Pessary system and method for pelvic floor ligament support

Abstract

The pessary system provides pelvic floor support for the USL and other ligaments. The pessary has an elongated probe with separately inflatable balloons, each balloon located substantially the same distance from the insertion end of the probe and inflated to a separate radial sector. The probe is inserted into the vaginal cavity and the inflated balloons provide mechanical support to the USL. By inflating each balloon separately, the mechanical USL support is varied from side to side to compensate for the difference in the degree and location of deterioration of the USL ligaments on both sides.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Application No. 63 / 168,784, filed Mar. 31, 2021, the entire contents of which are hereby expressly incorporated by reference.

Background Art

[0002] Urinary incontinence affects many women, especially in the elderly population. Symptoms of "overactive bladder" include urgency, frequent urination, nocturia, and the inability to urinate properly. Up to 75% of female patients in nursing homes experience some degree of urinary incontinence. To treat this condition, various surgical and non - surgical treatments are used.

[0003] Surgical treatment techniques used to treat stress urinary incontinence involve joining existing tissues or implanting mechanical structures to support internal organs. One particular treatment involves implanting a mid - urethral sling to provide support to the bladder and / or urethra. For example, U.S. Patent No. 10,426,594 discloses fixing a filamentous support element to the tissue lateral to the urethra and transplanting the filament into the fascial tissue to provide ligamentous support for the urethra between a first position and a second position. With this support, existing muscle tissue can apply pressure to the urethra better.

[0004] Surgical solutions are not available for all such conditions, and non - surgical techniques are frequently used to treat female incontinence in terms of risk and cost. Such techniques include the use of vaginal pessaries. A vaginal pessary is a removable device designed to support pelvic organ prolapse, where the bladder, rectum, or uterus is in a state of descending into the vagina. Conventional vaginal pessaries used for preventing prolapse are inserted into the vaginal cavity to prevent the prolapse of prolapsed organs such as the bladder (cystocele), rectum (rectocele), or uterus (uterine prolapse) by acting as a barrier against the descent of the prolapsed organ itself.

[0005] Pessaries are designed to be worn either long - term or temporarily and to be removable. Long - term wear configurations can cause ulceration, especially in elderly women. Therefore, a temporary pessary is preferred for this type of patient.

[0006] Pessaries are available in a variety of designs. Donut - shaped or ring - shaped pessaries are designed to surround the cervix and provide a platform within the vagina to prevent prolapse. An example of an expandable pessary is disclosed in U.S. Patent No. 6,645,137 to Ulmsten et al. Expandable pessaries are designed to be inserted into the vagina and then expanded to form a platform and function as a mechanical occlusion against organ prolapse.

[0007] One type of expandable pessary is the inflatable pessary as shown in U.S. Patent No. 6,470,890 to Diokno et al. Conventional inflatable pessaries are designed to be inserted into the vagina in a non - inflated state and positioned against the back of the pubic bone. The balloon portion is inflated to a desired amount with air, water, or saline. When inflated, the balloon expands in a 360 - degree region surrounding the pessary device, forming a ball or cylindrical shape around the pessary axis. The inflated balloon applies pressure to the surrounding area within the vaginal cavity to support the prolapsed organ. Such an inflatable pessary is also useful in the treatment of stress urinary incontinence because the inflated balloon applies pressure to the urethra to prevent urine leakage during normal activities.

[0008] Conventional pessary designs provide organ support and apply urethral pressure to relieve prolapse symptoms, but are not designed to address the underlying causes of prolapse. In particular, symptoms of bladder, bowel, and uterine prolapse, as well as bladder, bowel, and chronic pelvic pain, can result from weakened or damaged ligaments. A deficiency of collagen, the main structural component of ligaments, weakens the ligaments over time, and as a result, the ligaments stretch and cause prolapse. Since the pelvic muscles contract against the ligaments, the forces that open and close the bladder and bowel are also weakened, resulting in various bladder, bowel, and pain symptoms (see Petros PE&Ulmsten U., An Integral Theory Of Female Urinary Incontinence. Acta Obstetricia et Gynecologica Scandinavica, 1990;69;Supp.153:1-79.).

Summary of the Invention

Problems to be Solved by the Invention

[0009] Accordingly, there is a need for an improved vaginal pessary that provides targeted mechanical support to the uterosacral ligaments and other pelvic ligaments to treat prolapse and other conditions. It would be a further advantage to provide a pessary that can be used temporarily and is easily insertable and removable by a physician and the user. Additionally, such a pessary can be easily customized to support multiple different ligament regions within the pelvis, providing further advantages. Further advantages are provided when such a pessary design is also used as a platform for the support and placement of sensors and electrodes, such as for use with EMG recording and muscle stimulation.

Means for Solving the Problems

[0010] These problems and others are addressed by the inflatable pessary system disclosed herein. The inflatable pessary system is configured to provide specific mechanical support to the lax pelvic floor ligaments, thereby supporting the prolapsed organs and / or reducing other pelvic floor symptoms. Depending on the placement and configuration, ligament support is provided to address bladder, bowel, and / or uterine prolapse. By mechanically supporting the lax ligaments, improved treatment of bladder, bowel, and pain resulting from both prolapsed and non-prolapsed conditions associated with the lax ligaments is also provided.

[0011] In one embodiment, the pessary system includes an elongate flexible probe configured to be inserted into the vaginal cavity. Two inflatable balloon portions are separately inflatable and are disposed toward the insertion end of the probe. The probe is inserted into the vagina to position the balloon portions behind the cervix at the top of the posterior vagina. Each balloon is inflated with air or liquid, such as by use of a syringe attached to a fluid conduit leading to the balloon. The balloons are disposed on the probe such that when inflated, they expand laterally and in generally opposite directions from each other. As the balloons inflate, the lateral expansion forms expansion pockets in these regions of the vaginal wall, such as under the uterosacral ligaments (USL), applying pressure to specific regions of the vaginal wall and mechanically supporting the ligaments from below. By providing the targeted ligament support, expansion of the vaginal wall in other regions surrounding the pessary is limited in the areas where ligament weakness occurs, reducing or avoiding excessive distension of the vagina, and thus reducing ulceration, pain, and discomfort that such distension can cause.

[0012] By each balloon inflating separately, one balloon expands asymmetrically with respect to the other. This separately varies the mechanical support provided to each USL, compensating for differences in the degree of degradation and positioning of the bilateral USL ligaments. Since the balloons can be deflated and the probe can be easily removed periodically, for example, vaginal revascularization is possible and ulceration can be avoided.

[0013] The side balloon is formed directly on the surface of the probe. As an alternative, the balloon may be disposed in the inner core region of the probe and in the core of the probe surrounded by the outer sleeve. The outer sleeve is arranged to prevent the inflation of a part of the balloon, and the other balloon is inflated. In one embodiment, an opening is formed in the outer sleeve, and the sleeve is arranged so that the selected balloon is exposed through the opening. When these balloons are inflated, the balloons expand laterally away from the probe through their respective openings. The sleeve suppresses the inflation of the other balloons covered by the sleeve. Changes in the shape and size of the opening further control the size, shape, and position of each balloon when it inflates. In an embodiment where it is not necessary to inflate the balloons separately, a single balloon may be provided in alignment with the opening of the outer sleeve, and while the balloon expands through each opening during inflation, the inflation of the remaining portion of the balloon is suppressed by the outer sleeve.

[0014] A plurality of balloons selected to select a specific balloon that can be inflated to extend from the probe may be provided laterally along the length of the probe core and the position of the sleeve or opening on the outer sleeve. Each balloon arranged laterally is respectively coupled to a separate conduit for providing inflation fluid so that all the balloons can be inflated separately. As an alternative, some or all of the balloons, such as all the balloons on a given side of the probe, may be connected to a common fluid conduit.

