KR19990022959A - Surgical apparatus and method for performing laparoscopic urethral fixation, and apparatus for use - Google Patents

Abstract

Disclosed are a surgical apparatus and method for performing laparoscopic urethral fixation for correcting stress incontinence in women, and a device used therein. The device of the present invention includes an anchor for securing a bone, an anchor insertion mechanism, a drill actuation mechanism, a suture retractor, and a template. Urethral fixation is performed by laparoscopically securing one or more anchors to the pubis using an anchor insertion tool and a drill actuator.

Description

Surgical apparatus and method for performing laparoscopic urethral fixation, and apparatus for use

Stress urinary incontinence (SUI) in women, defined as unintentionally losing urine, can be an unacceptable problem for many women. Frequently, these incontinences occur when women who suffer from these problems have physical behaviors such as coughing or sneezing. Although effective surgical treatment has been in place for nearly 50 years, such treatment includes predominantly double surgery, with the limitation of preoperative surgery, which typically takes 6 to 8 weeks. Due to the nature of this surgical treatment, many women are prepared to simply rely on diaper-shaped uncomfortable pads or just refrain from behavior that causes incontinence.

In the normal resting state, the external pressure exerted by the surrounding muscle tissues on the urethra that can be folded is greater than the pressure exerted on the bladder, thus maintaining the excretory function. At the moment of physical activity such as coughing or sneezing, greater pressure is exerted on the dome of the full bladder. In women who do not suffer from stress urinary incontinence, a corresponding increase in external pressure acting on the urethra prevents unwanted urine from the bladder. However, stress incontinence patients do not.

The causes of stress incontinence are classified into two main categories: first, convulsive detrusor muscles, and second, tissues adjacent to the urethra at the urethra vesicular junction (UVJ), the area where the urethra enters the bladder. Loss of support. When the latter situation occurs, these urethral vesicular connections stretch into the vagina, reducing the pressure that can be applied to the urethra at the moment of stress (ie, stress). Countermeasures against sagging urethral vesicular connections can be readily determined by inserting the end of the swab into the urethra until the urethra reaches the urethral vesicular connection. Then, the patient is asked if he can tolerate it as if he is urinating, and the loss of bearing capacity of the urethral vesicular connection is easily confirmed by the upward movement of the wooden end of the swab. In this test, the external urethra acts as a support point for the end of the swab, and the height of the opposite end represents the downward slope of the urethral vesicular connection. U. S. Patent No. 4,072, 144 provides yet another device, which can be used to easily measure the angle of the urethral vesicular connection in a similar manner.

The first urethral fixation treatment to remove stress urinary incontinence due to sagging urethra was developed by Marshall, Maketi, and Cran's side in 1948, which is adjacent to the urethra vesicular junction on either side of the urethra. It is a method of fixing (called MMK treatment). Fixation in MMK treatment is called urethral fixation or anatomical culposuspension, which is accomplished by suturing tissue adjacent to the urethra in the urethral vesicular junction on either side of the urethra to the periosteum of the pubis. This treatment essentially alters the angular relationship between the urethra and the bladder by elevating the urethral vesicular connections, thus preventing sagging of the urethral vesicular connections when downward pressure is applied to these areas by various stresses.

Although MMK treatment has been completed over the years, the main principles remain the same. In 1955, Birch secured the fascia around the urethra to Cooper's ligament.

The method has been developed, which is a technically easier treatment in that the previous method must pass the needle through the periosteum of the pubis. Birch's treatment method was completed by laparoscopy, but the 5-year failure rate for Birch's treatment is 60%. Laparoscopic birch has more problems because it is time-consuming and extremely difficult when connected with sutures performed by laparoscopy.

Alternatively, urological treatments have been developed by Stamei, Laz and Payera, etc., but this is usually about blind treatment, which requires the use of a cystoscope to allow long needles to pass through the rectal fascia to the fascia around the urethra. . This urological treatment could avoid 10 cm midline or Pfannenstiel dissection, but gynecological treatment of MMK or birch was found to be more effective. Indeed, incisions in the urethra and bladder, as well as incisions around the urethra, help to fix all tissues during the treatment of MMK and birch, which helps to prevent urinary incontinence.

Recently, a modified method of MMK treatment has been developed, which uses an anchor anchored directly to the pubic bone on either side of the sumphgsis to fix the urethral vesicular connection. Such modified MMK treatment devices are commercially available from Mytec Surgical Products Inc., Norwood, Massachusetts, USA (see US Pat. Nos. 5,207,679, 5,217,486, and 4,899,743). In the Meitec-MMK treatment, a Pannenstiel dissection must be performed on the abdomen for access to Retzius's space. Regis's space is a potential space in terms of activity, including the various connective tissues and fats that must be dissected to provide sufficient access to these areas. Indeed, these synaptic tissues, particularly areolar adventitial tissues, typically become weak after adulthood, and are the basis for the initiation of stress incontinence in women with debilitating synergistic tissue.

In the Meitec-MMK treatment, once the space of the Regius is incised, a small anchor is secured to the pubis on either side of the genital simphysis. Each anchor is attached to a suture, which is threaded through a tissue adjacent to the urethra on either side of the urethra. The suture is then knotted by the suture, and the tissue adjacent to the urethra is pulled up, which maintains the angle of the urethra at the urethral vesicular connection to maintain the urethra in the proper position. While these Mytec-MMK treatments are very effective, they are complex procedures that can only be performed by highly skilled surgeons.

The present invention provides a novel anchor that can be used for laparoscopic urethral fixation treatment as well as an insertion mechanism for use in securing the anchor in a bore formed inside the patient. Such devices of the present invention are particularly suitable for laparoscopic urethral fixation, but are not limited to this range.

The present invention relates to a surgical device and method for performing laparoscopic urethral fixation for correcting stress urinary incontinence in women, and a device used therein. More specifically, the present invention is to provide a device for performing urethral fixation through laparoscopic technique, to significantly reduce the surgical period, discomfort, and recovery period of such surgery.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings.

1 is a cross-sectional view through the centerline of a patient suffering from stress urinary incontinence due to loss of support of tissue adjacent to the urethra at the urethral vesicular connection.

FIG. 2 is a cross sectional view similar to FIG. 1 showing a state in which structural defects have been corrected using the method and apparatus of the present invention.

3 is a plan view of an anchor for fixing a bone used in the method of the present invention.

4 is a side view of the anchor shown in FIG. 3.

5 is a plan view, in partial cross section, of a drill actuation mechanism according to the invention.

FIG. 6 is a side view of the drill actuator shown in FIG. 5. FIG.

FIG. 7 is an end view of the drill actuator shown in FIG. 5 taken along line 7-7. FIG.

8 is a plan view showing the anchor insertion mechanism of the present invention in a partial cross section.

9 is a side view of the anchor insertion mechanism shown in FIG. 8.

10 is a side view of the anchor insertion mechanism shown in FIG. 8 with the anchor shown in FIG. 3 loaded.

11 is a side view of the suture recoverer according to the present invention.

FIG. 12 is an end view of the suture retractor shown in FIG.

13 is a plan view of a suture line template according to the present invention.

FIG. 14 is a side view of the template shown in FIG. 13. FIG.

15 is a bottom view of the template shown in FIG. 13.

16 is an end view of the template shown in FIG. 13 taken along lines 16-16.

FIG. 17 is a perspective view showing the anatomy of the patient in cross section showing the use of the template shown in FIG. 13 in a surgical procedure.

18 is a perspective view showing another embodiment of a suture line template according to the present invention.

19 is a perspective view showing the anatomical portion of the patient in cross section showing the use of the anchor insertion instrument shown in FIG. 8 in a surgical procedure.

20 is a perspective view showing the anatomy of the patient in cross section and showing the surgical treatment of the present invention in which the suture retractor of FIG. 11 is used.

21 is a perspective view showing the anatomy of the patient in cross section and showing the surgical treatment of the present invention in which the suture is recovered from the reserve area.

Figure 22 is a perspective view showing the proper installation of anchors and sutures and the space of the resistus used in the present invention.

Figure 23 is a side view showing the anchor of the present invention fixed to the pubic bone of the patient as shown in the cross-section of the pubis.

24 is a perspective view of the anchor shown in FIG. 23.

FIG. 25 is a plan view of the anchor shown in FIG. 23. FIG.

FIG. 25A is a side view of the anchor shown in FIG. 23. FIG.

FIG. 26 is a plan view of the anchor shown in FIG. 23. FIG.

FIG. 27 is an end view showing the anchor shown in FIG. 23 from the proximal end toward the distal end; FIG.

Figure 28 is an end view showing another embodiment of the anchor according to the present invention from the proximal end to the distal end.

29 is an end view of another embodiment of the anchor according to the present invention from the proximal end toward the distal end.

30 is a cross sectional view of the anchor of the present invention taken along line 30-30 of FIG.

Figure 31 is a side view of the anchor insertion mechanism of the present invention showing a portion of the anchor insertion mechanism in cross section.

FIG. 32 is a cross-sectional side view of a portion of the anchor insertion mechanism of FIG. 31 loaded with anchors extending from a seam.

33 is a cross-sectional view taken along the line 33-33 of the anchor insertion mechanism shown in FIG.

34 is a cross-sectional view taken along the line 34-34 of the anchor insertion mechanism shown in FIG.

FIG. 35 is a cross-sectional view taken along the line 35-35 of the anchor insertion mechanism shown in FIG. 32. FIG.

According to the present invention, a surgical device for use in the treatment of laparoscopic urethral fixation, which is configured to lift the urethra at a predetermined angle by fixing the suture line between the anchor and the tissue adjacent to the urethra by laparoscopy. A surgical device comprising: (1) at least one anchor that can be secured to the pubis by laparoscopy, (2) an anchor insertion mechanism for securing the anchor to the pubis by laparoscopy, and (3) the A surgical device is provided that includes a suture retrieval mechanism for retracting sutures extending from the anchor into the vagina.

Such a device preferably further comprises at least one suture, and the anchor preferably has a passageway through which the at least one suture can be inserted. More preferably, a pair of said anchor and a pair of said sutures are provided.

In addition, the surgical device further includes a surgical template for guiding the suture line through the fascia and vaginal mucosa near the urethra during the urethral fixation treatment, as well as a bore into which the anchor can be inserted. It further comprises a drill actuating mechanism for forming therein.

In addition, there is provided a surgical method for performing laparoscopic urethral fixation on a patient,

(1) providing at least one anchor and at least one suture line,

(2) laparoscopically fixing the anchor to the pubis of the patient, and

(3) fixing the suture line between the anchor and the tissue adjacent to the urethra to lift the urethra at a predetermined angle.

Preferably, a space of a resist is provided before performing the step of fixing the anchor, wherein the anchor is fixed to the pubic bone adjacent to the space of the resist. In addition, the method further includes the step of forming a bore laparoscopically to the pubic bone, and the step of fixing the anchor to the pubic bone is to laparoscopically insert the anchor into the bore so that the anchor is fixed in the bore. It includes steps.

In this method, the anchor is provided with sutures extending from the anchor, wherein securing the suture line between the anchor and tissue adjacent to the urethra draws the suture line into the vagina through the fascia and vaginal mucosa around the urethra. And suspending the suture in the vagina. Preferably, a pair of anchors is provided, each said anchor having a suture extending from said anchor, each said anchor secured to the pubic bone adjacent to the space of said ledge, and each said suture is a fascia around the urethra. The suture is pulled into the vagina through the vaginal mucosa and then suspended in the vagina to be anchored to the tissue adjacent to the urethra.

Pulling the suture into the vagina through the fascia and vaginal mucosa around the urethra,

(1) providing a seam recovery device having an end portion,

(2) inserting the suture into the patient's vagina through the fascia and vaginal mucosa adjacent to the urethra,

(3) catching the suture with the retriever, and

(4) pulling the suture into the vagina by pulling the end of the retractor back into the vagina.

In addition, a seam template having at least one guide hole may be used. This template is positioned in the patient's vagina so that the guide hole is aligned with the vaginal mucosa adjacent to the urethra, and the suture is drawn through the guide hole of the template. Preferably, the suture has first and second ends, the first and second ends being drawn into the vagina through the fascia and vaginal mucosa around the urethra, respectively, the first end being the second end and the second end. Located at a predetermined distance, suspending the suture in the vagina includes suspending the first end to the second end.

In addition, anchors are provided that can be inserted into holes formed in the bone. These anchors are

(1) a body having a longitudinal axis, a proximal end, and a distal end,

(2) at least three wing members extending outwardly from the body and fixed to the body, each wing member being elastically bent from a normal retarded position to a compressed position, wherein each wing member is A first virtual having a distal end away from the body, wherein at least a portion of each outer end of each wing member penetrates the body at a predetermined angle to a cross section of the body perpendicular to the longitudinal axis; At least three wing members aligned along the face, and

(3) It includes a hole located adjacent to the proximal end of the body.

The body of the anchor has an upper portion and a lower portion, the upper portion of the body being defined by an upper line extending along the surface of the body parallel to the longitudinal axis, the first virtual surface being the surface of the body and the Intersect the top line at the intersection between the first virtual plane closest to the proximal end. The angle between the first virtual plane and the cross section is on the order of 20 to 60 degrees, preferably about 45 degrees.

The body of the anchor should be cylindrical in shape, the proximal end of the body providing a flat proximal end perpendicular to the longitudinal axis. The tab member extends from the proximal end of the body, and the hole is preferably located in the tab member. Preferably, the tab member has a width smaller than the diameter of the anchor, thus providing a means for correspondingly engaging the proximal end of the anchor body with the anchor insertion mechanism.

Each wing member extends outward from the body along a second imaginary surface penetrating the body at an angle to the cross section of the body perpendicular to the longitudinal axis. Alternatively, each wing member extends outwardly from the body at a point at the same distance from the proximal end of the body. In this case, the length of each wing member is selected such that at least a portion of the outer end of each wing member is aligned with the first virtual surface.

The anchor body further includes a channel located directly below each of the wing members, each channel having a length of at least the same size as the portion of the corresponding wing member located outwardly of the body, respectively. The wing member is at least partially positioned in the channel when the wing member of the is in the compressed position. Each said wing member is preferably provided with a cylindrical barb, and the barb extends curvilinearly away from the body radially and axially in the deployed position. The outer end of each of the barbs is tapered to align with the entirety of the outer end along the first imaginary plane. The channels are also preferably sized to receive the entirety of each barb upon compression.

In practice, the shape of the barbs may vary in many ways, but embodiments having three, four or five barbs are preferred. When the anchor has three wing members, one wing member extends downwardly from the bottom of the body and two wing members extend upwards from the top of the body. More preferably, when the anchor is viewed from the proximal end toward the distal end, the wing member has the upper line at the 12 o'clock position, the position between 10 o'clock and 11 o'clock, the position between 1 o'clock and 2 o'clock, and the 6 o'clock position. It extends from the outer circumference of the body when it is present. When the anchor has four wing members, the two wing members extend downward from the bottom of the body and the two wing members extend upward from the top of the body. More preferably, when looking at the anchor from the proximal end toward the distal end, the wing member has the upper line at the 12 o'clock position, the position between 10 and 11 o'clock, the position between 1 o'clock and 2 o'clock, 4 o'clock and 5 o'clock. It extends from the outer periphery of the body when in the position between hours and at the seven o'clock position. If the anchor has five wing members, the two wing members extend downward from the bottom of the body and three wing members extend upward from the top of the body. More preferably, when the anchor is viewed from the proximal end toward the distal end, the wing member has the upper line at the 12 o'clock position, about 12 o'clock position, the position between 10 o'clock and 11 o'clock, the position between 1 o'clock and 2 o'clock, It extends from the outer periphery of the body when in the position between 4 and 5 o'clock, and in the 7 and 8 o'clock position.

