Vaginal orthopedic method and device for pelvic support, post-operative and post-partum healing

Abstract

This invention describes various embodiments of a vaginal orthopedic system, method, and apparatus for pelvic support and postoperative and postpartum healing. In one embodiment, a vaginal orthopedic apparatus is disclosed, comprising: a main body portion including: a posterior surface and an anterior surface directly opposite the posterior surface; an indwelling feature connected to the main body portion at a lower end; wherein the indwelling feature includes a wall having an outer surface and an inner surface, the inner surface defining an opening of a predetermined diameter; wherein the indwelling feature includes a plurality of shoulder elements, each of the plurality of shoulder elements connecting the indwelling feature to the main body portion.

Description

Technical Field

[0001] This invention relates to a vaginal orthopedic method and apparatus, and more specifically, to a vaginal orthopedic method and apparatus for pelvic support and postoperative and postpartum healing. Background Technology

[0002] Pelvic organ prolapse (POP) is the bulging or herniation of one or more pelvic organs into or out of the vagina. The lifetime risk of developing POP is 30-50%. 2-4% of women will experience symptoms. In the United States, approximately 300,000 women undergo surgery each year to correct POP.

[0003] Currently, surgical methods for resolving POP involve autologous tissue repair of vaginal apex prolapse, which can be mainly classified as sacrospinous ligament fixation or uterosacral ligament suspension.

[0004] Sacrospinous ligament fixation (SSLF): The vaginal apex is suspended from the vaginal stump to the right sacrospinous ligament via an extraperitoneal approach using sutures.

[0005] Uterosacral ligament suspension (USLS): The vaginal tip is suspended from the vaginal stump to the bilateral uterosacral ligaments via sutures along the pelvic sidewalls via the intraperitoneal (intra-abdominal) peritoneum.

[0006] POP is often a recurrent problem. The best trial (Barber MD, Brubaker L, Burgio KL et al., Comparison of two transvaginal surgical methods and perioperative behavioral therapy for vaginal apex prolapse: Best randomized trials. JAMA. 2014;311(10):1023–1034. doi:10.1001 / jama.2014.1719) and subsequent studies (Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle) and its follow-up studies (Jelovsek JE, Barber MD, Brubaker L, Norton P, Gantz M, Richter HE, Weidner A, Menefee S, Schaffer J, Pugh N, Meikle) have been shown to be a leading indicator of recurrent vaginal apex prolapse. S;NICHD Pelvic Floor Disorders Network. Effects of uterosacral ligament suspension versus sacrospinous ligament fixation with or without perioperative behavioral therapy on surgical outcomes and prolapse symptoms at 5 years in a best-in-class randomized clinical trial of uterosacral ligament suspension versus sacrospinous ligament fixation with or without perioperative behavioral therapy for pelvic organ vaginal prolapse. JAMA. 2018 April 17; 319(15): 1554-1565. doi: 10.1001 / jama. 2018.2827. PMID: 29677302; PMCID: PMC5933329) found a 5-year reoperation rate of 8-11.9%. The highest recurrence rate was found in the anterior vaginal wall or “cystocele”. This may be because the posterior deviation of the vaginal long axis of the pelvic ligaments results in more absolute intra-abdominal pressure being applied to the anterior vaginal wall.

[0007] Current postoperative care standards include:

[0008] Reduce activity for 2 weeks, and then slowly resume normal activity over 6-12 weeks.

[0009] Pelvic rest for 6-12 weeks

[0010] Low-dose estrogen cream 1-2 times per week

[0011] Do not bathe or soak in water for the first 4-6 weeks after surgery.

[0012] Postoperative tissue healing includes four stages:

[0013] Stage 1: Inflammation

[0014] Phase 2: Proliferation

[0015] Phase 3: Reshaping

[0016] Stage 4: Maturity

[0017] Resuming normal activity at the start of the remodeling phase can prematurely burden developing type 1 collagen with increased load, subsequently leading to disordered or inadequate healing. In orthopedic literature, decompression orthoses can promote healing of severe wounds by relieving pressure and restricting movement, which would otherwise worsen the condition and slow healing.

[0018] In cases of postoperative POP recovery, adequate physical support or similar orthopedic interventions that provide support during the transition from the proliferative phase to the remodeling phase can allow for the formation of better-aligned type 1 collagen, resulting in more durable repairs and a lower chance of recurrence.

[0019] Previously, vaginal meshes had been used to help further regulate autologous tissue repair or reduce the rate of repeat surgery, but due to negative secondary effects, mesh kits have been banned in some jurisdictions, including the United States.

[0020] Estrogen creams have also been proposed as a postoperative treatment to regulate wound healing, but a recent study by Rahn et al. (Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative vaginal estrogen as adjunctive therapy for autologous tissue vaginal apex prolapse repair: a randomized clinical trial. JAMA. 2023;330(7):615–625. doi:10.1001 / jama.2023.12317) showed that women randomly assigned to receive perioperative vaginal estrogen did not experience improved surgical success rates.

[0021] Therefore, there are currently no proactive or prospective, complementary (for surgery) methods to regulate the healing process after POP surgery, childbirth, etc. Therefore, there may be a need for vaginal orthopedic systems, methods, and devices for postoperative healing following vaginal reconstruction surgery for pelvic organ prolapse (POP).

[0022] This background information is provided to reveal information that the applicant deems potentially relevant. It is not necessarily intended, nor should it be construed, as an admission that any of the above information constitutes part of prior art or forms part of general common sense in related art. Summary of the Invention

[0023] The following is a simplified summary of the general inventive concepts described herein to provide a basic understanding of some aspects of the invention. This summary is not a broad overview of the invention. It is not intended to limit the key or essential elements of the embodiments of the invention, nor is it intended to depict a scope beyond what is expressly or implied by the following description and claims.

