BR112016013947B1 - VAGINAL INSERT MANUFACTURING METHOD - Google Patents

Abstract

Vaginal insert manufacturing method. a manufacturing method for a vaginal insert. the vaginal insert may have a core, a cover and a withdrawal member. in various embodiments, the cover may be formed onto the vaginal insert.

Description

FUNDAMENTALS

[1] Urinary incontinence is a problem among women. It is estimated that over 50% of women occasionally urinate involuntarily and that approximately 25% of women will seek medical advice to deal with the problem. Stress incontinence, the most common type of urinary incontinence, refers to involuntary urination resulting from increased abdominal pressure. When involuntary urination occurs, it is due to increased pressure in the bladder for which there is no compensating back pressure from the bladder neck or urethra. This is usually the result of abnormal descent of the bladder neck and urethra to a lower position away from the intra-abdominal pressure system. Known as "hypermobility", this can be the result of some damage to the support mechanism that normally holds the urethra and bladder neck in a raised position along the back of the pubic bone.

[2] Lowering of the bladder neck and urethra that occurs, for example, when a woman coughs, sneezes, or laughs, can cause the involuntary release of urine. Although several factors can contribute to the development of stress incontinence, it is most prevalent among women between the ages of 35 and 65 and those who have had multiple vaginal deliveries.

[3] Stress incontinence is restrictive and unpleasant for women and can also be embarrassing. Many women use sanitary pads to deal with stress incontinence, although this is not a true solution to the problem and can be very inconvenient and unreliable. Surgical treatment may involve, among others, elevation of the anterior vaginal wall (Anterior Colporrhaphy), fixation of the paraurethral tissue to the periosteum of the pubic bone (Marshall-Marchetti-Krantz operation) or elevation of the anterior paracervical vaginal wall to the Cooper ligament (Burch Colposuspension). ) in order to elevate the bladder neck above the level of the pelvic floor and thus distribute pressure evenly to the bladder, bladder neck and middle urethra. Recently, a procedure known as "TVT" (Tension Free Vaginal Tape) has been developed in which a mesh tape is implanted underneath the urethra (usually mid-urethra), creating a mesh in which the urethra can twist during an increase in pressure. intra-abdominal. However, surgery is only suitable for severe cases and most women who suffer from stress incontinence do not need it and would certainly prefer to avoid surgical solutions.

[4] A non-surgical treatment involves the use of vaginal inserts that are inserted into the vagina by a doctor or the woman herself. Most vaginal insects are designed to apply pressure against the neck of the bladder in order to completely inhibit or block the flow of urine through the urethra. One problem with these devices is that they completely block the urethra and therefore need to be removed or retracted to allow the woman to urinate. To overcome this disadvantage, vaginal inserts have been developed having specialized shapes that do not completely block the urethra, but these vaginal inserts tend to be large, uncomfortable and intrusive. They also tend to cause irritation or pain in the vagina.

[5] Another common flaw is that most vaginal inserts also tend to be difficult, painful, or uncomfortable to insert and/or remove. To properly inhibit the flow of urine, the vaginal insert needs to be positioned correctly in the vaginal canal. As a result, a physician may be required to correctly position the vaginal insert. In most cases, the vaginal insert is adapted to remain in the vagina for an extended period (due to the time and expense of requiring a trained healthcare professional to insert the vaginal insert). However, when placed in the vagina for an extended period, the vaginal insert can cause vaginal infections, pressure sores and/or bleeding.

[6] The vaginal insert for the treatment of urinary incontinence should be of a size and shape configuration so that it can be comfortable during the insertion and removal process. A vaginal insert for the treatment of urinary incontinence also needs to be able to expand after insertion into the vagina and during use to provide effective incontinence protection. There is a need for a vaginal insert for the treatment of urinary incontinence that can be comfortable for use in a resting state and that can provide prevention of incontinence during a high stress event. There is a need for a method of manufacturing such a vaginal insert for the treatment of urinary incontinence. There is a need for a method of manufacturing to provide a vaginal insert that can be of a size and shape configuration so that the vaginal insert can be comfortable during insertion, the vaginal insert can expand after insertion to provide urinary incontinence prevention and the vaginal insert can be retracted to allow comfortable removal of the vaginal insert from the vagina.

SUMMARY

[7] A method of manufacturing a vaginal insert comprising the steps of providing a core, the core comprising an anchoring element; a support element; and a node connecting the anchor element and the support element; providing a cover preform; inserting the cover preform by inverting the cover preform over the core, resulting in a combination of core and cover preform; attaching a removal element to the cover preform; and converting the cover preform into a cover. In various embodiments, the cover preform comprises a first layer of material and a second layer of material in face-to-face relationship with the first layer of material and a first side seam and a second side seam connecting the first layer of material. to the second layer of material. In various embodiments, the cover preform comprises a rectangular, trapezoidal or trapezoidal-like shape when viewed in a flat, two-dimensional configuration. In various embodiments, the method further comprises the step of forming a joint of the support element in the cover preform. In various embodiments, the cover preform support element splice may be located proximate to the core support element. In various embodiments, the step of attaching the cover preform removal element further comprises the step of rotating the core and cover preform combination. In various embodiments, the method further comprises the step of shaping the cover to the core. In various embodiments, the step of forming the cover to the core further comprises the step of attaching a strip of material to the cover.

[8] A method of manufacturing a vaginal insert comprising the steps of providing a core, the core comprising an anchoring element; a support element; and a node connecting the anchor element and the support element; providing a cover preform, the cover preform comprising a first layer of material and a second layer of material in face-to-face relationship with the first layer of material; and a first side junction and a second side junction connecting the first layer of material to the second layer of material; forming a support member joint in the cover preform; inverting the cover preform over the core to form a core and cover preform combination; attaching a removal element to the cover preform; and forming a joint of the anchor element in the cover preform to convert the cover preform into a cover. In various embodiments, the cover preform comprises a rectangular, trapezoidal or trapezoidal-like shape in a flat, two-dimensional configuration. In various embodiments, the step of attaching the cover preform removal element further comprises the step of rotating the core and cover preform combination. In various embodiments, the step of attaching the removal element to the cover preform further comprises the step of attaching the removal element to an area of the cover preform that does not contain a side seam of the cover preform. In various embodiments, the method further comprises the step of shaping the cover to the core. In various embodiments, the step of forming the cover to the core further comprises the step of attaching a strip of material to the cover.

[9] A method of manufacturing a vaginal insert comprising steps of providing a core; providing a cover preform, the cover preform comprising a first layer of material and a second layer of material in face-to-face relationship with the first layer of material; a first side joint and a second side joint connecting the first layer of material to the second layer of material; top edges of the first layer of material and the second layer of material in a separate configuration; and bottom edges of the first layer of material and the second layer of material in a separate configuration; pleating the lower edges of the cover preform; forming the joint of a support element at the pleated lower edges of the cover preform; inverting the cover preform over the core to form a core and cover preform combination; pleating the upper edges of the cover preform; and forming a seam of an anchor element at the pleated upper edges of the cover preform to convert the cover preform into a cover. In various embodiments, the cover preform comprises a rectangular, trapezoidal or trapezoidal-like shape in a flat, two-dimensional configuration. In various embodiments, the method further comprises the step of attaching a removal element. In various embodiments, the step of attaching the cover preform removing element includes the step of rotating the combined core and cover preform. In various embodiments, the step of attaching the removal element to the cover preform further comprises the step of attaching the removal element to an area of the cover preform that does not contain a side seam of the cover preform. In various embodiments, the method further comprises the step of shaping the cover to the core.

[10] A method of forming a cover to a vaginal insert comprising the steps of providing a core, the core comprising an anchoring element; a support element; and a node connecting the anchor element and the support element; providing a cover preform, the cover preform comprising a first layer of material and a second layer of material in face-to-face relationship with the first layer of material; and a first side junction and a second side junction connecting the first layer of material to the second layer of material; inserting the core into the cover preform to form a core and cover preform combination; converting the cover preform into a cover; and shaping the cover to cover in the area of the core node. In various embodiments, the cover preform comprises a rectangular, trapezoidal or trapezoidal-like shape in a flat, two-dimensional configuration. In various embodiments, the step of shaping the cover to the core further comprises the step of reducing the size of the cover at the core node. In various embodiments, the step of reducing the size of the covering further includes: wrapping a strip of material around the covering, twisting a piece of material forming the covering, applying a heat treatment to the covering, or altering an elastic and/or changing property. or extendable coverage. In various embodiments, the step of reducing the size of the cover may further comprise a step of wrapping a strip of material around the cover at the core node. In various embodiments, the method further comprises the step of compressing the core anchor and sliding the strip of material over the compressed core anchor. In various embodiments, the method further comprises the step of maintaining the reduced size of the cover.

[11] A method of forming a cover to a vaginal insert comprising the steps of providing a core, the core comprising an anchoring element; a support element; and a node connecting the anchor element and the support element; providing a cover preform, the cover preform comprising a first layer of material and a second layer of material in face-to-face relationship with the first layer of material; and a first side junction and a second side junction connecting the first layer of material to the second layer of material; inserting the core into the cover preform to create a core and cover preform combination; converting the cover preform into a cover; supply of a range of material; wrapping the band of material around the cover at the location of the core node; and attaching the strip of material to the cover at the location of the core node. In various embodiments, the cover preform comprises a rectangular, trapezoidal or trapezoidal-like shape in a flat, two-dimensional configuration. In various embodiments, the step of inserting the core into the cover preform further comprises the step of inverting the cover preform onto the core. In various embodiments, the method further comprises the step of compressing the core anchor and sliding the strip of material over the compressed core anchor.

[12] A method of forming the cover to a vaginal insert comprising the steps of providing a core, the core comprising a longitudinal axis; and symmetry about the longitudinal axis; providing a cover preform, the cover preform comprising a longitudinal axis; and symmetry about the longitudinal axis when viewed in a flat, two-dimensional configuration; inserting the cover preform core; converting the cover preform into a cover; conformation of the cover on the core. In various embodiments, the core further comprises an anchor element, a support element, and a knot connecting the anchor element and the support element. In various embodiments, the cover preform further comprises a rectangular, trapezoidal or trapezoidal-like shape. In various embodiments, the step of shaping the cover to the core further comprises the step of reducing the size of the cover at the core node. In various embodiments, the step of reducing the size of the covering further includes: wrapping a strip of material around the covering, twisting a piece of material forming the covering, applying a heat treatment to the covering, or altering an elastic and/or changing property. or extendable coverage. In various embodiments, the step of reducing the size of the cover may further comprise a step of wrapping a strip of material around the cover at the core node. In various embodiments, the method further comprises the step of compressing the core anchor and sliding the strip of material over the compressed core anchor. In various embodiments, the method further comprises the step of maintaining the reduced size of the cover.

[13] A method of forming the cover for a core comprising the steps of providing a core; provision of a cover preform; inserting the core into the cover preform; converting the cover preform into a cover; reduction in the size of the coverage; and maintenance of the reduced size of the coverage. In various embodiments, the coverage dimension is reduced in a narrower part of the core. In various embodiments, the core comprises an anchor element, a support element, and a node connecting the anchor element and the support element. In various embodiments, the coverage dimension is reduced by one core node. In various embodiments, the step of reducing the size of the covering may further include: wrapping a strip of material around the covering, twisting a portion of a material that forms the covering, applying a heat treatment to the covering, or altering a property. elastic and/or extensible cover. In various embodiments, the step of reducing the size of the cover may further comprise a step of wrapping a strip of material around the cover. In various embodiments, the step of maintaining the reduced size of the cover may further include a step of attaching the strip to the cover.

[14] A core insertion module comprising a lower tier comprising a core compression tray; and a push bar positioned below the core compression tray; an upper level comprising a second pallet table; and a pre-compression bar positioned above the second pallet table; and an intermediate level between the lower level and the upper level and comprising a cylinder. In various embodiments, the core compression tray comprises at least one opening for receiving a core. In various embodiments, the core compression tray comprises a pair of jaws that shift at a 45° angle to the core insertion module to compress a core loaded within the core compression tray. In various embodiments, the cylinder is capable of rotating through 180°. In various embodiments, the second pallet table further comprises a transfer tube.

[15] A core insertion module comprising a lower tier comprising a core compression tray capable of transitioning from an open configuration to a closed configuration; and a compression bar positioned below the core compression tray; an upper level comprising a second pallet table capable of moving up and down; and a pre-compression bar positioned above the second pallet table; and a tier intermediate between the lower tier and the upper tier and comprising a cylinder; and a core fixing tool. In various embodiments, the core compression tray comprises at least one opening for receiving a core. In various embodiments, the core compression tray comprises a pair of jaws that shift at a 45° angle to the core insertion module to compress a core loaded within the core compression tray. In various embodiments, the cylinder is capable of rotating through 180°. In various embodiments, the second pallet table further comprises a transfer tube.

[16] A compression tray that includes a front jaw, a rear jaw, guide blocks, at least one opening for receiving an item to be compacted, and a pair of spaced jaw connection mechanisms connecting the front and rear jaw . In various embodiments, the front wedge and the rear wedge at a 45o angle compress a core loaded into the compression tray. In various embodiments, the front wedge and rear wedge change in relation to each other and maintain an aspect ratio of the compression tray opening. In various embodiments, the jaw connection mechanisms may be a rack gear arrangement, slides, guide rails, or linear bearings.

[17] A string and a knot module comprising a string module comprising a string block; a rope block clamp located on the rope block; a needle; a rope that pulls a fastening mechanism; and a rope clamp associated with the rope pulling the clamping mechanism; a mooring module comprising an upper mooring block; a lower mooring block; and a first funnel and a second funnel, the first and second funnels being associated with the lower mooring block. In various embodiments, the string module further comprises a source that provides an air pressure differential. In various embodiments, the string module further comprises a set of scissors. In various embodiments, the upper mooring block of the mooring module further comprises an upper part, a lower part and a central pin positioned within the upper part of the upper mooring block. In various embodiments, the top and bottom of the top tie block can move independently. In various embodiments, the lower mooring block of the mooring module further comprises an upper part, a lower part and a central pin positioned within the upper part of the lower mooring block. In various embodiments, the upper and lower parts of the lower mooring block can move independently. In various embodiments, the mooring module further comprises a rope path associated with the upper parts of the lower mooring block and the lower and upper parts of the upper mooring block. In various embodiments, a portion of the rope path associated with the upper mooring block is at a 90° angle to a portion of the rope path associated with the lower mooring block.

[18] A string and a knot module comprising a string module comprising a string block; a rope block clamp located on the block on the inside of the rope block; a needle; a rope that pulls a fastening mechanism; and a rope clamp associated with the rope pulling the clamping mechanism; and a pair of cover preform clamps; a mooring module comprising an upper mooring block; a lower mooring block; and a first funnel and a second funnel, the first and second funnels being associated with the lower mooring block; wire torques. In various embodiments, the string module further comprises a source that provides an air pressure differential. In various embodiments, the string module further comprises a set of scissors. In various embodiments, the top and bottom of the top tie block can move independently. In various embodiments, the upper and lower parts of the lower mooring block can move independently. In various embodiments, the mooring module further comprises a rope path associated with the upper parts of the lower mooring block and the lower and upper parts of the upper mooring block. In various embodiments, a portion of the rope path associated with the upper mooring block is at a 90° angle to a portion of the rope path associated with the lower mooring block.

[19] A node module comprising an upper mooring block comprising an upper part; a lower part; a central pin positioned inside the top of the top mooring block; a lower mooring block comprising an upper part; a lower part; a central pin positioned inside the top of the lower mooring block; a rope path associated with the lower and upper parts of the lower mooring block and associated with the lower and upper parts of the upper mooring block. In various embodiments, the top and bottom of the top tie block can move independently. In various embodiments, the top and bottom of the lower mooring block can move independently. In various embodiments, a portion of the rope path associated with the upper mooring block is at a 90° angle to the portion of the rope path associated with the lower mooring block.

[20] The strip forming the module comprising a first weft guide; a pair of feed rollers; a second weft guide; a scissor mechanism; and a chuck. In various embodiments, the chuck is able to rotate 360o. In various embodiments, the mandrel comprises at least one end which is hollow. In various embodiments, the chuck is connected to a vacuum. In various embodiments, the mandrel comprises a vacuum hole pattern. In various embodiments, the strip that forms the module further comprises a servomotor for driving at least one of the feed rollers. In various embodiments, the strip forming the module further comprises a bonding mechanism.

[21] The strip forming the module comprising a first weft guide; a pair of feed rollers; a second weft guide; a compressed air power supply; a scissor mechanism; and a chuck. In various embodiments, the chuck is able to rotate 360o. In various embodiments, the mandrel comprises at least one end which is hollow. In various embodiments, the chuck is connected to a vacuum. In various embodiments, the mandrel comprises a vacuum hole pattern. In various embodiments, the strip that forms the module further comprises a servomotor for driving at least one of the feed rollers. In various embodiments, the strip forming the module further comprises a bonding mechanism.

BRIEF DESCRIPTION OF THE FIGURES

[22] FIG. 1 is a perspective view of an exemplary embodiment of a vaginal insert.

[23] FIGS. 2 - 3 are perspective views of exemplary modalities of a kernel.

[24] FIGS. 4 - 6 are cross-sectional views of exemplary embodiments of support arms of a core.

[25] FIG. 7 is a perspective view of one embodiment of a core.

[26] FIG. 8 is a plan view of an exemplary embodiment of a possible relationship of support arms to the longitudinal axis of a core.

[27] FIG. 9 is a table showing exemplary performance ranges for median deflection and horizontal rotation (left/right of central axis), according to an exemplary embodiment of a core.

[28] FIG. 10 is a perspective view of an exemplary embodiment of an applicator for a vaginal insert.

[29] FIG. 11 is a cross-sectional view of the applicator of FIG. 10.

[30] FIG. 12 is a perspective view of the applicator of FIG. 10.

[31] FIG. 13 is a side view of an exemplary embodiment of component parts of a product package for a vaginal insert.

[32] FIGS. 14A - 14C are a series of graphics illustrating exemplary core specifications.

[33] FIG. 15 is a graph of vaginal insert performance that correlates force exerted to core size, diameter, and hardness.

[34] FIG. 16 is a table showing performance characteristics for exemplary core configurations of the core.

[35] FIG. 17 is an exemplary illustration of a part of a process for manufacturing an embodiment of a cover preform.

