WO2018213187A1

WO2018213187A1 - Pessary systems and methods

Info

Publication number: WO2018213187A1
Application number: PCT/US2018/032563
Authority: WO
Inventors: Michael D. VARDY
Original assignee: Vardy Michael D
Priority date: 2017-05-14
Filing date: 2018-05-14
Publication date: 2018-11-22

Abstract

A pessary cover for insertion of a pessary device therein can comprise a body comprising an internal pocket, first and second openings, and a band. The internal pocket can be configured to receive a portion of the pessary device. The first opening can be configured to receive a first portion of the pessary device. The second opening for receiving a second portion of the pessary device. The band can be positioned proximate a center of the body and can be disposed between the first and second openings. Upon application of a force to first and second side portions of the body, the pessary cover can fold, which causes the first and second openings to expand such that the pessary device is insertable within the internal pocket. The pessary cover can substantially conform to the shape of the pessary device when the pessary device is inserted within the internal pocket.

Description

PESSARY SYSTEMS AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application, filed 14 May 2018, claims the benefit of U.S. Provisional Patent Application No. 62/505,957, filed 14 May 2017, entitled "Pessary Systems and Methods," the entire contents and substance of which are hereby incorporated by reference as if fully set forth below.

TECHNICAL FIELD

[0002] Embodiments of the present disclosure relate to pessary systems and methods and in particular to accessories for pessary devices, including, but not limited to, pessary devices useful in treating pelvic organ prolapse including symptoms of pelvic pressure, heaviness or discomfort from cystoceles, rectoceles, uterine prolapse and enterocele as well as for urinary incontinence, urinary retention, urgency and frequency.

BACKGROUND OF THE INVENTION

[0003] Urinary incontinence can occur in a variety of clinical contexts and can include stress incontinence and urge incontinence. Stress incontinence is the involuntary loss of urine through an intact urethra, secondary to a sudden increase in intra-abdominal pressure, and in the absence of a bladder contraction. Urge incontinence is an inability to control urine leakage because of uninhibitable bladder contractions and may be a component of overactive bladder, including urgency (the sensation that the bladder is full when it is not), frequency and nocturia. Uterine prolapse is a downward displacement of the uterus so that the uterus and cervix extends towards or through the vaginal introitus.

[0004] Although the causes are multifactorial, many patients with clinically significant stress incontinence or uterine prolapse are women who have given birth several times. Pregnancy, labor, and delivery are among the factors that can damage the normal supports of the uterus, bladder neck and proximal urethra. In addition, continence deteriorates with increasing age, even in women who have not borne children, because intra-urethral pressure decreases after menopause due to atrophy of urogenital structures in the absence of premenopausal blood levels of estrogen. Stress incontinence is believed to occur when the proximal urethra drops below the pelvic floor because of pelvic relaxation. Once the pelvic muscles have relaxed, an increase in intra-abdominal pressure (such as occurs during coughing) can overcome urethral resistance to urine flow, and inadvertent leakage of urine from the urethra can occur.

[0005] The number of postmenopausal women is increasing dramatically because of the increasing life span of the population throughout the world. As a result, the incidence of stress incontinence is also increasing significantly. The increasing age of the world population is also increasing the incidence of other types of incontinence. In spite of its prevalence, however, treatments for incontinence have been somewhat inadequate. One of the most common responses to this condition is simply to use absorbent pads, which help contain the inadvertent urine flow. This approach has not met widespread satisfaction.

[0006] Pessaries provide another treatment option. Pessaries are instruments placed into the vagina to support the uterus, stabilize its position, and restore the intra-pelvic anatomic relationships that provide continence. Pessaries can be used for use in the treatment of pelvic organ prolapse including cystoceles, rectoceles, uterine prolapse and enterocele as well as for urinary incontinence. Pessary-like rings have also been used to deliver drugs intra-vaginally. There are many different forms of pessaries, but the most effective are silicone and flexible. To maintain pessary positioning and therefore support of the vaginal walls, pessaries must have some stiffness in their structure. Consequently, the pessary may cause rubbing or pressure at the point of contact against the vaginal wall. This can result in injury to the vaginal wall in the form of erosion. Superficial irritation and erosion may result in vaginal discharge, bleeding, and odor that may limit a patient's tolerance of this non-surgical option. A more serious erosion may result in a full thickness injury to the vaginal wall. In the worst-case scenario, this can result in a fistula between the bladder and the surrounding organs.

