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WO2009058131A1 - Procédé et appareil pour le traitement de réparations antérieures vaginales - Google Patents

Procédé et appareil pour le traitement de réparations antérieures vaginales Download PDF

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Publication number
WO2009058131A1
WO2009058131A1 PCT/US2007/082990 US2007082990W WO2009058131A1 WO 2009058131 A1 WO2009058131 A1 WO 2009058131A1 US 2007082990 W US2007082990 W US 2007082990W WO 2009058131 A1 WO2009058131 A1 WO 2009058131A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
needle
incision
support member
arms
Prior art date
Application number
PCT/US2007/082990
Other languages
English (en)
Inventor
Karen Pilney Montpetit
Matthew J. Olson
Original Assignee
Ams Research Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ams Research Corporation filed Critical Ams Research Corporation
Priority to CA2704205A priority Critical patent/CA2704205C/fr
Priority to PCT/US2007/082990 priority patent/WO2009058131A1/fr
Priority to BRPI0722130-4A priority patent/BRPI0722130A2/pt
Priority to AU2007360765A priority patent/AU2007360765B2/en
Priority to CN2007801020212A priority patent/CN101902987A/zh
Priority to KR1020107010632A priority patent/KR20100089079A/ko
Priority to EP07854514A priority patent/EP2214588A1/fr
Priority to JP2010532000A priority patent/JP5248620B2/ja
Publication of WO2009058131A1 publication Critical patent/WO2009058131A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings

