JP5248620B2 - Method and apparatus for treatment of anterior vaginal plastic surgery - Google Patents

Description

Detailed Description of the Invention

  Penis implants have been used for decades and offer a selection. The present invention relates generally to the field of urogenital surgery. More particularly, the invention relates to the treatment of vaginal or cervical prolapse and to a device suitable for use in such a procedure.

[Background Technology]
Prolapse of the cervix and vagina occurs when intra-abdominal pressure pushes the vagina out of the body. This condition occurs when the uterus-sacral ligament that holds the vagina in place in the body cavity is severed or damaged. As a result of such damage, the vagina is tilted in the opposite direction. Such tilt is uncomfortable and unhealthy and makes the vagina unsuitable for intercourse.

  Many techniques have been attempted to correct or ameliorate such prolapse and its symptoms, with some success. Non-surgical treatment of prolapse includes means for improving the factors involved in prolapse, including chronic cough, obesity, and constipation. Other non-surgical procedures may include pelvic muscle exercise, or estrogen supplementation. These treatments alleviate symptoms and prevent worsening, but the actual hernia remains. Although vaginal pessary is an early type of non-surgical procedure, complications can arise due to ulceration of the vaginal wall.

  It is expected to obtain a minimally invasive but highly effective device and method that can be used to treat pelvic organ prolapse with minimal or no side effects. Treatment using such a device should reduce pain, risk of manipulation, infection, and postoperative hospitalization. Furthermore, this treatment should also improve the quality of life for the patient.

[Summary of the Invention]
The present invention relates to a method and apparatus for cystocele repair. In one embodiment, the method includes establishing four pathways in tissue near the patient's bladder, introducing a mounting arm into each of these pathways, and placing a support member directly under the patient's bladder. Including the step of arranging. The support member is configured to allow a changeable attachment arm position, wherein the support member has an attachment arm so that the patient's bladder is supported by the support member. Each of which is connected to a support member. By applying this method, the bladder protrudes into the patient's vagina.

  In another embodiment, an apparatus for repairing a cystocele comprises a pair of upper mounting arms and a pair of lower mounting arms, braided support surfaces, and a pair of upper mounting arms and a pair of lower mounting arms. The distance between can be increased or decreased.

  In another embodiment, the present invention provides a kit for repairing cystocele. The kit includes a support device provided with a pair of upper mounting arms and a pair of lower mounting arms. Each of these mounting arms includes a connector configured to be removably associated with the tip of the needle. The kit further includes a first needle-like part and a second needle-like part. The first needle is disposed to extend from the incision on the left side of the patient through the patient's left obturator to the incision in the patient's vagina. At the incision on the patient's left side, the lower left end of the patient's pubic branch ends at the bottom of the patient's left obturator. The second needle is positioned to extend from the incision on the right side of the patient through the patient's right obturator to the incision in the patient's vagina. At the incision on the patient's right side, the lower right end of the patient's pubic branch ends at the bottom of the patient's right obturator.

  In another embodiment, the surgical implant kit includes an adjustable support device having at least two pairs of attachment arms. Each of these mounting arms includes a connector configured to be removably associated with the tip of the needle. Each connector has an opening configured to receive the tip of the needle. Each opening has a different shape. The kit further includes at least two needle-like parts. Each needle has a shape configured to be removably associated with one opening of at least two connectors.

  In another embodiment, the surgical implant kit includes an adjustable support device having at least two pairs of attachment arms, and the distance between each pair of attachment arms is adjustable. Each of the mounting arms includes a connector configured to tie with the tip of the needle, and the connector can be subsequently removed and reattached to the needle. Each connector has a mark on it for identification. The kit further includes at least two needle-like parts.

  In yet another embodiment, the present invention provides a surgical implant kit. The kit includes an adjustable support device having at least two pairs of mounting arms. Each of these mounting arms includes a connector configured to be removably associated with the tip of the needle. The kit further includes at least four needles, each needle having a handle, each handle having a color that matches the color of the corresponding connector.

[Brief description of the drawings]
A more complete appreciation of the present invention, and many of the attendant advantages thereof, will be better understood and readily obtained by reference to the following detailed description when considered in conjunction with the accompanying drawings.

  FIG. 1 is a fragmentary plan view of a changeable mounting arm support device.

  FIG. 2 is a fragmentary plan view of an alternative embodiment of a changeable mounting arm support device.

  FIG. 3 is a side view of the mounting arm of the changeable mounting arm support device according to the present invention.

  FIG. 4 is a plan view of the mounting arm of the changeable mounting arm support device according to the present invention.

