INTERNATIONAL PATENT APPLICATION of

Ariana M. Sopher Kaitlin E. Maier

and

Meegan P. Daigler

for a

PESSARY FOR PELVIC ORGAN PROLAPSE

PESSARY FOR PELVIC ORGAN PROLAPSE

RELATED APPLICATION

[0001] This application is a continuation-in-part of co-pending U.S. Patent

Application Serial No. 16/141,955, entitled PESSARY FOR PELVIC ORGAN

PROLAPSE, filed September 25, 2018, which claims the benefit of U.S. Provisional Application Serial No. 62/563,443, entitled PESSARY FOR PELVIC ORGAN

PROLAPSE, filed September 26, 2017, and also claims the benefit of U.S. Provisional Application Serial No. 62/827,230, entitled PESSARY FOR PELVIC ORGAN

PROLAPSE, filed April 1, 2019, the teachings of each of which applications are incorporated herein by reference.

GOVERNMENT LICENSE RIGHTS

[0002] This invention was made with government support under a Phase I Small

Business Innovation Research grant awarded by the National Institute of Health, grant application ID: 1 R43 HD097809-01. The government has certain rights in the invention.

FIELD OF THE INVENTION

[0003] This invention relates to pessaries for use in treating pelvic organ prolapse, and more specifically, to removable pessaries.

BACKGROUND OF THE INVENTION

[0004] About 50 percent of women over the age of 50 suffer from some degree of pelvic organ prolapse (“POP”). 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 slipped forward 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. Contributory factors for POP can include protracted labors, large babies, smoking, obesity, connective tissue disorders, upper respiratory disorders and repetitive strain injuries. The severity of POP can range from minor and asymptomatic to more severe degrees requiring medical intervention. In the latter case, women can choose to undergo reconstructive surgery using a surgical implant or a native tissue repair to resuspend the fallen structures.

Alternatively, women can manage non-surgically with a pessary.

[0005] Fig. 1 of the prior art presents a case of POP 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 the bladder 110, the uterus 112 and the vagina 114. In the case of 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.

[0006] 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. In function, the pessary resides in the vaginal canal and provides vertical support for the uterus, as well as lateral support for the bladder and/or rectum, if also prolapsed.

[0007] Fig. 2 of the prior art shows a pessary 200 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). When in position, the pessary supports the organs above it and prevents them from impinging upon or passing through the vaginal introitus (opening). However, pessaries can cause erosion of the vaginal lining (epithelium) if they are inappropriately sized or left in situ for prolonged periods. To fit a pessary, 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. Some women are able to remove and clean their pessaries themselves. The recommendations for self-cleaning have not been standardized, but for example, current Canadian practice advises any woman who is able to remove her own pessary to remove, wash and replace it once per week. Pessaries can be cumbersome and uncomfortable to insert and remove. The average pessary user is a postmenopausal woman and these women often experience vaginal atrophy and dryness as well as narrowing of the vaginal introitus, creating the potential for further difficulty and discomfort of insertion and removal. Currently available pessaries are manually folded or compressed to some degree before insertion. Although this can be helpful with enhancing the ease and comfort of the insertion, currently available 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. Furthermore, some pessaries are not removable by the patient at all.

[0008] The relative rigidity of pessaries and the difficulties in removal can result in a reliance on a healthcare practitioner for regular cleaning, an inability to experience vaginal intercourse and the pessary remaining inserted even when not necessary. It would be desirable for a pessary to be readily inserted and removed by the user, thereby improving the quality of life for that user. SUMMARY OF THE INVENTION

[0009] A pessary overcomes the disadvantages of the prior art by providing a collapsible pessary that can be readily inserted, removed and cleaned without the assistance of a health practitioner. In an embodiment, a pessary can consist of a stem and at least one petal member hingedly attached to an insertion end of the stem. The at least one petal member can rotate between a collapsed state and a deployed state. In the deployed state, the at least one petal member can extend outward from the stem, and in the collapsed state, the at least one petal member can be rotated upwards so that the diameter of the pessary is smaller in the collapsed state than in the deployed state. The pessary can have a plunger that can move within the stem along a vertical axis of the stem, wherein the plunger can slide away from the insertion end of the stem to allow the at least one petal member to rotate upwards into the collapsed state, and the plunger can slide towards the insertion end of the stem to push the at least one petal member into the deployed state. When the plunger is pushed towards the insertion end of the stem, a top of the plunger pushes upwards on the short segment causing the at least one petal member to rotate into the deployed state with the elongated segment extending outwards from the stem. The pessary can include a connection between the top of the plunger and the short segment of the at least one petal member, and when the plunger is pulled away from the insertion end of the stem, the top of the plunger can pull the short segment inwards and downwards, thereby rotating the elongated segment upwards into the collapsed state. The pessary can include a shelf at the insertion end of the stem, so that when the pessary is in a deployed state, the at least one petal member can be supported by the shelf. The pessary can include at least one sliding hinge between the stem and the at least one petal member. The sliding hinge can be hingedly attached to the at least one petal member, and the sliding hinge can be slidably attached within the interior of the stem. The sliding hinge can slide along the interior of the stem in a direction parallel to the vertical axis. The pessary can include a deformable membrane that can be connected to and located between a plurality of short segments. The deformable membrane can be connected to the top of the plunger. The at least one short segment can be connected to the top of the plunger. The at least one petal member can include a tab at the bend, and the plunger cap can have at least one groove, so that when the pessary is in a deployed state, the tab can be engaged with the groove. The at least one petal member can include at least two petal members, and the pessary can include an outer rim, so that the outer rim connects the at least three petal members thereby forming a unitary petal member. The at least one petal member can include at least two petal members, and the pessary can include a petal webbing between the petal members, the petal members and the petal webbing forming a unitary petal member. The pessary can include a stem cap, and in a deployed position, the short segment can be held between the plunger and the stem cap, thereby preventing the petal member from rotating out of the deployed position. The petal members can include an intermediate segment, and in a deployed state, the plunger can prevent the short segment from rotating upwards, thereby preventing the petal member from over-rotating out of the deployed position, and the plunger can prevent the intermediate segment from rotating inwards, thereby preventing the petal member from rotating back to the collapsed state. In the collapsed state, the at least one petal member can be substantially parallel to a vertical axis of the stem.

[0010] In an embodiment, a method of inserting a pessary can include collapsing the pessary into a collapsed state by rotating an elongated member of at least one petal member upwards to decrease the diameter of the pessary; inserting the pessary into the vaginal canal; and pushing a plunger upwards into a stem of the pessary, so that a top of the plunger pushes against the petal members, thereby extending the petal members outwards into a deployed state.

[0011] In an embodiment, a method of removing a pessary can include pulling a plunger downwards from the stem of a pessary, thereby allowing petal members to rotate out of a deployed state; and pulling the pessary downwards, thereby allowing the petal members to rotate into a collapsed state, decreasing the diameter of the pessary; and removing the pessary from the vaginal canal.

[0012] In another exemplary embodiment, the pessary can define a mushroom like shape with a set of radially outwardly hinged, supportive top and bottom members joined together at a hinged top apex and a bottom stem. In a compressed orientation the members fold radially inwardly along a central hinge that causes the apex to translate axially away from the stem. In a deployed orientation/shape, the outer perimeter expands radially along the central hinge line as each of the supportive members deploy via axial force (in the direction of the apex) applied to the stem and/or internal spring bias.

Preferably, the pessary is made of a unitary material, such as uniform durometer silicone, however, it is also envisioned that the pessary may be made of different components that are of the same or different materials, such as materials of multiple silicone durometers. Other materials can be used and still be within the scope of the present invention. The supportive members are defined by a thicker geometry as compared to the hinges. The stiffness of the supportive members can be adjusted by modifying the thickness of the members and/or material composition. In some embodiments, the supportive members can be made of a rigid or semi-rigid material and the supportive members and/or stem can be overmolded with a soft, pliable, biocompatible material cover, such as silicone. Various locking arrangements can be provided between the supportive members to prevent undesired collapse during wearing, which can be overcome by an axial pulling action on the stem. Hinges can be pivoting or live. In embodiments, hinges can be defined by a thinning of material. In an embodiment, the supportive members define four petals equally spaced at right angles about the perimeter. The space between petals 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. The stem can define, a knob, ring or cord assembly to facilitate grasping and removal. An applicator with a barrel and a plunger retains the pessary in a compressed state for application to the patient. The plunger is depressed after the applicator and pessary are inserted into the patient. When depressed, the plunger ejects the pessary from the barrel, and deploys the pessary within the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention description below refers to the accompanying drawings, of which: [0014] Fig. l is a cross sectional view of the pelvic organs in a prolapsed state, according to the prior art;

[0015] Fig. 2 is a view of an inserted pessary, according to the prior art;

[0016] Fig. 3 is a perspective view of a pessary for pelvic organ prolapse in a collapsed state, according to an embodiment;

[0017] Fig. 4 is a view of the pessary in a deployed state, according to an embodiment;

[0018] Fig. 5 is a view of the pessary being inserted in the collapsed state and in situ in a deployed state, according to an embodiment;

[0019] Fig. 6 is a cross-sectional view of the pessary along cross section line 6-6 of Fig. 3, according to an embodiment;

[0020] Fig. 7 is a cross-sectional view of the pessary along cross section line 7-7 of Fig. 4, according to an embodiment;

[0021] Fig. 8 is a view of a pessary with a connection between the plunger cap and the petal members shown in a collapsed state, according to an embodiment;

[0022] Fig. 9 is a view of the pessary of Fig. 8 with a connection between the plunger cap and the petal members and shown in a deployed state, according to an embodiment;

[0023] Fig. 10 is a view of a pessary with a sliding joint interface in a first collapsed state for insertion, according to an embodiment;

[0024] Fig. 11 is a view of the pessary of Fig. 10 with a sliding joint interface in an intermediary state, according to an embodiment;

[0025] Fig. 12 is a view of the pessary of Fig. 10 with a sliding joint interface in a deployed state, according to an embodiment;

[0026] Fig. 13 is a view of the pessary of Fig. 10 with a sliding joint interface in a second collapsed state for removal, according to an embodiment;

[0027] Fig. 14 is a view of a pessary with a connecting deformable membrane in a collapsed state, according to an embodiment;

[0028] Fig. 15 is a view of the pessary of Fig. 14 with a connecting deformable membrane in a deployed state, according to an embodiment; [0029] Fig. 16 is a view of a pessary with notches in the plunger cap and shown in a collapsed state, according to an embodiment;

[0030] Fig. 17 is a view of the pessary of Fig. 16 with notches in the plunger cap and shown in a deployed state, according to an embodiment;

[0031] Fig. 18 is a view of a pessary that can be operated without a plunger, shown in a collapsed state according to an embodiment;

[0032] Fig. 19 is a view of the pessary of Fig. 18 that can be operated without a plunger, shown in a deployed state according to an embodiment;

[0033] Fig. 20 is a perspective view of a unitary petal member for a pessary, according to an embodiment;

[0034] Fig. 21 is a top view of a unitary petal member for a pessary, according to an embodiment;

[0035] Fig. 22 is a top view of a unitary petal member for a pessary with three support members, according to an embodiment;

[0036] Fig. 23 is a view of a unitary petal member for a pessary with closely arranged cutout grooves, according to an embodiment;

[0037] Fig. 24 is a view of a unitary petal member for a pessary with petal lobes, according to an embodiment;

[0038] Fig. 25 is a view of a unitary petal member for a pessary with a circular profile, according to an embodiment;

[0039] Fig. 26 is a view of a unitary petal member for a pessary with a lobed outer rim, according to an embodiment;

[0040] Fig. 27 is a view of a stem with rectangular cavities for petal members, according to an embodiment;

[0041] Fig. 28 is a view of a stem with trapezoidal cavities for petal members, according to an embodiment;

[0042] Fig. 29 is a view of a stem with an alternate cavity shape, according to an embodiment;

[0043] Fig. 30 is a view of a stem with a cavity having no ceiling, according to an embodiment; [0044] Fig. 31 is a partial view of a pessary with a rigid stem cap in a collapsed state, according to an embodiment;

[0045] Fig. 32 is a partial view of the pessary with a rigid stem cap of Fig. 31, shown in a deployed state, according to an embodiment;