Definitions

  • the penile implant has been used for decades and provides a selected This invention relates generally to the field of urogenital surgery. More specifically, this invention relates to the treatment of vaginal or vault prolapse and to a device suitable for use in such treatment.
  • Vault or vaginal prolapse develops when intra-abdominal pressure pushes the vagina outside the body. This condition develops when the utero-sacral ligaments, which hold the vagina in position within the body cavity, are severed or damaged. The result of such damage is that the vagina has a tendency to invert which is uncomfortable and unhealthy, and renders the vagina unsuitable for intercourse.
  • Nonsurgical treatment of prolapse involves measures to improve the factors associated with prolapse, including treating chronic cough, obesity, and constipation. Other nonsurgical treatments may include pelvic muscle exercises or supplementation with estrogen.
  • Vaginal pessaries are the primary type of nonsurgical treatment, but there can be complications due to vaginal wall ulceration.
  • a minimally invasive yet highly effective device and method that can be used to treat pelvic organ prolapse with minimal to no side effects.
  • Such a device should reduce the complexity of the surgical procedure, be biocompatible, adjustable, and non-toxic.
  • the treatment methods using the device should reduce pain, operative risks, infections and post operative hospital stays. Further, the method of treatment should also improve the quality of life for patients.
  • the invention includes a method and apparatus for cystocele repair.
  • the method includes the steps of: establishing four pathways in tissue around a bladder of a patient, introducing an attachment arm into each of the pathways, and positioning a support member beneath the bladder of the patient.
  • the support member is configured to allow for a variable attachment-arm position, wherein the support member has each of the attachment arms connected thereto such that the bladder of the patient is supported by the support member. A bulge of the bladder into a vagina of the patient is reduced as a consequence of applying this method.
  • an apparatus for repairing cystocele includes a support surface knitted with a pair of superior attachment arms, and a pair of inferior attachment arms, wherein the distance between the pair of superior attachment arms and the pair of inferior attachment arms can be increased or decreased.
  • the invention includes a kit for repairing cystocele.
  • the kit includes a support apparatus including a pair of superior attachment arms and a pair of inferior attachment arms.
  • Each of the attachment arms includes a connector configured to removably mate with a tip of a needle.
  • the kit further includes a first needle configured to extend from an incision on the left side of the patient where a left inferior edge of the pubic ramus bone of the patient ends at the bottom of the left obturator foramen of the patient, through the left obturator foramen of the patient, to an incision in the vagina of the patient; and a second needle configured to extend from an incision on the right side of the patient where a right inferior edge of the pubic ramus bone of the patient ends at the bottom of the right obturator foramen of the patient, through the right obturator foramen of the patient, to the incision in the vagina of the patient.
  • a surgical implant kit in another embodiment, includes an adjustable support apparatus including at least two pairs of attachment arms, each of the attachment arms comprises a connector configured to removably mate with a tip of a needle. Each connector has an aperture configured to receive the tip of the needle. Each aperture has a different shape.
  • the kit further includes at least two needles, each needle having a tip having a shape configured to removably mate with one aperture of the at least two connectors.
  • a surgical implant kit includes an adjustable support apparatus including at least two pairs attachment arms, wherein the distance between the respective pairs of attachment arms is adjustable.
  • Each of the attachment arms includes a connector configured to mate with a tip of a needle, wherein the connector is capable of being subsequently removed and reattached to the needle.
  • Each connector has identifying indicia thereon.
  • the kit further includes at least two needles.
  • the invention includes a surgical implant kit including an adjustable support apparatus having at least two pairs of attachment arms.
  • Each of the attachment arms includes a connector configured to removably mate with a tip of a needle.
  • the kit further includes at least four needles, each needle having a handle and each handle having a color matching a color of a corresponding connector.
  • Figure 1 is a fragmentary top view of a variable attachment arm support apparatus
  • FIG. 2 is a fragmentary top view of an alternative embodiment of the variable attachment arm support apparatus
  • Figure 3 is a side view of an attachment arm of a variable attachment arm support apparatus of the present invention.
