Instrumentation for image-guided colpopexy

Abstract

Disclosed are devices and methods for performing image-guided colpopexy, such as sacrospinous ligament colpopexy, to treat pelvic organ prolapse. The device includes a rotatable and translatable vaginal device with image-guided markers, a fixation device, a retention anchor, a pulley, and a pusher wire, and is configured for transvaginal or subcutaneous access. By precisely positioning the vaginal device and fixation device, a pathway between the vaginal wall and the pelvic ligaments is established and used to insert a retention assembly that enables apposition and fastening of the vaginal wall to the pelvic ligaments during colpopexy.

Description

[Technical Field]

[0001] The present invention relates to the treatment of pelvic organ prolapse by fixating the vaginal wall to the pelvic ligaments under image guidance. Medical imaging allows for the viewing and visualization of a patient's pelvic structures. The vagina and pelvic ligaments are identified and accessed by medical interventional devices under imaging guidance, without the need for surgical incision. By precisely positioning the vaginal and fixation devices, a pathway between the vaginal wall and the pelvic ligaments is established and used to insert a retention assembly that allows for apposition and fastening of the vaginal wall to the pelvic ligaments during colpopexy. The image-guided colpopexy device is configured for transvaginal or subcutaneous access techniques. [Background technology]

[0002] Pelvic organ prolapse (POP) affects nearly 50% of women over the age of 50. While many women with POP do not require specific treatment, some experience reduced quality of life, including negative body image, sexual, urinary, and bowel dysfunction, and require clinical management.

[0003] Several options exist for managing POP. Non-invasive methods include biofeedback therapy, pelvic floor muscle strengthening exercises, or intravaginal support devices (e.g., pessaries). When non-invasive treatment options fail to control symptoms, invasive treatments such as surgery may be considered.

[0004] Surgeries for POP can be classified as either obstructive or reconstructive. Obstructive surgery involves narrowing, shortening, or completely closing the vagina to provide additional support for organs prolapsing through or compressing the vaginal walls. Reconstructive surgery aims to support the pelvic floor and hold prolapsing organs in place. The various reconstructive surgery options available to patients can be categorized by surgical approach (e.g., abdominal, vaginal, laparoscopic, or robotic), type of repair (e.g., repair with native tissue, mesh, or graft), and any concomitant procedures (e.g., hysterectomy).

[0005] Abdominal reconstructive surgery for POP generally involves sacrocolpopexy or sacrohysteropexy, which fixates the apex of the vagina or uterus posteriorly to the sacral promontory using surgical mesh. Vaginal reconstructive procedures performed without the use of synthetic mesh include anterior and posterior vaginal wall suturing, uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeus fascial suspension. While uterosacral ligament suspension is performed via an intraperitoneal approach, sacrospinous ligament fixation and iliococcygeus fascial suspension are performed via an extraperitoneal route. While traditional uterosacral ligament suspension involves plicating the uterosacral ligaments at or above the level of the ischial spines, modified uterosacral ligament suspension uses a suture passage through the coccygeus-sacrospinous ligament complex. Compared to sacrospinous ligament fixation, iliococcygeus fascial suspension uses the iliococcygeus fascia, located below the ischial spines and lateral to the rectum, as a suture site for attaching the vaginal vault. Posterior intravaginal sling or subcoccygeal sacrocolpopexy is a typical vaginal reconstruction procedure performed using synthetic mesh.

[0006] Surgery is highly effective in alleviating POP symptoms in 85%–100% of patients, but it poses a significant economic burden to the healthcare system. The annual incidence of POP surgery ranges from 1.5 to 1.8 cases per 1,000 women per year, and approximately 11% of women undergo POP surgery by age 80. Furthermore, up to 30% of women who undergo surgery require reoperation, and the total cost of POP surgery exceeds $1 billion annually in the United States alone. Furthermore, postoperative complications, including neurological symptoms, ureteral obstruction, and urinary tract infection, occur in 15%–30% of patients. Notably, the use of transvaginal mesh carries a high risk of mesh erosion, pain, and reduced mobility. In April 2019, the FDA ordered a suspension of the sale and distribution of surgical mesh products for transvaginal repair of POP.

[0007] Because patients with POP are often elderly and poorly able to tolerate extensive surgical procedures, safe, non-invasive, and efficient treatments that do not require lengthy and risky surgical procedures are highly desirable. Therefore, it is important to develop treatments that are highly effective in treating POP and that can be relatively easily implanted using minimally invasive interventional procedures.

[0008] The inventor's image-guided colpopexy system is based on the idea that the vaginal vault and pelvic ligaments of interest for colpopexy can be accurately identified and accessed under the guidance of medical imaging. A vaginal colpopexy device is introduced into the target body structure via a transvaginal or subcutaneous route to perform colpopexy without significant incision or disturbance of the surrounding tissue. The target pelvic ligaments may include the uterosacral ligament, sacrospinous ligament, and iliococcygeus fascia, depending on the clinical indication and the accessibility of the device. Summary of the Invention

[0009] To perform image-guided colpopexy, the patient is imaged and the target structures for intervention—the vaginal wall and pelvic ligaments—are identified and located. The vaginal wall is easily accessible by placing a vaginal probe directly within the vagina, while the target pelvic ligaments, located deep within the pelvis, are accessed via a transvaginal or subcutaneous route.

[0010] The transvaginal approach to image-guided colpopexy begins with the placement of a TV (transvaginal) vaginal device on the pelvis of a patient lying supine on an imaging scanner table. The TV vaginal device consists of a pelvic flap, a control hub, and a TV vaginal probe. The pelvic flap is positioned and fastened over the patient's pelvis to secure and stabilize the control hub for colpopexy. The TV vaginal probe is inserted through the center of the control hub and into the vaginal cavity. The patient is imaged to identify the TV vaginal probe and the target pelvic ligament. The TV vaginal probe houses a needle guide track. The distal tip of the TV vaginal probe near the vaginal vault is visualized and confirmed on imaging. The distal tip of the TV vaginal probe has an open lateral port for the needle guide track, which projects the needle into the target pelvic ligament.