[0046] Fig. 33 is a partial view of a pessary with petals that can be held in place by a plunger, shown in a collapsed state, according to an embodiment;

[0047] Fig. 34 is a partial view of the pessary of Fig. 33 with the petals in a deployed state, according to an embodiment;

[0048] Fig. 35 is a perspective view of a pessary with webbing between petals, according to an embodiment;

[0049] Fig. 36 is a perspective view of a domed pessary with resilient deformable petals, according to an illustrative embodiment;

[0050] Fig. 37 is a perspective view of a pessary with resilient deformable members connected to a base ring, according to an embodiment;

[0051] Fig. 38A is a side view of the domed pessary of Fig. 37 shown in a collapsed conformation, according to an illustrative embodiment;

[0052] Fig. 38B is a bottom view of the domed pessary of Fig. 37 shown in a collapsed conformation, according to an illustrative embodiment;

[0053] Fig. 38C is a top view of the domed pessary of Fig. 37 shown in a deployed conformation;

[0054] Fig. 39A is a diagram of a figure-eight pessary in a deployed

conformation, according to an illustrative embodiment;

[0055] Fig. 39B is a detailed view of the apex region A from Fig. 39A, according to an illustrative embodiment;

[0056] Fig. 39C is a detailed view of the hinge region B from Fig. 39A, according to an illustrative embodiment;

[0057] Fig. 39D is a detailed view of the hinge region B from Fig. 39A, according to another illustrative embodiment;

[0058] Fig. 39E is a detailed view of the central union region C from Fig. 39A, according to an illustrative embodiment; [0059] Fig. 40A is a diagram of a figure-eight pessary in a collapsed

conformation, according to an illustrative embodiment;

[0060] Fig. 40B is a detailed view of the central union region A from Fig. 40A, according to an illustrative embodiment;

[0061] Fig. 41 is a diagram of a pessary with petals that rotate about a central axis, according to an illustrative embodiment;

[0062] Fig. 42A is a partially cutaway diagram of the pessary of Fig. 41 showing inner workings of the pivoting hinge and shown in a collapsed state, according to an illustrative embodiment;

[0063] Fig. 42B is a cutaway view of a central pivoting hinge for the pessary of

Fig. 41 showing inner workings and shown in a deployed state, according to an illustrative embodiment;

[0064] Fig. 43 is a cutaway view of a central pivoting hinge for the pessary of

Fig. 41 showing inner workings and in a deployed state, according to another illustrative embodiment;

[0065] Fig. 44 is a perspective view of a pessary with enclosed rotating petals, according to an illustrative embodiment;

[0066] Fig. 45 is a perspective view of the pessary of Fig. 44, shown in the collapsed state;

[0067] Fig. 46 is a cross section of the pessary of Fig. 44 in the deployed state, taken along line 46-46 of Fig. 44, according to an illustrative embodiment;

[0068] Fig. 47 is a partially cutaway view of a rotating pessary that can be disassembled for cleaning, according to an illustrative embodiment;

[0069] Fig. 48 is a perspective view of a pessary with a sliding ring lock, according to an illustrative embodiment;

[0070] Fig. 49 is a perspective view of the pessary of Fig. 48 in a collapsed state, according to an illustrative embodiment;

[0071] Fig. 50 is a perspective view of the pessary of Fig. 48 in a deployed state, according to an illustrative embodiment; [0072] Fig. 51 A is a perspective view of a locking mechanism for the pessary of

Fig. 48, according to an illustrative embodiment;

[0073] Fig. 5 IB is a partially cut away perspective view of a locking mechanism for the pessary of Fig. 48 and shown in a deployed state, according to another illustrative embodiment;

[0074] 51C is a partially cut away perspective view of a locking mechanism pessary of Fig. 5 IB and shown in a collapsed state, according to the illustrative embodiment;

[0075] Fig. 5 ID is a partial perspective view of an upper portion of a pessary with a sliding ring, according to another embodiment;

[0076] Fig. 5 IE is a partial perspective view of the upper portion of the pessary of

Fig. 5 IB shown in a collapsed state, according to the embodiment;

[0077] Fig. 52 is a top view of a pessary with a rotating ring lock, according to an illustrative embodiment;

[0078] Fig. 53 is a cross sectional view of the pessary with a rotating ring lock taken along cross section line 53-53 of Fig. 52, according to an illustrative embodiment;

[0079] Fig. 54 is a top view of a pessary with a rotating ring lock in a collapsed state, according to an illustrative embodiment;

[0080] Fig. 55 is a cross sectional view of the pessary of with a rotating ring lock in a collapsed state, taken along cross section line 55-55 of Fig. 54, according to an illustrative embodiment;

[0081] Fig. 56 is a perspective view of a pessary with a twisting deployment shown in a deployed state, according to an illustrative embodiment;

[0082] Fig. 57 is a perspective view of the pessary with a twisting deployment shown in a collapsed state, according to an illustrative embodiment;

[0083] Fig. 58 is a perspective view of the pessary with a twisting deployment of

Fig. 56 showing a locking mechanism, according to an illustrative embodiment;

[0084] Fig. 59 is a partially cut away perspective view of the pessary with a twisting deployment of Fig. 56 showing the interior of the petals, according to an illustrative embodiment; [0085] Fig. 60 is a perspective view of the pessary with a twisting deployment of

Fig. 56 showing living hinges, according to an illustrative embodiment;

[0086] Fig. 61 is an exposed perspective view of a pessary according to an exemplary embodiment, defining four petals having flexible hinges at outer edges thereof, which are biased into a deployed orientation/shape as shown;

[0087] Fig. 62 is a perspective view of the pessary of Fig. 61, shown in the deployed orientation/shape;

[0088] Fig. 63 is a side view of the pessary of Fig. 61 shown in the deployed orientation/shape;

[0089] Fig. 64 is a side view of the pessary of Fig. 61 shown with petals radially compressed or collapsed against the radially outward bias of the spring force for application to a patient;

[0090] Fig. 65 is a side cross section of a pessary having flexible hinges at the outer edges, in which the hinges lock the petals into a deployed orientation/shape according to an exemplary embodiment;

[0091] Fig. 66 is a perspective view showing a pessary having flexible hinges at the outer edges, in which the petals are locked into a deployed orientation/shape by overlapping members;

[0092] Fig. 67 is a side view of the pessary of Fig. 66 in the deployed

orientation/shape showing the locking members;

[0093] Fig. 68 is a perspective view of a pessary having hinges at the outer edges and a continuous perimeter, which includes four radial drainage canals along the dome shaped top and perimeter edge, according to an exemplary embodiment;

[0094] Fig. 69 is a perspective view of a pessary having hinges at the outer edges and a continuous perimeter, which includes four, enlarged, radial drainage canals along the dome-shaped top and perimeter edge, according to another exemplary embodiment;

[0095] Fig. 70 is a perspective view of a pessary having hinges at the outer edges and a continuous perimeter relative to the dome-shaped top, which includes a plurality of drainage holes thereon, according to another exemplary embodiment; [0096] Fig. 71 is a bottom-oriented perspective view of the pessary of Fig. 70 showing a radial opening between supportive members to allow for drainage;

[0097] Fig. 72 is a side view of a pessary according to an exemplary embodiment, defining four petals having flexible hinges at outer edges thereof, which are biased into a deployed orientation/shape, and including a stem with a ring loop at the distal end thereof;

[0098] Fig. 73 is a side view of a pessary according to an exemplary embodiment, defining four petals having flexible hinges at outer edges thereof, which are biased into a deployed orientation/shape, and including a stem with a pull string at the distal end thereof;

[0099] Fig. 74 is a side view of a pessary according to an exemplary embodiment, having flexible hinges at outer edges thereof, which are biased into a deployed orientation/shape, and including a stem with a pull cord defined in the distal end thereof in an extended position and a looped position;

[00100] Fig. 75 is a perspective view of a pessary according to any of the embodiments of Figs. 61-74 shown in a compressed orientation/shape by the walls of an applicator for insertion into a patient, according to an exemplary embodiment;

[00101] Fig. 76 is a side cross section of a pessary having an overcenter locking mechanism and hinges defined by a pliable elastomeric (e.g. silicone) top cover that encapsulates the supportive members, according to an exemplary embodiment;

[00102] Fig. 77 is a side cross section of a pessary having an overcenter locking mechanism and live hinges between the supportive members, according to an exemplary embodiment;

[00103] Fig. 78 is a side cross section of a pessary having an overcenter locking mechanism and live hinges between the supportive members and stem, with hinges at the apex defined by a pliable elastomeric (e.g. silicone) top cover that encapsulates the supportive members, according to an exemplary embodiment;

[00104] Fig. 79 is a side cross section of a pessary constructed of at least two, discrete durometer levels of a pliable elastomeric material (e.g. silicone); and [00105] Fig. 80 is a side cross section of a pessary constructed of a single durometer of a pliable elastomeric material (e.g. silicone) with hinges defined by thinning of material from the inside of the structure.

[00106] Fig. 81 is a side cross section of a pessary constructed of a single durometer of a pliable elastomeric material (e.g. silicone) with some hinges that are defined by a thinning of material from the outside of the structure.

DETAILED DESCRIPTION

[00107] Fig. 3 is a perspective view of a pessary for pelvic organ prolapse in a collapsed state, according to a first embodiment. A vaginal pessary 300 can be used for treatment of pelvic organ prolapse, and can be retractable and/or collapsible. The pessary 300 can be easily insertable and removable when in a collapsed state. The pessary 300 can include a plurality of L-shaped petal members 310, a hollow stem 320 that can include a shelf 318 at or near the top of the hollow stem 320, a plunger 330 that can include a plunger cap 380 and can reside within the hollow stem 320, and at least one connection to join the petal member 310 to the top of the stem 320. In an embodiment, a pessary can be provided with four rigid or semi-rigid L-shaped petal members 310 with rounded edges 311. In various embodiments, a pessary can have more than or fewer than four petal members. The L-shaped petal members 310 can have a longer segment 314 that is the upper portion of the“L” shape, and a shorter segment 316 that is the lower portion of the“L” shape, so that the elongated segment 314 and the shorter segment 316 can have an angle between them. Each of the petal members 310 can be constructed with a rotation point 317 that can define a bend, or a point of transition, between the elongated segment 314 and the short segment 316. The petal members 310 can be attached to the stem 320 at a hinge. The long segment 314 can rotate from the approximately vertical orientation as shown in Fig. 3, to a position that can be approximately perpendicular to a vertical axis VA that describes a central line extending through and from the top end 350 through the bottom end 360. The material of the pessary can be a biocompatible FDA (U.S. Food and Drug Administration) approved silicone or plastic material. The exterior edges of the petal members can be rounded off, to avoid any sharp edges that might cause injury, infection or irritation to the user.

[00108] In the collapsed state shown in Fig. 3, the plunger 330 and plunger cap

380 can be in a lowered position with respect to the stem 320, and can be out of contact with the short segment 316. The short segment 316 can be oriented inwards towards the vertical axis VA, and the elongated segment 314 can be oriented upwards so as to be substantially aligned with the vertical axis VA. In the collapsed state the overall diameter of the pessary is at a minimum. Although the elongated segments 314 are referred to herein as being vertical, or parallel with the vertical axis VA, when they are in the collapsed state, it should be clear that the elongated segments 314 can hinge inward to a position beyond vertical, so that the elongated segments 314 are leaning inward towards the vertical axis, however, for the sake of clarity and readability, the collapsed state will be referred to herein as being vertical or parallel to the vertical axis.