[0015] In certain embodiments, a catheter-like tube having a closed end is configured to have a plurality of weakened portions along its length at which inflation occurs when fluid is injected into the tube. The tube is positioned within a pessary and surrounded by an outer sleeve. The outer sleeve is operative to allow lateral outward expansion from the probe only substantially where the openings are located and to inhibit expansion in other regions. The plurality of sleeves are provided with openings arranged differently to allow customization of the position of the inflatable balloon by using the appropriate sleeve. Alternatively, a blank sleeve may be provided with an appropriate tool so that a physician can create an opening at a desired position within the sleeve.

[0016] In addition to providing ligament support to each USL, lateral expansion of the balloon also functions to firmly fix the probe in place. This allows the probe to be used for additional and / or alternative purposes. One or more sliding sleeves carrying auxiliary balloons are fitted and arranged on the probe. Thereby, when the probe is inserted and fixed together with the primary balloon, the auxiliary balloons on the sleeve expand under other damaged or lax pelvic ligaments including the pubourethral ligament (PUL), arcus tendineus fascia pelvis (ATFP), cardinal ligament (CL), and perineal body (PB), providing additional support for the USL ligament and support for such ligaments. Ligament support enables the selective treatment of stress urinary incontinence, cystocele, rectocele / perineal descent syndrome, and addressing the symptoms of bladder, bowel, and chronic pelvic pain.

[0017] Electrodes and / or sensors are disposed at other positions on the lateral balloon or probe. These are used for EMG recording, muscle stimulation, and other purposes. The electrode and sensor wires may be outside the probe or the probe may be configured such that the connecting wires pass through the probe.

[0018] The flexible probe is configured with a very thin form factor and is generally easily used by elderly women with very narrow vaginal cavities. The probe is also of sufficient length to facilitate the insertion and removal process, particularly self-insertion and removal. At least the distal end portion (non-insertion end portion) of the probe is sufficiently flexible so that it can be folded and hold a portion of the probe outside the vagina inside the woman's undergarment. To enable easy determination of the insertion distance, a measurement indication such as marks at 1 cm intervals is provided on the probe.

[0019] Further features and advantages of the pessary system and method disclosed herein, as well as the structure and operation of various embodiments of the present invention, are disclosed in detail below with reference to the accompanying drawings.

Brief Description of the Drawings

[0020]

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DETAILED DESCRIPTION OF THE INVENTION

[0021] FIG. 1 is an anatomical structure diagram of a female pelvis 100 in an inner cross-section. The pubis 102 and the coccyx 104 are illustrated. Located between these bones are the uterus 106, the bladder 108, the rectum or intestine 110, and the vagina 112. Five suspensory pelvic ligaments are also shown. These are the pubourethral ligament (PUL) 122, the arcus tendineus fascia pelvis (ATFP) 124, the cardinal ligament (CL) 126, the uterosacral ligament (USL) 128, and the perineal body (PB) 130. Among other features, the external urethral ligament (EUL) 120 and the cervix 132 are also shown.

[0022] Looseness or damage to one or more of these ligaments, which may be due to collagen deficiency or other mechanisms, is theorized to be the cause of bladder, bowel, and uterine prolapse, as well as symptoms of bladder, bowel, and chronic pelvic pain. For example, weakening of the ligaments that support the organs can lead to downward stretching of the ligaments, potentially causing organ prolapse. Since the pelvic muscles contract against the ligaments, the forces that open and close the bladder and bowel are also weakened, resulting in specific bladder, bowel, and pain symptoms. The relationship between symptoms and ligament weakening is thought to be exponential, with even a small prolapse potentially causing significant symptoms. (See Petros PE, THE FEMALE PELVIC FLOOR: Function, Dysfunction and Management, According to the Integral Theory, 3rd Revised Edition, Springer Heidelberg, 2010.)

[0023] Figure 2 is a diagram and chart that summarizes the relationship between symptoms and specific ligaments and further identifies one or more organs affected. The ligaments are divided into three zones: a front zone that includes the PUL ligament, a middle zone that includes the AFTF and CL ligaments, and a rear or posterior zone that includes the USL and PB ligaments. The thickness of the horizontal bars in the chart indicates the relative degree of association with the problem ligaments according to the integral theory.

[0024] Referring to Figure 2, weakening of the ligaments in the front zone (front ligaments), when associated with stress urinary incontinence (SUI), can cause not only stress urinary incontinence (SUI) but also frequency, urgency, and fecal incontinence. Weakening of the ligaments in the middle zone (middle ligaments) can result in bladder prolapse with associated symptoms of urination, urgency, and chronic bladder infections. Weakening of the ligaments in the rear zone (back ligaments) that includes the USL ligament can lead to uterine prolapse, apical prolapse if there has been a hysterectomy, enterocele, and high rectal prolapse if the USL is separated laterally. The associated symptoms of USL relaxation include abnormal emptying of the bladder and bowel, urgency to go to the toilet, inability to empty (bladder and bowel), nocturia, frequent need to urinate, and chronic pelvic pain.

[0025] Figures 3A and 3B are diagrams of the basic features of an improved pessary 300 according to an embodiment, the pessary 300 providing controllable mechanical support targeting the uterosacral ligaments, thereby reducing symptoms and pain associated with or not associated with bladder, bowel, and uterine prolapse. Figure 3A shows the pessary 300 in an unexpanded state, and Figure 3B shows the pessary 300 of Figure 3A in an expanded state.

[0026] Referring to Figures 3A and 3B, the pessary 300 includes an elongate flexible probe 310 extending along a longitudinal axis 302. The probe 310 is formed from rubber, silicone rubber, or other flexible material that is biocompatible and safe for use inside the body. Suitable materials are known to those skilled in the art. The probe 310 is configured to be inserted into the vaginal cavity and has an insertion end 315 and a distal end 320. The probe 310 has a first inflatable portion 325 and a second inflatable portion 325'. Each inflatable portion 325, 325' (also referred to as a balloon) has a predetermined distance D1 from the insertion end 302. Each inflatable portion 325, 325' is in fluid communication with a fluid conduit 330, 330' respectively.

[0027] In this embodiment, the balloons 325, 325' are separately inflatable using a fluid such as air, water, or saline introduced into their respective conduits 330, 330'. By inflating separately, the balloons 325, 325' can inflate to different degrees. Such different inflations advantageously allow the pessary 300 to provide more accurate mechanical support to each ligament, such as the uterosacral ligament (USL) where one ligament is located slightly more laterally than the other. Further, since the inflation of the inflatable portions 325, 325' can expand the vagina asynchronously, different inflations can accommodate different elasticities at the posterior part of the vagina. This reduces the excessive unilateral pressure that can cause ulcers on the vaginal wall. In an alternative embodiment, the pair of lateral balloons may be coupled to the same fluid source and inflated together.

[0028] Various methods are used to provide the fluid and the inflation portions 325, 325'. In one embodiment, a syringe (not shown) is connected to each conduit 330, 330' via a luer lock with valve or other couplers 335, 335'. Other suitable couplers 335, 335' are well known to those skilled in the art. The amount of expansion of the expandable portions 325, 325' varies with the design of the expandable portion and the amount of fluid injected. For example, in a particular embodiment, the balloons can be inflated separately with up to 5 ml or up to 10 ml of liquid each. Of course, different amounts of inflation may be used depending on the size of the balloon and the desired degree of inflation.

[0029] The fluid conduits 330, 330' can be physically separate tubes and can be wholly or partly surrounded by an outer casing such as a thick tube through which the tubes of the conduits pass. The conduits 330, 330' are formed as channels integrally formed within a single tube. Combinations of separate conduit tubes and integral conduits may also be used. An outer casing or tube having an integral conduit, for example, has the same width or a different width than the probe 310. For example, the casing may have a smaller diameter than the pessary probe. Specific embodiments having a fluid conduit integrally formed within the tube are shown in FIGS. 10A - 10C described below.