[0011] Under image guidance, the TV vaginal probe is translated and rotated to push the vaginal vault toward the target pelvic ligament and align the needle guide track with the target pelvic ligament. Orientation of the TV vaginal probe is achieved by rotation about two different axes: swinging the control hub about the y-axis (i.e., the axis from the anus to the pubis in the supine position) while holding the pelvic flap as a fixed reference, and rotating the TV vaginal probe about the horizontal x-axis (i.e., the long axis of the vaginal cavity) by rotating the control hub clockwise or counterclockwise about the vaginal cavity.

[0012] The path from the distal tip of the needle guide track to the target pelvic ligament is estimated to provide the distance and rotation angle required for the needle to reach the target pelvic ligament from the distal tip of the needle guide track. The distance and rotation angle are calculated more precisely by the needle navigation program or manually from analysis of a 3D image of the pelvis including the TV vaginal device.

[0013] Following proper placement and rotation of the needle guide track and confirmation of its trajectory toward the target pelvic ligament, the fixation device is introduced through the needle guide track. The fixation device consists of a needle, head, body, handle, and retainer control gear. Before or during the intervention, a retainer is loaded into the hollow lumen of the needle and pushed forward by rotating the knob of the retainer control gear. The needle of the fixation device is inserted through the needle guide track of the TV vaginal probe and gently advanced past the distal opening of the needle guide track. The needle penetrates the vaginal wall and traverses the pelvic extraperitoneal space toward the target pelvic ligament. Operation of the retainer control gear releases the distal anchor of the retainer from the needle into the target pelvic ligament.

[0014] Once release of the distal anchor of the retainer is confirmed, the retainer and distal pulley wire are gently retracted. As a result of the pulling, the distal anchor spreads and is apposed to the target ligament. Under image guidance, the needle is retracted into the vaginal cavity, releasing the proximal anchor of the retainer and placing it in the vaginal cavity. The pulley wire, fixation device, and TV vaginal device are removed. Upon completion of the transvaginal colpopexy, the vaginal wall, apposed by the proximal anchor of the retainer, is fastened via the retaining wire to the target ligament, apposed by the distal anchor, thus forming a colpopexy.

[0015] The subcutaneous approach to image-guided colpopexy begins with the insertion of a subcutaneous (SC) vaginal probe into the vaginal cavity. The patient is positioned prone or semi-recumbent on the imaging scanner table to expose the buttocks and orient the fixation device needle. The patient is imaged to identify the SC vaginal probe and the target pelvic ligaments. The distal tip of the SC vaginal probe near the vaginal vault is visualized and identified by the imaging system. The distal tip of the SC vaginal probe contains an open lateral port, which is the final target for fixation device needle insertion. Under image guidance, the path from the appropriate subcutaneous skin site through the target pelvic ligaments to the intravaginal port is estimated to provide the distance and angle required for needle travel. The distance and rotation angle are calculated more precisely by a needle navigation program or manually from analysis of a 3D image of the pelvis, including the SC vaginal device.

[0016] A fixation device similar in function and structure to the fixation device for the transvaginal approach is used for the subcutaneous approach, except that it has a straighter, more rigid needle. The fixation device needle is inserted from the appropriate subcutaneous skin site through the target pelvic ligament and into the open lateral port of the vaginal probe, following a predetermined path across the subcutaneous fat, pelvic muscles, target ligament, extraperitoneal fat, and vaginal wall.

[0017] After confirming that the distal tip of the needle is positioned within the SC vaginal probe, the retainer control gear is operated to release the distal anchor of the retainer from the needle into the vaginal cavity.

[0018] Once the release of the distal anchor of the retainer is confirmed, the retainer and distal pulley wire are gently retracted. As a result of the pulling, the distal anchor spreads and is apposed to the vaginal cavity. Under image guidance, the needle is retracted into the target ligament, releasing the proximal anchor of the retainer and placing it in the target ligament. The pulley wire, fixation device, and SC vaginal device are then removed. Upon completion of the subcutaneous colpopexy, the vaginal wall, with the distal anchor of the retainer apposed, is fastened to the target ligament with the proximal anchor apposed via the retaining wire, thus forming a colpopexy.

[0019] The colpopexy procedure described in this embodiment is performed through a series of operations, including vaginal probe placement, imaging, positioning, needle penetration, pushing, pulling, and fixation, without large incisions or major disturbances to surrounding tissues. While the sacrospinous ligament is commonly used to fixate the vaginal vault, other pelvic ligamentous structures, such as the uterosacral ligament, can be applied to colpopexy. Various medical imaging systems, such as CT, MRI, ultrasound, fluoroscopy, and laparoscopy, can be used for image guidance. Positioning of the vaginal probe, needle, retainer, and wire can be performed manually, via a powered mechanism, or by operating a handheld device.

[0020] During and after colpopexy, it is beneficial to track and monitor the position and configuration of the device and retainer within the body. For this purpose, fiducial markers made of radiopaque materials such as barium sulfate or metal can be detected under fluoroscopy or CT. Some devices may be partially or completely coated with barium sulfate. Magnetically sensitive fiducial markers can be used to guide the procedure under MR imaging.

[0021] A first aspect of the present invention is a vaginal device for image-guided colpopexy, comprising: at least one pelvic flap fastened to the patient's pelvis to secure and stabilize the vaginal device; a control hub located at the center of the vaginal device, the control hub including a rotatable inner tube positioned within the vaginal cavity, a joint capable of rotating about at least two different axes while maintaining at least one pelvic flap as a fixed reference, and reference marks indicating degrees or rotations; at least one elongated curved vaginal probe received through the control hub, the probe including a proximal opening at a proximal end, a distal opening port at a distal end, and a curved needle guide track configured to angle the needle a predetermined number of degrees as it is advanced from the vagina into the target ligament; A vaginal device comprising:

[0022] In certain embodiments, the vaginal device further comprises a locking screw for securing and stabilizing the vaginal probe and the control hub.