[00109] The elongated segment 314 can have a length PL that can vary depending on the overall width of the pessary, which can be dependent upon the size of the vaginal canal introitus. In various embodiments, the length PL of a petal member can be in a range from approximately 0.75 to approximately 2.5 inches (+ 0.25 inches). The stem 320 can be a hollow cylinder with a shelf 318 at its uppermost end. Shelf 318 can be co formed with the stem 320. The shelf 318 can provide a resting place for the petal members when deployed, as well as a stopping point for the rotation of the petal members. The stem can include indented gripping surfaces 322 that can improve gripping during insertion and removal. A plunger 330 can be provided at the bottom end 360. When pushed upwards, the plunger can cause deployment of the petal members 310. As used herein, the directional terms, such as, but not limited to,“up” and“down”, “upward” and“downward”,“rear”,“rearward” and“forward”,“top”,“topmost” and “bottom”,“inside” and“outer”,“front” and“back”,“inner“ and“outer”,“interior” and “exterior”,“downward” and“upward”,“horizontal” and“vertical” should be taken as relative conventions only, rather than absolute indications of orientation or direction with respect to an acting direction of the force of gravity. [00110] Fig. 4 is a view of a pessary in a deployed state, according to an embodiment. Turning to Figs. 3 and 4, a pessary 300 can be arranged in either a collapsed state or a deployed state. The collapsed state is suitable for the insertion and removal of the pessary, and can be defined as the configuration in which the plunger 330 is at its lowest position and the elongated segment of each of the L-shaped petal members can be parallel with the vertical axis VA and the shorter segment of each petal member can be oriented inwards. In the collapsed state, the shorter segments 316 can protrude into the center of the stem. When the pessary is in its collapsed state, the diameter of the pessary is at a minimum. When the pessary is in a deployed state, the plunger 330 can be at an uppermost position, the plunger cap 380 can be protruding from the stem, and the elongated segments 314 of each of the petal members 310 can be resting upon and supported by the shelf 318 such that each of the elongated segments 314 can be extended outwards from the vertical axis VA. The pessary 300 can be deployed to the deployed state after insertion into the vaginal canal. In the deployed state, the pessary can have a maximum deployed diameter DD at the widest location. The deployed diameter DD of the pessary in the deployed state can vary based upon the size of the vaginal canal introitus. In an embodiment, the diameter DD of a deployed pessary can be in a range from approximately 1.75 to approximately 5 inches (+ 0.25 inches). The overall diameter of the pessary in a deployed state is greater than the overall diameter of the pessary in a collapsed state.

[00111] A pessary can be inserted by introducing the top end 350 of the pessary 300 into the opening of the vaginal canal and pushing upwards along the vaginal canal (and inwards with respect to the vaginal canal) until the pessary is in a desired position. Once the pessary 300 is inserted into the vaginal canal to the desired position, the plunger 330 can be pushed upwards within the hollow stem 320 to its highest position. As the plunger 330 moves upwards, the plunger cap 380 can engage with and push upwards on the short segment 316 of each petal member 310, thereby causing a rotational motion of the petal members. As the petal members 310 rotate, the elongated segments 314 can move downwards and outwards. The members can rotate approximately 90 degrees or more such that the short segments are approximately vertical (aligned so as to be parallel to the vertical axis VA) and the elongated segments 314 can be approximately perpendicular to the vertical axis VA. In this state, the elongated segments 314 can make contact with and can be supported by the shelf 318. The plunger 330 can remain at its highest position in the stem when the pessary is in its deployed state, and can constrain the L-shaped petal members 310 from rotating and returning to the collapsed state. When the plunger 330 is pulled downwards, the petal members 310 are no longer restrained and are thus free to rotate to the collapsed state with the elongated segments 314 in the vertical position. The pessary can have the smallest diameter in the collapsed state.

[00112] Fig. 5 is a view of a pessary in a deployed state, according to an embodiment. The pessary 300 is shown in a deployed state within a vaginal canal 114 for support of a uterus 116 as a therapy for pelvic organ prolapse. Pessary 300 A shows the pessary in a collapsed state prior to insertion and deployment. In its collapsed state, a pessary can have a collapsed diameter CD of approximately 1 inch (+ 0.5 inches). A soft silicone overmolding can provide for greater comfort during insertion, removal and deployment of the pessary.

[00113] Fig. 6 is a cross-sectional view of the pessary along cross section line 6-6 of Fig. 3, according to an embodiment. Fig. 6 shows the petal members 310 in a collapsed state. A plurality of joints 390 can be situated along the top end of the stem 320 and can connect the stem 320 with the petal members 310. Each petal member 310 can be connected to the stem 320 by at least one joint 390. The joint 390 can be an interface between the stem and each of the petal members and can retain the petal members in connection with the stem during rotation and the states of collapsed and deployed. The joint 390 can be a hinge structure. It is contemplated that in other embodiments, the joint 390 can be a ring-like circumferential feature. In the collapsed state, the plunger cap 380 can be situated within the stem 320, below the short segments 316 of each of the petal members 310.

[00114] Fig. 7 is a cross-sectional view of the pessary along cross section line 7-7 of Fig. 4, according to an embodiment. Fig. 7 shows the petal members in the deployed state. In the deployed state, the plunger cap 380 can be situated at the top end of the stem 320, engaging the short segments 316 of each of the petal members 310. During movement from the collapsed state to the deployed state, the motion of the petal members can be initiated when the plunger cap 380 is pushed upwards, coming into contact with the short segments 316 and urging them to rotate outwards as the plunger cap rises in the stem. When a removal of the pessary is desired, the plunger is moved to its downward position in the stem, drawing the plunger cap 380 downwards and out of contact with the petal members 310, allowing the elongated segments to return to the vertical orientation as the stem is pulled downwards.

[00115] Fig. 8 is a view of a pessary in a collapsed state and with a connection between the plunger cap and the petal members, according to an embodiment. In an embodiment, a pessary 800 can have a connection 802 that can be connected at one end to the top surface of the plunger cap 380, and can be connected at the other end to each of the short segments 316 of the petal members 310. The pessary 800 is depicted in a collapsed state in Fig. 8. Connection 802 can be fixed at its ends so that it can serve as a hinge during the movements (upwards and downwards) of the plunger cap 380. When the pessary 800 is converted from a deployed state to a collapsed state by pulling down on the plunger, the connections 802 can pull the short segments 316 inward and downward, thereby rotating the elongated segments 314 upward and inward into the collapsed state.

[00116] Fig. 9 is a view of the pessary in a deployed state and with a connection between the plunger cap and the petal members, according to an embodiment. When the pessary 800 is converted from a collapsed state to a deployed state by pushing the plunger up into the stem 320, the connections 802 can urge the short segments 316 upwards and outwards, thereby rotating the elongated segments outward and downward into the deployed state.

[00117] Figs. 10-13 show a pessary with a sliding joint interface, according to an embodiment. A pessary 1000 can have a connection 1002 that can be a sliding joint interface between the petal members 310 and the stem 320. The connection 1002 can slide up and down within the stem 320, and can permit the petal members 310 to rotate at the connection 1002. Fig. 10 is a view of a pessary with a sliding joint interface in a first collapsed state, according to an embodiment. In the first collapsed state shown in Fig. 10 the pessary 1000 is in a pre-insertion state and is ready for insertion. The plunger cap 380 can be below the short segments 316 of the petal members 310. The plunger cap 380 can be out of contact with the petal members 310 in the first collapsed state. The sliding connections 1002 are in their lowest position in the stem. The sliding connections 1002 can reside in part in grooves (not shown) on the interior surface of the stem 320, and the sliding connections 1002 can move upwards and downwards within the grooves. In the pre-insertion state, the petal members can be at least partially contained within the stem 320. In this pre-insertion state, the stem 320 can retain the elongated members 314 in a collapsed state, so that they cannot rotate into a deployed state during the insertion process.

[00118] Fig. 11 is a view of the pessary of Fig. 10 with a sliding joint interface in an intermediary state, according to an embodiment. In fig. 11, the plunger 330 is shown in an intermediate state, and moving upwards into a deployed position. The plunger cap 380 can be in contact with the short segments 316 of the petal members 310. In the intermediate state, the plunger cap 380 can begin urging the petal members 310 upwards until they emerge above the shaft 320. As the petal members move upwards, the sliding connections 1002 also move upwards to the top of the shaft. When the sliding

connections 1002 and the petal members 310 reach the end of their travel at the top of the shaft, the plunger cap 380 can push the short segments 316 upwards and outwards, so that the petal members 310 can begin to rotate at the sliding connections 1002. As the petal members 310 rotate, the elongated segments 314 can swing outwards and downwards towards the deployed position.

[00119] Fig. 12 is a view of the pessary of Fig. 10 with a sliding joint interface in a deployed state, according to an embodiment. The plunger cap 380 and the sliding connections 1002 are at their highest position in the stem. The elongated segments 314 are in the deployed position and are resting on and supported by the shelf 316.

[00120] Fig. 13 is a view of the pessary of Fig. 10 with a sliding joint interface in a second collapsed state for removal, according to an embodiment. The plunger cap 380 can be below the short segments 316 in the stem 320 and can be out of contact with the petal members 310. The plunger cap 380 can be at its lowest position in the stem 320. The sliding connections 1002 can remain in their highest position in the stem. As the pessary is removed in a downward movement through the vaginal canal, the walls of the vaginal canal can urge the petal members 310 to move upwards into the vertical orientation.

[00121] Fig. 14 is a view of a pessary with a connecting deformable membrane in a collapsed state, according to an embodiment. A pessary 1400 can have a connecting deformable membrane 1412 that connects petal members 1410. The pessary 1400 can have connections 1420 that can connect the petal members 1410 to the stem 320. The pessary 1400 can have a connection 1422 that connects the membrane 1412 to the plunger cap 380. The petal members 1410 can have an obtuse angle between the elongated segment 1414 and the short segment 1416. The short segments 1416 can be at least partially embedded within the deformable membrane 1412. In the collapsed state shown in Fig. 14, the deformable membrane can bulge inwards and downwards towards the interior of the shaft 320. In the collapsed state, the elongated segments 1414 can be in an approximately vertical orientation and can be aligned parallel to vertical axis VA. Connections 1420 join the petal members 1410 to the stem 320 and can function as a hinging joint. Connection 1422 joins the plunger cap 380 to the deformable membrane 1412.

[00122] Fig. 15 is a view of the pessary of Fig. 14 with a connecting deformable membrane in a deployed state, according to an embodiment. In the deployed state, the plunger cap 380 can be at its highest position in the stem 320, pushing up on the deformable membrane 1412 and causing it to bulge upwards. When the deformable membrane 1412 and short segments 1416 are pushed upwards by the plunger cap 380, the elongated segments 1414 rotate outwards and downwards around connections 1420 until they are in the deployed position, which can be perpendicular to the vertical axis VA. As the plunger is pushed upwards, the plunger cap 380 can push upwards on the deformable membrane 1412 through connection 1422, causing the petal members 1410 to rotate into the deployed position shown in Fig. 15. When the plunger is pulled downwards, the deformable membrane 1412 can be pulled downwards by connection 1422, causing the petal members to rotate back into the collapsed position shown in Fig. 14. [00123] Fig. 16 is a view of a pessary with notches in the plunger cap and shown in a collapsed state, according to an embodiment. A pessary 1600 can have silicone overmoldings 1602, a stem cap 1604, and a plunger cap 1610 that can include notches 1612. Stem cap 1604 can be a deformable membrane, or stem cap 1604 can be a rigid or semi-rigid cap. The pessary 1600 can have petal members 1620 with tabs 1622 near the hinge. Notches 1612 can engage the petal members 1620 at tabs 1622 to lock the petal members in a deployed state. Silicone overmoldings 1602 can cover the elongated segments of the petal members 1620, and can provide the petal members 1620 with a covering that can increase comfort for the user. In the collapsed state shown in Fig. 16, the plunger cap 1610 can be in a resting position that can be out of contact with the petal members 1620. The stem 1630 can include a shelf 1632 to support the petal members 1620 in the deployed state. In the collapsed state, the petal members 1620 can be in an approximately vertical orientation and aligned with the vertical axis VA.

[00124] When the pessary 1600 is manufactured, a hollow plunger 1640 can be inserted into the stem 1630. The plunger cap 1610 can have a plug 1642 within the bottom of the plunger cap 1610, and the plunger cap 1610 can be seated on the hollow plunger 1640 by insertion of the plug 1642 into the hollow plunger 1640. Petal members 1620 can then be added to the top of the stem 1630.

[00125] Fig. 17 is a view of the pessary of Fig. 16 with notches in the plunger cap and shown in a deployed state, according to an embodiment. Plunger cap 1610 can be pushed upwards in the stem, and the plunger cap 1610 can push upwards on the stem cap 1604 and/or petal members 1620, thereby rotating the petal members 1620 into a deployed position. In the deployed position, the petal members 1620 can be supported on the shelf 1632. In the deployed position, tabs 1622 can engage with grooves 1612, thereby locking the pessary 1600 in a deployed state. The tabs 1622 engaged in the grooves 1612 can hold the plunger cap 1610 in the upward position, thereby locking the petal members 1620 in the outstretched position.