[0030] The probe has a length L from the insertion end 315 to the distal end 320. The length L is sufficient to enable complete insertion of the probe 310 into the vaginal cavity and proper placement. In one embodiment, a portion of the probe remains outside to enable manipulation. A probe designed for insertion and removal by a third party such as a physician or nurse may be shorter than a probe designed for self-insertion and removal. For example, the length L is 20 cm to 60 cm, 30 cm to 50 cm, and a length of about 40 cm or more. In a particular embodiment, the pessary 300 has a sufficient length L such that when fully inserted into the vagina, a sufficient length of the probe remains outside the vagina to enable a physician to easily manipulate the position of the probe. For example, after insertion into the appropriate position, the portion of the probe 310 outside the vagina may be longer than the portion inside the vagina. The pessary 300 may be configured to cut the end 320 to adjust the length and then connect the couplers 335, 335' to the cut ends of the fluid conduits 330, 330'. In a further embodiment, the length L of the pessary is selected such that only a small portion of the pessary probe 310 remains outside after insertion, or none at all. The end of the inflation conduit remains outside to provide a gripping means for removing the pessary.

[0031] The probe has a relatively narrow width W. This provides a thin probe configuration that enables the pessary probe 310 to be easily inserted into the vagina even in the oldest women with the narrowest vaginas. Such a thin probe configuration is particularly useful when using the probe for the treatment of the bladder and bowel of frail women who reside in nursing facilities and 75% of whom have severe bladder / bowel symptoms. In a particular configuration, the probe 310 has a width of 1.5 cm to 1.6 cm. Other widths are possible. For example, the width W may be 1.3 cm to 1.7 cm and 1 cm to 2 cm. The probe may have an even narrower or wider width, although a relatively wide width may be more difficult to insert for certain patients.

[0032] The cross-sectional shape of the probe can be any suitable shape including circular, elliptical or rounded rectangular. The cross-sectional shape is selected to accommodate an auxiliary sleeve with an auxiliary "blow up" balloon further described below, allowing the sleeve to slide on the probe and be manually positioned laterally while restricting its axial rotation. The cross-sectional shape may also be selected to assist in the orientation of the pessary probe for easier self-insertion by a female.

[0033] The width and shape of the probe need not be constant along the entire length of the probe 310. For example, the width of the probe 310 at the portion intended for vaginal insertion may be narrower or wider than the portion intended to be left outside, or vice versa. In another embodiment, the vaginal insertion portion may be wider than the external portion. Thus, the insertion end has one of the widths within the aforementioned range. On the other hand, the distal end is larger to allow for easier manipulation of the probe and attachment of the inflation syringe. Similarly, the cross-sectional shape may vary at different positions along the length of the sleeve. For example, the insertion end may have a circular cross-section to provide easy insertion. On the other hand, the distal end generally has another shape such as elliptical, rectangular, triangular, or trapezoidal. The internal orientation of the probe is easily determined by touch at or near the distal end.

[0034] The configuration of the long pessary having a length of more than 40 cm facilitates the process of inserting and removing the probe and, if necessary, filling or emptying the lateral balloons with fluids of different volumes respectively. As described above, the probe 310 is flexible along its length. The degree of flexibility may vary along the length of the probe 310 based on internal structure and the like. The flexibility of the probe 310 enables a woman to easily self-insert and inflate the pessary 300. In certain embodiments where a portion beyond the minimum portion of the pessary remains outside the vagina after complete insertion, such as 1 cm to 2 cm or more, the external portion is sufficiently flexible so that it can be bent and held entirely or partially inside the woman's underwear during use. As described above, in the configuration where the pessary probe is fully or substantially inserted internally, the length of portions such as one or more fluid conduits used for inflation may be further extended. The conduit may be formed from a conventional flexible tubing material that can be bent to hold this portion of the pessary within the woman's underwear.

[0035] Figure 3C shows the inflated pessary 300 of Figure 3B as viewed from the insertion end 315 along the longitudinal axis 302. As shown in Figure 3C, in this embodiment, each inflatable portion 325, 325' expands laterally outward from the probe 310 when inflated. Considering a circular region centered on the longitudinal axis 302 and perpendicular to the longitudinal axis 302, the first inflatable portion 325 expands within a first radial sector 350 with respect to the longitudinal axis 302 of the probe 310. The second inflatable portion 325' expands within a second radial sector 350' with respect to the longitudinal axis 302. The width of each sector varies with the geometric shape and maximum inflation size of the inflatable portions 325, 325'. The specific angular arrangement and width of the sectors are selected considering the anatomical position of the ligaments supported against the vaginal wall.

[0036] The placement of pessary 300 will be described based on FIG. 4 showing the pessary 300 arranged to support the USL. The probe 310 of the pessary 300 is inserted into the vagina until the inflatable regions 325, 325' come behind the cervix and into the posterior part of the vagina behind the uterus 106. When the inflatable regions 325, 325' inflate, they expand laterally as described above, pressing against the vaginal wall and forming expansion pockets in those regions. These pockets support the ligaments when maintained by the balloons.

[0037] In a particular configuration, the lateral position of the balloon is selected such that when the balloon inflates, it positions the expansion pockets of the vaginal wall below the uterosacral ligament (USL) 128. By supporting the USL, the pessary 300 is used to assist in preventing uterine prolapse.

[0038] Also shown in FIG. 4 is one nerve plexus (NP) 410 on each side, anatomically supported by the USL 128. The NP 410 represents the sympathetic nerves (T11 - L2) and the sacral parasympathetic nerves (S2 - 4) located approximately 2 cm from the insertion point of the USL when the USL enters the lateral part of the cervix. The use of the pessary 300 places the inflatable portions 325, 325' in the region of the NP 410. The descent of the NP 410 can stimulate the nerves and then cause chronic pelvic pain referred to for certain nerve fiber target points (vagina = vulvodynia, bladder = interstitial cystitis, lower abdomen = chronic abdominal pain, sacral region = coccydynia, paraurethral = "muscle spasm", etc.). The inflated balloon supports the NP 410 to prevent or reduce the descent of the NP and relieve related pelvic pain such as the aforementioned pain.

[0039] Probe 310 also mechanically strengthens the USL and provides a firm fixation point for the posterior / inferior direction muscle strength that stretches the vagina, providing underlying support for the bladder base and the rectoanal stretch receptors. If the bladder base and the rectoanal stretch receptors are not supported, this can lead to premature activation of the micturition and defecation reflexes, which are perceived by the patient as bladder / bowel "urgency incontinence" and nocturnal "nocturia". Further, the same ligaments secure the muscles that stretch the urethra and anorectum to facilitate the excretion of urine and feces. This is perceived as urinary retention and constipation.

[0040] As described above, the different lateral expansions of the balloon are used to provide targeted support for different structures. As shown in FIGS. 3D - 3H, the lateral arrangements used when supporting different structures are described below based on the face of a 12 - hour clock. A longitudinal axis 302 is located at the center of the face, the 12 o'clock position is directed posteriorly, and the face of the clock is oriented radially. Sectors are defined according to the maximum inflated state in the design, but an inflatable portion that is not fully inflated need not fill its expansion sector. Thus, an inflatable portion having an expansion sector from 9:30 to 11:30 fills the 10 o'clock to 11 o'clock sector when inflated to the desired amount. The inflatable portions 325, 325' may also be sized and positioned to provide a combination of ligament support.

