APPARATUS AND METHOD FOR PELVIC ORGAN PROLAPSE REPAIR
BACKGROUND Field
The disclosure relates to a surgical method for pelvic organ prolapse repair and to an apparatus used in such surgical repair. In greater detail, the disclosure relates to a surgical graft comprising a macroporous mesh material used in the surgical repair of pelvic organ prolapse and related stress urinary incontinence. The disclosure also relates to a method for surgical repair of pelvic organ prolapse which employs the graft comprising a macroporous mesh material. The disclosure also relates to the use of a surgical glue comprising fibrinogen and thrombin both in conventional surgical methods for pelvic floor repair and in methods employing the graft material described above.
Description of the Related Art Pelvic Organ Prolapse
Approximately 50% of parous women lose pelvic floor support to an extent which results in prolapse of pelvic organs. Approximately 10% - 20% of these women will seek medical care for their symptoms. In America, more than 200,000 women undergo surgical treatment for pelvic organ prolapse every year, and the lifetime risk for an American woman to undergo such an operation is approximately 11%. Furthermore, the risk of experiencing prolapse increases with additional births; the risk in multiparous women is approximately six to twelve times that in primiparous women. Furthermore, approximately 10% - 25% of women age 15 - 64 experience syndromes related to pelvic organ prolapse. Pelvic organ prolapse in women can manifest, for example, as stress urinary incontinence, urgency incontinence, obstructive voiding symptoms, pelvic pressure and bloating, or chronic constipation. Symptoms vary depending on the degree of prolapse and whether the bowels and rectum or bladder are contributing to the prolapse.
Both continence and total pelvic organ support depend on the pelvic floor, and specifically on the strength of the muscles and connective tissue thereof. Stress urinary incontinence may in part be caused in alterations in the metabolism of collagen and elastin that makes up the connective tissue. For example, incontinent women have been shown to have a greater number and activity level of matrix metalloproteinases, which tend to degrade connective tissue, than do continent women, and women with stress urinary incontinence have been shown to have a lower collagen content in their endopelvic fascia and skin.
As a result, the simple replacement of natural biomaterial such as connective tissue has been thought to be ineffective over the long term, and surgical repair of pelvic organ prolapse and incontinence surgery therefore often involves the use of artificial graft materials. The conventional wisdom as to the proper materials to be employed in the surgical repair of pelvic organ prolapse has evolved in conjunction with modern general surgical concepts of abdominal hernia repair. At first, such repairs relied on the re-establishment of interconnection between the adjacent tissues. However, the use of tension-free biologic grafts eventually became widely accepted, and recently, the use of synthetic biocompatible materials has provided the most durable repair results. Because the methods for surgically correcting pelvic organ prolapse take advantage of developments in abdominal repair, the synthetic graft materials employed have been selected with a view to the strength and durability that is required in reconstructive surgery of the abdominal wall and the repair of groin hernias. As a result, the most popular and effective synthetic implants employed to date in the repair of pelvic organ prolapse are made from relatively strong polymeric fibers woven or knitted into a mesh. The strength of such meshes is generally linked to the type and number of fibers employed therein; meshes having a larger number of fibers, with smaller interstitial spaces, or "pores," generally have a higher strength. The polypropylene meshes employed in general abdominal surgery have generally had a pore size of greater than 75 square microns, to permit access to fibroblasts and collagen and immune cells to scavenge for bacteria. Commercially available meshes used in abdominal surgery have had sizes up to 1,500 square microns, and recent products specifically designed for treatment of pelvic organ prolapse and related conditions have pore sizes of up to approximately 2,380 square microns.
A number of problems have been observed when such conventional meshes are used in pelvic organ prolapse repair. Reported vaginal mucosal erosion rates vary from 3% to 25%. In one specific comparison between transvaginal pelvic organ prolapse repair with and without the use of a synthetic graft material, a 25% rate of erosion was observed at 24 months after surgery when the mesh graft was employed. Such erosion can lead to the failure of the graft and the recurrence of prolapse. Attempts have been made to overcome this high rate of erosion by pre-impregnating the mesh material with collagen in an attempt to promote absorption by local tissues under the vaginal lining and thus prevent mucosal erosion. However, such collagen-impregnated graphs do not appear to provide any benefit with respect to mucosal erosion.
Surgeons are thus faced with an unacceptably high rate of erosion as little as two years after surgery, the necessity of re-operation to remove or cover eroded mesh, and frequent failure of pelvic organ prolapse repairs. This is particularly unacceptable given that many women undergo this procedure relatively early in life, and thus face the prospect of recurrence and repeated surgical intervention.