[00126] Fig. 18 is a view of a pessary that can be operated without a plunger, shown in a collapsed state according to an embodiment. Pessary 1800 can be free of a plunger. This plungerless pessary 1800 can be inserted, deployed and removed with the assistance of an applicator. Fig. 18 shows pessary 1800 in a collapsed state. The pessary 1800 can include a hollow stem 1810 and a plurality of petal members 1820. An applicator can hold the petal members in the collapsed state during the insertion process, and then the applicator can be removed after insertion, so that the petal members can rotate into the deployed state. The stem 1810 can be provided with a shelf 1811 at one end for supporting the petal members 1820. The stem 1810 can have cavities 1812 at or near the top edge of the stem. Cavities 1812 can allow petal members 1820 to rotate within the cavities 1812. The number of cavities 1812 can be the same as the number of petal members 1820. The petal members 1820 can have an outer layer of silicone overmolding 1822 over a rigid interior layer 1824. A hinged lower edge 1826 can be connected to the stem 1820 by a snap fitted nub in a socket.

[00127] Fig. 19A is a view of the pessary of Fig. 18 in a collapsed state with an applicator. The applicator 1900 can constrain the pessary 1800 in the collapsed state for insertion. In various embodiments, a pessary 1800 can have resilient hinge members 1902 that can be a silicone or other stretchable material. When the pessary 1800 is in the collapsed state within the applicator housing 1904, the petals 1820 have been rotated upwards and the silicone hinge 1902 can be stretched. After the pessary 1800 and applicator 1900 have been inserted into the vaginal canal, a user can push up on the plunger 1906 to eject the pessary 1800 out of the applicator housing 1904.

[00128] Fig. 19B is a view of the pessary 1800 that has been ejected from the applicator 1900. When the pessary 1800 is ejected out of the applicator 1900, the silicone hinges 1902 can return to the relaxed state by pulling the petals down so that they can rotate in the direction of arrow 1910 around their hinged lower edges 1826 until they rest upon the supportive shelf 1811. The silicone hinges 1902 can bias the petals 1820 into the deployed state so that the pessary 1800 remains in the deployed state within the vaginal canal. In various embodiments, the pessary 1800 can be free of silicone hinges 1902, the petals 1820 can be allowed to over-rotate further in the direction of arrow 1910, so that the petals point slightly downwards, and can therefore be maintained in the deployed position by the natural downward force exerted on the pessary 1800 by the descending organs. [00129] Figs. 20-26 depict various alternative embodiments for the designs of the petal members as unitary petal members. These unitary petal members can be incorporated into various embodiments described herein, and can include features of the various embodiments. Fig. 20 is a view of a unitary petal member for a pessary, according to an embodiment. A unitary petal member 2000 for a pessary is shown in a fully extended and deployed state. The unitary petal member 2000 can be circular in shape and can includes a flexible and soft overmolding 2002 with multiple support members 2004 arranged within the unitary petal member 2000. Connection points 2008 can be hinged or otherwise connected to a stem (not shown). Cutout grooves 2010 can facilitate the collapse of the unitary petal member 2000 into a collapsed state with a smaller diameter for ease of insertion and removal.

[00130] Fig. 21 is a top view of a unitary petal member for a pessary, according to an embodiment. The unitary petal member 2100 is shown in a fully extended and deployed state. The unitary petal member 2100 can be circular in shape and can include a flexible and soft overmolding 2102 with multiple support members 2104 arranged within the unitary petal member 2100. The unitary petal member 2100 is shown with four support members 2104, however, a unitary petal member can have more or fewer support members 2104. Connection points 2108 can be hinged or otherwise connected to a stem (not shown). Cutout grooves 2110 can be widely dispersed and can be located along the interior surface of the unitary petal member to facilitate the collapse of the unitary petal member into a collapsed state with a smaller diameter for ease of insertion and removal. The cutout grooves can be spaced widely between the support members 2104.

[00131] Fig. 22 is a top view of a unitary petal member for a pessary with three support members, according to an embodiment. A unitary petal member 2200 is shown in a fully extended and deployed state. The unitary petal member 2200 can be circular in shape and can include a flexible and soft overmolding 2202 with three support members 2204 arranged within the unitary petal member 2200. Connection points 2208 can be hinged or otherwise connected to a stem (not shown). Cutout grooves 2210 are widely dispersed and are located along the interior surface of the unitary petal member to facilitate the collapse of the unitary petal member into a collapsed state with a smaller diameter for ease of insertion and removal.

[00132] Fig. 23 is a view of a unitary petal member for a pessary with closely arranged cutout grooves, according to an embodiment. The unitary petal member 2300 can be circular in shape and can include a flexible and soft overmolding 2302 with multiple support members 2304 arranged within the unitary petal member 2300.

Connection points 2308 can be hinged or otherwise connected to a stem (not shown). Cutout grooves 2310 can be narrowly arranged with respect to each other and can be located along the interior surface of the unitary petal member to facilitate the collapse of the unitary petal member into a collapsed state with a smaller diameter for ease of insertion and removal.

[00133] Fig. 24 is a view of a unitary petal member for a pessary with petal lobes, according to an embodiment. The unitary petal member 2400 can have a plurality of petal lobes 2402. In an embodiment, the unitary petal member can be provided with four petal lobes 2402, however, it is expressly contemplated that the unitary petal member can be provided with more than four petal lobes, or less than four petal lobes in various embodiments. The petal lobes 2402 can be joined at a central hub 2404. The petal lobes 2402 can include internal supports 2406. The central hub and/or petal lobes can be flexible to provide for transition from collapsed state to deployed state and a narrower diameter while in the collapsed state.

[00134] Fig. 25 is a view of a unitary petal member for a pessary with a circular profile, according to an embodiment. A unitary petal member 2500 can have a circular outer rim 2501 that can be a ring shape. A central hub 2502 can be connected to the outer rim 2501 by spokes 2506. While the illustrative unitary petal member includes four spokes 2506, it is contemplated that it can be provided with more than four or less than four spokes. The central hub and/or petal lobes can be flexible to provide for transition from collapsed state to deployed state and a narrower diameter while in the collapsed state.

[00135] Fig. 26 is a view of a unitary petal member for a pessary with a lobed outer rim, according to an embodiment. A unitary petal member 2600 can have an outer rim 2601, and outer rim 2601 can have multiple lobes 2604. Outer rim 2601 is shown with four lobes 2604, however, an outer rim 2601 can have more or fewer lobes than four. A central hub 2602 can be connected to the outer rim 2601 by spokes 2606. While the illustrative unitary petal member includes four spokes 2606, it is contemplated that in other embodiments, the petal member can be provided with more than four or less than four spokes. The outer rim 2601 can include widely dispersed grooves 2620 to facilitate collapse. The central hub and/or petal lobes can be flexible to provide for transition from collapsed state to deployed state and a narrower diameter while in the collapsed state.

[00136] Figs. 27-30 depict various cavity designs for the connection of the petal members to the top of the stem. Fig. 27 is a view of a stem with rectangular cavities for petal members, according to an embodiment. The top of a stem 2700 can be provided with multiple rectangular-shaped cavities 2702 that can function as seats for holding petal members. The stem 2700 can have passages 2704 that connect to the cavities 2702.

Petal members (not shown) can have a cord that extends from the base of the petal through the passage 2704. When the cord is pulled, the base of the petal member can be pulled into the cavity so that when the petal member is engaged within the cavity, the petal member can be held in a deployed position with the petal member extending outwards from the cavity. In various embodiments, the cord can be a string, a wire, etc.

[00137] Fig. 28 is a view of a stem with trapezoidal cavities for petal members, according to an embodiment. The top of a stem 2800 can be provided with multiple trapezoidal-shaped cavities 2802 that can function as seats for holding petal members.

The stem 2800 can have passages 2804 that connect to the cavities 2802. Petal members (not shown) can have a cord that extends from the base of the petal through the passage 2804. When the cord is pulled, the base of the petal member can be pulled into the cavity so that while the petal member is engaged within the cavity, the petal member can be held in a deployed position with the petal member extending outwards from the cavity. Turning back to Fig. 27, the rectangular cavities can hold the petal members in a more fixed position compared to the trapezoidal cavities of Fig. 28. The trapezoidal cavities 2802 can allow increased movement of the petal members up and down compared to the rectangular cavities of Fig. 27. [00138] Fig. 29 is a view of a stem with an alternate cavity shape, according to an embodiment. The top of a stem 2900 can have multiple cavities 2902 that can function as seats for holding petal members. Cavities 2902 can have a floor that can support the petal members (not shown) in a substantially horizontal position in the deployed state.

The cavities 2902 can have a sloped ceiling that can allow the petal members to be angled upwards during removal of the pessary. The stem 2900 can have passages 2904 that can connect to the cavities 2902. Petal members (not shown) can have a cord that extends from the base of the petal through the passage 2904.

[00139] Fig. 30 is a view of a stem with a cavity having no ceiling, according to an embodiment. The top of stem 3000 can have multiple cavities 3002. Cavities 3002 can have a floor that can support the petal members (not shown) in a substantially horizontal position in the deployed state. The cavities 3002 can be free of ceilings, so that the petal members can rotate upwards into a substantially vertical position in the collapsed state. The stem 3000 can have passages 3004 that can connect to the cavities 3002. Petal members can have a cord that extends from the base of the petal through the passage 3004. When the cord is pulled, the petal member can be pulled into the cavity 3002 so that the petal member can be held in a deployed position extending outward from the stem 3000. When the cord is relaxed, the petal members can rotate upwards into a collapsed state to facilitate insertion or removal of the pessary.

[00140] Fig. 31 is a partial cutaway view showing the inner workings of a pessary with a rigid stem cap for holding petals in place in a deployed state, according to an embodiment. A pessary 3100 with a rigid stem cap can have a stem 3102 with a rigid stem cap 3104, a plunger cap 3106, and petal members 3110. Petal members 3110 can have an elongated segment 3112, a short segment 3114, a bend 3116 between the elongated segment 3112 and the short segment 3114, and a hinge 3118 at the bend 3116. The bend 3116 can have an obtuse angle, so that the short segments 3114 and the elongated segments 3112 can be fixed at an angle greater than 90 degrees relative to each other. The petal members 3110 can be attached to the stem 3102 at the hinge 3118. Fig.

31 depicts the pessary with a rigid stem cap 3104 in a collapsed state. In the collapsed state, the plunger cap 3106 can be in a down position, as shown in Fig. 31, thereby allowing the short segments 3114 to be in a downward position within the stem 3102. In this collapsed state with the short segments in a downward position within the stem, the elongated segments 3112 can rest against the rigid stem cap 3104, and the pessary can have a smaller diameter than in the deployed state. In various embodiments, an inner wall of the stem 3102 can have an interengaging feature such as bumps or a ridge 3120, and a stem cap 3104 can have a corresponding interengaging feature such as a divot or groove 3122, so that the interengaging features can hold the stem cap up in the deployed state.

[00141] Fig. 32 is a partial cutaway view showing the inner workings of the pessary with a rigid stem cap of Fig. 31, shown in a deployed state, according to an embodiment. When the plunger cap 3106 is pushed up into the stem 3102, the plunger cap 3106 can push the short segments 3114 upwards, which can cause the petal members 3110 to rotate on the hinge 3118 until the elongated segments 3112 are in a deployed position. The ridge 3120 can be engaged with the groove 3122 to hold the pessary in the deployed position. In the embodiment shown in Fig. 32, the stem 3102 does not have (is free of) a shelf. In this embodiment without a shelf, the rigid stem cap 3104 can hold the petal members 3110 in the deployed position with the elongated segments 3112 extending outwards. When the petal members 3110 are rotated into the deployed position, the rigid stem cap 3104 can prevent the petal members 3110 from rotating beyond the deployed position. The short segments 3114 can be held in place between the plunger cap 3106 and the rigid stem cap 3104, so that the elongated segments 3112 can be maintained in the deployed position. When the plunger is pulled down, the short segments 3114 can rotate down into the stem 3102 and the elongated segments can rotate upwards back into the collapsed state shown in Fig. 31.