According to another embodiment of the present invention, there is provided an anchor insertion mechanism for laparoscopically inserting and securing an anchor in a bore formed in a bone. The anchor insertion mechanism includes an elongated rigid member, the rigid member

(1) an anchor receiving end that can be coupled correspondingly with the anchor,

(2) a cylindrical hollow intermediate portion having one end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end;

(3) a handle attached to said intermediate portion at the opposite end of said anchor receiving end, and

(4) providing a communication between the inside of the intermediate portion and the outside of the anchor insertion mechanism such that a suture extending from the anchor positioned on the anchor receiving end passes through at least a portion of the intermediate portion and the passageway from the anchor receiving end. Equipped with a passage.

The anchor insertion mechanism further includes at least one notch for retaining the seam, wherein the seam is tightened in the notch to tension the seam between the anchor and the notch distributed on the anchor receiving end. These notches are preferably adjacent to the passageway so that the ends of the sutures in which the moles are present in the passage can be fixed directly in the notch. Preferably, the passageway has an elongated diamond shaped outlet through the handle so that the two notches comprise opposite edges of this diamond shaped outlet. In this way, two ends of a single suture threaded threaded through an aperture of an anchor fixed on the end of the insertion instrument are tensioned, and the two ends are separated from each other in each notch. This feature prevents the sutures from intertwining.

The anchor receiving end is preferably configured to be hollow, and the interior of the anchor receiving end is in communication with the interior of the intermediate portion. In addition, the anchor receiving end has a slot that traverses the diameter of the anchor receiving end and extends at least partially along the diameter of the anchor receiving end, the slot being located at the end of the anchor receiving end opposite the intermediate part. . The tab member of the anchor has a width that is less than or equal to the width of the slot, and the tab member is positioned in the slot to engage the anchor with the anchor receiving end. Both the body of the anchor and the anchor receiving end are cylindrical and have substantially the same diameter as each other, and when the loaded anchor insertion mechanism is used to insert the anchor into the bore having a diameter smaller than the diameter of the intermediate portion, An end of the adjacent intermediate portion is configured to act as a stop. An inner diameter of the anchor receiving end is larger than the sum of the width of the tab member and twice the diameter of the suture line, and the tab member has a suture line passing through the hole located in the slot. In order to retain the anchor securely on the end, a releasable adhesive may be used.

The handle may be screwed onto the middle of the insertion mechanism. The handle has an upper and lower portion respectively aligned with the slot of the anchor insertion end, and the lower portion is heavier than the upper portion to facilitate proper insertion of the anchor while using the anchor receiving mechanism. Moreover, the intermediate portion has a plurality of ridges extending around its outer circumference, the ridges being located adjacent to the handle. The ridge interacts with the laparoscopic actuation channel to provide improved control during use of the anchor receiving mechanism.

The present invention also provides a loaded anchor insertion mechanism for use in combination with such an anchor receiving mechanism, which includes an anchor and a suture. This anchor is correspondingly and releasably engaged with the anchor receiving end of the anchor insertion mechanism, and the suture line passes through the passage of the anchor insertion mechanism and inside the intermediate portion from the anchor.

There is also provided a suture recovery device for use in laparoscopic urethral fixation. Such a seam recovery device (or seam recovery machine),

(1) a recovery end having a rod-shaped shaft of a rigid body having a longitudinal axis and a sharp end to penetrate tissue adjacent to the urethra, and

(2) includes a handle having a longitudinal axis,

The recovery end may be inserted into the vagina and into the space of the resistus through the tissue adjacent to the vaginal mucosa and urethra, so that the recovery end may be used to hold a suture located in the space of the register to recover the suture into the vagina. Can be. And an intermediate shaft positioned between the recovery end and the handle. The intermediate shaft and the shaft of the recovery end are fixed to each other at a constant angle, The handle and the intermediate shaft are fixed to each other at a constant angle, the angle between the intermediate shaft and the shaft of the recovery end is Almost equal to the angle between the intermediate shafts, the longitudinal axis of the shaft of the recovery end is substantially parallel to the longitudinal axis of the handle. When the angle between the handle and the intermediate shaft is between 50 degrees and 80 degrees, and the recovery end is inserted into the space of the register to catch the suture within the space of the patient's register, the handle is located in the space of the register. Is located on the outer surface of the patient's vagina to facilitate manipulation of the recovery end.

The diameter of the intermediate shaft is larger than the diameter of the shaft of the recovery end, and when the recovery end is inserted through the soft tissue of the patient, the end of the intermediate shaft adjacent the shaft of the recovery end passes through the soft tissue. Acts as a stop to prevent the The recovery end further comprises a return leg, the return leg extending parallel from the sharp end at regular intervals with the shaft of the recovery end. This return leg, the underside of the sharp end, and the shaft of the recovery end form a U-shaped region that can hold the suture when the U-shaped region is pulled over the suture. The recovery end is sufficient to provide access to the patient's Regis space when the recovery end is fully inserted into the vagina through tissue adjacent to the vaginal mucosa and urethra, but not so sharp that the sharp end can penetrate beyond the Regis space. Has a length. The recovery end may preferably be made of stainless steel, and the intermediate shaft and the handle may preferably be made of plastic.

Also provided is a method for recovering sutures extending from an anchor, wherein the anchor is secured to a hole in a patient's pubic bone and is configured such that the bore is positioned adjacent to the space of Ryzius over the fascia adjacent to the urethra. do. This way,

(1) providing a seam recovery mechanism,

1) a recovery end having a rod-shaped shaft of a rigid body having a longitudinal axis, a sharp end to penetrate the tissue adjacent to the urethra, and a return leg extending parallel to the shaft at a predetermined distance from the sharp end; A recovery portion capable of holding a suture line when a leg portion, a bottom surface of the sharp end portion, and the rod-shaped shaft form a U-shaped area and the U-shaped area is pulled over the suture line;

2) a handle having a longitudinal axis, and

3) providing a seam recovery mechanism comprising an intermediate shaft positioned between the recovery end and the handle;

(2) inserting the recovery end into the vagina of the patient;

(3) pushing the sharp end to a predetermined position through the vaginal mucosa and fascia adjacent to the urethra,

(4) pushing the recovery end upward into the space of the register by the handle so that the U-shaped area is located directly on the suture line;

(5) pulling the recovery end downward by the handle to hold the suture in the U-shaped area, and

(6) continuously pulling the recovery end downward by the handle so that the suture is drawn into the vagina until the recovery end is completely drawn into the vagina.

The U-shaped zone is sized to allow the suture to slide freely within the U-shaped zone as the recovery end is drawn into the vagina, thereby damaging the suture during the recovery step. It doesn't work. The handle remains on the outer surface of the vagina during this recovery step, so that the recovery end is easily manipulated while the recovery step is in progress.

Meanwhile, a template for guiding at least one suture line through the fascia and vaginal mucosa adjacent to the patient's urethra during urethral fixation treatment is provided, wherein the at least one suture is attached to an anchor fixed in the body of the patient over the urethra of the patient These templates

(1) first and second wing members extending laterally from both sides of the template, and

(2) has at least one suture guide hole located at a predetermined position within each wing member,

These templates are arranged in the vagina so that the wing member is positioned adjacent to either side of the urethra, and in each of the wing members the at least one hole is sutured from the body of the patient during urethral fixation treatment. It is positioned so that it can be withdrawn into the vagina through the hole.

The template further includes a trough having an arcuate cross section, the trough having a constant length and first and second ends, wherein the first and second wing members extend along the length of the trough on both sides of the trough. Extend away from the side. Further, the template is formed such that the first and second ends of the trough include end walls, the trough being dimensioned such that the patient's urethra can be positioned in the trough with the end wall adjacent the end of the urethra of the patient. Thus, the hole may be located on either side of the patient's urethra. The template further includes an alignment member extending away from the end wall of the trough, the alignment member having a longitudinal axis and extending parallel to the trough, the longitudinal axis of the alignment member being aligned with the centerline of the trough. The alignment member has an arcuate cross section and extends away from the trough, and the alignment member is sized to be positioned around the circumference of the catheter inserted into the urethra of the patient, thereby positioning the template in a predetermined position. The alignment member has an arcuate cross section and extends from the end wall toward the first and second ends of the trough over the inner surface of the trough, and the alignment member can be inserted into the patient's urethra to align the template. . Each of the wing members has first and second guide holes, and the first and second guide holes in each of the wing members are spaced apart from each other by a predetermined size. The first and second guide holes in each wing member are aligned along an imaginary line extending away from the trough vertically.

In addition, a surgical method for performing urethral fixation for a female patient is provided.

(1) providing first and second anchors, each of which has sutures having a pair of ends, respectively;

(2) inserting the anchor into the abdominal cavity of the patient;

(3) placing a surgical template within the patient's vagina so that one wing member extends laterally away from either side of the patient's urethra adjacent to the vaginal mucosa,

(4) passing one end of any of the sutures into the vagina through the fascia, vaginal mucosa, and any one guide hole adjacent to the urethra,

(5) repeating step (4) between the remaining three ends and the guide holes such that one end is drawn through each guide hole, and

(6) suspending the two ends of each suture in the vagina so that the suture raises the urethra at a predetermined angle.

Two ends of the suture extending from the first anchor pass through the fascia and vaginal mucosa adjacent to the urethra on one side of the patient's urethra, and the two ends of the suture extending from the second anchor are on the opposite side of the urethra of the patient. Through the fascia and vaginal mucosa adjacent to the urethra, after the suspending step is performed, each suture provides an upward force against the tissue on both sides of the patient's urethra. In the case where this surgical method further comprises a trough having an arcuate cross section, the trough has a constant length and first and second ends, and the wing member extends from both sides of the trough along the length of the trough. Extending away, wherein the positioning of the surgical template may be performed such that the urethra can be positioned in the trough for aligning the urethra of the gutter patient with the wing member adjacent to the vaginal mucosa on either side of the patient's urethra. Positioning the template within the vagina. In addition, the surgical method may further comprise inserting a catheter into the urethra of the patient with respect to the bladder, wherein positioning the template is such that the alignment member of the template is positioned immediately adjacent to the outer surface of the urethra. And securing around the circumference of at least a portion of the circumference of the portion of the catheter, whereby the template can be fixed in an appropriate position. In addition, such surgical methods may include determining the length of the patient's urethra, whereby the template is formed in a size corresponding to the length of the urethra and positioned in the vagina so that the end wall is positioned at the end of the patient's urethra. You will encounter

Passing one end of any one of the sutures into the vagina through the fascia, vaginal mucosa, and any one guide hole adjacent to the urethra,

(1) inserting a portion of the suture retractor into the abdominal cavity of the patient and into the vagina in the region where the anchor is located through the one guiding hole, the fascia adjacent the urethra above the hole, and the vaginal mucosa,

(2) holding the end of the suture by the suture retractor, and

(3) drawing the end of the suture line, which is held by the suture retractor, through the fascia, vaginal mucosa, and guide hole adjacent to the urethra so that the end of the suture line extends from the anchor into the patient's vagina.

According to another embodiment of the present invention, there is provided a surgical method for performing laparoscopic urethral fixation to a patient. This way,

(1) cutting at least a portion of the patient's Regius space,

(2) laparoscopically forming a bore in the pubic bone adjacent to the space of Regius,

(3) providing at least one anchor from which at least one suture extends;

(4) laparoscopically inserting the anchor to secure the anchor in the bore; and

(5) fixing the suture to tissue adjacent to the urethra in order to lift the urethra at a predetermined angle.

The suture is secured to the tissue adjacent to the urethra by pulling the suture into the vagina through the fascia and vaginal mucosa adjacent to the urethra and suspending the suture within the vagina. More preferably, a pair of bores are formed in the pubic bone and one such bore is formed on one side of the pubis above the fascia adjacent to the urethra. In addition, a pair of anchors, each of which sutures extend out, is provided, either of which anchors are inserted into each bore (ie, each bore has an anchor inserted therein). Either suture is drawn into the vagina through the vaginal mucosa adjacent to either side of the urethra and the fascia adjacent to the urethra, each suture suspending in the vagina, and one suture line on either side of the urethra. The urethra can be lifted at an angle by providing upward force on the tissue around the located urethra. In other words, the tissue adjacent to the urethra (preferably, the fascia and vaginal mucosa adjacent to the urethra) has sutures that provide upward force on each side of the urethra.

Forming the bore,

(1) inserting the laparoscopic into the patient to provide access and vision to Regis' space;

(2) forming a hole deep enough to access the bone of the reticular tissue into the pubis at a predetermined position with respect to the bore by means of a laser inserted through a laparoscopic channel;

(3) providing a drill actuation mechanism having a drilling end having a proximal end;

(4) inserting the drilling end of the drill mechanism through the laparoscopic channel, and

(5) pushing the proximal end of the perforated end into the hole to form the hole in the bone of the network under the hole.

The proximal end of the perforated end is sharply formed so as to be able to form the bore in the bone of the reticular tissue by the force of the hand, but not enough to accidentally penetrate the soft tissue or organ during the formation of the bore.

Preferably, the drill actuating mechanism comprises an elongated rigid member, the rigid member comprising:

(1) a perforated end having a distal end that is sharp enough to form a bore in the bone of the reticulated tissue with the aid of a hand, but not so sharp that an accidentally tender tissue or organ is seized during formation of the bore;

(2) a collar having a diameter larger than the diameter of the perforated end,

(3) a cylindrical intermediate portion attached to the perforated end in the collar and having a diameter larger than the diameter of the perforated end;

(4) A cylindrical guide that can be inserted into the laparoscopic working channel and has a first and second ends and a diameter greater than the diameter of the middle part, the first end being at the end of the middle part opposite the collar. Attached guides, and

(5) having a handle attached to the second end of the guide,

Inserting the distal end of the perforated end into a hole formed in the pubic bone deep enough to provide access to the reticular tissue and then forming the bore with a length corresponding to the length of the perforated end It can be used laparoscopically to form a bore in the pubis by pushing it while rotating into the hole by the handle.

Preferably, the incision step is

(1) inserting a balun incision into the space of the Regius,

(2) inflating the balun of the balun incision to separate accidental tissue within the space of Regius; and

(3) further incising the accidental tissue using a laser, electrocautery device, or both while observing the extent of the incision by the laparoscope.

Preferably, the step of inserting the anchor

(1) providing an anchor insertion mechanism comprising a rigid elongated member having an anchor receiving end at one end and a handle at the other end;

(2) loading the anchor at the anchor receiving end while the seam extends toward the handle along the length of the anchor insertion mechanism;

(3) inserting the anchor receiving end of the anchor insertion mechanism through a laparoscopic channel;

(4) inserting the anchor into the bore by pushing the anchor receiving end toward the bore with the anchor loaded; and

(5) pulling the anchor insertion mechanism away from the bore to release the anchor from the anchor receiving end.

The anchor insertion mechanism further includes an elastic band extending around its circumference, and the step of loading the anchor further comprises positioning the suture line between the elastic band and the anchor insertion mechanism. The elastic band is firmly fixed to the anchor insertion mechanism so as to face the anchor insertion mechanism, and the suture line is slidably moved between the elastic band and the anchor insertion mechanism during the pulling of the anchor insertion mechanism from the bore. And pull outward on the anchor to position the anchor in the bore.

And wherein pulling the anchor insert from the bore includes at least partially removing the anchor insert from the laparoscopic channel, and after the pulling of the anchor insert is performed, the suture is Receiving the tension between the anchor and the anchor insertion mechanism, and fixing the suture line

(1) providing a suture retractor having a pointed end,

(2) inserting an end of the suture retractor through the vaginal mucosa and fascia adjacent to the urethra into the vagina and into the space of the resistus,

(3) catching the suture by the suture retractor;

(4) drawing the suture into the vagina by the suture retractor; and

(5) a step of suspending the suture in the vagina.