[36] FIG. 18 is an exemplary illustration of a part of a sequential fabrication process of multiple cover preforms in a flat, two-dimensional configuration.

[37] FIGS. 19-20 are top-down views of exemplary embodiments of the cover preforms in a flat, two-dimensional configuration.

[38] FIG. 21 is a front view of a part of an exemplary embodiment of a first pallet onto which a cover preform can be loaded.

[39] FIG. 22 is a top view of a portion of the first pallet of FIG. 21.

[40] FIG. 23 is a side view of a portion of the first pallet of FIG. 21.

[41] FIG. 24 is a front view of a part of an exemplary embodiment of a loading accessory onto which a cover preform can be loaded.

[42] FIG. 25 is a side view of a portion of the charging attachment of FIG. 24.

[43] FIG. 26 is a front view of an exemplary embodiment of a cover preform loaded onto a portion of a first pallet.

[44] FIG. 27 is a front view of an exemplary embodiment of a cover preform loaded onto a portion of a loading fixture.

[45] FIG. 28 is a front view of an exemplary embodiment of a method of loading a first pallet with a cover preform that has been previously loaded onto a loading attachment.

[46] FIG. 29 is a front view of an exemplary embodiment of a portion of a first pallet with two cover preforms prior to pleating the cover preforms.

[47] FIG. 30 is a top view of an exemplary schematic of a cover preform in an open configuration prior to pleating.

[48] FIG. 31 is a top view of an exemplary layout of a cover preform during cover pleating.

[49] FIG. 32 is a top view of an exemplary layout of a cover preform before the pleat bars are removed.

[50] FIG. 33 is a top view of an exemplary schematic of a pleated cover preform in position for connection.

[51] FIG. 34 is a side view of an exemplary schematic of an exemplary process for removing a drop area from a cover preform.

[52] FIG. 35 is a front view of an exemplary embodiment of a core insertion module.

[53] FIG. 36 is a perspective view of an exemplary embodiment of the middle and lower levels of a core insertion module, where a cylinder and a core compression tray may be in the open position.

[54] FIG. 37 is a perspective view of an exemplary embodiment of the middle and lower levels of a core insertion module, where the cylinder and core compression tray may be in a closed position.

[55] FIGS. 38A and 38B are perspective views of exemplary embodiments of a core compression tray.

[56] FIGS. 39 - 42 are schematic illustrations of exemplary process steps of inserting a core into a cover preform.

[57] FIG. 43 is a front view of an exemplary embodiment of a partially fabricated vaginal insert with a removal member.

[58] FIGS. 44 - 46 are schematic illustrations of exemplary process steps for attaching a removal element to a cover.

[59] FIGS. 47 - 50 are schematic illustrations of exemplary process steps for lashing a removal element.

[60] FIG. 51 is a schematic illustration of an exemplary yarn path.

[61] FIGS. 52 - 55 are schematic illustrations of exemplary process steps for lashing a removal element.

[62] FIG. 56 is a perspective view of an exemplary embodiment of a core and cover preform on a second pallet.

[63] FIG. 57 is a perspective view of an exemplary embodiment of a core and cover preform on a third pallet.

[64] FIGS. 58 - 64 are schematic illustrations of exemplary process steps in transferring the core and cover preform combination from a second pallet to a third pallet.

[65] FIG. 65 is a perspective view of an exemplary embodiment of a pallet transfer module.

[66] FIG. 66 is a front view of an exemplary embodiment of a pallet insertion module.

[67] FIG. 67 is a perspective view of an exemplary embodiment of a compressor.

[68] FIG. 68 is a front view of an exemplary embodiment of a third pallet portion with a core and cover preform combination.

[69] FIG. 69 is a top view of the third pallet of FIG. 68.

[70] FIG. 70 is a schematic illustration of an exemplary process step in pleating a cover preform.

[71] FIG. 71 is a schematic top view of the process step of FIG. 70.

[72] FIG. 72 is a schematic illustration of an exemplary process step in pleating a cover preform.

[73] FIG. 73 is a schematic top view of the process step of FIG. 72.

[74] FIG. 74 is a schematic illustration of an exemplary process step in pleating a cover preform.

[75] FIG. 75 is a schematic top view of an exemplary process step in attaching a cover preform.

[76] FIG. 76 is a schematic illustration of an exemplary process step in attaching a cover preform.

[77] FIG. 77 is a schematic illustration of an exemplary process step in forming a band for a cover.

[78] FIG. 78 is a schematic illustration of an exemplary pattern of vacuum holes in a mandrel.

[79] FIG. 79 is a schematic illustration of an exemplary method of arranging a strip on a cover.

[80] FIG. 80 is a schematic illustration of an exemplary process of welding a strip to a cover.

DETAILED DESCRIPTION

[81] The present disclosure is generally directed to a method of manufacturing a vaginal insert for the treatment of urinary incontinence in women. The vaginal insert can provide tension-free incontinence treatment support perpendicular to the urethra (ie along the urethra). It should also be noted that, for some women, the vaginal inserts described may also be used as a treatment or part of a treatment for prolapse. Vaginal Insert:

[82] In various embodiments, the vaginal insert can be adapted to be stable in the vagina without significant longitudinal and/or rotational movement within the vagina. For example, the support and anchoring arms of the vaginal insert can be designed to resist longitudinal movement within the vagina. As another example, the tips of the support and/or anchor arms can be designed to resist rotational movement by working with the natural behavior of the vaginal wall, for example, being sized and/or shaped to induce the vaginal wall to hair. least partially envelop the tip, thus avoiding rotational motion. Stability can also be enhanced by using the support and/or anchor arms to provide contact between the vaginal insert and multiple points spatially located around the vaginal insert on the vaginal wall. In one embodiment, proper support-rendering placement of the vaginal insert can be considered to be where two support arms are positioned one on each side of the urethra while at least another support arm provides opposing force to the vaginal insert when the two support arms are positioned on either side of the urethra. support are subjected to urethral force during high stress events that cause the urethra to drop into the vagina.

[83] In various embodiments, the vaginal insert can be adapted to be disposable, used only for a relatively short time, and then discarded and replaced with a new vaginal insert (if necessary). Alternatively, the vaginal insert can be recycled for use by sterilizing between uses. The vaginal insert may be simple and easy to use and may optionally be inserted in the same user-friendly manner as a tampon is inserted into the vagina during menstruation, for example using an applicator. In one embodiment, the vaginal insert can be inserted in any orientation as long as the vaginal insert can naturally migrate into a correct treatment position due to the geometry of the vaginal insert. The vaginal insert can be small, have exemplary sizes described below, be comfortable, and once inserted, the woman no longer has to worry about it until it is removed. As with insertion, removal can be performed in a similar manner to an absorbent by pulling on a removal element.

[84] In various embodiments, the vaginal insert may include a core and a removal element. In various embodiments, the vaginal insert may include a core, a cover, and a removal member. Each of these components will be described in more detail below. An example of a vaginal insert 10 with a core 12, a cover 14 and a withdrawal member 16 can be seen in FIG. 1.

[85] Referring to FIG. 2, a perspective view of an exemplary embodiment of a core 12 for a vaginal insert 10 for treating urinary incontinence is illustrated. For ease of description, the core 12 may be arranged around a longitudinal axis 24 and divided into three basic elements. An upper section 18, within the hatched box, can be provided which can serve as an "anchoring" element to stabilize the vaginal insert 10 within the vagina. There may be at least one of three types of anchorage: axial anchorage which may act in a direction along the central axis of the vagina, radial anchorage which may act side by side or substantially perpendicular to the central axis of the vagina and/or rotational anchorage which will be described in more detail below. In one embodiment, the anchor 18 does not apply significant pressure to the wearer's vagina and/or urethra which can thereby result in greater comfort. A lower section 20, within the hatched box, can be provided which can serve as the "support" element for generating support. In various modalities, support can be generated at a sub-urethral site, for example the mid-urethra. Alternatively and additionally and/or optionally, support may be generated at the neck of the bladder. In various embodiments, the support member 20 may provide at least one type of anchorage, described above, to help anchor the vaginal insert 10 in position within the vagina. In various embodiments, the roles of the anchor 18 and support 20 may be exchanged or shared. In one embodiment, the anchors 18 and support 20 of the core 12 may function as an internal support structure for a cover 14.

[86] In one embodiment, an intermediate section may be provided which may act as a "knot" 22 and which may connect the anchors 18 and support 20. The node 22 of the core 12 may have a length which may be a small part of the total length of core 12. In various embodiments, the length of node 22 may be less than about 15, 20, or 30% of the entire length of core 12. In various embodiments, a node 22 having a short length in The overall length of the core 12 may allow for greater flexibility in varying the stiffness, comfort, and size of the core 12 compared to the same length core 12 with a larger knot 22.

[87] Various aspects of the design of the core 12 may favor the stability of the vaginal insert 10 in the vagina, including: the longitudinal design of the core 12 which may incorporate anchoring arms 26 adapted to prevent movement of the vaginal insert 10 deeper into the vagina and /or support arms 28 adapted to prevent movement of the vaginal insert 10 towards the entrance to the vagina; specially adapted arm tips, such as tips 30 and 32, which can resist rotational movement of the vaginal insert 10 insofar as they can be at least partially enveloped by the vaginal wall; a global conception that can take advantage of the phenomenon of loss of vaginal elasticity; and, a multidimensional appearance that may allow multiple arms 26 and/or 28 of core 12 to contact multiple and/or opposing vaginal surfaces simultaneously.

[88] In an exemplary embodiment, the anchor element 18 and the support element 20 may have four arms, 26 and 28, respectively. In an exemplary embodiment, two arms, 26 and 28, of each of the anchors 18 and 20, respectively, can generally exert pressure towards the anterior vaginal wall and two arms, 26 and 28, of each of the elements. anchors 18 and support 20, respectively, can generally exert pressure towards the posterior vaginal wall adjacent to the bowel. The distal part of the urethra extends into the vagina forming a recess between the urethral bulge and the vaginal wall. The anteriorly pressing arms 26 and/or 28 can fit into these natural recesses on either side of the urethra. In various exemplary embodiments, the anchor element 18 and the support element 20 may have more or less arms, 26 and 28, respectively. For example, anchor 18 could have more anchor arms 26 if there is concern about unwanted movement of vaginal insert 10.

[89] The support arms 28 can cause the tissue elevation around the urethra, optionally the middle urethra and/or bladder neck, to act as a net. This mesh can support the urethra in a tension-free fashion. In a woman in whom urine leaks during an event of exertion (eg, when abdominal pressure increases during coughing, sneezing, etc.), the urethra bends downwards but meets the mesh in its midsection. The meeting of the urethra and the mesh can cause an increase in intraurethral pressure with resultant urinary continence.

[90] In one embodiment, the anchor arms 26 can force the vaginal insert 10 to remain in situ within the vagina, unable to move substantially in or out of the vagina, or to rotate within the vagina. One reason this can occur could be due to the tendency of the vaginal walls to collapse and form an occluded lumen. The arms 26 or 28 of the core 12 can cause "loss of elasticity" of the vaginal walls in the upper arms with resulting sagging of the vaginal walls around the core 12 which thereby can stabilize the core 12. , in various embodiments, the anchor arms 26 may be flexible and/or elastic and/or resistant. Such flexibility may improve the ability of the anchor arms 26 to prevent movement of the vaginal insert 10 in the vagina. As there is force to be exerted on the vaginal insert 10 and to move the vaginal insert 10 further into the vagina, the flexible anchor arms 26 may tend to pull away. This spreading action of the anchor arms 26 can increase friction between the vaginal insert 10 and the vaginal wall, thus preventing movement within the vagina. While the anchor arms 26 may be flexible, it should be noted that they may be quite rigid and/or may be configured to diffuse to prevent unwanted movement of the vaginal insert 10 towards the entrance to the vagina. In one embodiment, the anchor arms 26 may be rigid, but the node 22 may be flexible, allowing the node 22 to provide flexible anchoring support. Movement towards the vaginal opening can also be resisted by the support arms 28 which tend to flare radially when pulled externally. These features work with the loss of elasticity behavior of the vaginal walls which also help to hold the vaginal device 10 in place.

[91] Referring to FIG. 2, the anchor arms 26 may have prongs 30 and the support arms 28 may have prongs 32. In various embodiments, the prongs 30 of the anchor arms 26 may be rounded or spherical in nature to provide smooth surfaces (i.e., no corners or stitches) for the loss of elasticity of the vaginal wall. In various embodiments, the tips 32 of the support arms 28 and/or corners of the core 12 may be rounded by a beveled edge along the anchor arms 26 and support arms 28 and at the tips 32, as shown in Figures 2 and 3 In various embodiments, the prongs 32 may be slightly rounded and/or have a chamfered edge. In one embodiment, the beveled edge of the support arms 28 may reduce the overall circumference of the core 12, relative to a fully spherical cross-section, when in a compressed mode for packaging within an applicator. The difference between a core 12 with a chamfered cross section and a core 12 with a spherical cross section can be seen in FIGS. 4 and 5. FIG. 6 illustrates a vaginal insert with a beveled cross section in an applicator 40.

[92] It is also illustrated in FIG. 3 a channel 34 which can cross-cut the core 12 whereby the core 12 can be "held" during fabrication and/or assembly of the core 12 by placing a bar through the channel 34. In one embodiment, the channel 34 can be circle in shape. In one embodiment, channel 34 may be shaped like a quadrilateral. As illustrated in FIG. 6, the channel 34 may be accessible through the quadrilateral-shaped tunnel 36 created by the beveled edges of the support arms 28 when compressed for housing in an applicator 40. In one embodiment, the channel 34 may not be smaller in circumference and/or dimension than the tunnel 36.

[93] In various embodiments, cores 12 of all sizes can have arms, anchor arms 26 and support arms 28, which can be of the same length. In various embodiments, cores 12 of all sizes may have the same overall length when compressed completely on the inside. An example of an internally compressed core 12 can be seen in FIG. 7. In one embodiment, the anchor arms 26 may be shorter than the support arms 28. In that embodiment, the longitudinal length of the anchor 18 may be less than the longitudinal length of the support element 20 when the core 12 was completely compressed on the inside. In this embodiment, the node 22 is not necessarily located at the midpoint of the longitudinal axis 24. In this embodiment, the core 12 may be symmetrical about the longitudinal axis 24, however, the core 12 is not necessarily symmetrical about a lateral axis which may be located at the midpoint of the longitudinal axis 24. In one embodiment, the anchor arms 26 may be of a consistent size in an array of different sizes of cores 12, although the support arms 28 may vary in size and/or performance. The anchor arms 26 may be the same size, in various embodiments, to facilitate manufacturing considerations. In various embodiments, the anchor arms 26 of the core 12 may operate independently, with respect to the longitudinal axis of the vagina, of the support arms 28.

[94] In various embodiments, the difference between the sizes of the cores 12 may be the angle of repose at which the support arms 28 project externally with respect to the longitudinal axis 24 of the core 12. In various embodiments, the size cores "larger" 12 may have a greater radial propagation angle of the support arms 28, therefore they may be "shorter" when placed close to a smaller sized core 12 (i.e. a core 12 which does not radially spread its support arms 28 so much). A potential advantage to this design may be that all 12 cores, no matter the radial propagation angle, can be inserted into a size of a 40 applicator.

[95] In one embodiment, the flexibility of the various core components 12 of a vaginal insert 10 can be designed for function and comfort for the wearer. In various embodiments, the core 12 of a vaginal insert 10 may be designed with at least one of four aspects of flexibility that can assist in achieving these goals of function and comfort. For example, the node 22 of the core 12 may allow flexibility between the anchor 18 and the support element 20, which may allow the vaginal insert 10 to conform to the arch structure of the vagina, as well as to adapt to any position taken. by the user (eg standing, sitting, bending, etc.) during daily activity. By being able to flex at node 22, the pressure exerted on the vaginal wall can be reduced compared to a vaginal insert 10 which does not flex at node 22.

[96] Another aspect of core 12 flexibility may relate to providing efficacy and comfort through varying vaginal planes, for example where the arms 26 and/or 28 adapt to contact the vaginal wall in different locations and/or angles of incidence, relative to each other, away from the longitudinal axis 24, as shown in FIG. 8, which may allow the core 12 of the vaginal insert 10 to be adaptable to different vaginal geometries/topography by rotating either to the left or to the right of the central axis of each arm.

[97] Another related aspect of flexibility may involve the ability of each of the arms, 26 and/or 28, to perform medial flexion, where each arm, 26 and/or 28, can be flexible toward the longitudinal axis 24 when compressed by the vaginal wall, allowing adjustment of the vaginal insert 10 to various vaginal diameters.

[98] A fourth aspect of flexibility may be the feature that each arm, 26 and/or 28, can operate individually, for example each arm, 26 and/or 28, being able to rotate clockwise or counterclockwise. clockwise around its axis allowing the core 12 of the vaginal insert 10 to overcome vaginal structural variability from one point of contact to the next.

[99] It should be noted, in various embodiments, at least one of these four aspects of flexibility may allow the core 12 of the vaginal insert 10 to yield effective support regardless of vaginal size, vaginal shape, vaginal depth, and/or across multiple planes.

[100] FIG. 9 is a table showing example performance ranges for medial deflection (distance from the tip of an arm or arms travels toward the longitudinal axis 24 of the core 12) and horizontal rotation (left/right movement perpendicular to the longitudinal axis 24) of according to an example embodiment of a 12 core. The numbers shown are in millimeters. It should be understood that horizontal rotation means rotation in axes perpendicular to the longitudinal axis of the vagina, particularly "right" and "left" when viewing the vagina in the longitudinal axis extending from the vaginal opening to the cervix. The intervals shown in FIG. 9 are amounts by which each arm could deviate from its natural position with respect to the longitudinal axis 24 of the core 12. Regarding medial deflection, it should be noted that when an arm is medially deflected, there is usually a corresponding arm on the other side of nucleus 12, which is also medially deflected (but perhaps not by the same amount), so in one modality the medial deflection numbers (in mm) are divided by two in order to approximate medial deflection for a single arm. It should also be noted that the numbers for medial deflection in the table in FIG. 9 represent the total amount of deflection for a single arm assuming the corresponding arm does not move. Also, in some modalities, the maximum amount of medial deflection is dictated by two opposing arms coming into contact with each other, preventing further medial deviation. In various embodiments, the minimum diameter of core 12 that can be achieved is 12 mm, with each arm representing a 6 mm portion of that total.