[0041] Figure 3D shows balloons 325, 325'. The balloons 325, 325' are positioned to expand against the anterior vaginal wall in the expansion sectors located at 9:30 to 11:30 and 12:30 to 2:30 respectively (when the pessary is inserted and properly positioned), and are support balloons on each side of the urethra to support the pubourethral ligament at the center of the urethra. Figure 3E shows balloons positioned to expand against the anterior vaginal wall behind the pubis in the posteriorly extending expansion sectors at 9 to 11 o'clock and 1 to 3 o'clock to support the insertion points of the levator muscles and the arcus tendineus fascia pelvis. Figure 3F shows balloons positioned to expand against the posterior vaginal wall approximately 1 to 3 cm from the vaginal introitus in the expansion sectors at 7 to 10 o'clock and 2 to 5 o'clock to support the deep transverse perineal ligament. Figure 3G shows balloons positioned to expand against the anterior vaginal wall in the region of the anterior surface of the cervix in the expansion sectors at 8 to 10 o'clock and 2 to 4 o'clock to support the cardinal ligament (for example, to treat a high bladder tumor or a transverse defect). Figure 3H shows balloons positioned to expand posteriorly against the anterior vaginal wall behind the cervix in the expansion sectors at 9:30 to 12 o'clock and 12 o'clock to 2:30 to support the insertion points on the uterosacral ligament.

[0042] In the above embodiments, the expansion sectors are spaced apart from each other such that they do not contact when the balloons filling the sectors are fully inflated. In a further embodiment, balloons 325, 325’ are positioned such that the expansion sectors are adjacent and the inflated balloons contact. This embodiment is useful, for example, for forming combined pockets in the vaginal wall that provide continuous support from one sector to the next, and by inflating the balloons separately, it is possible to adjust the degree of support provided on each side of the combined sectors (see Figure 3H). Generally, the sectors are adjacent or spaced apart, but do not overlap. However, in an alternative embodiment, the inflatable portions 325, 325’ may be formed and arranged to have some minimal overlap. The relative position of the expansion sectors 350, 350’ with respect to each other is specified by the angle between the centerlines of each sector. For example, the sectors are positioned such that the centerlines of the sectors are 90 degrees to 180 degrees apart, or 120 degrees to 180 degrees apart such that the sectors are at least substantially opposite each other, or approximately 180 degrees apart such that the sectors are substantially opposite each other. It should be understood that the position of each sector can also be defined by other criteria, such as with respect to the + / - rotation angle from the sagittal plane of the probe.

[0043] In short, both the angle between each of the sectors and the angular width of each sector are defined to position the balloons so as to provide the desired ligament support while limiting the pressure on the vaginal wall in other areas around the pessary where support is not required.

[0044] To enable proper placement of the inflatable portions 325, 325' within the vagina, the distance D1 from the insertion end 315 of the probe to the inflatable portion is selected to be the expected distance from the posterior portion of the vagina to the desired placement location of the inflatable portions 325, 325' behind the uterus. By fully inserting the probe 310, the inflatable portions 325, 325' are placed in the correct position. As an alternative, the distance D1 may be shorter than the expected distance from the desired position of the inflatable portions 325, 325' and the posterior of the vagina. The probe 310 may have a display indicating a distance interval, such as at 1 cm intervals. This display (mark) is used to measure when the probe has been inserted by an accurate amount and, optionally, to assist in measuring the orientation for placing the inflatable portions 325, 325' behind the uterus and on the sides of the USL 128, etc. The appropriate insertion distance is determined during a medical examination and communicated to the patient for reference during subsequent self-insertion. Other techniques are possible. For example, a physician may fit a given pessary 300 to the patient and then add a display to the probe 310 to indicate the appropriate length to be inserted. Further, as will be further described below with respect to FIGS. 8A - 8D and FIG. 9, a pessary system is provided in which the distance from the insertion end to the laterally inflatable portion is configured such that when the pessary probe is fully inserted, the inflatable portion is placed in a position appropriate for a particular patient for the provision of USL or other support.

[0045] Advantageously, pessary 300 disclosed herein can be used intermittently and is easily self-inserted. For example, a woman can self-insert and inflate pessary 300 for use during the day and then easily deflate and remove it at night. This allows the vaginal tissue to rest and enables blood circulation reconstruction, significantly reducing the tendency for ulcer formation. Pessary 300 is used when going out for social events and removed when the patient is at home. When used for nocturia, pessary 300 may be removed for sexual intercourse and then re-inserted to control nocturia throughout the night. When used to control symptoms such as chronic pelvic pain that periodically varies from mild to very severe, pessary 300 may be inserted only when the pain is periodically severe, sometimes at intervals of several days. It may be inserted to assist urine passage and then removed.

[0046] Figure 10A is a particular embodiment 1000 of the above-described pessary 300. Pessary 1000 has a probe body 1010 having a first inflatable portion 1025 and a second inflatable portion 1025'. The inflatable portions 1025, 1025' are supplied by respective conduits 1030, 1030' that pass through tube 1031 and enter the probe body 1010. A recess 1090 or other tactile element on one side of the probe body 1010 allows the person holding the probe to easily determine the orientation of the probe. Element 1090 may also be configured to more securely grip the probe body 1010 during insertion and removal. Conduits 1030, 1030' terminate at luer locks 1035, 1035' with valves. One conduit extends longer than the other conduit and / or protrudes at a specific angle to provide a clear indication of which conduit supplies which inflatable portion.

[0047] Figure 10B is a cross-sectional view taken along line B-B of the probe body 1010. The probe 1010 in this embodiment has a flat shape with a thickness W1 and a width W2, and the width W2 is larger than W1, for example, 1.5 to 2.5 times larger. The conduits 1030, 1030' are integrally formed within at least a portion of the probe body 1010 by a process such as molding the probe body 1010 around the tubes of separate conduits or an extrusion process. The central region 1040 of the probe body 1010 may be hollow to form a void. By having such a void, the flexibility of the probe with respect to a given manufacturing material can be increased, and the weight can be reduced.

[0048] Figure 10C is a cross-sectional view taken along line C-C of the tube 1031. Similarly, referring to Figure 10C, the conduits 1030, 1030' are integrally formed within at least a portion of the tube 1031. The central region 1045 of the tube 1031 is hollow.

[0049] In one embodiment, the hollow void 1040 within the probe body is closed such that internal air or other fluid is trapped inside. Similarly, the hollow void 1045 may be closed or open, may be connected to the void 1040, or may be separated from the void 1040. In a variant, the pessary 1000 may be configured such that air or other fluid can be selectively introduced into the void 1040 via an auxiliary valve (not shown). By adjusting the pressure of the air within the void 1040, the rigidity of the probe body 1010 can be increased or decreased. In an exemplary embodiment, the probe body 1010 has a thickness W1 of approximately 5 mm and a width W2 of approximately 10 mm.

[0050] Figure 10A shows the expandable portions 1025, 1025' in a partially expanded state, with the dotted line indicating the maximum expanded state. The expandable portions are configured to expand up to an expansion diameter ID1 perpendicular to the probe axis, which is 21 mm to 30 mm, and up to a diameter ID2 measured along an axis parallel to the probe axis, which is also 21 mm to 30 mm. The probe body may be provided in one or more lengths. For example, the front portion 1015 of the probe body 1010 may have a length L1 of 80 mm to 90 mm, such as 85 mm, or a length of 90 mm to 100 mm, such as 93 mm or 95 mm. The rear portion 1016 of the probe body has a length L2 and tapers. In an exemplary embodiment, L2 is 5 mm to 10 mm, for example 7 mm. The outer diameter of the tube 1031 is 3 to 5 mm, for example 4 mm or 4.2 mm. The conduits 1030, 1030' each have a diameter of 0.5 mm to 1.0 mm, for example 0.8 mm.