[0024] There is a need for vaginal orthopedic systems, methods, and devices for postoperative healing. There may also be a need for vaginal orthopedic systems, methods, and devices that are easy to insert and remove. There may also be a need for vaginal orthopedic systems, methods, and devices that can be customized to suit specific users.

[0025] According to one aspect of the invention, a vaginal orthopedic device is described, comprising: a main body portion having a posterior surface and a front surface opposite to the posterior surface, the main body portion including an anterior curve; and an indwelling feature extending outward from the posterior surface, the indwelling feature defining an opening therethrough, characterized in that the vaginal orthopedic device is configured to switch between a folded configuration and an unfolded configuration.

[0026] In some embodiments, one or more dimensions of the main body portion and / or the indwelling feature are related to one or more anatomical values ​​of the user of the vaginal orthopedic device.

[0027] In some embodiments, one or more of the dimensions include curvature, length, and width.

[0028] In some embodiments, one or more of the anatomical values ​​include vaginal opening width, genital slit, total vaginal length, or a combination thereof.

[0029] In some embodiments, the length of the front curve is between approximately 1 cm and 5 cm.

[0030] In some embodiments, the length of the front curve is approximately 2 cm.

[0031] In some embodiments, the body portion further includes a seam extending along its longitudinal axis.

[0032] In some embodiments, the main body portion is configured to fold and unfold around the seam to switch between the folded configuration and the unfolded configuration.

[0033] In some embodiments, the diameter of the indwelling feature is sized such that the vaginal orthopedic device is configured to be indwelled in the user's vaginal canal.

[0034] In some embodiments, the vaginal orthopedic device further includes: a plurality of shoulder elements, the plurality of shoulder elements extending from the body portion toward the indwelling feature.

[0035] In some embodiments, each of the plurality of shoulder elements includes a triangular body, wherein a first side of the triangular body is connected to the outer edge of the body portion, and a second side of the triangular body is connected to the upper surface of the retention feature.

[0036] In some embodiments, the indwelling feature may be folded toward the rear surface of the body portion to convert the opening into a plurality of slits.

[0037] In some embodiments, each of the plurality of slits is sized to accommodate the arm of the applicator device for inserting the vaginal orthopedic device into the user's vaginal canal.

[0038] In some embodiments, when a tensile force is applied to the indwelling feature, the indwelling feature is configured to fold toward the rear surface of the body portion to reduce the lateral diameter of the indwelling feature.

[0039] In some embodiments, the width of the indwelling feature is related to the width of the vaginal opening of the user of the vaginal orthopedic device.

[0040] In some embodiments, the length of the indwelling feature is related to the genital cleft value of the user of the vaginal orthopedic device.

[0041] In some embodiments, the vaginal orthopedic device is formed of a biocompatible material.

[0042] In some embodiments, the biocompatible material comprises silicone grease, biocompatible thermoplastic polyurethane, polylactic acid, or a combination thereof.

[0043] In some embodiments, the vaginal orthopedic device is formed of a flexible material, a semi-rigid material, a rigid material, or a combination thereof.

[0044] According to another aspect of the invention, a vaginal orthopedic device is described comprising: a curved body portion curved in a first direction; and an indwelling feature extending outward from the curved body portion in the first direction, the indwelling feature defining an opening therethrough, characterized in that the vaginal orthopedic device is switchable between a folded configuration and an unfolded configuration, in which the vaginal orthopedic device can be inserted into and removed from a user's vaginal canal, and in the unfolded configuration, the vaginal orthopedic device can be left in the user's vaginal canal and configured to apply force to the walls of the vaginal canal to treat one or more conditions.

[0045] In some embodiments, one or more dimensions of the curved body portion and / or the indwelling feature are related to one or more anatomical values ​​of the user of the vaginal orthopedic device.

[0046] In some embodiments, one or more of the dimensions include curvature, length, and width.

[0047] In some embodiments, one or more of the anatomical values ​​include vaginal opening width, genital slit, total vaginal length, or a combination thereof.

[0048] In some embodiments, the curved body portion further includes a seam extending along the longitudinal axis of the curved body portion.

[0049] In some embodiments, when the vaginal orthopedic device switches between a folded configuration and an unfolded configuration, the curved body portion is configured to fold and unfold along the seam.

[0050] In some embodiments, the vaginal orthopedic device further includes a plurality of shoulder elements extending from the curved body portion toward the indwelling feature, wherein the indwelling feature is connected to the curved body portion via the plurality of shoulder elements.

[0051] In some embodiments, each of the plurality of shoulder elements includes a triangular body, wherein a first side of the triangular body is connected to the outer edge of the body portion, and a second side of the triangular body is connected to the upper surface of the wall of the retention feature.

[0052] In some embodiments, in the folded configuration, the retention feature is configured to fold to convert the opening into a plurality of slits.

[0053] In some embodiments, each of the plurality of slits is sized to accommodate the arm of the applicator device for inserting the vaginal orthopedic device into the user's vaginal canal.

[0054] In some embodiments, when a tensile force is applied to the indwelling feature, the indwelling feature is configured to fold to reduce the diameter of the opening.

[0055] In some embodiments, the width of the indwelling feature is related to the width of the vaginal opening of the user of the vaginal orthopedic device.

[0056] In some embodiments, the length of the indwelling feature is related to the genital cleft value of the user of the vaginal orthopedic device.