BRIEF SUMMARY

[0007] Embodiments of the present disclosure can comprise a pessary cover for insertion of a pessary device therein comprising a body comprising an internal pocket configured to receive at least a portion of the pessary device; a first opening for receiving a first portion of the pessary device; a second opening for receiving a second portion of the pessary device; and a band proximate a center portion of the body, the band disposed between the first and second openings; wherein upon application of a force to first and second side portions of the body, the pessary cover is configured to fold and expand the first and second openings such that the pessary device is insertable within the internal pocket, and wherein the pessary cover is configured to substantially conform to the shape of the pessary device when the pessary device is inserted within the internal pocket.

[0008] Embodiments of the present disclosure can comprise pessary cover for use with a pessary device, the pessary cover comprising: a body comprising a front face and a back face; an internal pocket sized to receive the pessary device; a first opening for receiving a first side portion of the pessary device and a second opening for receiving a second side portion of the pessary device, the first and second openings disposed on the front face of the body; a band disposed proximate a center portion of the body, the band disposed between the first and second openings and disposed on the front face of the body; and one or more functional elements.

[0009] Embodiments of the present disclosure can comprise pessary system for treating urinary incontinence or prolapse comprising: a pessary device comprising a stem comprising a center portion and a top portion, the top portion having a larger diameter than the center portion; a disk integrably connected to the stem; and an annular balloon disposed on the pessary device such that a center void of the annular balloon is disposed about a portion of the stem of the pessary device, the annular balloon being selectively inflatable.

[0010] Embodiments of the present disclosure can comprise a pessary system comprising: a pessary device comprising a hollow annular body comprising an internal diaphragm disposed within an inner portion of the hollow annular body; a first face; and a second face; a cannula disposed proximate an outer perimeter of the annular body, the cannula disposed around at least a portion of the perimeter of the annular body and comprising one or more printed circuit elements; and one or more pockets for receiving one or more electrical devices coupled to the internal diaphragm, the one or more pockets integrably connected to the first face of the pessary device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIGS. 1 A and IB show an example ring pessary for use with one or more embodiments of the present disclosure.

[0012] FIGS. 2A-2D show an example pessary cover, in accordance with one or more embodiments of the present disclosure. [0013] FIG. 3 shows an example pessary drug delivery system, in accordance with one or more embodiments of the present disclosure.

[0014] FIG. 4 shows an example pessary device amenable for use with one or more electrical components, in accordance with one or more embodiments of the present disclosure.

[0015] FIG. 5 shows an example pessary device comprising a balloon, in accordance with one or more embodiments of the present disclosure.

[0016] FIGS. 6A and 6B show an example Gellhorn pessary for use with one or more embodiments of the present disclosure.

[0017] FIG. 7 shows an example annular balloon for use with a Gellhorn pessary, in accordance with one or more embodiments of the present disclosure.

[0018] FIG. 8 shows an example pessary extension system, in accordance with one or more embodiments of the present disclosure.

[0019] FIG. 9 shows an example handle for use with one or more embodiments of the present disclosure.

DETAILED DESCRIPTION

[0020] Although preferred embodiments of the disclosure are explained in detail, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the disclosure is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or carried out in various ways. Also, in describing the preferred embodiments, specific terminology will be resorted to for the sake of clarity.

[0021] It must also be noted that, as used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise.

[0022] Also, in describing the preferred embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

[0023] Ranges can be expressed herein as from "about" or "approximately" one particular value and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. [0024] By "comprising" or "containing" or "including" is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