[0051] Figure 5A shows a further embodiment of pessary 500 configured for use in electromyogram (EMG) evaluation and muscle stimulation. Pessary 500 is similar to pessary 300 shown in FIGS. 3A - 3C above, and includes a probe portion 510 having an insertion end 515 and expandable portions 525, 525' positioned laterally. In this embodiment, one or both of the expandable portions 525, 525' can include electrodes such as electrodes 560, 560'. Electrodes 560, 560' are used as electrical sensors and / or sites for applying electrical stimulation to the surrounding tissue. Lines 565, 565' electrically connect electrodes 560, 560' to a suitable circuit 562 such as an EMG sensing signal display and / or analysis system, a muscle stimulation device, or other circuitry as needed. Only one electrode 560, 560' is shown for each expandable portion 525, 525', but more than one electrode may be present. For example, each expandable portion 525, 525' may have two electrodes, one for EMG sensing of the electrical activity in the surrounding muscle tissue and one for stimulating the surrounding muscle tissue. Other devices such as pressure sensors can also be attached to the expandable portions 525, 525'. Such expandable portions 525, 525' of pessary 500 used for EMG evaluation and stimulation are more robust than similar expandable portions 325, 325' of pessary 300, as described above.

[0052] During use, the expandable portions 525, 525' carrying the EMG electrodes are inflated, for example with air, and expanded laterally. With the pessary properly positioned, this expansion causes the EMG electrodes to come directly above pelvic muscles such as the pubococcygeus muscle on both sides. While electrical recording or stimulation is occurring, the expanded balloon is firmly positioned over the muscle. FIG. 5B shows pessary 500 of FIG. 5A with the expandable portions 525, 525' inserted and expanded. These expand the elastic vaginal wall 575 (positioned beyond the outer vaginal wall 576) laterally, positioning the EMG electrodes 560, 560' adjacent to the pubococcygeus muscles 580, 580'.

[0053] The electrodes 560, 560' may be integrally formed with the expandable portions 525, 525' during manufacturing. As an alternative, the electrodes 560, 560' may be separately attached to the expandable portions 525, 525' either during manufacturing or during use. The wires 565, 565' connected to the electrodes 560, 560' are routed either within or along the outside of the probe 510.

[0054] There are various ways to attach electrodes or other sensor devices to the pessary 500. In one embodiment, the components are attached using an adhesive. As an alternative, referring to FIG. 5C, the electrodes are formed on an elastic sleeve 570. The elastic sleeve 570 is configured to slide on the probe 510, be disposed along the probe, and position the electrodes on the sleeve adjacent to the expandable portions 525, 525'. The sleeve 570 is shown in FIG. 5C as an open-ended cylinder. Alternatively, by closing one end completely or partially, the sleeve 570 slides only downward on the probe 510 until the insertion end of the probe reaches the closed end of the cylinder. The dimensions of the sleeve 570 and the placement of the electrodes are selected such that when the sleeve is fully attached to the probe 510, the sleeve positions the electrodes in a known desired location. The use of the open sleeve 570 allows electrodes, sensors, or other devices to be placed on the sleeve 570 at various positions along the length of the probe 510. An indication such as showing a few centimeters from the insertion end of the probe 510 is provided on the probe, thereby allowing the sleeve 570 to be placed at a specific location on the probe 510 such that the electrodes are positioned at the desired location during use of the pessary 500.

[0055] Although the separately expandable balloons 525, 525' are shown, in an alternative embodiment, the balloons 525, 525' are connected to a common fluid conduit and expand simultaneously.

[0056] According to a further embodiment, referring to FIG. 6A, the inflation of the inflatable portions 325, 325' firmly fixes the probe within the vaginal cavity. Thereby, the probe 310 is used as a platform for an additional support balloon. One or more auxiliary sleeves 625 are disposed at desired positions on the probe 310. Each sleeve 625 comprises an inflatable balloon 628 that can be inflated via respective fluid conduits 630. In an exemplary embodiment, the auxiliary sleeve balloon 628 inflates symmetrically to form a "donut" shape, although other configurations are possible. The auxiliary sleeve balloon 628 may be a single chamber, or may be branched or otherwise configured such that only a portion inflates.

[0057] The sleeve 625 is configured to be manually positioned along the probe 310, for example, by sliding it up and down, but is tight enough to remain in a set position on the probe when a pessary is inserted for use. The inflation of the balloon 628 further locks the sleeve 625 in a predetermined position on the probe 310.

[0058] A given auxiliary sleeve 625 is accurately positioned within the vaginal cavity by positioning the sleeve at a specific position on the probe 310, such as by referring to a distance indication 640. The sleeve 625 is disposed along the probe 310 for introducing the auxiliary balloon 628 and mechanically supports additional damaged or lax pelvic ligaments to treat a particular condition. For example, support is provided to the PUL, ATFP, CL, USL, and PB ligaments. As described above with respect to FIG. 2, the vulnerability of these ligaments is thought to be an important cause of organ prolapse such as bladder (cystocele), intestine (rectocele, perineal descent syndrome), and uterine / apex prolapse, as well as bladder / intestine / chronic pelvic pain symptoms.

[0059] As an example, referring to FIG. 6B, the auxiliary balloon sleeve 625 is positioned on the probe 310 such that the auxiliary balloon 628 is accurately positioned within the vaginal cavity immediately prior to the cervix 105, while the remainder of the probe 610 passes under the uterus 106 and remains at the posterior fornix of the vagina. The inflatable portions 325, 325' support the USL as described above. The auxiliary balloon 628, when inflated, provides mechanical support to the cardinal ligament 132 when inserted into the anterior cervical ring. Such auxiliary balloons are used for the support of "high bladder tumors" (transverse defects). In one embodiment, the auxiliary balloon 628 is configured not to surround the cervix. In the embodiment with reference to FIG. 6B where the auxiliary balloon 625 is used to support the cardinal ligament, the balloon can have a donut-like shape and can be made large enough to surround the cervix and press against the anterior lip of the cervix. The sleeve 625 has at least one solid portion 626. The solid portion 626 does not inflate and functions to prevent the auxiliary balloon 628 from inflating upward by a significant amount. Instead, it inflates mainly in the lateral direction to support both ends of the displaced cervical ligament. In one embodiment, two solid portions 626 are used and are positioned on both sides of the probe such that the inflated balloon 628 has a shape approximately like the number 8 when viewed axially.

[0060] Similarly, the auxiliary sleeve 625 or an additional sleeve can be positioned further down on the probe to support the pubourethral ligament anteriorly (in the case of SUI) and the rectocele and perineal body posteriorly. The balloon 628 can be bifurcated, whereby one portion raises one side to support the ligamentous structure. This form has the advantage of not blocking the urethra for urination or the intestine for defecation. FIG. 6C shows an auxiliary balloon sleeve 625 having a bifurcated balloon 628 of FIG. 6B and positioned to support two deep PB ligaments 130.

[0061] There are various ways to construct a pessary with an inflatable lateral balloon as disclosed herein. A particular embodiment of the pessary 700 is shown in FIGS. 7A and 7B in the non-inflated and inflated states, respectively. In this configuration, a pair of fluid conduits, such as lumens (fluid conduits) 730, 730', are housed within the outer sleeve 710. Each fluid conduit 730, 730' has respective inflatable balloon portions 725, 725' formed thereon. The fluid conduits 730, 730' can be formed of an elastic material, and the inflatable portions 725, 725' are formed as weakened or thinned regions of the respective conduit walls. Alternatively, the inflatable portions 725, 725' may be in the form of inflatable donuts attached to and in fluid communication with the respective fluid conduits. In a particular embodiment, each fluid conduit 730, 730' and its respective inflatable portion 725, 725' thereon are formed in a manner similar to a conventional balloon catheter, but a guide wire is not required.