[0023] In certain embodiments, the needle guide track of the vaginal device is curved within a range of 60-80 degrees to angle the needle as it is advanced from the vagina into the target ligament.

[0024] In certain embodiments, the control hub of the vaginal device is configured to achieve advancement and rotation of the vaginal probe by rotational and / or translational manipulation to gain access to the target area of ​​the vaginal cavity and target the target ligament guided by medical imaging.

[0025] In certain embodiments, the vaginal probe and / or needle guide track of the vaginal device has a curve and angle toward the target pelvic ligament to facilitate angling the needle at a predetermined degree as it is pushed through the probe.

[0026] A second aspect of the present invention is a fixation device for image-guided colpopexy, comprising: At least one needle having a hollow lumen, which may be curved or straight; at least one retainer including a distal anchor, a proximal anchor, and a retention wire connecting the distal and proximal anchors; one or more pulley wires connected to any one or more of the proximal anchor and the distal anchor; a pusher wire that pushes the at least one retainer forward and slides it through the needle lumen; The main body to which the needle is connected A fixing device comprising:

[0027] In certain embodiments, the body of the fixation device comprises at least one head to which the needle is locked or assembled together as one unit.

[0028] In certain embodiments, the body of the fixation device comprises any one or more of a control gear, a side knob, a rear knob, a slit ruler for a pusher wire, a slit ruler for one or more pulley wires, a slide indicator, and a handle.

[0029] In certain embodiments, each of the distal and proximal anchors of the fixation device is in the form of a rod, a cylinder, and a collapsible umbrella that can be inserted through a hollow lumen and that, when released from the hollow lumen, is freely rotatable and swingable at a joint connected to a retention wire.

[0030] In certain embodiments, the body of the fixation device comprises a slit ruler for one or more pulley wires and a slide indicator; the one or more pulley wires include a proximal pulley wire connected to a proximal anchor and a distal pulley wire connected to a distal anchor; The proximal portion of the distal pulley wire is placed within the slit ruler for one or more pulley wires and is locked and secured by the slide indicator.

[0031] In certain embodiments, the body of the fixation device further comprises a control gear, a side knob, a rear knob, and a slit ruler for one or more pulley wires; The proximal portion of the pusher wire is placed between the control gears and threaded through the rear knob, visible through the slit ruler.

[0032] In certain embodiments, the vaginal device further comprises fiducial markers for tracking the position or orientation of any one or more components of the device in medical imaging.

[0033] In certain embodiments, the fixation device further comprises fiducial markers for tracking the position or orientation of any one or more components of the device in medical imaging.

[0034] In certain embodiments, the vaginal device is constructed in part from metal, silicone, or a biocompatible polymer, including biodegradable or non-biodegradable polymers.

[0035] In certain embodiments, the fixation device is constructed in part from metal, silicone, or a biocompatible polymer, including biodegradable or non-biodegradable polymers.

[0036] A third aspect of the present invention is An apparatus for image-guided colpopexy comprising a vaginal device and a fixation device, Vaginal devices are at least one pelvic flap fastened to the patient's pelvis to secure and stabilize the vaginal device; a control hub located at the center of the vaginal device, the control hub including a rotatable inner tube positioned within the vaginal cavity, a joint capable of rotating about at least two different axes while maintaining at least one pelvic flap as a fixed reference, and reference marks indicating degrees or rotations; at least one elongated curved vaginal probe received through the control hub, the probe including a proximal opening at a proximal end, a distal opening port at a distal end, and a curved needle guide track configured to angle a needle of the fixation device a predetermined number of degrees as it is advanced through the vagina into the target ligament; Equipped with The fixing device is At least one needle having a hollow lumen, which may be curved or straight; at least one retainer including a distal anchor, a proximal anchor, and a retention wire connecting the distal and proximal anchors; one or more pulley wires connected to any one or more of the proximal anchor and the distal anchor; a pusher wire that pushes the at least one retainer forward and slides it through the needle lumen; The main body to which the needle is connected Equipped with.

[0037] A fourth aspect of the present invention is a method for image-guided colpopexy using a vaginal device, comprising: (a) placing a vaginal device in a patient's pelvis; (b) inserting a vaginal probe into the vaginal cavity so that the distal tip is proximate the vaginal vault; (c) performing medical imaging of the pelvis by one or more selected from CT, MRI, ultrasound, fluoroscopy, and laparoscopy to view and visualize the vaginal probe in the vaginal vault and the pelvic ligaments of interest; (d) indicating the location of the distal opening port of the vaginal probe and the pelvic ligament of interest on the medical imaging; (e) pushing the vaginal vault toward the target pelvic ligament and moving the vaginal probe so that the distal opening port of the vaginal probe is directed toward the target pelvic ligament; (f) determining three-dimensional coordinates of the distal opening port of the vaginal probe and the target ligament, and determining a path from the distal opening port of the vaginal probe to the target pelvic ligament; The method includes:

[0038] In certain embodiments, the method further comprises using a fixation device for a transvaginal approach; (a') projecting a needle having a hollow lumen across the vaginal wall into the target pelvic ligament; (b') placing a retainer, one or more pulley wires, and a pusher wire through said lumen of the needle before or during the intervention; (c') pushing the retainer with a pusher wire to release only the distal anchor from the needle into the target pelvic ligament; (d') retracting the needle so that the tip is positioned within the vaginal cavity; (e') pushing the proximal anchor with the pusher wire to eject the proximal anchor from the needle into the vaginal cavity; (f') removing one or more pulley wires, pusher wires, needles, and vaginal probes; Includes.

