Devices and methods for image-guided vaginal fixation

Abstract

Devices and methods for performing image-guided vaginal fixation, such as sacrospinous ligament vaginal fixation, to treat pelvic organ prolapse are disclosed. The device is configured for transvaginal or subcutaneous approach methods, including a rotatable and translatable vaginal device with image-guided indicia, an anchoring device, an anchor, and a pulley and pusher. A path is established between the vaginal wall and the pelvic ligament by precise placement of the vaginal device and the anchoring device and is used for insertion of a retention assembly that is capable of juxtaposing and securing the vaginal wall to the pelvic ligament for vaginal fixation.

Description

Technical Field

[0001] The present invention relates to a method for treating pelvic organ prolapse by image-guided fixation of the vaginal wall to pelvic ligaments. Medical imaging can display and visualize the patient's internal pelvic structures. Without surgical incisions, under image guidance, a medical intervention device is used to identify and access the vagina and pelvic ligaments. By precisely placing a vaginal device and an anchoring device, a path is established between the vaginal wall and the pelvic ligaments and is used for inserting a retention assembly that can juxtapose and fix the vaginal wall to the pelvic ligaments for colpofixation. The image-guided vaginal fixation device is configured for transvaginal or subcutaneous access. Background Art

[0002] Almost 50% of women over the age of 50 suffer from pelvic organ prolapse (POP). While many women with POP do not require special treatment, some of them experience a decline in quality of life, including negative views of body image, sexual dysfunction, urinary dysfunction, and bowel dysfunction, all of which require clinical treatment.

[0003] There are various options for the treatment of pelvic floor dysfunction (POP). Non-invasive methods include biofeedback therapy, pelvic floor muscle strengthening training, or intravaginal support devices (such as pessaries). When non-invasive treatment options fail to control symptoms, invasive treatments such as surgery are considered.

[0004] POP surgeries can be classified as obliterative surgeries or reconstructive surgeries. Obliterative surgeries include reducing, shortening, or completely closing the vagina, thereby providing additional support for organs that prolapse from or compress the vaginal wall. The aim of reconstructive surgeries is to support the pelvic floor and keep the prolapsed organs in their original positions. The various reconstructive surgical options useful to the patient can be classified according to the surgical approach (e.g., abdominal, vaginal, laparoscopic, or robotic approach), the type of repair (e.g., native tissue, mesh, or graft repair), and any concomitant surgeries (e.g., hysterectomy).

[0005] Abdominal reconstruction surgery for POP usually involves sacrocolpopexy or sacrouteropexy, in which a surgical mesh is used to fix the vaginal apex or the posterior part of the uterus to the sacral promontory. Vaginal reconstruction surgeries without using synthetic meshes include anterior and posterior colporrhaphy, uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeus fascia suspension. Uterosacral ligament suspension is performed through an intraperitoneal approach, while sacrospinous ligament fixation and iliococcygeus fascia suspension are performed through an extraperitoneal approach. Traditional uterosacral ligament suspension involves folding the uterosacral ligament at or above the level of the ischial spine, while modified uterosacral ligament suspension uses sutures to pass through the coccygeus-sacrospinous ligament muscle group. Compared with sacrospinous ligament fixation, iliococcygeus fascia suspension utilizes the iliococcygeus fascia below the ischial spine and lateral to the rectum as the suture site for connecting the vaginal vault. Posterior vaginal slingplasty or subcoccygeal sacropexy is a typical vaginal reconstruction surgery using synthetic meshes.

[0006] Although surgery is highly effective in relieving POP symptoms for 85% to 100% of patients, it imposes a heavy economic burden on the healthcare system. The annual incidence of POP surgery is 1.5 to 1.8 cases per 1,000 women per year, and approximately 11% of women undergo POP surgery before the age of 80. In addition, up to 30% of women who undergo surgery require repeat surgery, and the total annual cost of POP surgery in the United States alone exceeds $1 billion. Moreover, 15% - 30% of patients will experience postoperative complications such as neurological symptoms, ureteral obstruction, and urinary tract infections. In particular, the use of transvaginal mesh has high risks such as mesh erosion, pain, and immobility. In April 2019, the FDA ordered a halt to the sale and distribution of surgical mesh products for transvaginal repair of POP.

[0007] Since POP patients are usually older and have limited tolerance for major surgeries, there is a great need for a safe, non-invasive, and effective treatment method without the need for long and risky surgeries. Therefore, it is crucial to develop a treatment method that is highly efficient for POP treatment and relatively easy to implant through minimally invasive interventional surgery.

[0008] Our image-guided vaginal fixation system is based on the consideration that under the guidance of medical images, the target vaginal vault and pelvic ligaments for vaginal fixation intervention can be accurately identified and accessed. The vaginal fixation device is introduced into the target structure through a transvaginal or subcutaneous path for vaginal fixation without large incisions or causing significant interference to the surrounding tissues. Potential target pelvic ligaments include the uterosacral ligament, sacrospinous ligament, and iliococcygeus fascia, depending on the indications of clinical applications and the accessibility of the device. Summary of the Invention

[0009] For image-guided vaginal fixation, the patient is imaged to identify and localize the vaginal wall and pelvic ligaments as the target structures for intervention. When the vaginal wall can be easily accessed by directly inserting a vaginal probe into the vagina, the target pelvic ligaments deep within the pelvis can be accessed via a transvaginal or subcutaneous path.

[0010] The transvaginal approach for image-guided vaginal fixation first places a television (transvaginal) vaginal device above the pelvis of a patient lying supine on an image scanner table. The TV vaginal device consists of a pelvic flap, a control center, and a transvaginal probe. The pelvic flap is placed and fixed above the patient's pelvis to secure and stabilize the control center of the vaginal fixation. The transvaginal probe is inserted through the center of the control center into the vaginal cavity. The patient is imaged to identify the transvaginal probe and the target pelvic ligaments. The transvaginal probe contains a needle guide track. The distal tip of the transvaginal probe near the vaginal vault can be seen and confirmed via imaging. The distal tip of the transvaginal probe has a side opening for the needle guide track, through which a needle is inserted into the target pelvic ligament.