  • Figure 4 is a top view of an attachment arm of a variable attachment arm support apparatus of the present invention.
  • Figure 5 is a fragmentary top view of the variable attachment arm support apparatus that has been modified in accordance with the present invention
  • Figure 6 is a fragmentary top view of the variable attachment arm support apparatus that has been modified in accordance with the present invention
  • Figure 7 is a close up view of the weave pattern of an embodiment of the variable attachment arm support apparatus
  • Figure 8 is a close up view of an alternate weave pattern for the variable attachment arm support apparatus
  • Figure 9 is a top view of a surgical kit of an embodiment of the present invention.
  • Figure 10 is a perspective view of an embodiment of a right superior needle
  • Figure 11 is a top view of an embodiment of the right superior needle of the present invention.
  • Figure 12 is a bottom view of an embodiment of the right superior needle of the present invention.
  • Figure 13 is a left side view of an embodiment of the right superior needle of the present invention.
  • Figure 14 is a right side view of an embodiment of the right superior needle of the present invention.
  • Figure 15 is a front view of an embodiment of the right superior needle of the present invention.
  • Figure 16 is a rear view of an embodiment of the right superior needle of the present invention.
  • Figure 17 is a side perspective view of an embodiment of a left inferior needle shaft of the present invention, without a handle;
  • Figure 18 is a front perspective view of an embodiment of the left inferior needle shaft of the present invention, without a handle;
  • Figure 19 is a right side view of an embodiment of a left inferior needle shaft of the present invention, without a handle;
  • Figure 20 is a bottom view of an embodiment of the left inferior needle shaft of the present invention, without a handle;
  • Figure 21 is a front view of an embodiment of the left inferior needle shaft of the present invention, without a handle;
  • Figure 22 is a front view of an embodiment of a set of four needles and a support apparatus with four connectors, wherein the connectors are matched to the needles using colors;
  • Figure 23 is a perspective view of a first needle tip and removable connector of an embodiment of the present invention.
  • Figure 24 is a perspective view of a second needle tip and removable connector of an embodiment of the present invention.
  • Figure 25 is a front view of a patient showing the four needle entry incisions
  • Figure 26 is a perspective view of a right superior needle tip entering the left superior incision (the superior incision on the patient's left side);
  • Figure 27 is a perspective view of a right superior needle tip exiting the vaginal incision
  • Figure 28 is a front view of a right superior needle tip exiting the vaginal incision
  • Figure 29 is a perspective view of a right superior needle tip connected to the right superior connector (the superior connector on the surgeon's right side);
  • Figure 30 is a perspective view of the superior attachment arms and the support member in place and the inferior attachment arms extending outside the vaginal incision;
  • Figure 31 is a perspective view of a right inferior needle tip exiting the vaginal incision
  • Figure 32 is a perspective view of all the attachment arms and the support member in place and the sheaths removed;
  • Figure 33 is a top cross-sectional view of a removal tool disengaging a connector from a needle tip during a first phase.
  • Figure 34 is a top cross-sectional view of a removal tool disengaging a connector from a needle tip during a second phase.
  • FIG. 1 illustrates a variable attachment surgical support apparatus 10 of the present invention.
  • the apparatus 10 is configured to be surgically implanted in a female patient to repair anterior prolapse of the vagina.
  • the present invention may be used to correct central defects, midline defects, or both midline and central defects at once.
  • apparatus 10 comprises two superior attachment arms 12, two inferior attachment arms 13, and a support member 40.
  • Each of attachment arms 12 and 13 include a connector 30.
  • Each attachment arm 12 and 13 is covered by a sheath 14. Attachment arms 12 and 13 are connected to support member 40 by known means.
  • Sheath 14 is preferably of fabricated of polyethylene, although a variety of materials, such as polypropylene, nylon, polyester, or TeflonTM may be used while remaining within the scope of the invention.
  • the sheath is configured to be removed from the attachment arm after the attachment arm is in the desired position in the body.
  • Attachment arms 12 and 13 are preferably about 19 inches long and about 0.433 inches wide.
  • the attachment arms 12 and 13 are about 0.024 inches thick.
  • Attachment arms 12 and 13 are fabricated of a knit 4 or 6 mil polypropylene monofilament and are heat set at about 280-300 degrees Fahrenheit for 5-8 minutes.
  • support member 40 is about 10 cm long by about 5 cm wide and about 0.021 inches thick.