[0039] In certain embodiments, the method includes, for a transvaginal approach: confirming engagement of the distal anchor with the pelvic ligament using medical imaging or by gently pulling on one or more pulley wires; and Verifying engagement of the proximal anchor with the vaginal wall using medical imaging or by gently pulling on one or more pulley wires. Further, the present invention includes one or more of the following:

[0040] In certain embodiments, the method further comprises, for a subcutaneous approach using a fixation device: (a'') determining three-dimensional coordinates of the subcutaneous skin site from medical imaging and estimating a needle path from the subcutaneous skin site through the target ligament to the distal opening port of the vaginal probe, including the distance and angle of needle travel; (b'') inserting a needle having a hollow lumen from a subcutaneous site across the ligament and vaginal wall into a distal opening port of the vaginal probe; (c'') placing a retainer, one or more pulley wires, and a pusher wire through the lumen of the needle before or during the intervention; (d'') pushing the retainer with a pusher wire to eject only the distal anchor of the retainer from the needle into the vaginal cavity; (e'') retracting the needle so that the tip is positioned in the target ligament; (f'') pushing the proximal anchor of the retainer with a pusher wire to release the proximal anchor from the needle into the target ligament; (g'') removing one or more pulley wires, pusher wires, needles, and vaginal probes; Includes.

[0041] In certain embodiments, the method comprises, for a subcutaneous approach: confirming engagement of the distal anchor with the vaginal wall using medical imaging or by gently pulling on one or more pulley wires; and Verifying engagement of the proximal anchor with the target ligament using medical imaging or by gently pulling on one or more pulley wires. Further, the present invention includes one or more of the following:

[0042] In certain embodiments, the placement of the vaginal probe, needle, retainer, one or more pulley wires, and pusher wire is performed by a powered mechanism, manually, or by operating a manual device. [Brief explanation of the drawings]

[0043] [Figure 1A] FIG. 1 is a cross-sectional view of the pelvic anatomy of a supine woman, showing the relative positions of the vaginal vault, bilateral sacrospinous ligaments, other pelvic organs, and a transvaginal (TV) vaginal probe with a needle positioned in the vaginal cavity. [Figure 1B]FIG. 1 is a cross-sectional view of the pelvic anatomy of a supine woman, showing the relative positions of the vaginal vault, bilateral sacrospinous ligaments, other pelvic organs, and a transvaginal (TV) vaginal probe with a needle positioned in the vaginal cavity. [Figure 1C] FIG. 1 is a cross-sectional view of the pelvic anatomy of a supine woman, showing the relative positions of the vaginal vault, bilateral sacrospinous ligaments, other pelvic organs, and a transvaginal (TV) vaginal probe with a needle positioned in the vaginal cavity. [Figure 2A] FIG. 1 is a 3D wireframe perspective view of the TV vaginal device. [Figure 2B] FIG. 1 is a 3D wireframe perspective view of the TV vaginal device. [Figure 2C] FIG. 1 is a 3D wireframe perspective view of the TV vaginal device. [Figure 2D] FIG. 1 is a 3D wireframe perspective view of the TV vaginal device. [Figure 3A] 1 is an image of the prototype TV vaginal device before placement on the pelvis. [Figure 3B] Image of subject lying supine on a table with the prototype TV vaginal device positioned over her pelvis. [Figure 3C] Image of subject lying supine on a table with the prototype TV vaginal device positioned over her pelvis. [Figure 4A] FIG. 1 is a schematic perspective view of the female pelvic anatomy showing the pelvic bony structures, right sacrospinous ligament, vaginal cavity, vaginal vault, and a vaginal probe within the vaginal cavity. [Figure 4B] FIG. 1 is a cross-sectional view of the pelvic anatomy of a supine woman showing the vaginal vault, bilateral sacrospinous ligaments, other pelvic organs, and the distal end of a vaginal probe positioned near the vaginal vault. [Figure 5A] Same as Figure 4A, except the distal opening port of the vaginal probe has been moved and redirected towards the right sacrospinous ligament of interest. [Figure 5B] Same as Figure 4B, except the distal opening port of the vaginal probe has been moved and redirected towards the right sacrospinous ligament of interest. [Figure 6A]Same as FIG. 5A, except the vaginal probe includes a needle protruding from the opening port into the right sacrospinous ligament of interest. [Figure 6B] Same as FIG. 5B, except the vaginal probe includes a needle protruding from the opening port into the right sacrospinous ligament of interest. [Figure 7A] FIG. 1 is a perspective view of a TV vaginal device into which a fixation device is inserted, depicted in 3D. [Figure 7B] FIG. 10 is a wireframe perspective view of the TV vaginal device into which the fixation device is inserted. [Figure 7C] 10 is an image of a prototype fixation device for the transvaginal approach. [Figure 7D] 10 is an image of a subject lying supine on a table with the prototype TV vaginal device and the prototype fixation device inserted for a transvaginal approach. [Figure 8A] FIG. 1 is a perspective view of a fixation device for a transvaginal approach, depicted in 3D. [Figure 8B] FIG. 8B is an enlarged view of FIG. 8A of the main body of the fixation device. [Figure 8C] FIG. 10 is a cross-sectional view of a needle with a retainer, two pulley wires, and a pusher wire inserted therethrough. [Figure 8D] FIG. 13 is a wireframe perspective view of a fixation device for a transvaginal approach after placement of the distal pulley wire and pusher wire. [Figure 8E] Same as FIG. 8B, but after placement of the distal pulley and pusher wires. [Figure 8F] FIG. 10 is a diagram of the distal and proximal anchors of the retainer juxtaposed against the ligament and vaginal wall, which are fastened together by a retention wire connected to the distal and proximal anchors of the retainer. [Figure 8G] FIG. 10 is a cross-sectional view of a retainer with folded umbrella anchors and rod anchors and a needle with a proximal pulley wire threaded therethrough. [Figure 8H] Same as Figure 8F, except one of the rod anchors is replaced with an expanded umbrella anchor. [Figure 9A]1 is a CT image of a subject's pelvis with a TV vaginal probe containing a needle placed in the right sacrospinous ligament. [Figure 9B] CT image of a subject's pelvis with a retainer with the distal anchor placed in the right sacrospinous ligament and the proximal anchor placed in the vaginal cavity. [Figure 9C] FIG. 1 is a schematic perspective view of the female pelvic anatomy showing the vaginal vault fastened to the right sacrospinous ligament by a retainer. [Figure 10] FIG. 1 is a perspective view of a subcutaneous (SC) vaginal device for a subcutaneous approach, depicted in 3D. [Figure 11A] FIG. 1 is a schematic perspective view of the female pelvic anatomy showing the pelvic bony structures, right sacrospinous ligament, vaginal cavity, vaginal vault, and SC vaginal probe within the vaginal cavity. [Figure 11B] Transverse section of the pelvic anatomy of a woman in the prone position, showing the vaginal vault, bilateral sacrospinous ligaments, other pelvic organs, and the distal tip of the SC vaginal probe positioned near the vaginal vault. [Figure 12A] Same as Figure 11A, except the SC vaginal probe port has been moved and redirected toward the right sacrospinous ligament target, and the subcutaneously inserted needle entering the SC vaginal probe port crosses the right sacrospinous ligament target. [Figure 12B] Same as Figure 11B, except the SC vaginal probe port has been moved and redirected toward the right sacrospinous ligament target, and the subcutaneously inserted needle entering the SC vaginal probe port crosses the right sacrospinous ligament target. [Figure 13A] 3D perspective view of the SC vaginal device for the subcutaneous approach, with the needle inserted into the distal port of the vaginal probe. [Figure 13B] FIG. 10 is a close-up view of the SC vaginal probe for the subcutaneous approach, with the retainer anchor and partially exposed retention wire deployed through the inserted needle and into the distal port of the vaginal probe. [Figure 14] Image of subject lying prone on table with SC vaginal probe with needle inserted through right buttock for subcutaneous approach. DETAILED DESCRIPTION OF THE INVENTION