  FIG. 5 is a fragmentary plan view of a changeable mounting arm support device modified in accordance with the present invention.

  FIG. 6 is a fragmentary plan view of a changeable mounting arm support device modified in accordance with the present invention.

  FIG. 7 is a close-up view of a knitted pattern of one embodiment of a changeable mounting arm support device.

  FIG. 8 is a close-up view of an alternative knitted pattern of one embodiment of a changeable mounting arm support device.

  FIG. 9 is a plan view of a surgical kit according to an embodiment of the present invention.

  FIG. 10 is an overhead view of an embodiment of the upper right policy portion (upper policy portion held in the surgeon's right hand) according to the present invention.

  FIG. 11 is a plan view from above of an embodiment of the upper right policy portion according to the present invention.

  FIG. 12: is a top view from the bottom part of one Embodiment of the upper right policy-like part concerning this invention.

  FIG. 13 is a left side view of an embodiment of the upper right policy portion according to the present invention.

  FIG. 14 is a right side view of an embodiment of the upper right policy portion according to the present invention.

  FIG. 15 is a front view of an embodiment of the upper right policy portion according to the present invention.

  FIG. 16 is a rear view of one embodiment of the upper right policy portion according to the present invention.

  FIG. 17 is an overhead view from the side without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention.

  FIG. 18 is an overhead view from the front without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention.

  FIG. 19 is a right side view, without a handle, of one embodiment of the shaft of the lower left policy portion according to the present invention.

  FIG. 20 is a plan view from the bottom without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention.

  FIG. 21 is a front view, without a handle, of one embodiment of the shaft of the lower left policy portion according to the present invention.

  FIG. 22 is a front view of an embodiment of a support device having a set of four needles and four connectors, which are matched to each needle using a color.

  FIG. 23 is an overhead view of the distal end of the first needle-like portion and the removable connector according to one embodiment of the present invention.

  FIG. 24 is an overhead view of the distal end of the second needle-like portion and the removable connector according to an embodiment of the present invention.

  FIG. 25 is a front view of a patient showing four incisions through which needles are inserted.

  FIG. 26 is an overhead view of the tip of the upper right policy-like portion inserted into the upper left incision (upper incision on the left side of the patient).

  FIG. 27 is an overhead view of the tip of the upper right policy-like portion that passes through the incision in the vagina.

  FIG. 28 is a front view of the upper right policy portion passing through the incision in the vagina.

  FIG. 29 is an overhead view of the tip of the upper right policy portion connected to the upper right connector (upper connector on the right side of the surgeon).

  FIG. 30 is an overhead view of the upper mounting arm and the disposed support member and the lower mounting arm extending outside the incision in the vagina.

  FIG. 31 is a bird's-eye view of the tip of the lower right policy portion passing through the incision in the vagina.

  FIG. 32 is an overhead view of all of the mounting arms, the disposed support members, and the removed sheath.

  FIG. 33 is a plan view of a cross section of a recovery tool that removes the connector from the tip of the needle during the first phase.

  FIG. 34 is a plan view of a cross section of the recovery tool that removes the connector from the tip of the needle during the second phase.

[Detailed explanation]
Referring to the drawings throughout this specification, member numbers indicate the same or corresponding parts throughout the several views, and FIG. The device 10 is surgically implanted and positioned in a female patient to repair the vaginal forward escape. Using the present invention, central defects, midline defects, or both midline and central defects at once can be corrected. In the embodiment shown in FIG. 1, the device 10 includes two upper mounting arms 12, two lower mounting arms 13, and a support member 40. Each of the mounting arms 12 and 13 has a connector 30. Each of the mounting arms 12 and 13 is covered by a sheath 14. The mounting arms 12 and 13 are connected to the indicating member 40 by known means.

The sheath 14 is preferably made of polyethylene, although various materials (eg, polypropylene, nylon, polyester, or Teflon ^™ ) can be used within the scope of the present invention.

  Mounting arms 12 and 13 are preferably about 19 inches long and about 0.433 inches wide. Mounting arms 12 and 13 are approximately 0.024 inches thick. Mounting arms 12 and 13 are manufactured as knitted 4 mil or 6 mil polypropylene monofilament and heated at about 280-300 ° F. for 5-8 minutes. In one embodiment, the upper member 40 is about 10 cm long, about 5 cm wide, and about 0.021 inches thick. Member 40 is knitted 4 mil polypropylene monofilament and heated at about 310-330 ° F. for 5-8 minutes. Both the mounting arm and upper member have stitches of 27.5 needles / inch (± 2 needles) and 13 needles / inch (± 2 needles).