  • Both the attachment arm and support member have a stitch count of 27.5 courses/inch ( ⁇ 2 courses) and 13 wales/inch ( ⁇ 2 wales).
  • the attachment arms are knitted with bar settings of: Bar 1 : 1/0, 2/1 and Bar 2: 0/1 , 1/2.
  • the support member is a large pore mesh, knitted with bar settings of: Bar 1 : 1/0, 2/3, 2/1 , 2/3, 1/0, 1/2, 1/0, 1/2; Bar 2: 1/0,2/3,2/3, 1/0; and Bar 3: 2/3, 1/0, 112, 1/0, 2/3, 2/1 , 2/3, 2/1.
  • the attachment arms are connected to the support member after knitting. Weaving according to a given bar pattern is described, for example, in "Warp Knitting Production” by Dr. S. Raz, Melliand Textilberichte GmbH, Rohrbacher Str. 76, D-6900 Heidelberg, Germany (1987), the contents of which are incorporated by reference herein.
  • Attachment arms 12 and 13 and or sheaths 14 may also include indicia thereon to signify the correct orientation for implantation into a patient.
  • the indicia may include various markings, colors, apertures, symbols, or combinations thereof. Further, the indicia may be located on the attachment arms, the sheaths, or both.
  • sheaths 14 around attachment arms 12 include indicia 12A to show that attachment arms 12 are the superior attachment arms
  • sheaths 14 around attachment arms 13 include indicia 13A to show that attachment arms 13 are the inferior attachment arms.
  • Apparatus 10 includes dilating connectors 30. Suitable dilating connectors are disclosed in Published U.S. Patent Application Serial Nos. 2002/151762 and 2002/147382 and U.S. Patent Application Serial No. 10/386,897, filed Mar. 11 , 2003.
  • support member 40 Before implantation, support member 40 may be trimmed based on patient anatomy to provide a variable attachment arm position. Shape of support member 40 allows the attachment arm positions to be customized to repair a cystocele without lifting a patient's bladder and without placing undue tension on the bladder or vaginal wall.
  • Figure 1 illustrates a support member configured to maximize the distance between superior arms 16 and the inferior arms 18. Support 40 is cut along lines 20 and 22 to remove section 28.
  • support 40 is cut along lines 24 and 26 to remove section 30. This results in the configuration illustrated in Figure 5. In this configuration, the distance between superior arms 16 and inferior arms 18 can be maximized. Superior arms 16 are flexible to allow for movement to a position substantially parallel to inferior arms 18, or a position substantially skewed to inferior arms 18.
  • variable attachment surgical support apparatus 10 An alternative embodiment of the variable attachment surgical support apparatus 10 is shown in Figure 2. Before implantation, support member 40 can be trimmed to minimize the distance between superior arms 16 and the inferior arms 18. Support 40 is cut along lines 42 and 32 to remove section 38. Similarly, support 40 is cut along lines 34 and 36 to remove section 44. This results in the configuration illustrated in Figure 6. In this configuration, the distance between superior arms 16 and inferior arms 18 can be reduced. Superior arms 16 are flexible to allow for movement to a position substantially parallel to inferior arms 18, or a position substantially skewed to inferior arms 18.
  • attachment arm 12 includes tensioning suture 17.
  • Tensioning suture 17 passes through the mesh of attachment arm 12 multiple times, as shown in Figures 3 and 4.
  • Tensioning suture 17 is affixed to attachment arm 12 at points 19, to allow transfer of tension from the suture to the attachment arm.
  • tensioning sutures are included in all the attachment arms 12 and 13 of the support apparatus.
  • Tensioning suture 17 is configured to eliminate slack in a attachment arm that is already surgically implanted in the body. By tightening the attachment arm with suture 17, rather than pulling on the attachment arm itself, the surgeon prevents damage to the attachment arm due to deformation.
  • Attachment arm 12 also includes a connection point for loosening suture 16. Loosening suture 16 is pulled by the surgeon to loosen the installed support member, if necessary.
  • Apparatus 10 can be fabricated from a variety of synthetic and non-synthetic material.
  • Suitable non-synthetic materials include allografts, homografts, heterografts, autologous tissues, cadaveric fascia, autodermal grafts, dermal collagen grafts, autofascial heterografts, whole skin grafts, porcine dermal collagen, lyophilized aortic homografts, preserved dural homografts, bovine pericardium and fascia lata.
  • suitable materials include those disclosed in published U.S. patent application Ser. No. 200210072694.
  • synthetic materials include, but are not limited to, polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene, polygalactia Silastic, carbon-fiber, polyethylene, nylon, polyester (e.g. Dacron) polyanhydrides, polycaprolactone, polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic acid and polyphosphate esters. See Cervigni et al., The Use of Synthetics in the Treatment of Pelvic Organ Prolapse, Current Opinion in Urology (2001), 11 : 429-435.
  • the present invention includes a surgical kit 400.