[101] In various embodiments, the core 12 may be made in a plurality of sizes and/or exhibit specific performance characteristics, such as radially expanding support arms 28. In various embodiments, the diameter of a radially expanded anchor 18 can range from about 30 to about 33 mm. In various embodiments, the diameter of a radially expanded support member 20 can range from about 34 mm to about 52 mm. In various embodiments, the core 12 may also be made of different materials and/or materials that exhibit different performance characteristics, such as, for example, hardness. In various embodiments, core 12 can be constructed of a material or materials that can exhibit a Shore A hardness of 30 - 80. In various embodiments, core 12 can be manufactured in various Shore A hardnesses, including, but not limited to, , 40, 50 and 70.

[102] In various embodiments, the core 12 may be constructed from a single piece (monoblock). In various embodiments, the core 12 may have an anchoring element 18 and a supporting element 20 which can be supplied as separate (bi-polar) pieces that can be attached to form the core 12. In various embodiments, each element, in support 18 or anchor 20, can be made of two or more pieces.

[103] Referring to FIG. 1, a perspective view of a core 12 encased within a cover 14 provided with the removal member 16 is illustrated, in accordance with an exemplary embodiment of the vaginal insert 10. Cover 14 may optionally be any of the covers described in PCT/IL2004/000433; PCT/IL2005/000304; PCT/IL2005/000303; PCT/IL2006/000346; PCT/IL2007/000893; PCT/IL2008/001292; U.S. Provisional Patent Application No. 60/719,422; U.S. Provisional Patent Application No. 60/762,059; and U.S. Provisional Patent Application No. 60/960,492.

[104] In various embodiments, coverage 14 may be smooth. In various embodiments, the cover 14 may be formed from woven or non-woven material. Woven material may include, but are not limited to, textile fabrics which may be made from rayon, cotton, polyolefins or other synthetic yarns. Synthetics can be discontinuous or continuous filaments. Non-woven materials include, but are not limited to, spunbond wefts, bonded carded wefts and hydroentangled wefts. In various embodiments, cover 14 may be constructed of a spunbond nonwoven material. In one embodiment, the cover 14 may be treated with an aqueous solution to reduce frictional friction and to improve ease of insertion and withdrawal from a woman's vagina. In various embodiments, the cover 14 may be constructed of a non-woven material such as 33 g/m 2 of non-woven Fiberweb®, Catalog No. 097YLJO09P. In various embodiments, the cover 14 may be constructed of a non-woven material, such as, for example, comprised of about 50% polypropylene and about 50% polyethylene. In various embodiments, the cover 14 may be constructed of nylon. In various embodiments, cover 14 and removal member 16 may be constructed of the same unitary piece of material and/or at the same time and/or in the same process. In various embodiments, cover 14 and removal member 16 may be constructed of separate pieces of material. In various embodiments, cover 14 may be constructed of an absorbent material. In various embodiments, the cover 14 may be flexible and/or elastic. In various embodiments, cover 14 may be formed from a heat-shrink material. In various embodiments, the cover 14 may be formed of a material which may be extensible and/or elastic. In various embodiments, the cover elements 14 may be joined, sewn, sutured and/or welded. In various embodiments, the bonds, seams, sutures and/or welds may be located within the cover 14 opposite the vaginal wall. In various embodiments, the cover 14 and/or the core 12 may be adapted to allow free flow of vaginal discharge.

[105] In various embodiments, the removal member 16 may be constructed of a cotton material, but may be constructed of other materials. In various embodiments, the removal member 16 may be constructed of materials which may allow for the absorption of liquids or may be constructed of materials which do not allow for the absorption of fluids. In various embodiments, the removal member 16 may be a yarn or strip of 100% cotton fibers. In various embodiments, stripper 16 may be constructed of absorbent polyurethane, optionally with a silicone film coating that can provide a smooth surface to stripper 16. In various embodiments, stripper 16 may be a polyester silicone coated braid, an example of which is manufactured by Ashaway.

[106] In various embodiments, the removal member 16 of the vaginal insert 10 can be from about 14 cm to about 16 cm in length, although the length can be varied in different configurations of vaginal inserts 10. In one embodiment, the removal member 16 may be secured to cover 14 in a position whereby a pulling force towards the vaginal introitus can be substantially uniformly distributed over cover 14 as it collapses support arms 28 of core 12 within the vagina. In one embodiment, that position may be at the center of the cover 14 in the support element region 20, as illustrated in FIG. 1.

[107] In various embodiments, the cover 14 can reduce friction between the vaginal insert 10 and the vaginal wall. Pulling the removal member 16 can cause tensioning of the cover 14. The tensioning of the cover 14 can result in smoothing of the vaginal walls which can thus reduce the tent-like effect as described above and relieve the tension applied to the vaginal insert 10, allowing an easy and gentle removal of the vaginal insert 10 from the vagina. Furthermore, the pulling on the removal element 16 can cause the support arms 28 to collapse at least slightly towards the longitudinal axis 24 as a result of the force applied thereto by the cover 14, reducing the radial diameter of the core 12 and allowing for a removal. easy and smooth of the vagina insert 10.

[108] In addition to being used as an aid in removing the vaginal insert 10, a further use of the cover 14 may be to act as an extended cord between the support arms 28, which can provide tension-free sub-urethral support to the urethra. .

[109] Referring to FIGS. 10 - 12 , perspective views of an applicator 40 that can be used to implant a vaginal insert 10 in the treatment of urinary incontinence are illustrated. In one embodiment, the applicator 40 may comprise a housing 42 and a plunger 44. The housing 42 may be adapted to receive and/or store the vaginal insert 10. In various exemplary embodiments, the plunger 44 may be used to expel the insert. vaginal 10 of housing 42 during implantation of vaginal insert 10 into a vagina. FIG. 11 is a cross-section of FIG. 10 which can show the configuration of applicator 40 more clearly, including the interface between housing 42 and plunger 44. In various embodiments, housing 42 may be provided with an output 46. In various embodiments, output 46 may be provided with a plurality of flexible tabs ("petals") that can be pushed open when the vaginal insert 10 is expelled from the applicator 40. The outlet 46 is more clearly shown in FIG. 12.

[110] In the applicator 40, the vaginal insert 10 can be positioned so that the anchor element 18 of the core 12 exits the applicator 40 in the vagina first, followed by the support element 20 of the core 12, which exits at the end of the process. of implantation. In one embodiment, the vaginal insert 10 may be implanted to provide support for the urethra. In one embodiment, the vaginal insert 10 may be implanted to provide support for the bladder neck.

[111] In one embodiment, a user may receive the vaginal insert 10 in an individual package 50, as shown in FIG. 13. In one embodiment, different sizes and/or packages 50 with vaginal inserts 10 having different characteristics may be color coded to facilitate identification by a user of vaginal insert 10. FIG. 13 is a side view of component parts of a product pack 50 for a vaginal insert 10 for treating urinary incontinence. Product package 50 may include an applicator housing 42, core 12, cover 14, removal member 16, applicator plunger 44, and product wrapper 52. In one embodiment, product wrapper 52 may be wrapped around the applicator. 40, which when packaged may include the vaginal insert 10 within the housing 42. Thus, the product package 50 in its assembled form may be more or less cylindrical or in the form of an enclosed tampon.

[112] In one embodiment, inserting a vaginal insert 10 into the vagina may be similar to inserting a tampon. The user can use one hand to spread the lips, direct the front of the applicator 40 into the vagina, and compress the plunger 44 with the other hand, thereby employing the vaginal insert 10 of the applicator 40 in the vagina. In one embodiment, there is no need for a specific orientation of the vaginal insert 10 due to the generally symmetrical design of the core 12 around the longitudinal axis 24 of the core 12. Insertion of the vaginal insert 10 may be performed in any orientation. and/or anywhere 360° around the longitudinal axis 24 of the core 12 in the applicator 40.

[113] In various embodiments, even though the core 12 can be projected symmetrically, due to the fact that each of the arms, 26 and 28, can flex independently of the other arms, 26 and 28, when in situ and each vagina varies in shape slightly, the vaginal insert 10 cannot be symmetrically shaped when in use (see FIG. 8). Referring to FIG. 8 is a plan view showing a possible relationship of support arms 28 to longitudinal axis 24 of core 12 when vaginal insert 10 is in situ is illustrated. It should be noted that not every vagina has the same contours and internal structure, although some generalizations can be made around vaginal anatomical features. To this end, the core 12 may be designed to be adaptable to different vaginal characteristics that may be encountered, depending on the user of the vaginal insert 10. For example, each of the support arms 28 of the core 12 may be able to function independent. This can allow for maximum flexibility, maximum fit for any vaginal shape (cross section) and/or vaginal dimensions. Thus, it may happen that in a given cross-section, the support arms 28 of the core 12 will not be symmetrically spread around the longitudinal axis 24 of the core 12, as shown in FIG. 8.

[114] Core 12 may be manufactured and/or commercially available in a variety of sizes, with each size exhibiting different performance characteristics, operating dimensions, weight, and the like. In various embodiments, the different sized cores 12 may be made of the same material. In various embodiments, the different sized cores 12 may use different materials and/or different proportions of material. FIGS. 14A - 14C are a series of graphs illustrating example core 12 sizes. As can be seen from the graphs of FIGS. 14A - 14C , the core 12 can be produced in at least four sizes for an optimal fit for various vaginal dimensions and/or according to the severity of urinary incontinence. The various sizes may differ in the spread diameter of the support arm 28 and as a result may differ in overall length when deployed (i.e. the support arms 28 are spread out). In various embodiments, the anchor arms 26 may have identical implanted dimensions and/or performance characteristics in all sizes.

[115] In various embodiments, the core 12 may be constructed of liquid silicone (LSR) by injection molding. It is possible to use other materials, for example TPE, non-liquid silicone and others for a core 12 of the same size. In one embodiment, materials exhibiting varying degrees of Shore A hardness can be used to produce softer or stiffer cores 12.

[116] It should be understood that various size combinations can be made by varying the size and/or Shore A hardness. For example, sizes 1 and 2 can be made with a Shore A hardness of 70 while sizes 3 and 4 can have a Shore A hardness of 40. In various embodiments, all core sizes 12 can have the same Shore A hardness. In various embodiments, each individual size can be made in several versions, each exhibiting a different Shore A hardness . In summary, various combinations and permutations of functionality, sizes, performance characteristics, and/or materials of construction can be employed to apply the desired suburethral support force at certain working angles.

[117] In various embodiments, the radiating support arms 28 of the core 12 can create a total diameter of the core 12 of about 34 mm to about 52 mm in the cross-section of the wider support member 20 within the vaginal cavity. In various embodiments, the diameter can be larger or smaller depending on the individual needs of the wearer.

[118] FIG. 15 is a graph of core performance 12 that correlates the expansive force exerted by the support arms 28 (y-axis) to the amount of medial deflection (x-axis) and hardness (line bursts) for each of the four basic sizes shown in FIGS . 14A - 14C, through which the medial deflection is the distance in mm towards the longitudinal axis 24 of the core 12 of the natural expanded state of the support arm 28.

[119] The expansive force exerted by the support arms 28 is generally determined by the degree of hardness and/or the degree of medial flexion (medial deflection) of each of the support arms 28 with respect to the longitudinal axis, 24. is used in the construction of the core 12, such as, for example, liquid silicone, these forces can be measured for any given diameter of the support arms 28 of the core 12, knowing the performance characteristics of the specific material being used. Using this data on a graph where the x axis represents the diameter of core 12 and the y axis represents force, the forces exerted by the support arms 28 for a given size of core 12 and its degree of material hardness can be demonstrated. The slope represents the ratio of the force (grams) to the amount of medial deflection (mm).

[120] In designing and/or selecting a core 12 for use, certain performance considerations may be taken into account. It should be noted that the core support 12 is "activated" by the support arms 28 being compressed (i.e., deflected toward the longitudinal axis 24 of core 12 or "medial deflection") at least somewhat by the vaginal wall. In general, the stronger the compressive forces on the support arms 28, the stronger the support force that is exerted on the vaginal wall/suburethra via the support arms 28. For example, the support arms 28 must be compressed. to a certain minimum amount to provide sufficient counter-force for the support hugs 28 to render support. That is, if a vaginal insert 10 is inserted into the vagina and the core 12 is too small or the angle of radial expansion is too small, then sufficient force will not be applied to the support arms 28 of the vaginal wall to make the arms 28 28 to fight with the force necessary to render adequate and effective support. The impossibility of achieving this minimum value of compression in a resting state, shown as a minimum horizontal applied force line 60 in FIG. 15 at approximately 10g of force, on support arms 28 during a stressful event will reduce the effectiveness of the vaginal insert 10. It should be noted that in some modalities, the minimum applied force line 60 at 10g is approximate and may vary by ± 3 grams.

[121] Similarly, there is a maximum force exerted by the core 12 on the vaginal walls beyond which the user would experience discomfort while the vaginal insert 10 is in the vagina at rest and/or while the vaginal insert 10 is removed. In one embodiment, therefore, , the core 12 may be designed and/or selected for use not to exceed this maximum strength. This maximum force is represented in FIG. 15 as the bold horizontal line 62 at about 50 g of force. In one embodiment, 50 grams is approximate and may vary by ±5 grams. For example, if the radial expansion of the support arms 28 is too great, it will generate excessive force on the vaginal wall and the wearer may experience discomfort, which should be avoided.

[122] The graph of FIG. 15 can be used, in various embodiments, to determine the potential use for a specific core configuration 12 for a specific vaginal size. For example, D1 in the graph represents a vagina with a diameter of 33 mm. Referring to FIG. 15, it can be seen that size 1 cores 12 with Shore A hardnesses of S40 and S50 are not identified for use with this user due to the fact that they will not provide sufficiently effective support in a resting state. However, a number of other core sizes 12 and Shore A hardnesses are considered acceptable: Size 1 with a Shore A hardness device of 70 (providing strength of about 21 grams) Size 2 with a Shore A hardness device of 50 (providing force of about 25 grams) Size 2 with Shore A hardness device of 40 (providing force of about 20 grams) Size 3 with Shore A hardness device of 50 (providing force of about 38 grams) Size 3 with Shore A hardness of 40 (providing strength of about 28 grams) Size 4 with Shore A hardness device of 50 (providing strength of about 48 grams) Size 4 with Shore A hardness device of 40 (providing strength of about 35 grams)

[123] As another example, D2 in the graph represents a vagina 42.5 mm in diameter. Because of the size of this user's vagina, fewer options may be available to receive optimally effective vaginal support. In this example, likely choices would include: Size 3 with a Shore A hardness device of 70 (providing strength of about 22 grams) • Size 4 with a Shore A hardness device of 70 (providing strength of about 45 grams) • Size 4 with Shore A hardness device of 50 (providing force of about 22 grams) • Size 4 with Shore A hardness device of 40 (providing force of about 18 grams)

[124] It is observed that a size 4 core 12 of a low Shore A hardness material, e.g. 40, can be used for a wide range of vaginal diameters (approximately 30 mm to 45 mm), in a example.

[125] Above the maximum force line 62, the graph of FIG. 15 shows levels of force exertion of the various sizes of core 12 at different levels of medial deflection up to about 12 mm in total core 12 diameter. In one embodiment, each arm is approximately 6 mm in width, hence the minimum possible diameter distance when two opposing support arms make contact is 12 mm (6 mm + 6 mm). Specific numbers for selected core 12 sizes are shown in and described in more detail below with respect to FIG. 16.

[126] FIG. 16 is a table showing the specific performance levels for example core 12 core sizes and basic Shore A hardnesses depicted in FIG. 15. The minimum diameter column lists the diameter (in mm) at which two opposing arms 28 came into contact, thus substantially prohibiting any further medial deflection by the arms 28. In one embodiment, maximum force is exerted when the cores 12 most of the diameter or the minimum of it are compressed. The Maximum Strength column lists the maximum amount of force exerted by each Core 12 Shore A size and hardness listed at the 12mm diameter level.

[127] It should be noted that some of the information shown in FIG. 16 are also included in the tables of FIGS. 14A - 14 C. Where information does not fully conform, it should be understood that the widest range of values should be assigned to the modalities described here. For example, a range of values can be taken where the lower end of the range is from one table and the upper end of the range is from another table. It should also be noted that the values given are by way of example only and that the performance characteristics of Core 12 may vary depending on materials used for construction and/or size and/or Shore A hardness of Core 12.

[128] In various embodiments, many of the possible sizes of cores 12 may be appropriate for a specific user and sufficient support can be provided without exceeding the threshold of discomfort. This can be particularly true with 12 cores of low Shore A hardness and moderate slope. For example, a size 3 12 core (backing diameter - 45mm) made of soft silicone with a Shore A hardness of 40 may be suitable for a wide range of vaginal diameters: exerting a force of 12 grams on a diameter of 40 mm , 21 grams over a 35 mm diameter and 31 grams over a 30 mm diameter. In other words, in some embodiments, a single core size 12 can provide support for numerous vaginal dimensions. In one embodiment, a core 12 may be adapted for use by a variety of users, for example, by creating a core 12 with a low or moderate slope.

[129] It is possible that only a core size 12 will be adequate for a woman of a given vaginal diameter, especially if her vaginal dimensions are larger than average. In some embodiments, only sizes 3 or 4 would be adequate, while the smaller sizes would not exert the minimum required force support. Note that characteristics such as applied force, size of the vaginal insert 10 and/or overall comfort of the chosen vaginal insert 10 are highly dependent on each individual user and may also depend on the pathological response caused by the vaginal insert 10 to each user. individual.

[130] In an exemplary embodiment, reducing the distance between the support end 32 of a support arm 28 and the longitudinal axis 24 of the core 12 would increase the force exerted by the core 12 on the support leg 32. The operational importance of this may be that a relatively large vaginal insert 10 inserted into the vagina would exert a greater force on the vaginal walls compared to a smaller vaginal insert 10 inserted into the same vagina. Using this same reasoning, if external forces exerted on the vaginal insert 10 reduce the internal distance between its supporting arms 28 and the longitudinal axis 24 (e.g. during coughing, jumping, sneezing, etc.), a greater counterforce would be exerted. by the arms supporting 28 on the vaginal walls, thus increasing urethral support and the efficiency of preventing urinary leakage. Therefore, in an exemplary embodiment, a vaginal insert 10 may be designed with this counter generated activity stress in mind. Manufacturing Method for Vaginal Insert:

[131] As described above, in one embodiment, a vaginal insert 10 may have a core 12, a cover 14 and a withdrawal member 16. The manufacturing process for producing a vaginal insert 10 may include steps such as providing a preform cap 68, enclosing a core 12 within the cap preform 68 and providing a removal member 16. In various embodiments, the manufacturing process may also include a step of conforming cap 14 to core 12.

