Vaginal orthosis methods and devices for pelvic support and post-surgical and post-partum healing

Abstract

Described are various embodiments of vaginal orthosis systems, methods, and devices for pelvic support and post-surgical and post-partum healing. In one embodiment, a vaginal orthotics device is disclosed, comprising: a body portion comprising: a posterior surface and an anterior surface directly opposite the posterior surface; a retention feature, the retention feature connected at a lower end of the body portion, to the body portion; wherein the retention feature comprises a wall with an outer surface and an inner surface, the inner surface defining an opening of a pre-determined diameter; wherein the retention feature comprises a plurality of shoulder elements, each shoulder element of the plurality of shoulder elements connecting the retention feature to the body portion.

Description

VAGINAL ORTHOSIS METHODS AND DEVICES FOR PELVIC SUPPORT AND POST- SURGICAL AND POST-PARTUM HEALINGFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to vaginal orthotics methods and devices, and more particularly, to vaginal orthotics methods and devices for pelvic support and post-surgical and post-partum healing.BACKGROUND

[0002] Pelvic Organ Prolapse (POP) is a bulging or herniation of one or more pelvic organs into or out of the vagina. The lifetime risk of suffering from POP is 30-50%. 2-4% of women will become symptomatic. In the US, approximately 300,000 women undergo surgery to address POP each year.

[0003] Current surgical methods for addressing POP involve native tissue apical prolapse repair, which may be categorized, mainly, as Sacrospinous Ligament Fixation or Uterosacral Ligament suspension.

[0004] Sacrospinous Ligament Fixation (SSLF): vaginal apex suspended by sutures from vaginal cuff to the right sacrospinous ligament with extra-peritoneal approach.

[0005] Uterosacral Ligament Suspension (USLS): vaginal apex is suspended by sutures from vaginal cuff to bilateral uterosacral ligaments intra-peritoneal (intra-abdominally) along the pelvic sidewall.

[0006] Often, POP is a recurring concern. In the OPTIMAL trial (Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial. JAMA.2014;311(10): 1023- 1034. doi:10.1001 / jama.2014.1719) 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 S; NICHD Pelvic Floor Disorders Network. Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA. 2018 Apr 17;319(15): 1554-1565. doi: 10.1001 / jama.2018.2827. PMID: 29677302; PMCID: PMC5933329), reoperation rates at 5 years were found to be 8-11.9%. The area of highest reoccurrence is the anterior vaginal wallor “cystocele”. This may be because the posterior deflection of the long axis of the vagina to pelvic ligaments applies more of absolute intra-abdominal pressure along the anterior vaginal wall.

[0007] The current standard for post-operative care comprises:• Decreased activity for 2 weeks with slow resumption to normal activity by 6-12 weeks• Pelvic rest for 6-12 weeks• Low dose estrogen cream l-2x per week• No baths or soaking in water for initial 4-6 weeks following surgery.

[0008] Post-Surgical Tissue Healing comprises 4 stages:• Stage 1 : Inflammation• Stage 2: Proliferation• Stage 3: Remodeling• Stage 4: Maturation

[0009] A return to normal activity in the beginning of the remodeling stage may lead to premature increased loading of the developing Type 1 collagen, and subsequently to disordered or inadequate healing. In the orthopedic literature, offloading orthoses can allow severe wounds to heal by alleviating pressure and restricting movement that can otherwise aggravate and slow healing.

[0010] In the case of post-surgical POP recovery, a physically supportive orthopedic or orthopedic-like intervention during the end of proliferative and beginning of remodeling stages that provides adequate support, may allow for better aligned Type 1 collagen formation and therefore a more durable repair with less chance of recurrence.

[0011] Previously, vaginal mesh has been used to help further modulate native tissue repair, or decrease re-operative rate, but due to negative secondary effects, mesh kits are banned in some jurisdictions, including the US.

[0012] Estrogen cream has also been posited as a post-surgical treatment for modulating wound healing, but recent studies from Rahn et al. (Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial. JAMA. 2023;330(7):615-625. doi: 10.1001 / jama.2023.12317) indicate no improvement to surgical success in women randomized to perioperative vaginal estrogen.

[0013] Currently, therefore, there are no active methods or proactive, complementary (to surgery) methods, for modulating the healing process following POP surgery, birth, and the like. There may exist a need, therefore, for vaginal orthotics systems, methods, and devices for post-surgical healing after vaginal reconstructive surgery for pelvic organ prolapse (POP).

[0014] This background information is provided to reveal information believed by the applicant to be of possible relevance. No admission is necessarily intended, nor should be construed, that any of the preceding information constitutes prior art or forms part of the general common knowledge in the relevant art.SUMMARY

[0015] The following presents a simplified summary of the general inventive concept(s) described herein to provide a basic understanding of some aspects of the disclosure. This summary is not an extensive overview of the disclosure. It is not intended to restrict key or critical elements of embodiments of the disclosure or to delineate their scope beyond that which is explicitly or implicitly described by the following description and claims.

[0016] A need exists for vaginal orthotics systems, methods, and devices for post-surgical healing. There may also exist a need for easily insert-able and removable vaginal orthotics systems, methods, and devices. There may also exist a need for vaginal orthotics systems, methods, and devices, which may be custom-made to fit a particular user.