Most preferably, the suture has first and second ends, and these ends are drawn into the vagina at a distance from each other. These two ends are joined together in the vagina to lift the urethra at an angle.

In addition, the anchor insertion mechanism according to this embodiment preferably further comprises a press-in portion extending around the circumference of the anchor insert, in which the elastic band is located in this press-in portion. The anchor insertion mechanism may also include a cylindrical intermediate portion having a proximal end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end. The diameter of the anchor receiving end is almost equal to the diameter of the anchor, and the combined length of the anchor and the anchor receiving end is almost equal to the depth of the bore. In this configuration, during the step of inserting the anchor into the bore, the proximal end of the intermediate portion of the anchor insertion member acts as a stop so that the anchor can be inserted into the bore to the maximum possible depth.

The present invention also provides a drill actuator for laparoscopy forming a bore in the pubic bone of the patient during the urethral fixation treatment, the drill actuator includes an elongated rigid member, the rigid member,

(1) a perforated end having a distal end that is sharp enough to form a bore in the bone of the reticulated tissue with the aid of a hand, but not so sharp that an accidentally tender tissue or organ is seized during formation of the bore;

(2) a collar having a diameter larger than the diameter of the perforated end,

(3) a cylindrical intermediate portion attached to the perforated end in the collar and having a diameter larger than the diameter of the perforated end;

(4) A cylindrical guide that can be inserted into the laparoscopic working channel and has a first and second ends and a diameter greater than the diameter of the middle part, the first end being at the end of the middle part opposite the collar. Attached guides, and

(5) having a handle attached to the second end of the guide,

Inserting the distal end of the perforated end into a hole formed in the pubic bone deep enough to provide access to the reticular tissue and then forming the bore with a length corresponding to the length of the perforated end It can be used laparoscopically to form a bore in the pubis by pushing it while rotating into the hole by the handle.

Preferably, the perforated end having a conical cross section has both flat sides tapered from the proximal end of the perforated end to the cylindrical rear end of the perforated end, such that the drill actuating mechanism has a diameter corresponding to the diameter of the rear end. It can be used to form a bore. The overall length of the drill actuator is defined such that the drill actuator easily penetrates through the laparoscope to form a bore in the pubis of the patient during laparoscopic urethral fixation treatment. Preferably, the perforated end has a length of about 1 to 3 cm, the middle portion has a length of about 2 to 6 cm, and the guide portion has a length of about 50 to 55 cm.

Reference is now made to the drawings, in which like parts have been given the same reference numerals. 1 is a cross-sectional view along the centerline of a patient suffering from stress incontinence. Referring to FIG. 1, the bladder 1, the urethra 2, the urethral vesicular connection 3, the tissue adjacent to the urethra 4, the vagina 5, the uterus 6, the genital sympsis 7, and Regius space 8 is shown. In such patients, the urethra 2 and associated tissue 4 around the urethra are lagging into the vagina 5. During a period of stress such as coughing or sneezing, pressure acts on the bladder 1. Due to the weakness of the urethra 2, the surrounding muscle tissue cannot provide sufficient corresponding pressure to the urethra to prevent urinary tract during this stressed period. As is known in the prior art methods, in particular MMK treatment, the fixation of the tissue 4 near the urethra in the urethral vesicular connection 3 on either side of the urethra 2 supports the urethra and the urethra 2 To prevent sagging into the vagina (5). This allows the surrounding muscle tissue to provide sufficient pressure to the urethra 2 to prevent urinary tract during the stressed period.

Figure 2 shows that the support force of the urethra (2) is provided to the urethral vesicular connection (3) by the surgical operation of the present invention. First, note that the pubic bone 12 is shown in FIG. 2, which is a portion of the pubic bone placed just to the right of the genital simphysis. As will be described in more detail later, the anchor of the present invention is secured to the pubis on either side of such genital simphysis. A bore 13 is formed in the pubic bone 12, and an anchor 9 is fixed in the bore. Here, it is noted that the bore 13 and the anchor 9 are shown enlarged for clarity of explanation. Compound line 10 is secured to anchor 9, with two ends of suture 10 extending downward through vagina 8 into vagina 5. The end of suture 10 extends through the tissue 4 near the urethra in the urethral vesicular connection 3 into the vagina just to the right of the urethra 2. In the vagina, the two ends of the suture 10 are suspended from one another so that the suture line 10 is upwardly directed to the tissue 4 near the urethra on the right side of the urethra 2 adjacent to the urethral vesicular connection 3 of the suture 10. Provide power. The same anchor and suture are anchored to the pubic bone on the left side of the genital simphysis, the suture line as described above to provide upward force to the tissue 4 adjacent to the urethra on the left side of the urethra (2). Is inserted into. In this situation, sutures on each side of the urethra act to maintain the angle of the urethra in the urethral vesicular connection.

As will be described in more detail below, the process of fixing the anchor to the pubis 12 may be performed laparoscopy. Suture 10 may then be drawn into vagina 5 through tissue 4 immediately adjacent to urethra 2. Next, the two ends of the suture 10 are suspended by hand in the vagina 5. Here, it can be seen that the portion of the suture 10 located in the vagina 5 is epithelialized within a few days after treatment. In this form, the suture 10 is quickly covered by the epithelial tissue of the vagina 5, so that the suture 10 does not cause any discomfort or inflammation to the patient.

Surgical Technique

(A: Preoperative Surgery)

Identification of patients suitable for the techniques of the present invention can be accomplished by any of the prior art methods of identifying patients whose stress urinary incontinence (SUI) can be corrected by MMK or similar treatment. For example, the swab may be inserted into the urethra until the swab reaches the urethral vesicular connection (UVJ) as described above. Then, ask the patient if it can tolerate and monitor whether some of these swabs move on the outer surface of the urethra. The outer urethra acts as a support point for the swab, and the absence of such a urethral support in the urethral vesicular connection can be easily confirmed by the upward movement of the outer end of the swab. This indicates a downward slope of the urethra at the urethral vesicular junction, thus providing an indication of the structural cause of stress incontinence in the patient. However, other means may be used in the art to confirm this diagnosis or to identify other possible causes.

The patient's preparation for preoperative surgery follows standard procedures for laparoscopic or gynecological surgery, and does not require an enema. The patient is placed in a dorsal lithotomy position and standard parenteral antibiotics are added. Preferably, the patient may be in general anesthesia to minimize patient discomfort.

Then, a Foley urine (16 French, 10 cc balloon) is inserted into the urethra. The balloon of the poly urinary catheter is swelled and the catheter is pushed outward slightly to allow proper installation of the balloon at the connection between the bladder and the urethra. Such a suitable installation of the poly urinary catheter 14 is shown in FIG. 17, with some of the vagina 5 being cut off for clarity. The bladder 1 is then drained in its usual form using a poly urinary catheter so that the bladder contracts. As will be explained in more detail below, the method of the present invention for keeping the bladder in a contracted state is simplified. Moreover, when the template of the present invention is used, the poly urinary catheter 14 is preferably positioned as shown in Fig. 17, which will be described in more detail below.

It is also desirable to measure the length of the urethra of the patient in order to properly install the suture line, which is particularly advantageous when the template according to the invention is used. If the suture is installed adjacent to the bladder, there is a risk that the suture recovery mechanism will penetrate the bladder. Likewise, proper support of the urethra may not be achieved if the bladder is too far from the urethral vesicular connection. The length of the urethra (2) can be easily measured by any suitable means that can be inserted into the urethra, i.e. the surgeon at one end of the device is connected to the connection of the bladder to the urethra (i.e. You just need to be able to verify that it is located. The simplest means of providing such a measurement is to provide a scale along at least a portion of the length of the poly urinary catheter 14 as shown in FIG. In this form, if the balun of the poly urinary catheter is properly inflated in the bladder and the catheter is pulled outward to provide proper installation of the balun at the junction of the bladder and urethra, it is easily read immediately adjacent to the end of the urethra (2). The length of the urethra can be determined using a scale that can be used. The average length of the urethra is about 3 cm, typically in the range of 2.7 cm to 3.3 cm. As will be explained more clearly below, the suture template used in the method of the present invention may be manufactured in various dimensions to accommodate different lengths of urethra. At least two dimensions may be provided for the template, more preferably at least three dimensions are provided. Alternatively, a scale may be used to facilitate the proper installation of a template made in one dimension.

After the poly urinary catheter 14 has been installed and drained to the bladder 1, the pre-peritoneal region (the area between the abdominal wall and the peritoneum), more specifically the legius space (8) An incision in the middle of the patient's lower abdomen is provided to provide access. In order to install the anchor it is necessary to surgically incision the Regis's space 8 to provide visual access to the pubis. Thus, this incision is made down the fascia, thereby eliminating the eugenic or supportive connective tissue in the space 8 of Regius. Although the incision of this connective tissue in the space 8 of Regius can be performed in a conventional form via laparoscopy, the applicant has found that the balun incision procedure is more effective and simple.

The balun incision may be performed using a SPACEMAKER surgical balun incision manufactured by General Surgical Innovation in Portola Valley, California, USA, or an equivalent instrument. . These mechanisms have guide rods with small baluns attached. This guide rod inserts the guide rod into the central abdominal incision of the lower abdomen until its end reaches genital simphysis (ie, between the simphysis and the bladder) in Regis's space. The balun is then expanded in the Regis space (8) by filling the balun with approximately 300 [mu] s of saline solution or other suitable fluid and sufficient in the Regis space (8) to carry out the fixing procedure of the present invention. The bladder 1 is retracted to provide space and then separated from the surrounding connective tissue.

The spacemaker mechanism has an integral trocar that is normally left in the central incision of the lower abdomen for the installation of the laparoscopic, but the size currently available for the method of the present invention is very small. Obviously, an appropriate sized integral trocar can be left inside the cup after the shrunk balun is removed. Alternatively, a large 12 mm trocar is inserted into the central incision of the lower abdomen so far that the spacemaker mechanism is preferably removed entirely. A 12 mm WOLF procedure laser laparoscope (preferably Wolf 50/50 beam splitter camera) is inserted into the trocar. Then, the prefertonierous zone is preferably filled with a pressure of about 10 to 30 mmHg by CO ₂ to expand the space of the Regis to provide a good laparoscopic vision for this zone.

Although the balun incision procedure is very effective, incision of the space of the Regius is also typically required to provide the necessary access to the tissue adjacent to the pubic and urethra. This can be done through a laparoscope by a CO ₂ laser or by an electrocautery instrument, but preferably a further 5 mm trocar is inserted into the central line in front of the pubis. Then, irrigation, aspiration, and vovle instruments (such as those manufactured by US Sungical) are inserted into the ledge of space through small trocars. These instruments not only assist in the incision of the space of the Regius, but also provide the necessary irrigation and suction while other instruments required to carry out the procedure of the present invention are used through the trocar in the middle of the lower abdomen. These incisions provide a better view than standard MMK or birch treatments that perform a full abdominal incision, which allows the doctor to see the underside of the pubis where the anchor is installed without placing his head on the patient's abdomen. Because it is difficult. In this form, a preferred laparoscopic approach to tissues adjacent to the pubic and urethra necessary to carry out the methods of the present invention is provided.

(B: formation of a bore in the pubic bone)

First, it is noted that in the method of the present invention, various anchors can be used as long as the anchor can be easily fixed to the pubis and the suture can be attached thereto. Preferably, there is a MITEK anchor known as can be used in the present invention. As will be explained in more detail below, such anchors are secured by being pushed into the appropriately sized bore formed in the pubis.

In MITEK-MMK and related therapies, it is necessary to use a mechanical drill or a hand auger to insert the anchor (such as those sold by Mitek Surgical Prodnct, Inc.) into the pubis. These instruments can easily be used with large incisions in the middle of the lower abdomen, but cannot be inserted through the laparoscope for various reasons. Most importantly, these instruments must be sharp enough to allow the surgeon to penetrate the hard outer layers of pubis (periosteum and cortical bone). Since laparoscopic watches can sometimes be limited, the use of such sharp instruments risks penetrating the bladder or soft tissues. Moreover, the pubis 12 are about 45 degrees from the laparoscope, as shown in FIG. Therefore, the angle of the pubis 12 presents a difficulty to watch and operate, which is overcome by the apparatus and method of the present invention. It is not advisable to drill into the pubis through the laparoscope using the prior art, since there is a risk that the pubis 12 will be angled downward from the laparoscope, causing the drill or awl to slide downward during this drill operation. Because. When the end of the drill ultimately penetrates the rigid outer layer of the pubis, the drill may slide downward or be improperly positioned. Ideally, the bore is formed in the pubic bone 12 at an angle of about 45 degrees with respect to the surface of the pubic bone where the bore is formed. This angle can be from 20 degrees to 60 degrees, providing sufficient support for the anchors to be placed at the point where the bores are formed.

Applicant has developed a novel method and apparatus for forming a bore in the pubis through a laparoscope. This method and apparatus uses a sharp edge, but can properly position the bore in the pubis without the risk of the physician performing a misalignment while forming the bore. In order to form a bore without the necessity of using a sharp instrument, a laser is first used to form a conical hole in the pubic bone at the position of a predetermined bore. These holes are formed in periosteum or cortical bone, providing access to soft can cellous or trabecular bones. In this form, drill actuators (described in more detail below) are used to form bores of appropriate size.

First, a CO ₂ laser (e.g., 20 watts SHARPLAN) is inserted through the laparoscopic channel to form a hole in the pubis, slightly larger than the diameter of the laser beam in the pubis on either side of the soft genital sympsis. Used to form conical holes. The size of the laser beam is preferably about 2 mm, so that the diameter of the conical hole formed in the pubis is slightly larger than 2 mm. This hole is deep enough to reach the cancellulosced bone. A hole is formed on either side of the genital simphysis just above or about 1 cm from the fascia near the urethra in the urethral vesicular junction. FIG. 21 shows the space of Regius after the bores 9, 17 are formed in the pubis 12 on either side of such genital simpysis 7. The desired installation position can be easily determined through the laparoscopic lens, as the proper incision of the Regis's space 8 provides enough vision to adequately identify the patient's proper structure. If necessary, the surgeon may apply an upward force using one or more fingers against the tissue around the urethra on either side of the urethra in the vagina to properly position the two holes in the pubis.

If access to the cancelluloscopy is provided by a conical hole formed on either side of the genital simpysis using a laser, a bore for inserting the anchor can be easily formed using the drill actuator of the present invention. . Since the cancelous bone is much softer than the periosteum bone or cortical bone, there is no need to use sharp awls or drills to form the bore. Instead, bluntly drilled implements may be used, the ends of which are not sharp enough to penetrate the bladder or other soft tissues during normal use. This is highly desirable in that damage to the bladder or other soft tissue structures of the patient can be avoided and that the use of drill guides and MITEK instruments or similar devices is avoided. Not surprisingly, MITEK drill guides cannot be used in double abdominal fashion. The laser used to form the conical hole is easily aligned in a suitable position and there is no slip or other accidental movement during operation. The hole formed by the laser can be easily used to accurately form a bore for installing the anchor at a predetermined position.

The drill actuating mechanism of the present invention is shown in FIGS. 5 to 7, which includes an elongated rigid rigid member 20 having a proximal end including a conical perforated end 21. The distal end 22 of the conical perforated end 21 preferably has a cross section of size and shape corresponding to a hole formed in the pubis by a laser. In this form, it is relatively easy to align the conical drill end 21 in the hole. Further, preferably, the ends of the conical perforated ends 21 are formed in the moody so as not to penetrate soft tissues such as bladder during normal use (ie, not sharp enough to penetrate soft tissues or organs during normal use). Of course, the conical perforated end 21 should be formed in the form of a blade thin enough to form a bore in the soft canoelous bone through the laparoscope with the force of the hand. In this regard, the conical drill end 21 is preferably formed similarly to a flat bladed screwdriver. Thus, the perforated end 21 has tapered sides 23 and 24 which terminate in a portion 25 of circular cross section. The diameter of this circular cross section portion 25 is equal to the diameter of the bore to be formed in the pubis. A predetermined bore is easily formed in the hole by rotating the drill mechanism and simultaneously pushing the drilling end 21 into the hole of the pubis. The diameter of this portion 25 is approximately equal to the diameter of the body of the anchor inserted into the bore.