[0011] Under image guidance, the transvaginal probe is displaced and rotated to push the vaginal vault towards the target pelvic ligament and align the needle guide track with the target pelvic ligament. The orientation of the transvaginal probe is achieved by rotation around two different axes: swinging the control center around the y-axis (i.e., the axis pointing from the anus to the pubis in the supine position), while keeping the pelvic flap as a fixed reference; rotating the control center clockwise or counterclockwise around the horizontal x-axis (i.e., the long axis of the vaginal cavity) to rotate the transvaginal probe.

[0012] Estimate the path from the distal tip of the needle guide track to the target pelvic ligament 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 can be calculated more precisely through a needle navigation program or manually more precisely by analyzing 3D pelvic images containing the TV vaginal device.

[0013] After the needle guide track is properly placed and rotated and its trajectory towards the target pelvic ligament is confirmed, an anchoring device is introduced through the needle guide track. The anchoring device consists of a needle, a head, a body, a handle, and a retainer control gear. Before or during the intervention, a retainer is placed inside the hollow lumen of the needle, and the retainer is pushed forward by turning the knob of the retainer control gear. The needle of the anchoring device is inserted through the needle guide track of the TV vaginal probe and gently advanced beyond the distal opening of the needle guide track. The needle penetrates the vaginal wall and passes through the fat in the extraperitoneal pelvic space into the target pelvic ligament. Manipulate the retainer control gear to release the distal anchor of the retainer from the needle into the target pelvic ligament.

[0014] After confirming that the distal anchor of the retainer has been released, gently pull the retainer and the distal pulley wire backward. As a result of the pulling, the distal anchor opens and conforms to the target ligament. Under image guidance, by withdrawing the needle into the vaginal cavity, the proximal anchor of the retainer is released and placed within the vaginal cavity. The pulley wire, the anchoring device, and the TV vaginal device are removed. After performing transvaginal colpopexy, the vaginal wall to which the proximal anchor of the retainer conforms is fastened via the retention wire to the target ligament to which the distal anchor conforms, thereby forming colpopexy.

[0015] For the subcutaneous approach of image-guided colpopexy, an SC (subcutaneous) vaginal probe is first inserted into the vaginal cavity. The patient is placed in a prone or semi-recumbent position on the imaging scanner table, with the buttocks exposed and guided for placement of the needle of the anchoring device. The patient is imaged to identify the SC vaginal probe and the target pelvic ligament. The imaging system can visualize and confirm the distal tip of the SC vaginal probe located near the vaginal vault. The distal tip of the SC vaginal probe has a lateral opening, which is the ultimate target for insertion of the needle of the anchoring device. Under image guidance, the path from a suitable subcutaneous skin site through the target pelvic ligament to the vaginal orifice is estimated to provide the distance and angle required for needle navigation. This distance and rotational angle can be calculated more precisely by a needle navigation program or manually more precisely by analyzing 3D pelvic images containing the SC vaginal device.

[0016] The subcutaneous approach uses an anchoring device that has the same function and structure as the anchoring device for the transvaginal approach, but the needle is straighter and stiffer. The needle of the anchoring device is inserted from a suitable subcutaneous skin site through the target pelvic ligament to the lateral opening of the vaginal probe, and then passes through subcutaneous fat, pelvic muscles, the target ligament, extraperitoneal fat, and the vaginal wall along a predetermined path.

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

[0018] After confirming that the distal anchor of the retainer has been released, gently pull the retainer and the distal pulley wire backward. As a result of the pulling, the distal anchor opens and conforms to the vaginal cavity. Under image guidance, withdraw the needle to the target ligament, release the proximal anchor of the retainer, and place it at the target ligament. The pulley wire, the anchoring device, and the SC vaginal device are removed. After completing subcutaneous colpopexy, the vaginal wall to which the distal anchor of the retainer conforms is fixed to the target ligament to which the proximal anchor conforms via the retention wire, thereby forming colpopexy.

[0019] The colpopexy described in this embodiment is performed through a series of operations such as placing a vaginal probe, imaging, positioning, needling, pushing, pulling, and anchoring, without large incisions and without causing significant interference to surrounding tissues. Although the sacrospinous ligament is commonly used to fix the vaginal vault, other pelvic ligament structures (such as the uterosacral ligament) can also be used for colpopexy. Various medical imaging systems (including CT, MRI, ultrasound, fluoroscopy, and laparoscopy) can be used for image guidance. The positioning of the vaginal probe, needle, retainer, and wire can be manually performed via an electric mechanism by operating a manual operating device.

[0020] During or after colpopexy, it is beneficial to track and monitor the position and configuration status of the in-vivo devices and retainers. For this purpose, fiducial markers made of radiopaque materials containing barium sulfate or metal can be detected under fluoroscopy or CT examination. Some devices may be partially or fully coated with barium sulfate. Susceptibility fiducial markers can be used to guide the MRI imaging process.

[0021] A first aspect of the present invention is a vaginal device for image-guided colpopexy, comprising:

[0022] At least one pelvic flap, which is fastened above the patient's pelvis to fix and stabilize the vaginal device;

[0023] A control center, which is located at the center of the vaginal device. The control center includes a rotatable inner tube placed in the vaginal cavity, a joint that can rotate around at least two different axes while maintaining at least one pelvic flap as a fixed reference, and a reference marker indicating an angle or rotation; and

[0024] At least one elongated curved vaginal probe, which is accommodated through the control center. The vaginal probe includes a proximal opening at the proximal end, a distal opening at the distal end, and a curved needle guide track, which is configured to angle the needle at a predetermined angle when the needle advances from the vagina to the target ligament.