  • the kit 400 preferably includes at least two superior needles 7OR and 7OL.
  • Right superior needle 7OR is configured to be held in the surgeon's right hand and such that the tip of the needle enters an incision on the left side of the patient where the left adductor longus tendon of the patient inserts into a left portion of the pubic ramus bone of the patient, lateral to the edge of the pubic ramus bone, and travels through the top of the left obturator foramen to exit through an incision in the vagina of the patient.
  • Left superior needle 7OL is configured to be held in the surgeon's left hand and such that the tip of the needle enters an incision on the right side of the patient where the right adductor longus tendon of the patient inserts into a right portion of the pubic ramus bone of the patient, lateral to the edge of the pubic ramus bone, and travels through the top of the right obturator foramen to exit through an incision in the vagina of the patient.
  • the kits may further include the needles described in published U.S. patent application Ser. Nos. 20023- 006S246-AI; 2002-0151762-A1 ; 2002-0147382-A1 ; 2002-0107430-A1 , U.S.
  • the needles include needles as described in U.S. patent application Ser. No. 10/306,179 filed Nov. 27, 2002.
  • kits of the present invention may be packaged together as shown in Figure 9 with a cover 52 and tray 54.
  • the individual elements may be separately packaged or packaged in subassemblies depending on a variety of factors such as shelf life and sterilization requirements. They may be assembled at the manufacturing location or at the healthcare location. Any suitable sterilization procedure may be utilized to sterilize the contents of a kit. Suitable sterilization techniques include, but are not limited to, steam, ethylene oxide, electron beam, vapor (e.g. hydrogen peroxide or peracetic acid), gamma or plasma procedures.
  • the kit shown in Figure 9 includes a support apparatus including a mesh support member 40.
  • kits using biological support members may be made, and these modifications are within the scope of the invention as claimed.
  • a kit comprising a biologic graft may have the biologic graft pre-attached to the attachment arms, or the graft may be separate from the attachment arms and require the surgeon to attach the attachment arms to the graft, as discussed below.
  • the kit shown in Figure 9 also includes four needles: right inferior needle 60R 1 left inferior needle 6OL, right superior needle 7OR, and left superior needle 7OL. Embodiments of these needles are shown in Figures 10-21 and are described herebelow.
  • Figures 10-16 illustrate an embodiment of right superior needle 7OR of the present invention.
  • Left superior needle 7OL is a mirror image of the right superior needle 7OR.
  • Right superior needle 7OR includes indicia 71 R, handle 72R, shaft 74R, curved portion 76R, and tip portion 78R.
  • Indicia 71 R designates whether the needle is the right or left needle by pointing to the surgeon's right or left side, as the surgeon holds the needle handle. (The surgeon's right side corresponds to the patient's left side.)
  • Left inferior needle 6OL includes a handle 62L, a shaft 64L, a curved portion 66L, and a tip portion 68L.
  • Left inferior needle 6OL is configured to be held in a surgeon's left hand such that tip 68L enters an incision 530L on the right side of the patient where a right inferior edge of the pubic ramus bone of the patient ends at a bottom of the right obturator foramen of the patient, and travels through the right obturator foramen to exit through an incision in the vagina of the patient.
  • Right inferior needle 6OR is configured to be held in a surgeon's right hand such that tip 68R enters an incision on the left side of the patient where a left inferior edge of the pubic ramus bone of the patient ends at a bottom of the left obturator foramen of the patient, and travels through the left obturator foramen to exit through an incision in the vagina of the patient.
  • the above-described needles may be disposable or reusable.
  • Figures 23 and 24 are perspective views of a needle tips having a cross sections that are configured to match the cross sections of a connector aperture.
  • Figure 23 shows that the cross section of portion 450 of needle tip portion 478 is a triangle.
  • the cross section of portion 450 matches triangle shaped aperture 460 in connector 490.
  • Figure 24 shows that the cross section of portion 451 of needle tip portion 479 is a square.
  • the cross section of portion 451 matches square shaped aperture 461 in connector 491.
  • each needle tip has a cross section that matches the cross section of an aperture of the corresponding connector, and the tip cross section is incompatible with the other connector apertures.
  • the cross section of the portion 450 a triangle, would not fit in aperture 461 , a square, and vice versa.
  • Figures 25-32 illustrate an exemplary method for using the disclosed surgical support apparatus 10 having a mesh support member 40.
  • the patient In preparation for surgery, the patient is placed in a modified dorsal lithotomic position with hips flexed, legs elevated in stirrups and buttocks even with edge of the surgical table.