[00142] Fig. 33 is a partial cutaway view showing the inner workings of a pessary with petals that can be held in place by a plunger, shown in a collapsed state. A pessary 3300 can have a stem 3302, a plunger 3304 with a plunger cap 3306, and petal members 3310. Petal members 3310 can have an elongated segment 3312, an intermediate segment 3314, and a short segment 3316. The petals 3310 can be maintained in the collapsed state by the plunger 3304. In the collapsed state with the plunger in the down position, the short segment 3316 can rest against the side of the plunger cap 3306, so that the plunger cap 3306 can prevent the short segment 3316 from rotating inwards. By preventing the short segments 3316 from rotating inwards, the plunger cap 3306 also prevents the elongated segments 3312 from rotating outwards into the deployed position. When the plunger 3304 is pushed up into the stem 3302, the plunger cap 3306 can push upwards on the intermediate segments 3314, causing the intermediate segments 3314 to rotate up and out, and thereby causing the elongated segments 3312 to rotate out and down into the deployed position.

[00143] Fig. 34 is a partial cutaway view showing the inner workings of the pessary of Fig. 33 with the petals in a deployed state, according to an embodiment. The pessary 3300 can be free of a supporting shelf for the petal members 3310, and the petal members 3310 can be held in a deployed position by the plunger cap 3306. In the deployed position, the short segments 3316 can contact the bottom of the plunger cap 3306. The bottom of the plunger cap 3306 can prevent the short segments 3316 from rotating upwards. Because the plunger cap 3306 prevents the short segments 3316 from rotating upwards, the petal members 3310 cannot over-rotate out of the deployed position. There is no need for a shelf on the stem, because the plunger cap 3306 can maintain the petal members 3310 in the deployed position, with the elongated segments 3312 extending outwards. The plunger cap 3306 can also prevent the intermediate segments 3314 from rotating inwards. In the deployed position, the intermediate segments 3314 can rest against the side of the plunger cap 3306, so that the petal members 3310 cannot rotate into the collapsed position. The plunger cap 3306 can prevent the petal members 3310 from rotating into the collapsed position by preventing the intermediate segments 3314 from rotating inward and downward, and the plunger cap 3306 can prevent the petal members from over-rotating out of the deployed position with the elongated segments extending outward by preventing the short segments 3316 from rotating upwards. The pessary 3300 can be locked into the deployed position with the petal members 3310 supported by the plunger cap 3306.

[00144] Pulling down on the plunger 3304 can cause the pessary 3300 to transition into the collapsed state. When the plunger 3304 is pulled down, the bottom of the plunger cap 3306 can push down on the short segments 3316, thereby causing the short segments 3316 to rotate downward and outward. When the short segments 3316 rotate downward, the elongated segments rotate upwards into the collapsed position.

[00145] Fig. 35 is a perspective view of a pessary with webbing between petals, according to an embodiment. A pessary 3500 can have a stem 3502, a plunger 3504, petal members 3510 with short segments 3512 and elongated segments 3514, and a petal webbing 3520. The petal webbing 3520 can connect the petal members 3510, thereby forming a unitary petal member 3530. The petal members 3510 and the petal webbing 3520 together can form a supportive surface that can work together to support the pelvic organs. The petal webbing 3520 can be made of a silicone or other deformable material, so that the petal webbing 3520 can fold when the pessary 3500 is transitioned into the collapsed state. The petal webbing 3520 can at least partially envelop the elongated segments 3514 with the silicone or other material, as well as providing additional supportive material between the elongated segments 3514. The petal webbing 3520 is depicted in Fig. 35 as a solid disc, however, the petal webbing can be a series of concentric rings connecting the petal members 3510, or the petal webbing 3520 can be a net or a mesh, or other arrangements of material connecting the petal members 3510. In various embodiments, unitary petal members such as the unitary petal members shown in Figs. 20-26 can be used in place of the unitary petal member 3520 shown in Fig. 35.

[00146] Fig. 36 is a perspective view of a domed pessary with resilient deformable petals, according to an illustrative embodiment. A pessary 3600 can have three or more resilient deformable petal members 3602 that can be joined at the top. Resilient deformable petal members 3602 can be ribs defining a curved dome shape. Resilient deformable petal members 3602 can be connected by a skin (not shown) forming a dome, and the skin can be a silicone overmolding, or other soft flexible material such as silicone. Resilient deformable petal members 3602 can have indented finger tabs 3604.

A resilient deformable petal member 3602 can have an outer perimeter 3606, a recess portion 3608, and a finger tab 3604, so that a radius distance from a central vertical axis to the outer perimeter 3606 is greater than a radius distance from the central vertical axis to the finger tab 3604. The pessary 3600 can be inserted by pinching the finger tabs 3604 towards each other to decrease the overall diameter of the pessary 3600, including the diameter at the outer perimeter 3606. Once the pessary 3600 is inserted, the finger tabs 3604 can be released and the pessary can return to the resting state shown in Fig. 36. To remove the pessary 3600, the finger tabs 3604 can be pinched towards each other to decrease the overall diameter of the pessary 3600.

[00147] In various embodiments, a lower portion of the deformable petal members

3602 can be connected by a string 3610 that can be a silicone, a nylon material with a silicone coating, or other material. String 3610 can be connected to each petal member 3602, and the strings from each petal member can be joined together. The pessary can be removed by pulling on the string 3610. Pulling on the string 3610 can cause the resilient deformable petal members 3602 to move towards each other and decrease the overall diameter of the pessary 3600, including the diameter at the outer perimeter 3606. Pulling on the string 3610 can also exert a force on the pessary 3600 to remove the pessary as the deformable petal members 3602 have moved towards each other.

[00148] Fig. 37 is a perspective view of a pessary with resilient deformable members connected to a base ring, according to an embodiment. A pessary 3700 can have 3 or more resilient deformable petal members 3702 that can be joined at the top, and can be connected to a base ring 3704. Resilient deformable petal members 3702 can be ribs forming a curved dome shape. A soft skin 3706 can connect the resilient deformable petal members 3702 and/or the base ring 3704. Soft skin 3706 can be a soft plastic, a silicone, or other biocompatible material. Base ring 3704 can have one or more ring breaks 3708 in the internal structure of the base ring 3704 to allow the base ring 3704 to be collapsed for easier insertion and removal of the pessary 3700. Base ring 3704 can be overmolded with or entirely comprised of silicone or other soft biocompatible material, and the silicone can cover or encapsulate the ring breaks 3708. Ring breaks 3708 may not be complete cuts or gaps, but can be portions of the ring that are thinner or otherwise weakened to allow easy collapsibility. In various embodiments, the pessary 3700 can have recess portions and finger tabs to ease removal. In various embodiments, the pessary 3700 can have strings connecting multiple lower portions of the base ring 3704 or finger tabs, and the strings can be connected together. Pulling on the string can help to collapse the base ring 3704 and can help to remove the pessary 3700.

[00149] Fig. 38A is a side view of the domed pessary of Fig. 37 shown in a collapsed conformation, according to an illustrative embodiment. A user can flatten or otherwise collapse the pessary 3700 by squeezing sides of the base ring 3704 together and collapsing the base ring 3704 at the ring breaks 3708. Ring breaks 3708 are shown exposed and without silicone overmolding in Fig. 38A for clarity, but it should be clear that ring breaks 3708 can be encapsulated to avoid protruding edges. Fig. 38B is a bottom view of the domed pessary of Fig. 37 shown in a collapsed conformation, according to an illustrative embodiment. The base ring 3704 can have two or more ring breaks 3708 to allow easy collapsibility for ease of insertion. Pessary 3700 can have petal breaks 3802 where the resilient deformable petal members 3702 meet the ring 3704. Petal breaks 3802 can allow the pessary 3700 to collapse more fully for ease of insertion. The pessary 3700 can be overmolded with silicone or other soft biocompatible material, and the silicone can cover or encapsulate the petal breaks 3802. Petal breaks 3802 may not be complete cuts or gaps, but can be portions of the resilient deformable petal members 3702 that are thinner or otherwise weakened to allow easy collapsibility. When the pessary 3700 is released, the resilient deformable petal members 3702 can bias the pessary into the deployed conformation shown in Fig. 37. Fig. 38C is a top view of the domed pessary of Fig. 37 shown in a deployed conformation. When a user releases the pessary, the resilient deformable petal members 3702 can return to their unstressed conformation and can bias the pessary 3700 into the deployed conformation.

[00150] Fig. 39A is a diagram of a figure-eight pessary in a deployed

conformation, according to an illustrative embodiment. A figure eight-shaped pessary 3900 in a deployed conformation can have a structural frame with three or more helical petal members 3902. The exemplary figure-eight pessary in Fig. 39A is shown with four helical petal members 3902. The helical petal members 3902 can be joined at the apex 3904 and at the bottom 3906. The figure-eight pessary 3900 can have a central union 3908, and the helical petal members 3902 can be hingedly joined at the central union 3908. The portion of the figure-eight pessary 3900 between the apex 3904 and the central union 3908 can be a supportive portion 3910, and the portion of the pessary between the central union 3908 and the bottom 3906 can be a pinchable handle portion 3912.

[00151] A helical petal member 3902 can have an upper hinge 3920 at the largest diameter section of the supportive portion, and a lower hinge 3922 at the largest diameter section of the pinchable handle portion. The region of the petal member 3902 between the upper hinges 3920 and the apex 3904 can be a top region 3930, the region of the petal member 3902 between the upper hinges 3920 and the lower hinges 3922 can be a middle region 3932, and the region of the petal member 3902 between the lower hinges 3922 and the bottom 3906 can be a lower region 3934. The upper region 3930 can provide support for the pelvic organs.

[00152] The apex 3904 and the bottom 3906 can be connected with a tensioner

3940. Tensioner 3940 can include an elastic cord or a tension spring between the apex 3904 and the bottom 3906. The tension force between the apex 3904 and the bottom 3906 can bias the pessary into the deployed conformation shown in Fig. 39A. The figure-eight pessary 3900 can have a silicone overmolding, and the silicone overmolding can be molded over the frame in the deployed conformation, so that the silicone overmolding can bias the figure-eight pessary 3900 in the deployed conformation. The frame of the pessary 3900 can be molded or otherwise constructed in the deployed conformation, so that the frame biases the pessary 3900 into the deployed conformation. The figure-eight pessary 3900 can be collapsed by pinching the lower portion of the figure-eight pessary, and the figure-eight pessary can return to a resting deployed conformation when the lower portion is released.

[00153] Fig. 39B is a detailed view of the apex region A from Fig. 39A, according to an illustrative embodiment. In various embodiments, the apex 3904 and/or bottom 3906 can be molded or otherwise constructed with a resilient deformable unitary joint between the petal members 3902. The frame can be molded with a unitary apex 3904 with the petal members 3902 extending outward in the deployed conformation. The resilient deformable unitary joint can be semi-rigid, and can bias the frame into the deployed conformation. [00154] Fig. 39C is a detailed view of the hinge region B from Fig. 39A, according to an illustrative embodiment. In various embodiments, upper hinge 3920 and/or lower hinge 3922 can be a unitary hinge. A portion of the petal member 3902 can be removed to create a thinner section 3950, or the petal member can be molded with a thinner section 3950 and a gap 3952. The living hinge can allow the frame to bend easily into the deployed conformation.

[00155] Fig. 39D is a detailed view of the hinge region B from Fig. 39A, according to another illustrative embodiment. In various embodiments, the upper region 3930, middle region 3932, and lower region 3934 of the petal members 3902 can be distinct components. A pivoting hinge can connect the upper region 3930 and the middle region 3932, so that the regions of the petal members can rotate freely relative to each other, and/or a pivoting hinge can connect the middle region 3932 and the lower region 3934 of the petal members so that the regions of the petal members can rotate freely relative to each other. The pivoting hinge can include a pin 3960 connecting regions of the petal member so that the regions of the petal member can rotate around the pin 3960.

[00156] Fig. 39E is a detailed view of the central union region C from Fig. 39A, according to an illustrative embodiment. In various embodiments, a central union 3908 can include a union ring 3970. Union ring 3970 can have a rectangular cross section, and the petal members 3902 can have mating slots 3972 that can be sized and shaped to accommodate the union ring 3970. The mating slots 3972 can define at least a portion of a shape that is larger than the cross section of the union ring 3970, so that the union ring 3970 can be snapped into the slots 3972, and the slots 3972 can retain the union ring 3970. The union ring can have mechanical stops 3974 that can be bumps or other extensions outward from the union ring between the petal members 3902. The mechanical stops 3974 can prevent the petal members 3902 from sliding around the union ring 3970.