[0025] It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

[0026] Embodiments of the present disclosure can comprise pessary systems and methods comprising accessories for use with conventional pessary devices. In some embodiments, the accessories can allow for cushioning, broader distribution of contact, decreased friction to reduce erosion of the vaginal wall, and the like. In some embodiments, the pessary systems and methods can comprise disposable pessary covers, configured to accommodate any of the commonly-used pessaries, including ring and Gellhorn pessaries. In some embodiments, the pessary systems can comprise an inflatable annular balloon amenable to fitting on a stem of a Gellhorn pessary. This system can be advantageous because the device can be selectably inflatable or deflatable to reduce the effects (e.g., erosion, discharge, fistula, and odor) of sharp edges of the Gellhorn disk on the vaginal wall. For instance, the balloon can be inflated to increase the surface area of contact of the Gellhorn device with the vaginal wall. In some embodiments, the pessary systems can comprise a clamp for assisting with removal of a pessary device. In some embodiments, the pessary device can include one or more functional elements for providing various functionalities to the pessary device. This can be particularly advantageous because pessary devices are amenable to being left in the vagina of a patient for extended periods of time (e.g., up to six months). Therefore, pessary devices can provide a platform for including functional elements (e.g., sensors, monitors, drug- delivery devices).

[0027] FIGS. 1A and IB illustrate an exemplary ring pessary 100 used to control urinary incontinence or a prolapse for use in accordance with one or more embodiments of the present disclosure. As illustrated in FIG. 1A, the ring pessary 100 can comprise an annular body 102. In some embodiments, the annular body 102 can be hollow. In some embodiments, the ring pessary 100 can comprise a diaphragm 104 attached to an inner surface of the annular body 102 for providing additional support to the ring pessary 100. In some embodiments, the annular body 120 can have a circular cross-section having a diameter or thickness that is greater than a thickness of the diaphragm 104. In some embodiments, ring pessary 100 can comprise a plurality of stress relief portions 106 (e.g., apertures or holes) for facilitating repeated folding of the pessary. As illustrated in FIG. 1 A, these stress relief portions 106 can be of varying sizes and disposed on various portions of the pessary device 100.

[0028] In some embodiments, the ring pessary 100 can be amenable to folding along a central axis, as shown at FIG. IB. Those skilled in the art would understand that folding the ring pessary 100 along a central axis can facilitate insertion into the vagina and once in place, the pessary device 100 can retains original shape. For instance, the pessary device 100 may be composed of an elastic material that permits elastic deformation of the pessary device 100 upon application of force. However, the pessary device 100 is also capable of returning to its original shape. As such, in some embodiments, the pessary device 100 may be composed of an inert rubber material (e.g., medical- grade silicone).

[0029] Embodiments of the present disclosure can comprise a pessary cover for covering at least a portion of a pessary device and, in some embodiments, facilitating incorporating one or more functional elements with a pessary device (e.g., the pessary device 100 shown in FIGS. 1A and IB). FIGS. 2A-2D show a pessary cover 200, in accordance with one or more embodiments of the present disclosure. In some embodiments, the pessary cover 200 can comprise a body 202 comprising an internal pocket 204 configured to receive at least a portion of the pessary device 100, as shown in FIG. 2D. In some embodiments, the pessary cover 200 can comprise a first opening 206a and a second opening 206b, the first and second openings 206a, 206b for receiving a first side portion 108a of the pessary device 100 and a second side portion 108b of the pessary device 100, respectively. The first and second openings 206a, 206b can be separated by a band 208 disposed proximate a center portion of the body 202 of the pessary cover 200.

[0030] As illustrated at FIGS. 2A-2C, in some embodiments, the body 202 of the pessary cover 200 can be sized and configured so as to receive the pessary device 100. Those skilled in the art will understand that the pessary cover 200 can be any shape so as to fit on any pessary device now known or later discovered. The presently disclosed pessary covers can be advantageous as the pessary covers can reduce friction during deployment along the entirety of the device, shield a wire form from view (to be aesthetically pleasing), help control the device during insertion and removal, help the device to stay in place, and/or create more contact area for applying pressure when inserted within a patient.

[0031] As illustrated at FIGS. 2B, in some embodiments, the pessary 100 cover can be configured to fold upon application of a force to first and second side portions 210a, 210b of the body 202. Upon application of the force, the first and second openings 206a, 206b can expand such that the pessary device 100 can be insertable within the internal pocket 204, as illustrated at FIG. 2C. Once the pessary device 100 is inserted through the first and second openings 206a, 206b, the pessary cover 200 can be configured to substantially conform to the shape of the pessary device 100 when the pessary device is inserted within the internal pocket, as illustrated at FIG. 2D. When the pessary device 100 is inserted within the pessary cover 200, the band 208 can be positioned behind the pessary device 100.