[132] For the vaginal insert 10 to be effective in reducing leakage episodes due to urinary incontinence, the vaginal insert 10 needs to be small enough for insertion and removal from the vagina, but also needs to be able to expand radially after insertion and during wear. The core 12 and the vaginal insert 10, therefore, must be able to transition between a compacted configuration and a radially expanded configuration. To avoid constraining this transition between configurations, the cover 14 must be sized large enough to allow the core 12 to expand to its required largest dimension during wear. While the cover 14 must be large enough to allow expansion of the core 12, the cover 14 must also be correctly sized to aid in the removal of the vaginal insert 10. As described here, pulling the removal member 16 can result in a force to pull to be substantially evenly distributed over the cover 14 which can function by collapsing the support arms 28 of the core 12 towards the longitudinal axis 24 of the core 12, thus reducing the radial diameter of the core 12 and allowing for smooth and easy removal of the vaginal insert 10 from the vagina. Cover 14, therefore, should not be as large as the size of cover 14 has little effect on support arms 28 of core 12 when pulling removal member 16 during removal of vaginal insert 10.

[133] In one embodiment, cover 14 may conform to the shape and/or size of core 12. As mentioned above, in various embodiments, cover 14 may act as a sling extended between arms, such as support arms. 28, of core 12. In such embodiments, cover 14 may provide free suburethral tension support to the urethra. Also, as described in this document, the core 12 can transition from a compacted configuration to a radially expanded configuration to provide support for the urethra. Cover 14 may be shaped to the size and/or shape of core 12 in order to provide cover 14 with the necessary tension to allow cover 14 to properly act as a cord and support for the urethra. Without being bound by theory, it is believed that a cover 14 that does not conform to the size and/or shape of the core 12, or has not been properly shaped to the size and/or shape of the core 12, will be too loose as an inclusion for core 12 and will not provide adequate support for the urethra. As mentioned above, the cover 14, however, must not be overly conformed to the size and/or shape of the core 12 as this could prevent the core 12 from expanding radially to the extent necessary to provide adequate support for the urethra. In various embodiments, the cover 14 may be shaped to the core 12 through a process that can reduce the dimensions of the cover 14 and maintain the reduced dimensions of the cover 14. In various embodiments, the cover 14 may be formed to the core 12 through a process that can reduce the dimensions of the cover 14 at the narrowest part of the core 12, such as, for example, the node 22. In various embodiments, the dimensions of the cover 14 can be reduced through processes such as, but not limited to, involving a strip of material around the cover 14, "tighten" the cover 14 by twisting the material formation of the cover 14, apply a heat treatment to the cover 14 as a cover 14 formed of a heat-shrinkable material and/or altering the elastic properties and/or extensibles of cover 14. In one embodiment, the shape of cover 14 and/or dimensions may be substantially similar to the expanded shape and/or dimensions of core 12. In one embodiment, the internal volume of the cover 14 can be substantially similar to the volume of the expanded core 12.

[134] Cover 14 can be formed from a cover preform 68. A cover preform 68 can be created by at least one of two methods. A first method of creating a cover preform 68 may include folding a single material in half, bringing the two halves together in a face-to-face relationship and at least a portion of the two halves together to create the area of at least one bond. binding. A second method for creating a cover preform 68 may include providing two separate materials together in a face-to-face relationship and at least a portion of the two separate materials together to create the area of at least one bonding area. The area of at least one bond, resulting from any method just described, can ultimately provide at least one seam for a cover 14. In various embodiments, a cover preform 68 can have at least one bonding area. . In various embodiments, a cover preform 68 may have at least two area connections. In various embodiments, a cover preform 68 may have at least three area connections. Once the cover preform 68 completely encircling a core 12 and forming the cover preform 68 has been fully sewn to prevent the core 12 material from escaping the boundaries of the cover preform 68, one can say that the cover preform 68 has been converted to a cover 14. In various embodiments, the cover 14 may have at least one seam. In various embodiments, the cover 14 may have at least two seams. In various embodiments, the cover 12 may have at least three seams. In various embodiments, the cover 12 may have at least four seams.

[135] The terms “welded” and “welding” refer to joining, adhering, connecting, securing, or using another similar process to join two elements. Two elements will be considered connected when they are joined, adhered, connected, fixed, or similar, directly or indirectly to each other, for example, when each is directly connected to the intermediate elements. Bonding can occur by adhesives, pressure bonding, thermal bonding, ultrasonic bonding, joining, suturing and/or soldering.

[136] FIG. 17 provides an exemplary illustration of a method of manufacturing a cover preform 68. As illustrated in FIG. 17, a single material 90 may be used. The material 90, in an unfolded configuration, may have two opposite and spaced machine direction edges, such as edges 92 and 94. The material 90 may enter a folding zone 96, where the material 90 may be folded such that the two halves of the material 90 can be created with one half placed in face-to-face relationship with the other half of the material 90. The folding of the material 90 can be accomplished through the use, for example, of a folding plate. The folding of material 90 may bring edge 94 to a position substantially adjacent to edge 92. The resulting fold 98 in material 90 may remain parallel and spaced from edges 92 and 94, and fold 98 and edges 92 and 94 may continue to fold. move in the direction of the machine. The folded material 90 may continue in a connection zone 100, wherein at least a part of one half of the folded material 90 may be connected to at least a part of the other half of the folded material 90. The connection may be accomplished by the methods, such as, but not limited to, adhesives, pressure bonding, thermal bonding, ultrasonic bonding, joining, suturing and/or soldering.

[137] The bonding of at least a part of the two halves of the folded material 90, or, in various embodiments, the bonding of at least a part of the two separate materials, can form at least one bonding area. The at least one bonding area may ultimately provide at least one junction of a cover 14. A bonding area may have a width deemed adequate to maintain the integrity of the bonding area, and the resulting junction of coverage 14. In various In embodiments, a bonding area can have a width from about 0.1, 0.2, 0.3, 0.4, or 0.5 mm to about 0.6, 0.7, 0.8, 0 .9 or 1.0 mm.

[138] Referring to FIG. 17, in the exemplary embodiment of the illustrated method, two connection areas 84 and 86 can be created. Since the connection areas, such as the connection areas 84 and 86, can ultimately provide a joint for the cover 14, the connection areas 84 and 86 can provide a part of the shape of the cover preform 68. In various embodiments, the cover preform 68 may have a rectangular, trapezoid, or trapezoid-like shape when viewed in a flat two-dimensional configuration. A trapezoid-like shape can have at least two parallel sides and the other two sides can be non-parallel, can have an arc, or can be any shape as desired. As can be seen in the exemplary illustration of FIG. 17, the connecting areas 84 and 86 which have been formed can provide a cover preform 68 which can have a trapezoid shape when viewed in a flat two-dimensional configuration.

[139] In various embodiments, the maximum desired width of the cover preform 68, in a flat two-dimensional configuration, as its widest dimension may be narrower than the width of the supplied material(s) 90 ) and bonded together to form the cover preform 68. In these various embodiments, an area of the chip material may be located between the bonding areas, such as bonding areas 84 and 86, and the edges and/or folds of the material 90, used to produce cover preform 68. In the exemplary embodiment illustrated in FIG. 17, bond areas 84 and 86 may be located internal to edges 92 and 94 and bend 98 of material 90. Trim areas 102 may therefore be located between bond areas 84 and 86, and edges 92 and 94, and the fold 98 of the material 90. Since the material 90 can be further processed into a cover preform 68, the trim areas 102 can be separated from the connecting areas 84 and 86, such as the trim remains. 110. Removal of trim remnants 110 will be discussed below in this document.

[140] Material 90 may enter a perforation zone 104, where perforations 106 may be imposed on material 90. Perforations 106 may be created through the use of any perforation cutter deemed suitable. Perforations 106 may be perforations 106 that extend through the material 90 cross-machine direction. The perforations 106 may provide a separation between ultimately the two cover preforms 68. In various embodiments, the perforations 106 may not extend into the trim areas 102 located between the bonding areas 84 and 86, and the edges 92 and 94, and the fold 98 of the material 90. In various embodiments, without being bound by theory, it is believed that failure to extend the perforations 106 to the trim areas 102 may allow for efficient removal of the trim areas 102 during manufacturing process.

[141] To remove the chipping areas 102, the material 90 can enter a chip removal zone 108, where the cutter can be used to separate the chipping areas 102, as well as the chip remains 110, from the material 90. Shavings 110 may be pulled away from material 90 by any method deemed suitable, such as vacuum. After the chip areas 102 have been removed, as well as the chip remains 110, the connection areas 84 and 86 can become junctions, such as the side junctions 72 and 74 of a cover preform 68.

[142] It should be noted that, in various embodiments, the machine direction length of material(s) 90 provided to manufacture a cover preform 68 may be sufficient to manufacture a single preform. cover shape 68 or, in various embodiments, the machine direction length of the supplied material(s) 90 may be sufficient to manufacture various cover preforms 68, such as, for example, a tape 112 of the cover preforms 68 manufactured in a sequential manner. FIGS. 17 and 18 provide exemplary illustrations of a tape 112 of the cover preforms 68. FIG. 17 may provide an illustration of a tape 112 of pre- and post-separation of cover preforms from trim areas 102. FIG. 18 may provide an illustration of a tape 112 of the pre-separation of the cover preforms 68 from the trim areas 102.

[143] Referring to FIG. 18, an exemplary embodiment of a portion of a tape 112 of the cover preforms 68 may be illustrated. In FIG. 18, two separate materials 90 can be placed in a face-to-face relationship. Each of the materials 90 may have parallel and spaced edges, such as edges 92 and 94 that extend in the machine direction. At least a portion of the two separate materials 90 may be bonded and bonding areas 84 and 86 may be created. Trim areas 102 may be located between bond areas 84 and 86, and edges 92 and 94 of materials 90. As can be seen in the exemplary embodiment of FIG. 18, the width W3 of the materials 90 forming the cover preform 68 may be greater than the largest width of the cover preform 68, such as the width W2 of the cover preform 68.

[144] As illustrated in the exemplary embodiments of FIG. 17 and FIG 18, tape 112 of cover preforms 68 illustrate that the largest width W2 of a first cover preform 68 is sequentially adjacent to the largest width W2 of the next cover preform 68 and the longest width The narrow width W1 of a first cover preform 68 is sequentially adjacent to the narrower width W1 of the next cover preform 68. Without being bound by theory, it is believed that maintaining the narrower widths W1 of the two covering preforms 68 in an adjacent relationship, as well as maintaining the wider widths W2 of two covering preforms 68 in an adjacent relationship, can provide for more efficient incorporation of perforation 106 between cover preforms 68, as well as for more efficient removal of chip areas 102 as chip remains 110.

[145] In a manufacturing process for sequential fabrication of cover preforms 68, a connected tape 112 of cover preforms 68 may be present prior to separation of the chip areas 102 as chip remains 110 as illustrated in FIG. . 18. In a manufacturing process for sequential manufacturing of cover preforms 68, a connected tape 112 of cover preforms 68 may be present after separating the trim areas 102 as trim remnants 110, as illustrated in FIG. . 17. A single cover preform 68 may be separated from the connected tape 112 of cover preforms 68 by breaking perforations 106 between two adjacent cover preforms 68.

[146] FIGS. 19 and 20 provide example illustrations of cover preforms 68 in two-dimensional and flat configurations, which may be separated from a tape 112 into cover preforms 68. How can cover preform 68 be manufactured from a single material 90 folded over itself or of two materials 90 placed face to face, covering preform 68, 70 and 80 of material 90 with one layer, such as layer 70, overlapping the other layer, as layer 80. In the exemplary embodiments illustrated in FIGS. 19 and 20, layer 70 is facing the viewer. Cover preform 68 may have bonded side seams, such as side seams 72 and 74. Cover preform 68 may have top edges 76 of each layer 70 and 80 which are not bonded together. Cover preform 68 may have bottom edges 78 of each layer 70 and 80 that are not bonded together. In various embodiments, when viewed in a flat, two-dimensional configuration, the cover preform 68 may have the rectangular configuration, as illustrated in the exemplary embodiment of FIG. 19. In various embodiments, when viewed in a flat, two-dimensional configuration, the cover preform 68 may have the trapezoidal configuration as illustrated in the exemplary embodiment of FIG. 20. In various embodiments, when viewed in a flat, two-dimensional configuration, a cover preform 68 may have a trapezoid configuration. In various embodiments, when viewed in a flat, two-dimensional configuration, the cover preform 68 may have any other configuration as deemed suitable to provide a cover 14 to include a core 12.

[147] During the manufacturing process, the upper edges 76 of each layer 70 and 80 and the lower edges 78 of each layer 70 and 80 may be bonded together to finally form the cover 14 for a core 12 of an insert. 10. The lower edges 78 of each layer 70 and 80, when bonded, may form a bonded area 168 that can be located proximate the supporting element 20 of the core 12. The upper edges 76 of each layer 70 and 80, when bonded , can form a bonded area 318 which can be located close to the anchor element 18 of the core 12.

[148] In various embodiments, when viewed in a flat, two-dimensional configuration, a cover preform 68 may have the rectangular configuration, as illustrated in the example embodiment of FIG. 19. Cover preform 68 may have an initial longitudinal length L1, measured as the distance from the top edge 76 to the bottom edge 78 of layers 70 and 80. Each of the edges, top edge 76 and bottom edge 78 of the respective layers 70 and 80 may have an initial upper edge width W1 and an initial lower edge width W2, respectively. In an embodiment as illustrated in FIG. 19, in which the cover preform 68 may have a rectangular configuration, the initial upper edge width W1 and the initial lower edge width W2 may be the same.

[149] In one embodiment, the core 12 may be symmetrical about the longitudinal axis 24 of the core 12, as well as symmetrical about the lateral axis of the core 12 where the lateral axis of the core 12 can be located at the midpoint of the longitudinal axis 24 of the core 12. core 12. These symmetries can be present when core 12 can be in a compressed configuration and when core 12 can be in a radially expanded configuration. In such an embodiment, a cover preform 68 may be provided which may be symmetrical and/or may assume symmetry about the longitudinal axis 82 of the cover preform 68, as well as may be symmetrical and/or may assume symmetry about the lateral axis of cover preform 68 wherein the lateral axis of cover preform 68 may be located at the midpoint of the longitudinal axis 82 of cover preform 68. These symmetries of cover preform 68 may be visible when the cover preform 68 can be viewed in a flat, two-dimensional configuration, as before the inclusion of a core 12 within the cover preform 68. FIG. 19 provides an illustration of a preform. cover 68 in a flat, two-dimensional configuration and cover preform 68 may have a symmetrical configuration about the longitudinal axis 82 of cover preform 68 and about the lateral axis located at the midpoint of the longitudinal axis 82 of the preform - form of coverage to 68.

[150] In various embodiments, when viewed in a flat, two-dimensional configuration, a cover preform 68 may have the trapezoidal configuration, as illustrated in the example embodiment of FIG. 20. Cover preform 68 may have an initial longitudinal length L1, measured as the distance from the upper edge 76 to the lower edge 78 of layers 70 and 80. Each of the edges, upper edge 76 and lower edge 78 of the respective layers 70 and 80 may have an initial upper edge width W1 and an initial lower edge width W2, respectively. In an embodiment as illustrated in FIG. 20, in which the cover preform 68 may have a trapezoidal configuration, the initial upper edge width W1 may not be the same as the initial lower edge width W2. In such an embodiment, the width of the upper edge W1 can be smaller than the width of the lower edge W2.

[151] In one embodiment, the core 12 may be symmetrical about the longitudinal axis 24 of the core 12, however, the core 12 may not be symmetrical about the lateral axis of the core 12 where the lateral axis of the core 12 may be located in the midpoint of the longitudinal axis 24 of the core 12. These symmetries of the core 12 about the longitudinal axis 24 of the core 12 can be present when the core 12 can be in a compressed configuration and when the core 12 can be in a radially expanded configuration. In such an embodiment, a cover preform 68 may be provided which may be symmetrical and/or may assume symmetry about the longitudinal axis 82 of the cover preform 68. The symmetry of the cover preform 68 about the longitudinal axis 82 of the cover preform 68 may be visible when the cover preform 68 can be viewed in a flat, two-dimensional configuration, as before the inclusion of a core 12 within the cover preform 68. FIG. 20 provides an illustration of a cover preform 68 in a flat, two-dimensional configuration and the cover preform 68 may be symmetrical about the longitudinal axis 82 of the cover preform 68 but may not be symmetrical about the axis. lateral located at the midpoint of the longitudinal axis 82 of the cover preform 68.

[152] As described in this document, FIG. 14 provides examples of core 12 configurations when core 12 may be in a deployed/radially expanded configuration. Cover preform 68 may be suitably sized to include a core 12 as described herein. It should be noted that as the core 12 can be supplied in various sizes, the cover preform 68 can also be supplied in various starting sizes in accordance with the size of the core 12. In various embodiments, the cover preform 68 in a flat, two-dimensional configuration and before the inclusion of a core 12 may have an initial longitudinal length L1 from about 90, 92, 94, 96, 98, 99 or 100 mm to about 101, 102, 104, 106, 108 or 110 mm. In one embodiment, the cover preform 68 in a flat, two-dimensional configuration and prior to the inclusion of a core 12 may have an initial longitudinal length L1 of about 100 mm ± 1 mm. In various embodiments, the cover preform 68 in a flat, two-dimensional configuration prior to the inclusion of a core 12 may have a top edge width W1 and a bottom edge width W2 of about 40, 42, 44, 46 , 48, 50, 52, 54, 56, 58 or 60 mm to about 70, 72, 74, 76, 78, 80, 82, 84, 86, 88 or 90 mm. In one embodiment the cover preform 68 in a flat, two-dimensional configuration may be rectangular in shape and the upper edge width W1 may be the same as the lower edge width W2. In one embodiment, the cover preform 68 in a flat, two-dimensional configuration may have a shape such as a trapezoidal shape, and the upper edge width W1 may be different from, for example, smaller than, the lower edge width. W2.