[00157] The supportive portion 3910 of the petal members 3902 can rotate, or lean over, along arrow 3976 to reach the fully deployed conformation, while the pinchable handle portion 3912 of the petal members 3902 can rotate, or lean, along arrow 3978 to reach the fully deployed conformation. In a fully deployed conformation, petal members 3902 can be at a minimum angle MA relative to the union ring 3970, and the upper diameter of the supportive portion of the frame at the upper hinges 3920 can be at the maximum diameter. The mating slots 3972 can have a maximum height MH that can limit how far the petal members can rotate relative to the union ring 3970, thereby limiting the maximum diameter of the supportive portion at the upper hinges. Limiting the maximum diameter of the supportive portion can increase comfort for the user of the pessary. When the user pinches the pinchable handle region of the frame in a region that can include the lower hinges 3922, the petal members can rotate relative to the union ring 3970 in a direction opposite to arrows 3976 and 3978, and the angle of the petal members 3902 relative to the union ring 3970 can increase.

[00158] Fig. 40A is a diagram of a figure-eight pessary in a collapsed

conformation, according to an illustrative embodiment. In the collapsed state, the petal members 3902 have been deformed out of the helical shape of the deployed

conformation, and are now in a more vertical arrangement. A user can apply a pinching force along arrows 4002 at or near the lower hinges 3922 to squeeze the lower hinges 3922 towards each other, thereby elongating the pessary 3900, and decreasing the diameter of the pessary 3900 at the upper hinges 3920.

[00159] The petal members 3902 can be molded into the helical shape shown in

Fig. 39A, so that a force is required to deform the petal members 3902 out of the helical shape and into the shape shown in Fig. 40A, and the molded shape of the petal members 3902 can bias the pessary 3900 back into the deployed conformation of Fig. 39A when the pessary 3900 is released by the user. A silicone overmolding can be molded over the pessary 3900 in the deployed conformation, and the silicone overmolding can bias the pessary into the deployed conformation. A unitary joint at the apex and/or the bottom of the pessary can bias the pessary into the deployed conformation. A tensioner can bias the pessary into the deployed conformation.

[00160] Fig. 40B is a detailed view of the central union region A from Fig. 40A, according to an illustrative embodiment. Petal members 3902 are now in a more vertical arrangement, and petal members 3902 are at a maximum angle A relative to the union ring. Mating slots 3972 are taller than the union ring 3970, and now have extra space at the top and/or bottom of the mating slot 3972. The width of the mating slots 3972 can be approximately the same as the width of the cross section of the union ring 3970, so that the petal members can pivot side to side, but cannot rock in and out. Mechanical stops 3974 prevent the petal members 3902 from sliding around the union ring 3970.

[00161] Fig. 41 is a diagram of a pessary with petals that rotate about a central axis, according to an illustrative embodiment. A pessary 4100 can have at least two rigid petals 4102, 4104 that can rotate about a central axis 4106. In the deployed state, the upper petal 4102 can be rotated into a position that is rotationally remote from the lower petal 4104. In various embodiments, pessary 4100 can have a knob 4108 that can be rotated to rotate the lower petal 4104 from the collapsed state to the deployed state relative to the upper petal 4102, and/or from the deployed state to the collapsed state. Various means can be used for biasing the pessary into a deployed state.

[00162] Fig. 42A is a partially cutaway diagram of the pessary of Fig. 41 showing inner workings of the pivoting hinge and shown in a collapsed state, according to an illustrative embodiment. In a collapsed state, the lower petal 4104 can be parallel to the upper petal 4102. The upper petal 4102 can have an upper hinging member 4210, and the lower petal 4104 can have a lower hinging member 4220. The lower hinging member 4220 can have a tooth 4222 extending radially outward from the lower hinging member 4220. The upper hinging member 4210 can have a locking recess 4212 and a slide 4214. The upper petal 4102 can be biased towards the lower petal 4104 by various means that can include a tensioner such as a tension spring inside of the hinge, or a silicone overmolding surrounding the pivoting hinge that has been molded around the pivoting hinge in the deployed position. As the upper petal 4102 and the lower petal member 4104 are biased towards each other, the lower petal 4104 rotates along arrow 4230 relative to the upper petal 4102, and the tooth 4222 is urged along the slide 4214 and into the locking recess 4212. When the tooth 4222 is in the locking recess 4212 the pessary is in a relaxed and deployed state.

[00163] Fig. 42B is a cutaway view of a central pivoting hinge for the pessary of Fig. 41 showing inner workings and shown in a deployed state, according to an illustrative embodiment. In the deployed state, the tooth 4222 is held within the locking recess 4212. The upper hinging member 4210 and the lower hinging member 4220 are biased towards each other, thereby holding the tooth 4222 within the locking recess 4212.

[00164] Fig. 43 is a cutaway view of a central pivoting hinge for the pessary of Fig. 41 showing inner workings and in a deployed state, according to another illustrative embodiment. Pessary 4100 can have a compression spring 4302 that can bias the lower petal 4104 away from the upper petal 4102, and the pessary 4100 can have a retention lip 4304 that can retain the lower petal 4104 together with the upper petal 4102, thereby limiting how far the compression spring 4302 can force the lower petal 4104 away from the upper petal 4102. The lower petal 4104 can have a groove 4306 that can travel along a thread 4308 on the upper petal 4102. In the relaxed and deployed state shown in Fig.

43, the compression spring has forced the lower petal 4104 to rotate and travel downwards along thread 4308, and the lower petal 4104 is at the most distant point from the upper petal 4102. To insert the pessary, a user can rotate the lower petal 4104 upwards and around the thread 4308 into the collapsed state, and when the user releases the pessary the compression spring 4302 can return the pessary to the deployed state.

[00165] Fig. 44 is a perspective view of a pessary with enclosed rotating petals, according to an illustrative embodiment. A pessary 4400 can have an outer petal 4402 and an inner petal 4404 that can rotate relative to each other around a central axis. The outer petal 4402 can be a rigid member with an inner chamber 4406 that can

accommodate the inner petal 4404. Outer petal 4402 can be overmolded with a silicone casing 4408 that can encapsulate the outer petal 4402 and the inner petal 4404. In various embodiments, the silicone overmolding can have holes that can allow for drainage. The inner petal 4404 can be rotationally remote from the outer petal 4402 in the deployed state shown in Fig. 44. Fig. 45 is a perspective view of the pessary of Fig. 44, shown in the collapsed state. Inner petal 4404 can rotate into the inner chamber 4406 of the outer petal 4402. Rotating the inner petal 4404 into the inner chamber 4406 can decrease the size of the pessary so that it can be inserted into the vaginal canal. Fig. 46 is a cross section of the pessary of Fig. 44 in the deployed state, taken along line 46-46 of Fig. 44, according to an illustrative embodiment. The pessary 4400 can have one or more torsion springs 4602 that can bias the inner petal 4404 into a deployed state that is rotationally remote from the outer petal 4402. The torsion spring 4602 can be connected to, or can press against, spring tabs 4604 on the outer petal 4402 and the inner petal 4404.

[00166] The pessary 4400 can be manufactured by molding the outer petal in two halves along line 46-46 of Fig. 44, and then overmolding the silicone casing around each half separately. The pessary 4400 can then be assembled by snapping the two halves of the outer petal together around the inner petal. An additional layer of silicone overmolding can then seal the snap at the seam.

[00167] Fig. 47 is a partially cutaway view of a rotating pessary that can be disassembled for cleaning, according to an illustrative embodiment. A rotating pessary 4700 can have an upper petal 4702 and a lower petal 4704. Upper petal 4702 and lower petal 4704 can have a silicone overmolding 4706 that can increase comfort for the user. Upper petal 4702 can include an axle 4708, and the lower petal 4704 can rotate around the axle 4708. The pessary 4700 can have a removable endcap 4710. A user can remove the endcap 4710 from the axle 4708 to disassemble the pessary 4700. The lower petal 4704 can be separated from the upper petal 4702 so that each component can be cleaned separately.

[00168] Fig. 48 is a perspective view of a pessary with a sliding ring lock, according to an illustrative embodiment. A pessary 4800 can have three or more hinged petals 4802 that can be joined together at an apex 4804. Petal members 4802 can have an upper hinge 4806, a middle hinge 4808, and a lower hinge 4810. The petal members 4802 can be attached to a sliding ring 4812 that can slide along a central stem 4814. Sliding ring 4812 can slide along the central stem 4814 to move the pessary 4800 between a deployed state and a collapsed state. In various embodiments a silicone overmolding, or other soft material can surround the petal members 4802.

[00169] Fig. 49 is a perspective view of the pessary of Fig. 48 in a collapsed state, according to an illustrative embodiment. The sliding ring 4812 can be at the lowest position along the central stem 4814, and upper hinges 4806 and lower hinges 4810 can be bent. Fig. 50 is a perspective view of the pessary of Fig. 48 in a deployed state, according to an illustrative embodiment. The sliding ring can be at the highest position along the central stem 4814, and the middle hinges 4808 can be bent. In the deployed position, the petals 4802 are extending radially outward from the central stem, and the diameter of the pessary around the middle hinges 4808 is at a maximum diameter. In various embodiments, a silicone overmolding 5002 or other soft material that can surround the petals can be expanded outwards with the petals, so that the petals 4802 and the silicone overmolding together can support the pelvic organs.

[00170] Fig. 51 A is a perspective view of a locking mechanism for the pessary of Fig. 48, according to an illustrative embodiment. The central stem 4814 can have one or more locking bumps 5102 that extend outwards from the stem 4814. Stem 4814 can be hollow and/or flexible, and stem 4814 can flex to allow the sliding ring 4812 to pass over the locking bumps 5102. The locking bumps 5102 can retain the sliding ring 4812 in the upward position, thereby locking the petals 4802 in the deployed state extending radially outward from the central stem 4814. A user can release the pessary 4800 from the deployed state by squeezing the stem 4814 inward along arrows 5104, so that the sliding ring 4812 can pass over the locking bumps 5102 and can slide downward on the stem 4814 into the collapsed state.

[00171] Fig. 5 IB is a partially cut away perspective view of a locking mechanism for the pessary of Fig. 48 and shown in a deployed state, according to another illustrative embodiment. The central stem of the pessary can include an outer sleeve 5110 and an inner slider 5112 that can slide, or telescope, within the outer sleeve 5110. The tops of the petals 4802 can be attached at a top of the slider, and the bottoms of the petals 4802 can be attached to the sleeve. Although only two petals are shown in Fig. 5 IB for clarity, it should be clear that the pessary can have more than two petals 4802. The inner slider 5112 can have a ridge 5114 or lip around at least a portion of the circumference of the inner slider 5112, and the outer sleeve 5110 can have one or more bumps 5116 or extensions that can extend inward from an interior wall of the slider. The bumps 5116 and the ridge 5114 can limit the movement of the pessary between a deployed state and a collapsed state, because a force must be exerted on the pessary to move the ridge 5114 past the bumps 5116. Additionally, the pessary can be molded so that it is biased to the deployed stage, or it can have a spring (not shown) biasing it to the deployed stage which stretches in the collapsed state. [00172] 51C is a partially cut away perspective view of a locking mechanism pessary of Fig. 5 IB and shown in a collapsed state, according to the illustrative embodiment. To collapse the pessary, a user can pull on the outer sleeve so that the bumps 5116 can move past the ridge 5114 and the outer sleeve 5110 can move relative to the inner slider 5112. When a user pulls on the outer sleeve to remove the stem from the vagina, the outer sleeve can extend away from the petals, and the pessary can collapse.

As the pessary collapses, the petals can fold upwards for ease of removal. In various embodiments, the outer sleeve can be provided with a string 5118, so that a user can pull on the string in removing the pessary.