[0017] In accordance with an aspect of the disclosure, there is described a vaginal orthotics device, comprising: a body portion having a posterior surface and an anterior surface opposite the posterior surface, the body portion comprising an anterior curve; and a retention feature extending away from the posterior surface, the retention feature defining an opening therethrough, wherein the vaginal orthotics device is configured to move between a collapsed configuration and a deployed configuration.

[0018] In some embodiments, one or more dimensions of the body portion and / or the retention feature are correlated with one or more anatomic values of a user of the vaginal orthotics device.

[0019] In some embodiments, the one or more dimensions comprise a curvature, a length, and a width.

[0020] In some embodiments, the one or more anatomic values comprise an introital width value, a genital hiatus value, a total vaginal length value, or combinations thereof.

[0021] In some embodiments, a length of the anterior curve is between about 1 cm and 5 cm.

[0022] In some embodiments, the length of the anterior curve is about 2 cm.

[0023] In some embodiments, the body portion further comprises a seam that runs along a longitudinal axis thereof.

[0024] In some embodiments, the body portion is configured to be folded and unfolded about the seam to move between the collapsed configuration and the deployed configuration.

[0025] In some embodiments, a diameter of the retention feature is sized so that the vaginal orthotics device is configured to be retained in a vaginal canal of the user.

[0026] In some embodiments, the vaginal orthotics device further comprises a plurality of shoulder elements, the plurality of shoulder elements extending from the body portion towards the retention feature.

[0027] In some embodiments, each of the plurality of shoulder elements comprises a triangular body, wherein a first edge of the triangular body is connected to an outer edge of the body portion and a second edge of the triangular body is connected to an upper surface of the retention feature.

[0028] In some embodiments, the retention feature is foldable toward the posterior surface of the body portion to transform the opening into a plurality of slits.

[0029] In some embodiments, each of the plurality of slits is sized to receive an arm of an applicator device for inserting the vaginal orthotics device into the vaginal canal of the user.

[0030] In some embodiments, the retention feature is configured to fold toward the posterior surface of the body portion to decrease a transversal diameter of the retention feature when a pulling force is applied to the retention feature.

[0031] In some embodiments, a width of the retention feature is correlated with an introital width of the user of the vaginal orthotics device.

[0032] In some embodiments, a length of the retention feature is correlated with a genital hiatus of the user of the vaginal orthotics device.

[0033] In some embodiments, the vaginal orthotics device is formed from a biocompatible material.

[0034] In some embodiments, the biocompatible material comprises silicone, biocompatible thermoplastic polyurethane, polylactic acid, or combinations thereof.

[0035] In some embodiments, the vaginal orthotics device is formed from a flexible material, a semi-rigid material, a rigid material, or combinations thereof.

[0036] In accordance with another aspect of the disclosure, there is described a vaginal orthotics device comprising: a curved body portion curving in a first direction; and a retention feature extending away from the curved body portion in the first direction, the retention feature defining an opening therethrough, wherein the vaginal orthotics device is movable between a collapsed configuration in which the vaginal orthotics device is insertable and removable from a vaginal canal of a user, and a deployed configuration in which the orthotics device is retainable in the vaginal canal of the user and is configured to apply a force to a wall of the vaginal canal to treat one or more ailments.

[0037] In some embodiments, one or more dimensions of the curved body portion and / or the retention feature are correlated with one or more anatomic values of the user of the vaginal orthotics device.

[0038] In some embodiments, the one or more dimensions comprise a curvature, a length, and a width.

[0039] In some embodiments, the one or more anatomic values comprises an introital width value, a genital hiatus value, a total vaginal length value, or combinations thereof.

[0040] In some embodiments, the curved body portion further comprises a seam that runs along a longitudinal axis of the curved body portion.

[0041] In some embodiments, the curved body portion is configured to fold and unfold along the seam when the vaginal orthotics device is moved between the collapsed configuration and the deployed configuration.

[0042] In some embodiments, the vaginal orthotics device further comprises a plurality of shoulder elements extending from the curved body portion towards the retention feature, wherein the retention feature is connected to the curved body portion via the plurality of shoulder elements.

[0043] In some embodiments, each of the plurality of shoulder elements comprises a triangular body, wherein a first edge of the triangular body is connected to an outer edge of the body portion and a second edge of the triangular body is connected to an upper surface of the wall of the retention feature.

[0044] In some embodiments, in the collapsed configuration, the retention feature is configured to fold to transform the opening into a plurality of slits.

[0045] In some embodiments, each slit of the plurality of slits is sized to receive an arm of an applicator device for inserting the vaginal orthotics device into the vaginal canal of the user.

[0046] In some embodiments, the retention feature is configured to fold to decrease a diameter of the opening when a pulling force is applied to the retention feature.

[0047] In some embodiments, a width of the retention feature is correlated with an introital width of the user of the vaginal orthotics device.

[0048] In some embodiments, a length of the retention feature is correlated with a genital hiatus of the user of the vaginal orthotics device.

[0049] In accordance with another embodiment of the disclosure, there is disclosed a system, comprising: a vaginal orthotics device configured to move between a collapsed configuration and a deployed configuration; and an applicator configured to engage with the vaginal orthotics device to deliver the vaginal orthotics device to a vaginal canal of a user while the vaginal orthotics device is in the collapsed configuration, wherein the applicator is configured to transform the vaginal orthotics device from the collapsed configuration to the deployed configuration within the vaginal canal.