SUMMARY
In another embodiment, a biologically compatible and implantable prosthetic graft material comprising a generally flat, flexible mesh having a length and a width and having pores, at least 30% of the pores having a size from about 2.5 to about 24 mm2, is provided.
In a further embodiment, the size of at least some of the pores is within a range of 3-
15 mm2.
In a further embodiment, the size of at least some of the pores is within a range of 4-
12 mm2. In a further embodiment, the size of at least some of the pores is within a range of 5-9 mm2.
In a further embodiment, the width is suitable for use in a surgical procedure for pelvic organ prolapse repair.
In a further embodiment, the width is within a range of 9-11 cm.
In a further embodiment, the width is approximately 10 cm.
In a further embodiment, the length is within a range of 12-22 cm.
In a further embodiment, the length is approximately 15 cm.
In a further embodiment, the width is suitable for use in a surgical procedure for the treatment of stress urinary incontinence.
In a further embodiment, the width is within a range of 0.5 - 1.7 cm.
In a further embodiment, the width is within a range of 0.8 - 1.4 cm. In a further embodiment, the width is within a range of 1.0 - 1.2 cm.
In a further embodiment, the length is within a range of 40 - 60 cm.
In a further embodiment, the length is within a range of 45 - 55 cm.
In a further embodiment, the length is within a range of 49 - 51 cm.
In a further embodiment, the graft material further comprises a pair of arms extending in a transverse direction with respect to the length of the graft material.
In a further embodiment, the arms comprise the same material as the graft.
In a further embodiment, the arms comprise a material having a pore size less than that of the graft material.
In a further embodiment, the material is not bioabsorbable.
In a further embodiment, the material comprises a woven polypropylene mesh.
In a further embodiment, the material has a weight of 35-45 g/cm.
In a further embodiment, at least some of the pores contain a sealing agent.
In a further embodiment of the prosthetic graft material, the sealing agent comprises thrombin.
In a further embodiment of the prosthetic graft material, the sealing agent additionally comprises fibrinogen or a gelatin matrix.
In a further embodiment of the prosthetic graft material, the sealing agent comprises a synthetic polymer.
In a further embodiment, the sealing agent is slow setting.
In a further embodiment, a biologically compatible and implantable prosthetic sheet is provided, the sheet comprising a mesh and having pores configured to allow tissues on both sides of the sheet to come into substantial contact immediately after the sheet is implanted.
In a further embodiment, the mesh is formed from woven fibers.
In a further embodiment, the mesh is a fabric formed from knitted fibers.
In a further embodiment, the fibers are monofilament fibers.
In another embodiment, a surgical kit assembly is provided that comprises: a graft comprising the biologically compatible and implantable prosthetic sheet described above, and a sealant agent in an amount effective, when applied to the sheet, to cause all portions of the sheet in contact with surrounding tissue to adhere to the tissue. In a further embodiment of the kit assembly, the sealing agent comprises thrombin.
In a further embodiment of the kit assembly, the sealing agent additionally comprises fibrinogen or a gelatin matrix.
In a further embodiment of the kit assembly, the sealing agent comprises a synthetic polymer.
In another embodiment, a surgical method of pelvic organ prolapse repair is provided that comprises: dissecting a lining of the vagina to accommodate a graft comprising the biologically compatible and implantable prosthetic sheet described above; inserting the graft between the vaginal lining and the pelvic floor; injecting a sealing agent between the graft and the vaginal lining; and surgically attaching the graft to the vaginal lining.
In a further embodiment of the surgical method, the sealing agent comprises thrombin.
In a further embodiment of the surgical method, the sealing agent additionally comprises fibrinogen or a gelatin matrix.
In a further embodiment of the surgical method, the sealing agent comprises a synthetic polymer.
In a further embodiment, the method further comprises applying pressure to the graft and vaginal lining after attachment.
In a further embodiment, the pressure is applied for at least two minutes.
In another embodiment, a surgical method of pelvic organ prolapse repair is provided that comprises: dissecting a lining of the vagina to accommodate a graft comprising a biologically compatible and implantable prosthetic graft material having a length and a width and having pores with a size in a range of 4-12 mm2 and having a pair of arms extending in a transverse direction with respect to the length of the graft material; inserting the graft between the vaginal lining and a pelvic floor; and surgically attaching the graft to the vaginal lining.