In order to provide sufficient support for the anchor of the present invention, it is also important that the anchor is located deep in the pubis. In order to provide the proper depth of the bore, a collar 26 is provided on the drill actuator. The collar 26 has a larger diameter than the conical drilling end 21 and thus acts as a stop which prevents the drill actuator from penetrating further into the bore. The collar 26 is shown tapered to a diameter between the conical perforated end 21 and the middle portion 27, but the collar 26 may also consist of an end of the middle portion 27 that is not tapered only. The middle portion 27 has a diameter much larger than the diameter of the conical perforated end 21 and is located at the opposite end of the collar 26. The intermediate portion 27 not only provides the collar 26 but also provides strength to the drill actuator. However, the middle portion 27 must be constructed with a smaller diameter than the laparoscopic working channel because it must provide sufficient visibility for the working area. Preferably, the length of the conical drill end 21 is about 1 cm to 3 cm, more preferably 1.4 cm. The length of the middle portion is preferably about 2 cm to 6 cm 1 and more preferably about 5 cm.

In order to provide stability during the drilling process, a cylindrical guide 28 is included in the drill actuator. Guide portion 28 has first and second ends 29, 30. The first end 29 is attached to the middle portion 27 at the opposite end of the collar 26. The cylindrical guide 28 preferably has a diameter slightly smaller than the working channel of the laparoscope. In this form, the guide 28 provides the necessary stability in the laparoscope to properly install the bore. Preferably, the second end 30 of the guide 28 is attached to the handle 31. While the handle 31 is shown having a flat end 32 and a curved gripping surface 33, the handle 31 can be modified in any number of forms, ie, within a range sufficient for use in the present invention. There is a number. The handle 31 facilitates proper manipulation of the perforated end 21 through the laparoscope and provides a surface 32 that is sufficiently firm against the force applied to complete the perforation process. Preferably, the guide 28 has a length of about 50 cm to 55 cm, more preferably about 52 cm. Therefore, the overall length of the drill actuator of the present invention provides sufficient access to the pubis while at the same time providing ergonomically effective drilling through the laparoscope and preventing the drill mechanism from interfering with anesthesia.

(C: insertion of anchor in the pubic bone)

One preferred embodiment of using the present invention is shown in Figures 3 and 4, which is the same as that disclosed in US Pat. No. 5,207,679. The anchor 9, preferably made of titanium alloy or other suitable material, has a cylindrical body 40 and a conical end 44 attached thereto. At least two bendable barbs 41 are curved outwardly from the body 40. At the pedestal end of the conical end 44 a groove 42 is provided on either side of the body 40. Moreover, the cylindrical end 45 extends away from the body 40 adjacent to the groove 42. The longitudinal axis of the cylindrical end 45 is aligned with the longitudinal axis of the body 40. Preferably, the diameter of the cylindrical end 45 is equal to the diameter of the body 40 in the groove 42 located on the opposite side of the body 40. As will be explained in more detail below, this structure facilitates the attachment of the anchor 9 to the insertion mechanism.

As best shown in FIG. 4, the body 40 and the cylindrical end 45 have holes 43 therethrough. The hole 43 is sized to receive the sutures appropriate for the fastening process of the present invention. Preferably, O GORE-TEX sutures may be used, and the anchor 9 and the accompanying hole 43 should be configured to the corresponding size. The use of GORE-TEX seams is desirable for reasons of strength and inelasticity. If desired, any other type of suture may be used. The portion of the suture line shown in FIG. 3 is inserted through the hole 43.

The insertion of the anchor 9 is made relatively straight, ie the anchor must be pushed completely into the bore already formed in the pubis. Preferably, the anchor 9 is inserted into the bore in the pubis until the conical end 44 reaches the distal end of the bore. The bore should be at least as long as the length of the anchor 9 and preferably considerably long to provide sufficient support for the anchor. As the anchor 9 is pushed into the bore, the deflectable barb 41 is compressed against the body 40, which is inserted through the rigid periosteum and conical bore surrounding the bore. However, in the bore, the barbs 41 are elastically acted into the soft cancellose bone to fix the anchor. A slight pull on the end of suture 10 causes barbs 41 to float.

In order to insert the anchor 9 into the bore previously formed in the pubis, the anchor insertion mechanism shown in FIGS. 8 to 10 can be used. Thus, after the drill actuating mechanism has been used to form the required bore, the anchor insertion mechanism of the invention loaded with the anchor and the threaded sutures thereon is inserted into the laparoscope for proper positioning of the anchor 9.

The anchor insertion mechanism of the present invention includes an elongated rigid member 50 having a handle 51 at one end and an anchor receiving end 52 provided at an opposite end of the rigid member 50. As with the drill actuation mechanism, the handle 51 may be configured in many forms, but only the preferred embodiment of such a handle is shown in the figures. The anchor receiving end 52 has a structure similar to that shown in FIGS. 4-6 of US Pat. No. 5,207,679. The anchor receiving end 52 is configured to correspondingly receive the anchor 9 to facilitate the use of the anchor 9 into the bore. Naturally, the longitudinal axis of the anchor receiving end 52 should be aligned with the longitudinal axis of the rigid member 50. The anchor receiving end 52 is essentially cylindrical and has a diameter corresponding to that of the anchor 9. In this way, at least a portion of the anchor receiving end 52 can pass through the bore in the pubis during the anchor insertion process so that the anchor can be properly positioned completely into the bore.

The anchor receiving end 52 has a pair of guide tabs 53 extending from an end of the anchor receiving end 52 on either side thereof. The guiding tab 53 is sized and shaped so as to be correspondingly received in the groove 42 located on either side of the anchor 9. The anchor receiving end 52 also has a cylindrical slot 54 aligned with the longitudinal axis of the anchor receiving end 52. The cylindrical slot 54 must be formed in a size and shape corresponding to this end 45 in order to correspondingly receive the cylindrical end 45 of the anchor 9. Preferably, the distance between each guiding tab 53 is slightly less than the distance between each corresponding groove 42 on the anchor 9. In this form, the guiding tab 53 and the cylindrical slot 54 exert a compressive force on the anchor 9, thereby fixing it more firmly when the anchor 9 is loaded on the anchor receiving end 52.

Since the suture 10 extends outwards on either side of the anchor 9, it is desirable to provide a means to ensure that the suture 10 is not polished by the pubic bone surrounding the bore during insertion. Thus, a pair of tapered grooves 55 are provided on either side of the anchor insertion mechanism and extend from the end of the anchor receiving end 52 along at least a portion of the length of the rigid member 50. As shown in FIG. 10, the anchor 9 is mounted on the insertion mechanism, and the groove 55 allows the suture line to be protected by a portion of the rigid member 50 and the anchor receiving end 52 during insertion. do. Since no groove in the suture ensures the strength and durability of the fixation, it is important that the suture is not damaged in any form.

The anchor receiving end 52 should be of sufficient length to allow the anchor 9 to be fully installed deep in the bore. Therefore, the combined length of the anchor receiving end 52 and the anchor 9 in the loaded state as shown in FIG. 10 should be the same as the dimensions of the bore formed in the pubic bone. Because the diameter of the rigid member 50 is significantly larger than the diameter of the anchor receiving end 52, the proximal end 56 of the rigid member 50 is firmly in contact with the pubic bone and is firmly in contact with the pubis. In this way, the surgeon can confirm that the anchor is inserted to the full depth.

As in the drill actuation mechanism of the present invention, the rigid member 50 also includes an intermediate portion 57 and a guide portion 58. The middle portion 57 must have a diameter sufficiently smaller than the diameter of the laparoscope to provide a proper view of the physician, and the middle portion 57 has a proximal end 56 as described above. Preferably, the intermediate portion 57 has a length of 2 cm to 6 cm, more preferably 5 cm. An important point here is that the suture 10 extends along the depth of the middle portion 57 on either side of the middle portion 57 as shown in FIG. 10. This recognizes that the diameter of the intermediate portion 57 must not only be easily inserted through the laparoscope, but must also be determined to provide an appropriate view.

The guide 58 needs to be slightly smaller than the diameter of the guide for the drill actuator described above, as the seam 10 extends along either side of the guide 58 as shown in FIG. 10. to be. In view of this, the sum of the diameter of the suture 10 and the diameter of the guide 58 should be slightly smaller than the inner diameter of the laparoscopic working channel. In this form, the guide provides reliable support to the physician during the anchor insertion process. Preferably, guide 58 has a length of 50 cm to 55 cm, more preferably about 52 cm. This provides the full length corresponding to the length of the drill mechanism, thereby providing the same advantages with regard to the length of the drill mechanism.

In order to effectively carry out the method of the present invention laparoscopically, it is necessary to ensure that the two ends of the suture 10 are as tightly controlled as possible. If the sutures are suspended away from the anchor 9 or the anchor insertion mechanism, these ends are generally joined in the space of the resist, making the process of suturing the sutures difficult. Although sutures can be secured manually against the anchor insertion mechanism, we have developed a method to do this in a more effective manner. Thus, first and second indentations 59, 60 are preferably provided around the cone of the guide 58. Small rubber bands 61 (as shown in FIG. 10) or other suitable elastic bands may be respectively fixed in the two indentations, and these two ends of the seam 10 may be guided as shown. 58) It is held under the rubber band 61 on either side. Preferably, the first indentation 59 is located at a distance of about 10 cm from the ends of the guiding tab 53. Preferably, the second press-fit portion 60 is located at a distance of about 40 cm from the guide tab 53. In relation to the elastic band, these two indentations act to fix the suture 10 on the side of the anchor insertion mechanism.

In addition to securing the sutures on the anchor insertion mechanism, the combination of the indentation and elastic bands further improves the laparoscopic treatment of the present invention in the process of positioning the anchor and retracting the sutures. As shown in Figure 20, the anchor insertion mechanism of the present invention is a predetermined anchor and suture assembly attached thereto is inserted through the laparoscope for installation of the anchor as described above. Once the anchor is positioned in the bore, the anchor insertion mechanism is pulled out using the handle 51 attached thereto. The combination of these indentations 59, 60 and rubber bands 61 provides tension in the seam 10 that pulls outward on the anchor 9 received in the bore. This outward force acting on the anchor 9 extends the barbs 41 outward into the cancellose bone surrounding the bore, thus securing the anchor 9. In other words, the force acting outward on the seam 10 by the drag generated by the combination of the indentation and the elastic band acts to deploy the pre-compressed barbs 41 on the anchor 9. The anchor 9 is more firmly fixed in the inside.

To facilitate external surgical treatment according to the present invention, the drill actuator and anchor insertion mechanism described above may be provided in the form of a reusable surgical device.

(D: fixation of tissue adjacent to the urethra at the urethral vesicular connection through the suture)

Once the anchor and suture assembly is secured in the bore formed in the pubis, it is then necessary to use both ends of the suture to lift the tissue near the urethra on the side of the corresponding urethra at the urethral vesicular connection. Applicants have found that a more effective means of doing this is to pull these ends into the vagina through tissue near the urethra. In this form, both ends are easily coupled to one another in the vagina to provide the necessary support, eliminating the need for laparoscopic suture knots. Clearly, a means must be provided to recover the end of the suture.

A method of performing suture recovery is shown in FIG. 20, which is a perspective view in partial cross-section of a patient's abdomen. As shown in Figure 20, the anchor insertion mechanism of the present invention is partially recovered from the patient through the laparoscope, the first indentation portion 59 together with the rubber band 61 is subjected to a tension force between the anchor and the anchor insertion mechanism. In this case, the ends of the sutures simply fall into the space of the resist as with the fiber yarns and are difficult to recover. The ends of the suture can be tensioned by pulling outward on the suture between the anchor and the anchor insertion mechanism, but this does not require an additional pair of bands. Therefore, the combination of the indentation part and the birth band is more effective in this regard.

When the anchor insertion mechanism is partially removed to apply tension to the end of the suture in the manner shown in FIG. 20, after the suture recovery mechanism is inserted into the vagina, one side of the urethra to retrieve any of the suture end as shown. Pushed upward into the space of Regius on the side. Thus, the suture recovery device must have a sharp point that passes completely through the entire thickness of the fascia adjacent to the urethra and the vaginal mucosa adjacent to the urethra. The suture recovery mechanism must also be provided with means for pulling through the entire thickness of the fascia and vaginal mucosa around the urethra by the entry and exit opening caused by the sharp point after holding the suture end. Each end is drawn into the vagina at an appropriate location in this form. Preferably, one end is drawn into the vagina about 1 cm away from the urethral vesicular connection, and the other end is drawn into the vagina 2 cm laterally from the urethra. In other words, each end penetrates tissue adjacent to the urethra along an imaginary line extending vertically from the urethra. Each end is then pulled out of the vagina to hang.

The ends of the sutures are tied together using a series of knots for standard surgery, each knot sliding by hand to a point in the vagina in the area where the suture ends have already been recovered. These ends are tied together tightly enough so that suture 10 generates an upward force on the tissue adjacent to the urethra to lift the urethra from the urethral vesicular connection and maintain the urethra at an appropriate angle. The location of the urethra is easily observed by the physician as the treatment is performed, so that the urethra is maintained at an angle. The entire process (anchor insertion, suture retrieval, etc.) is then repeated for the anchor located on the opposite side of the genital simpysis, where the suture end for this anchor is located near the urethra on the other side of the urethra as described above. Drawn through the tissue into the vagina. The knot is then performed in the same way, lifting the other side of the urethra to keep the urethra complete along the urethral vesicular connection.

The result of the final process is well illustrated in FIG. 2, which maintains the urethra at an appropriate angle of suture 10 on the opposite side of suture 10 and corresponding urethra. Here, it is important that there is no time to directly pull the suture upwards beneath the urethra, since there is a risk of suturing the suture in doing so. After the knot is completed, the remaining ends of suture 10 are cut off at the knot. The part of the suture that is left in the vagina is epithelialized after 3 or 4 days, so the patient cannot feel the suture fixed. This allows permanent fixation of the tissues around the urethra on both sides of the urethra, thereby keeping the urethra at the correct angle to eliminate stress incontinence. After the knot process is complete, the surgical area inside the patient is filled with diluted lidocaine solution, the laparoscope and trocar are removed and applied to the incision site, a strong lidocaine solution, to close the incision in the usual manner. Next, the poly urinary catheter is removed and the patient recovers in the usual manner. Normal activity is possible after a few days.

(E: seam recovery machine)

Various instruments may be used to pull the end of suture 10 through the entire thickness of the fascia and vaginal mucosa near the urethra. For example, the US Surgical Auto-Stitch tool can be used effectively for this process. However, the instrument to be used must be able to be easily inserted from the vagina into the space of the resistus through the tissue around the urethra. In addition, the surface in contact with the suture 10 must be completely smooth to eliminate cutting or breakage of the suture 10 to ensure the effectiveness of the treatment. Applicants have developed a new suture retriever for this purpose to provide a means for convenient and simple retrieval of the end of the suture.

The suture recovery device of the present invention includes a metal recovery end 65, an intermediate shaft 66, and a handle 67, as shown in FIG. The intermediate shaft 66 and the handle 67 can be molded to conventional shapes from polycarbonate or similar materials. As shown in FIG. 12, the handle 67 is preferably knurled to facilitate gripping and handling of the retriever. The metal recovery end 65 is preferably made of stainless steel and rigidly molded into the period 68 of the intermediate shaft 66.

