WO2021242888A1 - Dispositif de pessaire vaginal pour prolapsus d'organe pelvien à construction effondrable améliorée - Google Patents

Dispositif de pessaire vaginal pour prolapsus d'organe pelvien à construction effondrable améliorée Download PDF

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Publication number
WO2021242888A1
WO2021242888A1 PCT/US2021/034300 US2021034300W WO2021242888A1 WO 2021242888 A1 WO2021242888 A1 WO 2021242888A1 US 2021034300 W US2021034300 W US 2021034300W WO 2021242888 A1 WO2021242888 A1 WO 2021242888A1
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WIPO (PCT)
Prior art keywords
pessary
height
stem
pessary device
outer diameter
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PCT/US2021/034300
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English (en)
Inventor
Kaitlin E. MAIER
Meegan P. DAIGLER
Ariana M. SOPHER
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Reia, Llc
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Publication date
Application filed by Reia, Llc filed Critical Reia, Llc
Publication of WO2021242888A1 publication Critical patent/WO2021242888A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion

Definitions

  • This invention relates to pessaries for use in treating pelvic organ prolapse (POP), and more specifically, to removable pessaries.
  • POP pelvic organ prolapse
  • pelvic organ prolapse About 50 percent of women over the age of 50 suffer from some degree of pelvic organ prolapse.
  • the female pelvic organs include the bladder, uterus, vagina and rectum.
  • a prolapse is a medical condition in which at least one organ of the body has collapsed forward, backward, or downward.
  • Pelvic organ prolapse can result from weakening of the pelvic floor muscles and loss of integrity of the pelvic floor connective tissue, which allows for abnormal uterine or vaginal descent. In certain cases, the uterus or portions of the vagina can descend through the opening to the vagina.
  • Symptoms of pelvic organ prolapse include pelvic discomfort, difficulty with urinating and voiding, and sexual dysfunction.
  • pelvic organ prolapse can include a history of pregnancy and childbirth, advanced age, smoking, obesity, connective tissue disorders upper respiratory disorders, repetitive strain injuries, and neuropathies.
  • the severity of pelvic organ prolapse can range from minor and asymptomatic to more severe degrees requiring medical intervention. In the latter case, women can choose to undergo reconstructive surgery to resuspend the fallen structures.
  • women can manage their prolapse with a pessary.
  • the present invention is directed to such a pessary device for non-surgical management of pelvic organ prolapse.
  • FIG. 1 of the prior art presents a case of pelvic organ prolapse in which certain of the pelvic organs have descended from a female pelvic region 100.
  • the female pelvic region 100 is shown in a side view such that the front side 102 is oriented to the left and the rear side 104 is to the right.
  • the pelvic region 100 is supported by a skeletal frame 106.
  • a plurality of prolapsed organs 108 have descended from the pelvic region below the pelvic floor axis 109 that corresponds to a plane running from front to rear along the bottom of the pelvic region. Ordinarily, the pelvic organs are disposed above axis 109.
  • the prolapsed organs 108 that have descended below axis 109 to include a bladder 110, a uterus 112 and the vagina 114.
  • this organ has become inverted, such that the interior lining is now an exterior surface, to the great discomfort of the person for whom it is an ordinary recessed organ.
  • a rectum 116 remains situated above axis 109, but it is contemplated that eventually, it can descend through axis 109 to join the other prolapsed organs 108.
  • a pessary is a device that can be inserted into the vagina to support the descending organs. Pessaries can be recommended for women who do not wish to undergo surgery, for pregnant women, or for women with other serious health issues which makes surgery too risky. Pessaries are primarily made of medical grade silicone, with some containing internal plastic support structures for added rigidity. Some pessaries are entirely or partially made of acrylic. In function, the pessary resides in the vaginal canal and provides support for the descending organs.
  • the pessary device of Fig. 2A (as shown inserted in Fig. 3) are attempts known in the prior art to manage and treat pelvic organ prolapse, commonly known as a "Gellhorn” pessary and “Ring with Support” pessary, respectively.
  • the Gellhorn pessary 200 can include a knob 212 with a stem 214 extending upward and a support 216 at the upper end of the stem 214.
  • the support 216 can include a ring 218 and drainage holes 220.