[0032] In some embodiments, the pessary cover 200 can be sized and shaped so as to cover only a portion of the underlying pessary device 100, as shown for example in FIGS. 2A-2C. In some embodiments, the pessary cover 200 can be sized and shaped so as to cover the entire underlying pessary device lOOe.

[0033] In some embodiments, as shown in FIGS. 2A-2D, the pessary cover 200 can be discshaped to correspond to a ring-shaped pessary (such as that shown in FIGS. 1A and IB). In other embodiments, the pessary cover can be tubular, cube-shaped, or cylindrical to cover a correspondingly shaped pessary. In some embodiments, the pessary device can be a Gehrung or a Gellhorn pessary and the pessary cover 200 can be specially adapted for use with such devices, as discussed in more detail below.

[0034] In some embodiments, the pessary cover 200 can be composed of a sheet-like material. As used herein, "sheet-like" can refer to a material that is thin and flat. For instance, in some embodiments, the pessary cover 200 can be composed of a sheet-like material that has a thickness of from about 1 mm to about 2 mm. In some embodiments, the pessary cover 200 can be composed of a non-woven or a plastic film. For instance, the pessary cover 200 can be composed of silicone or any other material that can be used intravaginally. In some embodiments, the material can preferably be latex free, but need not be. In some embodiments, the material can be or can be antimicrobial or adapted to include an antimicrobial agent. In some embodiments, the material can be resistant to the absorption of odor. [0035] In some embodiments, the pessary cover 200 can be made or printed based on the known size of the pessary and a size specific print file for all the most widely used pessaries. For instance, in some embodiments, the pessary cover 200 can be fabricated using 3D printing.

[0036] In some embodiments, the pessary cover 200 may include a sealant for adhering the pessary cover 200 to the pessary device 200 in order to hold the pessary cover 200 in place.

[0037] In some embodiments, the pessary system can include one or more functional elements. FIGS. 3-5 show various functional elements for which the described pessary devices can be adapted to include. In some embodiments, the functional elements can be coupled to the pessary device itself. In other embodiments, the function elements can be coupled to a pessary cover, as illustrated, for example, in FIGS. 2A-2D. In some embodiments, the functional elements can be printed directly on the pessary device. In some embodiments, the pessary device can include a housing that is configured to couple a function element, e.g., a motor or a battery, to the pessary.

[0038] FIG. 3 illustrates an exemplary a drug delivery system 300 for inclusion of a pessary device 302, according to one or more exemplary embodiments. The drug delivery system 300 can include a cannula disposed 304 proximate an outer perimeter of the pessary 302 and a reservoir 306 in fluid communication with the cannula 304. In some embodiments, the cannula 304 can comprise a hollow tube through which a drug or other liquid can be delivered to the area around the pessary device 302. In some embodiments, the reservoir 306 can comprise an aperture (not shown) for delivering a drug to the cannula 304 and a locking device (not shown) for facilitating refilling of the reservoir. In some embodiments, the cannula 304 can be disposed about an entire outer perimeter of the pessary 300. In some embodiments, the locking device can be a luer lock facilitating refiling of the reservoir 306.

[0039] In some embodiments, the drug delivery system 300 can be incorporated on a pessary cover, as discussed above with respect to FIGS. 2A-2C. For instance, when the pessary system is inserted within a patient for treating uterine prolapse, the drug delivery system 300 can be on a face of the pessary device 302. The face can be disposed away from the vaginal wall such that the face containing the first and second openings 206a, 206b is in contact with the vaginal wall. In some embodiments, the drug delivery system 300 can be integrated or otherwise coupled with the pessary device 302 itself. For instance, the cannula 304 may be coupled to the annular ring 308 of the pessary device 302 and the reservoir 306 can be coupled to the annular ring 308 of the pessary device 302. [0040] In some embodiments, the cannula 304 can deliver one or more agents including, but not limited to, hormone cream or medication, deodorant or perfumes, local estrogen, trimo-sam, metronidazole, lubricants, lidocaine or other anesthetics, pain-reducing medicines, transdermal overactive bladder medication, anticholinergics and beta agonists, antibiotics or agents designed to stimulate a male partner for erectile dysfunction, or other drugs or agents that can be injected into these channels during regular pessary maintenance visits, or they can be prefabricated with medication already in the cannula 304 . In some embodiments, the cannula 304 may provide slow release delivery of a drug or other agent to the surrounding tissue. In other embodiments, the cannula 304 may provide immediate release of a drug or other agent to the surrounding tissue. In some embodiments, the cannula 304 can be used to irrigate the vagina without removing the pessary. This can be particular advantageous in cases where removal and replacement is particularly uncomfortable. This may reduce the need to remove and replace the pessary, which can be painful.