[0057] According to another embodiment of the present invention, a system is disclosed comprising: a vaginal orthopedic device configured to switch between a folded configuration and an unfolded configuration; and a dispenser configured to be coupled to the vaginal orthopedic device to deliver the vaginal orthopedic device into a user's vaginal canal when the vaginal orthopedic device is in the folded configuration, wherein the dispenser is configured to convert the vaginal orthopedic device from the folded configuration to the unfolded configuration within the vaginal canal.

[0058] In some embodiments, the applicator includes: an outer portion including a distal end having a plurality of arms configured to engage with the vaginal orthopedic device when the vaginal orthopedic device is in the folded configuration, the outer portion defining an interior; and an inner portion at least partially disposed within the interior, the inner portion being configured to slide relative to the outer portion along its longitudinal axis.

[0059] In some embodiments, when the vaginal orthopedic device is engaged with the applicator, the inner portion is configured to slide and apply force to the vaginal orthopedic device to disengage the vaginal orthopedic device from the applicator.

[0060] In some embodiments, the vaginal orthopedic device includes: a curved body portion; and an indwelling feature extending from the curved body portion, the indwelling feature defining an opening therethrough.

[0061] In some embodiments, the vaginal orthopedic device may be folded and unfolded along its longitudinal axis to switch between the folded configuration and the unfolded configuration, wherein, in the folded configuration, the opening is converted into a plurality of slits configured to receive a plurality of the arms of the applicator.

[0062] According to another aspect of the invention, a method is disclosed comprising: folding a vaginal orthopedic device into a folded configuration; inserting the vaginal orthopedic device into a user's vaginal canal; and unfolding the vaginal orthopedic device in the vaginal canal to change the vaginal orthopedic device from the folded configuration to the unfolded configuration, such that the vaginal orthopedic device remains in the vaginal canal, the unfolded vaginal orthopedic device exerting force on the wall of the vaginal canal to treat one or more conditions of the user.

[0063] In some embodiments, the method further includes engaging the vaginal orthopedic device in the folded configuration with the applicator device before insertion, wherein the insertion includes inserting the vaginal orthopedic device into the user's vaginal canal via the applicator device.

[0064] In some embodiments, coupling the vaginal orthopedic device to the applicator device includes inserting a plurality of arms of the applicator device into a plurality of corresponding slits defined by the vaginal orthopedic device.

[0065] In some embodiments, deploying the vaginal orthopedic device includes sliding a first portion of the applicator device relative to the plurality of arms to apply force to the vaginal orthopedic device and disengage the vaginal orthopedic device from the plurality of arms of the applicator.

[0066] In some embodiments, the method further includes: converting the vaginal orthopedic device from the unfolded configuration to the folded configuration within the vaginal canal; and removing the vaginal orthopedic device from the vaginal canal.

[0067] In some embodiments, converting the vaginal orthopedic device includes applying a pulling force to the vaginal orthopedic device.

[0068] Other aspects, features, and / or advantages will become more apparent from the following non-limiting description of specific embodiments given by way of example only with reference to the accompanying drawings. Attached Figure Description

[0069] Several embodiments of the present invention will be provided by way of example only with reference to the accompanying drawings, wherein:

[0070] Figure 1 Showing a front view of a vaginal orthopedic device according to one embodiment;

[0071] Figure 2 A perspective view of a vaginal orthopedic device according to one embodiment is shown;

[0072] Figure 3 A side view of a vaginal orthopedic device according to one embodiment is shown;

[0073] Figure 4A Showing a bottom view of an applicator device for unfolding a folded vaginal orthopedic device according to one embodiment;

[0074] Figure 4B Showing a top view of an applicator device for unfolding a folded vaginal orthopedic device according to one embodiment;

[0075] Figure 4C Showing a front view of an applicator device in a receiving configuration according to one embodiment;

[0076] Figure 5A Showing a bottom view of the indwelling element according to one embodiment;

[0077] Figure 5B Showing a bottom view of the indwelling element according to another embodiment;

[0078] Figure 6 Showing a side cross-sectional view of a pelvic floor anatomical model having an inserted vaginal orthotics device in use and in an unfolded configuration according to one embodiment;

[0079] Figure 7A A perspective view showing an embodiment of a cage-shaped main body portion of a vaginal orthopedic device according to one embodiment;

[0080] Figure 7BA perspective view showing an embodiment of a cage-shaped main body portion of a vaginal orthopedic device according to another embodiment;

[0081] Figure 7C A perspective view showing an embodiment of a cup-shaped main body portion of a vaginal orthopedic device according to one embodiment; and

[0082] Figure 7D A perspective view showing an embodiment of a vaginal orthopedic device with a diving board-shaped main body according to one embodiment.

[0083] The elements in several of the accompanying figures are shown for simplicity and clarity and are not necessarily depicted to scale. For example, the dimensions of some elements may be exaggerated relative to others to facilitate understanding of the various currently disclosed embodiments of the invention. Furthermore, common but well-understood elements that are useful or necessary in commercially viable embodiments are generally not depicted to provide a less obstructed view of these various embodiments of the invention. Detailed Implementation

[0084] Various embodiments and aspects of this specification will be described with reference to the details discussed below. The following descriptions and figures are illustrative of this specification and should not be construed as limiting it. Numerous specific details are described to provide a thorough understanding of the various embodiments of this specification. However, in some cases, well-known or conventional details have not been described to provide a concise discussion of the embodiments described herein.

[0085] Furthermore, numerous specific details are set forth to provide a thorough understanding of the embodiments described herein. However, those skilled in the art will understand that the embodiments described herein can be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the embodiments described herein.