[0050] In some embodiments, the applicator comprises: an outer portion comprising a distal end having a plurality of arms configured to engage with the vaginal orthotics device when the vaginal orthotics device is in the collapsed configuration, the outer portion defining an interior; and an inner portion arranged at least partially within the interior, the inner portion being configured to slide relative to the outer portion along a longitudinal axis thereof.

[0051] In some embodiments, when the vaginal orthotics device is engaged with the applicator, the inner portion is configured to slide and exert a force on the vaginal orthotics device to disengage the vaginal orthotics device from the applicator.

[0052] In some embodiments, the vaginal orthotics device comprises: a curved body portion; and a retention feature extending from the curved body portion, the retention feature defining an opening therethrough.

[0053] In some embodiments, the vaginal orthotics device is foldable and unfoldable along a longitudinal axis thereof to transform the vaginal orthotics device between the collapsed configuration and the deployed configuration, and wherein, in the collapsed configuration, theopening is transformed into a plurality of slits configured to receive the plurality of arms of the applicator.

[0054] In accordance with another aspect of the disclosure, there is disclosed a method comprising: folding a vaginal orthotics device into a collapsed configuration; inserting the vaginal orthotics device into a vaginal canal of a user; and deploying the vaginal orthotics device in the vaginal canal to cause the vaginal orthotics device to transform from the collapsed configuration to a deployed configuration such that the vaginal orthotics device is retained in the vaginal canal, the retained vaginal orthotics device applying a force to a wall of the vaginal canal to treat one or more ailments of the user.

[0055] In some embodiments, the method further comprises, prior to inserting the vaginal orthotics device, engaging the vaginal orthotics device in the collapsed configuration to the applicator device, wherein the inserting comprises inserting the vaginal orthotics device into the vaginal canal of the user via the applicator device.

[0056] In some embodiments, coupling the vaginal orthotics device to the applicator device comprises inserting a plurality of arms of the applicator device into a plurality of corresponding slits defined by the vaginal orthotics device.

[0057] In some embodiments, deploying the vaginal orthotics device comprises sliding a first portion of the applicator device relative to the plurality of arms to exert a force on the vaginal orthotics device and cause the vaginal orthotics device to disengage from the plurality of arms of the applicator.

[0058] In some embodiments, the method further comprises: transforming, in the vaginal canal, the vaginal orthotics device from the deployed configuration to the collapsed configuration; and removing the vaginal orthotics device from the vaginal canal.

[0059] In some embodiments, transforming the vaginal orthotics device comprises applying a pulling force to the vaginal orthotics device.

[0060] Other aspects, features and / or advantages will become more apparent upon reading of the following non-restrictive description of specific embodiments thereof, given by way of example only with reference to the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Several embodiments of the present disclosure will be provided, by way of examples only, with reference to the appended drawings, wherein:

[0062] FIG. 1 illustrates a front view of a vaginal orthotics device, in accordance with one embodiment;

[0063] FIG. 2 illustrates a perspective view of a vaginal orthotics device, in accordance with one embodiment;

[0064] FIG. 3 illustrates a side view of a vaginal orthotics device, in accordance with one embodiment;

[0065] FIG. 4A illustrates a bottom-up view of an applicator device for deploying a folded vaginal orthotics device, in accordance with one embodiment;

[0066] FIG. 4B illustrates a top-down view of an applicator device for deploying a folded vaginal orthotics device, in accordance with one embodiment;

[0067] FIG. 4C illustrates a front view of an applicator device, in a receiving configuration, in accordance with one embodiment;

[0068] FIG. 5 A illustrates a bottom-up view of a retention element, in accordance with one embodiment;

[0069] FIG. 5B illustrates a bottom-up view of a retention element, in accordance with another embodiment;

[0070] FIG. 6 illustrates a side view cross-section of a pelvic floor anatomical model with an inserted vaginal orthotics device in use which is in a deployed configuration, in accordance with one embodiment;

[0071] FIG. 7A illustrates perspective views of embodiments of a cage-shaped body portion of a vaginal orthotics device, in accordance with one embodiment;

[0072] FIG. 7B illustrates perspective views of embodiments of a cage-shaped body portion of a vaginal orthotics device, in accordance with another embodiment;

[0073] FIG. 7C illustrates perspective views of embodiments of a cup-shaped body portion of a vaginal orthotics device, in accordance with one embodiment; and

[0074] FIG. 7D illustrates perspective views of embodiments of a diving board shaped body portion of a vaginal orthotics device, in accordance with one embodiment.

[0075] Elements in the several drawings are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating understanding of the various presently disclosed embodiments. Also, common, but well-understood elements that areuseful or necessary in commercially feasible embodiments are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present disclosure.DETAILED DESCRIPTION

[0076] Various implementations and aspects of the specification will be described with reference to details discussed below. The following description and drawings are illustrative of the specification and are not to be construed as limiting the specification. Numerous specific details are described to provide a thorough understanding of various implementations of the present specification. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of implementations of the present specification.

[0077] Furthermore, numerous specific details are set forth in order to provide a thorough understanding of the implementations described herein. However, it will be understood by those skilled in the relevant arts that the implementations described herein may 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 implementations described herein.