In another embodiment, a surgical method of pelvic organ prolapse repair is provided that comprises: dissecting a lining of the vagina to accommodate a graft comprising a nonsynthetic material; inserting the graft between the vaginal lining and a pelvic floor; injecting a sealing agent between the graft and the vaginal lining; and surgically attaching the graft to the vaginal lining.
In a further embodiment, the nonsynthetic material is selected from the group consisting of animal or cadaver submucosa, animal or cadaver dermis, and cadaver or harvested tensor fascia lata or rectus fascia.
In another embodiment, a surgical method of treating stress urinary incontinence is provided that comprises: dissecting a lining of the vagina to accommodate a graft comprising a biologically compatible and implantable prosthetic graft material having a length and a width suitable for use in a surgical procedure for the treatment of stress urinary incontinence and having pores, at least some of the pores having a size from about 2.5 to about 24 mm2; and inserting the graft beneath the urethra.
A further embodiment relates to use of thrombin or a synthetic polymer in the preparation of a medicament for sealing an implantable prosthetic graft to the vaginal lining.
In a further embodiment, the medicament is for sealing the graft in combination with surgical attachment.
In a further embodiment, the graft material is a graft material as described above.
In a further embodiment, the medicament further comprises fibrinogen and/or a gelatin matrix.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows a graft for use in repair of pelvic organ prolapse using a perianal surgical approach.
FIG. 2 shows a graft for use in repair of anterior pelvic organ prolapse using a transobturator needle approach.
FIG. 3 shows a sling-shaped graft for use in providing pubo-urethral support for treatment of stress urinary incontinence.
FIG. 4 shows a schematic view of helical needles employed in the transobturator approach for repair of pelvic organ prolapse.
FIG. 5 shows commercially available helical needles employable in this transobturator approach, together with a commercially available graft. FlG. 6 shows a schematic view of the helical needles of FIG. 4 that are provided with a level device.
FIG. 7 shows a schematic view of a curved needle employed in the perianal approach.
FIG. 8 shows commercially available curved needles employable in the perianal approach, together with a commercially available graft.
FIG. 9 shows a schematic view of needles employed in the surgical procedure for providing pubo-urethral support for treatment of stress urinary incontinence.
FIG. 10 shows commercially available needles employable in the procedure for providing pubo-urethral support for treatment of stress urinary incontinence, together with a commercially available sling-shaped graft.
FIG. 11 shows a schematic view of the needles of FIG. 10 that are provided with a level device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present disclosure relates to materials used in the surgical treatment of pelvic organ prolapse, as well as to methods for employing these materials in the surgical treatment of such prolapses. Conventionally, mesh materials have been employed which vary in pore size from approximately 1 to 2.3 square millimeters. However, such pore sizes do not in general allow for significant contact between layers of tissue on either side of the graft material when it is initially placed in the body; in general, the tissue must grow into the interstitial pores to complete the repair process. The density of the mesh, which is determined by the caliber of the individual strands, can vary from light (about 28 gm/cm) to medium (about 35 to about 45 gm/cm) to heavyweight mesh (greater than about 45 gm/cm). Studies have not demonstrated that there is a significant difference in strength between these categories. These conventional meshes have often been developed with a view to their use in the repair of abdominal hernias, where significant strength is required of the artificial graft. However, in general, pelvic organ prolapse repairs do not fail (i.e., experience erosion of vaginal mucosa) because of tears in the mesh material of the graft itself. Rather, it is the insufficient anchoring of the mesh to the pelvis within the vaginal mucosa which leads to a failure of the prolapse repair. The proper approach to addressing this fault would not be to strengthen the mesh, as has conventionally been attempted, but rather to improve its anchoring in the surrounding vaginal mucosal tissue.
Improvements in anchoring of synthetic mesh, such as the use of the transobturator approach, have greatly reduced the recurrence of prolapse. Rather than recurrence of prolapse caused by weak mesh or insufficient anchoring, erosion rates are rapidly becoming the current technical surgical challenge. What is needed is an improvement in the way in which the graft becomes integrated with the surrounding mucosal tissue so that a strong tissue interface will be formed and the mucosa will not experience erosion.
Therefore, this disclosure fundamentally relates to a biologically compatible and implantable prosthetic sheet, wherein the sheet has pores configured to allow tissues on both sides of the fabric to come into substantial contact immediately after the sheet is implanted. Such a sheet could comprise, for example, woven or knitted monofibers. As described below, the pores should have a size of at least 2.5 square millimeters.