  In another embodiment, the mounting arm is knitted using the bar settings of bar 1: 1/0, 2/1 and bar 2: 0/1, 1/2. The support member is a large pore mesh, 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 It is knitted using. The mounting arm is connected to the support member after knitting. Weaving according to a given bar pattern is, for example, “Warp Knitting Production” by Dr. S. Raz, Melliand Textilberichte GmbH, Rohrbacher Str. 76, D-6900 Heidelberg, Germany (1987), the contents of which are hereby incorporated by reference. Is incorporated by reference).

  The mounting arms 12 and 13 and / or the sheath 14 may also be provided with markings thereon to indicate the correct orientation for implantation into the patient. The indicia may include various markings, colors, openings, symbols, or combinations thereof. Further, the indicia may be positioned on the mounting arm, the sheath, or both. In the embodiment shown in FIG. 1 or 2, the sheath 14 near the mounting arm 12 is provided with an indicia 12A indicating that the mounting arm 12 is an upper mounting arm, and the sheath 14 near the mounting arm 13 is attached to the mounting arm 12. A mark 13A indicating that the arm 13 is a lower mounting arm is provided.

  The device 10 includes an expansion connector 30. Suitable expansion connectors are disclosed in published US Patent Application Nos. 2002/151762 and 2002/147382, and US Patent Application No. 10 / 386,897 filed on March 11, 2003.

  Prior to implantation, the support member 40 may be shaped based on the patient's anatomy to provide a changeable mounting arm position. The shape of the support member 40 allows the customized mounting arm to repair the cystocele without lifting the patient's bladder or applying excessive pressure on the bladder or vaginal wall. For example, FIG. 1 illustrates a support member configured to maximize the distance between the upper arm 16 and the lower arm 18. Support 40 is cut along line 20 and line 22 to remove area 28. Similarly, support 40 is cut along line 24 and line 26 to remove area 30. This result is the configuration illustrated in FIG. In this configuration, the distance between the upper arm 16 and the lower arm 18 can be maximized. The upper arm 16 is flexible to allow movement to a position substantially parallel to the lower arm 18 or to a position substantially tilted with respect to the lower arm 18.

  An alternative embodiment of a changeable mounting surgical support device is shown in FIG. Prior to implantation, the support member 40 may be shaped to minimize the distance between the upper arm 16 and the lower arm 18. Support 40 is cut along line 42 and line 32 to remove area 38. Similarly, support 40 is cut along line 34 and line 36 to remove area 44. This configuration is illustrated in FIG. In this configuration, the distance between the upper arm 16 and the lower arm 18 can be reduced. The upper arm 16 is flexible to allow movement to a position substantially parallel to the lower arm 18 or to a position substantially tilted with respect to the lower arm 18.

  With reference to FIGS. 3 and 4, an embodiment of a mounting arm for a surgical device is shown. In one embodiment, the attachment arm 12 includes a tensioning suture 17. As shown in FIGS. 3 and 4, the tension applying suture 17 passes through the mesh of the mounting arm 12 a plurality of times. A tensioning suture 17 is affixed to the mounting arm 12 at position 19 to allow transfer of tension from the suture to the mounting arm. In one embodiment, tensioning sutures are provided on all of the mounting arms 12 and 13 of the support device. The tensioning suture 17 is configured to reduce slack in a mounting arm that has been surgically implanted in the body. Rather than pulling the mounting arm itself, the surgeon prevents the mounting arm from being damaged due to out of shape by tightening the mounting arm with a suture. Damage to the surrounding tissue due to excessive movement of the mounting arm during adjustment can also be avoided. The mounting arm 12 also includes a junction for the relaxing suture 16. The relaxation suture 16 is pulled by the surgeon to loosen the installed support member as needed.

  Device 10 can be made from a variety of synthetic and non-synthetic materials. Suitable non-synthetic materials include allografts, homografts, heterografts, autologous tissues, cadaveric membranes, autografts, skin collagen grafts, self fascia heterografts, whole skin grafts, porcine skin collagen, lyophilized Aortic homografts, preserved dural homografts, bovine pericardium, and femoral fascia. Other examples of suitable materials include those disclosed in U.S. Patent Application Publication No. 20000021007294. Suitable examples of synthetic materials include but are not limited to: polypropylene, cellulose, polyvinyl, silicone, polytetrafluoroethylene, polygalactin, Silastic, carbon fiber, polyethylene, nylon®, polyester (eg, Dacron), polyanhydrides, polycaprolactone, polyglycolic acid, poly-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.