[0025] In some embodiments, the vaginal device further includes locking screws to fix and stabilize the vaginal probe and the control center.

[0026] In some embodiments, the needle guide track of the vaginal device is curved within a range of 60 - 80 degrees to angle the needle when it advances from the vagina to the target ligament.

[0027] In some embodiments, the control center of the vaginal device is configured to achieve the advancement and rotation of the vaginal probe through rotational and / or translational operations, so as to enter the target site of the vaginal cavity and align with the target ligament under the guidance of medical imaging.

[0028] In some embodiments, the vaginal probe and / or the needle guiding track of the vaginal device are curved and angled towards the target pelvic ligament so that when the needle is inserted and pushed through the probe, the needle can be bent at a predetermined angle.

[0029] A second aspect of the present invention is an anchoring device for image-guided vaginal fixation, comprising:

[0030] At least one needle, which is curved or straight and has a hollow lumen;

[0031] At least one retainer, which includes a distal anchor, a proximal anchor, and a retaining wire connecting the distal anchor and the proximal anchor;

[0032] One or more pulley wires, which are connected to any one or more of the proximal anchor and the distal anchor;

[0033] A pusher wire, which pushes at least one retainer forward to slide through the lumen of the needle; and

[0034] A body, to which the needle is connected.

[0035] In some embodiments, the body of the anchoring device includes at least one head, to which the needle is locked or assembled as a unit.

[0036] In some embodiments, the body of the anchoring device includes any one or more of a control gear, a side knob, a rear knob, a slit ruler for the pusher wire, a slit ruler for one or more pulley wires, a sliding indicator, and a handle.

[0037] In some embodiments, both the distal anchor and the proximal anchor of the anchoring device have the form of a rod, a cylinder, and a collapsible umbrella, which can be inserted through the hollow lumen and, when released from the hollow lumen, can freely rotate and swing at the joint connected to the retaining wire.

[0038] In some embodiments, the body of the anchoring device includes a slit ruler and a sliding indicator for one or more pulley wires, and

[0039] 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,

[0040] wherein, the proximal extension of the distal pulley wire is placed in the slit ruler for one or more pulley wires and is locked and fixed by the sliding indicator.

[0041] In some embodiments, the body of the anchoring device further includes a control gear, a side knob, a rear knob, and a slit ruler for one or more pulley wires.

[0042] Wherein, the proximal extension of the pusher wire is placed between the control gears, spirals through the rear knob, and is visible through the slit scale.

[0043] In certain embodiments, the vaginal device further includes fiducial markers for tracking the positioning or location of any one or more components of the device using medical imaging.

[0044] In certain embodiments, the anchoring device further includes fiducial markers for tracking the positioning or location of any one or more components of the device using medical imaging.

[0045] In certain embodiments, part of the vaginal device is composed of metal, silicon, or a biocompatible polymer, and the biocompatible polymer includes biodegradable or non - biodegradable polymers.

[0046] In certain embodiments, part of the anchoring device is composed of metal, silicon, or a biocompatible polymer, and the biocompatible polymer includes biodegradable or non - biodegradable polymers.

[0047] The third aspect of the present invention is

[0048] A device for image - guided vaginal fixation, comprising a vaginal device and an anchoring device,

[0049] Wherein the vaginal device includes:

[0050] At least one pelvic flap fastened above the patient's pelvis to fix and stabilize the vaginal device;

[0051] A control center located at the center of the vaginal device, the control center including a rotatable inner tube placed in the vaginal cavity, a joint that can rotate around at least two different axes while maintaining at least one pelvic flap as a fixed reference, and a reference marker indicating an angle or rotation; and

[0052] At least one elongated and curved vaginal probe received by the control center, the vaginal probe including a proximal opening at the proximal end, a distal opening at the distal end, and a curved needle - guiding track configured to angle the needle of the anchoring device at a predetermined angle when advancing from the vagina to the target ligament.

[0053] Wherein, the anchoring device includes:

[0054] At least one needle, which is curved or straight and has a hollow inner cavity;

[0055] At least one retainer, which includes a distal anchor, a proximal anchor, and a retaining wire connecting the distal anchor and the proximal anchor;

[0056] One or more pulley wires connected to any one or more of the proximal anchor and the distal anchor;

[0057] A pusher wire that pushes at least one retainer forward to slide through the lumen of the needle; and

[0058] A body to which the needle is attached.

[0059] A fourth aspect of the present invention provides a method for performing image-guided vaginal fixation using a vaginal device, the method comprising the steps of:

[0060] (a) Placing the vaginal device in the patient's pelvis;

[0061] (b) Inserting a vaginal probe into the vaginal cavity and positioning the distal tip of the vaginal probe near the vaginal vault;

[0062] (c) Performing medical imaging of the pelvis using one or more of CT, MRI, ultrasound, fluoroscopy, and laparoscopy to visualize and observe the vaginal probe and the target pelvic ligament in the vaginal vault;

[0063] (d) Indicating the positions of the distal opening of the vaginal probe and the target pelvic ligament on the medical image;

[0064] (e) Moving the vaginal probe to push the vaginal vault towards the target pelvic ligament and aligning the distal opening of the vaginal probe with the target pelvic ligament; and

[0065] (f) Obtaining three-dimensional coordinates of the distal opening of the vaginal probe and the target ligament to determine the path from the distal opening of the vaginal probe to the target pelvic ligament.

[0066] In certain embodiments, the method is for a transvaginal approach and further uses an anchoring device, comprising the steps of:

[0067] (a’) Extending a needle having a hollow lumen through the vaginal wall into the target pelvic ligament;

[0068] (b’) Passing a retainer, one or more pulley wires, and a pusher wire through the lumen of the needle before or during the intervention;

[0069] (c’) Pushing the retainer by the pusher wire to release only the distal anchor from the needle into the target pelvic ligament;

[0070] (d’) Withdrawing the needle to place its tip within the vaginal cavity;

[0071] (e’) Pushing the proximal anchor by the pusher wire to release the proximal anchor from the needle into the vaginal cavity; and

[0072] (f’) Removing one or more pulley wires, the pusher wire, the needle, and the vaginal probe.