Alternatively, a graft may be employed in the surgery which comprises a mesh in which the pore size employed for the central portion of the graft is greatly increased in comparison to conventional mesh materials. Heretofore, the development of these graft materials was conditioned by their primary use in abdominal surgery, and the requisite strength required in such surgeries led developers of the mesh to consider materials having a pore size of, at most, approximately 2.4 square millimeters. Such a pore size is adequate for the infiltration by individual cells such as macrophages and fibroblasts, and the development of blood vessels and angiogenesis and collagen fibers, which allow for limited tissue ingrowth after the graft has been implanted in the body for some time. However, this pore size is inadequate to allow the mucosal tissue to establish significant tissue to tissue contact via the pores when the graft is implanted. It is speculated that such significant tissue to tissue contact, beginning when the graft is originally sutured in place within the body, is key to significantly decreasing the rate of mucosal erosion following the surgical procedure. At the same time, a larger pore size can be tolerated in the surgical repair of pelvic organ prolapse, because the strength required of the synthetic graft is not as great as in the case of abdominal hernia repair. In general, graft materials which foster substantial tissue to tissue contact when implanted, and have sufficient strength for use in the surgical repair of pelvic organ prolapse, will have a pore size from about 2.5 to about 24 square millimeters, more preferably within a range of 3 - 15 square millimeters, still more preferably within a range of 4 - 12 square millimeters, and even more preferably within a range of 5 - 9 square millimeters. Also, any combination of higher and lower ends of these ranges is included within the scope of this disclosure.
Furthermore, the pore size need not be uniform throughout the graft. Grafts combining any number of different pore sizes within the above ranges are specifically contemplated. Additionally, grafts having some pores that are outside the above ranges, in addition to pores that are within the above ranges, are also specifically contemplated. In an embodiment, approximately 30% or more of the pores have a size within a range of 2.5 to about 24 square millimeters. More preferably, approximately 50% or more of the pores have a size within a range of 2.5 to about 24 square millimeters. Even more preferably, approximately 70% or more of the pores have a size within a range of 2.5 to about 24 square millimeters. Most preferably, approximately 90% or more of the pores have a size within a range of 2.5 to about 24 square millimeters. In a specific embodiment, a graft having some 1 mm pores in addition to some 10 mm pores, for example, is contemplated. The graft should permit significant tissue to tissue contact when implanted.
Furthermore, a medium weight mesh, with a weight of 35-45 gm/cm, is entirely adequate for such uses. Nevertheless, both lighter and more heavyweight meshes can also be used in appropriate circumstances. Thus, mesh weights that vary from as low as about 15 gm/cm (or even lower using high strength materials) to as high as about 200 gm/cm, more preferably from about 20 to about 100 gm/cm, and still more preferably from about 30 (including about 28) to about 70 gm/cm can be used. Also, any combination of higher and lower ends of these ranges is included within the scope of this disclosure.
Materials that are known in the surgical graft arts may be employed for the fibers constituting the mesh. These materials include both bioabsorbable and non-bioabsorbable materials. Examples of bioabsorbable materials include animal or cadaver submucosa, animal or cadaver dermis, cadaver or harvested tensor fascia lata or rectus fascia. However, absorbable prosthetic materials are absorbed by the action of macrophages, which replace the mesh with scar tissue which does not have the same strength as the reinforced tissue. It is therefore preferable that non-bioabsorbable mesh materials be employed. Exemplary non- bioabsorbable materials include polytetrafluoroethylene, polyethylene terephthalate (e.g., Dacron®), and polypropylene. It is well known that single loops of polypropylene suture through the vaginal mucosa are easily incorporated into the mucosa. The individual strands of larger pore mesh made from polypropylene resemble such sutures and will therefore also be incorporated well into the vaginal mucosa. Accordingly, polypropylene is the preferred material for use in the fibers constituting the mesh. In addition, to facilitate manipulation and implantation, the mesh may also be impregnated with a wax, carbohydrate, or other rapidly absorbable matrix. This impregnated substance will rapidly degrade in vivo with no side effects.
In use, the mesh material can be cut to a length and width appropriate for use in the surgical procedure. In general, an appropriately sized mesh for use in pelvic organ prolapse repair has a length within a range of about 10 to about 30 cm, more preferably 12 - 22 cm, and preferably approximately 15 cm, and a width within a range of about 7 to about 15 cm, more preferably from about 9 to about 11 cm, and preferably approximately 10 cm. An appropriately sized mesh for use as a sling in surgical treatment of stress urinary incontinence has a length approximately within a range of about 40 to about 60 cm, more preferably about 45 to about 55 cm, and most preferably about 49 cm to about 51 cm, and a width within a range of about 0.5 to about 1.7 cm, more preferably about 0.8 to about 1.4 cm, and most preferably about 1.0 cm to about 1.2 cm. The mesh may be made of woven fibers or knitted fibers. Again, any combination of upper and lower ends of these ranges is included within the scope of this disclosure.