[0062] The outer sleeve 710 has openings 712, 712' that are respectively aligned with the inflatable portions 725, 725'. During inflation, the balloon portions 725, 725' expand laterally outward through the respective openings 712, 712'. When inflated outside the pessary, the balloon portions 725, 725' of a single conduit 730, 730' tend to expand into a donut or ball shape, but the expansion of each balloon portion 725, 725' of the pessary 700 is restricted by the pressure from other balloon portions and / or fluid conduits, as well as by the outer sleeve 710.

[0063] In an alternative embodiment where it is not necessary to inflate separately, a single balloon is provided, such as expanding naturally in a toroidal shape around the tube used for inflation. The opening of the outer sleeve allows for directional inflation at the desired axial position while suppressing inflation in other regions. Such an embodiment is shown in FIGS. 7C and 7D. The pessary 750 has a balloon portion 755 that can be inflated via a fluid conduit 760. The outer sleeve 710 having the openings 712, 712' is positioned so as to define a region of the probe 750 where the balloon 755 can expand laterally by aligning the openings with the balloon 755.

[0064] FIG. 8A shows a further embodiment 800 where the position of the laterally expandable portion relative to the insertion end is selected from two or more predetermined positions to allow for a custom fit for a given patient. In this configuration, each fluid conduit 830, 830' operates as a manifold for supplying a plurality of expandable portions along the length of the probe 810. For example, conduit 830 provides expandable portions 825a and 825b located at distances D1 and D2 from the insertion end 815. Similarly, conduit 830' provides expandable portions 825a' and 825b'. The outer sleeve 835 is positioned along the longitudinal axis of the probe and covers one pair of expandable portions 825a, 825a' or 825b, 825b' while leaving the other pair uncovered. During the inflation operation, the uncovered pair of expandable portions expands while the sleeve 835 suppresses the inflation of the covered pair. By using multiple sleeves on the probe, if there are additional expandable portions on the probe, the inflation of that portion can be selectively blocked.

[0065] FIG. 8B is a modification of the embodiment of FIG. 8A. The outer sleeve 840 is configured to slide over the probe 810 and has one or more openings such as openings 845, 845'. The sleeve 840 is positioned on the probe 810, and each opening 845, 845' exposes a selected inflatable portion such as inflatable portions 825a, 825a' while covering other inflatable portions with the sleeve. When fluid is introduced into conduits 830, 830', the inflatable portions 825a, 825a' exposed by the openings 845, 845' expand and expand laterally beyond the outer sleeve 840, while the other inflatable portions 825b, 825b' are restricted by the outer sleeve 840 and confined within the sleeve 840. Depending on the overall geometric shape of the pessary 800, a single outer sleeve 840 may be positioned along the probe 810 to expose one pair of inflatable portions 825a, 825a' or the other pair 825b, 825b'. As an alternative, the pessary 800 may be provided with a plurality of outer sleeves 840 each having an opening positioned to align with a selected pair of inflatable portions. The arrangement of the sleeve 840 and the openings thereon may also be configured to determine the exposed inflatable portion by reversing the orientation of the sleeve such that, with the sleeve in the same position on the probe, the first end of the sleeve is closest to the insertion end of the probe or closest to the distal end of the probe.

[0066] FIG. 8C is a modification of FIG. 8B, and the inflatable portions 825a, 825a', 825b, 825b' are formed along the lengths of their respective fluid conduits 830, 830'. Similar to FIG. 8B, the probe 850 has openings 850a, 850a', 850b, 850b' that expose the respective inflatable portions that allow for lateral expansion. The outer sleeve 840 is positioned along the length of the probe 850, and openings 845, 845' are disposed in the outer sleeve 840 adjacent to the inflatable portions positioned at the desired locations. When fluid is introduced into a given fluid conduit such as conduit 830, all of the inflatable portions along its length are subjected to inflation. However, only the inflatable portions adjacent to the respective openings of the outer sleeve 840 can expand laterally outward from the probe, while the inflation of the other inflatable portions is restricted by the outer sleeve.

[0067] A further modification of this embodiment is shown in FIG. 8D. In this configuration, rather than having a plurality of discrete inflatable portions along the lengths of the fluid conduits 830, 830', the fluid conduits instead have elongate inflatable portions such as elongate inflatable portions 860, 860'. The position of the lateral expansion relative to the insertion end is determined by the position of the outer sleeve 840 and the openings 845, 845' therein.

[0068] As a further alternative example, referring to FIG. 9, pessary 900 has a main probe body 910 having inflatable portions 925, 925' that are inflatable through respective fluid conduits 930, 930'. The inflatable portions may be integral with the probe body 910 or may be formed on an internal lumen or other conduit and positioned adjacent to an opening of the probe body 910. Different sized end caps, such as end caps 915a, 915b, are provided to enable selection of a desired distance between the insertion end of pessary 900 and the inflatable portions 925, 925' at a desired position when the pessary 900 is fully inserted. For example, use of end cap 915a positions the inflatable portions 925, 925' at a distance D1 from the insertion end, and use of end cap 915b positions the inflatable portions 925, 925' at a distance D2 from the insertion end.

[0069] End caps 915a, 915b are attached to the probe body 910 by various mechanisms. For example, the end caps are somewhat elastic and are attached using a friction fit to the probe body 910. To prevent removal, a mechanical retention structure, such as a detent 935 configured to engage an opening of the probe body 910 or other structure of the probe body, may be used. Various other retention mechanisms known to those skilled in the art are used. In a further variant, the pessary system is configured such that adjustment of the distance between the insertion end and the inflatable portions 925, 925' is possible by enabling selection of the attachment position of a single end cap along the probe body. For example, the end cap and the probe body may be configured such that the end cap snap fits into two or more different positions. Other mechanisms known to those skilled in the art that enable an adjustable attachment position may be used.

[0070] As described in other embodiments, when it is not necessary to separately expand the balloons laterally, the double balloon / inflation catheter structures of FIGS. 8A-8D and 9 can be replaced with a single balloon and inflation catheter. According to further embodiments, various methods are provided for providing pelvic floor ligament support to treat prolapse and perineal descent syndrome, uterine / apex prolapse, bladder / intestinal / chronic pelvic pain symptoms, and other conditions.

[0071] In one treatment, a pessary such as pessary 300 of FIG. 3A is provided and inserted into the vagina by a physician or user, etc., and the inflatable portion of the pessary is placed behind the cervix. This involves inserting the pessary to its maximum extent or inserting the pessary in an amount less than the full amount. When inserted in an amount less than the full amount, the insertion measurement value is first recorded during fitting, and then the same amount is made available for the patient to self-insert. (Even when complete insertion is desired, the insertion measurement distance can be recorded and communicated to the patient.)

[0072] The balloons are then inflated separately with an amount sufficient to position each balloon beneath its respective USL. The appropriate inflation amount is determined by the treating physician, for example, based on the degree of pain relief or reduction in the sense of urgency when the balloon inflates. As an alternative, in the case of significant prolapse, the appropriate inflation amount is determined by inflation and a test of whether the balloon is held fast, and when the fit is secure, the amount of fluid required for each side is recorded. The required inflation amount may be determined by the patient based on the degree of pain relief or reduction in the sense of urgency when the balloon inflates.

[0073] The measured value of the inflation volume is also recorded and communicated to the patient or recorded by the patient so that the patient can subsequently perform self-insertion therapy and inflate each balloon by the appropriate volume. For example, the fluid can be introduced by a syringe or other mechanism having a display of the measured value of the introduced fluid volume. The display is used to measure the fluid volume introduced by the physician for the patient to use and to select the fluid volume used to inflate each inflatable portion 325, 325'.