[0073] In certain embodiments, the transvaginal approach method further comprises one or more of the following steps:

[0074] Confirming the engagement of the distal anchor with the pelvic ligament by using medical imaging or gently pulling one or more pulley wires; and

[0075] Confirming the engagement of the proximal anchor with the vaginal wall by using medical imaging or gently pulling one or more pulley wires.

[0076] In certain embodiments, the method for further using a subcutaneous approach of the anchoring device comprises the following steps:

[0077] (a”) Obtaining three-dimensional coordinates of the subcutaneous skin site from medical imaging to estimate the needle path from the subcutaneous skin site through the target ligament to the distal opening of the vaginal probe, including the distance and angle of needle navigation;

[0078] (b”) Inserting a needle with a hollow lumen from the subcutaneous site, through the target ligament and the vaginal wall, and into the distal opening of the vaginal probe;

[0079] (c”) Passing a retainer, one or more pulley wires, and a pusher wire through the lumen of the needle before or during the intervention;

[0080] (d”) Pushing the retainer by the pusher wire to release only the distal anchor of the retainer from the needle into the vaginal cavity;

[0081] (e”) Withdrawing the needle to place its tip at the target ligament;

[0082] (f”) Pushing the proximal anchor of the retainer by the pusher wire to release the proximal anchor from the needle to the target ligament; and

[0083] (g”) Removing one or more pulley wires, the pusher wire, the needle, and the vaginal probe.

[0084] In certain embodiments, the subcutaneous approach method further comprises one or more of the following steps:

[0085] Confirming the engagement of the distal anchor with the vaginal wall by using medical imaging or gently pulling one or more pulley wires; and

[0086] Confirming the engagement of the proximal anchor with the target ligament by using medical imaging or gently pulling one or more pulley wires.

[0087] In certain embodiments, the positioning of the vaginal probe, the needle, the retainer, one or more pulley wires, and the pusher wire is performed manually by an electric mechanism or by operating a manual device. Description of the Drawings

[0088] Figure 1A - 1CIt is a transverse sectional view of the female pelvic structure in the supine position, showing the vaginal fornix, bilateral sacrospinous ligaments, other internal pelvic organs, and a transvaginal (TV) vaginal probe with a needle placed in the vaginal cavity.

[0089] Figure 2A - 2D It is a 3D solid view and wireframe perspective view of the TV vaginal device.

[0090] Figure 3A It is an image of the prototype TV vaginal device before being placed above the pelvis.

[0091] Figure 3B - 3C They are two images of a human body lying supine on a table with the prototype TV vaginal device placed above the pelvis.

[0092] Figure 4A It is a schematic perspective view of the female pelvic structure, showing the pelvic bone structure, the right sacrospinous ligament, the vaginal cavity, the vaginal fornix, and the vaginal probe in the vaginal cavity.

[0093] Figure 4B It is a transverse sectional view of the female pelvic structure in the supine position, showing the vaginal fornix, bilateral sacrospinous ligaments, other internal pelvic organs, and the distal tip of the vaginal probe placed near the vaginal fornix.

[0094] Figure 5A Same as Figure 4A but with a vaginal probe, the distal opening of which is displaced and reoriented to the target right sacrospinous ligament.

[0095] Figure 5B Same as Figure 4B but with a vaginal probe, the distal opening of which is displaced and reoriented to the target right sacrospinous ligament.

[0096] Figure 6A Same as Figure 5A but with a vaginal probe that contains a needle extending from the opening to the right target sacrospinous ligament.

[0097] Figure 6B Same as Figure 5B but with a vaginal probe that contains a needle extending from the opening to the right target sacrospinous ligament.

[0098] Figure 7A It is a 3D solid view of the TV vaginal device with an anchoring device inserted.

[0099] Figure 7B It is a wireframe perspective view of the TV vaginal device with an anchoring device inserted.

[0100] Figure 7C It is an image of the prototype anchoring device for transvaginal access.

[0101] Figure 7DIt is an image of a human body lying supine on a table with a prototype TV vaginal device, and a prototype anchoring device is inserted through the prototype TV vaginal device for a transvaginal approach.

[0102] Figure 8A It is a 3D perspective view of an anchoring device for a transvaginal approach.

[0103] Figure 8B It is Figure 8A an enlarged view above the main body of the anchoring device.

[0104] Figure 8C It is a cross-sectional view of the needle through which a retainer, two pulley wires, and a pusher wire are inserted.

[0105] Figure 8D It is a wireframe perspective view of the anchoring device for a transvaginal approach with the distal pulley wire and pusher wire placed.

[0106] Figure 8E Same as Figure 8B except that the distal pulley wire and pusher wire are placed.

[0107] Figure 8F It is a schematic diagram of the distal and proximal anchors of the retainer that fit the ligament and vaginal wall, where the ligament and vaginal wall are fastened by retention wires connected to the distal and proximal anchors of the retainer.

[0108] Figure 8G It is a cross-sectional view of the needle through which a retainer with a folded umbrella-shaped and rod-shaped anchor and a proximal pulley wire are inserted.

[0109] Figure 8H Same as Figure 8F except that a rod-shaped anchor is replaced by an unfolded umbrella-shaped anchor.

[0110] Figure 9A It is a CT image of a human pelvis, where the TV vaginal probe contains a needle placed in the right sacrospinous ligament.

[0111] Figure 9B It is a CT image of a human pelvis, where the distal anchor of the retainer is located at the right sacrospinous ligament and the proximal anchor is located within the vaginal cavity.

[0112] Figure 9C It is a schematic perspective view of the female pelvic anatomy, showing that the vaginal vault is fastened to the right sacrospinous ligament by means of a retainer.