A preferable configuration for grafts employed in the treatment of pelvic organ prolapse is shown in Figure 1. This configuration is preferentially employed in the perianal surgical approach described below. In Figure 1, reference numeral 101 indicates the central portion of the graft, which comprises the mesh material described above. Reference numeral 102 indicates arms which extend in a transverse direction with respect to the length of the central portion 101. The arms 102 may comprise a mesh material which has a smaller pore size than that of the mesh material of the central portion 101. One reason for employing a material having a smaller pore size for the arms 102 is that these arms 102 benefit from a high degree of friction for successful ingrowth and anchoring in the tissue. However, it is not necessary that the arms have a different pore size than that of the central portion of the graft, and the same material may be used for both the arms and central portion of the graft. The arms are covered with a removable plastic sheath to facilitate movement within the pelvic tissue. The arms may be secured to the central portion of the graft using rivets or any other method known in the art.
Another preferable configuration for grafts employed in the treatment of pelvic organ prolapse is shown in Figure 2. This configuration is preferentially employed in the transobturator surgical approach described below, and chiefly differs from the configuration shown in Figure 1 in that it has two pairs of arms connected to the central portion. In Figure 2, reference numeral 201 indicates the central portion of the graft, which comprises the mesh material described above. Reference numeral 202 indicates a pair of superior arms which extend in a transverse direction with respect to the length of the central portion 201. Similarly, reference numeral 203 indicates a pair of inferior arms which extend in a transverse direction with respect to the length of the central portion 201 and spaced along that direction from the superior arms 202. The arms 202 and 203 may comprise a mesh material which has a smaller pore size than that of the mesh material of the central portion 201. As with the graft employed in the perianal approach, one reason for employing a material having a smaller pore size for the arms 202 and 203 is that these arms benefit from a high degree of friction for successful ingrowth and anchoring in the tissue. However, as described above, it is not necessary that the arms have a different pore size than that of the central portion of the graft, and the same material may be used for both the arms and central portion of the graft. The arms are also covered with a removable plastic sheath to facilitate movement within the pelvic tissue. If necessary, the arms may be secured to the central portion of the graft using rivets or any other method known in the art.
A preferable configuration for a graft employed in the treatment of female urinary incontinence is shown in Figure 3. This configuration differs from the configurations shown in Figures 1 and 2 in that it is a narrow rectangular piece of mesh used as a sling to properly position the urethra, thus mimicking normal pubo-urethral support. In Figure 3, reference numeral 301 indicates a central portion of the graft, which comprises the mesh material described above and which is designed to cooperate with a tensioning suture 302 to maintain the mesh pore shape independent of the tension placed on the graft. The structure of this suture and its interaction with the mesh are described in detail in United States Patent Nos. 7,083,568, 6,971,986, 6,652,450, and 6,612,977, all of which are incorporated herein by reference in their entirety. Reference numerals 303 and 304 indicate the lateral sections of the graft, comprising the same mesh but not cooperating with the tensioning suture, so that the pore size and shape thereof is affected as the sling is tensioned. The tensioning suture 302 serves to transfer mesh adjustment forces from one portion of the mesh to other portions of the mesh, such as the interface between the central portion 301 of the graft and lateral sections 303 and 304. The suture affords effective repositioning of the graft while avoiding undesirable permanent deformation thereof. The suture is preferably threaded along the length of the graft. More preferably, the suture is connected thereto at some points. For example, the suture may be affixed at the junctures between the central portion 301 of the graft and the lateral portions 303 and 304 thereof The lateral portions 303 and 304 may comprise a mesh material which has a different pore size than that of the mesh material of the central portion 301. However, it is not necessary that the lateral portions of the graft have a different pore size than that of the central portion, and the same material may be used for both the lateral and central portions of the graft.