[0086] In this specification, an element may be described as "configured to" perform one or more functions or "configured for" such functions. Generally, an element configured to perform or configured for performing a function is enabled to perform said function, or is adapted to perform said function, or is modified to perform said function, or is operable to perform said function, or is otherwise capable of performing said function.

[0087] When introducing elements of aspects of the invention or examples thereof, the article is intended to indicate the presence of one or more of the stated elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that additional elements may be present in addition to those listed. The term “exemplary” is intended to mean “example.” The phrase “one or more of the following: A, B, and C” means “at least one A and / or at least one A and / or at least one C.”

[0088] The following disclosure relates to methods and apparatus for vaginal orthopedics and / or pessaries, which preferably provide a non-surgical alternative for the treatment of pelvic organ prolapse and relieve symptoms of pelvic laxity. The apparatus and methods disclosed herein are suitable for individuals with vaginal-pelvic anatomy who require postoperative pelvic organ support.

[0089] The present invention relates to vaginal orthopedic devices and methods for use in the postoperative stage for patients undergoing POP surgery, which are preferably safer and provide the same or improved anatomical outcomes in the patient's anterior chamber compared to current industry standards that only allow pelvic rest and mild activity, as well as prior art pessaries and vaginal orthopedic devices.

[0090] The devices and methods disclosed in this article can be used preoperatively, for prolapse or vaginal reconstruction surgery, as a preventative measure to avoid surgery, for patients with early pelvic organ prolapse, and postpartum to provide support during postpartum healing.

[0091] The disclosed device can be used for postoperative support of pelvic organs. Use of the disclosed method and device during the postoperative tissue remodeling / healing phase in patients following pelvic organ prolapse surgery may include intravaginal placement and use of the device starting 2 weeks postoperatively. Typically, when the device is deployed within the patient's vaginal canal, it rests on the patient's levator palpebrae superioris, close to absorbable sutures and maintaining contact with intact tissue.

[0092] The disclosed device is safe and preferably made of biocompatible and soft materials.

[0093] The embodiments disclosed herein are generally suitable for most patients to use comfortably inside the vagina, including those who have undergone vaginal reconstruction and perineal repair surgery: the device preferably does not extend beyond the vaginal opening or vaginal incision.

[0094] Preferably, the device disclosed herein is self-retaining and, through its retention feature, remains in the user's vagina under the intra-abdominal pressure generated during standard daily activities (sitting, standing, walking). Preferably, the device provides support to the user's anterior wall (e.g., Figure 6 (See description). The material is typically rigid enough to withstand intra-abdominal pressure, yet flexible enough to facilitate placement, folding / compression, and removal. The material can be soft, rigid, semi-rigid, or a combination thereof.

[0095] In one embodiment, the advantages of the invention lie in its compact / foldable size and easy-to-use applicator and method of administration, allowing patients of dexterity as determined by a clinician to easily insert and remove the device themselves. The patient can remove and clean the device daily.

[0096] The disclosed device is preferably foldable into a small-diameter shape, allowing for comfortable insertion into the user's vaginal canal. The disclosed device can be coupled (engaged) with an applicator and / or adapter to aid in insertion.

[0097] Preferably, the exposed device automatically folds when pulled out of the user's vagina to make removal easy and safe.

[0098] In some embodiments, the disclosed apparatus and methods can be customized based on patient measurements (e.g., length, width, thickness, or other cleft region indicators).

[0099] Figure 1 Showing a front view of a vaginal orthopedic device 100 according to an embodiment.

[0100] The vaginal orthopedic device 100 includes a main body portion 104. The main body portion 104 includes a posterior surface 112 and an anterior surface directly opposite the posterior surface (e.g., ...). Figure 2 and Figure 3 (As shown in the diagram). The indwelling feature 110 is coupled to the distal or lower end 124 of the body portion 104. The indwelling feature 110 includes a wall 114 having an outer surface 118 and an inner surface 116, the inner surface defining an opening of a predetermined diameter 120 (as shown in the diagram). Figure 2 (As shown). The indwelling feature 110 is coupled to the body portion 104 by a plurality of shoulder elements 108 having a fin-like triangular shape, two of which are shown in this embodiment. The upper surface of the indwelling feature 110 is coupled to the outer edge of the body portion 104 on both sides of the distal / lower end 124 of the body portion 104.

[0101] In the illustrated embodiment, the device 100 is in an unfolded configuration 102. In the unfolded configuration, the device 100 can be inserted into the user's vaginal canal in its folded configuration so that it remains on the user's levator ani plate in its unfolded configuration. When unfolded, the predetermined diameter 120 of the opening 206 of the indwelling feature 110 holds the device in position within the user's vaginal canal.

[0102] In the illustrated embodiment, the main body 104 has a "diving board" shape, slightly curved inward toward the rear surface 112 at the top 122, and relatively flat at the bottom 124.

[0103] The illustrated device 100 comprises a flexible, bendable (soft or semi-rigid) and biocompatible material, such as silicone. In some embodiments, the material may be rigid. The material may include, but is not limited to, biocompatible thermoplastic polyurethane (TPU), polylactic acid (PLA), and other biocompatible polymers and / or plastics. Other materials known in the art and used in the development of vaginal pessaries and / or orthopedic devices may also be used to develop device 100. The material is preferably easy to clean.

[0104] The main body 104 includes a seam 106 extending along the length of the main body.

[0105] Figure 2 A perspective view of the vaginal orthopedic device 100 is shown. In this view, the front surface of the main body portion 104 is more readily visible.