[0078] In this specification, elements may be described as “configured to” perform one or more functions or “configured for” such functions. In general, an element that is configured to perform or configured for performing a function is enabled to perform the function, or is suitable for performing the function, or is adapted to perform the function, or is operable to perform the function, or is otherwise capable of performing the function.

[0079] When introducing elements of aspects of the disclosure or the examples thereof, the articles “a,” “an,” “the,” and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. The term “exemplary” is intended to mean “an example of.” The phrase “one or more of the following: A, B, and C” means “at least one of A and / or at least one of B and / or at least one of C.”

[0080] The following disclosure relates to methods and devices for vaginal orthotics and / or pessaries, which preferably provide non-surgical alternatives for the treatment of pelvic organ prolapse and to relieve the symptoms of pelvic relaxation. The devices and methods disclosedherein indicated for use in persons with vaginal pelvic anatomy in need of post-surgical pelvic organ support.

[0081] The following disclosure relates to vaginal orthotics devices and methods for use during the postoperative phase for patients undergoing surgery for POP, which are preferably safe and provide equal or improved anatomic outcomes in the patient's anterior compartment compared to the current industry standard of pelvic rest and light activity alone, as well as prior art pessaries and vaginal orthotics devices.

[0082] Devices and methods disclosed herein may be employed pre-surgery, for prolapse or vaginal reconstructive surgery, pre-surgery, as a preventative measure to avoid surgery, for patients with early-stage pelvic organ prolapse, and post-partum, in order to provide support during post-partum healing.

[0083] The disclosed devices may be indicated for use in post-surgical support of pelvic organs. Employing the disclosed methods and devices during a patient's post-surgical, tissue remodulation / healing phase following pelvic organ prolapse surgery may comprise placement and use of the device, intravaginally initiated 2 weeks after a surgery. Generally, when deploying the device in the patient's vaginal canal, it rests on the patient's levator plate, such that it is next to resorbable sutures and remains in contact with intact tissue.

[0084] The disclosed devices are safe, preferably manufactured with biocompatible and soft materials.

[0085] The embodiments disclosed herein tend to be comfortable for intravaginal use in most patients, including patients who have undergone reconstructive vaginal surgery and perineorrhaphy: the device preferably does not extend beyond the introitus or opening of the vagina.

[0086] Preferably, the devices disclosed herein are self-retaining, and are retained in a user's vagina with a retention feature, throughout intra-abdominal pressure incurred during standard daily activities (sitting, standing, walking). Preferably, the device provides support to a user's anterior wall (illustrated in FIG. 6). Its material is generally rigid enough to withstand intra- abdominal pressures, but flexible enough for placement, folding / compressing, and removal. The material may be soft, rigid, semi-rigid, or some combination thereof.

[0087] In an embodiment, an advantage of the present disclosure is its compactible / foldable size and easy-to-use applicator and application method, making it easy for dexterously capablepatients, as determined by clinician, to insert and removed themselves. The patients may remove and clean the device daily.

[0088] The disclosed devices are preferably easy to fold within a shape of small diameter, allowing it to be comfortably inserted into a user's vaginal canal. The disclosed devices may be coupled (engaged) with an applicator and / or adaptor to help with insertion.

[0089] Preferably, the disclosed devices fold automatically when being pulled out of a user's vagina to make removal easy and safe.

[0090] In some embodiments, the disclosed devices and methods may be personalized to patient measurements- (for example, length, width, thickness or other hiatal area metrics).

[0091] FIG. 1 illustrates a front view of a vaginal orthotics device 100 according to an embodiment.

[0092] The vaginal orthotic device 100 comprises a body portion 104. The body portion 104 comprises a posterior surface 112 and an anterior surface (shown in FIGS. 2 and 3), directly opposite the posterior surface. Connected to the body portion 104 a distal or lower end 124, is a retention feature 110. The retention feature 110 comprises a wall 114 with an outer surface 118 and an inner surface 116, the inner surface defining an opening (shown in FIG. 2) of a predetermined diameter 120. The retention feature 110 is connected to the body portion 104 by a plurality of shoulder elements 108- in this embodiment two are shown, with a fin-like triangular shape, connecting the upper surface of the retention feature 110 to the outer edges of the body portion 104 on either side of the distal / lower end 124 of the body portion 104.

[0093] In the illustrated embodiment, the device 100 is in a deployed configuration 102. In the deployed configuration, the device 100 may be inserted into a vaginal canal of a user in its collapsed configuration, to rest on the user's levator plate in its deployed configuration.Deployed, the opening 206 pre-determined diameter 120 of the retention feature 110 keeps the device in place in the user's vaginal canal.

[0094] In the illustrated embodiment, the body portion 104 has a “diving board” shape, slightly curving inwards, towards the posterior surface 112, at a tip end 122, while being relatively flat at the lower end 124.

[0095] The illustrated device 100 comprises a bendable, flexible (soft or semi-rigid), and biocompatible material, such as silicone. The material may be rigid in some embodiments. 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 to develop vaginal pessaries and / or orthotics devices may be used to develop the device 100. The material is preferably easy to clean.

[0096] The body portion 104 comprises a seam 106 which runs the length of the body portion.

[0097] FIG. 2 shows a perspective view of a vaginal orthotics device 100. In this view, the anterior surface of the body portion 104 is more readily seen.

