on an end of the inner core of the present invention.

[0030] Fig. 10 shows a handle of the outer sheath of the present invention.

[0031] Figs. 11 -12 depict removal of the cap of the spiral anchor of the present invention.

[0032] Fig. 13 depicts the loaded device, comprising inner core, outer sheath, and uncapped spiral anchor of the present invention.

[0033] Figs. 14-16 depict use of the device of the present invention.

[0034] Fig. 17 shows the implant of the present invention with the two stage clip of the present invention.

[0035] Fig. 18-20 show an alternative method of attachment of the mesh of the present invention.

[0036] Figs. 21-22 show the crimper-cutter of the present invention.

[0037] Figs. 23-25 show the needle driver of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0038] Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views. The following description is meant to be illustrative only, and not limiting other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description.

[0039] A first embodiment of the present invention is a system for placement of a secure attachment for anchoring a mesh implant into lateral soft tissues in locations which replicate the patients natural attachment sites of the levator and fascial support. An overview of such a system is seen in Figs. 1-3. Fig. 1 depicts a spiral anchor. The anchor may be constructed of metal or a hard plastic polymer. It has a plastic cap covering the sharp point to protect the staff prior to placement, as seen in Fig. 4. The cap is round where the spiral anchor comes out but the opposite end is rectangular with rounded edges, as seen in Fig. 5. These rounded edges allow the cap to fit into an open slot on the patient end of the inner core, Fig. 6. This allows the anchor to remain fixed into the device while it rotates into the tissue. The rectangular section should fit relatively loosely into the inner core to allow it to easily slip off once the surgeon has rotated the end anchor into the tissue as he/she pulls the device out of the operative field.

[0040] Fig. 2 depicts the inner core. The inner core must be pliable to allow angled rotation while inside the outer sheath; yet rigid enough to allow the end with the spiral anchor to rotate when the surgeon twists the end after it is loaded. The material could be of plastic, or metal. There can be a notch in both ends of the inner core to allow the suture to be relatively fixed as the rotation occurs and allow the tail of the suture to come out the end of the device and not become caught while applying the anchor into tissue, as seen in Figs. 7 and 8. [0041] The opposite end of the inner core is corrugated to allow for a gloved hand to apply traction and maintain grip while the thumb and index finger twists the end. There is

optionally a disposable clip on the end that prevents the spiral clip from being exposed out the end of the device prior to direct placement against tissue, as seen in Figs.2 and 9. This maintains the safety to staff and avoidance of the anchor from being exposed to other tissue in the patient as the device is applied to the desired anchoring site.

[0042] Fig. 3 shows the outer sheath of the present invention. The outer sheath serves as the guide for the inner core. The outer sheath does not rotate and this can be held in place by the surgeon's hand. It must be semi-rigid. As a surgeon approaches the operative field, he/she can gently bend the device to allow for entry into both the anterior and posterior compartments, as seen in Figs. 14, 15, and 16. This flexibility allows for perpendicular placement of the spiral anchor flush to the desired location. The length should be sufficient to fit into any pelvis. The end has a handle like a "ski pole", as seen in Figs. 3 and 10, to allow the surgeon to grasp comfortably the device as the opposite hand guides its end into the operative field. The groves should accommodate at least the third, fourth, and fifth fingers, as the thumb and index finger will be use to twist the anchor into place. [0043] Both the inner core and the outside sheath must be flexible to allow for varying degrees of angular bending allowing a broad range of placement options. The key principle is that the inner core must be able to rotate as the surgeon twists the end against the tissue in a perpendicular direction. The outer core must not only be flexible but also hold its position as it is bent into position. The inner core must be flexible enough to accommodate the outer bending. This is critical that the device has such flexibility. This gives the surgeon the ability to bend the device into any lateral placement area of the pelvis. A surgeon would be able to slightly bend the device to anchor in the posterior compartment against the white line, ileococcygeous or the sacrospinous ligament. A greater degree of bending would be required to access the inner obturator foramen or more anterior segment of the white line. This degree of flexibility accommodates any pelvis of any patient.