  • the patient's bladder is emptied.
  • a catheter is not required during the procedure, but may aid in identifying the urethra during the procedure.
  • a weighted vaginal retractor or other suitable vaginal retraction may also be used.
  • Markings are then made to identify the locations for needle entry incisions.
  • the vaginal dissection is completed prior to marking needle entry incisions to allow for digital palpation along the ischiopubic ramus.
  • the needle entry points are palpated internally and externally with the thumb and index finger before marking, as discussed hereafter.
  • the edge of the ischiopubic ramus is palpated beginning at the level of the vaginal incision, continuing along the edge of the bone cephalad toward the level of the clitoris denoting where the adductor longus tendon inserts into the pubic ramus.
  • the superior skin incisions are marked approximately at this location and lateral to the edge of the bone.
  • the markings are made according to the same method on both sides (right and left) of the patient's body. Both marks lie in a straight line at the approximate level of the clitoris.
  • the edge of the inferior pubic ramus is palpated until it ends at the bottom of the obturator foramen.
  • the inferior skin incisions are then marked.
  • the inferior skin incisions are located at a point approximately 3 centimeters below and 2 centimeters lateral to the superior marks. Again, the markings are made according to the same method on both sides of the patient's body.
  • a small vertical stab incision is made over all four markings to provide needle entry incisions.
  • Right superior incision 540R, left superior incision 540L 1 right inferior incision 530R, and left inferior incision 530L are all shown in Figure 25. (Right and left with regard to the incisions are the patient's right and left sides.)
  • Tip 78R of right superior needle 7OR is then inserted through left superior incision 540L, through the left obturator foramen, and then through the vaginal incision
  • Tip of right superior needle 7OR is pointed perpendicular to the skin with tip 78R in the left superior incision 540L, shown in Figure 33.
  • the thumb from the surgeon's right hand is on the outside curve of needle to control the needle movement as it perforates the obturator membrane and muscle. The right thumb pushes the needle through the obturator muscle and membrane.
  • the needle shaft and handle is positioned at a 45 s angle to the patient's vertical axis and close to the patient's body.
  • the needle handle is rotated to move the needle tip and curve around the posterior surface of the ischial pubic ramus toward the vaginal incision and index finger. (If the needle tip hits the pubic bone during rotation, the needle is retracted.
  • the needle tip is then penetrated beyond initial insertion depth and rotate again toward the vaginal incision.
  • the needle tip is palpated with the surgeon's finger.
  • the finger meets the needle tip as it moves around the pubic ramus. (If the needle tip cannot be located, the needle tip is retracted to just behind the pubic ramus and advanced again.)
  • the needle tip is guided by the surgeon with the surgeon's finger towards the vaginal incision until the needle tip extends through the vaginal incision, shown in Figures 27 and 28.
  • the support member is then oriented so that the tail of the graft points away from the surgeon.
  • the right superior connector is connected to the tip of the right superior needle, the tip extending out of the vaginal incision, as shown in Figure 36.
  • the superior needle connectors are closest to the leading edge of the graft that will be below the bladder neck.
  • the surgeon Before attaching the connectors, the surgeon ensures that the self-fixating mesh and graft are not twisted. However, the connectors are removable once snapped onto the needle. This feature of the invention enables the physician to make adjustments to support member 40 as needed. For example, a surgeon may wish to remove area 28 and area 30 of support member 40 to increase the distance between superior arms 16 and inferior arms 18. Alternatively, a surgeon may wish to remove area 38 and area 44 of support member 40 to decrease the distance between superior arms 16 and inferior arms 18. [00079] The connector 30 is attached to the needle 78 and the needle is rotated back through the skin incision pulling the connector and associated insertion sheath and graft into position. The process is then repeated with the left needle on the patient's right side.
  • Connector 30 includes deflector tabs 102 and 104. Needle 78 is inserted into connector 30 and locked in place between tabs 102 and 104. To retract needle 78 from connector, removal tool 106 is used. Removal tool 106 includes a first inclined surface 108 and a second inclined surface 110. As tool 106 is moved toward needle 78, surface 110 contacts tab 102 and surface 108 contacts tab 104. As tool is moved closer toward needle 78, tab 102 moves away from tab 104 as shown in Figure 34. This configuration allows for deflection of the connector 30 to enable the needle 78 to separate from connector.