[0098] When the vaginal orthotics device 100 is placed in a user's vaginal canal, the anterior surface 202 is typically in direct contact with the user's anterior wall, providing support for organs, stitches, sutures, and the like, while reducing the effects of intra-abdominal pressure.

[0099] In this view, it can be seen that, the retention feature 110 comprises an inner surface 116, the inner surface 116 defining an opening 206 of a pre-determined diameter 120. The predetermined diameter 120 is preferably large enough to keep the device 100 in place in a user's vaginal canal.

[0100] FIG. 3 illustrates a side view of a vaginal orthotics device 100. In this view, the shape of the body portion 104 can be more readily seen. In the “diving board” shape, the body portion 104 comprises an anterior curve 302, at the tip portion. The curve 302 is typically around 2cm in length, curved towards the posterior surface 112. Exact dimensions may vary, and the range may be 1-5 cm. The lower end 124 does not curve, and is generally flat, in the illustrated, “diving board” shaped embodiment.

[0101] The device is compatible with varying user's anatomies, including patients who have had their cervix removed, and patients with a cervix and / or uterus.

[0102] The dimensions of the vaginal orthotics device 100, and its features (i.e. body portion, retention feature, etc.), are generally determined based on patient measurements, or an average of patient measurements. Patient measurements may comprise, for example, Introital Width (IW), genital hiatus (gh), and Total Vaginal Length (TVL). Additional patient measurements or specific anatomic values may also be used to determine the dimensions of the device 100. The dimensions may comprise a curvature, a length, and a width.

[0103] For example, in a device 100 custom made for a patient, the retention feature 110 may have a width determined by correlation with measurement of IW, a length determined by correlation with measurement of genital hiatus (gh), and a thickness determined based on balancing retention vs ease of insertion-removal. The body portion 104, including a divingboard shape, may have a height determined by correlation with measurement of TVL, and an angle curvature may be determined based on a patient's specific anatomic values.

[0104] The exact dimensions may be customizable to a user, by taking relevant measurements of the user's anatomy. Various methods of taking measurements of a user's vaginal anatomy are known in the art, including those developed by the owners of the present application, for example, those taught in PCT / CA2018 / 000173, the contents of which are hereby incorporated by reference.

[0105] FIG. 4A illustrates a bottom-up view of an applicator device 402 for deploying a vaginal orthotics device- folded (collapsed) configuration 400 in a user's vaginal canal, in accordance with one embodiment.

[0106] The applicator device 402 comprises: a receiving configuration 418 (shown) and a deploying configuration (not shown), an outer portion 414 comprising two or more retention feature receiving arms 410, the retention feature receiving arms being sized and configured for insertion into a retention feature 110 of a vaginal orthotics device in its folded (collapsed) 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 part, by the inner portion 412 extending outwardly from an upper end 442 of the hollow center 416 of the inner portion 412. The deploying configuration is characterized by the inner portion 412, upon having an external pressure (force) exerted upon it, such as a user's thumb or finger, is pushed to an upper end 446 (shown in FIG. 4C) of the hollow center 416, the upper end 446 being directly opposite the upper end 442.

[0107] The inner portion 412 may then exert a pressure (force) on both the retention feature 110 of the vaginal orthotics device 100, and on an inner side 420 of the retention feature receiving arms 410. The pressure on the retention feature 110 pushes the device up and off the applicator device 402. In its folded (collapsed) configuration 404, the vaginal orthotics device and applicator may be inserted into a user's vaginal canal. The retention feature 110 helps to locate the user's levator plate upon contact. The user may then deploy and disengage the device by pushing on the inner portion, forcing the vaginal orthotics device 100 off of the applicator device 402, moving it from its folded (collapsed) configuration 404 to its deployed configuration 102 within the vaginal canal.

[0108] FIG. 4B illustrates a top-down view of an applicator device 402 for deploying a vaginal orthotics device- folded (collapsed) configuration 400 in a user's vaginal canal, in accordance with one embodiment.

[0109] In the folded (collapsed) configuration 404, an applicator locking element 408 on the inner surface 116 of the retention feature, folds into a semi-opening 406 at the posterior surface of the lower end 124 of the body portion 104, leaving slits 448 on the inner surface into which the retention feature receiving arms 410 may be inserted. The body portion 104 folds along the length of the seam 424, shown in this image from the anterior surface.

[0110] FIG. 4C illustrates a front view of an applicator device 402, in the receiving configuration 418. In the receiving configuration 418, the inner portion 412 extends outwards from the hollow center 416, at the upper end 442.[OHl] The deploying configuration is characterized by the inner portion 412, upon having an external pressure (force) exerted upon it, such as a user's thumb or finger, is pushed to an upper end 446 of the hollow center 416, the upper end 446 being directly opposite the upper end 442.

[0112] FIG. 5A and FIG. 5B illustrate a bottom-up views of embodiments of the retention element 500a and 500b. Retention elements 500a and 500b have slightly differing dimensions, with retention elements 500b having a slightly greater thickness 506b and shorter length 504b in order to better accommodate an applicator device 402.

[0113] Retention element 500a has a thickness 506a, which is constant based on the applicator dimensions, to help keep the retention feature on the applicator until it is deployed. Similarly, retention element 500a has a constant length 504a, based on the applicator dimensions.