The metal recovery end 65 includes a rigid rod-shaped shaft 69 and a sharp end 70 that can penetrate the tissue near the urethra. The diameter of the proximal end 68 is preferably much larger than the diameter of the shaft 69 and acts as a stop limiting the penetration of the suture recovery mechanism into the space of the resistus. Thus, the length of the shaft 69 and the end 70 must be chosen so that the sharp end 70 cannot destroy the surrounding soft tissues when the suture recovery mechanism is inserted through the vagina into the space of the resist.

The recovery end 65 also includes a return leg 71 extending away from the sharp end 70 in the same direction as the shaft 69. The underside of the shaft 69, the return leg 71, and the sharp end 70 create an inverted U-shaped area that can hold the suture 10 for retrieval. The distance between the return leg 71 and the shaft 69 in this inverted U-shaped region is preferably approximately equal to the diameter of the suture 10. In this configuration, after the sharp end 70 penetrates the tissue near the urethra adjacent to the vagina to enter the space of the Regis as shown in FIG. 20, the inverted U-shaped region moves downward beyond the suture end. Pulled to knot the suture. Then, the metal recovery end 65 is pulled through the tissue near the urethra so that the end of the suture 10 is caught between the shaft 69 and the return leg 71 directly below the sharp end 70. It stays true. The ends of the sutures slide slid within the U-shaped area, but are nevertheless drawn into the vagina.

One distinctive feature of the sealed retractor of FIG. 12 is the inner surface of the metal recovery end 65 which contacts the suture 10 so that the suture 10 may move freely within the inverted U-shaped portion when the suture retractor is recovered. This should be round and smooth. This prevents the seam from being knotted or loosened, while allowing the end of the seam to be recovered. Therefore, only the sharp part of the metallic material recovery end 65 becomes the sharp end 70.

Although the handle 67, the intermediate shaft 66, and the retrieval end 65 may be located along the same longitudinal axis to form a rigid and elongated structure, the applicant has found that the members of the retractor have an angular relationship as shown in FIG. It was found that the process of the present invention can be simplified if This is especially the case when the template of the present invention (described above) is used. Accordingly, the metal recovery end 65 is preferably positioned at an angle of about 50 degrees to 80 degrees with respect to the intermediate shaft 66, more preferably at an angle of about 60 degrees (this angle is designated as A in FIG. 11). ). Likewise, the handle 67 is preferably positioned at an angle of about 50 degrees to 80 degrees, more preferably at an angle of about 80 degrees (these angles are designated B in FIG. 11). Therefore, the longitudinal axis of the shaft 69 of the metal recovery end 65 is parallel to the longitudinal axis of the handle 67. In this form, the intermediate shaft 66 is positioned substantially parallel to the longitudinal axis of the vagina when the recoverer of the present invention is used. Then, the metal recovery end 65 extends upwardly through the tissue adjacent to the urethra into the space of the resist. As best seen in FIG. 20, the handle 67 extends downwardly at the outer surface of the vagina, so the sharp end 70 is easy through the tissue adjacent to the urethra by simply applying an upward force on the handle 67. Are encouraged.

As shown in FIG. 11, the region between the handle 67 and the intermediate shaft 66 and the region between the intermediate shaft 66 and the recovery end 65 are slightly curved to facilitate installation. Here, the angles A and B are quite large and preferably they are closed relative to each other as much as possible so that the parallel relationship between the handle 67 and the recovery end 65 is maintained. Moreover, this shape causes the return end 65 to enter the space of the resistus at an angle of approximately 90 degrees with respect to the tensioned suture end (ie, the suture end tensioned between the anchor and the anchor insertion mechanism). This vertical relationship not only effectively captures the suture line but also improves the observation of recovery through the laparoscope.

Preferably, the intermediate shaft 66 has a length of about 2 cm to 6 cm, more preferably about 4 cm. The cross sectional area of the intermediate shaft 66 is chosen only to provide the necessary strength while at the same time not interfering with vision in the vagina during this process. Likewise, the handle 67 preferably has a length of 4 cm, with no length limitation since the handle 67 is completely maintained on the outer surface of the body. The diameter of the handle 67 is selected to provide a means for comfortably holding the suture recovery mechanism. Preferably, the diameter of the handle 67 is 3 cm.

(F: Surgical template)

Although the installation of the suture at the urethral vesicular connection can be performed by just feeling the right position in the vagina, especially with regard to the poly urinary tract, we have developed a new template that simplifies the proper installation of the suture. . This template not only prevents damage to the bladder, damage to the urethra, or vascular accidents, but also ensures proper distance between these ends so that the tissue around the urethra is placed between the two ends of the suture line to provide the necessary support. Clearly, if these ends are positioned too close to each other, the sutures break through the tissue near the urethra and fail to fix it. The template thus has at least two holes that can be properly positioned on either side of the urethra. The suture retractor is then inserted through these holes and then through the tissue around the urethra to grasp the end of the suture as described above.

The template of the preferred embodiment is shown in FIGS. 13 to 17. The template includes an arcuate cross-section trough 80, which is selected to a size that retains the urethra of the patient when properly positioned. The first and second vane members 81, 82 extend perpendicularly to the longitudinal axis of the trough 80, preferably in the manner shown, away from both sides of the trough 80. More preferably, the first and second vane members 81 and 82 extend vertically away from both sides of the trough at the recall edges 83 and 84 of the trough. First and second suture guide holes 85 and 86 are located in each wing member 81 and 82 as shown. These guide holes are positioned so that when the patient's urethra is properly positioned in the trough 80, the guide holes 85 and 86 on each wing member indicate the proper position of the suture line. The first guide hole 85 is positioned such that the first end of the suture 10 penetrates the tissue near the urethra about 1 cm away from the urethra adjacent to the urethral vesicular junction. The second guide hole 86 is preferably located about 1 cm from the urethra along a line perpendicular to the longitudinal axis of the trough 80. In other words, the distance between the first guide hole 85 and the second guide hole 86 is preferably about 1 cm. In this way, the surgeon can confirm that there is sufficient tissue around the urethra between the two suture ends.

The template of the present invention can only be fixed by hand, the downwardly inclined nature of each of the wing members 81, 82 below is suitable for the doctor's finger to be positioned underneath. An additional alignment member may preferably be provided with a minimum, but an end wall 87 is provided at the end of the trough 80 that is furthest from the suture guide hole. Thus, as long as the template is configured to an appropriate size for the length of the patient's urethra, the surgeon may secure the template with the end wall 87 in contact with the outermost end 89 of the urethra 4 for proper alignment. There is a number. For example, if the length of the patient's urethra is determined to be 3 cm, the distance between the end wall 87 and the first and second guide holes 85, 86 is about 2.5 cm to 3.2 cm, preferably about 2.8 cm. These guide holes are located between about 0.25 cm and 0.5 cm from the base end 91 of the wing member. As long as the template is positioned with the end wall 87 in contact with the outermost part of the urethra, the physician spreads that the sutures will be properly positioned without risk of penetrating the bladder or urethra.

The surgeon may use two fingers under the wing members 81 and 82 to hold the template in the proper position, but Applicants have provided the arch alignment member 88 secured to the end wall 87 in some way. It was found that it can be used properly to fix the template without the need to support it. The alignment member 88 is preferably positioned parallel to the trough 80, and the centerline of the alignment member 88 is aligned with the centerline of the trough 80. The alignment member 88 may extend away from the trough 80 as shown in FIG. 13 or may be extended away from the end wall directly along the interior of the trough 80 as shown in FIG.

When the embodiment of FIGS. 13-16 is used, the alignment member 88 is preferably arranged around the poly urinary tract 14 as shown in FIG. 20 when the alignment member 88 is made of an elastic material. It is sized to be tightly snapped together. Thus, it is firmly retained in the alignment member 88 of the shaft of the poly urinary catheter, while the surgeon only pulls out on the poly urinary catheter and at the same time until the end wall 87 contacts the end 89 of the urethra 2. This slides into the vagina toward the urethra. Thus, if the size of the template is chosen to be of an appropriate size based on the length of the urethra, the polycatheter is placed at the ureal vesicular junction and the template is likewise positioned at the appropriate location.

As another embodiment providing various sizes for the template of the present invention, a single large dimension template can be used provided the alignment member 88 snaps around the shaft of the poly urinary catheter 14 at a suitable location. Combined. Thus, instead of the end wall 87 contacting the end 89 of the urethra 2, the end wall 87 is aligned to an appropriate degree along the shaft of the poly urinary catheter 14 based on the pre-measured length of the urethra. . Likewise, the end 90 of the alignment member 88 may also be aligned to an appropriate degree along the shaft of the poly urinary catheter 14 to provide proper installation of the template based on the length of the urethra of the patient.

FIG. 18 shows another embodiment of the template of the invention in which the alignment member 88 extends along the interior of the trough 80. In this embodiment, the alignment member 88 is inserted into the urethra with the poly urinary catheter 13 until the end wall 87 of the template contacts the end of the urethra 2. Thus, of course, it ensures proper installation of the seam of the template of appropriate dimensions.

Finally, the template of the present invention may be made of any suitable material, such as polycarbonate or other plastics approved by the FDA. The template can be easily molded in the manner of the prior art and preferably can be manufactured as a portable single item. Drill actuators and anchor inserts, on the other hand, must be made of medical grade stainless steel. However, the handle can be made of polycarbonate or other plastics approved by the FDA.

(G: anchor and anchor insertion mechanism of another preferred embodiment)

As described above and well illustrated in FIG. 19, the pubis 12 are pulled away from the laparoscope at an angle of about 45 degrees to 60 degrees. Thus, the bore in the pubic bone extending vertically from the surface of the bone extends inward at an angle of about 20 degrees to 60 degrees. In other words, when the bore 13 is shown in cross section as shown in cross section of the pubis 12 in FIG. 23, the angle X between the surface 100 and the bore 13 of the pubis is 20 to 60 degrees. Degrees, preferably about 45 degrees. During the laparoscopic surgery treatment of the present invention, the surgeon can easily change the angle X to provide an angle corresponding to the angle of the anchor (preferably about 45 degrees). This is done by expanding or contracting the cavity of the abdomen as necessary to change the angle of the laparoscopic channel with respect to the pubis. Since the inner surface 102 of the cortical bone 101 is parallel to the outer surface 100 of the pubis 12, the same angular relationship exists inside the bore. When an anchor as shown in FIGS. 3 and 4 is used, it can be immediately seen that the angular relationship of this surface 102 and the bore 13 contacts the lower barb of the anchor with the surface 102. Since the cancelous bone 103 provides only a very small support force for the anchor, the contact between the bottom barb of the anchor of FIGS. 3 and 4 and the surface 102 is a principle of preventing the anchor from being pulled out of the bore. Provide only supportive support

When anchors of the type shown in FIGS. 3 and 4 are tested for pulling strength, they are typically pulled only in the direction of arrow B. FIG. However, after the urethral curative surgery of the present invention is performed, any force on the anchor often occurs in the direction of arrow A. Naturally, only the fact that the lower barb is in contact with the surface 102 can cause the anchor to be pulled out of the bore due to the force acting in the direction of arrow A. This is due to the fact that the end of the anchor to which the suture is fixed can provide downward rotational force in the direction of the arrow A because the cancellose bone 103 provides a small support force.

In order to overcome the problems of the prior art anchor mentioned above, the applicant has developed the shape of the new anchor shown in Figs. A disadvantage of the prior art is that the angular relationship between the bore 13 and the surface 102 is determined by the fact that the orientation of the wing member or barb is in contact with the outer end of the wing member (ie, the portion that contacts the inner surface 102 of the cortical bone). It is overcome by modifying it to have an angular relationship corresponding to Thus, as best shown in FIGS. 24 and 25, the anchor 139 includes a cylindrical body 140, at least three wing members or barbs 141, 142, 143, and a hole 150 located within the tab member. The body 140 is configured in a similar form to the prior art, but the distal end 160 may be rounded to relatively easily push the distal end 160 into the cancellulostomy bone. Conical shapes of the prior art can also be used. The proximal end 161 is preferably configured perpendicular to the longitudinal axis of the body 140 to provide a flat proximal surface that can cooperate with the new anchor insertion mechanism now described. The hole 150 serves the same intention as described above (ie, the means for attaching the suture to the anchor) and should be configured as smooth as possible so that the surface and edges of the hole 150 prevent the suture from knotting. In practice, the holes 150 can be highly abrasive or coated to reduce friction.

As shown in Figs. 24 to 26, the tab member 151 preferably has a height 163 corresponding substantially to the diameter of the body 140 and a width 1640 smaller than the diameter of the body 140. Tab member The length 165 of 151 should be sufficient to provide the size 0 of the suture line through the hole 150. Also preferably, the length of the tab member 151 is perpendicularly away from the proximal end 161. Extending to make it easier to cooperate and engage with the anchor insertion mechanism.

As explained above, the most important feature of the anchor shown in FIGS. 23-30 is the arrangement of the wing members or the barbs. As with conventional anchors, the barbs may be elastically bent (ie, shape-memory) from the normal local position (position shown) to the compression position. In this retarded position, the barbs preferably extend from the body 140 in a curved manner as shown in the radial and axial directions. In the compressed position, however, the barbs extend almost straight so that the anchor can be inserted into a bore formed in the bone in a prior art manner (see, eg, US Pat. Nos. 5,207,679 and 5,217,486). In order to facilitate compression and insertion, a number of channels 170 are provided along the length of the body 140. One channel 170 is positioned underneath each wing member and aligned together. In addition, each channel is sized to receive at least some, preferably all, of the corresponding vane members aligned together. In this way, when the wing member is compressed during the anchor insertion process, the compressed and straightened wing member is positioned entirely in the channel located adjacent thereto.

By the wing member in the compressed state, the anchor corresponds to the diameter of the body 40, so that the anchor inserted into the bore has a diameter slightly larger than the diameter of the body 140. As the wing member extends into the bore beyond the inner surface 102 of the cortical bone, the wing member returns to its original retarded position, which allows the cancellose bone to retract from the wing member due to inherent elasticity (or due to shape memory). This is because it is not hard enough to support the spring action. As shown in FIG. 23, since the diameter of the bore 13 is only slightly larger than the diameter of the body 40, the outer end of the wing member contacts the inner surface 102 to prevent the anchor from being removed from the bore. . For example, the outer end of the pushing 141 is stationary relative to the inner surface 102 as shown in FIG.

30 shows a cross section of the channel 170, which is a cross section of the anchor of FIG. 26. As shown, the channel 170 preferably has a depth sufficient for the entire wing member to be compressed into the channel. In addition, as shown in FIG. 24, the length of each channel 170 is of sufficient length only to accommodate all of these wing members when the corresponding wing members are compressed. Thus, the channels may be of different lengths depending on the different lengths of the corresponding wing members. The end 171 of the channel 170 (see FIG. 24) is also aligned with respect to the longitudinal axis 162 as shown corresponding to the outer end of the wing member, which is angled in a manner described in more detail below. To achieve.

In order to contact at least a portion of the outer end of each wing member with the inner surface 102 of the cortical bone adjacent to the bore 13, when the bores 13 are positioned not perpendicular to the outer surface 100 of the pubis, respectively. At least a portion of the outer end of is aligned along the first virtual surface 175 penetrating through the body 140 (see FIG. 25A). In the anchors of the prior art, these virtual surfaces are perpendicular to the longitudinal axis 162 so that all of the outer surface of each wing member is uniformly aligned. However, in the anchor of the present invention, the first virtual surface passes through the body at an angle with respect to the cross section 1176 passing through the body 140, and the cross section 176 is perpendicular to the longitudinal axis 162. As can be appreciated, the angle F of FIG. 25A is preferably approximately equal to the angle X of FIG. 23, so that at least a portion of the outer end of each barb is adjacent to the bore 13 with the inner surface ( 102). Thus, the angle F is preferably 20 degrees to 60 degrees, more preferably about 45 degrees. The outer ends of the wing members are preferably tapered as shown so that the entirety of each outer end lies along the first virtual surface 175. Thus, these outer ends 144, 145, 146 corresponding to the barbs 141, 142, 148 are aligned along the first virtual surface 175 to provide additional support when the anchor is secured to the bore 13.