[0044] As an example of use of the present system, the patient may be properly prepared for surgery. During the operation, the circulator unwraps the system and places the anchoring system on the operative field. The surgeon selects the mesh packaged for the procedure indicated and it is opened. Individual spiral tissue anchors (or in pairs) are opened as needed. [0045] The surgeon dissects the compartment to be repaired with a single central incision, and exposes the tissue to serve as the fixation point for the spiral tissue anchor. While the surgeon dissects the appropriate space the surgical tech inserts the anchor into the end of the inner core and places the inner core into the outer sheath. The protective cap is removed with the spiral anchor recessed into the end of the sheath to prevent injury, as seen in Figs. 11 and 12. The safety clip is left on the space between the inner core and handle, to be removed by the surgeon after the end of the device is in place against the appropriate fixation point. [0046] The surgeon then gently shapes the sheath to allow easy placement of the anchoring device to the operative field, as seen in Figs. 14-16. One finger guides the end of the device into the point of placement, i.e., the obturator fascia, white line, ileococcygeus, or sacrospinous ligament. The opposite hand holds the device securely with the "ski pole" grip. Once the end of the device is against the desired anchoring point the safety clip is removed and the surgeon gently plunges the end into place against the resistance felt by the tissue, as in Fig. 13. With one finger of the opposite hand verifying location, the hand holding the device twists the anchor into place with the index finger and thumb. The device is removed leaving the anchor in place with the attached suture. The surgeon gently "tugs" on the suture to verify the anchor has achieved adequate placement to allow for a secure site to support the mesh in place.

[0047] The desired graft or implant is brought into the operative field and applied to the sutures with the method selected by the design team. Two methods are preferred, those being two stage crimping or free hand tying.

[0048] A two stage crimper/cutter is a preferred embodiment of the present invention, as seen in Figs. 21-22. If the two stage crimping method is used, the suture is attached to the ends of the mesh using a two stage crimp. The crimper is applied. The first stage applies gentle pressure against the suture to avoid spontaneous slippage, but still allows the surgeon to slide the mesh further toward the anchor or away until all anchors are attached to the arms of the mesh. The crimping device can then crimp the second stage and secure the mesh into exact location. By incorporating a method of cutting the suture into the crimping device the surgeon can quickly crimp and cut with the same final motion once the mesh has been adjusted into final position.

[0049] Alternatively, the suture and mesh may be attached by free hand tying, as seen in Figs. 18 and 20. In this embodiment, the spiral Anchor incorporates an islet opening in its base that inserts into the inner core, as in Fig. 19. A surgical tech can thread the suture of choice that a surgeon selects. Both ends are brought out through the notches so when the anchor is secured into the tissue, two strands are brought out. The surgeon then threads the ends through the holes in the mesh arms and ties each arm into the operative field, as seen in Fig. 20. This allows the surgeon to lay the mesh up into the field and apply tension based on the tension placed on the knots attached to the short mesh arms. This provides a simple method of attachment. It is still important to have mesh arms to allow the knots to move laterally away from the incision lines and away from the vaginal epithelium. Once the defect is corrected the single incision is closed.

[0050] Another embodiment of the present invention is the needle driver, seen in Figs. 23- 25. In a preferred embodiment, this needle driver is curved and serves multiple tasks. As an alternative for attachment to the obturator fascia, the needle driver passes a toggle bolt into the obturator fascia and injects anesthetic as the needle moves through the space, Fig. 24. It also hydro dissects once passing through the obturator. The device comprises a plunger,

which advances the toggle into the space lateral to the obturator membrane, Fig. 25. The device is controlled via a thumb control. Following placement, the toggle with suture is attached to the mesh implant as described earlier. The toggle may be of two designs. The first opens after full penetration through the obturator. The second embodies the ability to expand laterally as it exits the needle tip and is advanced into the appropriate tissue plane i.e. white line, ileococcygeous, sacrospinous ligament or the obturator foramen. [0051] The system of the present invention is preferably single use. A single device has the ability to perform all the attachments for all the procedures. There would be no need for multiple needles or packages. It is envisioned that the spiral tissue anchors may be provided separately packaged to allow for individual use depending on the number of anchoring sites the surgeon selects. For example, one package may be useful for a mid-urethral sling and posterior compartment apical support, and two packages may be useful for anterior compartment support.

[0052] U.S. Publication 2005/0245787, U.S. Publication 2005/0250977, U.S. Patent 6,802,807, U.S. Patent 6,911,003, U.S. Patent 7,048,682, and U.S. Patent 6,971,986 are herein incorporated by reference.

[0053] Obviously, numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.