  • Tool 106 can be disposed into connector 30 through aperture 112. Tool can be removed from aperture, or slidably fastened thereto while remaining within the scope of the invention. It shall be understood that removal tool 106 can comprise a variety of configurations while remaining within the scope of the invention.
  • the partially implanted apparatus is shown in Figure 37, with superior attachment arms and support member 40 implanted and the inferior attachment arms extending outside the body through the vaginal incision. The insertion sheaths and mesh are then cut below the indicia on the end portion of the plastic sheath and discarded. This step allows the sheath to slide freely relative to the mesh. The sheaths are not removed at this time.
  • the tip of the right inferior needle is inserted through left inferior incision 530L, through the left obturator foramen, and then through the vaginal incision.
  • the tip of the right inferior needle is pointed perpendicular to the skin with the tip in the left inferior incision.
  • the exit point for the needle is confirmed to be clear of the bladder wall by the surgeon placing their right index finger at the distal end of the vaginal incision and visualizing where needle exits the distal end of vaginal incision.
  • the surgeon's right thumb is on the outside curve of needle to control the needle movement as it perforates the obturator membrane and muscle. The right thumb pushes the needle through the obturator muscle and membrane.
  • the needle shaft and handle is positioned parallel to the patient's vertical axis and close to the patient's body.
  • the needle handle is rotated, moving the needle tip and curve toward the distal end of the vaginal incision. The surgeon must use care during this step to prevent bleeding.
  • the needle tip is then palpated as it moves through the distal end of the vaginal incision.
  • the right inferior needle tip is shown extending outside the vaginal incision in Figure 31.
  • the right inferior connector is connected to the right inferior needle tip. Again, before attaching the connectors, the surgeon ensures that the self-fixating mesh and graft are not twisted. However, the connectors are removable once snapped onto the needle. The needle is rotated back through the skin incision pulling the connector and associated plastic insertion sheath and graft into position. The above process is repeated with the left inferior needle on the patient's right side. [00085] The insertion sheath and mesh are then cut below the indicia on the end portion of the plastic sheath and discarded. This step allows the sheath to slide freely relative to the mesh. The sheaths are not removed at this time.
  • an instrument may be placed between the mesh and vaginal wall and pulled down, or away from the vaginal wall until proper tension is achieved.
  • Each of the four plastic sheaths are removed and discarded, while ensuring the support member graft is not over tensioned. Once the plastic sheaths are removed, further adjustment is minimized.
  • the tensioning suture exiting the skin incision on each side is grasped using a hemostat.
  • the suture is wrapped around the hemostat to improve the grip and pulled up or out to tighten until proper tension is achieved.
  • the surgeon uses a hemostat or a clamp to pull from each of the hanging loosening sutures.
  • the surgeon uses the clamps to pull down and loosen the attachment arm mesh as desired.
  • the surgeon should exercise caution to avoid pulling on tab 18 on loosening suture 16 to loosen the attachment arm mesh.
  • a biologic graft is used, the following steps are performed before making the vaginal incision.
  • the biologic graft is removed from the package and prepared per included instructions, if needed.
  • a precut biologic is prepared by orienting the graft with the tail portion pointing at the surgeon.
  • the graft material is inserted into the open clamp using printed marks as guides to center the graft. (The printed side of the plastic sheath is facing the surgeon as the surgical apparatus is placed in the body.)
  • the clamp is released to secure graft material.
  • a desired suture is passed up through the clamp using a suturing mark as a guide.
  • the suture is then passed down using the opposite suturing mark as the guide.
  • the passed sutures are then secured using the surgeon's knot(s) of choice.
  • the clamp sutures are cut by passing a scissors or a scalpel down the scissors slot on each side of the clamp. The clamps are then removed. The clamp attachment sutures remain with the clamp. The surgeon assesses the attachment of the graft material mesh tape. The protective sheath is slid over the mesh connection to aid deployment. [00092] The preceding steps are repeated on the opposite side of the graft. The sutures are passed such that the attachment knots are all on the same side of the graft. The biologic is placed in a saline bath to keep it hydrated during the remainder of the procedure. The graft tail is trimmed at the time of vaginal marking and dissection to reflect patients anatomy, if needed.