[0106] When the vaginal orthopedic device 100 is placed inside the user's vaginal canal, the anterior surface 202 is usually in direct contact with the user's anterior wall, providing support for organs, sutures, and sutures, while reducing the impact of intra-abdominal pressure.

[0107] As can be seen in this view, the indwelling feature 110 includes an inner surface 116 that defines an opening 206 of a predetermined diameter 120. The predetermined diameter 120 is preferably large enough to hold the device 100 in position within the user's vaginal canal.

[0108] Figure 3 A side view of the vaginal orthopedic device 100 is shown. In this view, the shape of the main body portion 104 is more readily apparent. In the "diving board" shape, the main body portion 104 includes a front curve 302 at its top. The length of curve 302 is typically around 2 cm, curving towards the rear surface 112. The exact dimensions may vary and can range from 1 to 5 cm. In the illustrated "diving board" shaped embodiment, the lower end 124 is not curved and is generally flat.

[0109] The device is compatible with the anatomy of different users, including patients who have had their cervix removed, as well as patients with a cervix and / or uterus.

[0110] The dimensions and features of the vaginal orthopedic device 100 (i.e., the main body, placement features, etc.) are typically determined based on patient measurements or the average of patient measurements. Patient measurements may include, for example, vaginal opening width (IW), genital cleft (gh), and total vaginal length (TVL). Additional patient measurements or specific anatomical values ​​may also be used to determine the dimensions of the device 100. Dimensions may include curvature, length, and width.

[0111] For example, in a patient-customized device 100, the indwelling feature 110 may have a width determined by association with measurements of IW, a length determined by association with measurements of the genital cleft (gh), and a thickness determined based on ease of use in balancing indwelling and insertion / removal. The main body portion 104, including a diving board shape, may have a height determined by association with measurements of TVL, and the angular curvature may be determined based on specific anatomical values ​​of the patient.

[0112] By measuring the user's anatomical structure, precise dimensions can be customized for the user. Various methods for measuring a user's vaginal anatomy are known in the art, including those developed by the owner of this application, such as the method taught in PCT / CA2018 / 000173, the contents of which are hereby incorporated by reference.

[0113] Figure 4A Showing a bottom view of an applicator device 402 for deploying a vaginal orthopedic device (folded (contracted) configuration 400) within a user's vaginal canal according to an embodiment.

[0114] The applicator device 402 includes: a receiving configuration 418 (shown) and an unfolding configuration (not shown); an outer portion 414 including two or more indwelling feature receiving arms 410, the indwelling feature receiving arms being sized and configured to insert into the indwelling feature 110 of the vaginal orthopedic device in the folded (contracted) configuration 404; and a hollow center 416 for receiving an inner portion 412, the inner portion having a generally cylindrical shape. The receiving configuration is preferably characterized in that the inner portion 412 extends outward from the upper end 442 of the hollow center 416 of the inner portion 412. The unfolding configuration is characterized in that when the inner portion 412 is subjected to external pressure (force) applied thereto (e.g., a user's thumb or finger), it is pushed to the upper end 446 of the hollow center 416 (e.g., when the inner portion 412 is subjected to external pressure (force) applied thereto (e.g., a user's thumb or finger) (e.g., when the user's thumb or finger is applied thereto), it is pushed to the upper end 446 of the hollow center 416 (e.g., when the user's thumb or finger is applied thereto). Figure 4C As shown in the figure, the upper end 446 is directly opposite the upper end 442.

[0115] The inner portion 412 then applies pressure (force) to both the indwelling feature 110 of the vaginal orthopedic device 100 and the inner side 420 of the indwelling feature receiving arm 410. The pressure applied to the indwelling feature 110 pushes the device upward and disengages it from the applicator device 402. In the folded (retracted) configuration 404, the vaginal orthopedic device and applicator can be inserted into the user's vaginal canal. The indwelling feature 110 helps to position the user's levator ani plate upon contact. The user can then unfold and disengage the device by pushing the inner portion, thereby forcing the vaginal orthopedic device 100 out of the applicator device 402, switching it from the folded (retracted) configuration 404 to the unfolded configuration 102 within the vaginal canal.

[0116] Figure 4B Showing a top view of an applicator device 402 for deploying a vaginal orthopedic device (folded (contracted) configuration 400) within a user's vaginal canal according to an embodiment.

[0117] In the folded (retracted) configuration 404, the dispenser locking element 408 on the inner surface 116 of the indwelling feature folds into a semi-opening 406 at the rear surface of the lower end 124 of the body portion 104, leaving a slit 448 on the inner surface for insertion of the receiving arm 410 of the indwelling feature. The body portion 104 folds along the length of the seam 424, shown from the front surface in this figure.

[0118] Figure 4C Showing a front view of the dispenser device 402 in receiving configuration 418. In receiving configuration 418, the inner portion 412 extends outward from the hollow center 416 at the upper end 442.

[0119] The unfolded configuration is characterized in that when the inner part 412 is subjected to external pressure (force) applied thereto (such as a user's thumb or finger), the inner part 412 is pushed to the upper end 446 of the hollow center 416, which is directly opposite to the upper end 442.

[0120] Figure 5A and Figure 5B A bottom view showing embodiments of indwelling elements 500a and 500b. Indwelling elements 500a and 500b have slightly different dimensions, with indwelling element 500b having a slightly larger thickness 506b and a shorter length 504b to better fit the dispenser device 402.

[0121] The indwelling element 500a has a thickness 506a, which is fixed based on the size of the dispenser, to help retain the indwelling feature on the dispenser before deployment. Similarly, the indwelling element 500a has a fixed length 504a based on the size of the dispenser.