As will be described further below, in this respect it is desirable to define the top of the anchor by an upper line 166 extending along the surface of the body 140 parallel to the longitudinal axis 162. The first virtual surface 175 intersects the top line 166 at the intersection between the surface of the body 140 and the first virtual surface 175 adjacent the proximal end 161. In other words, the barb extending from the body 140 at a point adjacent the upper line 166 has an outer end proximate to the proximal end 161. The outer end extends from the proximal end 161 farther from the top line 166 where the barb extends from the body 140. Thus, the upper portion of the body 40 is defined as half of the body 40 adjacent to the upper line 166, with the remainder being lower.

In order to provide the alignment as described above, the wing member can extend from the anchor body in various shapes. More preferably, each barb has a similar length, providing the bending properties of each barb so that the anchor is pushed straight into the bore. Thus, each wing member preferably extends from the body 140 along a second virtual surface penetrating the body 140 at an angle with respect to the cross section 176. As will be appreciated, the angle between this second virtual plane and cross section 176 is approximately equal to the angle of FIG. 25A. Alternatively, the wing member may extend from the anchor body at the same point from the proximal end 161 (ie, along a plane extending perpendicular to the longitudinal axis 162). In order to provide proper alignment to the outer ends of the barbs, the lengths of the barbs do not need to be configured equal to each other in this embodiment.

Various shapes and numbers of barbs may be used to provide adequate support during use. Three preferred arrangements are shown in FIGS. 27-29. In the embodiment of FIG. 27, corresponding to FIGS. 23 to 26, five barbs are used. Thus, the barbs 141, 142, 143 extend upward from the top of the body, while the barbs 148, 149 extend downward from the bottom. When the anchor is viewed from the proximal end to the distal end (see FIGS. 27-29), the barbs 141 are generally aligned with the top line of the body 140. For simplicity, this is defined as the 12 o'clock position in the standard clockwise direction. Thus, barbs 141 are about 12 o'clock, barbs 142 are about 10 and 11 o'clock, barbs 143 are between 1 and 2 o'clock, barbs 149 are between 4 and 5 o'clock, and barbs 148 is located between 7 and 8 o'clock. Here, an odd barb extends from the top of the body, because more bearing capacity is required in these areas.

In the embodiment of FIG. 28, three barbs 152, 153, 154 are used, of which two barbs extend from the top of the body 140. Preferably, barbs 153 are between 10 and 11 o'clock, barbs 152 are between 1 and 2 o'clock, and barbs 154 are in the 6 o'clock position. In FIG. 29, four barbs 155, 156, 157, 158 are used, two extending downward from the bottom of the body 140. Preferably, barbs 155 are between 10 and 11 o'clock, barbs 156 are between 1 and 2 o'clock, barbs 157 are between 4 and 5 o'clock, and barbs 158 are between 7 and 8 o'clock. Located in between. Here, it should be noted that any other arrangement and number may be used, and only three embodiments are presented as preferred embodiments for the convenience of description.

The anchor of the present invention may consist of any material and number, but titanium or titanium alloy is preferred. The anchor is also preferably capable of single molding, but the wing member is preferably molded separately and attached to the body 140 during assembly. For example, wing members or barbs may be attached to the body 140 in the manner shown in US Pat. Nos. 5,207,679 and 5,217,486. Preferably, the barb consists of a wing-shaped member and may be formed of titanium or nickel-titanium wire in a known form.

As described above, the hole 150 of the anchor 139 is configured to allow the suture line 180 to penetrate. In this form, two suture ends may be used in the manner described above to extend from the aperture 180 to lift tissue adjacent to the urethra, for example, at the urethral vesicular connection. Here, it is important that during such a procedure the seam should be protected from breaking or other wear to ensure strength. Although the proximal end of the anchor shown in FIGS. 23 to 30 may be modified to the one shown in FIGS. 3 to 4 and may be used with the anchor insertion mechanism shown in FIGS. Anchor insertion mechanisms have also been developed that can be used with anchors. This new anchor insertion mechanism not only protects the seam but also facilitates proper alignment of the anchor in the bore while also providing a means to tension the seam end as shown in FIG. 20.

31 to 35, the insertion mechanism comprises an elongated rigid member 250, the rigid member 250 is an anchor receiving end 252, and the anchor receiving end A hollow cylindrical intermediate portion 253 having a proximal end 260 adjacent to 252 and preferably larger in diameter than the end 252 and attached to the intermediate portion 253 at the opposite end of the anchor receiving end 252. A handle 251 and a passage 254 providing communication between the interior of the intermediate portion 253 and the insertion mechanism. Since the anchor receiving end 252 is preferably hollow and the interior thereof communicates with the interior of the intermediate portion 253, an anchor with a seam extending therefrom can be secured to the end 252 and the seam (preferably, A pair of suture ends) penetrates through the end 252, at least the intermediate portion 253, and the passage 254. As shown in FIG. 31, the passage 254 is preferably provided inside the handle 251, ending at the rear face of the handle 251. As the passage 254 communicates with the interior of the intermediate portion 253, the suture end extends along the entire length of the insertion mechanism and is released to the rear face 255 of the handle 251. Thus, as shown in FIG. 32, suture end 260, 261 is released from the anchor 139 retained at end 252 to the rear face 255 through the entire interior of the insertion instrument. Although suture ends may be released from the interior of the inlet in several locations, the posterior surface 255 provides a convenient location for the physician during laparoscopic urethral fixation and similar treatments. Moreover, the sutures are located entirely in the insertion mechanism, so no knots or breaks can occur during the insertion process. Here, it should be noted that the lengths of the suture end 260, 261 are shown to be shrunk for simplicity.

The anchor receiving end 252 should be configured to engage correspondingly with the particular anchor used. As described above, the diameter of the end 252 should be the same as the diameter of the anchor body to facilitate insertion of the anchor. In the embodiment shown in FIGS. 31 and 32, the end 252 has a slot 256 that partially intersects the diameter of this end and its length, the slot 256 being the tab member of the anchor 139. 151 can be accommodated accordingly. Since it is important that the anchor 139 is properly aligned in the bore in the pubis, the slot 256 prevents the anchor from rotating during the anchor insertion process. Preferably, the slot 256 has a diameter slightly larger than or equal to the tab member 151 of the anchor 139, so that the tab member 151 can be installed in the slot 256. The tab member 151 may be wedged in the slot 256 to hold the anchor on the end 252, or the end 258 of the end 252 may be anchored by an adhesive which is removable. It may be fixed to the proximal end 161 of the. FDA approved epoxy or other adhesives may be used, but the bond between the distal end 258 and the proximal end 161 should be easily released after the anchor has been placed in the bore by simply pushing the insertion instrument out of the bore. Moreover, since the seam ends are preferably tensioned between the anchor and the handle 251 in the manner described below, the seam ends 260 and 261 also serve to hold the tab member 151 in the slot 256. .

As best shown in cross-sectional views in FIGS. 33 and 34, the wall thickness of the end 252 is such that a seam 180 passing through the hole 150 of the tab member of the anchor is secured on the end 252. Should not be compressed by the inner wall of the end 252. In other words, the inner diameter of the anchor receiving end 252 should be larger than the sum of the width of the tab member 151 and twice the diameter of the suture line 180. In this way, suture 180 can be more protected from damage during anchor insertion.

Obviously, in order to properly position anchor 139, anchor receiving end 252 must have a sufficient length to be inserted through the cortical bone so that the barbs of all anchors can be properly deployed. The proximal end 161 of the anchor 139 is substantially adjacent to the inner surface 102 of the cortical bone surrounding the bore when the anchor is properly positioned in the bore (ie, when the outer ends of all barbs are placed in contact with the inner surface of the cortical bone). Since it is preferable to align, the anchor receiving end 252 has a length (about 5 mm to 8 mm) that is slightly larger than or equal to the thickness of the cortical bone. The end 260 of the intermediate portion 253 not only acts to move the anchor into the bore but also acts as a stop, because its diameter is preferably larger than the bore and the anchor body being inserted into the bore. Thus, the proper length for the end 252 not only moves the anchor to a depth sufficient to allow the anchor to be inserted deep enough into the bore, but also prevents the anchor from moving too deep into the bore. In the latter situation, the stability of the anchor is guaranteed but the suture may be damaged by the edge of the bore after the surgical treatment is completed.

In order to easily manipulate the anchor insertion mechanism within the laparoscope, a plurality of protrusions 259 are preferably provided around the circumference of the intermediate portion 253. These protrusions 259 are preferably located near the handle 151, more preferably 5 cm to 10 cm away from the handle. Since the diameter of the intermediate portion 253 is slightly smaller than the diameter of the laparoscope which is preferably used (preferably 7.8 mm to 8.0 mm), the projections 259 assist in controlling the insertion instrument during the treatment of the present invention. Preferably, the projection 259 is formed to a size that cooperates with the laparoscope of the standard rubber grommets.

The handle 252 may be fixed to the middle portion 253 by any means, but preferably the handle 252 is screwed to the middle portion 253. Thus, corresponding male and female members are provided respectively at the handle and the intermediate portion. The handle 251 preferably has a curved gripping surface. In this embodiment, the handle 251 is preferably provided with different upper and lower portions 271 and 272, respectively. When anchor 139 is secured to end 252 such that its top line is aligned with top 271 of handle 251, the surgeon can easily ascertain whether the anchor has been properly inserted into the bore. As long as the upper portion 271 extends directly upwards during anchor insertion, proper installation is made. The lower portion of the handle 251 is preferably heavier than the upper portion 271. This difference in weight also provides alignment, since gravity causes the insertion instrument to rotate to the correct position in the laparoscopic channel. Clearly, such alignment means (ie oriented handles) require precise engagement of handle 251 and intermediate portion 253. Of course, other alignment means, such as guide lines, height adjusting bubbles, or the like may also be used.

As described above, the suture end extending from the anchor not only assists in retaining the anchor on the anchor receiving end 25 but also during the suture retrieval step shown in FIG. 20 (ie, the insertion instrument may be partially removed from the laparoscope). Help). Appropriate tension may be provided by at least one notch in which the suture end is wedged. Preferably, the notch is aligned near this passage so that the suture end can extend directly into the notch through the passage. Accordingly, these notches 280 and 281 are preferably provided on the rear surface 255 of the handle 251. In practice, passage 254 is preferably provided to handle 251 within elongated diamond shaped outlet 279, such that notches 280 and 281 constitute narrow edges facing each other of outlet 279 as shown. . As suture line ends 260 and 261 exit passage 254 through outlet 279, these ends engage into notches 280 and 281, respectively. In this way, the ends are tensioned between notches 280 and 281 and the holes 150 of the anchors. After the anchor is inserted into the bore, the seam ends 260, 261 slide into their respective notches as they are partially pulled out of the channel into the insertion mechanism and laparoscopically, thereby providing the desired tension at the seam end required in the suture recovery step. Keep it. To further improve the tension of the seam, the passage 254 is tapered from the middle portion 253 to the outlet 254 to provide additional engagement of the seam end within the passage 254 end portion.

Here, the intermediate portion 253 preferably has a length of about 52 cm to 55 cm to facilitate its use through the laparoscope.

In order to facilitate the process of quickly and appropriately inserting the anchor, the anchor 139 and the anchor insertion mechanism of the present invention are in the stacked form of FIG. 32 (the seam is attached and coupled in consideration of tension as shown). May be provided to a doctor. An anchor may be releasably attached to the anchor receiving end as shown. In this way, the surgeon preferably has two preloaded insertion instruments (an anchor 139 associated with the anchor insertion end and a suture pulled between the notch and the anchor on the handle 251). Just open the device. Such a preloaded insertion mechanism may be constructed inexpensively enough for single use, or may provide manufacturers with the ability to reuse hygienic and repositionable anchor insertion mechanisms. Such surgical devices for performing laparoscopic urethral fixation may also include a drill implement, a suture retractor, and a template of one or more dimensions, all of which are described above. In this form, the surgeon can have all the instruments necessary for fast and simple urethral fixation in a small sterile device.

Claims (114)