[0113] Figure 10 It is a 3D perspective view of a subcutaneous (SC) vaginal device for a subcutaneous approach.

[0114] Figure 11AIs a schematic perspective view of the female pelvic anatomical structure, showing the pelvic bone structure, the right sacrospinous ligament, the vaginal cavity, the vaginal vault, and the SC vaginal probe within the vaginal cavity.

[0115] Figure 11B Is a transverse cross-sectional view of the female pelvic anatomical structure in the prone position, showing the vaginal vault, the bilateral sacrospinous ligaments, other internal pelvic organs, and the distal tip of the SC vaginal probe placed near the vaginal vault.

[0116] Figure 12A Same as Figure 11A but with an SC vaginal probe, the port of which is displaced and redirected to the target right sacrospinous ligament, and the subcutaneous insertion needle inserted into the port of the SC vaginal probe penetrates through the target right sacrospinous ligament.

[0117] Figure 12B Same as Figure 11B but with an SC vaginal probe, the port of which is displaced and redirected to the target right sacrospinous ligament, and the subcutaneous insertion needle inserted into the port of the SC vaginal probe penetrates through the target right sacrospinous ligament.

[0118] Figure 13A Is a 3D perspective view of the SC vaginal device for subcutaneous access, where the needle is inserted into the distal opening of the vaginal probe.

[0119] Figure 13B Is an enlarged view of the SC vaginal probe with an insertion needle for subcutaneous access, through which the retainer anchor and the partially exposed retaining wire are deployed into the distal opening of the vaginal probe.

[0120] Figure 14 Is an image of a human body with an SC vaginal probe in the prone position on a table, and the needle is inserted into the SC vaginal probe from the right buttock for subcutaneous access. Detailed Description

[0121] Figure 1A - 1C Shows the key anatomical structures related to colpopexy in the female pelvis: the vagina 101, the right sacrospinous ligament 102, and the left sacrospinous ligament 103. Figure 1B Represents the pelvis in the coronal plane, while Figure 1C Represents the pelvis in the axial plane. Considering the position and orientation of the sacrospinous ligament relative to the vagina in the 3D anatomical structure, the vaginal probe 104 needs to rotate around two axes (the roll axis and the yaw axis) to align from the vaginal vault to the target sacrospinous ligament. According to the convention of the aircraft main axis, the roll rotation 105 corresponds to the rotation around the x-axis, and the yaw rotation 106 corresponds to the rotation around the y-axis. The yaw angle 107, that is, the angle between the long axis of the vaginal probe 104 and the needle 108, as Figure 1BThe roll angle 109 (indicated by a clock face representing a cross section of the vagina) of the vaginal probe 104 directed toward the target sacrospinous ligament is within the range of 60-80 degrees as shown in the mid-pelvic coronal plane. Figure 1C As shown in the mid-pelvic axial plane, the right sacrospinous ligament 102 is aligned within the range of 7-8 o'clock (indicated by arrow 110), or the left sacrospinous ligament 103 is aligned within the range of 4-5 o'clock.

[0122] Figure 2A - 2D A transvaginal (TV) vaginal device is shown having a pelvic flap 201 fixed (fastened) above the patient's pelvis to fix and stabilize a control hub 202 for colpopexy. An inner tube 203 of the control hub 202 placed inside the vaginal cavity is constructed to be smooth in structure and to rotate freely within the vaginal cavity. A TV vaginal probe 204 is inserted through the center of the control hub 202 into the vaginal cavity. The TV vaginal probe 204 includes a needle guide track 205. The distal tip of the TV vaginal probe 204 has an opening for the needle guide track 205 through which the needle can be extended in a suitable direction. The distal ends of the TV vaginal probe 204 and the needle guide track 205 are smoothly curved and angled toward the target pelvic ligament so that when the needle is inserted and pushed through the needle guide track 205 to enter the target pelvic ligament, the angle of the needle is within a range of 60-80 degrees.

[0123] The control hub 202 can be rotated at the joint 206 connected to the pelvic valve 201 according to the rotation angle indicated by arrow 207. This rotation enables 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 keeping the pelvic valve as a fixed reference, such as Figure 1A - 1B Once the position and orientation of the control hub 202 are determined, the control hub is fixed to the pelvic valve 201 by means of a locking screw 208. The TV vaginal probe 204 can also rotate around the control hub 202, as shown by arrow 209. Figure 1A and 1C As shown, this rotation allows the TV vaginal probe to rotate around the horizontal x-axis (i.e. the long axis of the vaginal cavity) by toggling the control hub 202 clockwise or counterclockwise around the vaginal cavity. Once the position and direction of the TV vaginal probe 204 are determined, the probe can be fixed to the control hub 202 by locking screws 210. Figure 3A An image of a prototype TV vaginal device is shown. Figure 3B - 3C Two images showing a person lying supine on a table with the prototype TV vaginal device positioned over the pelvis. The control hub displays a clock face reference marking indicating the rotation angle of the vaginal probe.

[0124] Figure 4A and 4BShows the placement of the TV vaginal probe 401 for transvaginal colpopexy in the vaginal cavity 402. In this approach, as shown in the cross-sectional anatomy, the patient is in Figure 3B the supine position as shown. The distal end 403 of the TV vaginal probe is located near the vaginal vault 404 and can be observed and confirmed by imaging. Identify the target right sacrospinous ligament 405.

[0125] Figure 5A and 5B Show that the distal tip 501 of the TV vaginal probe is moved and rotated to push the vaginal vault towards the target right sacrospinous ligament 502, thereby guiding the opening 503 of the vaginal probe to the target right sacrospinous ligament 502. This positioning operation is performed under image guidance. Estimate the path from the distal end of the needle guidance track of the vaginal probe to the target pelvic ligament to provide the distance and rotation angle required for the needle to reach the target pelvic ligament from the distal tip of the needle guidance track. The typical distance from the distal tip of the needle guidance track at the vaginal wall to the target pelvic ligament is in the range of 4 - 6 cm. The distance and rotation angle can be calculated more precisely by a needle navigation program or manually by analyzing 3D pelvic images containing the transvaginal device.