[0122] The dispenser locking element 408 between the indwelling element 500a and the length 504b has slightly different dimensions: the dispenser locking element 502b is shorter along the horizontal axis than the dispenser locking element 502a, but protrudes further downward from the indwelling feature 110. The dispenser locking element 502b is thus designed to better fit the dispenser device 402 by providing more gripping material to the indwelling feature receiving arm 410. When the device 100 is in its folded (retracted) configuration 404, the dispenser locking element 408 folds into the semi-opening 406 and protrudes downward, resting on the inner portion 412 of the dispenser device 402, which pushes the dispenser locking element 408 upward to release the device 100 from its position on the dispenser device 402.

[0123] Figure 6 A side cross-sectional view of a pelvic floor anatomical model having an inserted vaginal orthopedic device 606 in use and in an deployed configuration is shown.

[0124] The vaginal orthopedic device 100 can be deployed within the user's vagina to redistribute weight from the user's anterior wall to their levator ani plate, thereby providing the user with increased internal support and counteracting and distributing the increased intra-abdominal pressure. This increased support aids in the user's recovery after vaginal reconstruction surgery, wherein the anterior surface 202 of the device 100 supports sutures and / or stitches from the surgery. In other embodiments, the device 100 can provide support for prolapsed organs, including in patients with pelvic organ prolapse. The device can be used as a preventative measure for patients with early (stage 2) prolapse, providing support to the patient's anterior wall and preventing the prolapse from worsening. Alternatively, it can be used for patients recovering from pelvic organ prolapse surgery to reduce the risk of recurrence by supporting the anterior wall and redistributing weight. The device can be used by users recovering postpartum as a postpartum healing method by providing support to the user's pelvic organs and redistributing the load to the user's levator ani plate.

[0125] In the illustrated embodiment, the anterior surface 202 is a smooth or solid surface, preferably in contact with the anterior wall 620. The anterior surface 202 provides support for wound healing (i.e., for patients with vaginal sutures / stitches) without snagging on the sutures. In another embodiment, the anterior surface 202 has a wire or truss structure, forming a support, mesh, or wire surface 202. This may be preferred for patients who only require posterior, vaginal apex, or perineal support (rather than additional support for minimizing / relieving stress on the sutures) (e.g., postpartum women). The vaginal orthopedic device 100 can support the urethra 626 and / or bladder 616, reducing or minimizing bladder emptying incompletely—in the illustrated embodiment, the flat anterior surface 202 provides support for suspending the urethra 626 (and preventing it from bending) and allows for more complete urination. The device 100 can be used to help straighten the patient's urethra 626 to support urination.

[0126] In the illustrated embodiment, during use, the rear surface 112 is oriented toward the rear of the user / patient's body, and the front surface 202 is in contact with the patient's anterior wall 620.

[0127] According to another embodiment, in use, the device can be "flipped" (so that the front surface 202 faces the back of the user's body) to provide additional rectal and / or perineal support, which can relieve symptoms of outlet obstruction constipation in patients—diving board flat surface—that is, the front surface 302 will be oriented toward the posterior wall 628 and / or the patient's rectum 618, thereby minimizing the retention of feces in the distal anorectal region.

[0128] In the proposed embodiment, the shape is adapted for cases without a cervix. In patients with a cervix, the shape can be adapted to fit the cervix. For patients with a cervix, this embodiment will be located in the posterior fornix, which will provide a certain gap between the anterior curve 302 of the tip 122 and the anterior wall near the cervix, a placement comparable to that of conventional prior art pessaries. Further gaps between the tip 122 and the anterior wall can be achieved if the anterior surface 202 of the device 100 is positioned in direct contact with the anterior wall and the tip is curved. The gap between the tip of the device 100 and the anterior wall near the cervix or vaginal cuff helps to avoid damaging any sutures or stitches on the anterior wall and vaginal stump.

[0129] The embodiments disclosed in this invention are generally suitable for most patients to use comfortably inside the vagina, including those who have undergone vaginal reconstruction surgery and perineal repair surgery. Device 100 preferably does not extend beyond the vaginal opening or vaginal incision. Vaginal orthopedic device 100 is preferably positioned with no material within the patient's sensory area, remaining above the levator ani muscle.

[0130] When deployed in the body in the deployment configuration 102, the vaginal orthopedic device 100 is able to remain in place by virtue of the indwelling feature 110 and its predetermined diameter 120.

[0131] For example, device 100 can be removed by a user or a healthcare professional. Device 100 is removed by pulling it out of vaginal canal 622 through indwelling feature 110. A user can grasp and pull the indwelling feature 110 with their fingers, causing the vaginal orthopedic device 100 in its unfolded configuration to fold into a folded (contracted) configuration 404 for easy removal. The opening 206 of the indwelling feature 110 can act as a loop – the user can grasp the loop by hooking their fingers around it, or by inserting another applicator device into the opening 206 to pull the vaginal orthopedic device 100 downwards, causing it to fold into a folded (contracted) configuration 404 for easy removal from vaginal canal 622.

[0132] Figure 7A -D shows various embodiments of the main body 700 of the vaginal orthopedic device.

[0133] Figure 7A This diagram shows a perspective view of cage-shaped main body portion 702 and cage-shaped main body portion 722, a front view of cage-shaped main body portion 720, and a bottom view of cage-shaped main body portion 720 according to one embodiment.

[0134] Figure 7B This diagram shows a perspective view of a cage-shaped main body portion 708, a front view of a cage-shaped main body portion 726, and a bottom view of a cage-shaped main body portion 728, according to another embodiment.