[0114] The applicator locking elements 408 between retention element 500a and length 504b are slightly varying dimensions: Applicator locking element 502b is shorter along the horizontal axis, but protrudes further downwards from the retention feature 110, when compared to applicator locking element 502a. Applicator locking element 502b is designed to better accommodate the applicator device 402, by giving the retention feature receiving arms 410 more material to grip. When the device 100 is in its folded (collapsed) configuration 404, the applicator locking element 408 folds into the semi-opening 406, and protrudes downwards, resting on the inner portion 412 of the applicator device 402, which pushes up on the applicator locking element 408 to release the device 100 from its position on the applicator device 402.

[0115] FIG. 6 illustrates a side view cross-section of a pelvic floor anatomical model 606 with an inserted vaginal orthotics device in use which is in a deployed configuration.

[0116] The vaginal orthotics device 100 may be deployed in a user's vagina to redistribute weight from a user's anterior wall to their levator plate, therefore providing more internal support for the user, off-setting and distributing increases in intra-abdominal pressure. Added support may help a user recover after vaginal reconstructive surgery, wherein the anterior surface 202 of the device 100 may support stitches and / or sutures from the surgery. In other embodiments, the device 100 may provide support for prolapsed organs, including in patients with pelvic organ prolapse. The device may be used as a preventative means, for patients with early (stage 2) prolapse, providing support to the anterior wall of the patient and preventing the prolapse from worsening. It may alternatively be used for patients recovering from pelvic organ prolapse surgery, to reduce risk of recurrence by supporting the anterior wall and redistributing the weight. The device may be used for user's recovering after giving birth, as a post-partum healing method, by providing support to the user's pelvic organs and redistributing load to the user's levator plate.

[0117] In the illustrated embodiment, the anterior surface 202 is one smooth or solid surface, preferably in contact with the anterior wall 620, the anterior surface 202 providing support wound healing, i.e. for patients with vaginal stitches / sutures, without catching the stitches. In another embodiment, the anterior surface 202 is a of a wire or truss structure, making up a scaffold, mesh, or wire surface 202. This may be preferable for use in patients that only require posterior, apical, perineum support (rather than additional support for minimizing / relieving strain on sutures)- for example, women that are post-partum. The vaginal orthotics device 100 may support the urethra 626 and / or the bladder 616, decreasing or minimizing incomplete bladder emptying-the flat anterior surface 202 in the illustrated embodiment provides a support to sling the urethra 626 (and avoid it kinking) and allow more complete voiding. The device 100 may be used to help straighten a patient's urethra 626, in order to support urination.

[0118] In the illustrated embodiment, when in use, the posterior surface 112 is oriented towards a posterior side of a user / patient's body, with the anterior surface 202 in contact with a patient's anterior wall 620.

[0119] In accordance with another embodiment, when in use, the device may be “flipped” (with the anterior surface 202 facing a posterior side of the user's body) in order to provide additional rectal and / or perineal support, which can relieve a patient's outlet constipation symptoms- the diving board flat surface- i.e. the anterior surface 302 would be orientedtowards the posterior wall 628 and / or the patient's rectum 618, minimizing the trapping of stool in the distal anorectum.

[0120] In the presented embodiment, the shape is adapted to the absence of cervix. In patients with a cervix, the shape may be adapted to accommodate the cervix. For patients with a cervix, the present embodiment would be located in the posterior fornix which would give some spacing between the anterior curve 302 at the tip end 122, and the anterior wall near the cervix, this placement being comparable to placement of traditional, prior art pessaries. Further spacing between the tip end 122 and the anterior wall could 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 spacing between the tip end of the device 100 and the anterior wall near the cervix or cuff helps to avoid disrupting any stitches or sutures on the anterior wall and cuff.

[0121] The embodiments disclosed herein tend to be comfortable for intravaginal use in most patients, including patients who have undergone reconstructive vaginal surgery and perineorrhaphy. The device 100 preferably, does not extend beyond the introitus or opening of the vagina. The vaginal orthotics device 100 is preferably positioned with no material in the patient's sensation zone, remaining in place above the levator ani muscle.

[0122] When deployed in the body in the deployed configuration 102, the vaginal orthotics device 100 is able to self-retain, remaining in-place, by virtue of the retention feature 110 and its pre-determined diameter 120.

[0123] The device 100 may be removed by a user or by a health care professional, for example. The device 100 is removed by pulling the device 100 out of the vaginal canal 622 by the retention feature 110. A user may grip, with their fingers, the retention feature 110, and pull, causing the vaginal orthotics device 100 in its deployed configuration to fold into the folded (collapsed) configuration 404 for easy removal. The opening 206 of the retention feature 110 may act as a loop- the user may grip the loop by hooking their fingers around the loop, or by inserting another applicator device, into the opening 206, in order to pull down on the vaginal orthotics device 100, causing it to fold into the folded (collapsed) configuration 404 for easy removal from the vaginal canal 622.

[0124] FIG. 7A-D illustrates various embodiments of the body portion 700 of the vaginal orthotics device.

[0125] FIG. 7A illustrates perspective views of a cage-shaped body portion 702, 722, a front view of the cage-shaped body portion 720, and a bottom view of the cage-shaped body portion 720, in accordance with one embodiment.

[0126] FIG. 7B illustrates a perspective view of a cage-shaped body portion 708, a front view of the cage-shaped body portion 726, and a bottom view of the cage-shaped body portion 728, in accordance with another embodiment.