[0126] In Figure 2B , after the needle guidance track 205 of the TV vaginal probe 204 is advanced and rotated and its trajectory towards the target pelvic ligament is confirmed, an anchoring device is introduced through the needle guidance track 205. Figure 6A and 6B Show the needle 601 as part of the anchoring device, which extends from the opening of the vaginal probe to penetrate the vaginal wall and pass through the extraperitoneal pelvic fat into the target pelvic ligament, in the direction shown by the arrow 602.

[0127] Figure 7A Show the TV vaginal probe 701, through which the anchoring device 702 is inserted. Specifically, the needle 703 of the anchoring device 702 is inserted through the needle guidance track of the vaginal probe 701. Figure 7C Shows an image of the prototype anchoring device. Figure 7D Shows the insertion of the prototype anchoring device into the prototype TV vaginal device placed on a supine human body.

[0128] Figure 8A - 8B Shows the anchoring device, which consists of a needle 801, a head 802, a body 803, and a handle 804. The body 803 houses a retainer control gear 805, which can be rotated by turning the side knob 806 or the rear knob 807. The body 803 also includes a slit scale 808, a slit scale 809, and a sliding indicator 810. Figure 8CA needle 801 is shown, the hollow lumen of which is equipped with a retainer consisting of a distal anchor 811, a proximal anchor 812, and a retaining wire 813. The lumen of the needle 801 also contains a distal pulley wire 814 connected to the body through the distal anchor 811, a proximal pulley wire 815 connected to the body through the proximal anchor 812, and a pusher wire 816. The needle including the retainer, pulley wire, and pusher wire is fastened to the head 802. Different types of needles and retainers assembled with the head can be prepared as a unit before the process begins. Each unit can be replaced by locking to the body of the anchor device for repeated processes. Figure 8D - 8E The proximal extension of the distal pulley wire 814 is shown placed at the slit ruler 809, with the end of the distal pulley wire 814 locked and secured by the sliding indicator 810. The proximal extension of the pusher wire 816 is located between the control gears 805, spirals through the rear knob 807, and is visible through the slit ruler 808.

[0129] Under image guidance, after the position of the needle 801 of the anchoring device is determined to be located with its distal tip in the extraperitoneal fat space immediately posterolateral to the target ligament, the distal anchor of the retainer 811 is released from the needle by turning the knob 806 or 807 to advance the pusher wire 816. The advancement of the retainers 811-812 is monitored by observing the movement of the pusher wire 816 and the distal pulley wire 814 through the slit rulers 808 and 809, respectively, and the movement of the slide indicator 810.

[0130] After confirming that the distal anchor 811 is released, the needle 801 is withdrawn into the vaginal cavity under image guidance, and the distal pulley line 814 is pulled back. As a result of the pulling, the distal anchor 811 is opened and fits with the target ligament 817, as shown in FIG. Figure 8F As shown. After the needle is withdrawn into the vaginal cavity, the knob 806 or 807 is further rotated forward to advance the pusher wire 815 to release the proximal anchor 812, causing it to open and fit against the vaginal wall 818. The proximal pulley wire 815 can be removed simply by pulling it in the direction indicated by the arrow 819. The vaginal wall 818 fitting against the proximal anchor 812 is fastened to the target ligament 817 fitting against the distal anchor 811 by the retaining wire 813, thus forming a colpopexy.

[0131] Figure 8G Another embodiment of a distal anchor 820 is shown, which is shaped like an umbrella and is folded within the needle 801. When the distal anchor 820 is exposed and released from the needle, it will unfold and conform to the target ligament 817, such as Figure 8H In addition to the umbrella-shaped distal anchor 820, Figure 8G and 8H The design and operation of the rest of theFigure 8C and 8F are the same.

[0132] Figure 9A -B shows a CT image of the pelvis with the patient in the supine position, in which the TV vaginal probe 901 is placed in the vagina. The metal needle 902 is inserted through the vaginal probe 901 into the right sacrospinous ligament 903. The linear black line on the CT image is an imaging artifact caused by the metal object. Through the needle placement holder of the anchoring device, its distal metal anchor 904 is located in the right sacrospinous ligament, while the proximal metal anchor 905 is located in the vaginal cavity. After the procedure of transvaginal colpopexy is completed, the vaginal vault that fits against the proximal anchor 905 is fixed to the target ligament that fits against the distal anchor 904, as Figure 9C shown.

[0133] Figure 10 shows a subcutaneous (SC) vaginal device, which has a valve 1001 fastened above the patient's pelvis for fixing and stabilizing the SC vaginal device during colpopexy. The center of the SC vaginal device has a control center 1002, and two cylindrical SC vaginal probes 1003 and 1004 with different diameters are inserted through the control center as an assembly unit. The proximal ends of the two SC vaginal probes have openings, and separate side openings 1005 are provided at their distal ends. The two SC vaginal probes are assembled and aligned so that their distal openings coincide. The large-diameter probe 1003 is inserted into the vaginal cavity and advanced so that its distal tip abuts against or is placed near the cervix, such that the opening 1005 of the probe is positioned approximately at the vaginal vault and pushed against the target pelvic ligament. The large-diameter probe 1003 also rotates about its long axis (rolling axis) so that its opening 1005 points to the target pelvic ligament. Once the position and orientation of the large-diameter probe 1003 are determined, the probe is fixed to the control center 1002 by a locking screw 1006. The orientation of the small-diameter probe 1004 can be further modified and fine-tuned by rotating the probe about the yaw axis so that the openings and orientations of the SC vaginal probes are precisely aligned from the vagina to the target pelvic ligament. The position and orientation of the small-diameter probe 1004 are fixed by a locking screw 1007.