[0044] Figures 1A-1C show the important female pelvic structures involved in colpopexy: the vagina 101, the right sacrospinous ligament 102, and the left sacrospinous ligament 103. Figure 1B shows the pelvis in a coronal plane, and Figure 1C shows the pelvis in a transverse plane. Given the location and orientation of the sacrospinous ligaments relative to the vagina in the 3D anatomy, the vaginal probe 104 requires rotation about two axes (roll and yaw) to aim from the vaginal vault toward the target sacrospinous ligament. Following the convention of aircraft axes, roll rotation 105 corresponds to rotation about the x-axis, and yaw rotation 106 corresponds to rotation about the y-axis. The yaw angle 107, which is the angle between the long axes of the vaginal probe 104 and the needle 108, is in the range of 60-80 degrees, as shown in the coronal plane of the pelvis in Figure 1B. The roll angle 109 of the vaginal probe 104 aimed at the target sacrospinous ligament, when viewed in terms of a clock face representing a cross section of the vagina, is in the 7-8 o'clock range (indicated by arrow 110) to target the right sacrospinous ligament 102, or in the 4-5 o'clock range to target the left sacrospinous ligament 103, as shown in the cross section of the pelvis in FIG. 1C.

[0045] 2A-2D show a transvaginal (TV) vaginal device having a pelvic flap 201 fastened to the patient's pelvis to secure and stabilize a control hub 202 for colpopexy. The inner tube 203 of the control hub 202, which is positioned inside the vaginal cavity, is smooth and configured to rotate freely within the vaginal cavity. The TV vaginal probe 204 is inserted into the vaginal cavity through the center of the control hub 202. The TV vaginal probe 204 houses a needle guide track 205. The distal tip of the TV vaginal probe 204 has an opening for the needle guide track 205, which directs the needle in the desired direction. The distal ends of the TV vaginal probe 204 and needle guide track 205 have a smooth curve and angle toward the target pelvic ligament, allowing the needle to be easily oriented at an angle within a range of 60-80 degrees as it is pushed through the needle guide track 205 to access the target pelvic ligament.

[0046] The control hub 202 can rotate at a joint 206 connected to the pelvic flap 201 according to a rotation angle indicated by arrow 207. This rotation allows the TV vaginal probe 204 to rotate about the y-axis (i.e., the axis from the anus to the pubic bone in the supine position) while maintaining the pelvic flap as a fixed reference, as shown in FIGS. 1A and 1B. Once the position and orientation of the control hub 202 are determined, the control hub is secured to the pelvic flap 201 by a locking screw 208. Furthermore, the TV vaginal probe 204 can rotate about the control hub 202, as indicated by arrow 209. This rotation allows the TV vaginal probe 204 to rotate about the horizontal x-axis (i.e., the long axis of the vaginal cavity) by rotating the control hub 202 clockwise or counterclockwise about the vaginal cavity, as shown in FIGS. 1A and 1C. Once the position and orientation of the TV vaginal probe 204 is determined, the probe is secured to the control hub 202 by a locking screw 210. An image of the prototype TV vaginal device is shown in FIG. 3A. Two images of a subject lying supine on a table with the prototype TV vaginal device positioned on her pelvis are shown in FIGS. 3B and 3C. The control hub displays clock face reference marks that indicate the rotation angle of the vaginal probe.

[0047] 4A and 4B show the placement of a TV vaginal probe 401 within the vaginal cavity 402 for a transvaginal approach to colpopexy. In this approach, shown in a cross-sectional anatomical view, the patient is in the supine position shown in FIG. 3B. The distal tip 403 of the TV vaginal probe near the vaginal vault 404 is visualized and confirmed on imaging. The right sacrospinous ligament 405 of interest is identified.

[0048] Figures 5A and 5B show the distal tip 501 of the TV vaginal probe being moved and rotated to push the vaginal vault toward the target right sacrospinous ligament 502, directing the vaginal probe's open port 503 toward the target right sacrospinous ligament 502. This positioning is performed under image guidance. The path from the distal tip of the vaginal probe's needle guide track to the target pelvic ligament is estimated to provide the distance and rotation angle required for the needle to reach the target pelvic ligament from the distal tip of the needle guide track. The typical distance from the distal tip of the needle guide track in the vaginal wall to the target pelvic ligament is in the range of 4 to 6 cm. The distance and rotation angle are calculated more accurately by a needle navigation program or manually from analysis of a 3D image of the pelvis including the TV vaginal device.