A surgical device for use in the treatment of laparoscopic urethral fixation, which is configured to lift the urethra at a predetermined angle by fixing a suture line between an anchor secured to the pubic bone and a tissue adjacent to the urethra by laparoscopy. In (1) at least one anchor that can be secured to the pubis by laparoscopy; (2) an anchor insertion mechanism for fixing the anchor to the pubis by laparoscopy; and (3) A surgical device comprising a suture retrieval mechanism for retracting sutures extending into the vagina from the anchor. The surgical device of claim 1, further comprising at least one suture, wherein the anchor has a passageway through which the at least one suture can be inserted. 3. The surgical device of claim 2 comprising a pair of said anchor and a pair of said sutures. The surgical device according to claim 2, further comprising a surgical template for guiding the suture line through the fascia and vaginal mucosa near the urethra during the urethral fixation treatment. The surgical device of claim 1, further comprising a drill actuating mechanism for forming a bore in the pubis into which the anchor can be inserted. The method of claim 1 wherein the anchor is (1) a body having a longitudinal axis, a proximal end, and a distal end, (2) at least three wing members extending outwardly from the body and fixed to the body, each wing member being elastically bent from a normal retarded position to a compressed position, wherein each wing member is A first virtual having a distal end away from the body, wherein at least a portion of each outer end of each wing member penetrates the body at a predetermined angle to a cross section of the body perpendicular to the longitudinal axis; At least three wing members aligned along the face, and (3) A surgical device comprising a hole located adjacent the proximal end of the body. The method of claim 1, wherein the anchor insertion mechanism comprises an elongated rigid member, the rigid member is (1) an anchor receiving end that can be coupled correspondingly with the anchor, (2) a cylindrical hollow intermediate portion having one end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end; (3) a handle attached to said intermediate portion at the opposite end of said anchor receiving end, and (4) providing a communication between the inside of the intermediate portion and the outside of the anchor insertion mechanism such that a suture extending from the anchor positioned on the anchor receiving end passes through at least a portion of the intermediate portion and the passageway from the anchor receiving end. Surgical device with aisle. 8. The system of claim 7, further comprising at least one suture, wherein the anchor is correspondingly and releasably coupled to the anchor receiving end of the anchor insertion mechanism, the suture being in the middle of the intermediate portion and from the anchor. Surgical device for providing a pre-loaded anchor insertion device through the passage of the anchor insertion device. The apparatus of claim 5, wherein the drill actuating mechanism comprises an elongated rigid member, wherein the rigid member is (1) a perforated end with a distal end that is sharp enough to form a bore in the bone of the reticulated tissue with the aid of a hand, but not sharp enough to inadvertently penetrate soft tissues or organs during the formation of the bore; (2) a collar having a diameter larger than the diameter of the perforated end, (3) a cylindrical intermediate portion attached to the perforated end in the collar and having a diameter larger than the diameter of the perforated end; (4) A cylindrical guide that can be inserted into the laparoscopic working channel and has a first and second ends and a diameter greater than the diameter of the middle part, the first end being at the end of the middle part opposite the collar. Attached guides, and (5) having a handle attached to the second end of the guide, Inserting the distal end of the perforated end into a hole formed in the pubic bone deep enough to provide access to the reticular tissue and then forming the bore with a length corresponding to the length of the perforated end A laparoscopic device that can be used laparoscopically to cause the drill actuator to form a bore in the pubis by pushing it into the hole by the handle. A surgical method of performing laparoscopic urethral fixation on a patient, (1) providing at least one anchor and at least one suture line, (2) laparoscopically fixing the anchor to the pubis of the patient, and (3) fixing the suture line between the anchor and tissue adjacent to the urethra to lift the urethra at a predetermined angle. 11. The method of claim 10, further comprising the step of cutting at least a portion of the space of the ledge before fixing the anchor, wherein the anchor is fixed to the pubis adjacent the space of the ledge. Way. 11. The method of claim 10, further comprising the step of forming a bore by laparoscopy in the pubic bone, wherein the step of securing the anchor to the pubis comprises laminating the anchor into the bore so that the anchor is fixed in the bore. Surgical operation method comprising the step of doing. 11. The method of claim 10, wherein the anchor is provided with sutures extending from the anchor, and the step of securing the suture line between the anchor and tissue adjacent to the urethra may include suturing the suture line into the vagina through the fascia and vaginal mucosa around the urethra. And pulling the sutures into the vagina. 12. The method of claim 11, wherein a pair of anchors is provided, each anchor having a suture extending from the anchor, each anchor anchored to the pubic bone adjacent to the space of the ledge, and each suture is urethral. A method of surgery in which the suture is pulled into the vagina through the surrounding fascia and vaginal mucosa and then secured to the tissue adjacent to the urethra by suspending the suture in the vagina. 14. The method of claim 13, wherein the step of pulling the suture into the vagina through the fascia and vaginal mucosa around the urethra (1) providing a seam recovery device having an end portion, (2) inserting the suture into the patient's vagina through the fascia and vaginal mucosa adjacent to the urethra, (3) catching the suture with the retriever, and And (4) pulling the suture into the vagina by pulling the end of the retractor back into the vagina. The method of claim 13, (1) providing a suture template having at least one guide hole, and (2) further comprising positioning the template within the patient's vagina such that the guide hole is aligned with the vaginal mucosa adjacent to the urethra, And the suture is drawn through the guide hole of the template. 14. The suture line of claim 13, wherein the suture line has first and second ends, wherein the first and second ends are respectively drawn into the vagina through the fascia and vaginal mucosa around the urethra, the first end being the Positioned at a distance from a second end, wherein suspending the suture in the vagina comprises suspending the first end to the second end. An anchor that can be inserted into a hole formed in a bone, (1) a body having a longitudinal axis, a proximal end, and a distal end, (2) at least three wing members extending outwardly from the body and fixed to the body, each wing member being elastically bent from a normal retarded position to a compressed position, wherein each wing member is A first virtual having a distal end away from the body, wherein at least a portion of each outer end of each wing member penetrates the body at a predetermined angle to a cross section of the body perpendicular to the longitudinal axis; At least three wing members aligned along the face, and (3) an anchor comprising a hole located adjacent the proximal end of the body. 19. The apparatus of claim 18, wherein the body has a top and a bottom, the top of the body is defined by a top line extending along the surface of the body that is parallel to the longitudinal axis, the first virtual surface being the An anchor that intersects the top line at an intersection point between a surface of a body and the first imaginary plane closest to the proximal end, wherein the angle between the first imaginary plane and the cross section is about 20 to 60 degrees. 20. The anchor of claim 19, wherein the body is cylindrical. 21. The anchor of claim 20 wherein the proximal end of the body provides a flat proximal end perpendicular to the longitudinal axis. 21. The anchor of claim 20 further comprising a tab member extending from the proximal end of the body, wherein the aperture is located within the tab member. 20. The anchor of claim 19 wherein each wing member extends outwardly from the body along a second imaginary surface penetrating the body at an angle up to a cross section of the body perpendicular to the longitudinal axis. 20. The wing of claim 19 wherein each of said wing members extends outwardly from said body at a point at the same distance from the proximal end of said body, wherein the length of each of said wing members is at least a portion of the outer end of each of said wing members. The anchor selected to align with the first virtual plane. 24. The device of claim 23, wherein the body further comprises a channel located directly below each of the wing members, each channel being at least the same size as a portion of the corresponding wing member located outwardly of the body. An anchor having a length, wherein the wing member is at least partially positioned within the channel when each wing member is in the compressed position. 25. The apparatus of claim 24, wherein the body further comprises a plurality of channels, one of the plurality of channels being located directly below each of the vane members, wherein each of the channels is located out of the body. And a length of at least the same size as the corresponding portion of the wing member, wherein the wing member is at least partially positioned in the channel when each wing member is in the compression position. 26. The anchor of claim 25, wherein each of the wing members has a cylindrical barb, the barb extending curvilinearly away from the body radially and axially in the deployed position. 27. The anchor of claim 26, wherein each of the wing members has a cylindrical barb, the barb extending curvilinearly away from the body radially and axially in the deployed position. 28. The anchor of claim 27 wherein the outer ends of each of the barbs are tapered to align with the entirety of the outer ends along the first imaginary plane. 29. The anchor of claim 28 wherein the outer ends of each of the barbs are tapered to align with the entirety of the outer ends along the first imaginary plane. 23. The anchor of claim 22 wherein the tab member has a width less than the diameter of the body. 21. The anchor of claim 20 wherein the anchor has three wing members, one wing member extending downward from the bottom of the body, and two wing members extending upward from the top of the body. 33. The method of claim 32, wherein when the anchor is viewed from the proximal end toward the distal end, the wing member has the top line at a 12 o'clock position, a position between 10 and 11 o'clock, a position between 1 and 2 o'clock, and 6 An anchor extending from the outer periphery of the body when in the position of view. 21. The anchor of claim 20, wherein the anchor has four wing members, two wing members extending downward from the bottom of the body, and two wing members extending upward from the top of the body. 35. The method of claim 34, wherein when looking at the anchor from the proximal end toward the distal end, the wing member has the top line at a 12 o'clock position, a position between 10 and 11 o'clock, a position between 1 and 2 o'clock, and 4 o'clock. An anchor extending from the outer periphery of the body when in a position between and five o'clock and seven o'clock. 21. The anchor of claim 20, wherein the anchor has five wing members, two wing members extending downward from the bottom of the body, and three wing members extending upward from the top of the body. 35. The method of claim 34, wherein when the anchor is viewed from the proximal end toward the distal end, the wing member has the upper line at the 12 o'clock position, about 12 o'clock position, between 10 o'clock and 11 o'clock, between 1 o'clock and 2 o'clock. An anchor extending from the outer periphery of the body when in position, between 4 and 5 o'clock, and at 7 and 8 o'clock positions. An anchor insertion mechanism for laparoscopically inserting and fixing an anchor in a bore formed in a bone, An elongated rigid member, said anchor having at least one suture extending from said anchor, said rigid member (1) an anchor receiving end that can be coupled correspondingly with the anchor, (2) a cylindrical hollow intermediate portion having one end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end; (3) a handle attached to said intermediate portion at the opposite end of said anchor receiving end, and (4) providing a communication between the inside of the intermediate portion and the outside of the anchor insertion mechanism such that a suture extending from the anchor positioned on the anchor receiving end passes through at least a portion of the intermediate portion and the passageway from the anchor receiving end. Anchor insertion mechanism with passage. 39. The anchor of claim 38, further comprising at least one notch for retaining a seam, wherein the seam is tightened within the notch such that tension is applied to the seam between the notch and an anchor distributed on the anchor receiving end. Insertion mechanism. 40. The anchor insertion mechanism of claim 39, further comprising a second notch for retaining a seam, wherein each of the notches is positioned adjacent to the passageway. 39. The anchor insertion mechanism of claim 38, wherein the passageway penetrates the handle. 39. The anchor receiving end of claim 38, wherein the anchor receiving end is hollow, the interior of the anchor receiving end communicates with the interior of the intermediate portion, and the anchor receiving end traverses the diameter of the anchor receiving end and at least partially. And a slot extending along the diameter of said anchor receiving end, said slot being located at the end of said anchor receiving end opposite said intermediate portion. 42. The anchor receiving mechanism of claim 41, wherein the handle is screwed on the intermediate portion. 42. The ridge of claim 41, wherein the intermediate portion has a plurality of ridges extending around its periphery, the ridges located adjacent to the handle, and wherein the ridges provide improved control during use of the anchor receiving mechanism. Anchor receiver to interact with the working channel of the laparoscope. 39. The anchor of claim 38, wherein the handle has upper and lower portions respectively aligned with the slots of the anchor insertion end, and wherein the lower portion is heavier than the upper portion to facilitate proper insertion of the anchor during use of the anchor receiving mechanism. Receptacles. 41. The anchor receiving mechanism of claim 40, wherein the passageway passes through the handle, the passageway having an elongated diamond shaped outlet, the notch forming a corresponding edge of the outlet. A loaded anchor insertion mechanism for use in combination with the anchor receiving mechanism of claim 38, Includes anchors and sutures, And the anchor is correspondingly and releasably engaged with the anchor receiving end of the anchor insertion mechanism, the suture line passing through the passage of the anchor insertion mechanism and the interior of the intermediate portion from the anchor. 48. The device of claim 47, wherein the anchor is (1) a body having a longitudinal axis, a proximal end, and a distal end, (2) a plurality of wing members extending outwardly from the body and fixed to the body, each wing member having at least three wing members capable of elastically bending from a normal delay position to a compressed position; and (3) a hole located adjacent the proximal end of the body, A loaded anchor insertion mechanism, wherein the seam passes through the hole. 49. The method of claim 48, wherein the anchor receiving end is hollow, the interior of the anchor receiving end communicates with the interior of the intermediate portion, and the anchor receiving end traverses the diameter of the anchor receiving end and at least partially. A slot extending along the diameter of the end, the slot being positioned at the end of the anchor receiving end opposite the intermediate portion, the anchor further comprising a tab member extending from the proximal end of the body, A hole is located in the tab member, wherein the tab member has a width that is less than or equal to the width of the slot, and the tab member is positioned in the slot to engage the anchor with the anchor receiving end. . The body of claim 49 wherein the body of the anchor and the anchor receiving end are both cylindrical and have substantially the same diameter as each other, and the loaded anchor insertion mechanism is used to insert the anchor into a bore having a diameter smaller than the diameter of the intermediate portion. And an end portion of the intermediate portion adjacent to the anchor receiving end is configured to act as a stop. 51. The loading according to claim 50, wherein an inner diameter of the anchor receiving end is larger than the sum of the width of the tab member and twice the diameter of the suture line, wherein the tab member has a suture line passing through the hole located in the slot. Anchor insertion mechanism. 50. The device of claim 49, wherein the anchor extends out of the body and has at least three wing members secured to the body, each wing member being elastically bent from a normal delay position to a compression position. Each wing member having an outer end away from the body, wherein at least a portion of each outer end of each wing member is angled at 90 degrees or less from a cross section of the body perpendicular to the longitudinal axis. Stacked anchors inserted along the first virtual surface passing through the body. 50. The system of claim 49, wherein the body has a top and a bottom, the top of the body being defined by a top line extending along the surface of the body parallel to the longitudinal axis, wherein the first virtual surface is Intersects the top line at the intersection between the surface of the body and the first imaginary surface closest to the proximal end, the handle having a top and a bottom, the top of the handle aligned with the top line of the body of the anchor, A lower portion of the handle extends downwardly from the upper portion to facilitate proper alignment during use of the loaded anchor insert. 50. The apparatus of claim 49, wherein the passageway further passes through the handle and the loaded anchor insertion mechanism further comprises at least one notch positioned adjacent to the passageway, wherein the notch is screwed into the notch. A loaded anchor insertion mechanism configured to be tensioned to the suture line between the anchor and the notch. 50. The loaded anchor insertion mechanism of claim 49 wherein the anchor is secured to the anchor receiving end by a releasable adhesive. A loaded anchor insertion mechanism for use in combination with the anchor of claim 18, A suture extending from the hole of the anchor, and Anchor insertion mechanism for fixing by anchoring the anchor into the bore formed in the bone, The anchor insertion mechanism includes an elongated rigid member, the rigid member is (1) an anchor receiving end that can be correspondingly and releasably coupled to the anchor, (2) an intermediate portion having one end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end; and (3) A loaded anchor insertion mechanism comprising a handle attached to the intermediate portion at an opposite end of the anchor receiving end. 57. The method of claim 56 wherein the anchor receiving end and the intermediate portion are both hollow and the anchor insertion mechanism has a passageway providing communication between the interior of the intermediate portion and the exterior of the anchor insertion mechanism, the suture line being the A stacked anchor insertion mechanism configured to penetrate the anchor receiving end, the at least a portion of the intermediate portion, and the passage from a hole, respectively. A drill actuator comprising an elongated rigid member, The rigid member, (1) a perforated end having a distal end that is sharp enough to form a bore in the bone of the reticulated tissue with the aid of a hand, but not so sharp that an accidentally tender tissue or organ is seized during formation of the bore; (2) a collar having a diameter larger than the diameter of the perforated end, (3) a cylindrical intermediate portion attached to the perforated end in the collar and having a diameter larger than the diameter of the perforated end; (4) A cylindrical guide that can be inserted into the laparoscopic working channel and has a first and second ends and a diameter greater than the diameter of the middle part, the first end being at the end of the middle part opposite the collar. Attached guides, and (5) having a handle attached to the second end of the guide, Inserting the distal end of the perforated end into a hole formed in the pubic bone deep enough to provide access to the reticular tissue and then forming the bore with a length corresponding to the length of the perforated end A drill mechanism that can be used laparoscopically to form a bore in the pubis by pushing it into the hole while rotating by the handle. 59. The drilling tool according to claim 58, wherein the drilling end having a conical cross section has both flat sides tapered from the proximal end of the drilling end to the cylindrical rear end of the drilling end, such that the drill actuating mechanism corresponds to the diameter of the rear end. A drill actuator that can be used to form a bore having a diameter. 59. The drill actuator of claim 58, wherein the length of the drill actuator is defined such that the drill actuator easily penetrates the laparoscope to form a bore in the pubic bone of the patient during laparoscopic urethral fixation treatment. 