  Referring to FIG. 9, in another aspect, the present invention relates to a surgical kit 400. The surgical kit preferably includes at least two upper policy features 70R and 70L. The upper right policy portion 70R is configured to be held by the surgeon's right hand, so that the tip of the needle portion enters the incision on the left side of the patient. In this incision, the patient's left long adductor tendon is inserted in the left part of the patient's pubic branch, to the side of the end of the pubic branch, moves through the top of the left obturator, and the patient's Go out through the incision in the vagina. The upper left policy upper portion 70L is configured to be held by the surgeon's left hand so that the tip of the needle enters the incision on the right side of the patient. In this incision, the patient's right long adductor tendon is inserted in the right part of the patient's pubic branch, to the side of the end of the pubic branch, and moves through the top of the left obturator, Go out through the incision in the vagina.

  In an alternative embodiment of the present invention, the kit may further comprise needles as described in the following U.S. Patent Application Publications and U.S. Provisional Applications: U.S. Patent Application Publication No. 20020023-006S246-Al, 2002-0151762. -A1, 2002-0147382-A1, 2002-0107430-A1, 2002-0099258-A1, and 2002-0099259-A1; and US provisional application number 60 / 263,472 (filed January 23, 2001), 60 / 269,829 (filed Feb. 20, 2001), 60 / 281,350 (filed Apr. 4, 2001), 60 / 295,068 (filed Jun. 1, 2001), 60 / 306,915 (2001) Filed on July 20, 2001), and 60 / 332,330 (filed on November 20, 2001). In an embodiment particularly suitable for surgical procedures beyond an obturator, the needle comprises the needle described in US Provisional Application No. 10 / 306,179 (filed November 27, 2002).

  The various components of the kit of the present invention can be packaged as shown in FIG. Alternatively, the individual components may be packaged separately or in subassemblies that depend on various factors such as shelf life and sterilization requirements. These can be assembled at the manufacturing site or the medical site. Any suitable sterilization procedure can be utilized to sterilize the contents of the kit. Suitable sterilization techniques include, but are not limited to: steam, ethylene oxide, electron beam, vapor (eg, hydrogen peroxide or peracetic acid), gamma procedure or plasma procedure.

  The kit shown in FIG. 9 includes a support device including a mesh support member 40. It should be readily understood by those skilled in the art that kits using biological support members as described above can be made, and that these modifications are within the scope of the invention as claimed. It is. Furthermore, a kit with a biotechnological graft may have a biotechnological graft pre-attached to the mounting arm, or the graft may be separated from the mounting arm, as described below. A surgeon is needed to attach the mounting arm. The kit shown in FIG. 9 is also provided with four needle-like parts, a lower right policy-like part 60R, a lower left policy-like part 60L, an upper right policy-like part 70R, and an upper right policy-like part 70L. Embodiments of these needles are shown in FIGS. 10-21 and are described herein below.

  Figures 10-16 illustrate an embodiment of the upper right policy portion 70R of the present invention. (The upper left policy portion 70L is a mirror image of the upper right policy portion 70R.) The upper right policy portion 70R includes a mark 71R, a handle 72R, a shaft 74R, a curved portion 76R, and a tip portion 78R. When the surgeon holds the needle handle, the mark 71R indicates whether the needle upper portion is the left or right needle by indicating toward the right or left side of the surgeon (surgeon). Corresponds to the patient's left side.)

  An exemplary shaft of the lower left policy feature 60L that does not have a handle 62L is illustrated in FIGS. (The lower right policy portion 60R is a mirror image of the upper left policy portion 60L.) The lower left policy portion 60L includes a handle 62L, a shaft 64L, a curved portion 66L, and a tip portion 68L. The lower left policy feature 60L is configured to be held in the left hand of the surgeon so that the tip portion 68L enters the incision 530L on the right side of the patient. In this incision, the lower right end of the patient's pubic branch ends at the bottom of the patient's right obturator. The tip portion 68L then moves through the right closure hole and exits through the incision in the patient's vagina. The lower right policy portion 60R is configured to be held in the surgeon's right hand so that the tip portion 68R enters the incision on the left side of the patient. In this incision, the lower left end of the patient's pubic branch ends at the bottom of the patient's left obturator. The tip portion 68R then moves through the right closure hole and exits through the incision in the patient's vagina. This is illustrated in FIG. The needle-like portion described above may be disposable or reusable.