[0041] In some embodiments, the drug or other agent can be injected into the cannula 304 during regular pessary maintenance visits via a luer lock 310 which can permit filling and re-filling the cannula and reservoir. In some embodiments, the luer lock 310 can be attached to a tube for loading the pessary with a drug or other agent. In some embodiments, the pessary can be prefabricated with medication in the cannula. In other embodiments, a patient can choose to "load" the treatment medication into the drug delivery system 300 herself on a regular basis to provide a predetermined/known amount of medication delivered via a luer lock 310 and tube that may attach to the luer lock. In some embodiments, the tube may be long enough to extend outside the vagina of the user.

[0042] FIG. 4 illustrates an exemplary pessary system for incorporating one or more electrical devices 400, according to one or more embodiments of the present disclosure. In some embodiments, the pessary system for incorporating one or more electrical devices 400 can comprise a cannula 404 disposed proximate an outer perimeter of the pessary device 402 and one or more pockets 406a, 406b for receiving one or more electrical devices. In some embodiments, the pessary system for incorporating one or more electrical devices 400 can comprise printed circuits printed on a surface of the cannula 404 with varying intervals. For instance, the printed circuits can allow for delivery of low voltage to the surrounding tissue, such as the base of the bladder. This may allow for impacting bladder function and to treat various forms of sexual dysfunction and vaginal atrophy. Electrical function can be programmed to propagate from left to right or in a circular fashion as research dictates. For instance, the printed circuity can provide for electrical recording or electrical stimulation.

[0043] In some embodiments, the one or more electrical devices can comprise a communication terminal in communication with a device (e.g., a mobile phone, a portable laptop, a tablet, a desktop computer). The communication terminal can then transfer data about the pessary device to 402 the device. For instance, the communication terminal may transmit image data (e.g., photos or videos of the surrounding tissue to detect erosion) or sensor data (e.g., blood sensor data or other sensor data detecting erosion or bleeding of the surrounding tissue). In some embodiments, the communication terminal can communicate with the device over Bluetooth or WiFi.

[0044] In some embodiments, the one or more electrical devices can be incorporated on a cover, as discussed above with respect to FIGS. 2A-2C. For instance, when the pessary system is inserted within a patient for treating uterine prolapse, the one or more electrical devices can be on a face of the pessary device away from the vaginal wall such as the face that is opposite the first and second openings. In some embodiments, the one or more electrical devices can be integrated or otherwise coupled with the pessary device itself. For instance, the cannula 404 can be coupled to the annular ring of the pessary device 402 and the one or more pockets can be coupled to the diaphragm of the pessary device 402.

[0045] For instance, the pessary cover can comprise a cannula 402, a first housing 406a, a second housing 406b, and printed circuity. In some embodiments, the cannula 402 can comprise a T-doc style cannula to relay biofeedback/pressure sensors information. In some embodiments, the first or second housing can comprise a motor and the first or second housing can comprise a battery or Bluetooth receiver/transmitter to allow for functioning of vibratory or electrical functioning. For instance, the one or more electrical devices may include a light source (e.g., LED), a camera (e.g., for monitoring erosion progression and healing, or to study drug effects on healing erosion/incisions), a blood activated sensor/alarm (e.g., via Bluetooth, WiFi, sound, or LED).

[0046] In some embodiments, the housing can be integrably connected with the pessary cover (e.g., built into the pessary cover). In other embodiments, the housing can be detachably connected to the pessary device 402. In some embodiments, the housing 406a, 406b can be adhered to the pessary device. For instance, the housing may snap into the pessary cover. In some embodiments, the housing can be water proof. [0047] In some embodiments, the pessary device 402 can include an alarm programmed to ring when the pessary 402 has been neglected for a predetermined limit of time, which can reduce fistula formation sometime seen in the nursing home setting.