  • This prior art pessary 200 is inserted into the vagina 114 to support the prolapsed organs 108 of Fig. 1.
  • the pessary 200 can be placed in the vagina 114 just above axis 109 and can stay in place due to residual tone of the pelvic floor muscle group 202 and at least one of a suction, a friction force and/or larger size (so as to cause the vaginal wall to indent around the perimeter of the pessary 200).
  • the pessary supports the organs above it and prevents them from impinging upon or passing through the vaginal introitus (opening) 204.
  • pessaries can cause erosion of the vaginal lining (epithelium) if they are inappropriately sized or left in situ for prolonged periods.
  • a healthcare practitioner for example, a physician, a physician's assistant, a nurse or midwife assesses the size of the vaginal introitus 204 and depth.
  • the pessary can be lubricated, inserted and positioned behind the pubic symphysis 206 (a bony structure in the skeletal frame 106).
  • Pessaries in the prior art tend to be rigid and difficult to remove and re-insert by the user alone. Many women return to the practitioner every three to six months to have their pessary removed, cleaned, and replaced.
  • pessaries are not able to significantly decrease in cross-sectional area.
  • During removal it can be difficult to fold the pessary, often resulting in the pessary being removed in its full or close to full size and shape, which causes discomfort and difficulty.
  • These attributes make self-maintenance of the pessary very painful, if not impossible, and consequently, few women with a pessary are able to remove, clean, and insert their own pessaries.
  • some pessaries are not removable by the patient at all.
  • the knob 212 is relatively small in diameter. The vast majority of patients are unable to grasp it for removal and practitioners need to use forceps to grip the knob 212 for removal. When the pessary 200 is lubricated to attempt to minimize the pain and tearing with insertion, or when it is lubricated after having been in the vagina, this further increases the difficulty of holding the pessary during both insertion and removal.
  • the protruding, rigid knob on the existing stem can result in a pressure point when in constant contact with the vaginal wall leading to irritation, pressure sores and, in extreme cases, fistulas into the bladder or rectum.
  • a pessary that better enables self-maintenance additionally increases accessibility to prolapse management.
  • a pessary that enables users to remove it and clean it themselves increases opportunity for treatment. Therefore, there is a particular need for a pessary device that can be inserted and removed easily by a non-medically trained user without the assistance of a medical practitioner.
  • pessaries can be provided in a collapsible form to help aid in insertion and removal of the pessary device.
  • a collapsible pessary there are many concerns as to the construction of such a collapsible pessary. For example, there is a concern with movable parts and components that would be inserted into the body. Such parts and components of the pessary must be safe and comfortable for the patient.
  • a pessary with such movable components must be reliably capable of collapsing and expanding when needed. Such a pessary must also be capable of being manufactured on a large scale and at reasonable cost.
  • the present invention preserves the advantages of prior art pessary devices, provides new advantages not found in currently available pessaries, and overcomes many disadvantages of such currently available pessaries.
  • the pessary of the present invention overcomes the disadvantages of the prior art by providing a pessary that can be readily inserted, removed, and cleaned without the assistance of a health or medical practitioner.
  • the present invention provides a new and novel pessary device that improves the ease of removal of the pessary for both patients and practitioners.
  • the pessary of the present invention includes a unique easy-to-access loop on a stem of the pessary that can fit a finger therein. The loop can be easily located by a patient so they can insert their finger therein so they may pull down on the stem to, in turn, remove the pessary.
  • the removal loop does not rely on pinch strength for pessary removal.
  • the loop additionally allows practitioners to more easily locate the removal point for the pessary and eliminates the need for forceps or additional tools.
  • the soft, silicone loop decreases the amount of pressure that the knob on the Gellhorn pessary stem typically applies to the vaginal canal because of its flexible, deformable structure.
  • the present invention addresses the various concerns and disadvantages of known pessaries.
  • the present invention provides an improved collapsible pessary that can actuate between a collapsed state and an expanded state.
  • the pessary of the present invention provides various structures, parts, and components to enable the pessary to remain deployed in the supportive position so that it may reliably provide the desired supportive capabilities.
  • other structures, such as webbing may be provided to prevent failure of the pessary and undesirable overcollapsing.
  • a unique ridge structure prevents over-rotation of the supportive members.