[0049] Following advancement and rotation of the needle guide track 205 of the TV vaginal probe 204 of Figure 2B and confirmation of the trajectory of the needle guide track 205 toward the target pelvic ligament, a fixation device is introduced through the needle guide track 205. Figures 6A and 6B show needle 601, which is part of the fixation device, protruding from the open port of the vaginal probe, and needle 601 piercing the vaginal wall and traversing the pelvic extraperitoneal space toward the target pelvic ligament in the direction indicated by arrow 602.

[0050] Figure 7A shows a TV vaginal probe 701 into which a fixation device 702 is inserted. Specifically, the needle 703 of the fixation device 702 is inserted through the needle guide track of the vaginal probe 701. An image of the prototype fixation device is shown in Figure 7C. The prototype fixation device inserted into the prototype TV vaginal device placed on a supine subject is shown in Figure 7D.

[0051] 8A and 8B show a fixation device consisting of a needle 801, a head 802, a body 803, and a handle 804. The body 803 houses a retainer control gear 805 that is rotated by rotating a side knob 806 or a rear knob 807. The body 803 further includes a slit ruler 808, a slit ruler 809, and a slide indicator 810. FIG. 8C shows a needle 801 having a hollow lumen loaded with a retainer consisting of a distal anchor 811, a proximal anchor 812, and a retention wire 813. The lumen of the needle 801 further includes a distal pulley wire 814 connected through the body of the distal anchor 811, a proximal pulley wire 815 connected through the body of the proximal anchor 812, and a pusher wire 816. The needle, including the retainer, pulley wire, and pusher wire, is fastened to the header 802. Different types of needles and retainers assembled with the header can be prepared as a unit before surgery. Each unit can be replaced for repeated surgeries by locking it to the body of the fixation device. Figures 8D and 8E show the proximal portion of the distal pulley wire 814 positioned in the slit ruler 809, where the end of the distal pulley wire 814 is locked and secured by the slide indicator 810. The proximal portion of the pusher wire 816 is positioned between the control gear 805, threaded through the rear knob 807, and visible through the slit ruler 808.

[0052] After placement of fixation device needle 801 is confirmed under image guidance with the distal tip of needle 801 positioned in the extraperitoneal fat space just posterolateral to the target ligament, the distal anchor of retainer 811 is released from the needle by rotating knob 806 or 807 to advance pusher wire 816. Advancement of retainers 811 and 812 is monitored by observing the movement of pusher wire 816 and distal pulley wire 814 through slit rulers 808 and 809, respectively, and the movement of slide indicator 810.

[0053] Once release of the distal anchor 811 is confirmed, the needle 801 is retracted into the vaginal cavity under image guidance while the distal pulley wire 814 is pulled back. As a result of the pulling, the distal anchor 811 spreads and is apposed to the target ligament 817 in FIG. 8F . After the needle is retracted into the vaginal cavity, further forward rotation of the knob 806 or 807 advances the pusher wire 815, releasing the proximal anchor 812, which spreads and is apposed to the vaginal wall 818. The proximal pulley wire 815 is removed by pulling only one end of the wire in the direction indicated by arrow 819. The vaginal wall 818, with the proximal anchor 812 apposed, is fastened to the target ligament 817, with the distal anchor 811 apposed, via the retention wire 813, i.e., a vaginal fixation is formed.

[0054] Figure 8G shows another embodiment of distal anchor 820 that is umbrella-shaped and in a collapsed configuration within needle 801. When released from the needle uncovered, distal anchor 820 unfolds as shown in Figure 8H to appose target ligament 817. With the exception of umbrella-shaped distal anchor 820, the design and operation of the remainder of Figures 8G and 8H are the same as those of Figures 8C and 8F, respectively.

[0055] 9A and 9B show CT images of a subject's pelvis lying supine with a TV vaginal probe 901 placed in the vagina. A metal needle 902 is inserted through the vaginal probe 901 and into the right sacrospinous ligament 903. The straight black lines in the CT images are imaging artifacts from the metal object. A retainer is placed through the needle of the fixation device, with the distal metal anchor 904 of the retainer positioned in the right sacrospinous ligament, while the proximal metal anchor 905 is positioned within the vaginal cavity. Upon completion of the transvaginal colpopexy, the vaginal vault with the proximal anchor 905 apposed is fastened to the target ligament with the distal anchor 904 apposed, as shown in FIG. 9C.

[0056] FIG. 10 shows a subcutaneous (SC) vaginal device having a flap 1001 that fastens to the patient's pelvis to secure and stabilize the SC vaginal device for colpopexy. The center of the SC vaginal device has a control hub 1002 into which two cylindrical SC vaginal probes 1003 and 1004 of different calibers are inserted as one assembled unit. The two SC vaginal probes are open at their proximal ends and have separate open lateral ports 1005 at their distal ends. The two SC vaginal probes are assembled and aligned so that their distal ports match. The large-caliber probe 1003 is inserted into the vaginal cavity so that its open port 1005 is positioned generally in the vaginal vault and pushed toward the desired pelvic ligament, and advanced so that its distal tip is positioned against or near the cervix. Additionally, the large bore probe 1003 is rotated about its long axis (roll axis) so that the open port 1005 faces the target pelvic ligament. Once the position and orientation of the large bore probe 1003 is determined, the probe is secured to the control hub 1002 by a locking screw 1006. The orientation of the small bore probe 1004 can be further corrected and fine-tuned by rotating the probe about its yaw axis to precisely align the open port and SC vaginal probe from the vagina to the target pelvic ligament. The position and orientation of the small bore probe 1004 is fixed by a locking screw 1007.