[0127] For the cage-shaped body portion embodiments, the tip end 122 is slightly rounded.

[0128] A cage / mesh structure with openings may define a generally cylindrical body shape, with a rounded or flat lower end 124.

[0129] In some embodiments, the cage-shaped body portion 702 or 708 may be employed in order to fill spaces in the vaginal cavity, therefore providing more support for the anterior wall.

[0130] FIG. 7C illustrates a perspective view of a cup-shaped body portion showing its internal structure 704 and outer structure 730, and a bottom view of the cup-shaped body portion 732, in accordance with one embodiment.

[0131] In this embodiment, the tip end 122 is slightly rounded, and further comprises a tip end 122.

[0132] A solid cup structure may define a generally cylindrical body shape, and may further comprise internal support elements 714. The cup shape 704 may comprise a rounded or flat lower end 124, which may be defined by a top opening 712.

[0133] FIG. 7D illustrates a perspective view of a diving board shape 706, a front view of the diving board shape 734, a side view of the diving board shape 736, and a back view of the diving board shape 738 of the body portion 700, in accordance with one embodiment.

[0134] The diving board shape 706 is defined by the tip end 122 being angled away from the lower end 124 inwards, the angle being defined by the anterior curve 302, while the lower end 124 is a generally flat surface 718.

[0135] The body portions 700, including, but not limited to the cage shapes 702, 708, the cup shape 704, diving board shape 706, may be connected to various embodiments of the retention feature 110 a plurality of shoulder elements 108, generally at the lower end 124 of the body portion.

[0136] Further to the description of the vaginal orthotics device as described in FIG. 4B, the retention feature is configured to fold toward the posterior surface of the body portion todecrease a transversal diameter of the retention feature when a pulling force is applied to the retention feature.

[0137] While the present disclosure describes various embodiments for illustrative purposes, such description is not intended to be limited to such embodiments. On the contrary, 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 in the appended claims. Information as herein shown and described in detail is fully capable of attaining the above-described object of the present disclosure, the presently preferred embodiment of the present disclosure, and is, thus, representative of the subject matter which is broadly contemplated by the present disclosure.

Claims

CLAIMSWhat is claimed is:

1. A vaginal orthotics device, comprising: a body portion having a posterior surface and an anterior surface opposite the posterior surface, the body portion comprising an anterior curve; and a retention feature extending away from the posterior surface, the retention feature defining an opening therethrough, wherein the vaginal orthotics device is configured to move between a collapsed configuration and a deployed configuration.

2. The vaginal orthotics device of claim 1, wherein one or more dimensions of the body portion and / or the retention feature are correlated with one or more anatomic values of a user of the vaginal orthotics device.

3. The vaginal orthotics device of claim 2, wherein the one or more dimensions comprise a curvature, a length, and a width.

4. The vaginal orthotics device of claim 2, wherein the one or more anatomic values comprise an introital width value, a genital hiatus value, a total vaginal length value, or combinations thereof.

5. The vaginal orthotics device of claim 1, wherein a length of the anterior curve is between about 1 cm and 5 cm.

6. The vaginal orthotics device of claim 5, wherein the length of the anterior curve is about 2 cm.

7. The vaginal orthotics device of claim 1, wherein the body portion further comprises a seam that runs along a longitudinal axis thereof.

8. The vaginal orthotics device of claim 7, wherein the body portion is configured to be folded and unfolded about the seam to move between the collapsed configuration and the deployed configuration.

9. The vaginal orthotics device of claim 1, wherein a diameter of the retention feature is sized so that the vaginal orthotics device is configured to be retained in a vaginal canal of the user.

10. The vaginal orthotics device of claim 1, further comprising a plurality of shoulder elements, the plurality of shoulder elements extending from the body portion towards the retention feature.

11. The vaginal orthotics device of claim 10, wherein each of the plurality of shoulder elements comprises a triangular body, wherein a first edge of the triangular body is connected to an outer edge of the body portion and a second edge of the triangular body is connected to an upper surface of the retention feature.

12. The vaginal orthotics device of claim 1, wherein the retention feature is foldable toward the posterior surface of the body portion to transform the opening into a plurality of slits.

13. The vaginal orthotics device of claim 12, wherein each of the plurality of slits is sized to receive an arm of an applicator device for inserting the vaginal orthotics device into the vaginal canal of the user.

14. The vaginal orthotics device of claim 1, wherein the retention feature is configured to fold toward the posterior surface of the body portion to decrease a transversal diameter of the retention feature when a pulling force is applied to the retention feature.

15. The vaginal orthotics device of claim 1, wherein a width of the retention feature is correlated with an introital width of the user of the vaginal orthotics device.

16. The vaginal orthotics device of claim 1, wherein a length of the retention feature is correlated with a genital hiatus of the user of the vaginal orthotics device.

17. The vaginal orthotics device of claim 1, wherein the vaginal orthotics device is formed from a biocompatible material.

18. The vaginal orthotics device of claim 17, wherein the biocompatible material comprises silicone, biocompatible thermoplastic polyurethane, polylactic acid, or combinations thereof.

19. The vaginal orthotics device of claim 1, wherein the vaginal orthotics device is formed from a flexible material, a semi-rigid material, a rigid material, or combinations thereof.