  • the present invention provides a pessary device that performs better than prior art pessaries, is more reliable and is easier and more efficient to manufacture than prior art pessaries.
  • FIG. 1 is a cross sectional view of the pelvic organs in a prolapsed state, according to the prior art
  • FIG. 2A and 2B show a prior art pessary device
  • FIG. 3 shows the prior art device of Fig. 2A inserted into a patient
  • FIG. 4 shows perspective view of a pessary in a deployed/expanded condition according to a first embodiment of the present invention
  • Fig. 5 shows a perspective view of the pessary of Fig. 4 in a collapsed condition
  • FIG. 6 is a side view of the pessary of Fig. 4;
  • FIG. 7 is a perspective view of the pessary of Fig. 4 in an installed and locked condition
  • FIG. 8 is a perspective view of the pessary of Fig. 4 in an intermediate condition
  • FIG. 9 is a perspective view of the pessary of Fig. 4 in a collapsed condition for installation;
  • FIG. 10 is a perspective view of another exemplary embodiment of the present invention.
  • FIG. 11 is a bottom perspective view of the pessary of Fig. 10;
  • Fig. 12 is a cross-sectional view of the pessary of Fig. 10;
  • Fig. 13 is a perspective view of a pessary in an over-collapsed condition
  • FIG. 14 is a top perspective view of the pessary of Fig. 4 with a unitary mold insert;
  • Fig. 15 is a cross-sectional view of the pessary of Fig. 4 being molded
  • Fig. 16 is a top view of the pessary of Fig. 4 with a unitary mold insert
  • Fig. 17 is a top view of the pessary of Fig. 4 with a two part mold insert;
  • Fig. 18 is a top view of the pessary of Fig. 4 with a multi-piece mold insert
  • Fig. 19 is a bottom view of an alternative embodiment of the instant invention with alignment features
  • Fig. 20 is a bottom perspective view of an alternative embodiment of the instant invention with alignment features
  • Fig. 21 is a cross-sectional view of the pessary of Fig. 20;
  • Fig. 22 is a bottom perspective view of an alternative embodiment of the instant invention with alternative alignment features;
  • Fig. 23 is a cross-sectional view of the pessary of Fig. 22;
  • Fig. 24 is a bottom perspective view of an alternative embodiment of the instant invention with further alternative alignment features;
  • Fig. 25 is a cross-sectional view of the pessary of Fig. 24;
  • FIG. 26 is a top perspective view of an alternative embodiment of the present invention.
  • FIG. 27 is bottom perspective view of the alternative embodiment of Fig. 26 showing mold parting lines;
  • Fig. 28 is a bottom view of a further alternative embodiment.
  • Fig. 29 is a top view of the embodiment of Fig. 28.
  • linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Further, to the extent that directional terms like top, bottom, up, or down are used, they are not intended to limit the systems, devices, and methods disclosed herein. A person skilled in the art will recognize that these terms are merely relative to the system and device being discussed and are not universal.
  • the pessary 300 includes a stem 310 and supportive members 320, with a central ring or ridge, 330 disposed therebetween.
  • the stem 310 can include a finger hold, or loop, 312 at a proximal or lower end thereof.
  • the finger hold 312 can have a maximum dimension that is greater than an outer diameter of the stem 310.
  • a ridge or central ring 330 can extend radially outward.
  • the stem 310 can extend distally, or upwards, towards the central ring 330.
  • the central ring 330 can be circular and have a maximum outer diameter that is larger than outer diameter of the stem 310.
  • the ring 330 may be continuous or discontinuous.
  • the pessary 300 can be defined by a general mushroom -like shape.
  • the top of the mushroom-like shape can be defined by the support portion 320 which includes a set of radially outwardly hinged support members 322a, 322b, 322c, 322d, as seen in Figs. 5 and 9.
  • the supportive member 320 in the illustrated embodiment includes four distinct members 322a, 322b, 322c, 322d that are preferably equally spaced about the circumference of the pessary 300, when viewed from the top.
  • the pessary can include other numbers of petals for example three, five, six, etc.
  • the space between support members, or petals, 322a-d can be open or enclosed by a thin membrane or other structures between the petals that can be perforated with holes, and/or formed with canals for through-drainage.
  • Each respective support 322a-322d can include a lower support 324a and an upper support 324b.