  23 and 24 are overhead views of the needle-like portion having a cross-sectional view, which are arranged so as to coincide with the cross-section of the connector opening. FIG. 23 shows that the cross section of the portion 450 of the needle-like tip 478 is a triangle. The cross section of the portion 450 coincides with the triangular opening 460 in the connector 490. FIG. 24 shows that the cross section of the portion 451 of the needle-like portion tip portion 479 is a quadrangle. The cross section of the portion 451 coincides with the rectangular opening 461 in the connector 491.

  In one embodiment, each of the needle tips has a cross-section that matches the cross-section of the corresponding cometor opening, which cross-section does not match the opening of the other connector. For example, the cross section of the portion 450 that is a triangle does not fit into the opening 461 that is a square. The reverse is also true. Thus, even if the connectors are mistaken, it is physically impossible for the surgeon to insert the needle tip into the wrong connector without damaging the needle tip or connector. Other shaped tips and openings are also possible within the scope of the present invention.

  FIGS. 25-32 illustrate an exemplary method for using the surgical support device 10 of the present invention having a mesh support member 40. When performing the surgery, the patient is placed in the quarry position, which is a modified dorsal position, and the legs are raised with the hips and hips bent to the end of the operating table. The patient's bladder is empty. A catheter is not required during this procedure, but may assist in identifying the urinary tract during this procedure. Weighted vaginal retractors or other suitable vaginal retraction can also be used.

  It is then necessary to use a skin pencil to mark the length of the vaginal incision starting from below the bladder neck and beyond the most prominent site of prolapse to the least prolapse site. (Due to individual techniques and patient anatomy, variations can occur in specific incisions.) Incisions are made over this marking. If desired, the incision site may be filled with saline. An Allis forceps is placed on the edge of the incision to expose the incision. The patient's bladder is the lateral groove and dissects the vagina until after the vaginal cavity. This dissection allows palpation of the medial end of the inferior pubic bone and helps advance the upper and lower policy features to the bladder-free exit point. The patient's cystocele can then be reduced with midline plication.

  A marking is then formed to identify the location of the needle entry incision. Vaginal dissection is completed prior to marking the needle entry incision and allows palpation with a finger along the sciatic pubic branch. As will be described later in this specification, the needle entry point is touched with the thumb and index finger from inside and outside before marking.

  The end of the sciatic pubic branch is then palpated. This palpation begins at the level of the vaginal incision and is directed along the bone edges to the level of the clitoris. Here, the long adductor tendon is in the pubic branch. The upper skin incision is marked approximately at this location on the side of the bone edge. The markings are made according to the same method on both sides (right side and left side) of the patient's body. Both markings are lined up approximately at the level of the clitoris. Palpate until the edge of the pubic branch ends at the bottom of the obturator foramen. The lower skin incision is then marked. This lower skin incision is placed at a point 2 cm laterally about 3 cm below the upper marking. These markings are also made according to the same method on both sides of the patient's body.

  A small longitudinal stub incision is made over all four markings to provide an incision for needle entry. Right upper incision 540R, left upper incision 540L, right lower incision 530R, and left lower incision 530L are all shown in FIG. 25 (the right and left for the incision are the right and left sides of the patient).

  The surgical kit described in FIG. 9 is empty. The entire package has been checked to ensure that it will not be defective when shipped, and the kit components have been inspected for damage.

  The following method describes that the mounting arm on the surgeon's right side (the patient's left side) is surgically placed before the mounting arm on the surgeon's left side (the patient's right side). However, it should be readily understood by those skilled in the art that either arm is first installed and such modifications are within the scope of the invention as claimed.

  Subsequently, the tip 78R of the upper right policy portion 70R is inserted through the left upper incision 540L, through the left closing hole, and then through the vaginal incision 524. As shown in FIG. 33, the distal end of the upper right policy-like portion 70R is applied perpendicularly to the skin using the distal end 78R in the upper left incision 540L. The thumb of the surgeon's right hand is on the outer curved surface of the needle and controls the movement of the needle to puncture the membrane and muscle of the obturator. The thumb pushes the needle through the obturator muscle and membrane. The needle shaft and handle are positioned near the patient's body at an angle of 45 ° to the patient's vertical direction. The handle of the needle-like part rotates and the tip of the needle-like part moves. Bend around the posterior surface of the sciatic pubic branch towards the vaginal incision and index finger. (If the tip of the needle hits the pubic bone during rotation, the needle will retract. The tip of the needle then advances beyond the initial penetration depth and rotates again towards the vaginal incision. .) The tip of the needle is palpated with the surgeon's finger. When the finger moves around the pubic branch, it meets the tip of the needle. (If the tip of the needle-like part cannot be located, the needle-like part retracts immediately after the pubic branch and advances again.) As shown in FIGS. 27 and 28, the tip of the needle-like part is The surgeon uses the surgeon's fingers to guide the vaginal incision until the tip extends through the vaginal incision.