20. A vaginal orthotics device comprising: a curved body portion curving in a first direction; and a retention feature extending away from the curved body portion in the first direction, the retention feature defining an opening therethrough, wherein the vaginal orthotics device is movable between a collapsed configuration in which the vaginal orthotics device is insertable and removable from a vaginal canal of a user, and a deployed configuration in which the orthotics device is retainable in the vaginal canal of the user and is configured to apply a force to a wall of the vaginal canal to treat one or more ailments.

21. The vaginal orthotics device of claim 20, wherein one or more dimensions of the curved body portion and / or the retention feature are correlated with one or more anatomic values of the user of the vaginal orthotics device.

22. The vaginal orthotics device of claim 21, wherein the one or more dimensions comprise a curvature, a length, and a width.

23. The vaginal orthotics device of claim 21, wherein the one or more anatomic values comprises an introital width value, a genital hiatus value, a total vaginal length value, or combinations thereof.

24. The vaginal orthotics device of claim 20, wherein the curved body portion further comprises a seam that runs along a longitudinal axis of the curved body portion.

25. The vaginal orthotics device of claim 24, wherein the curved body portion is configured to fold and unfold along the seam when the vaginal orthotics device is moved between the collapsed configuration and the deployed configuration.

26. The vaginal orthotics device of claim 20, further comprising a plurality of shoulder elements extending from the curved body portion towards the retention feature, wherein the retention feature is connected to the curved body portion via the plurality of shoulder elements.

27. The vaginal orthotics device of claim Error! Reference source not found., wherein each of the plurality of shoulder elements comprises a triangular body, wherein a first edge of the triangular body is connected to an outer edge of the body portion and a second edge of the triangular body is connected to an upper surface of the wall of the retention feature.

28. The vaginal orthotics device of claim 20, wherein, in the collapsed configuration, the retention feature is configured to fold to transform the opening into a plurality of slits.

29. The vaginal orthotics device of claim 28, wherein each slit of the plurality of slits is sized to receive an arm of an applicator device for inserting the vaginal orthotics device into the vaginal canal of the user.

30. The vaginal orthotics device of claim 29, wherein the retention feature is configured to fold to decrease a diameter of the opening when a pulling force is applied to the retention feature.

31. The vaginal orthotics device of claim 20, wherein a width of the retention feature is correlated with an introital width of the user of the vaginal orthotics device.

32. The vaginal orthotics device of claim 20, wherein a length of the retention feature is correlated with a genital hiatus of the user of the vaginal orthotics device.

33. A system, comprising: a vaginal orthotics device configured to move between a collapsed configuration and a deployed configuration; and an applicator configured to engage with the vaginal orthotics device to deliver the vaginal orthotics device to a vaginal canal of a user while the vaginal orthotics device is in the collapsed configuration, wherein the applicator is configured to transform the vaginal orthotics device from the collapsed configuration to the deployed configuration within the vaginal canal.

34. The system of claim 33, wherein the applicator comprises: an outer portion comprising a distal end having a plurality of arms configured to engage with the vaginal orthotics device when the vaginal orthotics device is in the collapsed configuration, the outer portion defining an interior; andan inner portion arranged at least partially within the interior, the inner portion being configured to slide relative to the outer portion along a longitudinal axis thereof.

35. The system of claim 34, wherein, when the vaginal orthotics device is engaged with the applicator, the inner portion is configured to slide and exert a force on the vaginal orthotics device to disengage the vaginal orthotics device from the applicator.

36. The system of claim 34, wherein the vaginal orthotics device comprises: a curved body portion; and a retention feature extending from the curved body portion, the retention feature defining an opening therethrough.

37. The system of claim 36, wherein the vaginal orthotics device is foldable and unfoldable along a longitudinal axis thereof to transform the vaginal orthotics device between the collapsed configuration and the deployed configuration, and wherein, in the collapsed configuration, the opening is transformed into a plurality of slits configured to receive the plurality of arms of the applicator.

38. A method compri sing : folding a vaginal orthotics device into a collapsed configuration; inserting the vaginal orthotics device into a vaginal canal of a user; and deploying the vaginal orthotics device in the vaginal canal to cause the vaginal orthotics device to transform from the collapsed configuration to a deployed configuration such that the vaginal orthotics device is retained in the vaginal canal, the retained vaginal orthotics device applying a force to a wall of the vaginal canal to treat one or more ailments of the user.

39. The method of claim 38, further comprising, prior to inserting the vaginal orthotics device, engaging the vaginal orthotics device in the collapsed configuration to the applicator device, wherein the inserting comprises inserting the vaginal orthotics device into the vaginal canal of the user via the applicator device.

40. The method of claim 39, wherein coupling the vaginal orthotics device to the applicator device comprises inserting a plurality of arms of the applicator device into a plurality of corresponding slits defined by the vaginal orthotics device.

41. The method of claim 40, wherein deploying the vaginal orthotics device comprises sliding a first portion of the applicator device relative to the plurality of arms to exert a force on the vaginal orthotics device and cause the vaginal orthotics device to disengage from the plurality of arms of the applicator.

42. The method of claim 38, further comprising: transforming, in the vaginal canal, the vaginal orthotics device from the deployed configuration to the collapsed configuration; and removing the vaginal orthotics device from the vaginal canal.

43. The method of claim 42, wherein transforming the vaginal orthotics device comprises applying a pulling force to the vaginal orthotics device.

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