  • the lower support 324a can be pivotally connected, via a lower hinge 326a, to a node that extends above the central ring 330, the lower and upper supports 324a, 324b can be connected via a central hinge 326b, and the upper support 324b can be connected to an apex region 328 via a top hinge 326c.
  • the aforementioned node can have an outer diameter that is less than the diameter of the central ring 330.
  • Each of the support members 322a-322d can be formed having the same dimensions and construction but may be different than each other instead, if desired.
  • the lower and upper supports 324a, 324b can each be defined by a thicker geometry as compared to the hinges 326a-326c.
  • the stiffness of the supportive members 320 can be defined by the thickness of the upper and lower members 324a, 324b and/or material composition.
  • the various hinges 326a-326c of the instant design can be pivoting hinges or living hinges. In some embodiments, the hinges 326a-326c can be defined by a thinning of material to create living hinges.
  • the supportive members 320 can be made of a rigid or semi-rigid material and the supportive members 320 and/or stem 310 can be overmolded with a soft, pliable, biocompatible material cover, such as silicone.
  • the lower and upper support members 324a, 324b can be folded radially inwardly along the central hinge 326b that can cause the top apex 328 to be translated axially away from the stem 310.
  • the first configuration, or insertion shape, of the support portion can be used during insertion as the maximum outer diameter D1 (as seen in Fig. 9) is a first, smaller, value relative to the other conditions.
  • the outer perimeter, or maximum outer diameter D2 of the support portion 320 can expand radially outward about the central hinge 326a line, relative to the central vertical axis of the pessary 300, as each of the supportive members deploy via axial force (in the direction of the apex) applied to the stem, and/or a downward axial force applied to the apex (such as from prolapse), and/or internal spring bias.
  • the maximum outer diameter D2 is a second value that is larger than the first maximum outer diameter D1 value.
  • the overall height H2 as seen in Fig.
  • the support portion 320 has a second height that is less than the first height HI of the pessary 300 in the first configuration, as seen in Fig. 9.
  • the support portion 320 passes through an intermediate condition, as seen in Fig. 6, having a maximum outer diameter D3 that is larger than the first diameter D1 of the first condition and the second diameter D2 second condition.
  • the movement from the intermediate condition to the second condition provides for a locking arrangement due to the maximum outer diameter D2 in the second configuration being less than the outer diameter D3 of the pessary in the intermediate condition, as seen in Figs. 6 and 7.
  • the three heights HI, H2, H3 identified herein are defined from as a height from the top most part of the support portion 320 to the bottom most part of the stem 310.
  • the bottom hinge 326a is free to rotate the supportive members 324a, 324b down towards the stem 310, however the pessary 300 includes a center ring or ridge 330 just below the lower support members 324a which can help to prevent the bottom hinge 326a from over rotating the lower support members 324a too far down in the second condition.
  • an arc-shaped surface 329 can be complimentary to the radius of curvature of the ridge 330 so that the arc-shaped surface 329 can rest against the ridge 330.
  • the center ring 330 can protrude around the diameter of the stem 310 and fits into a joint bounded by the arc-shaped surface 329 of the bottom hinge 326a, filling in the space where material was removed, or was not present, to create the bottom hinge 326a. If there is downward force on the pessary 300 (such as from a prolapse), the upper support members 324b will flatten onto the respective lower support members 324a, as seen in Fig. 8, and when the lower support members 324a start to deform down, the ridge 330 prevents the lower support members 324a from rotating any further. This allows the pessary 300 to remain supportive.
  • the central hinge 326b can be configured such that until a downwards force is applied to the top apex 328 of the pessary 300, the edges 325a, 325b of successive upper and lower support members 324a, 324b can be in contact with each other, as in Fig. 9, so the pessary 300 remains elongated for insertion purposes. Further, during insertion, the apex region 328 of the pessary 300 can be pressed against the prolapse while an upward force is applied to the stem 310.
  • the upward force on the stem 310 can press the top 328 of the pessary 300 against the prolapse, this compressive force can cause a radially outward force on the central hinge 326b, causing the lower and upper support members 324a, 324b to rotate inward towards each other, as seen in Fig. 6.