These grafts may be employed in the surgical repair of pelvic organ prolapse or stress urinary incontinence as described below. Three specific surgical procedures, in which the grafts described above are inserted transvaginally with anchoring arms secured by needles inserted using either a transobturator or perianal approach, are described herein for the repair of pelvic organ prolapse or stress urinary incontinence. However, the surgical methods disclosed herein are not limited to these procedures. Any procedure involving a graft used to provide support for pelvic organs, whether to repair prolapse, promote continence, or for any other reason, are also contemplated for use with the graft material described herein, the use of surgical glue described herein, or both. Examples thereof include the transobturator sling, retro-pubic sling, transvaginal sling, tension-free tape sling, transvaginal graft cystocele repair, midurethral sling, sub-urethral sling, and sub-urethral or transobturator male sling. The first exemplary method in which the graft disclosed herein may be used is a surgical procedure for the repair of cases of anterior prolapse in which needles are inserted into the patent using a transobturator approach in order to secure the arms of the graft shown in Figure 2. This method may be used with the grafts described above to treat all types of anterior defects, including central, lateral, proximal, and distal defects. In this approach, helical needles are employed to provide level two anterior vaginal wall support. In brief, the surgical procedure may be accomplished as follows. The preferred incision for anterior repair is first made, deflecting laterally toward the ischial pubic ramis to facilitate needle passage. The cystocele may be reduced with interrupted sutures if required. The needle entry points are then marked on the vulvar skin. The superior incision is at the level of the clitoris. The inferior incision should be approximately 2 centimeters lateral and 3 centimeters inferior from the superior entry point. The needles employed are helical needles such as those depicted schematically in Figure 4. These needles are commercially available from American Medical Systems, as part of the Perigee® system. Figure 5 shows a photograph of these commercially available needles together with the graft that is part of the commercial kit. The needle portion (that is, the part that is not the handle) of the instruments depicted in Figures 4 and 5 has a superior pass with a length of 10.16 cm and an inferior pass with a length of 13.335 cm. Needles having a similar configuration, but which are 15-50% larger, may be employed for obese patients. Similar needles may also be employed which have a level indicator incorporated into the handle that is visible to the surgeon when gripping the handle and that serves to indicate the proper angle at which the needle should be held during entry. A standard bubble-type level of the type used in carpentry may be employed as the level indicator. Examples of the needles provided with these level indicators are shown in schematic form in Figure 6. Figure 6(a) depicts the superior needle, in which the level has an angle of 45° with respect to the longitudinal axis of the handle. Figure 6(b) depicts the inferior needle, in which the level has an angle of 90° with respect to the longitudinal axis of the handle. When the needle is held at the proper angle for entry, the bubble will be centered in the level. Starting with the patient's left side, the superior needle is inserted. The angle of the needle should be approximately 45 degrees from the patient's midline. A finger is placed in the vagina to palpate and to intercept the needle as it passes through the levators. With direct finger guidance, the needle is rotated around the descending ramus and passed through the side wall into the vagina and through the vaginal incision, exiting at the level of the bladder neck. Connectors are then attached to the needle tips, and the mesh arms are pulled through the incisions. This path is then repeated on the patient's contralateral side. The inferior needles are inserted so that the tip of the needle is pointed directly at the ischial spine. A lateral insertion technique has been shown to provide easier insertion and better access to the inferior-medial aspect of the obturator ring. The needle is driven proximally toward the ischial spine. The exit is within 2 centimeters from the ischial spine. After each pass, connectors are attached to the needle tips and each arm is pulled through until the armpit of the graft is at the lateral edge of the cystocele. Once the graft has been customized to the patient and put in position, the inferior arms are adjusted, elevating the anterior wall and bladder into a more normal position. The superior arms are then gently adjusted and placed under the bladder neck. The tension may then be adjusted. After closing the incision, the plastic sheath covering the arms is removed, the mesh arms are cut, and the skin incisions are closed, e.g. with Dermabond®. The mesh should now site underneath the cystocele in a tension free manner, providing comprehensive level two anterior vaginal wall support.