[0048] FIG. 5 illustrates a pessary system 500 comprising a balloon 502, in accordance with one or more exemplary embodiments. For instance, the pessary device or cover can include an additional portion filled with air. In such embodiments, the pessary device or cover can be more akin to a bag and support an additional bag that can be filled with air to fill the balloon 502. For example, in some embodiments, the pessary device or cover can support a deflated balloon. In use, the balloon 502 can be filled to a desired sized for a more comfortable fit or to assist with uterine prolapse. In some embodiments, the pessary system 500 comprising a balloon 502 can further comprise a luer lock 504 for filling and refilling the balloon as desired. In some embodiments, the luer lock 504 may attach to a tube for facilitating ease of filling the balloon.

[0049] FIG. 6 illustrates a Gellhorn pessary device 600 that can be used with one or more embodiments of the presently disclosed pessary systems. Generally, a Gellhorn pessary device 600 can comprise a stem 602 and a dish 604. A Gellhorn pessary device can serve space-filling functions in the event of vaginal or uterine prolapse. The general structure and design of the Gellhorn pessary 600 can cause a disproportionate amount of pressure at the stem 602 and dish 604 into the vaginal wall leading to an increase in the risk of anterior and posterior wall erosions. Prolonged unattended pessaries also are at increased risk of fistula formation.

FIG. 7 illustrates an annular balloon 702 that can be adapted for use with a Gellhorn pessary 600. The annular balloon 702 can be disposed on the pessary device 600 such that a center void of the annular balloon 702 is disposed about a portion of the stem 602 of the pessary device 600. In some embodiments, the annular balloon 702 can be selectively inflatable to manage positioning of the pessary device 600 within the patient's vagina. For instance, a patient may choose to inflate or deflate the annular balloon 702 to provide added support in the case of discomfort. In some embodiments, the annular balloon 702 can comprise a valve 704 (e.g., a sliding valve) to permit easily inflating or deflating the annular balloon 702. In some embodiments, the positioning of the annular balloon about the stem 602 of the Gellhorn pessary device 600 can be varied depending on the desired placement of the Gellhorn pessary device 600 in the vagina.

[0050] The annular balloon 702 can be composed of an elastic material. For example, the annular balloon 702 can be composed of rubber, silicone, latex, or other elastic. [0051] FIG. 8 illustrates a pessary extension system 800, in accordance with one or more embodiments of the present disclosure. In some embodiments, as illustrated at FIG. 8, the pessary extension system 800 can comprise a threaded tip 802 and a bolt 804 that can be adapted to screw into the threaded tip 802. In some embodiments, the device can comprise a curved handle 806 to increase ease of grasping the pessary extension system 800. The pessary extension system 800 can be useful for instance for women who manage their own Gellhorn pessary device and struggle with removing it.

[0052] In some embodiments, the presently disclosed pessary covers 200 can include a handle structure 808 adapted to an outer edge of the pessary cover 200, as illustrated in FIG. 9. In some embodiments, the handle can permit bending the dish of a Gellhorn pessary against the stem to assist with removal of the device. This can be advantageous because it can make removal less painful.

[0053] In some embodiments, the cover can comprise more than one handle. Having more than one handle can be useful in the event one or more of the handles break, for instance.

[0054] Embodiments of the present disclosure can include a clamp for removing a pessary device from a patient. In embodiments adapted for the Gellhorn pessary, the clamp can be similar to a babcock clamp but the tip of the clamp can be sized for grasping a top portion of the Gellhorn pessary. For instance, the tip of the clamp can have two rounded portions such that when the clamp is used to remove the Gellhorn pessary, the rounded portions can fit about a top portion of the Gellhorn pessary. In some embodiments adapted for a ring pessary, the claim can be similar to a babcock clamp but the tip of the clamp can be sized for grasping around the body of the ring. For instance, the tip of the clamp can be flat such that when the clamp is used to remove the ring pessary, the flat portions can fit on either side of the body of the ring.