[153] As an illustrative example of a combination of core 12 and cover preform 68, a core 12 may have an anchor 18, a support element 20, and a node 22 located between the anchor 18 and the support element 20. In the implanted/radially expanded configuration, anchor element 18 of core 12 may have a radial diameter of about 32 mm ± 1 mm, support element 20 may have a radial diameter of about 41 mm ± 1 mm and the length of the core 12 may be about 42 mm ± 1 mm. The cover preform 68 for such a core 12 may have a trapezoidal configuration and may have the following initial dimensions when viewed in a flat, two-dimensional configuration and prior to the inclusion of the core 12: a longitudinal length L1 of about 100 mm ± 1 mm, a top edge width W1 of about 50 mm ± 1 mm and a bottom edge width W2 of about 61 mm ± 1 mm.

[154] As another illustrative example of a combination of core 12 and cover preform 68, a core 12 may have an anchor 18, a support element 20, and a node 22 located between the anchor 18 and the support element 20. In the implanted/radially expanded configuration, anchor element 18 of core 12 may have a radial diameter of about 32 mm ± 1 mm, support element 20 may have a radial diameter of about 50 mm ± 1 mm and the length of the core 12 may be about 37 mm ± 1 mm. The cover preform 68 for such a core 12 may have a trapezoidal configuration and may have the following initial dimensions when viewed in a flat, two-dimensional configuration and prior to the inclusion of the core 12: a longitudinal length L1 of about 100 mm ± 1 mm, an upper edge width W1 of about 50 mm ± 1 mm and a lower edge width W2 of about 80 mm ± 1 mm.

[155] It should be understood that as the cover preform 68 undergoes the processing steps described in this document, the size dimensions of the cover preform 68 may change, such as becoming smaller than the dimensions initials of the cover preform 68. For example, the cover preform 68 may have initial size dimensions, such as an initial longitudinal length L1. As the cover preform 68 undergoes further processing, such as at least one edge, such as the top edge 76 of layers 70 and 80 being bonded and/or chip removal being removed, the resulting longitudinal length of the preform cover shape 68 at the time of insertion of core 12 into cover preform 68, inclusion of core 12 within cover preform 68 and/or the end joint of cover preform 68 may be less than the initial longitudinal length L1.

[156] During the manufacturing process the cover 14 can be manipulated to assume the desired configuration in accordance with the desired configuration of the core 12. The cover 14 can therefore be shaped to the core 12. As described in this document, the core 12 can having a node 22 located between the anchor element 18 and the support element 20. In an embodiment in which the core 12 is symmetrical about the longitudinal axis 24 of the core 12, and the lateral axis located at the midpoint of the longitudinal axis 24 of the core 12, node 22 may be located at the midpoint of the longitudinal axis 24 of the core 12. In an embodiment in which the core 12 may be symmetrical about the longitudinal axis 24 of the core, but not symmetrical about the lateral axis located at the midpoint of the longitudinal axis 24 of the core 12, the node 22 may not be located at the midpoint of the longitudinal axis 24 of the core 12. In such an embodiment, the support arms 28 may be larger than the anchor arms 26 and on 22 may be closer to anchor points 30 of core 12 and further away from anchor points 32 of core 12. In either embodiment, cover 14 may be adapted to the desired configuration of core 12 by placing cover 14 in the area where node 22 of core 12 is located.

[157] To include a core 12 within the cover preform 68, the cover preform 68 can be converted from a flat, two-dimensional configuration to a three-dimensional configuration to provide a space between the two layers 70 and 80, of the material 90 of the cover preform 68 into which the core 12 is desired to be inserted. The process of converting the cover preform 68 from a two-dimensional configuration to a three-dimensional configuration may include loading the cover preform 68 into a first pallet which may have pins 124 and 126 for opening cover preform 68. An exemplary embodiment of a first pallet 120 which may have pins 124 and 126 can be illustrated in FIGS. 21 - 23.

[158] FIG. 21 provides an illustrative example of a front view of a portion of a first pallet 120 with a base of 122 and a location 118 where a cover preform 68 can be loaded. FIG. 22 provides a top view of a first pallet 120 with at least one location 118 where a cover preform 68 can be loaded. FIG. 23 provides a side view of a first pallet 120 with a location 118 where a cover preform 68 can be loaded. It should be noted that the first pallet 120 can have as many locations 118 as desired for loading cover preforms 68 for conversion from a two-dimensional configuration to a three-dimensional configuration. In various embodiments, the first pallet 120 may have at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 locations 118 for receiving a two-dimensional cover preform 68 for converting a preform. three-dimensional cover shape 68. In various embodiments, a first pallet 120 may have from about 1, 2, 3, 4 or 5 locations 118 to about 6, 7, 8, 9 or 10 locations 118.

[159] Referring to FIG. 21 - 23, each location 118 on the first pallet 120 may have a pair of mounting brackets such as mounting brackets 128 and 130. Mounting brackets 128 and 130 may each be manufactured from any material deemed suitable, such as , but not limited to, steel, aluminum, plastic, etc. Mounting brackets 128 and 130 may have the ability to transition from a closed configuration (illustrated in FIG. 22) to an open configuration (illustrated in FIG. 23). Mounting brackets 128 and 130 may be pivotally connected to each other so that movement of one mounting bracket such as mounting bracket 128 may cause movement of the other mounting bracket such as mounting bracket 130. for example, causing the mounting bracket 128 to transition from a closed configuration to an open configuration, as for example, by depressing the base of a mounting bracket 128, may result in the mounting bracket 130 completing the same transition. Each mounting bracket 128 and 130 may be operatively connected with the first pallet 120 in any manner deemed suitable to allow the transition from a closed configuration to an open configuration, such as through the use of a hinge. Each mounting bracket 128 and 130 may have a hemispherical shape on its respective inwardly facing side, so that when the two mounting brackets 128 and 130 can be brought together in a closed configuration as illustrated in FIG. 22, the two hemispheres may form a complete circle around an open area 132. Each of the mounting brackets 128 and 130 may have a height H1, which may be any height deemed suitable for the manufacturing process described herein.

[160] With reference to FIGS. 21 - 23, each mounting bracket 128 and 130 may be associated with a pair of pegs 124 and 126. For example, the mounting bracket 128 may be associated with a pair of pegs 124 and the mounting bracket 130 may be associated with a pair of pins 126. The pairs of pins 124 and 126 may each have a base portion that can be associated with the inward facing side of each mounting bracket 128 and 130, respectively. The base portion of each pair of pins 124 and 126 may be associated with their respective mounting brackets 128 and 130 by any means deemed suitable, for example soldering or the use of screws. Each pair of pins 124 and 126 can have a portion that can extend beyond the height H1 of the mounting brackets 128 and 130, so that the cover preform 68 can be mounted over the portions of the pairs of pins 124 and 126 that extend beyond mounting brackets 128 and 130.

[161] In various embodiments, each pair of pins, such as pins 124, may be two separate components, associated with the same respective mounting bracket, such as mounting bracket 128. In such embodiments, each location 118 on the first pallet 120 may having two mounting brackets 128 and 130 and four individual pegs each with its own base associated with its respective bracket 128 and 130 (e.g. two individual pegs 124 each peg 124 associated with mounting bracket 128 and two individual pegs 126, each pin 126 associated with mounting bracket 130). In various embodiments, each pair of prongs such as prongs 124 may be manufactured from a single material and molded into a configuration such that the two prongs such as prongs 124 extend from the same base of the material. In such embodiments, each location 118 on the first pallet 120 may have two mounting brackets 128 and 130 and four individual pegs wherein two pegs 124 extend from a single common base associated with the mounting bracket 128 and two pegs 126 if extend from a single common base associated with mounting bracket 130.

[162] As described above, the mounting brackets 128 and 130 may each have a hemispherical shape on their inwardly facing sides so that when the mounting brackets 128 and 130 are in a closed configuration, the hemispherical shapes can form a complete circle around an open area 132. The base material of the pins 124 and 126 can be configured so that they follow the same curvature as the mounting brackets 128 and 130. It should be noted that the inward facing side of the mounting brackets assembly 128 and 130 need not have a hemispherical shape to form a full circle and an open area 132. The open area 132 can allow multiple rods, such as push rods and/or pre-insertion rods, to pass through the pallets (first , second and third pallets described here). The open area within each of the pallets can in any way be considered adequate to allow the passage of the various rods. In various embodiments, the open area can be circular, square, rectangular, etc. The shape of the open area can be defined by the pallet, for example, the shape of the open area 132 can be defined by the inward facing side of mounting brackets 128 and 130.

[163] Pins 124 and 126 may be manufactured from any material deemed suitable, such as, but not limited to, steel, aluminum, plastic, etc. The pins 124 and 126 can be of any shape and configuration as deemed suitable that can allow the pins 124 and 126 to open and close and maintain the cover preform 68 during conversion from a cover preform 68 flat, two-dimensional to a three-dimensional cover preform 68 and during the provision of an additional joint to the cover preform 68. During this process, pins 124 and 126 shall not impede any other activity or process step in the process of manufacturing. In various embodiments, pins 124 and 126 may be mirror images of each other. The pegs 124 and 126 may each have a height H2 exceeding the mounting brackets 128 and 130. The height H2 of the pegs 124 and 126 may be less than the initial total longitudinal length L1 of the cover preform 68 so that the pins 124 and 126 may not interfere with further processing of cover preform 68, such as bonding lower edges 78 of layers 70 and 80 of cover preform 68.

[164] As noted above, mounting brackets 128 and 130 can transition from a closed configuration, as in FIG. 22, for an open configuration, as in FIG. 23. Like pins 124 and 126, each may have a base associated with mounting brackets 128 and 130, pins 124 and 126 may undergo the same transition in configuration (i.e., from a closed configuration to an open configuration). Referring to FIG. 22, mounting brackets 128 and 130, may be in a closed configuration. The pin bases 124 and 126 may be associated with the mounting brackets 128 and 130 so as to allow the portion of the prongs 124 and 126 to extend beyond the mounting brackets 128 and 130 to be in close proximity to each other when mounting brackets 128 and 130 are in a closed configuration. In various embodiments, pins 124 and 126 may contact each other (e.g., a pin 124 in contact with a pin 126) when mounting brackets 128 and 130 are in a closed configuration. Referring to FIG. 23, when mounting brackets 128 and 130 have transitioned to an open configuration, the portion of pegs 124 and 126 that extend beyond mounting brackets 128 and 130 may also transition to an open configuration and pegs 124 and 126 may move. directionally away from each other. This movement of the pins 124 and 126 away from each other can cause the cover and cover 68 to convert from a flat, two-dimensional configuration to an open, three-dimensional configuration as the pins 124 and 126 away from each other can strain the layers 70 and 80 of the cover preform 68 away from each other.

[165] As described above, in various embodiments, a tape 112 of the cover preforms 68 can be manufactured. In various embodiments, such as the embodiment illustrated in FIG. 18, the cover preforms 68 in a strip 112 of cover preforms 68 may have a trapezoidal configuration and the top edges 76 of layers 70 and 80 of two cover preforms 68 may be adjacent to each other and the lower edges 78 of layers 70 and 80 of two cover preforms 68 may be adjacent to each other. As described above, it is believed that this arrangement can provide better efficiency in removing areas of shavings 102 such as scrap remnants 110. In order to convert each cover preform 68 from a two-dimensional configuration to a three-dimensional configuration, a preform The individual cover form 68 may be detached from the tape 112 of the cover preforms 68 and loaded onto a first pallet 120 at a location 118 having pins 124 and 126.

[166] In various embodiments, it may be desirable to bond the lower ends 78 of layers 70 and 80 of the cover preform 68 after loading the cover preform 68 onto the first pallet 120. Bonding the lower edges 78 of the layers 70 and 80 of the cover preform 68 may form a bonding area 168 which may ultimately form a joint, such as a supporting joint element 174 which may be located proximate the supporting member 20 of a core 12. In such embodiments, the cover preform 68 may be loaded onto the first pallet 120 so that the top edges 76 of the layers 70 and 80 of the cover preform 68 are closer to the mounting brackets 128 and 130 and the lower ends 78 of layer 70 and 80 of cover preform 68 are closer to the top of pins 124 and 126. Cover preform 68 may have an initial longitudinal length L1 greater than height H2 of the portion of the pins 124 and 126, ultrap baking the mounting brackets 128 and 130. A portion of the cover preform 68 extending beyond the height H2 of the prongs 124 and 126 may be joined to form the bonding area 168 which may in turn form a joint such as the element joint. support 174 of cover 14.

[167] As noted above, cover preforms 68 may be fabricated into a strip 112 of cover preforms 68 wherein the top edges 76 of two sequential cover preforms 68 may be adjacent to each other and the lower edges 78 of the two sequential cover preforms 68 may be adjacent to each other. As such, the cover preforms 68 can be set to be manufactured in an alternate sequence of cover preforms 68. As the cover preforms 68 can be in alternating sequence on the tape 112 of the cover preforms 68, any other cover preform 68 on tape 112 can be in a ready-to-load configuration onto first pallet 120 by placing top edges 76 of layers 70 and 80 of cover preform 68 closer to the mounting brackets. 128 and 130 on the first pallet 120. To provide efficiency in the manufacturing operation, the alternate cover preform 68 which may not be in a ready-to-load configuration on the first pallet 120 may be placed over a loading fixture 134 of a cover preform 68, as illustrated in FIGS. 24 and 25. FIG. 24 provides a front view of a loading fixture 134 of a cover preform 68 and FIG. 25 provides a side view of a loading fixture 134 of a cover preform 68. Loading fixture 134 of a cover preform 68 may have an anchor base 136 and a support 138 of a cover preform 68. cover 68. As described above, in various embodiments, cover preform 68 may have a trapezoidal configuration. As the cover preform 68 can have a trapezoidal configuration, the support 138 of the cover preform 68 can also have a trapezoidal configuration. Loading attachment 134 of a cover preform 68 may provide a definitive location for loading cover preforms 68 that may not be in close configuration when separated from the tape 112 of cover preforms 68 to be loaded. on the first pallet 120.

[168] Referring to FIGS. 26-28, loading a cover preform 68 onto a first pallet 120 and a cover preform 68 into a loading fixture 134 of the cover preform 68 can be illustrated. In one embodiment, a cover preform 68 can be considered to be in the configuration ready for loading of the first pallet 120 when, at the time when the cover preform 68 can be separated from the tapes 112 of the cover preforms, cover 68, cover preform 68 may be connected to tape 112 of cover preforms 68 through lower edge 78 of layers 70 and 80, cover preform 68 and upper edges 76 of layers 70 and 80 are the leading edge of the tape 112 of the cover preforms 68. In this embodiment, the cover preform 68 may be separated from the tape 112 by breaking the perforations 106 between the connected lower edges 78 of the cover preform 68. cover 68 on strip 112 and the next adjacent cover preform 68 on strip 112. Separate cover preform 68 can be directly loaded onto first pallet 120 at first available location 118.

[169] Referring to FIG. 26, this separate cover preform 68 can be loaded onto the first pallet 120 with the upper edges 76 of layers 70 and 80 of the cover preform 68 closest to the mounting arms 128 and 130, and the lower edges 78 of the layers 70 and 80 of cover preform 68 which extend beyond pins 124 and 126. Cover preform 68 may be positioned such that side seams, such as seam 74, are perpendicular to the plane of the first pallet 120. Positioning the cover preform 68, such that the side joint 74 may be perpendicular to the location of the first pallet 120, may include rotating, clockwise or counterclockwise, the cover preform 68 about pins 124 and 126, until the side joint 74 can be perpendicular to the plane of the first pallet 120. Positioning the side joints, such as the joint 74, perpendicular to the plane of the first pallet 120 can prevent the removal element 16 from being associated with the vaginal insert 1 0 inside the side junctions 72 and 74. If the withdrawal element 16 is associated with the vaginal insert 10 inside the lateral junctions 72 and 74, pulling the withdrawal element 16 during removal of the vaginal insert 10 from the vagina, this can weaken the lateral junctions. 72 and 74 of the vaginal insert 10, which may compromise the integrity of the vaginal insert 10.

[170] In an embodiment in which cover preforms 68 are fabricated on a tape 112 with an alternating sequence of cover preforms 68 (as illustrated in FIGS. 17 and 18), after a first preform of cover 68 has been detached from the tape 112 and loaded onto the first pallet 120, the next adjacent cover preform 68 may be detached from the tape 112 and loaded into the loading fixture 134 of the cover preform 68, as illustrated in FIG. 27. As illustrated in FIG. 27, the cover preform 68 can be loaded onto a cover preform holder 138 68 with the lower edges 78 of the layers 70 and 80 closer to the base 136 of the loading fixture 134 of the cover preform 68 Referring to FIG. 28, to transfer the cover preform 68 from the cover preform 68 loading fixture 134 to the first pallet 120, the cover preform 68's loading fixture 134 can be rotated 180°, thereby positioning , cover preforms 68 located in loading fixture 134 of cover preform 68 in the correct orientation for loading onto first pallet 120. Cover preforms 68, which initially had lower edges 78 of layers 70 and 80 of the cover preform 68 as their leading edge while being separated from a tape 112 of the cover preform 68, now have the top edges 76 of layers 70 and 80 of the cover preform 68 as their leading edge and in the correct orientation to position the top edges 76 of layers 70 and 80 of the cover preform 68 closest to the mounting arms 128 and 130 of the first pallet 120.