The perianal approach may be employed for the surgical repair of vaginal vault and posterior prolapse in a minimally invasive manner which accomplishes tension-free apical suspension. The procedure begins with the placement of sutures for reference at the apex. The preferred method for apical and posterior wall dissection is employed, leaving approximately 2 centimeters of vaginal wall below the apex intact for attachment. The midline incision is kept to 4 centimeters or less. Two small perianal skin incisions are then made. These points are measured 3 centimeters lateral and 3 centimeters inferior from the anus. The needles employed are curved needles such as that depicted schematically in Figure 7. These needles are commercially available from American Medical Systems, as part of the Apogee® system. Figure 8 shows a photograph of these commercially available needles together with the graft that is part of the commercial kit. The needle portion (that is, the part that is not the handle) of the instruments depicted in Figures 7 and 8 has a length of 17.78 cm. Needles having a similar configuration, but which are 15-50% larger, may be employed for obese patients. The needle tip is inserted through the perianal skin incision with handle oriented in a 12 o'clock position. Throughout the needle pass, the forefinger of the alternate hand is placed in the perirectal space palpating the needle underneath the levator muscle. This hand placement helps protect the rectum by deviating it medially. Passing the needle along the lateral pelvic side wall can maintain safety and avoid trauma to the pudendal nerve and vessels. The needle tip is guided digitally just anterior to the ischial spine. The forefinger is used for palpation as the tip penetrates the illial-coccygeous muscle just anterior to the ischial spine. The mesh arm is connected to the needle tip and retracted to the skin incision. Once positioned underneath the vaginal epithelium and fascia, the graft may be attached to the apex at the points marked at the start of the procedure. The rectal vaginal fascia are closed over the mesh and the vaginal incision is closed. The initial adjustment of the graft is then made by placing fingers at the apex and holding back the vault. The final position of the vault is adjusted by pulling the graft arms. Excess tension should be avoided. The plastic sheaths over the arms are then removed, the mesh ends are cut just below skin level, and the stab incisions are closed, e.g. with Dermabond®. The resulting configuration provides suspension from the ischial spines replicating the original cardinal ligament structure and restoring vaginal access to a normal anatomic position.
The final exemplary method in which the grafts described above may be employed is a the insertion of a sub-urethral sling using a transvaginal approach to ameliorate urethral hyper-mobility and intrinsic sphincter deficiency, which are primary causes of stress urinary incontinence in women. This method employs the sling-shaped graft of Fig. 3. In brief, the surgical procedure may be accomplished as follows. The patient is placed in the dorsal lithotomy position with thighs slightly folded over the abdomen and buttocks, oriented to allow good visualization and vaginal access. The bladder should be empty. A Foley catheter is employed to identify the urethra. The medial border of the obturator foramen is palpated, locating the base of the adductor longus tendon, approximately at the level of the clitoris. At this location, just inferior to the tendon and lateral to the bone, a skin incision is made. This procedure is repeated on the patient's contralateral side. The vaginal incision is made starting approximately 0.5 centimeters below the meatus in the area of the mid-urethra. This area may be infiltrated with saline or lidocane with epinephrine if desired for better visualization and easier dissection. The vaginal incision is laterally dissected. If Metzenbaum scissors are used, the scissors are advanced until the tip touches the inferior portion of the bone, about 1 to 1.5 centimeters. This is performed bilaterally. The surgeon should be able to insert a fingertip into the tunnel created.
Three different needle configurations may be employed, tight helical, wide helical, or C shape, depending on patient anatomy and physician preference. These needle configurations are depicted schematically in Figure 9. These needles are commercially available from American Medical Systems, as part of the Monarc® system. Figure 10 shows a photograph of these commercially available needles together with the graft that is part of the commercial kit. The needle portion (that is, the part that is not the handle) of the central (tight helical) instruments depicted in Figures 9 and 10 have a superior pass with a length of 10.16 cm. Needles having a similar configuration, but which are 15-50% larger, may be employed for obese patients; the wide helical needle shown on the left-hand side of Figures 9 and 10 is an example of such a needle. Similar needles may also be employed which have a level indicator incorporated into the handle that is visible to the surgeon when gripping the handle and that serves to indicate the proper angle at which the needle should be held during entry. A standard bubble-type level of the type used in carpentry may be employed as the level indicator. Examples of the needles provided with these levels are shown in schematic form in Figure 11. In these needles, the level has an angle of 45° with respect to the longitudinal axis of the handle. When the needle is held at the proper angle for entry, the bubble will be centered in the level.