[0057] 11A and 11B show the placement of an SC vaginal probe 1101 within the vaginal cavity 1102 for a subcutaneous approach in colpopexy. In this approach, the SC vaginal probe 1101 corresponds to a combination of the large- and small-bore vaginal probes of FIG. 10. The primary function of the SC vaginal probe is to provide a distal opening port 1103 for a conduit for needle placement from the fixation device into the vaginal cavity under image guidance. Additionally, as shown in the cross-sectional anatomical view, the patient is in a prone position with the buttocks exposed and facing upward for needle placement. Alternatively, the patient may be placed in a semi-recumbent position to allow for more perpendicular placement of the needle toward the target ligament. The distal opening port 1103 of the SC vaginal probe near the vaginal vault 1104 is visualized and confirmed on imaging. The right sacrospinous ligament 1105 of interest is identified.

[0058] 12A and 12B show the distal opening port 1201 of the vaginal probe being moved and rotated to push against the vaginal vault and toward the target right sacrospinous ligament 1202. This positioning is performed under image guidance. The path from the appropriate subcutaneous site to the target pelvic ligament 1202 and distal opening port 1201 of the vaginal probe is estimated to provide the distance and angle required for needle movement. The distance and rotation angle are calculated more precisely by a needle navigation program or manually from an analysis of a 3D image of the pelvis including the SC vaginal device. The needle 1203 from the fixation device is inserted in the direction indicated by the arrow 1204 at the subcutaneous site, traversing the subcutaneous fat, pelvic muscles, target ligament, extraperitoneal fat, and vaginal wall to the distal opening port 1201.

[0059] In the subcutaneous approach to colpopexy, the fixation device used in the transvaginal approach, shown in Figures 8A-8H, is also used and follows the same functions and operations for fixation. However, the type of needle used may differ between the two approaches. For example, in the subcutaneous approach without a needle guide track, a straighter, more rigid needle is preferred compared to the transvaginal approach, in that the needle trajectory is determined by the needle guide track of the transvaginal probe. Figures 13A and 13B show the needle 1301 from the fixation device inserted into the distal opening port of the vaginal probe. After confirming that the distal tip of the needle 1301 is within the vaginal probe, the distal anchor 1302 of the retainer is released from the needle by rotating the knob of the fixation device and advancing the pusher wire. The advancement of the retainer is monitored through the slit ruler and slide indicator of the fixation device. Once release of the distal anchor 1302 is confirmed, the needle 1301 is retracted into the extraperitoneal fat space posterolateral to the target ligament, while the distal pulley wire is retracted. Due to the tension, the distal anchor 1302 spreads and is apposed to the vaginal wall. Further forward rotation of the fixation device knob advances the pusher wire, releasing the proximal anchor into the extraperitoneal fat space posterolateral to the target ligament. The proximal anchor is exposed and released, spreading and apposing the target ligament. The pulley wire, vaginal probe, and fixation device are removed. Upon completion of the subcutaneous colpopexy, the vaginal wall apposed by the distal anchor 1302 is fastened to the target ligament apposed by the proximal anchor via the retention wire 1303, similar to the transvaginal colpopexy shown in FIG. 9C, thus forming a colpopexy. FIG. 14 shows an image of a subject lying prone on a table with an SC vaginal probe with a needle inserted through the right buttock for a subcutaneous approach.

[0060] Vaginal fixation devices, including vaginal probes, fixation devices, and retainers, can include fiducial markers made of radiopaque materials, including barium sulfate or metal, that can be detected under fluoroscopy or CT. Some devices may be partially or entirely coated with barium sulfate. Magnetically sensitive fiducial markers can be used to guide surgery under MR imaging. Additionally, some parts of vaginal fixation devices, including vaginal probes, fixation devices, and retainers, can be made of metal, biocompatible polymers, or silicone.

Claims

1. 1. A vaginal device for image-guided colpopexy, comprising: at least one pelvic flap fastened to the patient's pelvis to secure and stabilize the vaginal device; a control hub located at the center of the vaginal device, the control hub including a rotatable inner tube positioned within the vaginal cavity, a joint that can rotate about at least two different axes while keeping the at least one pelvic flap as a fixed reference, and reference marks indicating degrees or rotations; at least one elongated curved vaginal probe received through the control hub, the probe including a proximal opening at a proximal end, a distal opening port at a distal end, and a curved needle guide track configured to angle a needle a predetermined number of degrees as it is advanced from the vagina into the target ligament; A vaginal device comprising:

2. 1. A fixation device for image-guided colpopexy, comprising: At least one needle having a hollow lumen, which may be curved or straight; at least one retainer including a distal anchor, a proximal anchor, and a retention wire connecting the distal and proximal anchors; one or more pulley wires connected to any one or more of the proximal anchor and the distal anchor; a pusher wire that pushes the at least one retainer forward and slides it through the lumen of the needle; a body to which the needle is connected; A fixing device comprising:

3. 1. An apparatus for image-guided colpopexy, comprising: It has a vaginal device and a fixation device, The vaginal device comprises: at least one pelvic flap fastened to the patient's pelvis to secure and stabilize the vaginal device; a control hub located at the center of the vaginal device, the control hub including a rotatable inner tube positioned within the vaginal cavity, a joint that can rotate about at least two different axes while keeping the at least one pelvic flap as a fixed reference, and reference marks indicating degrees or rotations; at least one elongated curved vaginal probe received through the control hub, the probe including a proximal opening at a proximal end, a distal opening port at a distal end, and a curved needle guide track configured to angle a needle of the fixation device a predetermined number of degrees as it is advanced through the vagina into the target ligament; Equipped with The fixing device comprises: At least one needle having a hollow lumen, which may be curved or straight; at least one retainer including a distal anchor, a proximal anchor, and a retention wire connecting the distal and proximal anchors; one or more pulley wires connected to any one or more of the proximal anchor and the distal anchor; a pusher wire that pushes the at least one retainer forward and slides it through the lumen of the needle; a body to which the needle is connected; 1. An apparatus for image-guided colpopexy, comprising:

4. 10. The vaginal device of claim 1, further comprising a locking screw for securing and stabilizing the vaginal probe and the control hub.