[171] Referring to FIGS. 17 - 28, in an exemplary embodiment, a first pallet 120 may have six locations 118 onto which the two-dimensional cover preforms 68 can be loaded and a loading fixture 134 of the cover preform 68 may have six supports 138 cover preform 68 onto which the two dimensional cover preform 68 can be loaded. In that exemplary embodiment, the process of loading the various cover preforms 68 from a tape 112 of alternating sequence cover preforms 68 (as illustrated in FIGS. 17 and 18) onto the first pallet 120 may include the alternating steps of loading a cover preform 68 from tape 112 onto the first pallet 120 with the top edges 76 of layers 70 and 80 closest to the mounting arms 128 and 130 followed by loading the next preform of cover 68 on tape 112 on loading fixture 134 of capping preform 68 with lower edges 78 of layers 70 and 80 closest to base 136 of loading fixture 134 of capping preform 68. These process steps can be continue until all six positions 118 of first fin 120 and all six holders 138 of cover preform 68 of loading fixture 134 of cover preform 68 have a cover preform 68 loaded. In this embodiment, therefore, twelve cover preforms 68 can be separated from the tape 112 of cover preforms 68. Since all six positions 118 of the first pallet 120 are loaded with a cover preform 68, the cover preforms 68 can be positioned such that the side joints 72 and 74 can be perpendicular to the plane of the first pallet 120. The mounting arms 128 and 130 can be operated such that the mounting arms 128 and 130 and the pins 124 and 126 transition from a closed configuration to an open configuration. The transition of the mounting arms 128 and 130 from the closed configuration to an open configuration can be accomplished by pressing down the base of a mounting arm, such as the mounting arm 128, and causing them to hinge open. This movement can result in the pivotally secured mounting arm 130 also transitioning to an open configuration. Pins 124 and 126, in the open configuration, can push layers 70 and 80 of the cover preform 68 away from each other, thereby causing the cover preform 68 to be in an open configuration. The first pallet 120 with six cover preforms 68 located thereon can be moved to the next stage of the manufacturing process and a first "empty" pallet 120 can be obtained (thus, another first pallet 120). The loading fixture 134 of the cover preform 68 can be inverted 180° over the first "empty" pallet 120 and the cover preforms 68, which had been loaded onto the holders 138 of the cover preform 68 of the cover fixture. loading 134 of the cover preform 68, can be transferred to the first "empty" pallet 120 by sliding them off the holders 138 of the cover preform 68 and down onto the pins 124 and 126 of the first "empty" pallet. 120. After transferring the six cover preforms 68 from the loading fixture 134 of the covering preform 68 to the first "empty" pallet 120, the loading fixture 134 of the covering preform 68 will be emptied of the cover preforms 68, the first pallet 120, which had been "emptied" is now fully loaded with cover preforms 68 and can be moved to the next stage of the manufacturing process, and the preform sequence coverage 68 can start again with another first pallet 120 and a loading fixture 134 of the cover preform 68.

[172] The next step in the manufacturing process may include pleating and sealing the bottom edges 78 of layers 70 and 80 of the cover preform 68. Pitching and sealing the bottom edges 78 of layers 70 and 80 of the cover preform 68 can result in the formation of a bonding area 168 which can ultimately form a joint, such as a joint of the support member 174 of the cover 14.

[173] As described above, a cover preform 68 can be positioned on the first pallet 120 such that the top edges 76 of layers 70 and 80 of the cover preform 68 can be positioned closest to the mounting arms. 128 and 130 of the first pallet 120. The lower edges 78 of the layers 70 and 80 of the cover preform 68 may therefore extend beyond the pins 124 and 126. The lower ends 78 of the layers 70 and 80 may be bonded to form a connection area 168. The connection area 168 may ultimately become the junction of the support element 174 and may ultimately be located proximate the support element 20 of the core 12.

[174] FIGS. 29 - 34 provide exemplary illustrations of exemplary process steps in which the lower edges 78 of layers 70 and 80 of the cover preform 68 may be pleated and bonded, thereby forming the bonding area 168. A first pallet 120, with at least one three-dimensional cover preform 68 open therein, can enter a pleat forming module. Cover preform 68 can be in an open configuration, as well as pins 124 and 126 of first pallet 120 can be in an open configuration. The pleat forming module may pleat layers 70 and 80, thereby forming the connection area 168. The connection area 168 may ultimately become a joint of the support element 174 of a cover 14 and may be located in close proximity to the support element 20 of a core 12 of a vaginal insert 10.

[175] As described above with respect to FIGS. 26 and 28, a two-dimensional cover preform 68 can be loaded onto a first pallet 120 and positioned such that the side seams 72 and 74 can be perpendicular to the plane of the first pallet 120. The first pallet 120 can be transported to the pleat forming module with the side joints 72 and 74 of the cover preform 68 perpendicular to the plane of the first pallet 120.

[176] FIG. 29 provides an exemplary illustration of a portion of a first pallet 120 having a cover preform 68 loaded thereon and held in an open configuration by opposing pairs of pins, such as pins 124. It should be understood that pins 126 cooperate with pins 124 to hold cover preform 68 in an open configuration, however, only pins 124 are visible to the viewer in the illustration of FIG. 29. The crease forming module may have crease bars 150 which may operate in a paired fashion. For example, with reference to FIG. 29, two cover preforms 68 are visible in an open configuration and five pleat bars 150 are visible. The pleat bars 150 can extend behind the lower edges 78 of the open cover preforms 68 and close together to form the pleat of layers 70 and 80 of the cover preforms 68. When the pleat bars 150 move to the readiness position to pleat a cover preform 68, one pleat bar 150 of the pair of pleat rods 150 can be positioned on one side of the cover preform 68, and the other pleat bar 150 of the pair of pleat bars 150 can be positioned on the opposite side of the cover preform 68. After the pair of pleat bars 150 has lowered into position, each pleat bar 150 moves to the side of a cover preform 68 to create a crease. FIG. 30 provides a top view illustration of a cover preform 68 and two pleat bars 150 positioned opposite each other in the ready-to- pleat position of cover preform 68. Directional arrows may indicate the direction in which that each crease bar 150 can move to provide a crease in the cover preform 68. It should be noted that while FIG. 30 is a top view, the illustration of the first pallet 120 is not visible in FIG. 30 to provide clarity of illustration.

[177] As pleat bars 150 move toward each other to create pleats in cover preform 68, pins 124 and 126 can bend together and hold cover preform 68 to prevent pleats come apart. The pleated cover preform 68, when viewed in top view, may resemble an "H" configuration. FIG. 31 provides a top view of the "H" configuration of the cover preform 68 after the pair of pleat bars 150 have pleated layers 70 and 80 of the cover preform 68 and the pins 124 and 126 have transitioned from the open configuration to a closed configuration. Referring to FIG. 32, it can be seen that a support bar 152 can be moved into position proximate the pleated cover preform 68 to maintain the pleated cover preform 68 in the pleated "H" configuration and/or ensure that the pleated cover preform 68 is maintained. pins 124 and 126 fold together before crease bars 150 are removed. The pleat bars 150 can be removed and the pleated cover preform 68 can be transported to a binding assembly to connect the pleated layers 70 and 80. The support bar 152 can also be removed before, during, or after the transporting the first pallet 120 to the binding assembly. The bonding of pleated layers 70 and 80 of cover preform 68 can bond at least two layers of material. In various embodiments, as the pair of pleat bars 150 can bend layers 70 and 80 in and toward each other, bonding can be through at least four layers of material. FIGS. 31 and 32 can each provide an illustration of the four layers of material from layers 70 and 80 of the cover preform 68 that can be bonded to form the bonding area 168. Also visible in FIGS. 31 and 32, is a center pleat 158 within the "H" configuration. The pleat center 158 may be the location of the pleated cover preform 68, where material from layers 70 and 80 can be brought into close proximity to each other as a result of the movement of the pleat bars 150. In various embodiments, there may be less than 10 mm of gap between the material of layers 70 and 80 at the center pleat 158. In various embodiments, there may be from about 0, 1, 2, 3, 4, or 5 mm to about 6, 7, 8, 9 or 10 mm gap between the material of layers 70 and 80 at pleat center 158.

[178] FIG. 33 provides a top view of a pleated cover preform 68 within a binding assembly. Bonding may occur by any means deemed suitable, such as, but not limited to, adhesives, pressure bonding, thermal bonding, ultrasonic bonding, joining, suturing and/or soldering. In the exemplary embodiment illustrated in FIG. 33, pleated cover preform 68 may be subjected to ultrasonic bonding to create a bonding area 168 (shown in FIG. 34). Ultrasonic binders may have an internal solenoid valve that can move the rod in and out of position when the binding cycle has been triggered. Any ultrasonic rod 154 and anvil 156, deemed suitable, may be used to form the bonding area 168.

[179] Once the attachment of each of the cover preforms 68 to the first pallet 120 is complete, the first pallet 120 can be routed to a chip removal station. FIG. 34 provides an illustration of an exemplary embodiment of a chip removal station. Bonding of layers 70 and 80 of cover preform 68 may occur in the area of layers 70 and 80 that extends beyond height H2 of pins 124 and 126. In various embodiments, all material in layers 70 and 80 of the preform -cover shape 68 that extends beyond height H2 of pins 124 and 126 can be bonded to create a bonding area 168. In various embodiments, less than all of the material in layers 70 and 80 of cover preform 68 that extends beyond height H2 of pins 124 and 126 may be bonded to create a bonding area 168. In such embodiments, a trim area 164 may be located between bonding area 168 and lower edges 78 of layers 70 and 80 of the cover preform 68. The chipping area 164 may be removed at a chip removal station. Since the first pallet 120 can advance through the chip removal station, a trim wheel 162, such as a trim wheel 162 suspended from a support arm 172, can press on the chip area 164 and pull the trim area 164 upwards to separate the trim area 164 from the connection area 168. In various embodiments, the trim wheel 162 may be a pair of friction wheels. Trimming area 164 may be further pulled away from bonding area 168 by any means deemed suitable, such as, for example, a vacuum 166. Control rollers 160 may prevent cover preform 68 from being pulled from the pins 124 and 126. Control rollers 160 may be suspended from a mounting arm 170.

[180] After pleating and bonding edges 78 of layers 70 and 80 of a cover preform 68, the cover preform 68 may have a single opening, where a portion of at least one edge of layers 70 and 80 remains unbound. A core insertion module 180 may insert a core 12 into the cover preform 68 through the opening of the cover preform 68. In various embodiments, the insertion of the core 12 into the cover preform 68 may be simply to move the core 12 through the opening and into the space between layers 70 and 80 of the cover preform 68. In such embodiments, the joint of the support member 174 may be on an external surface of the cover 14. In various embodiments, the insert of the core 12 in the cover preform 68 may include the steps of inverting the cover preform 68 and then moving the core 12 through the opening and into the open space between layers 70 and 80 of the preform. shroud shape 68. In such embodiments, the support element junction 174 may be located on a surface of the internal vaginal insert 10. In various embodiments, the insertion of the core 12 into the shroud preform 68 may include the step of inverting the preform 68. - form of coverage at 68 along and over the core 12 while the core 12 is moved through the opening and into the space between layers 70 and 80 of the cover preform 68. During the process of inserting a core 12 within the cover preform 68, the core insertion module 180 can also transfer the combination of the core 12 and the cover preform 68 to a second pallet 188.

[181] FIG. 35 provides a front view illustration of an exemplary embodiment of a core inserter module 180. The core inserter module 180 may receive a core 12 in a core compression tray 190, transfer the core 12 from the core compression tray 190. core 190 to cover preform 68 (provided on a first pallet 120) and positioning the combination of core 12 and cover preform 68 on a second pallet 188. Transferring core 12 from core compression tray 190 to a cover preform 68 may include inserting the core 12 into the cover preform 68 via any of the insertion methods described above. Such an insertion method - inverting the cover preform 68 while moving the core 12 into the cover preform 68 - may be further described herein. To carry out the insertion of the core 12 into the cover preform 68 and the transfer of the combination of the core 12 and the cover preform 68 to a second pallet 188, the core insertion module 180 may have three primary levels. An upper tier 182 may provide a location where a second pallet 188 can be loaded to receive the combination of core 12 and cover preform 68 after insertion of core 12 into cover preform 68. Upper tier 182 may include a table 198 on which the second pallet 188 may be positioned. In various embodiments, the table 198 can move up and down within the core insertion module 180. For example, the table 198, with a second pallet 188 positioned thereon, can lower to the middle level 184 of the module of insertion. core insert 180 to be in close proximity to the first pallet 120, which may be positioned within the intermediate level 184 of the core insert module. The upper tier 182 may also include pre-compression bars 202 that can provide initial compression of a cover preform 68 onto the core 12. An intermediate tier 184 may include a cylinder 194 and a cylinder crank 196. A first pallet 120 can be positioned within cylinder 194 and cylinder crank 196 can be used to rotate cylinder 194 to invert first pallet 120. First pallet 120 can have at least one cover preform 68 positioned thereon. Cover preform 68 may have side seams 72 and 74 and a support member joint 174. Cover preform 68 may have an opening between upper edges 76 of layers 70 and 80 of the cover preform 68. Top edges 76 of layers 70 and 80 may be positioned close to mounting arms 128 and 130 of a location 118 of first pallet 120. Intermediate level 184 may also include a core attachment tool 204 that may be used to secure the core 12 in the core compression tray 190. The core 12 can be placed in an opening 220 in the core compression tray 190 and the core clamping tool 204 can be used to push the core 12 further into the opening 220, such that the core 12 can be positioned below the top surface 224 of the core compression tray 190. The core clamping tool 204 can help maintain a uniform depth of the core(s) 12 loaded in the tray. core compression tray 190. Lower level 186 may include core compression tray 190. A core 12 may be placed in an opening of core compression tray 190 and thereby prepared for insertion into a preform of core 190. cover 68. Core compression tray 190 may have a crank 192 which can be used to move core compression tray 190 between an open and closed configuration. The lower level 186 may also include push bars 200 which may push the core 12 upwards into the cover preform 68 and further into the second pallet 188.

[182] FIG. 36 provides a perspective view of an exemplary embodiment of the mid-level 184 and low-level 186 of a core insertion module 180. The core compression tray 190 and cylinder 194 are each in an open configuration and awaiting input. loading cores 12 and a first pallet 120, respectively. FIG. 37 provides a perspective view of an exemplary embodiment of the mid-level 184 and low-level 186 of a core insertion module, wherein the core compression tray 190 and cylinder 194 are each in a closed configuration. Core compression tray 190 was pushed into core insert module 180 and cylinder 194 was rotated 180°. Rotation of cylinder 194 180° can invert first pallet 120 located within cylinder 194. FIG. 38A provides a perspective view of an exemplary embodiment of a core compression tray 190 in the open, uncompressed configuration, and FIG. 38B provides a perspective view of an exemplary embodiment of a core compression tray 190 in a closed, compressed configuration. The core compression tray 190 may have a core compression tray crank 192, front and rear jaws 206 and 208, respectively, guide blocks 210, an opening 220 for receiving the core(s) 12 to be( in) loaded into the core compression tray 190, at least one jaw connection mechanism, such as a rack gear arrangement 222, and a guide rail 212. A jaw connection mechanism may connect the jaws 206 and 208 such that the jaws 206 and 208 can move together. Additional examples of the jaw connection mechanism include, but are not limited to, slides, guide rails, and linear bearings. The core compression tray 190, in transitioning from an open configuration to a closed, compressed configuration, can maintain the shape of the apertures 220 (i.e., the aspect ratio between the axes can be maintained) and the jaws 206 and 208 can compress to the same degree.

[183] A core 12 may be placed in an opening 220 between the guide blocks 210 during loading of the cores 12 into the core compression tray 190. The guide rail 212 can help guide the core compression tray 190 as per the tray. The core compression tray 190 is pulled from the core inserter module 180 and pushed to the core inserter module 190. In various embodiments, the core compression tray 190 can compress the loaded core(s) 12. ) into the core compression tray 190 after movement of the core compression tray 190 to the core insertion module 180. In various embodiments, the core compression tray 190 can compress the core(s) 12 loaded into the core compression tray 190 as the core compression tray 190 is pushed into the core insertion module 180. To compress the core(s) 12 loaded into the 190 core compression, the front jaws and 206 and 208 may move 45° with respect to the core insertion module 180 to compress the cores 12. The movement of the jaws 206 and 208 towards each other to compress the core(s) 12 may be caused by air cylinders, pneumatic power, hydraulic power, or manual manipulation of the core compression tray 190. Pulling the core compression tray 190 out of the core insertion module 180 and into an open configuration can cause the jaws to 206 and 208 release their compression. In various embodiments, the core compression tray 190 may have at least one opening 220 for receiving a core 12. In various embodiments, the core compression tray 190 may have from 1, 2, 3, 4 or 5 openings 220 to 6, 7, 8, 9 or 10 openings 220. In various embodiments, the core compression tray 190 may have the same number of openings 220 and locations 118 on the first pallet 120.

[184] Referring to FIGs 39 - 42, schematic illustrations for the process of operating a core insertion module 180 may be illustrated. Since these are schematic illustrations and for clarity of illustration, many of the surrounding details of the core insert module 180 have been removed from the illustrations. As can be seen in FIG. 39, a second empty pallet 188 may be loaded onto the upper level 182 of the core insertion module 180. The second pallet 188 may have a base 214 and at least one handle 216 to hold the combination of the core 12 and the preform of cover 68. While second pallet 188 is illustrated as having a handle 216, second pallet 188 may have from 1, 2, 3, 4 or 5 handles 216 to 6, 7, 8, 9 or 10 handles 216. In various embodiments , the second pallet 188 may have the same number of handles 216 as the number of locations 118 on the first pallet 120. The second empty pallet 188 may be loaded onto a second pallet table 198 which may be able to move down from the upper level 182 of the core insertion module 180 for the first pallet 120 located in the middle level 184 of the core insertion module 180. The second pallet table 198 may have a transfer tube 218 which can guide the combination of the core 12 and of the cover preform 68 during the transition from the combi connecting the core 12 and the cover preform 68 to the second pallet 188. The transfer tube 218 may also guide a pre-compression bar 202 and a push bar 200 during their respective movement within the core insertion module. 180. A first pallet 120 with at least one cover preform 68 loaded on it can be loaded on the intermediate level 184 of the core insertion module 180. Loading of the first pallet 120 on the intermediate level 184 of the core insertion module 180 may include placing the first pallet 120 within the cylinder 194 such that the joint of the support member 174 can be oriented upwards towards the second pallet 188. As the first pallet 120 exits the pleat forming module, the pins 124 and 126 of the first pallet 120 are in a closed configuration. Since the first pallet 120 can be moved and loaded to the middle level 184 of the core insertion module 180, pins 124 and 126 can transition from a closed configuration to an open configuration. It should be noted that only pins 124 are visible in FIG. 39, however, both pin pairs 124 and 126 can transition to an open configuration. The opening of the pins 124 and 126 also results in the layers 70 and 80 moving in a direction away from each other and therefore an opening of the cover preform 68. This opening of the cover preform 68 can create a flat surface. of the cover preform 68 on the support element 20 of the core 12.