The needle corresponding to the patient's left side is grasped. The needle is oriented so that the tip is perpendicular to the incision on the skin surface. One hand grasps the needle handle. The index finger from the opposite hand is placed in the vaginal tunnel. The thumb from this hand is placed on top of the outer curve of the needle to help advance the needle tip through the obturator foramen and associated soft tissue. The needle tip is inserted and the needle is pushed through the tissue as far as possible, then the handle is rotated with a slight wrist movement onto the finger tip. The needle shaft is kept at 35 to 45 degrees to the sagittal plane of the patient and close to the patient's body. Where needles incorporating level devices such as those depicted in Figure 11 are employed, the proper angle of the needle shaft may be confirmed with reference to the level. The needle is rotated while keeping the needle tip on the finger tip to exit at the vaginal incision. With the needle tip protruding from the vaginal incision, the mesh is connected to the needle using the mesh connectors and the needle is retracted back through the obturator incision following the same path used to advance the needle to the vaginal incision, carrying the mesh with the needle. The mesh is then cut, removing the needle and connector. This sequence is repeated on the patient's other side. Cystoscopy may be performed at the physician's discretion. The ends of the mesh and plastic sheath are then grasped with hemostats or hands to tension it. The mesh is positioned under the urethra without tension. A male scissors, right angle or other appropriate surgical instrument is used between the urethra and mesh to help ensure proper positioning and tensioning. If the patient is under local anesthesia, the bladder may be filled and a Valsalva maneuver or cough may be used to determine proper tension of the mesh. This may not be applicable for every patient, as many patients with stress urinary incontinence will not leak when they are in a supine or lithotomy position. Once positioning is achieved, the plastic sheaths are carefully pulled off, exposing the mesh. The tensioning instrument is kept in place between the urethra and mesh while sliding the plastic sheaths off the sling. This helps prevent the mesh from being positioned too snugly against the urethra while removing the sheaths. If further adjustment of mesh sling position is necessary, the tensioning suture 302 woven into the mesh enables it to be tightened or loosened as desired without compromising mesh integrity. To move the mesh more proximal to the urethra, the ends of the mesh are wrapped around a smooth clamp exiting from the skin incisions and gently pulled. To move the mesh away from the urethra, the clamp is gently pulled between the urethra and mesh away from the urethra, bringing more slack to the portion of the mesh under the urethra. The tensioning suture 302 is held to the mesh so that all stretch of the polypropylene mesh occurs away from the portion proximal to the urethra. Once final hammock position and tension has been achieved, the mesh is trimmed at the insertion points close to skin level and the excess is discarded. A catheter and/or vaginal pack can be used at the surgeon's discretion and a voiding trial may be given when the patient becomes ambulatory.
The disclosure further relates to the use of a surgical sealing agent, such as a glue, in surgical methods for pelvic organ prolapse repair such as those described above. Several type of such glue are commercially available, for example, from Baxter. One such glue contains fibrinogen and thrombin and is sold as Tisseel®. Other glues that may be employed in the disclosed methods and kits and with the disclosed graft materials include glues containing a gelatin matrix and thrombin (commercially available from Baxter as FloSeal Hemostatic Matrix) and glues containing polymers that bond to form a sealant (one such glue, containing two synthetic polyethylene glycols, is commercially available from Baxter as CoSeal® Surgical Sealant). The glue is employed in the surgical procedures just prior to final suture placement in the vaginal lining. A fibrinogen-thrombin-based glue such as Tisseel® sets quite rapidly (within a few seconds) and in some cases it may be desirable to modify the glue by diluting the thrombin solution 10 to 1 to make it slow-setting. "Slow-setting" means a glue that requires at least sixty seconds to set. Slow-setting glue permits the surgeon sufficient time to properly place the graft before placement of the final sutures. The glue need not be made slow-setting in every case, however; the thrombin solution may be diluted to a lesser extent, or may remain undiluted, so long as the surgeon has sufficient time to place the final sutures and close the mucosa over the graft before the glue sets. Glues containing a gelatin matrix and thrombin, such as FloSeal Hemostatic Matrix, and glues containing polymers that bond to form a sealant, such as CoSeal® Surgical Sealant, take from one to two minutes to set, and so no dilution thereof would be necessary. The glue is injected into the space under the graft and the final sutures are placed. The area into which the glue was injected is then subjected to pressure for 3 minutes to set the glue, completing the surgical procedure. A shorter period of pressure may be sufficient when the thrombin solution is less dilute or is undiluted. As a result, in the final configuration the graft is sandwiched between the pelvic floor and the vaginal mucosa, with the surgical glue contributing to hemostasis and holding the graft in place.
The glue may be employed in any surgical method for pelvic organ prolapse repair, and with any conventional graft materials. Although the macroporous mesh grafts described herein are preferred for use in methods in which the surgical glue is employed, the use of the glue with any conventional pelvic organ prolapse repair technique, such as those listed above, is contemplated. The use of the glue with nonsynthetic graft materials, such as the animal or cadaver submucosa, animal or cadaver dermis, cadaver or harvested tensor fascia lata or rectus fascia described above, is specifically contemplated.