[0134] Figure 11A and 11B shows the placement of the SC vaginal probe 1101 in the vaginal cavity 1102 for a subcutaneous approach to colpopexy. In this approach, the SC vaginal probe 1101 is associated with Figure 10corresponds to the large-caliber and small-caliber combined vaginal probe. The main function of the SC vaginal probe is to provide a catheter for its distal opening 1103 to place a needle from the anchoring device into the vaginal cavity under image guidance. In addition, as shown in the cross-sectional anatomical diagram, the patient is in the prone position, exposing the buttocks and lifting them upward to place the needle. Alternatively, the patient can also take a semi-recumbent position to place the needle more vertically towards the target ligament. The distal opening 1103 of the SC vaginal probe near the vaginal vault 1104 can be seen and confirmed in imaging. The target right sacrospinous ligament 1105 is determined.

[0135] Figure 12A and 12B shows that the distal opening 1201 of the vaginal probe is moved and rotated so that the vaginal vault is oriented towards the target right sacrospinous ligament 1202 and is pushed towards the target right sacrospinous ligament 1202. This positioning operation is performed under image guidance. The paths from a suitable subcutaneous site to the target pelvic ligament 1202 and to the distal opening 1201 of the vaginal probe are estimated to provide the distances and angles required for needle navigation. The distances and rotation angles can be calculated more precisely by a needle navigation program or manually and precisely by analyzing 3D pelvic images containing the SC vaginal device. The needle 1203 from the anchoring device is inserted into the subcutaneous site in the direction shown by the arrow 1204, passing through the subcutaneous fat, pelvic muscles, target ligament, extraperitoneal fat, and vaginal wall, and entering the distal opening 1201.

[0136] For subcutaneously accessed vaginal fixation, a Figure 8A transvaginal access anchoring device as shown in -H can also be used, and its functions and operations for anchoring are the same. However, the types of needles used in the two methods may be different. For example, for the subcutaneous method that does not use a needle guiding track, a straighter and stiffer needle is preferred compared to the transvaginal method because the trajectory of the needle in the transvaginal approach is defined by the needle guiding track of the transvaginal probe. Figure 13A and 13BShows a needle 1301 inserted from an anchoring device into the distal opening of a vaginal probe. After confirming that the distal tip of the needle 1301 is located within the vaginal probe, the distal anchor 1302 of the retainer is released from the needle by turning the knob of the anchoring device to advance the pusher wire. The advancement of the retainer is monitored by the slit scale and sliding indicator of the anchoring device. After confirming that the distal anchor 1302 has been released, the needle 1301 is withdrawn into the extraperitoneal fat space posterior to the lateral side of the target ligament while pulling back the distal pulley wire. The distal anchor 1302 opens due to the pulling force and adheres to the vaginal wall. The knob of the anchoring device is further rotated forward to advance the pusher, thereby releasing the proximal anchor into the extraperitoneal fat space posterior to the lateral side of the target ligament. The proximal anchor is exposed and released to open and adhere to the target ligament. The pulley wire, vaginal probe, and anchoring device are all removed. After the subvaginal fixation is completed, the vaginal wall in contact with the distal anchor 1302 is fastened to the target ligament in contact with the proximal anchor by the retention wire 1303, i.e., subvaginal fixation is formed, similar to Figure 9C the transvaginal colpopexy shown. Figure 14 Shows an image of a human body lying prone on a table, with an SC vaginal probe, and a needle inserted from the right buttock into the SC vaginal probe for a subcutaneous approach.

[0137] The subvaginal fixation device including the vaginal probe, anchoring device, and retainer may include fiducial markers made of radiopaque materials such as barium sulfate or metal to be detected under fluoroscopy or CT examination. Part of the device may be partially or fully coated with barium sulfate. Susceptibility fiducial markers can be used to guide the MRI imaging process. In addition, the part of the subvaginal fixation device including the vaginal probe, anchoring device, and retainer is made of metal, biocompatible polymer, or silicone.

Claims

1. A vaginal device for image-guided vaginal fixation, comprising: At least one pelvic flap, which is fixed above the patient's pelvis to fix and stabilize the vaginal device; A control center, which is located at the center of the vaginal device. The control center includes a rotatable inner tube placed in the vaginal cavity, a connector that can rotate around at least two different axes while maintaining at least one pelvic valve as a fixed reference, and a reference mark indicating an angle or rotation; And At least one elongated curved vaginal probe, which is accommodated by the control center. The vaginal probe includes a proximal opening at the proximal end, a distal opening at the distal end, and a curved needle guiding track, and the curved needle guiding track is configured such that the needle forms an angle at a predetermined angle while advancing from the vagina to the target ligament.

2. An anchoring device for image-guided vaginal fixation, comprising: At least one needle, which is curved or straight and has a hollow inner cavity; At least one retainer, which includes a distal anchor, a proximal anchor, and a retaining wire connecting the distal anchor and the proximal anchor; One or more pulley wires, which are connected to any one or more of the proximal anchor and the distal anchor; A pusher wire, which pushes at least one retainer forward to slide through the inner cavity of the needle; and A body, to which the needle is connected.

3. An apparatus for image-guided vaginal fixation, the apparatus comprising a vaginal device and an anchoring device, Wherein the vaginal device includes: At least one pelvic flap, which is fixed above the patient's pelvis to fix and stabilize the vaginal device; A control center, which is located at the center of the vaginal device. The control center includes a rotatable inner tube placed in the vaginal cavity, a connector that can rotate around at least two different axes while maintaining at least one pelvic valve as a fixed reference, and a reference mark indicating an angle and rotation; And At least one elongated curved vaginal probe, which is accommodated by the control center. The vaginal probe includes a proximal opening at the proximal end, a distal opening at the distal end, and a curved needle guiding track. The curved needle guiding track is configured such that the needle of the anchoring device forms an angle at a predetermined angle while advancing from the vagina to the target ligament, Wherein the anchoring device includes: At least one needle, which is curved or straight and has a hollow inner cavity; At least one retainer, which includes a distal anchor, a proximal anchor, and a retaining wire connecting the distal anchor and the proximal anchor; One or more pulley wires, which are connected to any one or more of the proximal anchor and the distal anchor; A pusher wire, which pushes at least one retainer forward to slide through the inner cavity of the needle; and A body, to which the needle is connected.