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

L'invention porte sur un appareil pour réparer une cystocèle comprenant un élément de support réglable, une paire de bras de support supérieurs liés de façon continue audit élément de support, et une paire de bras de support inférieurs liés de façon continue audit élément de support. Selon l'invention, la distance qui sépare les deux bras de support supérieurs et les deux bras de support inférieurs peut être augmentée ou diminuée par modification de la forme de l'élément de support.
PCT/US2007/082990 2007-10-30 2007-10-30 Procédé et appareil pour le traitement de réparations antérieures vaginales WO2009058131A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CA2704205A CA2704205C (fr) 2007-10-30 2007-10-30 Procede et appareil pour le traitement de reparations anterieures vaginales
PCT/US2007/082990 WO2009058131A1 (fr) 2007-10-30 2007-10-30 Procédé et appareil pour le traitement de réparations antérieures vaginales
BRPI0722130-4A BRPI0722130A2 (pt) 2007-10-30 2007-10-30 Aparelho para reparar cistocele, método, e, kit para reparar cistocele
AU2007360765A AU2007360765B2 (en) 2007-10-30 2007-10-30 Method and apparatus for treatment of vaginal anterior repairs
CN2007801020212A CN101902987A (zh) 2007-10-30 2007-10-30 用于阴道前部修复治疗的方法和装置
KR1020107010632A KR20100089079A (ko) 2007-10-30 2007-10-30 질내부 치료용 방법 및 장치
EP07854514A EP2214588A1 (fr) 2007-10-30 2007-10-30 Procédé et appareil pour le traitement de réparations antérieures vaginales
JP2010532000A JP5248620B2 (ja) 2007-10-30 2007-10-30 前膣形成術の処置のための方法および装置

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2007/082990 WO2009058131A1 (fr) 2007-10-30 2007-10-30 Procédé et appareil pour le traitement de réparations antérieures vaginales

Publications (1)

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WO2009058131A1 true WO2009058131A1 (fr) 2009-05-07

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EP (1) EP2214588A1 (fr)
JP (1) JP5248620B2 (fr)
KR (1) KR20100089079A (fr)
CN (1) CN101902987A (fr)
AU (1) AU2007360765B2 (fr)
BR (1) BRPI0722130A2 (fr)
CA (1) CA2704205C (fr)
WO (1) WO2009058131A1 (fr)

Cited By (2)

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Publication number Priority date Publication date Assignee Title
EP2155106A1 (fr) * 2007-04-04 2010-02-24 Ajay Rane Trousse de réparation d'avulsion de releveur
US9439676B2 (en) 2012-03-23 2016-09-13 Terumo Kabushiki Kaisha Puncture apparatus

Families Citing this family (2)

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Publication number Priority date Publication date Assignee Title
JP2732750B2 (ja) 1992-03-26 1998-03-30 信越半導体株式会社 Ｃｚ単結晶のドープ装置
AU2008339026B2 (en) * 2007-12-14 2013-05-09 Vonyoon Enterprises, Llc Endoscopic mesh delivery system with integral mesh stabilizer and vaginal probe

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WO2005110274A2 (fr) * 2004-05-07 2005-11-24 Ams Research Corporation Methode et appareil pour reparation des cystoceles

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US7131943B2 (en) * 2000-03-09 2006-11-07 Ethicon, Inc. Surgical instrument and method for treating organ prolapse conditions
US6612977B2 (en) * 2001-01-23 2003-09-02 American Medical Systems Inc. Sling delivery system and method of use

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Publication number Priority date Publication date Assignee Title
WO2003096929A1 (fr) * 2002-05-15 2003-11-27 American Medical Systems, Inc. Implants et procedes de soin pelvien ameliores
WO2005110274A2 (fr) * 2004-05-07 2005-11-24 Ams Research Corporation Methode et appareil pour reparation des cystoceles

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2155106A1 (fr) * 2007-04-04 2010-02-24 Ajay Rane Trousse de réparation d'avulsion de releveur
US9439676B2 (en) 2012-03-23 2016-09-13 Terumo Kabushiki Kaisha Puncture apparatus

Also Published As

Publication number Publication date
AU2007360765B2 (en) 2014-03-13
BRPI0722130A2 (pt) 2014-04-08
CA2704205A1 (fr) 2009-05-07
CN101902987A (zh) 2010-12-01
JP5248620B2 (ja) 2013-07-31
JP2011502020A (ja) 2011-01-20
AU2007360765A1 (en) 2009-05-07
KR20100089079A (ko) 2010-08-11
CA2704205C (fr) 2015-10-27
EP2214588A1 (fr) 2010-08-11

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