[0055] The present invention can combine endosee with vitalview and Fetal scalp sampling kit for sacrospinous ligament fixation.

EMBODIMENTS

[0056] Embodiment 1. A pessary cover for insertion of a pessary device therein comprising: a body comprising an internal pocket configured to receive at least a portion of the pessary device; a first opening for receiving a first portion of the pessary device; a second opening for receiving a second portion of the pessary device; and a band proximate a center portion of the body, the band disposed between the first and second openings; wherein upon application of a force to first and second side portions of the body, the pessary cover is configured to fold and expand the first and second openings such that the pessary device is insertable within the internal pocket, and wherein the pessary cover is configured to substantially conform to the shape of the pessary device when the pessary device is inserted within the internal pocket.

[0057] Embodiment 2. A pessary cover for use with a pessary device, the pessary cover comprising: a body comprising a front face and a back face; an internal pocket sized to receive the pessary device; a first opening for receiving a first side portion of the pessary device and a second opening for receiving a second side portion of the pessary device, the first and second openings disposed on the front face of the body; a band disposed proximate a center portion of the body, the band disposed between the first and second openings and disposed on the front face of the body; and one or more functional elements.

[0058] Embodiment 3. A pessary system for treating urinary incontinence or prolapse comprising: a pessary device comprising a stem comprising a center portion and a top portion, the top portion having a larger diameter than the center portion; a disk integrably connected to the stem; and an annular balloon disposed on the pessary device such that a center void of the annular balloon is disposed about a portion of the stem of the pessary device, the annular balloon being selectively inflatable.

[0059] Embodiment 4. A pessary system comprising: a pessary device comprising a hollow annular body comprising an internal diaphragm disposed within an inner portion of the hollow annular body; a first face; and a second face; a cannula disposed proximate an outer perimeter of the annular body, the cannula disposed around at least a portion of the perimeter of the annular body and comprising one or more printed circuit elements; and one or more pockets for receiving one or more electrical devices coupled to the internal diaphragm, the one or more pockets integrably connected to the first face of the pessary device.

[0060] Embodiment 5. The systems or devices of one or more of the previous embodiments wherein the body further comprises one or more functional elements.

[0061] Embodiment 6. The systems or devices of one or more of the previous embodiments wherein the one or more functional elements comprise a drug administration system comprising: a cannula disposed proximate an outer perimeter of the body; a reservoir in fluid communication with the cannula, the reservoir comprising an opening for delivering a substance to the cannula; and a lock disposed proximate the opening of the reservoir. [0062] Embodiment 7. The systems or devices of one or more of the previous embodiments wherein one or more functional elements comprise a vibratory system comprising: a cannula disposed proximate an outer perimeter of the cover body; and one or more pockets for receiving one or more electrical devices.

[0063] Embodiment 8. The systems or devices of one or more of the previous embodiments wherein one or more electrical devices comprise one or more of a blood detection system, a vibratory device, a speaker, a microphone, a sensor, an alarm, a camera, or a light source.

[0064] Embodiment 9. The systems or devices of one or more of the previous embodiments wherein the body is disk-shaped.

[0065] Embodiment 10. The systems or devices of one or more of the previous embodiments wherein the body is composed of a sheet-like material.

[0066] Embodiment 11. The systems or devices of one or more of the previous embodiments wherein the sheet-like material is composed of one or more of a non-woven film or a plastic film.

[0067] Embodiment 12. The systems or devices of one or more of the previous embodiments further comprising a balloon.

[0068] Embodiment 13. The systems or devices of one or more of the previous embodiments wherein the one or more electrical devices comprise a communication terminal in communication with a mobile device, the communication terminal transmitting data about the pessary device to the mobile device.

[0069] It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purposes of description and should not be regarded as limiting the claims.

[0070] Accordingly, those skilled in the art will appreciate that the conception upon which the application and claims are based can be readily utilized as a basis for the design of other structures, methods, and systems for carrying out the several purposes of the embodiments and claims presented in this application. It is important, therefore, that the claims be regarded as including such equivalent constructions.