[00173] Fig. 5 ID is a partial perspective view of an upper portion of a pessary with a sliding ring, according to another embodiment. Turning to Figs. 48 and 5 ID, the upper portion of a pessary as shown in Fig. 5 ID can be adapted for use with a sliding ring 4812 and stem 4814 as shown in Fig. 48. A pessary 5 ID can have a sliding ring that can be free of a locking mechanism. A pessary 5130 can have a plurality of rigid or semi rigid petals 5132 that can be rotatably connected to a fixed upper ring 5134, pins, or other rotatable hinging mechanisms. Petals 5132 can have an upper hinge 5136 where petal members rotate around a ring 5134, a middle hinge 4808 that can include a pin or other rotating hinge, and a lower hinge 4810 at or near sliding ring 4812. In various

embodiments a silicone overmolding, or other soft material can surround the petals 5132. Sliding ring 4812 can slide along the central stem 4814 to move the pessary 5130 between a deployed state and a collapsed state.

[00174] Fig. 5 IE is a partial perspective view of the upper portion of the pessary of Fig. 5 ID shown in a collapsed state, according to the embodiment. A user can slide the sliding ring 4812 downwards to transform the pessary 5130 into the collapsed state with a minimum diameter for insertion. After the pessary has been inserted, the user can slide the sliding ring 4812 upwards to transform the pessary into the deployed state. After the pessary 5130 has been inserted and is in the deployed conformation, the pessary can remain in the deployed, supportive state shown in Fig. 51 A due to the placement of the pessary 5130 in the body and the natural distribution of forces within the body. The majority of forces acting on the pessary 5130 while the pessary is in the deployed conformation within the body are exerted downwards on the pessary, thereby maintaining the pessary in a stable and supportive deployed conformation. The tops of the petals 5132 can be cut or otherwise manufactured with interlocking angled ends 5138 so that in the deployed state they can meet at the apex to form a smooth dome top.

[00175] Fig. 52 is a top view of a pessary with a rotating ring lock, according to an illustrative embodiment. A pessary 5200 can have a plurality of broad petals 5202 that can support the pelvic organs. Petals 5202 can be attached to a stem 5204 at flexible joints 5206. A rotating ring lock 5208 can have extended locking portions 5210 and notches 5212. The extended locking portions 5210 can extend radially outward beyond the flexible joints 5206 to support the petals 5202. In various embodiments the pessary can have a silicone overmolding that forms a membrane to enclose the space between the petals (not shown). The rotating ring lock 5208 can be rotated in the direction of arrow 5214 to unlock the pessary 5200. When the notches 5212 are under the flexible joints 5206 the petals 5202 can fold downwards into the collapsed position. Fig. 53 is a cross sectional view of the pessary with a rotating ring lock taken along cross section line 53- 53 of Fig. 52, according to an illustrative embodiment. An extended locking portion 5210 is shown extending under the petal 5202 and supporting the petal 5202 in the deployed state.

[00176] Fig. 54 is a top view of a pessary with a rotating ring lock in a collapsed state, according to an illustrative embodiment. The rotating ring 5208 lock has been rotated around the stem 5204 so that the notches 5212 are under the flexible joints 5206. Petals 5202 are bent downwards through the notches 5212 into the collapsed state. Fig.

55 is a cross sectional view of the pessary of with a rotating ring lock in a collapsed state, taken along cross section line 55-55 of Fig. 54, according to an illustrative embodiment. Petals 5202 can be flexed downward into the collapsed state, and the extend locking portions can extend outward between the petals 5202 without interfering with the petals 5202 folding downward into the collapsed state.

[00177] Fig. 56 is a perspective view of a pessary with a twisting deployment shown in a deployed state, according to an illustrative embodiment. A pessary 5600 can have a plurality of three or more petals 5602. The upper ends of the petals 5602 can be flexibly joined to the top of the stem 5604, and petals can have a hinge 5606. The lower ends of the petals 5602 can be flexibly joined to a sliding and rotating ring 5608 that can slide along and rotate around the stem 5604. The pessary 5600 can have a silicone overmolding 5610 connecting the petals 5602 to form a supportive webbing between the petals 5602.

[00178] Fig. 57 is a perspective view of the pessary with a twisting deployment shown in a collapsed state, according to an illustrative embodiment. Ring 5608 can be slid downward along arrow 5702 and can be rotated along arrow 5704 to transition the pessary 5600 into the collapsed state. In the collapsed state, petals 5602 can be elongated and twisted around the stem 5604 to minimize the diameter of the pessary 5600.

[00179] Fig. 58 is a perspective view of the pessary with a twisting deployment of Fig. 56 showing a locking mechanism, according to an illustrative embodiment. In Fig.

58, only two petals 5602 are shown for clarity, but it should be clear that pessary 5600 can have more than two petals. Stem 5604 can have spiral grooves 5804, and ring 5608 can have one or more threads that can slide within the spiral grooves 5804, so that the ring 5608 can be guided through the motion up and down the stem 5604 and the rotational motion around the stem 5604 at the same time. The stem 5604 can have one or more locking bumps 5802 that extend outwards from the stem 5604. Stem 5604 can be hollow and/or flexible, and stem 5604 can flex to allow the sliding ring 5608 to pass over the locking bumps 5802. The locking bumps 5802 can retain the sliding ring 5608 in the upward position, thereby locking the petals 5602 in the deployed state extending radially outward from the stem 5604. A user can release the pessary 5600 from the deployed state by squeezing the stem 5604 inward along arrows 5806, so that the sliding ring 5608 can pass over the locking bumps 5802 and can slide downward on the stem 5604 into the collapsed state.

[00180] Fig. 59 is a partially cut away perspective view of the pessary with a twisting deployment of Fig. 56 showing the interior of the petals, according to an illustrative embodiment. In Fig. 59, only two petals 5602 are shown for clarity, but it should be clear that pessary 5600 can have more than two petals. Petals 5602 can have rigid floats 5902 within the petals 5602, and the petals can include a silicone overmolding 5904 that contains the rigid floats 5902. Silicone overmolding 5904 can form the flexible joints between the top of the petals 5602 and the stem 5604, the flexible joints between the bottom of the petals 5602 and the ring 5608, and the joints 5606 in the petals 5602.

[00181] Fig. 60 is a perspective view of the pessary with a twisting deployment of Fig. 56 showing living hinges, according to an illustrative embodiment. In various embodiments, the petals 5602 can be molded together as one part along with the sliding and rotating ring 5608 and a fixed ring 6002. The fixed ring 6002 can be fixedly attached to the top of the stem 5604, so that the tops of the petals 5602 are held in a fixed position relative to the top of the stem, and the petals can have flexible joints where the petals meet the fixed ring. Petals 5602 can have living hinges as part of the unitary structure between the petals 5602 and the fixed ring 6002, and the petals can have living hinges as part of the unitary structure between the petals 5602 and the sliding and rotating ring 5608. Petals 5602 can also have unitary living hinges at hinge 5606.

[00182] Fig. 61 and Fig. 62 show a pessary 6100 defining a domed-top shape in the depicted deployed orientation. The pessary 6100 can include a series of members that essentially define radially extended petals 6110. There are four petals 6110 in this embodiment, but more or fewer can be defined in alternate arrangements. In Fig. 61, the dome-shaped (when deployed) pessary 6100 in this embodiment also includes a stem 6120, which is a straight-cylindrical bottom-extension in this embodiment, but can more particularly define other shapes, such as a graspable knob 6220 (with a flared tip 6222 and pinched mid-section 6224 as shown in Fig. 62). The pessary 6100 has arched, supportive top members that meet at the apex 6140 of the dome and flat, supportive bottom members 6150 that meet at the stem 6120 at the base of the dome. Each arched top member 6130 is connected to a flat supportive bottom member 6150 by a flexible hinge 6160. The arched top members 6130 are connected at the apex 6140 of the dome by flexible hinges (shown schematically as dashed-lines 6230). Likewise, the flat bottom members 6150 are connected to the stem 6120, 6220 by flexible hinges (shown schematically as dashed lines 6240). In the preferred embodiment, the entire device (including the supportive members and stem) are made of a unitary material, such as a single durometer, medical-grade silicone. In some embodiments, supportive members 6130, 6150 and stem 6120, 6220 are overmolded with an elastomeric, biocompatible cover layer 6170 of material, such as medical-grade silicone or soft nylon. The flexible hinges 6230, 6240 and the biocompatible cover layer 6170 can be molded as part of the supportive members 6130, 6150 and/or stem 6120, 6220, and/or can be separate components. The supportive members can be constructed from any acceptable, biocompatible material, or combination of materials, such as medical grade polymers (e.g. nylon, acrylic, polycarbonate, etc.) and/or metals (such as medical grade stainless steel, nickel alloys, aluminum alloys, titanium, etc.). In further embodiments, described below, some or all of the supportive members can be constructed from a similar material (e.g. silicone) as the overmolded cover, but could be of a higher durometer (hardness). The hinges can be live hinges with a unitary construction from a flexible material, or can be pivoting hinges with discrete halves and a hinge pin structure. Hinges can be formed unitarily with one or both supportive members/stem or can be separately attached. In various embodiments, described below, some or all of the hinges can be defined by the appropriate shape and size provided to the silicone at the hinge junctions. Construction techniques should be clear to one of skill.

[00183] Typically, when inserted, the user applies axial force to the stem 6120, in the direction of the apex 6140 to cause radially outward deployment of the petals 6110 as depicted in Fig. 63. In another embodiment, the hinges 6160 are preferably configured and arranged to be spring-biased, such as in the form of live hinges, to achieve a normal bias in the deployed orientation, so the pessary returns to its deployed position automatically without user intervention. It is also envisioned that additional spring biasing members may be employed to carry out this spring-biasing action. In such an embodiment, the petals 6110 are, thus, normally biased by such spring force into a deployed orientation as also depicted in Fig. 63. This depicted mushroom shape, when deployed, allows the pessary 6100 to remain secured within the patient’s vaginal cavity, and support it, during normal wear.

[00184] As shown in Fig. 64, the pessary is inserted into the patient in the depicted, compressed orientation, where pressure is applied (e.g. by the depicted hand 6410) radially inwardly (arrows 6420). This causes the hinges to move and the apex 6140 of the petal structure to shift axially upwardly (arrow 6430), away from the stem 6220. Deployment, under axial biasing force (manual pressing of the stem or spring loading), occurs in the direction opposite arrows 6420 and 6430.

[00185] Depending upon the degree of applied spring force at the hinges, the pessary may adequately retain its shape during various activities by the patient. The continuity of the deployed shape can be enhanced by providing a deployment locking mechanism as shown generally in Fig. 65. This pessary 6500 includes petal structures 6510, a domed top 6512 and a stem 6520, and can be constructed with arched upper supportive members 6530 similar to the pessary 6100 described above. To assist in locking the structure, the bottom supportive members 6550 of petals 6510 are

downwardly arched as shown. Hence, the hinges 6560 are overcenter in the deployed state such that the pessary gets wider before getting narrower when moving from the deployed state to the collapsed state. The hinges 6560 between members 6530, 6550 (and/or respective top and bottom hinges 6580, 6590 at the apex 6540 and/or stem 6520) can be spring-loaded to maintain this deployed and locked shape. This shape has resistance to collapsing and tends to remain deployed when inward radial pressure (arrows 6570) is applied. More particularly, the top and bottom supportive members 6530 and 6550 bottom-out on each other when radially inward pressure (arrows 6570) is applied. However, by pulling on the stem 6520, the overcenter locking force can be overcome and collapse of the petal structure can occur.

[00186] Another embodiment of a locking structure or mechanism is shown in the pessary 6600 of Figs. 66 and 67. This embodiment includes a supportive member petal structure 6610 as described above. The locking mechanism comprises a pair of overlapping pieces applied to or molded with each respective supportive member 6530 and 6550 as shown. Each member 6632 and 6652 includes a respective shoulder 6534 and 6554, each of which interengages with the other to provide a secure lock against axial motion— which can result in, or from, undesired radial compression of the pessary 6600. The locking action of this mechanism 6632 and 6652 can be overcome by axially pulling (arrow 6710) upon the stem 6620/6720 (note differing ring/knob shapes as described further below) to cause the lower members 6650 to hinge first, thereby releasing interference between the shoulders 6534, 6554. This allows further axial motion and radial compression of the pessary to occur for planned removal from the patient.