[0074] A single syringe is used successively to introduce a predetermined fluid volume into one conduit 330 and then into the other conduit 330' to inflate the inflatable portions 325, 325' in sequence. As an alternative, two syringes may be connected to respective conduits 330, 335' and inflated simultaneously. Instead of an initial fluid injection by volume, air may be injected until a predetermined pressure is reached, at which point the volume of air injected may be recorded for subsequent use. The two syringes may be connected together or physically separated from each other. In a connected configuration, the syringe plungers are pushed down separately, or the syringe plungers are connected to each other to be pushed down simultaneously.

[0075] In a further configuration, an adjustable fixed-volume syringe is provided so that the total volume of fluid injected when each plunger is pushed down fully is set to a desired volume. The syringe is configured by a physician to set an appropriate fluid injection volume during an initial pessary fitting session. The total injection volume is configured, for example, by adjusting the length of the plunger stem inserted into the syringe. For example, the tip of the plunger is attached to the stem by a threaded or slidable rod. Adjustment mechanisms suitable for fixed-volume syringes are known to those skilled in the art.

[0076] In a particular embodiment shown in FIG. 11, a pair of adjustable fixed-volume syringes 1102, 1102' are provided, each syringe having a plunger 1104, 1104' with respective plunger tips 1106, 1106' and adjustable-length stems 1108, 1008'. The two syringes 1102, 1102' are physically connected to each other and are configured such that both ends 1110, 1110' of the plungers can be connected to an injection coupler 1120 that fluidly connects each syringe to a respective inflation conduit. The conduit coupler and syringes are configured such that each syringe fits only into the injection port of the coupler 1120 for the pessary balloon for which the syringe volume is set.

[0077] When the pessary is configured as shown in FIGS. 8A and 8B, the treatment method further includes the step of selecting one or more inflatable openings at a specific distance from the insertion end of the probe from among a plurality of openings at various different positions along the probe. This step is done by placing the outer sleeve 840 having the openings 845, 845' on the probe 810 and positioning the sleeve so that the selected inflatable portion is exposed while restricting the inflation of other such portions. The method includes the steps of receiving the pessary with a plurality of outer sleeves each having an opening at a different position, and selecting a specific sleeve from the plurality of sleeves. The method includes the steps of receiving the pessary and the outer sleeve, forming an opening in the sleeve at the selected position on the sleeve, and then placing the sleeve on the pessary so as to expose the selected inflatable portion.

[0078] When the pessary is configured as shown in FIGS. 8A and 8B, the treatment method further includes the step of selecting the outer sleeve 840 having the openings 845, 845' therein, positioning the sleeve on the probe so that the openings are positioned at a specific distance from the insertion end, and adjusting the axial position of the position where the inflatable portion expands laterally when inflated.

[0079] When the pessary is configured as shown in FIG. 9, the treatment method further includes the step of adjusting the distance between the inflatable portion and the insertion end of the probe by placing the selected end cap on the pessary probe body 910. The method includes the steps of receiving a pessary having a plurality of end caps of different sizes and selecting a specific end cap from the plurality of end caps of different sizes.

[0080] In a further treatment method, an auxiliary balloon sleeve is fitted onto the pessary by a physician or the like. The sleeve is positioned on the pessary such that when the pessary is inserted by a specified amount (e.g., completely or to a length defined as above), the balloon of the sleeve is positioned to provide auxiliary ligament support.

[0081] In a particular method for positioning the sleeve, the sleeve is configured to fit loosely over the pessary probe 310. Firm fixation of the top of the probe in the vagina is obtained by inflating two rear balloons on the probe. The sleeve is then slid along the probe 310 to the exact position necessary to support the damaged ligament. Alternatively, if the sleeve fits more tightly onto the pessary, the sleeve may be pre-positioned on the pessary prior to insertion. The balloon on the sleeve then inflates. The distance from a fixed marker on the pessary probe to the auxiliary balloon is recorded. The amount of fluid required is also recorded.

[0082] In a particular treatment method, the positioning is determined such that the sleeve with the auxiliary balloon is positioned within the vaginal cavity immediately prior to the cervix 132. After the pessary is inserted, the primary balloon inflates independently to support the USL and the auxiliary balloon inflates to secondarily support the CL. When the use of the pessary is no longer desired, the balloons are deflated and the pessary is removed from the vagina.

[0083] In a variant of the treatment method, an auxiliary balloon is positioned on the probe to provide mechanical support for the posterior, intermediate, or anterior ligaments for treatment in various states as detailed in FIG. 2. Thus, in various examples, (i) in a method of treating rectal tumors, uterine prolapse / apical prolapse, defecation disorders, frequency of urination and urgency of urination, nocturia, fecal incontinence, defecation disorders, or pelvic pain, the auxiliary balloon is positioned to support the posterior ligaments (such as USL and PB), (ii) in a method of treating bladder tumors, excretion disorders, frequency of urination and urgency of urination, and the vaginal cuff, the auxiliary balloon is positioned to support the intermediate ligaments (such as ATFP and CL), (iii) in a method of treating stress urinary incontinence, frequency of urination and urgency of urination, and fecal incontinence, the auxiliary balloon supports the anterior ligaments (such as PUL) and is positioned to indicate the intestinal tumor and perineal descent syndrome posteriorly. In a variant of the treatment method, two or more auxiliary balloons are used to support multiple different ligaments.

[0084] According to a further embodiment, a method of performing electromyogram (EMG) evaluation and / or muscle stimulation includes inserting a pessary, such as the pessary 500 as shown in FIG. 5A, into the vagina (e.g., by a physician) and positioning the inflatable portion of the pessary behind the cervix. This may involve inserting the pessary to its maximum extent or inserting the pessary in an amount less than the full amount. These balloons are inflated separately by an amount sufficient to hold the pessary in place. A sensor attached to the pessary detects an internal electrical signal, and the internal electrical signal is conveyed by a wire to an EMG sensing system that can record the signal and convert these signals into a graph, sound, or numerical value. The output values are interpreted by an expert or used during the performance of other procedures.

[0085] The EMG sensors are attached to the inflatable portions 525, 525’ of the pessary, and the steps of inflating these portions are performed to position the EMG electrodes at desired locations, such as directly above the pelvic muscles on both sides of the vagina. The method includes receiving the pessary and then attaching the pessary to the EMG sensors, for example, by an adhesive or via a sliding sleeve 560, prior to the procedure. Other steps include positioning one or more EMG sensors at other locations on the pessary, in addition to or instead of the EMB sensors associated with the inflatable portions 525, 525’. Such sensors are disposed on the body of the probe or on a sleeve fitted to the probe and may comprise or be attached to an auxiliary balloon sleeve, as described with respect to FIG. 6A, for example.

[0086] In a further method, in addition to or as an alternative to the EMG sensors, muscle stimulation electrodes are attached to the pessary in a similar manner as described above for the EMG sensors. The pessary is inserted and inflated to fix the pessary in place, and if the electrodes are in the inflatable portion, the position of the electrodes is adjusted as necessary. An electrical signal is then applied to the electrodes to stimulate the muscles adjacent to the electrodes. In a particular method, the muscle stimulation electrodes are attached to or provided on the inflatable portions 525, 525’ and the inflation is used to position the electrodes above the pelvic muscles on both sides, such as the pubococcygeus muscle, and then an electrical signal is applied to stimulate these muscles. Other steps include positioning one or more electrodes for muscle stimulation at other locations on the pessary, in addition to or as alternative muscle stimulation electrodes, associated with the inflatable portions 525, 525’. Such sensors are disposed on the body of the probe or on a sleeve fitted to the probe and may comprise or be attached to an auxiliary balloon sleeve, as described with respect to FIG. 6A, for example.