61. The drill actuator of claim 60, wherein the drilling end has a length of about 1 to 3 cm. 62. The drill actuator of claim 61, wherein the intermediate portion has a length of about 2 to 6 cm. 62. The drill actuator of claim 61, wherein the guide has a length of about 50 to 55 cm. An anchor insertion mechanism for laparoscopically inserting and anchoring an anchor in a bore preformed in a bone during urethral fixation treatment, The anchor has at least one suture line extending from the anchor, the anchor insertion mechanism comprises an elongated rigid member, the rigid member being (1) an anchor receiving end capable of holding the anchor, (2) a cylindrical intermediate portion having one end adjacent to the anchor receiving end and having a diameter larger than the diameter of the anchor receiving end; (3) A cylindrical guide that can be inserted into the laparoscopic operating channel and has a first and second ends and has a diameter larger than the diameter of the middle part, the first end being opposite the proximal end of the middle part. A guide attached to the, and (4) An anchor insertion mechanism having a handle attached to a second end of the guide portion. 65. The method of claim 64, further comprising at least one indentation extending around the circumference of the angler insertion mechanism, wherein the indentation is sized to receive an elastic band, the elastic band extending the suture line to the elasticity. And an anchor insertion mechanism configured to hold between a band and said anchor insertion mechanism. 66. The anchor insertion mechanism of claim 65, further comprising a pair of tapered grooves extending along both sides of the anchor receiving end and at least partially along the length of the intermediate portion. 66. The method of claim 65, further comprising a second press-in portion extending around the circumference of the angler insertion mechanism, the second press-in portion being sized to receive an elastic band, wherein the elastic band defines the suture line. And an anchor insertion mechanism configured to hold between the elastic band and the anchor insertion mechanism, each of the press-fitting portions extending around the guide portion. 67. The anchor of claim 65 wherein the anchor receiving end extends from either end side of the anchor receiving end opposite the intermediate portion and the guide is correspondingly received in a corresponding groove on the anchor to accommodate the anchor. Anchor insertion mechanism for securing on the end. 66. The anchor insertion mechanism of claim 65, wherein the overall length of the anchor insertion mechanism is defined such that the anchor insertion mechanism readily penetrates through the laparoscope for insertion of the anchor into the pubic bone of the patient during laparoscopic urethral fixation treatment. 70. The anchor insertion mechanism of claim 69 wherein the intermediate portion has a length of about 2 cm to 6 cm and the guide portion has a length of about 50 cm to 55 cm. A loaded anchor insertion mechanism for use in combination with the anchor insertion mechanism of claim 65, The sutures include an extended anchor and at least one elastic band, The anchor is positioned on the anchor receiving end and secured by the anchor receiving end, the elastic band is located in the press-in portion, and the suture extends along at least a portion of the length of the anchor insertion mechanism to A loaded anchor insertion mechanism held between the elastic band and the press-fit portion. The method of claim 71 wherein (1) a second press-in portion extending around the original portion of the anchor insertion mechanism, the second press-in portion being sized to receive the elastic band so as to retain the suture line between the elastic band and the anchor insertion mechanism; A second press fit portion configured to extend each of the press fit portions around the guide portion; and (2) a second anchor band positioned within the second press fit portion, the loaded anchor further comprising a second elastic band configured to retain the seam between the second elastic band and the second press fit portion. Insertion mechanism. The method of claim 71 wherein The anchor, (1) a cylindrical body having a conical end, (2) at least two barbs which may be curved in a curved direction away from the body, (3) a cylindrical end having a diameter smaller than the diameter of the body and extending away from the body at the end of the body opposite the conical end; (4) a pair of grooves extending from the cylindrical end along a portion of the length of the body, and (5) a portion of the cylindrical end portion and the body includes a hole therethrough; The anchor insertion mechanism, (1) a pair of guide tabs extending from one end side of the anchor receiving end portion opposite to the intermediate portion; (2) a cylindrical slot penetrating a portion of said anchor receiving end, and (3) A loaded anchor insertion mechanism further comprising a pair of tapered grooves extending along both sides of the anchor receiving end and at least partially along the length of the intermediate portion. Suture recovery device for use in laparoscopic urethral fixation, (1) a recovery end having a rod-shaped shaft of a rigid body having a longitudinal axis and a sharp end to penetrate tissue adjacent to the urethra, and (2) includes a handle having a longitudinal axis, The recovery end may be inserted into the vagina and into the space of the resistus through the tissue adjacent to the vaginal mucosa and urethra, so that the recovery end may be used to hold a suture located in the space of the register to recover the suture into the vagina. Seam recovery mechanism. 75. The suture recovery device according to claim 74, further comprising an intermediate shaft positioned between the recovery end and the handle. 78. The method of claim 75, wherein the intermediate shaft and the shaft of the recovery end is fixed to each other at a constant angle, The handle and the intermediate shaft are fixed to each other at a constant angle, the shaft of the intermediate shaft and the recovery end And the angle between the handle and the intermediate shaft is substantially equal to the angle between the handle and the intermediate shaft such that the longitudinal axis of the shaft of the recovery end is substantially parallel to the longitudinal axis of the handle. 77. The method of claim 76, wherein the angle between the handle and the intermediate shaft is between 50 degrees and 80 degrees, and wherein the recovery end is inserted into the space of the ledge to hold the suture in the space of the resident ledge. The handle is suture recovery mechanism located on the outer surface of the patient's vagina to facilitate manipulation of the recovery end in the space of the register. 77. The end of the intermediate shaft of claim 76 wherein the diameter of the intermediate shaft is greater than the diameter of the shaft of the recovery end and when the recovery end is inserted through the soft tissue of the patient, the end of the intermediate shaft adjacent to the shaft of the recovery end is Suture recovery mechanism that acts as a stop to prevent the shaft from penetrating soft tissue. 75. The apparatus of claim 74, wherein the recovery end further comprises a return leg, wherein the return leg extends in parallel with the shaft at a predetermined distance from the sharp end, the return leg and the sharp end. And a suture recovery mechanism capable of catching the suture when the underside of the and the shaft of the recovery end form a U-shaped region and the U-shaped region is pulled over the suture. 80. The method of claim 79, wherein the recovery end is sufficient to provide access to the patient's Regis space when the recovery end is fully inserted into the vagina through tissue adjacent to the vaginal mucosa and urethra, but the sharp end is at the Regis space. Suture recovery device having a length that is not sufficient to penetrate beyond. 81. A seam recovery mechanism according to Claim 80 wherein said recovery end is comprised of stainless steel and said intermediate shaft and said handle are comprised of plastic. A template for guiding at least one suture through the fascia and vaginal mucosa adjacent to the patient's urethra during urethral fixation treatment. The at least one suture is attached to an anchor fixed in the body of the patient over the urethra of the patient, the template having at least one guide hole, the template being located in the vicinity of the vaginal mucosa adjacent to the urethra and during urethral fixation And the suture is configured to withdraw from the cavity of the patient's body through the at least one hole into the vagina. 83. The apparatus of claim 82, further comprising first and second wing members extending laterally from opposite sides of the template, The at least one hole is located in each of the wing members, the template is aligned in the vagina so that the wing member is located adjacent to either side of the urethra, and in each of the wing members the at least one hole is A template positioned to allow sutures to be recovered from within the patient's body through the at least one hole into the vagina during urethral fixation treatment. 84. The apparatus of claim 83, further comprising: a trough having an arcuate cross section, the trough having a constant length and first and second ends, wherein the first and second wing members extend along the length of the trough. The template extends away from both sides of the. 85. The gutter of claim 84, wherein the first and second ends of the trough comprise end walls, the trough being dimensioned such that the patient's urethra may be located in the trough with the end wall adjacent the end of the urethra of the patient. And a template in which the hole can be positioned on either side of the urethra of the patient. 85. The apparatus of claim 84, further comprising an alignment member extending away from an end wall of the trough, wherein the alignment member has a longitudinal axis and extends in parallel to the trough, the longitudinal axis of the alignment member being at a centerline of the trough. Template aligned. 87. The apparatus of claim 86, wherein the alignment member has an arcuate cross section and extends away from the trough, the alignment member being sized to be positioned around the circumference of the catheter inserted into the urethra of the patient. Template positioned to the position of. 87. The device of claim 86, wherein the alignment member has an arcuate cross section and extends from the end wall onto the inner surface of the trough toward the first and second ends of the trough, wherein the alignment member is a patient to align the template. Template that can be inserted into the urethra of the. 84. The template according to claim 83, wherein each of said wing members is provided with first and second guide holes, and wherein said first and second guide holes in each said wing member are spaced from each other by a predetermined size. A template for guiding the distal end of the suture line through tissue adjacent to the urethra on either side of the urethra during urethral fixation treatment, At least one suture is attached to an anchor secured within the body of the patient over the urethra of the patient, The template, (1) gutter passages of arcuate cross section having a constant length and first and second ends, (2) first and second wing members extending horizontally away from both sides of the trough, and (3) includes at least one suture guide hole positioned in a predetermined position in each of the wing members, The template is aligned with the patient's vagina so that the patient's urethra is located in the trough and at least one wing member is positioned adjacent to either side of the urethra, and the guide holes in each wing member are urethral and urethral elements. Template located at a certain distance from the cystic area. 92. The apparatus of claim 90, further comprising vertical end walls fixed to the first and second ends of the trough, and alignment members attached to the end walls and extending away from the end walls. A template having an arcuate cross section, the longitudinal axis of the alignment member being parallel to the longitudinal axis of the trough. 92. The template of claim 91, wherein the alignment member is made of an elastic material that can be secured around the catheter, providing a means for positioning the template to be aligned within the vagina of the patient when the catheter is inserted into the urethra of the patient. 92. The vane of claim 92, wherein each of said vane members has first and second guide holes, each of said first holes being located adjacent to said trough, and each of said second holes being within said vane member. A template positioned around the at least one centerline from the first hole. 94. The template of claim 93, wherein the distance between the end wall and each of the first guide holes is on the order of 2.5 cm to 3.3 cm. 95. The template according to claim 93, wherein the first and second guide holes in each of the wing members are aligned along an imaginary line extending vertically away from the trough. A surgical device for use in laparoscopic urethral fixation treatment, the device for surgical operation in which the urethra is lifted at a predetermined angle by fixing a suture line between a laparoscopically anchored anchor and a tissue adjacent to the urethra. (1) at least one anchor fixing the bone, (2) at least one anchor insertion mechanism of paragraph 38, (3) the drill implement of paragraph 58, and (4) A surgical device comprising a suture recovery device. 100. The surgical device of claim 96, further comprising the template of claim 82. A surgical device for use in laparoscopic urethral fixation treatment, the device for surgical operation in which the urethra is lifted at a predetermined angle by fixing a suture line between a laparoscopically anchored anchor and a tissue adjacent to the urethra. (1) at least one anchor insertion mechanism of paragraph 47, (2) the drill implement of paragraph 58, and (3) Surgical device comprising a suture recovery device. 99. The surgical device of claim 98, further comprising the template of claim 82. 98. The surgical device of claim 97, wherein the surgical device is equipped with the pair of loaded anchor insertion mechanisms of claim 47. As a surgical method for performing laparoscopic urethral fixation on a patient, (1) cutting at least a portion of the patient's Regius space, (2) laparoscopically forming a bore in the pubic bone adjacent to the space of Regius, (3) providing at least one anchor from which at least one suture extends; (4) laparoscopically inserting the anchor to secure the anchor in the bore; and (5) fixing the suture to tissue adjacent to the urethra in order to lift the urethra at a predetermined angle. 102. The method of claim 101 wherein the suture is secured to tissue adjacent to the urethra by pulling the suture into the vagina through the fascia and vaginal mucosa adjacent to the urethra and suspending the suture in the vagina. 107. The method of claim 102, wherein a pair of bores are formed in the pubic bone, one such bore is formed on one side of the pubis above the fascia adjacent to the urethra, and a pair of anchors, each of which suture lines extend out, is provided. The anchor of is inserted into each bore, either suture is drawn into the vagina through the vaginal mucosa adjacent to either side of the urethra and the fascia adjacent to the urethra, each suture suspending in the vagina, A method of surgery in which one suture line lifts the urethra at a predetermined angle by providing upward force on tissue around the urethra located on either side of the urethra. 102. The method of claim 101, wherein forming the bore (1) inserting the laparoscopic into the patient to provide access and vision to Regis' space; (2) forming a hole deep enough to access the bone of the reticular tissue into the pubis at a predetermined position with respect to the bore by means of a laser inserted through a laparoscopic channel; (3) providing a drill actuation mechanism having a drilling end having a proximal end; (4) inserting the drilling end of the drill mechanism through the laparoscopic channel, and And (5) pushing a proximal end of the puncture end into the hole to form the hole in the bone of the reticular tissue below the hole. 107. The sharp edge of claim 104, wherein the proximal end of the perforated end is sufficient to form the bore in the bone of the reticulated tissue by the force of a hand, but not sufficient to inadvertently penetrate the soft tissue or organ during formation of the bore. Configured surgical methods. 107. The method of claim 104, wherein said cutting step (1) inserting a balun incision into the space of the Regius, (2) inflating the balun of the balun incision to separate accidental tissue within the space of Regius; and (3) A method of surgical surgery comprising the step of further incising the accidental tissue using a laser, electrocautery device, or both while observing the extent of the incision by the laparoscope. 102. The method of claim 101, wherein inserting the anchor is (1) providing an anchor insertion mechanism comprising a rigid elongated member having an anchor receiving end at one end and a handle at the other end; (2) loading the anchor at the anchor receiving end while the seam extends toward the handle along the length of the anchor insertion mechanism; (3) inserting the anchor receiving end of the anchor insertion mechanism through a laparoscopic channel; (4) inserting the anchor into the bore by pushing the anchor receiving end toward the bore with the anchor loaded; and And (5) pulling the anchor insertion mechanism away from the bore to release the anchor from the anchor receiving end. 107. The method of claim 107, wherein the anchor insertion mechanism further comprises an elastic band extending around its circumference, and the loading of the anchor comprises: positioning the suture line between the elastic band and the anchor insertion mechanism. And the suture is firmly fixed to the anchor insertion mechanism by the elastic band and wherein the suture is pulled from the bore during the step of pulling the anchor insertion mechanism from the bore. And a sliding movement between and pulled out on the anchor to position the anchor in the bore. 107. The method of claim 107, wherein pulling the anchor insert from the bore comprises at least partially removing the anchor insert from the laparoscopic channel, wherein pulling the anchor insert is performed. After the suture is tensioned between the anchor and the anchor insertion mechanism, fixing the suture (1) providing a suture retractor having a pointed end, (2) inserting an end of the suture retractor through the vaginal mucosa and fascia adjacent to the urethra into the vagina and into the space of the resistus, (3) catching the suture by the suture retractor; (4) drawing the suture into the vagina by the suture retractor; and (5) a method of surgery comprising suturing the suture in the vagina. 107. The apparatus of claim 107, wherein the at least one suture has first and second ends extending from the anchor, and both the first and second ends are anchored after the step of pulling the anchor insertion mechanism. Receiving tension between the insertion mechanism and the anchor, and fixing the suture line (1) providing a suture retractor having a pointed end, (2) inserting an end of the suture retractor through the vaginal mucosa and fascia adjacent to the urethra into the vagina and into the space of the resistus, (3) holding the first end of the at least one suture by the suture retractor; (4) drawing the first end into the vagina by the suture retractor; (5) repeating steps (2) to (4) for the second end such that the second end of the at least one suture is drawn into the vagina at a distance from the first end; And And (6) suspending the first and second ends of the suture in the vagina to lift the urethra at a predetermined angle. A method for recovering sutures extending from an anchor, wherein the anchor is secured to a hole in a patient's pubic bone and is configured such that the bore is positioned adjacent to the space of Ryzius over the fascia adjacent to the urethra. (1) providing a seam recovery mechanism, 1) a recovery end having a rod-shaped shaft of a rigid body having a longitudinal axis, a sharp end to penetrate the tissue adjacent to the urethra, and a return leg extending parallel to the shaft at a predetermined distance from the sharp end; A recovery portion capable of holding a suture line when a leg portion, a bottom surface of the sharp end portion, and the rod-shaped shaft form a U-shaped area and the U-shaped area is pulled over the suture line; 2) a handle having a longitudinal axis, and 3) providing a seam recovery mechanism comprising an intermediate shaft positioned between the recovery end and the handle; (2) inserting the recovery end into the vagina of the patient; (3) pushing the sharp end to a predetermined position through the vaginal mucosa and fascia adjacent to the urethra, (4) pushing the recovery end upward into the space of the register by the handle so that the U-shaped area is located directly on the suture line; (5) pulling the recovery end downward by the handle to hold the suture in the U-shaped area, and (6) continuing to pull the recovery end downward by the handle so that the suture is drawn into the vagina until the recovery end is completely drawn into the vagina. 117. The method of claim 111, wherein the U-shaped zone is sized to allow the suture to slide freely within the U-shaped zone as the recovery end is drawn into the vagina, so that the recovery step proceeds. The sutures are not damaged during the process. 117. The method of claim 112, wherein the handle remains on the outer surface of the vagina during the recovery step, thereby facilitating manipulation of the recovery end during the recovery step. 117. The apparatus of claim 113, wherein the intermediate shaft and the rod shaft are fixed at an angle to each other, the handle and the intermediate shaft are fixed at an angle to each other, and an angle between the intermediate shaft and the rod shaft is Almost equal to the angle between the handle and the intermediate shaft, the longitudinal axis of the rod-shaped shaft of the recovery end is positioned substantially parallel to the longitudinal axis of the handle, such that the handle is positioned to the outer surface of the vagina during the recovery step. Way.