  Subsequently, the support member is placed so that the tail of the graft faces outward from the surgeon. As shown in FIG. 36, the upper right connector is connected to the distal end of the upper right policy-like portion, and this distal end extends outside the incision in the vagina. The upper striated connector is closest to the tip of the graft under the bladder neck.

  Prior to connecting the connector, the surgeon makes sure that the self-fixing mesh and graft are not twisted. However, the connector can be removed even once it is fitted onto the needle-like part. This feature of the present invention allows the clinician to make adjustments to the support member 40 when needed. For example, the surgeon may wish to remove region 28 and region 30 of support member 40 to increase the distance between upper arm 16 and lower arm 18. Alternatively, the surgeon may wish to remove region 38 and region 44 of support member 40 to reduce the distance between upper arm 16 and lower arm 18.

  A connector 30 is attached to the needle 78 and this needle rotates to pull the connector and associated insertion sheath and graft through the skin incision and into place. This process is then repeated with the left needle on the right side of the patient.

  It may be desirable to remove the connector 30 from the needle 78 during this procedure. This process is described with reference to FIGS. Connector 30 includes deflector tabs 102 and 104. A recovery tool 106 is used to recover the needle 78 from the connector. The recovery tool 106 has a first inclined surface 108 and a second inclined surface 110. When the tool 106 is moved toward the needle 78, the surface 110 contacts the tab 102 and the surface 108 contacts the tab 104. When the tool is moved closer toward the needle 78, the tab 102 is moved away from the tab 104, as shown in FIG. This configuration allows bending of the nectar 30 that allows the needle 78 to be separated from the connector. Tool 106 may be placed into connector 30 through opening 112. The tool can be removed from the opening or slidably secured, and these are also within the scope of the present invention. It should be understood that it is also within the scope of the present invention for the recovery tool 106 to include various configurations.

  A partially implanted device is shown in FIG. 37, which has an implanted upper mounting arm and support member 40 and a lower mounting arm that extends out of the body through a vaginal incision. . The insertion sheath and mesh are then cut under the mark at the end of the plastic sheath and discarded. This sheath is not removed at this point.

  Subsequently, the tip of the lower right policy portion is inserted through the left lower incision 530L, through the left obturator hole, and then through the vaginal incision. The tip of the lower right policy portion is applied perpendicularly to the skin using the tip in a lower left incision. The surgeon places his right index index finger at the distal end of the vaginal incision and visualizes the distal end of the vaginal incision through which the needle exits, so that the needle outlet is free of the bladder wall Be confirmed. The thumb of the surgeon's right hand is on the outer curved surface of the needle and controls the movement of the needle to puncture the membrane and muscle of the obturator. The thumb pushes the needle through the obturator muscle and membrane.

  The needle shaft and handle are positioned near the patient's body, parallel to the patient's vertical direction. The needle handle rotates and the needle tip moves and bends toward the distal end of the incision in the vagina. The surgeon must use this step with caution to prevent bleeding. The tip of the needle is then palpated as it moves through the distal end of the vaginal incision. The lower right policy feature extending outward from the vaginal incision is shown in FIG.

  A lower right connector is connected to the tip of the lower right policy portion. Also, before connecting the connector, the surgeon makes sure that the self-fixing mesh and graft are not twisted. However, the connector can be removed even once it is fitted onto the needle-like part. The needle rotates to pull the connector and associated plastic insertion sheath and graft into place. This process is repeated using the lower left policy on the right side of the patient.

  The insertion sheath and mesh are then cut under the mark at the end of the plastic sheath and discarded. This step allows the sheath to slide freely with respect to the mesh. This sheath is not removed at this point.

  Subsequently, a cystoscopy is preferably performed to check the integrity of the uterus and bladder. Any vaginal contraction is then removed to allow the mesh tension to be adjusted to reduce bladder swelling. The surgeon verifies that the mesh lies flat and overlaps under the vaginal wall. The upper tip of the support member should be positioned under the bladder neck without application of tension. The lower tail of the support member should be positioned at the distal end of the vaginal incision or toward the vaginal apex without tension.