[0135] In the embodiment of the cage-shaped main body, the top 122 is slightly rounded.

[0136] The cage / mesh structure with openings can be defined as having a cylindrical body shape and a round or flat lower end 124.

[0137] In some embodiments, cage-shaped body portion 702 or cage-shaped body portion 708 may be used to fill the space in the vaginal cavity, thereby providing more support for the anterior wall.

[0138] Figure 7C A perspective view of the inner structure 704 and the outer structure 730 of the cup-shaped main body portion, and a bottom view of the cup-shaped main body portion 732, are shown according to one embodiment.

[0139] In this embodiment, the tip 122 is slightly rounded and further includes the tip 122.

[0140] The solid cup-shaped structure may be defined as having a generally cylindrical body shape and may further include an inner support element 714. The cup shape 704 may include a circular or flat lower end 124, which may be defined by a top opening 712.

[0141] Figure 7D This diagram shows a perspective view of a diving board shape 706 of a main body portion 700 according to one embodiment, a front view of a diving board shape 734, a side view of a diving board shape 736, and a rear view of a diving board shape 738.

[0142] The shape 706 of the diving board is defined by the top end 122 at an angle inward toward the bottom end 124, the angle being defined by the front curve 302, while the bottom end 124 is a generally flat surface 718.

[0143] The main body portion 700 (including, but not limited to, cage-shaped 702, cage-shaped 708, cup-shaped 704, and diving board-shaped 706) can be coupled to various embodiments of the indwelling feature 110 via a plurality of shoulder elements 108, typically at the lower end 124 of the main body portion.

[0144] Supplements such as Figure 4B The description of the vaginal orthopedic device indicates that when a pulling force is applied to the indwelling feature, the indwelling feature is configured to fold toward the posterior surface of the main body portion to reduce the lateral diameter of the indwelling feature.

[0145] While various embodiments are described herein for illustrative purposes, such description is not intended to limit the scope to these embodiments. Rather, the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents without departing from the embodiments, the general scope of which is defined by the appended claims. The data shown and described in detail herein are fully capable of achieving the above-described objectives of the invention and the presently preferred embodiments, and therefore represent the broad scope of the invention.

Claims

1. A vaginal orthopedic device, comprising: The main body portion has a rear surface and a front surface opposite to the rear surface, the main body portion including a front curve; as well as A retention feature, extending outward from the rear surface, defines an opening therethrough. The vaginal orthopedic device is configured to switch between a folded configuration and an unfolded configuration.

2. The vaginal orthopedic device according to claim 1, characterized in that, One or more dimensions of the main body and / or the indwelling feature are related to one or more anatomical values ​​of the user of the vaginal orthopedic device.

3. The vaginal orthopedic device according to claim 2, characterized in that, One or more of the dimensions include curvature, length, and width.

4. The vaginal orthopedic device according to claim 2, characterized in that, One or more of the anatomical values ​​include vaginal opening width, genital slit, total vaginal length, or a combination thereof.

5. The vaginal orthopedic device according to claim 1, characterized in that, The length of the front curve is between approximately 1 cm and 5 cm.

6. The vaginal orthopedic device according to claim 5, characterized in that, The length of the front curve is approximately 2 cm.

7. The vaginal orthopedic device according to claim 1, characterized in that, The main body further includes a seam extending along its longitudinal axis.

8. The vaginal orthopedic device according to claim 7, characterized in that, The main body is configured to fold and unfold around the seam, switching between the folded configuration and the unfolded configuration.

9. The vaginal orthopedic device according to claim 1, characterized in that, The diameter of the indwelling feature is set by a size setting so that the vaginal orthopedic device is configured to be indwelled in the user's vaginal canal.

10. The vaginal orthopedic device according to claim 1, characterized in that, It further includes a plurality of shoulder elements that extend from the body portion toward the retention feature.

11. The vaginal orthopedic device according to claim 10, characterized in that, Each of the plurality of shoulder elements includes a triangular body, wherein a first side of the triangular body is connected to the outer edge of the body portion, and a second side of the triangular body is connected to the upper surface of the retention feature.

12. The vaginal orthopedic device according to claim 1, characterized in that, The retention feature can be folded toward the rear surface of the main body to convert the opening into a plurality of slits.

13. The vaginal orthopedic device according to claim 12, characterized in that, Each of the plurality of slits is sized to accommodate the arm of the applicator device for inserting the vaginal orthopedic device into the user's vaginal canal.

14. The vaginal orthopedic device according to claim 1, characterized in that, When a tensile force is applied to the indwelling feature, the indwelling feature is configured to fold toward the rear surface of the body portion to reduce the lateral diameter of the indwelling feature.

15. The vaginal orthopedic device according to claim 1, characterized in that, The width of the indwelling feature is related to the width of the vaginal opening of the user of the vaginal orthopedic device.

16. The vaginal orthopedic device according to claim 1, characterized in that, The length of the indwelling feature is related to the reproductive cleft value of the user of the vaginal orthopedic device.

17. The vaginal orthopedic device according to claim 1, characterized in that, The vaginal orthopedic device is made of biocompatible materials.

18. The vaginal orthopedic device according to claim 17, characterized in that, The biocompatible material comprises silicone grease, biocompatible thermoplastic polyurethane, polylactic acid, or a combination thereof.

19. The vaginal orthopedic device according to claim 1, characterized in that, The vaginal orthopedic device is formed of flexible material, semi-rigid material, rigid material, or a combination thereof.