4. The vaginal device according to claim 1, further comprising a locking screw for fixing and stabilizing the vaginal probe and the control center.

5. The vaginal device according to claim 1, wherein the needle guiding track is bent within a range of 60 - 80 degrees so that the needle forms an angle while advancing from the vagina to the target ligament.

6. The vaginal device according to claim 1, Among them, The control center is configured to achieve the advancement and rotation of the vaginal probe through its rotational and / or translational operations, so as to be able to enter the target site of the vaginal cavity and align with the target ligament under the guidance of medical imaging.

7. The vaginal device according to claim 1, Among them, The vaginal probe and / or the needle guiding track are bent and angled towards the target pelvic ligament, so that when the needle is inserted and pushed through the probe, the needle can be angled at a predetermined angle.

8. The anchoring device according to claim 2, wherein the main body includes at least one head, and the needle is locked to or assembled with the head as a unit.

9. The anchoring device according to claim 2, wherein the main body includes any one or more of a control gear, a side knob, a rear knob, a slit ruler for the pusher wire, a slit ruler for one or more pulley wires, a sliding indicator, and a handle.

10. The anchoring device according to claim 2, wherein each of the distal anchor and the proximal anchor has a rod-shaped, cylindrical, and collapsible umbrella-shaped form that can be inserted through the hollow inner cavity and can freely rotate and swing at the joint connected to the holding wire when released from the hollow inner cavity.

11. The anchoring device according to claim 2, wherein the main body includes a slit ruler for one or more pulley wires and a sliding indicator, and 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, Among them, The proximal extension of the distal pulley wire is placed in the slit ruler for one or more pulley wires and is locked and fixed by the sliding indicator.

12. The anchoring device according to claim 11, wherein the main body further includes a control gear, a side knob, a rear knob, and a slit ruler for one or more pulley wires, Among them, The proximal extension of the pusher wire is placed between the control gears, spirals through the rear knob, and can be observed through the slit ruler.

13. The vaginal device according to claim 1, wherein the vaginal device further includes a reference marker for tracking the positioning or location of any one or more components of the device using medical imaging.

14. The anchoring device according to claim 2, wherein the vaginal device further includes a reference marker for tracking the positioning or location of any one or more components of the device using medical imaging.

15. The vaginal device according to claim 1, wherein a part of the vaginal device is composed of metal, silicon, or a biocompatible polymer containing a biodegradable or non-biodegradable polymer.

16. The anchoring device according to claim 2, wherein a part of the vaginal device is composed of metal, silicon, or a biocompatible polymer containing a biodegradable or non-biodegradable polymer.

17. A method of performing image-guided vaginal fixation using the vaginal device of claim 1, the method comprising the following steps: (a) Placing the vaginal device within the patient's pelvis; (b) Inserting a vaginal probe into the vaginal cavity and positioning the distal tip of the vaginal probe near the vaginal vault; (c) Performing medical imaging of the pelvis using one or more of CT, MRI, ultrasound, fluoroscopy, and laparoscopy to display and visualize the vaginal probe and the target pelvic ligaments within the vaginal vault; (d) Indicating on the medical image the position of the distal opening of the vaginal probe and the target pelvic ligaments; (e) Moving the vaginal probe to gently push the vaginal vault towards the target pelvic ligament and align the distal opening of the vaginal probe with the target pelvic ligament; and (f) Obtaining three-dimensional coordinates of the distal opening end of the vaginal probe and the target ligament to determine the path from the distal opening of the vaginal probe to the target pelvic ligament.

18. The method according to claim 17, for a transvaginal approach, further using the anchoring device of claim 2, comprising the following steps: (a') Extending a needle having a hollow lumen through 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 by the pusher wire to release only the distal anchor from the needle into the target pelvic ligament; (d') Withdrawing the needle to place its tip within the vaginal cavity; (e’) Pushing the proximal anchor by the pusher wire to release the proximal anchor from the needle into the vaginal cavity; and (f') Removing one or more pulley wires, the pusher wire, the needle, and the vaginal probe.

19. The method according to claim 18, further comprising one or more of the following steps: Confirming the engagement of the distal anchor with the pelvic ligament by using medical imaging or gently pulling one or more pulley wires; and Confirming the engagement of the proximal anchor with the vaginal wall by using medical imaging or gently pulling one or more pulley wires.

20. The method according to claim 17, for a subcutaneous method, further using the anchoring device of claim 2, comprising the following steps: (a”) Obtaining three-dimensional coordinates of the subcutaneous skin site by medical imaging to estimate the needle path from the subcutaneous skin site through the target ligament to the distal opening of the vaginal probe, including the distance and angle of needle navigation; (b”) Inserting a needle having a hollow lumen from the subcutaneous site to pass through the target ligament and the vaginal wall into the distal opening 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 by the pusher wire to release only the distal anchor of the retainer from the needle into the vaginal cavity; (e”) Withdrawing the needle and placing its tip at the target ligament; (f”) Pushing the proximal anchor of the retainer by the pusher wire to release the proximal anchor from the needle into the target ligament; and (g”) Removing one or more pulley wires, the pusher wire, the needle, and the vaginal probe.

21. The method according to claim 20, further comprising one or more of the following steps: The engagement of the distal anchor with the vaginal wall is confirmed by using a medical image or gently pulling one or more pulley wires; The engagement of the proximal anchor with the target ligament is confirmed by using medical imaging or gently pulling one or more pulley wires.

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

Images