[185] Cores 12 can be loaded into core compression tray 190 with support arms 28 of cores 12 oriented upwards towards second pallet 188. Core clamping tool 204 can still be used to push core 12 into the opening 220 of the core compression tray 190 so that the core 12 is below the top surface 224 of the core compression tray 190. The core compression tray 190 can be pushed into the core insertion module 180. In various embodiments, pushing the core compression tray 190 into the core insertion module 180 may cause the core compression tray 190 to transition from an open, uncompressed configuration to a closed, compressed configuration. In various embodiments, the core compression tray 190 may transition from an open, uncompressed configuration to a closed, compressed configuration after the core compression tray 190 has been pushed into the core insertion module 180. In both In some cases, compression of the core compression tray 190 can be activated through air cylinder, pneumatic power, hydraulic power, or manual manipulation of the core compression tray 190. It should be noted that the core compression tray 190 , when in a closed and compressed configuration, compresses the entire core 12 from top to bottom. To compress the core 12, the guide blocks 210 of the front and rear jaws 206 and 208 can move toward each other at a 45° angle relative to the core insertion module 180. In various embodiments in which the compression tray of core 190 has transitioned from an open, uncompressed configuration after being pushed into core insertion module 180, compression of core(s) 12 can occur at any of the following times: before, during, or after lowering the second pallet 188 from the upper level 182 to the middle level 184 of the core insertion module 180 or before, during, or after lowering the pre-compression bars 202 from the upper level 182 to the middle level 184 to pre-compress the cover preform 68 into the core 12.

[186] Cylinder 194 can be inverted 180°, using cylinder crank 196 to invert cylinder 194. Inverting cylinder 194 can cause the joint of support member 174 of cover preform 68 to change orientation, such that the joint of the support member 174 can be oriented towards the core 12 and can be closer to the core 12. The inverted orientation of the cover preform 68 can be seen in FIG. 40.

[187] Referring to FIG. 40, the second pallet table 198 can be lowered from the upper level 182 to the middle level 184 so that the second pallet 188 can be closer to the first pallet 120. Although the transfer tube 218 can be illustrated (as in Fig. 40) as having a length such that the transfer tube 218 is in proximity to the base of the first pallet 120, in various embodiments the transfer tube 218 may have a length such that when the second pallet table 198 is lowered from the upper level 182 to the middle level 184, the transfer tube 218 may extend through the open area 132 in the first pallet 120 and may extend as far as the joint of the support element 174 of the preform of cover 68. In various embodiments the transfer tube 218 may extend into the cover preform 68 such that it can be closer to the junction of the support element 174 of the cover preform 68.

[188] Referring to FIG. 41, since the second pallet 188 is lowered from the upper level 182 to the middle level 184 to be closer to the first pallet 120, a pre-compression bar 202 can lower from the upper level 182 of the core 180 and can move through the open area in the handle of the second pallet 216, through an open area in the transfer tube of the second pallet 218, through the open area 132 in the first pallet 120, and between pins 124 and 126 of the first pallet for pushing the support member joint 174 of the cover preform 68 against the support arms 28 of the core 12. In various embodiments, by pushing the support member joint 174 of the cover preform 68 against the arms support 28 of the core 12, the pre-compression bar 202 can partially insert the cover preform 68 into the support element 20 of the core 12, such that, when the process is completed, the cover preform 68 may be loose on core 12. After the partial insertion of the cover preform 68 into the support element 20 of the core 12, the precompression bar 202 can be retracted.

[189] Referring to FIG. 42, after the precompression bar 202 can be retracted, the push bar 200 can move up from the lower level 186 of the core insertion module 180. The push bar 200 can move up through the opening 220 of core compression tray 190, through open area 132 of first pallet 120, and through guide tube 218 of second pallet table 198. Push bar 200 may extend upward to move compressed core 12 into towards the second pallet 188. This thrust of the compressed core 12 towards the second pallet 188 inserts the compressed core 12 into the cover preform 68, the compressed core 12 moving through the opening in the cover preform 68 and the cover preform 68 is inverted over the compressed core 12. The combination of the core 12 and the cover preform 68 is also pushed up onto the handle of the second pallet 216 of the second pallet 188, as may be seen in FIG. 42. After the combination of the core 12 and the cover preform 68 has reached the handle of the second pallet 216, the push bar 200 and the second pallet table 198 can all be retracted to their respective home positions. In other words, the push bar 200 can be lowered and the second pallet table 198 can be raised.

[190] After inserting the core 12 into the cover preform 68 and after loading the combination of core 12 and cover preform 68 onto the second pallet 188, the support arms 28 of the core and element region support element 20 of vaginal insert 10 may extend above the upper surface of the handle of second pallet 216. As described herein, a withdrawal member 16 may be associated with vaginal insert 10 in the region of support member 20 of vaginal insert 10. The second pallet 188 with the combination of core 12 and cover preform 68 can be transported to a row and node module. In various embodiments, the row and knot module may associate a removal element 16 with the region of the support element 20 of the vaginal insert 10 and may create two knots in the removal element 16. The double tie of the removal element 16 can hold the withdrawal member 16 in place on the vaginal insert 10 and can provide the user of the vaginal insert 10 with a place to grip the withdrawal member 16 during withdrawal of the vaginal insert 10 from the vagina.

[191] The combination of core 12 and cover preform 68 on second pallet 188 can enter a row and node module with the joint of support element 174 exposed above the handle of second pallet 216. After processing by the module of row and knot, the upper edges 72 of the layers 70 and 80 of the cover preform 68 may not yet be bonded and a removal element 16 may be attached to the cover preform 68 in the area where the support element joins. 174 and tied twice. FIG. 43 provides a schematic exemplary embodiment of the product after processing in the row and node module.

[192] The thread and knot module can attach a take-out element 16 to the cover preform 68 and can create lower and upper knots 230 and 232 on the take-out element 16. The thread and knot module can use various mechanical assemblies and air/vacuum to control the removal element 16 as it is measured, cut and tied. Assemblies associated with the stringing and tying processes include: mooring block assemblies, a needle assembly, scissor assemblies, and cover 68 preform and removal member clamp assemblies.

[193] The entire process in the wire and node module has two main steps. The first step may be to insert a stripper 16 into the combination of the core 12 and the cover preform 68 and the second step may be to create two nodes in the stripper element 16. FIGS. 44 - 46 provide schematic illustrations of embodiments of process steps for inserting a removal member 16, such as, for example, a wire 244 into the combination of core 12 and cover preform 68, and FIGS. 47 - 54 provide schematic illustrations of embodiments of process steps for the double lashing of a removal member 16.

[194] Referring to FIG. 44, a schematic illustration of a wire placement module may be illustrated. The yarn laying module may include a spool 246 of yarn 244. The spool 246 of yarn 244 may be located in an unwound position and the yarn 244 may be allowed to flow freely from the spool 246 during the general yarn laying process. . In various embodiments, a mechanical weight may be attached to the yarn 244 to maintain tension in the yarn 244. The yarn 244 can move through a block of yarn 240 which can move toward a needle 238 and back. In various embodiments, movement of wire 244 through wire block 240 may be effected by an air pressure differential. In various embodiments, the air pressure differential may be such that the highest pressure area is located in the area of the core 12 and cover preform 68 combination. In various embodiments, the movement of the wire 244 through the block of yarn 240 can be effected by pushing the yarn 244 with air. In various embodiments, movement of yarn 244 through yarn block 240 may occur by pulling on yarn 244 with vacuum. Since the yarn block 240 can move towards the needle 238, the movement of the yarn block 240 can move the yarn 244 the same amount as the movement of the yarn block 240. An inner yarn clamp 242, located inside block of wire 240, may be used to stop wire 244 from moving when wire 244 is desired not to move. A hollow needle 238 may allow the thread 244 to move through the needle 238. In various embodiments, any type of component that provides a channel for the thread 244 may be used in place of a hollow needle 238. Opposite the needle 238, and on the other side of the combination of core 12 and cover preform 68, a wire pulling clamp mechanism 234 can be located. Thread pulling mechanism 234 can move forward/backward with needle mechanisms 238. A thread clamp 236 within thread pull/clamp mechanism 234 can be used to hold thread 244 after needle 238 has The cover preform 68 is perforated and the wire 244 is pushed through the cover preform 68.

[195] Referring to FIG. 45, a schematic view of the basic thread supply process 244 may be illustrated. It should be noted that, although not illustrated in FIG. 45, two funnels 256 associated with lower tie block 262 can be lowered into position and on either side of cover preform 68 prior to wire placement of cover preform 68. More details on funnels 256 and on The mooring process will be provided below. A second pallet 188 that holds a combination of the core 12 and the cover preform 68 may be attached in position for providing the removal element 16, such as in the wire form 244. Since the second pallet 188 may be attached in position, the combination of core 12 and cover preform 68 can be rotated. Rotation can provide that needle 238 and thread 244 cannot puncture the joint of support element 174 since puncturing the joint of support member 174 can weaken the overall joint of support member 174.

[196] Air can be pushed towards the base of the second pallet 214 from under the second pallet 188. Air can still move through the second pallet support 216 which can "swell" and cover the cover preform 68. above the support arms 28 of the core 12. Accompanying the "swell" and the cover of the cover preform 68, cover preform 68 clips, 248 and 250, can close on the cover preforms 68 and the core 12. Closing the cover preform clips 248 and 250 can retract the support arms 28 of the core 12 as well as the cover preform 68. As the cover preform 68 has been "swelled" and has been covered prior to closing the cover preform clamps 248 and 250, a portion of the cover preform 68 may extend above the height of the cover preform clamps 248 and 250. second pallet 188 and closing the cover preform clamps 248 and 250 can therefore cause the cover preform 68 is covered on top and provides a location where needle 238 can pass through yarn 244.

[197] The two funnels 256 associated with the lower mooring block can be lowered with a funnel 256 on either side of the housed cover preform 68. To move yarn 244 through cover preform 68, needle 238 may be moved forward toward cover preform 68. Needle 238 may move through an opening in first funnel 256, four layers pleated and lodged cover preform 68 and through an opening in second funnel 256 located on the opposite side of cover preform 68. Yarn block mechanism 240 is movable towards the rear of needle 238 and can feed about ¼ inch of yarn 244 through needle 238. Yarn 244 that has been fed by needle 238 through first funnel 256, the four layers of pleated and lodged cover preform 68 and second funnel 256 can be captured by the wire clamp 236 on the wire pulling clamp mechanism 234 which can also move forward towards the cover preform 68. The wire pulling clamp 236 can secure the wire end 244 and the wire mechanism. 240 wire block can be free ted.

[198] Referring to FIG. 46, the needle 238 and yarn pulling clamp mechanism 234 can be moved back to their initial positions. Insofar as the wire 244 can be stapled and secured by the wire clamp 236 to the wire pull clamp mechanism 234, the wire 244 can be pulled by the wire traction clamp mechanism 234 and the backward movement distance by the Wire pull clamp mechanism 234 may set the length of wire 244. Wire 244 may be clamped in the middle, at the location of housed cover preform 68, by wire clamp 254 to prevent it from slipping during the process. of mooring. Tightening on yarn 244 can be performed until the first knot is created. Once the desired length of thread 244 is obtained and thread 244 has been clamped by thread clamp 254, thread can be cut by thread cutter 252 located in close proximity to needle 238 and thread pressure clamp 242 can be cut. be stapled to prepare yarn 244 for the next cycle.

[199] The tying of yarn 244 may begin at the same time as feeding of yarn 244 through the first funnel 256, through the four layers of the lodged and pleated cover preform 68, and through the second funnel 256 to the wire pulling clamp 234. The lashing may include the steps of lowering the upper and lower lashing blocks, 260 and 262, respectively, and the funnels 256 into position when the core 12 and cover preform 68 are clamped by the first time. Funnels 256 may be in position before needle 238 moves through core 12 and cover preform 68. As illustrated in FIG. 47, the yarn 244 may be fed through two funnels 256 which are located on either side of the pleated and lodged cover preform 68. It should be noted that the funnels 256 may be used to position the yarn 244 on the mooring blocks. The hoppers 256 can be opened when they are in the mooring position, following a mechanical cam. As the mooring blocks, 260 and 262, move up the spar module, the funnels 256 exit the mechanical cam and close. In various embodiments, the funnels 256 may be held closed by the use of small magnets. Each mooring block, 260 and 262, can move independently of the other mooring block, 260 and 262. Each of the mooring blocks, 260 and 262, can have upper and lower parts that can also move independently. The upper mooring block 260 can have a top 228 and a bottom 226. The bottom mooring block 262 can have a top 278 and a bottom 276.

[200] Once the wire 244 is cut, as illustrated in FIG. 47, mooring blocks 260 and 262 and funnels 256 move upward to align the yarn as illustrated in FIG. 48. The yarn 244 remains clamped by the yarn clamp 254, however, the yarn 244 can be released from the yarn pull clamp mechanism 234. The yarn entry point 258 at the lower tie block 262 may be at the bottom of the yarn. lower lashing block 262. Wire gripper 254 can continue to secure wire 244 while funnels 256 and upper and lower lashing blocks 260 and 262 are lifted.

[201] Referring to FIG. 49, once the wire 244 has been lifted by the upward movement of the funnels 256 and the upper and lower mooring blocks 260 and 262, the wire holders 270 can be used to momentarily hold the wire 244 and prevent it from being collected in relation to the products. The yarn supports 270 can support the weight of the yarn 244 until the yarn 244 can be placed on the mooring blocks, 260 and 262. From this point forward, the funnels 256 can remain closed for the remainder of the process.

[202] Referring to FIG. 50, the mooring blocks, 260 and 262, can be lowered to the wire supports 270 and a vacuum can be used to pull rope 244 through the mooring blocks, 260 and 262. The mooring blocks, 260 and 262, can have a yarn path 274 that can create a knotted loop around center pins, such as center pins 264 and 266. Center pins 264 and 266 can be used to force a knot to be created at a specific location on the wire 244. In various embodiments, center pins 264 and 266 may be located on tops, 228 and 278, of mooring blocks, 260 and 262, respectively. For example, center pin 264 can be located on top 278 of lower lashing block 262 and center pin 266 can be located on top 228 of upper lashing block 260. Since yarn 244 can be fed through the path of the yarn 274 and around a central pin, 264 or 266, a clamp 268 may be used to secure the yarn 244 while the knot is created. The path of wire 274 can be illustrated in FIG. 51. For clarity, the mooring block details are not shown in the illustration in FIG. 51, however, the path of thread 274 illustrated can demonstrate the path that thread 244 can follow around center pin 264 on lower tie block 262 and center pin 266 on upper tie block 260. The path of thread 274 can be a "loop knot" path on the upper and lower lashing blocks, 260 and 262. In various embodiments, the upper lashing block portion 260 of the yarn path 274 may be at 90° to and from the upper lashing block portion 260 of the yarn path 274. lower tie 262 of the thread path 274.

[203] Referring to FIG. 50, the yarn 244 can follow the path of the yarn 274 which can lead the yarn 244 around the center pin 264 located at the top 278 of the lower tie block 262. The yarn 244 can continue to follow the path of the yarn 274 until the bottom 226 of the upper lashing block 260 where the wire 244 can be stapled by the wire clamp 268 located at the bottom 226 of the upper lashing block 260.

[204] As can be seen in the schematic illustration of FIG. 52, the upper mooring block 260 can move upwards which can cause the top and bottom parts, 278 and 276, of the lower mooring block 262 to open. Opening the top and bottom 278 and 276 of the lower mooring block 262 may allow the center pin 264 to retract. As the upper tie block 260 can continue to move upward, the yarn 244 can be tightened and the portion of the yarn 244 that has been wrapped around the center pin 264 can form the bottom knot 230. The bottom knot 230 it may be tightened by upward movement of the upper lashing block 260 and the wire clamp 268 at the bottom 226 of the upper lashing block 260. The lower lashing block 262 may remain open for the remainder of the process. The wire clamp 254 can also be released at this time.

[205] Upon completion of the lower knot 230, the upper tie block 260 can move downwards to take out the yarn 244 again to form a second knot 232. As with the lower knot 230, the yarn 244 follows the path of the yarn. 274 which can wrap wire 244 around center pin 266 on top 228 of top mooring block 260. FIG. 53 provides a schematic representation of a step in this process. Referring to FIG. 54, once the wire 244 has been wrapped around the center pin 266 at the top 228 of the upper lashing block 260, a wire clamp 268 at the top 228 of the upper lashing block 260 can be used to secure the wire 244 while knot 232 is tightened. The top 228 of the upper mooring block 260 can move up and open the top 228 of the bottom 226 of the top mooring block 260 to allow the center pin 266 to retract. To the extent that the top 228 of the top tie block 260 can continue to move upwards, the yarn 244 can be tightened and the portion of the yarn 244 that has been wrapped around the center pin 266 can form the top knot 232. The top knot 232 can be tightened by upward movement of the top 228 of the top tie block 260.

[206] FIG. 55 is a schematic illustration that can demonstrate that once the knots, 230 and 232, can be formed, the mooring blocks, 260 and 262, can move up to their initial positions. A yarn control mechanism 272 can move forward to capture the yarns and prevent them from being gripped towards the combination of the core 12 and the cover preform 68 on the second pallet 188, while the indexes of the second pallet 188 for the next part of the manufacturing process and the cover grips 248 and 250 can be retracted. It should be noted that while the mooring module may be described as having an upper mooring block 260 and a lower mooring block 262, in various embodiments the mooring module may have only one mooring block. In these embodiments, the mooring module can produce a first knot in the yarn, reposition the yarn in the same mooring block, and create a second knot in the yarn.

[207] After the wire 244 which can form the removal member 16 is attached, it may be beneficial to transfer the combination of core 12 and cover preform 68 to a third pallet 280. Transferring the combination of core 12 and Cover preform 68 for third pallet 280 may allow for inversion of the combination of core 12 and cover preform 68 and allow for bonding of upper edges 76 of layers 70 and 80 of cover preform 68 , thereby completely enclosing the core 12 and converting the cover preform 68 into a cover 14. FIG. 56 provides a perspective view of an exemplary embodiment of the combination of core 12 and cover preform 68, in which core 12 is positioned within cover preform 68 with removal element 16 secured in the region of the element. support 20, however, one end of the cover preform 68 remains unbonded. FIG. 57 provides a perspective view of an exemplary embodiment of a third pallet 280 in which the combination of core 12 and cover preform 68 can be inverted from the configuration illustrated in FIG. 56. In other words, the combination of core 12 and cover preform 68 on second pallet 188 provides for removal member 16 to be secured to cover preform 68 and visible externally to second pallet 188. core 12 and cover preform 68 of FIG. 57 illustrates that, after the transfer from the second pallet 188 to the third pallet 280, the removal element 16 and support element 20 of the combination of core 12 and cover preform 68 are within the third pallet 280 and the element anchor 18 extends beyond the outer surface of the third pallet 280.