20. A vaginal orthopedic device, comprising: The main body portion is bent in a first direction; as well as A retention feature, extending outward from the curved body portion in the first direction, defines an opening therethrough. The vaginal orthopedic device is movable between a folded configuration and an unfolded configuration, in which the vaginal orthopedic device can be inserted into and removed from the user's vaginal canal, and in the unfolded configuration, the vaginal orthopedic device can be left in the user's vaginal canal and configured to apply force to the walls of the vaginal canal to treat one or more conditions.

21. The vaginal orthopedic device according to claim 20, characterized in that, One or more dimensions of the curved body portion and / or the indwelling feature are related to one or more anatomical values ​​of the user of the vaginal orthopedic device.

22. The vaginal orthopedic device according to claim 21, characterized in that, One or more of the dimensions include curvature, length, and width.

23. The vaginal orthopedic device according to claim 21, characterized in that, One or more of the anatomical values ​​include vaginal opening width, genital slit, total vaginal length, or a combination thereof.

24. The vaginal orthopedic device according to claim 20, characterized in that, The curved body portion further includes a seam extending along the longitudinal axis of the curved body portion.

25. The vaginal orthopedic device according to claim 24, characterized in that, When the vaginal orthopedic device switches between a folded configuration and an unfolded configuration, the curved main body portion is configured to fold and unfold along the seam.

26. The vaginal orthopedic device according to claim 20, characterized in that, It further includes a plurality of shoulder elements extending from the curved body portion toward the retention feature, wherein the retention feature is connected to the curved body portion via the plurality of shoulder elements.

27. Claim error! The vaginal orthopedic device described in the reference information was not found, characterized in that, Each of the plurality of shoulder elements includes a triangular body, wherein a first side of the triangular body is connected to the outer edge of the body portion, and a second side of the triangular body is connected to the upper surface of the wall of the retention feature.

28. The vaginal orthopedic device according to claim 20, characterized in that, In the folded configuration, the retention feature is configured to fold to convert the opening into a plurality of slits.

29. The vaginal orthopedic device according to claim 28, characterized in that, Each of the plurality of slits is sized to accommodate the arm of the applicator device for inserting the vaginal orthopedic device into the user's vaginal canal.

30. The vaginal orthopedic device according to claim 29, characterized in that, When a tensile force is applied to the indwelling feature, the indwelling feature is configured to fold to reduce the diameter of the opening.

31. The vaginal orthopedic device according to claim 20, characterized in that, The width of the indwelling feature is related to the width of the vaginal opening of the user of the vaginal orthopedic device.

32. The vaginal orthopedic device according to claim 20, characterized in that, The length of the indwelling feature is related to the reproductive cleft value of the user of the vaginal orthopedic device.

33. A system comprising: The vaginal orthopedic device is configured to move between a folded configuration and an unfolded configuration; as well as A dispenser configured to couple with the vaginal orthopedic device to deliver the vaginal orthopedic device into the user's vaginal canal when the vaginal orthopedic device is in the folded configuration within the vaginal canal. The applicator is configured to convert the vaginal orthopedic device from the folded configuration to the unfolded configuration within the vaginal canal.

34. The system according to claim 33, characterized in that, The applicator includes: An outer portion, including a distal end having a plurality of arms configured to engage with the vaginal orthopedic device when the device is in the folded configuration, the outer portion defining the interior; and An inner portion, which is at least partially disposed within the interior, is configured to slide relative to the outer portion along its longitudinal axis.

35. The system according to claim 34, characterized in that, When the vaginal orthopedic device is engaged with the applicator, the inner portion is configured to slide and apply force to the vaginal orthopedic device to disengage the vaginal orthopedic device from the applicator.

36. The system according to claim 34, characterized in that, The vaginal orthopedic device includes: The main body of the curved section; and An indentation feature extends from the curved body portion and defines an opening therethrough.

37. The system according to claim 36, characterized in that, The vaginal orthopedic device is foldable and unfoldable along its longitudinal axis to switch between the folded configuration and the unfolded configuration, wherein, in the folded configuration, the opening is converted into a plurality of slits configured to receive a plurality of the arms of the applicator.

38. A method comprising: Fold the vaginal orthopedic device into a foldable configuration; The vaginal orthopedic device is inserted into the user's vaginal canal; as well as The vaginal orthopedic device is unfolded within the vaginal canal to change the vaginal orthopedic device from the folded configuration to the unfolded configuration, such that the vaginal orthopedic device remains in the vaginal canal, and the remaining vaginal orthopedic device applies force to the wall of the vaginal canal to treat one or more conditions of the user.

39. The method according to claim 38, characterized in that, This further includes engaging the vaginal orthopedic device, in its folded configuration, with the applicator device before insertion. The insertion includes inserting the vaginal orthopedic device into the user's vaginal canal via the delivery device.

40. The method according to claim 39, characterized in that, Coupling the vaginal orthopedic device to the applicator device includes inserting a plurality of arms of the applicator device into a plurality of corresponding slits defined by the vaginal orthopedic device.

41. The method according to claim 40, characterized in that, Deploying the vaginal orthopedic device includes sliding a first portion of the applicator relative to a plurality of the arms to apply force to the vaginal orthopedic device and disengage the vaginal orthopedic device from the plurality of the arms of the applicator.

42. The method according to claim 38, characterized in that, Further includes: The vaginal orthopedic device is converted from the unfolded configuration to the folded configuration within the vaginal canal; as well as Remove the vaginal orthopedic device from the vaginal canal.

43. The method according to claim 42, characterized in that, Converting the vaginal orthopedic device includes applying a pulling force to the vaginal orthopedic device.

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