  If the mesh needs to be loose, an instrument may be placed between the mesh and the vaginal wall and pushed down, or it may be separated from the vaginal wall until the proper tension is obtained. Each of the four plastic sheaths is removed and discarded, ensuring that no excessive tension is applied to the support member graft. Once the plastic sheath is removed, further adjustment is minimized.

  When the mesh needs to be tightened, the tensioning sutures present in the skin incisions on both sides are grasped using hemostatic forceps. The suture is wrapped around the hemostat to improve grip and is pulled to tighten until the proper tension is obtained. To loosen the biotechnological graft, the surgeon uses hemostatic forceps or clamps to pull from each of the sagging relaxation sutures. The surgeon uses a clamp to pull down and loosen the mesh of the mounting arm, if desired. The surgeon should take care to avoid pulling the tab 18 over the relaxation suture 16 to loosen the attachment arm mesh.

  Subsequently, the surgeon cuts one end of each relaxing suture and pulls tab 18 until the entire relaxing suture is removed. The mesh is then trimmed at the level of the subcutaneous tissue and all five incisions are closed. Excess vaginal tissue can be cut off. Variations on this step can occur due to individual techniques and patient anatomy. The final implanted device is shown in FIG.

  After surgery, the catheter and / or vaginal pack can be used at the surgeon's discretion, but should be removed prior to discharge. During this time, antibiotic prophylaxis should be done. The patient's ability to empty the bladder should be confirmed before discharge.

  If a biotechnological graft is used, the following steps are performed before the vaginal incision is made. The biotechnological graft is removed from the package and, if necessary, prepared for each included instruction. A pre-cut biotechnological product is prepared by orienting the graft with a tail pointed to by the surgeon. The graft material is inserted into the open clamp using a printed mark as a guide to the center of the graft. (When the surgical device is placed in the body, the printed side of the plastic sheath faces the surgeon.) Open the clamp to secure the graft material. The desired suture is passed through the clamp using a suture mark as a guide. The suture is then advanced downward using a reverse stitching mark as a guide. The passed suture is then tightened using the surgeon's select knot. If necessary, further connections are created. The clamp suture is cut. Fit the hole in either side of the clamp by advancing the scissors or by pulling down the scissors. The crank is then removed. The clamp attachment suture remains with the clamp. The surgeon evaluated the attachment of the mesh tape of graft material. A protective sheath is slid across the mesh connection to aid in extension.

  The previous step is repeated on the other side of the graft. The suture passes so that all of the attachment knots are on the same side of the graft. The biotechnological product is placed in saline to keep it hydrated for the remainder of the procedure. The graft tail, if necessary, is trimmed to reflect the patient's anatomy during vaginal marking and dissection.

  Furthermore, when using biotechnical products, the surgeon should take care when pulling the mounting arm from the body so that the sheath covers the graft connection and the graft material and graft connection are not damaged.

  All patent applications and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated. Various modifications and variations of the present invention are possible in light of the above teachings. Accordingly, the accompanying drawings and the description herein are presented for illustrative purposes to facilitate understanding of the invention and should not be construed as limiting the scope of the invention. Should be understood.