Claims

CLAIMS We Claim:

1. A pessary cover for insertion of a pessary device therein comprising:

a body comprising:

an internal pocket configured to receive at least a portion of the pessary device; a first opening for receiving a first portion of the pessary device;

a second opening for receiving a second portion of the pessary device; and a band proximate a center portion of the body, the band disposed between the first and second openings;

wherein upon application of a force to first and second side portions of the body, the pessary cover is configured to fold and expand the first and second openings such that the pessary device is insertable within the internal pocket, and

wherein the pessary cover is configured to substantially conform to the shape of the pessary device when the pessary device is inserted within the internal pocket.

2. The pessary cover of Claim 1, wherein the body further comprises one or more functional elements.

3. The pessary cover of Claim 2, wherein the one or more functional elements comprise a drug administration system comprising:

a cannula disposed proximate an outer perimeter of the body;

a reservoir in fluid communication with the cannula, the reservoir comprising an opening for delivering a substance to the cannula; and

a lock disposed proximate the opening of the reservoir.

4. The pessary cover of Claim 2, wherein the one or more functional elements comprise a vibratory system comprising:

a cannula disposed proximate an outer perimeter of the cover body; and

one or more pockets for receiving one or more electrical devices.

5. The pessary cover of Claim 4, wherein the one or more electrical devices comprise one or more of a blood detection system, a vibratory device, a speaker, a microphone, an alarm, a camera, or a light source.

6. The pessary cover of Claim 1, wherein the body is disk-shaped.

7. The pessary cover of Claim 1, wherein the body is composed of a sheet-like material.

8. The pessary cover of Claim 7, wherein the sheet-like material is composed of one or more of a non-woven film or a plastic film.

9. The pessary cover of Claim 1, further comprising a balloon.

10. A pessary cover for use with a pessary device, the pessary cover comprising:

a body comprising:

a front face and a back face;

an internal pocket sized to receive the pessary device;

a first opening for receiving a first side portion of the pessary device and a second opening for receiving a second side portion of the pessary device, the first and second openings disposed on the front face of the body;

a band disposed proximate a center portion of the body, the band disposed between the first and second openings and disposed on the front face of the body; and

one or more functional elements.

11. The pessary cover of Claim 10, wherein the one or more functional elements comprise a drug administration system comprising:

a cannula disposed proximate an outer perimeter of the body;

a lock disposed proximate the opening of the reservoir.

12. The pessary cover of Claim 10, wherein the one or more functional elements comprise a vibratory system comprising:

a cannula disposed proximate an outer perimeter of the body; and

one or more pockets for receiving one or more electrical devices.

13. The pessary cover of Claim 12, wherein the one or more electrical devices comprise one or more of a blood detection system, a vibratory device, an alarm, a camera, or a light source.

14. The pessary cover of Claim 10, wherein the body is disk-shaped.

15. The pessary cover of Claim 10, wherein the body is composed of a sheet-like material.

16. The pessary cover of Claim 15, wherein the sheet-like material is composed of one or more of a non-woven film or a plastic film.

17. The pessary cover of Claim 10, wherein at least a portion of the body forms a balloon.

18. A pessary system for treating urinary incontinence or prolapse comprising:

a pessary device comprising:

a stem comprising a center portion and a top portion, the top portion having a larger diameter than the center portion;

a disk integrably connected to the stem; and

an annular balloon disposed on the pessary device such that a center void of the annular balloon is disposed about a portion of the stem of the pessary device, the annular balloon being selectively inflatable.

19. A pessary system comprising:

a pessary device comprising:

a hollow annular body comprising an internal diaphragm disposed within an inner portion of the hollow annular body;

a first face; and

a second face;

a cannula disposed proximate an outer perimeter of the annular body, the cannula disposed around at least a portion of the perimeter of the annular body and comprising one or more printed circuit elements; and

one or more pockets for receiving one or more electrical devices coupled to the internal diaphragm, the one or more pockets integrably connected to the first face of the pessary device.

20. The system of Claim 19, wherein the one or more electrical devices comprise a communication terminal in communication with a mobile device, the communication terminal transmitting data about the pessary device to the mobile device.

21. The system of Claim 19, wherein the one or more electrical devices comprises a sensor.

22. The system of Claim 19, wherein the one or more electrical devices comprises a speaker.

23. The system of Claim 19, wherein the one or more electrical devices comprises an alarm.