[00187] Reference is made to Fig. 68, which shows a pessary 6800 with spaces between supportive members entirely enclosed by a thin membrane, cover or layer of material 6810 that completely obscures supportive members and hinges with or without locking mechanisms as described in any of the above exemplary embodiments (Figs. 61- 67). Thus, the depicted pessary is a fully sealed unit that avoids contamination of internal structures by biological materials, dirt, fluids, etc. To provide drainage, the membrane 6810 that encloses spaces between supportive members includes shallow (a few millimeters in width/depth) formed canals 6820, that extends between notches in the perimeter edge 6830 and the apex 6840 of the top dome 6850. The size and placement of canals is highly variable. In this embodiment, there are four canals positioned at 90- degree offsets from each other and between supportive members.

[00188] Another fully enclosed pessary 6900 with a membrane 6910 is shown. Larger canals 6920 are provided between supportive members (not shown) of a type described above (Figs. 61-67). The canals can be any size and shape and generally define wedge-like cutouts in the overall perimeter edge 6930.

[00189] The exemplary pessary 7000 of Figs. 70 and 71 defines a thin membrane of material that encloses space between supportive members that includes ports or holes 7030 and 7032 along the dome-shaped top in the space between supportive members (not shown) of a type described above (Figs. 61-67). The depicted holes 7030, 7032 are of differing size, defining smaller holes 7030 closer to the apex 7040. The holes are circular or ovular as depicted. The size, placement and shape of holes along the top can be highly variable in alternate arrangements. In this embodiment, the bottom 7130 (Fig. 71) defines cutouts 7140 that follow the general edge profile the bottom supportive members as described above, so as to provide drainage through the interior of the deployed pessary 7000 relative to the top holes 7030, 7032.

[00190] As described above, the geometry of the stem can vary. The pessary 7200 of Fig. 72, which is otherwise constructed in any manner described above (Figs. 61-71), can define a molded ring shape 7210 at the distal end of the stem 7220. This shape is of sufficient diameter DR to allow an adult finger or other tool to grasp, and apply axial pulling force, to (e.g.) remove the pessary 7200 from the patient.

[00191] Alternatively, the pessary 7300 (Fig. 73) can include a stem of any shape.

The depicted stem 7320 is, by way of non-limiting example, as a knob-shaped stem described above. The stem 7320 includes a through-hole 7330 at its distal end, into which is inserted and secured a separate string or cord 7350 of biocompatible material (e.g. silicone, polymer monofilament or non-dissolving suture material).

[00192] Fig. 74 shows a pessary 7400 constructed with supportive members and hinges in accordance with any of the above embodiments (Figs. 61-71). The stem 7420 extends downwardly as a pliable, cord-like extension 7440 that ends in an enlarged distal bulb 7442. The length of the extension 7430 is highly variable in exemplary

implementations. The stem 7420 includes a hole or ring 7450 with in inner diameter IDR that is slightly smaller than the outer dimension (diameter width, etc.) ODB of the bulb 7442. When applied to the patient, the bulb 7442 can be passed through the hole 7450 so that the extension 7430 forms a loop as shown in the right-hand version of pessary 7400. This loop can reduce the overall length of the extension and allow for a grasping structure for removal of the pessary 7400 from the patient.

[00193] While not shown, it is contemplated in various arrangements that the stem can define a telescoping structure that interconnects with the inner side of the apex. This can be used to further stabilize the pessary shape in a deployed orientation— for example acting as a stop against further expansion. The telescoping structure can also serve as a lock— for example including detents and/or a rotational arrangement that allows the user to rotate or otherwise actuate the stem between a locked and unlocked state.

[00194] Fig. 75 shows an arrangement in which a pessary 7510 according to any of the embodiments above (Figs. 61-74) is inserted into the distal end 7522 of an applicator 7520. The applicator can be any acceptable biocompatible material with a main cylindrical (or other shape) barrel 7524 having an inner diameter IDC sized and arranged to retain the pessary 7510 in a compressed state. The applicator 7520 includes an axially movable (double-arrow 7530) plunger 7540 positioned below a ridge 7550 for finger placement and leverage molded on the bottom end of the applicator body. In application, the user inserts the applicator 7520 containing the compressed pessary 7510 into the vaginal cavity and when positioned at the appropriate depth, presses the plunger axially inwardly to force the pessary out of the barrel 7524. As the pessary 7510 exits the barrel, the applicator can be drawn out of the cavity, allowing the pessary to radially expand to its biased deployed orientation/shape. The plunger 7540 can be spring-loaded to return to an outermost state in embodiments or can be free-floating, driven axially outwardly by the bottom/stem of the pessary when it is loaded into the barrel in a compressed state.

Note that the length of the barrel can vary. It should be long enough to ensure the pessary remains compressed when fully loaded thereinto.

[00195] Figs. 76-80 show cross sections of pessaries, according to various, exemplary embodiments. These embodiments represent arrangements of material compositions to adjust the stiffness of supportive members to define the overall structure. By way of non-limiting example, the exemplary pessaries each define an overcenter locking arrangement. Other locking, stem and structural arrangements (as described above) are expressly contemplated in alternate embodiments. With reference to Fig. 76, the pessary 7600 defines a structure that includes a stem 7620, and set of discrete, rigid or semi-rigid supportive top members 7630 and bottom members 7650. These members are encapsulated by the overmolded (e.g.) silicone cover 7670. The cover itself provides unitary hinge locations, which can be defined by a thinning of the material and absence of rigid or semi-rigid material. For example, hinge lines 7672 are provided at the apex 7640. Similarly, hinge lines 7674 are provided between rigid or semi-rigid top supportive members 7630 and bottom members 7650. Hinge lines 7676 are provided at the junction with the stem 7620. The stem is constructed of a discrete shaft 7622 of rigid or semi rigid material, which is covered by a unitary extension 7624 of the overmolded cover 7670. In this, and other embodiments described below, the distal end of the stem 7620 defines a molded loop formed as an extension of the cover 7670.

[00196] With reference to Fig. 77, the depicted embodiment of the pessary 7700 includes live hinges between all joints. Hence, the rigid or semi-rigid top and bottom members 7730 and 7750, respectively, are joined by a thin, unitarily molded hinge 7732. The top members 7730 are joined at the apex 7740 by a thin, unitarily molded hinge structure 7734. Likewise, the inner stem cylinder 7722 of stem 7720 is joined to each of the bottom members 7750 by a thin hinge 7736. The overmolded cover 7770 of (e.g.) silicone reinforces the hinge regions and is similarly thin at hinge lines.

[00197] In the embodiment of the pessary 7800 in Fig. 78, live hinges 7832 are provided between rigid or semi-rigid top members 7830 and bottom members 7850. Live hinges 7836 are also provided between the bottom members 7850 and the cylindrical, rigid or semi-rigid material shaft 7822 of the stem 7820. The apex 7840 is joined exclusively by the pliable material (e.g. silicone) cover 7870, and the apex hinge joints 7834 can be defined by a thinning of the cover material and absence of rigid or semi-rigid material.

[00198] In the embodiment of the pessary 7900 in Fig 79, rigid or semi-rigid material members are omitted in favor of two layers 7910 and 7920 of pliable (e.g.

silicone) material. As shown, the inner layer 7910 defines the semi-rigid skeleton with live hinges 7912, 7914 and 7916. The inner layer 7910 is preferably constructed from a higher durometer silicone in an exemplary embodiment. This durometer can vary and can be determined by experimental processes according to ordinary skill. The outer layer 7920 can be overmolded onto the inner layer 7910, and constructed from a lower durometer material. Because the inner material is biocompatible, (e.g. a harder form of silicone), it can remain exposed on (e.g.) the inside surface 7950 of the pessary 7900. Conversely, the pliable outer layer 7920 can also cover the interior in other embodiments. The preferably higher durometer inner layer can also form the cylindrical shaft (core) 7922 of the stem 7926. Further, it is possible that the inner layer and the outer layers are of the same durometer and it is possible that the materials of the inner and outer layers are the same or different from each other. Alternatively, one or more of the hinges can be entirely constructed from the durometer of the inner layer 7910 or the outer layer 7920 rather than constructing hinges from both durometers (these alternative embodiments are not shown).

[00199] Another embodiment of the pessary 8000, shown in Fig. 80, provides a structure composed of a single pliable elastomeric material (e.g. silicone) of an appropriate durometer. The thickness TMT of the top members 8030 and thickness TMB of the bottom members 8050 is chosen to provide sufficient rigidity and structural integrity— while the thickness TMHA, TMHP and TMHS of hinges 8032, 8034 and 8036 can be less thick to allow for flexibility at these locations. Thicknesses can be based upon material characteristics (hardness, flexibility, and tear-resistance) and the width of the respective component. More generally, this embodiment is refined by varying thicknesses to afford increased or decreased rigidity at locations in the structure as desired. The stem 8020 is likewise designed to provide needed rigidity to the shaft, based upon a sufficiently wide dimension WS for a given length of stem extension.

[00200] Fig. 81 shows a cross section of a further embodiment of a pessary of the present invention which represents an alternative hinge geometry to enable more effective cleaning and collapsing of the pessary. By way of non-limiting example, the exemplary pessary defines an overcenter locking arrangement. Other locking, stem and structural arrangements (as described above) are expressly contemplated in alternate embodiments. With reference to Fig. 81, the pessary 8100 employs hinges 8132, 8136 that are defined by a thinning of material from the outside of the structure, rather than from the inside of the structure as described in previous embodiments, such as seen in Figs. 76-80. Therefore, in accordance with the present invention, any or all hinges 8132, 8134, and 8136 can be constructed by a thinning of material from either the inside or outside of the structure.

[00201] Note, that in some embodiments, rigid or semi-rigid material can be used for some members while pliable material (with the same or differing durometer) can be used for other members in the same pessary structure. Note also that the thickness of all features including the supportive members and/or (e.g.) silicone hinges in the above embodiments is highly variable, based, in part, upon the material’s flexibility and durability under stress/cyclic loading, as well as the width of the hinges.

[00202] Note that the pessary of any of the above-described embodiments (Figs. 61-81) can define a top surface with a variety of fully or partially hemispherical, or otherwise curvilinear, shapes. The thickness of supportive members can vary based upon the material employed and desired strength in a manner clear to those of skill. The overall perimeter of the pessary in both the deployed and compressed state can also vary depending upon the anatomy of the patient and/or other factors.

[00203] It should be clear to one of ordinary skill that the foregoing describes various embodiments of pessaries that can be flexible and can assume a smaller diameter during insertion and removal for greater convenience and comfort. The functions of the pessary and the variable geometry of the diameter can provide for easier handling by the user. This in turn can allow the user to provide their own personal care for the pessary without visiting a health practioner, greater spontaneity for intimacy, and the ability to remove the pessary when not needed. In various embodiments, a thin membrane of silicone or other flexible material can enclose the space between petals to create a supportive structure that can be collapsed during removal.

[00204] The foregoing has been a detailed description of illustrative embodiments of the invention. Various modifications and additions can be made without departing from the spirit and scope of this invention. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments of the apparatus and method of the present invention, what has been described herein is merely illustrative of the application of the principles of the present invention. For example, in other embodiments for insertion purposes, the pessary can include an applicator that wholly or partially encases the pessary in its collapsed state. The upward and downward motion of the plunger, as well as insertion and removal of the pessary, can be accomplished by manipulation of an applicator. The removal of the pessary can be performed with an assisting applicator. The applicator can be a string in further embodiments. The petals can be formed in a variety of geometries that all have in common the reduction of diameter in the collapsed state. In general, the term“rigid” or “semi-rigid” in association with pessary structural members should be taken broadly to include not only rigid plastics and metals, but also pliable, elastomers, such as silicone, having a high durometer and/or sufficient thickness to afford desired stiffness to the underlying structural component. Also, as used herein, various directional and orientational terms (and grammatical variations thereof) such as“vertical”,“horizontal”, “up”,“down”,“bottom”,“top”,“side”,“fro nt”,“rear”,“left”,“right”,“forward”, “rearward”, and the like, are used only as relative conventions and not as absolute orientations with respect to a fixed coordinate system, such as the acting direction of gravity. Additionally, where the term“substantially” or“approximately” is employed with respect to a given measurement, value or characteristic, it refers to a quantity that is within a normal operating range to achieve desired results, but that includes some variability due to inherent inaccuracy and error within the allowed tolerances (e.g. 1-2%) of the system. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this invention.