  • a radial force on the outer diameter of the pessary such as the vaginal walls, can cause the lower supports 324a to “draw” the stem 310 up towards the apex 328 and “lock” into a secure dome structure rather than elongate into an unsupportive state, as seen in Fig. 7.
  • the entire pessary 300 can be made of a unitary piece of material, such as uniform durometer silicone. However, it is also envisioned that the pessary 300 may be made of different components that are of the same or different materials, such as materials of multiple silicone durometers.
  • the unitary design of the instant pessary 300 can be molded as a single piece of material, as will be discussed below. In some embodiments, additional manufacturing steps can be performed, such as subtractive manufacturing steps to smooth or remove sharp edges, or other unwanted portions of material. Further, in some embodiments, the pessary can be manufactured out of two or more pieces of material. It is understood that other materials can be used and still be within the scope of the present invention.
  • the lower support members 324a of the petals are preferably downwardly arched, as shown in Figs. 6 and 8. Due to the downward arch of the lower support 324a, the central hinges 326b are further from the apex 328 than the lower hinges 326a in the deployed state, or second configuration, as seen in Fig. 7, such that the pessary gets wider, as seen in Fig. 6, before getting narrower when moving from the deployed state (Fig. 7) to the collapsed condition (Fig. 5).
  • the lower hinges 326a can be spring-loaded to maintain this deployed shape naturally, as seen in Fig. 7.
  • the second configuration, or deployed shape has a shape that has resistance to collapsing, or elongating, into the first configuration and tends to remain deployed when inward radial pressure is applied from the vagina, for example.
  • the lower and upper support members 324a, 324b can bottom-out on each other when radially inward pressure is applied and the stem 310 is “drawn” up.
  • the locking force can be overcome and the pessary 300 can collapse to the smaller diameter D1 by way of the support structure 320.
  • the resting state of the pessary 300 is when it is substantially domed, as seen in Fig. 7, and once inserted, the device 300 deploys to this naturally supportive condition.
  • a pessary 400 can further include webbing 450, 452 between respective supportive arm members 422a-422d where they come together at both the stem 410, proximate the lower hinge 426a and at the apex 428, proximate the top hinge 426c.
  • webbing 450, 452 can reenforce the respective support arm members 422a-422d to provide added structural integrity to the pessary 400.
  • the webbing 450, 452 can reduce side to side movement of the petals 422a-422d, e.g. twisting of the petals, which can result in tearing of the pessary 400 or over collapsing one or more support members 422a-422d of the pessary 400, as shown in Fig. 13.
  • This webbing 450, 452 is similar in concept to the thin membrane that can enclose the space between petals (as described in commonly owned US patent application Serial No. 16/832,839, incorporated by reference in its entirety herein).
  • the thin membrane, or “webbing” is only present near the top and bottom hinges 426c, 426a. Additionally, the webbing can be present in additional locations if needed.
  • the pessary is designed to be inserted in the first elongated condition of Fig. 5, into the vagina to correct a prolapse.
  • the first condition permits the device to comfortably be inserted.
  • An applicator not shown, with a barrel and a plunger may retain the pessary 300 in a compressed state for easier insertion to the patient.
  • the plunger can be depressed after the applicator barrel and pessary 300 are inserted into the patient. When depressed, the plunger can eject the pessary 300 from the barrel and deploys the pessary 300 within the patient.
  • an upward or distal force can be applied to the stem 310 to deploy the pessary to the second configuration for providing proper support of the prolapsed tissue, as shown in Fig. 7 for example, where the pessary 300 can remain until it is necessary for removal.
  • the user or practitioner can locate the removal feature 312 at the end of the stem 310 and apply a downward or proximal force to the stem 310.
  • the downward force can cause the lower, center, and upper hinges 326a-326c of the pessary 300 to pivot to elongate and reduce the overall diameter of the support portion 320 of the pessary 300, as the pessary is being removed.
  • the pessary 300 according to the present invention can be formed as a single, unitary, piece of material at the point of manufacturing, for example via a molding step.
  • Figs. 14-18 illustrate alternative embodiments of how the pessary of the present invention can be manufactured, such as by injection molding.
  • a multi-piece mold 500 can create a negative of the pessary and can be filled with silicone, or other flowable material, typically using liquid injection molding or compression molding.
  • the mold 500 can, as illustrated, include multiple pieces including a stem portion 510, a lower support portion 520, an upper support portion 530 and an insert 540.