5. 10. The vaginal device of claim 1, wherein the needle guide track is curved within a range of 60-80 degrees to angle the needle as it is advanced from the vagina into the target ligament.

6. 10. The vaginal device of claim 1, wherein the control hub is configured to achieve advancement and rotation of the vaginal probe by rotational and / or translational manipulation to gain access to a target site in the vaginal cavity and to target a target ligament guided by medical imaging.

7. 10. The vaginal device of claim 1, wherein the vaginal probe and / or needle guide track have a curve and angle toward a target pelvic ligament to facilitate angling the needle at the predetermined degree as the needle is pushed through the probe.

8. 3. The fixation device of claim 2, wherein the body comprises at least one head to which the needle is locked or assembled together as a unit.

9. 3. The fixation device of claim 2, wherein the body comprises any one or more of a control gear, a side knob, a rear knob, a slit ruler for a pusher wire, a slit ruler for one or more pulley wires, a slide indicator, and a handle.

10. 3. The fixation device of claim 2, wherein each of the distal and proximal anchors is in the form of a rod, a cylinder, and a collapsible umbrella that can be inserted through a hollow lumen and that can freely rotate and swing at a joint connected to the retention wire when released from the hollow lumen.

11. the body includes a slit ruler for one or more pulley wires and a slide indicator; the one or more pulley wires include a proximal pulley wire connected to the proximal anchor and a distal pulley wire connected to the distal anchor; The fixation device of claim 2 , wherein a proximal portion of the distal pulley wire is positioned within the slit ruler for one or more pulley wires and is locked and secured by the slide indicator.

12. the body further comprises a control gear, a side knob, a rear knob, and a slit ruler for one or more pulley wires; The fixation device of claim 11 , wherein a proximal portion of the pusher wire is disposed between the control gears, threaded through the rear knob, and visible through the slit ruler.

13. 10. The vaginal device of claim 1, wherein the device further comprises fiducial markers for tracking the position or orientation of any one or more components of the device in medical imaging.

14. The fixation device of claim 2 , wherein the device further comprises fiducial markers for tracking the position or orientation of any one or more components of the device in medical imaging.

15. 10. The vaginal device of claim 1, wherein the device is constructed in part from metal, silicon, or a biocompatible polymer, including a biodegradable or non-biodegradable polymer.

16. The fixation device of claim 2 , wherein the device is constructed in part from metal, silicon, or a biocompatible polymer, including biodegradable or non-biodegradable polymers.

17. 10. A method for image-guided colpopexy using the vaginal device of claim 1, comprising: (a) placing the vaginal device in the patient's pelvis; (b) inserting the vaginal probe into the vaginal cavity so that the distal tip is proximate the vaginal vault; (c) performing medical imaging of the pelvis by one or more selected from CT, MRI, ultrasound, fluoroscopy, and laparoscopy to display and visualize said vaginal probe in the vaginal vault and pelvic ligaments of interest; (d) indicating the location of the distal opening port of the vaginal probe and the target pelvic ligament on medical imaging; (e) pushing the vaginal vault toward the target pelvic ligament and moving the vaginal probe so as to point the distal opening port of the vaginal probe toward the target pelvic ligament; (f) determining three-dimensional coordinates of the distal opening port of the vaginal probe and the target ligament and determining a path from the distal opening port of the vaginal probe to the target pelvic ligament; A method comprising:

18. For the transvaginal approach, the fixation device according to claim 2 is further used, (a') projecting a needle having a hollow lumen across the vaginal wall into the target pelvic ligament; (b') placing a retainer, one or more pulley wires, and a pusher wire through the lumen of the needle before or during the intervention; (c') pushing the retainer with the pusher wire to eject only the distal anchor from the needle into the target pelvic ligament; (d') retracting the needle so that the tip is positioned within the vaginal cavity; (e') pushing the proximal anchor with the pusher wire to eject the proximal anchor from the needle into the vaginal cavity; (f') removing the one or more pulley wires, pusher wires, needles, and vaginal probes; 18. The method of claim 17, comprising:

19. confirming engagement of the distal anchor with the pelvic ligament using medical imaging or by gently pulling on the one or more pulley wires; and confirming engagement of the proximal anchor with the vaginal wall using medical imaging or by gently pulling on the one or more pulley wires.

20. The method of claim 18, further comprising one or more of:

20. For a subcutaneous approach, the fixation device according to claim 2 is further used, (a'') determining three-dimensional coordinates of a subcutaneous skin site from medical imaging and estimating a needle path from said subcutaneous skin site through the target ligament to a distal opening port of a vaginal probe, including the distance and angle of needle travel; (b'') inserting a needle having a hollow lumen from the subcutaneous site across the target ligament and vaginal wall into the distal opening port of the vaginal probe; (c'') placing a retainer, one or more pulley wires, and a pusher wire through the lumen of the needle before or during the intervention; (d'') pushing the retainer with the pusher wire to eject only the distal anchor of the retainer from the needle into the vaginal cavity; (e'') retracting the needle so that the tip is positioned in the target ligament; (f'') pushing the proximal anchor of the retainer with the pusher wire to eject the proximal anchor from the needle into the target ligament; (g'') removing the one or more pulley wires, pusher wires, needles, and vaginal probes; 18. The method of claim 17, comprising:

21. confirming engagement of the distal anchor with the vaginal wall using medical imaging or by gently pulling on the one or more pulley wires; and confirming engagement of the proximal anchor with the target ligament using medical imaging or by gently pulling on the one or more pulley wires.

21. The method of claim 20, further comprising one or more of:

22. 21. The method of claim 18 or 20, wherein positioning the vaginal probe, the needle, the retainer, the one or more pulley wires, and the pusher wire is performed by a powered mechanism, manually, or by operating a manual device.

Images