[0087] It is understood that the method includes both EMG sensing and muscle stimulation, and these activities may be performed in sequence or simultaneously and may use the same or different electrodes.

[0088] Various aspects, examples, and pessary examples and methods for use are disclosed and described herein. Modifications, additions, and changes may be made by those skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

Claim 1 A pessary system for providing pelvic floor ligament support, comprising an elongate probe extending along a longitudinal axis and configured to be inserted into a vaginal cavity, having an insertion end and a distal end; a sleeve having a front portion closest to the insertion end and a body extending along the longitudinal axis, the body having a first side opening and a second side opening provided distally of the front portion; a first inflatable portion located at a substantially first distance from the insertion end and provided adjacent to the first side opening; a second inflatable portion located at substantially the first distance from the insertion end and provided adjacent to the second side opening; at least one conduit in fluid communication with the first inflatable portion and the second inflatable portion; wherein the first inflatable portion and the second inflatable portion are inflatable using fluid introduced through the at least one conduit respectively; the expansion of the first inflatable portion and the second inflatable portion is restricted by the sleeve; when inflated, the first inflatable portion expands from the longitudinal axis laterally into a first radial sector through the first opening; when inflated, the second inflatable portion expands from the longitudinal axis laterally into a second radial sector through the second opening. A system characterized by the above. Claim 2 The probe has a front section adjacent to the insertion end and a rear section adjacent to the distal end, wherein at least a part of the rear section of the probe has sufficient flexibility such that when the front section of the probe is inserted into the treatment position within the vaginal cavity of the patient, a part of the rear section remains outside the vagina and is held within the undergarment worn by the patient. The system according to claim 1, characterized by the above. Claim 3 The position of the sleeve along the longitudinal axis of the probe is adjustable, wherein by adjusting the position of the sleeve, the first distance is changed. The system according to claim 1, characterized by the above. Claim 4 The width of the probe perpendicular to the longitudinal axis along a part of the pessary configured for insertion into the vagina is 1 cm to 2 cm. The system according to claim 1, characterized by the above. Claim 5 The system according to claim 1, wherein the intermediate line of the first sector and the intermediate line of the second sector are separated by 90 degrees to 180 degrees.

6. The at least one conduit includes a first conduit and a second conduit, The first conduit includes a first elongated tube having the first inflatable portion formed therein, The second conduit includes a second elongated tube having the second inflatable portion formed therein, and the system according to claim 1 is characterized in that.

7. The first inflatable portion is the balloon portion of a first balloon catheter, The first conduit is the tube portion of the first balloon catheter, The second inflatable portion is the balloon portion of a second balloon catheter, The second conduit is the tube portion of the second balloon catheter, and the system according to claim 6 is characterized in that.

8. The sleeve is an outer sleeve, and the system according to claim 1 is characterized in that.

9. Each of the first inflatable portion and the second inflatable portion is configured to expand over a first expansion distance toward the distal end of the probe and a second expansion distance toward the insertion end of the probe when inflated, The second expansion distance is different from the first expansion distance, and the system according to claim 1 is characterized in that.

10. A circumferentially inflatable portion, A third conduit in fluid communication with the circumferentially inflatable portion, Further comprising, The circumferentially inflatable portion is located at a second distance longer than the first distance from the insertion end of the probe, The circumferentially inflatable portion is independently inflatable from the first inflatable portion and the second inflatable portion, and the system according to claim 1 is characterized in that.

11. An electromyogram sensor attached to the first inflatable portion, and At least one of the muscle stimulation electrodes attached to the first inflatable portion Further comprising, and the system according to claim 1 is characterized in that.

12. The system according to claim 1, further comprising an inflatable auxiliary sleeve slidably engaged with the outer wall of the probe and movable along the longitudinal axis.

13. The at least one conduit is A first conduit in fluid communication with the first inflatable portion, A second conduit in fluid communication with the second inflatable portion, Including, The first inflatable portion and the second inflatable portion are independently inflatable, The system is, further comprising a first lumen and a second lumen respectively connected to the first conduit and the second conduit, A source of a measured amount of fluid is connected to each of the first lumen and the second lumen, respectively. The system according to claim 1, characterized in that.

14. A lumen connected to a source of the measured amount of fluid, A valve configured to selectively connect the lumen to each of the first conduit and the second conduit, further comprising, The first inflatable portion and the second inflatable portion are independently inflatable by the fluid introduced through the lumen. The system according to claim 13, characterized in that.

15. To enable injecting a measured amount of fluid into the first conduit and the second conduit respectively, a first syringe and a second syringe removably connected to the first conduit and the second conduit respectively are further provided, The first syringe and the second syringe are adjustable constant volume syringes coupled to each other. The system according to claim 13, characterized in that.

16. The first inflatable portion and the second inflatable portion are a first portion and a second portion of a common balloon. The system according to claim 1, characterized in that.

17. The insertion end of the probe further comprises an adjustable end cap, The end cap is configured to enable selective adjustment of the first distance. The system according to claim 1, characterized in that.

18. The insertion end of the probe further comprises a plurality of end caps selectively attachable thereto, Each of the end caps is configured to impart a different first distance when attached to the insertion end of the probe. The system according to claim 1, characterized in that.

19. A customizable pessary system for providing pelvic floor ligament support, An elongated probe extending along a longitudinal axis, configured to be inserted into the vaginal cavity, having an insertion end and a distal end, A first pair of inflatable portions each having an inflatable left side portion and an inflatable right side portion, each located distally along the probe by a first distance from the insertion end, and configured to expand laterally from the probe with respect to the longitudinal axis when inflated, the first pair of inflatable portions; A second pair of inflatable portions each having an inflatable left side portion and an inflatable right side portion, each located distally along the probe by a second distance from the insertion end, and configured to expand laterally from the probe with respect to the longitudinal axis when inflated, the second pair of inflatable portions; A sleeve having a body and extending along the longitudinal axis to a first position and configured to be adjustably disposed on the probe, wherein at the first position, the first pair of inflatable portions is exposed and the second pair of inflatable portions is covered by the body of the sleeve; The sleeve prevents the second pair of inflatable portions from expanding beyond the sleeve to a second position, and at the second position, the second pair of inflatable portions is exposed and the first pair of inflatable portions is covered by the body of the sleeve; The sleeve prevents the first pair of inflatable portions from expanding beyond the sleeve, a customizable pessary system characterized by this.

20. The left side portion of the first pair of inflatable portions and the left side portion of the second pair of inflatable portions are connected to a common left inflation conduit; The right side portion of the first pair of inflatable portions and the right side portion of the second pair of inflatable portions are connected to a common right inflation conduit; The system according to claim 19, characterized in that the left side portion of the first pair of inflatable portions and the left side portion of the second pair of inflatable portions are inflatable independently of the right side portion of the first pair of inflatable portions and the right side portion of the second pair of inflatable portions.

21. The sleeve comprises at least one lateral opening disposed distally spaced from the front of the sleeve; At the first position, the first pair of inflatable portions is exposed through the at least one lateral opening, and at the second position, the second pair of inflatable portions is exposed through the at least one lateral opening; When the first pair of expandable portions and the second pair of expandable portions exposed through the at least one lateral opening expand, the left lateral portions and the right lateral portions of the first pair and the second pair of expandable portions expand outwardly through the at least one lateral opening into a plurality of non-overlapping radial sectors with respect to the longitudinal axis of the probe. The system according to claim 19, characterized in that.

22. The left lateral portion of the first pair of expandable portions is expandable independently of the right lateral portion of the first pair of expandable portions. The left lateral portion of the second pair of expandable portions is expandable independently of the right lateral portion of the second pair of expandable portions. The system according to claim 21, characterized in that.

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