FIG. 1 is a fragmentary plan view of a changeable mounting arm support device. FIG. 2 is a fragmentary plan view of an alternative embodiment of a changeable mounting arm support device. FIG. 3 is a side view of the mounting arm of the changeable mounting arm support device according to the present invention. FIG. 4 is a plan view of the mounting arm of the changeable mounting arm support device according to the present invention. FIG. 5 is a fragmentary plan view of a changeable mounting arm support device modified in accordance with the present invention. FIG. 6 is a fragmentary plan view of a changeable mounting arm support device modified in accordance with the present invention. FIG. 7 is a close-up view of a knitted pattern of one embodiment of a changeable mounting arm support device. FIG. 8 is a close-up view of an alternative knitted pattern of one embodiment of a changeable mounting arm support device. FIG. 9 is a plan view of a surgical kit according to an embodiment of the present invention. FIG. 10 is an overhead view of an embodiment of the upper right policy portion (upper policy portion held in the surgeon's right hand) according to the present invention. FIG. 11 is a plan view from above of an embodiment of the upper right policy portion according to the present invention. FIG. 12: is a top view from the bottom part of one Embodiment of the upper right policy-like part concerning this invention. FIG. 13 is a left side view of an embodiment of the upper right policy portion according to the present invention. FIG. 14 is a right side view of an embodiment of the upper right policy portion according to the present invention. FIG. 15 is a front view of an embodiment of the upper right policy portion according to the present invention. FIG. 16 is a rear view of one embodiment of the upper right policy portion according to the present invention. FIG. 17 is an overhead view from the side without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention. FIG. 18 is an overhead view from the front without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention. FIG. 19 is a right side view, without a handle, of one embodiment of the shaft of the lower left policy portion according to the present invention. FIG. 20 is a plan view from the bottom without a handle of an embodiment of the shaft of the lower left policy portion according to the present invention. FIG. 21 is a front view, without a handle, of one embodiment of the shaft of the lower left policy portion according to the present invention. FIG. 22 is a front view of an embodiment of a support device having a set of four needles and four connectors, which are matched to each needle using a color. FIG. 23 is an overhead view of the distal end of the first needle-like portion and the removable connector according to one embodiment of the present invention. FIG. 24 is an overhead view of the distal end of the second needle-like portion and the removable connector according to an embodiment of the present invention. FIG. 25 is a front view of a patient showing four incisions through which needles are inserted. FIG. 26 is an overhead view of the tip of the upper right policy-like portion inserted into the upper left incision (upper incision on the left side of the patient). FIG. 27 is an overhead view of the tip of the upper right policy-like portion that passes through the incision in the vagina. FIG. 28 is a front view of the upper right policy portion passing through the incision in the vagina. FIG. 29 is an overhead view of the tip of the upper right policy portion connected to the upper right connector (upper connector on the right side of the surgeon). FIG. 30 is an overhead view of the upper mounting arm and the disposed support member and the lower mounting arm extending outside the incision in the vagina. FIG. 31 is a bird's-eye view of the tip of the lower right policy portion passing through the incision in the vagina. FIG. 32 is an overhead view of all of the mounting arms, the disposed support members, and the removed sheath. FIG. 33 is a plan view of a cross section of a recovery tool that removes the connector from the tip of the needle during the first phase. FIG. 34 is a plan view of a cross section of the recovery tool that removes the connector from the tip of the needle during the second phase.

Claims (11)

A device for repairing a cystocele,
An adjustable support member comprising a substantially diamond-shaped member having a midpoint and a distal end ;
A pair of upper support arms knitted continuously with the support member proximate the midpoint ; and
Proximal to the end, comprising a pair of lower support arms that are knitted continuously with the support member;
The apparatus wherein the distance between the pair of upper support arms and the pair of lower support arms can be increased or decreased by changing the shape of the support member. A kit for repairing a cystocele,
The apparatus of claim 1, wherein a pair of upper mounting arms and a pair of lower mounting arms are provided.
A first needle disposed to extend from an incision on the right side of the patient through the right obturator of the patient to an incision in the vagina of the patient; and on the left side of the patient A second needle-like portion arranged to extend from the incision through the patient's left obturator to the incision in the patient's vagina,
Each of the mounting arms comprises a connector configured to be removably associated with the tip of the needle-like portion;
At the incision on the right side of the patient, the tendon of the patient's right adductor longus muscle enters the right side of the patient's pubic branch to the side of the end of the pubic branch,
A kit in which, at the incision on the left side of the patient, the tendon of the patient's left adductor longus muscle enters the left side of the patient's pubic branch to the side of the end of the pubic branch. Before KiSo location is provided with a biotechnology graft kit according to claim 2. Biological Engineering graft is attached in advance to at least one attachment arm of the two pairs, kit of claim 2. Before KiSo location is provided with a biotechnology graft tied over support member braided kit of claim 2. The kit according to claim 2 , wherein the distance between the upper mounting arm and the lower mounting arm can be reduced by removing a part from the adjustable support member. The kit according to claim 2 , wherein the distance between the upper mounting arm and the lower mounting arm can be increased by removing parts from the adjustable support member. Before KiSo location is,
Support member is knitted using the first bar set; are knitted continuously with and the support member has a plurality of mounting arms,
The kit of claim 2 , wherein the plurality of mounting arms are knitted using a second bar setting. The apparatus of claim 1 having a pair of upper mounting arms and a pair of lower mounting arms; and at least four needles,
Each of the upper mounting arm is provided with a connector that is configured to associate with the tip of the needle-like portion, each connector opening configured to receive removably the tip of the needle-like portion Each opening has a different shape,
A surgical implant kit, wherein each of the needles has a tip having a shape configured to mate with a particular opening in the connector. The kit according to claim 9 , wherein
Each of the connectors has a plurality of deflection tabs movable from a first position to a second position;
The kit, wherein the tip of the needle-like portion is locked to the connector when the deflection tab is in the first position, and the needle-like portion is cleared when the deflection tab is in the second position. The kit of claim 10 , further comprising a removal tool configured to release the needle-like portion from the connector.

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