[208] Schematic illustrations for the process of transferring the core 12 and cover preform 68 combinations from the second pallet 188 to a third pallet 280 may be illustrated in Figures 58 - 64 with reference also to Figures 65 - 67 in transfer module 300. The transfer module 300 may have a loading zone 302 of the second pallet 188, wipers of the removal element 288, a loading zone 304 of the third pallet 280, an inverter 308 and an inverter crank 322 , a compressor 284 and a compressor handle 286, push bars 292 and a push bar handle 294, and a foot pedal 306. The inverter 308 can rotate 180° and can also raise and lower the second pallet 188 in its inverted orientation ( i.e. after rotation of inverter 308). A second pallet 188 can be transported to the loading zone of the second pallet 302 of the transfer module 300 after attaching the removal element 16 to the cover preform 68. By transporting the second pallet 188 to the loading zone of the second pallet 302, the second pallet 188 may be passed through a set of removal element cleaners 288 to ensure that the removal elements 16 are not caught on any components of the transfer module 300, such as the guide rails. The second pallet 188 can be loaded into an inverter 308 which can invert the second pallet 188 into position for transferring the combination of core 12 and cover preform 68. The loading zone of the second pallet 304 and the inverter 308 may be positioned above the compressor 284. A third empty pallet 280 may be loaded into the third pallet loading zone 304. The third pallet loading zone 304 may include a lifting tray which can lift the third pallet 280 upwards towards to the compressor 284. The loading zone of the third pallet 304 may therefore be positioned below the compressor 284. The third pallet 280 may have locations 290 for receiving the combinations of the core 12 and the cover preform 68. The third 280 pallet can any number of locations that is deemed suitable. In one embodiment, the third pallet 280 may have at least one location 290. In one embodiment, the third pallet may have from about 1, 2, 3, 4 or 5 locations 290 to 6, 7, 8, 9 or 10 locations 290. In various embodiments, the third pallet 280 may have the same number of locations 290 as the number of locations 118 on the first pallet 120.

[209] Referring to FIG. 58, the second pallet 188 can be loaded into a second pallet loading zone 302 located above a compressor 284 and placed in the inverter 308 and the third pallet can be loaded into a third pallet loading zone 304 located below a compressor 284 The second pallet can be loaded with the combination of core 12 and cover preform 68 facing upwards, away from compressor 284. Referring to FIG. 59, the second pallet 188 can be inverted by holding the handle of the inverter 322 and rotating the inverter 180o until the combination of core 12 and cover preform 68 is oriented downwardly towards the compressor 284. Referring to FIG. 60, the inverter 308 and the second pallet 188 can be lowered to their lowest position so that the support element 20 and the removal element 16 are positioned with the compressor 284. A vacuum can be used to assist in the removal of the removal element 16 in the openings of compressor 284. Using foot pedal 306, foot pedal 306 can be depressed downward causing an associated lever to lift third pallet 290 upward towards compressor 284. Referring to FIG. 61, the compressor identifier 286 can be activated to retract the jaws of the compressor 284 and move the compression blocks 298, located within the base 296 of the compressor 284, toward each other. Compressor blocks 298 may change at a 45° angle to the transfer module 300. To enable the change, compressor 284 may have jaw connection mechanisms such as, but not limited to, slides, guide rails, bearings linear or rack and pinion arrangements. The compression may collapse the core combination 12 and cover preform 68 to allow transfer of the core combination 12 and cover preform 68 from the second pallet 188 to the third pallet 290. In various embodiments, compression of compressor 284 may be activated through air cylinder, pneumatic power, hydraulic power, or manual manipulation of compressor 284. Referring to FIG. 62, the push rods 292 can be activated to move through an open area at the base of the second pallet 188 and push the combination of core 12 and cover preform 68 out of the second pallet 188 and onto the third pallet 280. Referring to FIG. 63, after transferring the combination of core 12 and cover preform 68 from the second pallet 188 to the third pallet 280, the push rods 292 can be retracted and the second pallet 188 can be inverted and returned to position. original initial 188 from second pallet. Compressor handle 286 can be operated to release compressor 284 and third pallet 280 can be lowered, releasing foot pedal 306. Third pallet 280 can continue in the manufacturing process as illustrated in FIG. 64.

[210] The third pallet 280 can carry a combination of core 12 and cover preform 68 of a pleat module. As the cover preform 68 may already have side seams 72 and 74 and a supporting splice member 174, the pleat module may provide an anchoring element for the cover preform 68 joining. to the formation of pleats in layers 70 and 80 of the cover preform 68 at the beginning of the manufacturing process, the top edges of layers 70 and 80 of the cover preform 68 may be pleated in an "H" configuration, such as as seen from the top of the cover preform 68. After the cover preform 68 can be pleated, layers 70 and 80 of the cover preform 68 can be bonded together to create a joint anchor that can complete the cover 14, which can completely enclose the core 12 within the cover 14.

[211] Referring to Figs. 68 - 76, the pleat module can pleat and bond layers 70 and 80 of the cover preform 68 to create a joint anchor end. FIG. 68 provides a front view and FIG. 69 provides a top view of a third pallet 280 as it can be transmitted to the pleat module. The anchor 18 of the core 12 may extend above the third pallet 280 and a portion of the cover preform material 68 may extend beyond the anchor 18. FIG. 70 may provide a front view and FIG. 71 can provide an overhead view of the descent of the pins 310 within the cover preform 68 and the movement of the insert bars 312 to the sides and in the middle of the cover preform 68. In one embodiment, four pins 310 may assist in maintaining the open configuration of the cover preform 68. FIG. 72 may provide a front view and FIG. 73 can provide a top view of the movement of the insert bars 312 into the cover preform 68 between the pins 310. This movement of the insert bars 312 can create the "H" configuration of the pleat. FIG. 74 may provide an illustration, once the pleat has been created, the pins 310 can be removed from within the cover preform 68. After the pins 310 are withdrawn from within the cover preform 68, the layers 70 and 80 of the cover preform 68 can be bonded, such as, for example, ultrasonically welded, as illustrated in FIG. 75. Once the bonding of layers 70 and 80 of cover preform 68 is complete, insert bars 312 may retract to their initial positions and cover preform 68 may have a bonded area 318 which can finally become the joint anchor for the cover preform 68. Once the joint anchor for the cover preform 68 can be formed, the core 12 can be completely enclosed within the cover 14 As can be seen in the exemplary embodiment illustrated in FIG. 76, an adjustment area 320 can be created during the bonding process. This snap area 320 can be removed in a manner similar to the previously described methods for removing snap areas.

[212] Although the cover 14 may have a core 12 enclosed within, it may be desirable to conform the cover 14 to the general shape and configuration of the core 12. Reasons and methods for forming a cover 14 from a core 12 have been previously discussed. A method such as forming and attaching a strip may be further described herein. A band-forming module can apply a band 344 to the cover 14 of the vaginal insert 10. In various embodiments, the band 344 can be configured from a material such as a non-woven material. In various embodiments, the strip 344 may be formed from a material such as a film. In various embodiments, the band 344 may be formed from a woven material. In various embodiments, the strip 344 may be formed from a material which may be the same material used to form the cover 14.

[213] The band-forming process can produce a small band 344 of material that can be placed over the cover 14 of the vaginal insert 10. The band-forming process 344 can be illustrated in FIG. 77. Material 330 for strip 344 may be fed from a roll and may be routed through a mechanical mesh guide 332 to feed rollers 334. Material 330 may be about 3, 4, or 5 inches wide. mm to about 6, 7 or 8 mm. In one embodiment, material 330 may be about 6 mm wide. In one embodiment, one of the rollers 334 can be controlled via a servo motor and the other feed rollers 334 can be driven by friction. Each frictionally driven roller may have an adjustable spring tensioner to increase or decrease the force of rollers 334. In various embodiments, movement of material 330 through web guide 332 may be effected by an air pressure differential. In various embodiments, the air pressure differential may be such that the low pressure area is located in the area of the mandrel 340. In one embodiment, the material 330 may move through the mechanical mesh guide 332 when being pushed by compressed air medium. In various embodiments, movement of material 330 through web guide 332 may occur by pulling material 330 with a vacuum. Feed rollers 334 may feed material 330 into a second mesh guide mechanism 336. Second mesh guide mechanism 336 may use compressed air to feed material 330 onto mandrel 340. Material 330 may be fed to a mandrel 340 and the mandrel can use a vacuum to control the material 330 as it is placed on the mandrel. Once the desired length of material 330 has been fed onto mandrel 340, a cutter, such as scissors 338, on second net guide mechanism 336 can cut material 330. Mandrel 340 can rotate and material 330 can wrap around mandrel 340. FIG. 78 provides an illustration of a pattern of vacuum holes 350 on the mandrel 340 to hold the material 330 for the strip 344 in position on the mandrel 340. The pattern 350 may have a series of horizontal holes to the left of an inverted "C". . The material 330 can be placed over the chuck on the right side of the "C" (i.e. the three vertical holes in the pattern 350) and the chuck 340 and the pattern 350 can continue to rotate until the end of the cutting material 330 overlaps the three vertical holes in pattern 350. Once material 330 has overlapped over mandrel 340, material 330 can be bonded to itself, such as, for example, using an ultrasonic antenna 342 or any other method of bonding which is referred to herein - such as, for example, adhesive, thermal bonding and/or pressure bonding. Bonding of material 330 to itself can occur in the open area of the reverse "C" in pattern 350. Bonding of material 330 to itself can create band 344, which can be placed over cover 14 of vaginal insert 10.

[214] Once a band 344 has been fabricated, it can be placed over a cover 14 of a vaginal insert 10. FIG. 79 may illustrate the process of placing a strip 344 on a cover 14 of a vaginal insert 10. The mandrel 340 may have two sections: the upper section may be connected to a source of vacuum and may be the location where material 330 may wrap around the mandrel 340 to form the band 344. The lower section of the mandrel may be hollow to allow the vaginal insert 10 to be pushed into the mandrel to allow the band 344 to be slid over the cover 14 of the vaginal insert 10 The anchor 18 of the vaginal insert 10 can be compressed. After compression of the anchor 18 of the vaginal insert 10, the third pallet 280 on which the vaginal insert 10 is located can be lifted upwards and the compressed anchor 18 of the vaginal insert 10 can be positioned within the mandrel 340 A strip peeler 356 located on the mandrel 340, and above the strip 344, can move down the mandrel 340 and toward the vaginal insert 10. While the strip peeler 356 can move under the mandrel, stripper The band 356 can move the band 344 that was in position on the mandrel 340 down onto the compressed anchor 18 of the vaginal insert 10. The third pallet 280 can be lowered, the anchor 18 of the vaginal insert can be removed from inside the mandrel 340 and the band 344 may be in position over the vaginal insert 10.

[215] A heat staking process can weld the strip 344 to the cover 14 of the vaginal insert 10 on both the front and rear sides of the vaginal insert 10. FIG. 80 provides a schematic view of an exemplary process of heat sealing the band 344. Heated elements 358 may be briefly compressed to the band 344 on the cover 14 of the vaginal insert 10 to form the solder that can hold the band 344 in position on the cover 14. of the vaginal insert 10.

[216] After manufacturing the vaginal insert 10 and conforming the cover 14 to the core 12 of the vaginal insert 10, the vaginal insert 10 may be placed in an applicator 40 as described herein to facilitate insertion of the vaginal insert 10 into the vagina.

[217] It is noted that while the description presented herein provides an exemplary embodiment of the process of manufacturing a vaginal insert 10, additional embodiments are also contemplated. For example, the exemplary embodiment of the manufacturing process described herein may generally describe inserting a core 12 into a cover preform 68 through an opening between the top edges 76 of the two layers 70 and 80 of the cover preform 68. 68. It is observed that, in various embodiments, the insertion of the core 12 into the cover preform 68 may occur through an opening between the lower edges 78 of the two layers, 70 and 80, of the cover preform. 68 or through an opening between the side edges of layers 70 and 80 of the cover preform 68. It is also contemplated that while the description herein generally describes bonding to the lower edges 78 of layers 70 and 80 of a preform. cover shape 68 prior to bonding top edges 76 of layers 70 and 80 of cover preform 68, in various embodiments, top edges 76 of layers 70 and 80 of cover preform 68 may be bonded prior to bonding from to lower remnants 78 of layers 70 and 80 of cover preform 68.

[218] It is noted that while the description herein generally provides an exemplary embodiment of each insert core module 180, additional embodiments for the stringer and knot modules, the transfer module 300, the pleat module, and the forming module range are also covered. For example, in some portions of the description here, some components of different modules are described as being "above" or "below" other components of the same module, and in some portions of the description here, some components are described as being in a particular "level" of the module, such as an "upper level", "medium level" or "low level". It is envisaged that the orientation of the modules may be inverted such that, for example, components that are described as being "on top" of another component may, in various contemplated embodiments, be "below" that component and that some components that currently described as being of a "higher level" may, in various contemplated embodiments, be of a "lower level".

[219] For reasons of brevity and brevity, any ranges of values set forth in this disclosure contemplate all values within the range and should be interpreted as supporting claims that indicate any subranges having endpoints that are whole number values within the range in specified question. In a hypothetical example, a disclosure in a range ranging from 1 to 5 would be considered to support claims in any of the following ranges: 1 to 5; 1 to 4; 1 to 3; 1 to 2; 2 to 5; 2 to 4; 2 to 3; 3 to 5; 3 to 4; and 4 to 5.

[220] The dimensions and values disclosed in this document should not be understood as being strictly limited to the exact numerical values quoted. Instead, unless otherwise specified, each dimension is intended to mean the quoted value and a functionally equivalent range around that value. For example, a dimension disclosed as "40mm" should be interpreted as "about 40mm".

[221] All documents cited in the Detailed Description are, in relevant part, incorporated herein by reference; citation of any document should not be construed as an admission that it is prior art in relation to the present invention. To the extent that any meaning or definition of a term in this written document conflicts with any meaning or definition of a term in a document incorporated by reference, the meaning or definition given to the term in this written document shall control.

[222] While specific embodiments of the present invention have been illustrated and described, it will be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to encompass in the appended claims all such changes and modifications which are within the scope of this invention.

Claims (20)

1. Rope and knot module characterized in that it comprises: a. a string module comprising: i. a block of rope; ii. a rope block clamp located within the rope block; iii. a needle; iv. a clamp mechanism for pulling the rope; and v. a rope clamp associated with the rope pulling clamp mechanism; B. a mooring module comprising: i. a top mooring block; ii. a lower mooring block; and iii. a first funnel and a second funnel, each of the first and second funnel associated with the lower mooring block. 2. Rope and knot module, according to claim 1, characterized in that the string module further comprises a source that provides an air pressure differential. 3. Rope and knot module, according to claim 1, characterized in that the string module also comprises a set of scissors. 4. Rope and knot module, according to claim 1, characterized in that the upper mooring block of the mooring module further comprises an upper part, a lower part and a central pin positioned inside the upper part of the mooring block. top mooring. 5. Rope and knot module, according to claim 4, characterized in that the upper and lower parts of the upper mooring block can move independently of each other. 6. Rope and knot module, according to claim 1, characterized in that the lower mooring block of the mooring module further comprises an upper part, a lower part and a central pin positioned inside the upper part of the mooring block. bottom mooring. 7. Rope and knot module, according to claim 6, characterized in that the upper and lower parts of the lower mooring block can move independently of each other. 8. Rope and knot module, according to claim 1, characterized in that the mooring module further comprises a rope path associated with the upper and lower parts of the lower mooring block and the lower and upper parts of the top mooring. 9. Rope and knot module, according to claim 8, characterized in that a part of the path of the rope associated with the upper mooring block is at a 90o angle to a part of the path of the rope associated with the block bottom mooring. 10. Rope and knot module characterized in that it comprises: a. a string module comprising: i. a block of rope; ii. a rope block clamp located within the rope block; iii. a needle; iv. a clamp mechanism for pulling the rope; v. a rope clamp associated with the rope pulling clamp mechanism; and saw. a pair of cover preform clips; B. a mooring module comprising: i. a top mooring block; ii. a lower mooring block; iii. a first funnel and a second funnel, each of the first and second funnel associated with the lower mooring block; and iv. a rope clamp. 11. Rope and knot module, according to claim 10, characterized in that the string module further comprises a source that provides an air pressure differential. 12. Rope and knot module, according to claim 10, characterized in that the string module also comprises a set of scissors. 13. Rope and knot module, according to claim 10, characterized in that the upper and lower parts of the upper mooring block can move independently of each other. 14. Rope and knot module, according to claim 10, characterized in that the upper and lower parts of the lower mooring block can move independently of each other. 15. Rope and knot module, according to claim 10, characterized in that the mooring module further comprises a rope path associated with the upper and lower parts of the lower mooring block and the lower and upper parts of the top mooring. 16. Rope and knot module, according to claim 15, characterized in that a part of the path of the rope associated with the upper mooring block is at a 90o angle to a part of the path of the rope associated with the block bottom mooring. 17. Node module characterized in that it comprises: a. an upper mooring block comprising: i. an upper part; ii. a lower part; iii. a central pin positioned within an upper part of the upper mooring block; B. a lower mooring block comprising: i. an upper part; ii. a lower part; iii. a central pin positioned within an upper part of the lower mooring block; ç. a rope path associated with the lower and upper parts of the lower mooring block and associated with the lower and upper parts of the upper mooring block. 18. Node module, according to claim 17, characterized in that the upper part and the lower part of the upper mooring block can move independently of each other. 19. Node module, according to claim 17, characterized in that the upper and lower part of the lower mooring block can move independently of each other. 20. Knot module, according to claim 17, characterized in that a part of the path of the rope associated with the upper mooring block is at a 90o angle to a part of the path of the rope associated with the mooring block bottom.

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