  • the mold 500 can contain a single insert piece 540 that fills the interior space inside the dome shape support portion 320 of the pessary 300. Once the injection molding is complete, and the pessary 300 is ready for removal, the single piece insert 540 can be removed upon the curing of the silicone.
  • This one part insert 540 is illustrated in Fig. 16, for example.
  • the insert can be in two, or more, parts 542a, 542b to aid in removal, as shown in Fig. 17.
  • the two parts of the insert 542a, 542b can be complimentary, or symmetrical pieces.
  • the insert can be further broken up into more than 2 parts, such as four parts 544a, 544b, 544c, 544d, as seen in Fig. 18.
  • the molds 540, 542a, 542b, 544a-d can be sandwiched between the upper mold portion 530 and the lower mold portion 520 where there are openings between the support members 322a-d of the pessary 300.
  • Figs. 14-18 show various embodiments of molding configurations, but the outside molds can be broken up in a myriad of ways and the insert can be a single part or numerous parts, and the parts can be broken up by a myriad of parting lines. All of these variations are considered to be part of and within the scope of the present invention.
  • the pessary 600 can be manufactured in two separate parts 602, 604 and assembled together in a secondary manufacturing operation.
  • the parting lines 662a, 662b, 662c, 662d between the two pieces 602, 604 can be on the lower portion 624a of the respective support members 622a, 622b, 622c, 622d.
  • the parting line 662a, 662c can be straight across on all support members, or the parting line 662b, 662d can incorporate a dovetail for alignment on all supportive members.
  • a combination of straight parting lines 662a, 662c and dovetail parting lines 662b, 662d can be used.
  • the dovetail features 622b, 622d can align the two parts 602, 604 properly to aid in assembling and adhering the two parts together.
  • the pessary can include two parts that can be split in the bottom section of the supportive arm in various ways.
  • one part can contain an external facing half of the bottom portion of the supportive arm and the other portion contains the internal facing half of the bottom portion of the supportive arm and the stem.
  • These two pieces can be adhered, connected, chemically welded, or secured together with, for example, a silicone adhesive, glue or the like.
  • various alignment features can be provided to help to align the two parts during assembly, thus providing for a more accurate manufacturing process.
  • the alignment features themselves can have a number of different alternatives.
  • These alternatives can include a clearance fit, be “line-to-line,” or even have an interference fit, i.e. the male feature can be smaller than, flush with, or oversized compared to the female feature.
  • the illustrated embodiments make use of a tighter fit that can allow the two parts to stay together during assembly, reducing the need to be held together by an external fixture while the adhesive cures.
  • the pessary 700 can include a first support portion 722 and a second support portion 724.
  • the two support portions 722, 724 can be secured together using various adhesives or other mechanical or chemical fasteners.
  • the embodiment includes a notched connection 770 to ensure proper alignment between the two pieces.
  • the support portion can include a first support portion 722 connected to the stem 710 portion via the lower hinge 726a and a second support portion 724 connected to the upper support portion via the center hinge 726b.
  • the first support portion 722 can include an outer face 722a that is radially outward facing in the first orientation and face the stem in the second configuration.
  • the outer face of the first support portion can include a protrusion 772 that extends outward from a central area of the outer face 722a and a ridge 774 on a lower end of the outer face 722a, closer to the lower hinge 726a.
  • the protrusion 772 is shown as a having a rectangular shape, though other cross section shapes can be used as needed.
  • the second support portion 724 can include an inner face 724a that is sized and shaped to be received by the outer face 722a of the first support portion 722.
  • a face 724b of the second support portion 724 can abut the ridge 774 of the first support portion 722 and the second support portion 724 can include an opening 776 that is sized to receive the protrusion 772 of the first support portion 722.
  • the opening 776 can be slightly smaller than the protrusion 772 to create an interference fit.
  • the alignment features can include an undercut protrusion 773 as shown in Figs. 22 and 23.
  • the undercut protrusion 773 geometry provides for a trapezoidal cross section, as seen in Fig. 23, to hold the two parts together during assembly.
  • the female alignment feature 777 can be a through-hole, where the male alignment feature 775 would be visible on the outside surface of the pessary as shown in Fig. 22.
  • the male alignment feature 775 would be visible on the outside surface of the pessary as shown in Fig. 22.
  • the female alignment feature 778 can be a pocket, or a partial bore that does not extend through the entire thickness of the support member 720, where the male alignment feature 773 does not go all the way through the other part and is thus not visible, as seen in Figs. 24 and 25.
  • the stem 910 is rotated so that the finger loop 912 can be oriented so that the loop is at an approximately 45 degree angle between support members 922a, 922b, as shown in Fig. 26 and additionally similar to the bottom view of Fig. 28.
  • This alternative arrangement can enable alternative mold configurations.
  • Fig. 27 illustrates one such possible mold configuration. For the sake of ease, the mold itself is not illustrated, rather the location of each piece of the mold are demarcated on the respective surfaces of the pessary 900.
  • a first lower part 990 of the mold and a second lower part 992 of the mold can be split along the line shown that extends parallel to a longitudinal axis of the stem 910 up till approximately the central hinge 926b where a third piece 994 of the mold extends over the upper portion of the support members.
  • a single or multi-piece insert 996 can be inserted in the cavity of the support member 920. This particular mold configuration can allow the final molded pessary 900 to not have visible markings or flash from where the mold parts are separated in highly visible surfaces on the pessary.
  • the pessary device of the present invention can be made of known materials that are suitable for pessary devices, such as silicone with or without inserts made of nylon or other rigid material, as discussed in detail above. As shown in Figs 28 and 29, such rigid inserts 1090 are configured to prevent various components of the pessary 1000 of the present invention from being too stretchy or to minimize the possibility of tearing of the silicone portion 1092.
  • the pessary of the present invention can also be made out of silicone that is a different durometer from the supportive portion of the pessary to either increase rigidity or flexibility of pessary, as discussed above.

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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un pessaire présentant des structures, parties et composants divers pour permettre au pessaire de rester déployé dans une position de support de telle sorte qu'il peut présenter de manière fiable les capacités de support souhaitées. Une structure de crête empêche la sur-rotation des éléments de support. Le pessaire peut être formé de préférence par moulage par injection, le moule ayant au moins un insert. La géométrie du pessaire peut permettre au pessaire d'avoir la rigidité, la flexibilité, la capacité d'articulation et la souplesse requises le cas échéant pour obtenir un pessaire qui est supérieur aux pessaires de l'art antérieur.
PCT/US2021/034300 2020-05-28 2021-05-26 Dispositif de pessaire vaginal pour prolapsus d'organe pelvien à construction effondrable améliorée WO2021242888A1 (fr)

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US202063031332P 2020-05-28 2020-05-28
US63/031,332 2020-05-28

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024073824A1 (fr) * 2022-10-06 2024-04-11 Sayco Pty Ltd Pessaire doté d'une fonction de retrait

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4677967A (en) * 1984-11-01 1987-07-07 New Mexico State University Foundation Intravaginal anchor
US20130327338A1 (en) * 2012-06-11 2013-12-12 Hologic, Inc. Intra-uterine device and related methods
US20140158138A1 (en) * 2008-04-23 2014-06-12 Contipi Ltd. Pessaries for prolapse alleviation
US20180296388A1 (en) * 2015-10-13 2018-10-18 Contipi Medical Ltd. Three dimensional devices and methods for prolapse alleviation
US20190091062A1 (en) * 2017-09-26 2019-03-28 Dartmouth-Hitchcock Clinic Pessary for pelvic organ prolapse

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4677967A (en) * 1984-11-01 1987-07-07 New Mexico State University Foundation Intravaginal anchor
US20140158138A1 (en) * 2008-04-23 2014-06-12 Contipi Ltd. Pessaries for prolapse alleviation
US20130327338A1 (en) * 2012-06-11 2013-12-12 Hologic, Inc. Intra-uterine device and related methods
US20180296388A1 (en) * 2015-10-13 2018-10-18 Contipi Medical Ltd. Three dimensional devices and methods for prolapse alleviation
US20190091062A1 (en) * 2017-09-26 2019-03-28 Dartmouth-Hitchcock Clinic Pessary for pelvic organ prolapse

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024073824A1 (fr) * 2022-10-06 2024-04-11 Sayco Pty Ltd Pessaire doté d'une fonction de retrait

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