CN105828749B

CN105828749B - The manufacturing method of vaginal inset

Info

Publication number: CN105828749B
Application number: CN201480068687.0A
Authority: CN
Inventors: S·A·阿德勒; S·A·安斯沃思; T·W·海伦伊科; C·A·桑普尔; B·W·托麦克; S·A·奥尔森
Original assignee: Kimberly Clark Worldwide Inc
Current assignee: Kimberly Clark Worldwide Inc
Priority date: 2013-12-20
Filing date: 2014-12-15
Publication date: 2018-08-21
Anticipated expiration: 2034-12-15
Also published as: MX348343B; BR112016014140A2; CN105828749A; MX2016007923A; BR112016014140B1; EP3082652A4; EP3082652A1

Abstract

A method of manufacture vaginal inset.The vaginal inset can have core, covering and remove element.In various embodiments, the covering can conform to the vaginal inset.

Description

The manufacturing method of vaginal inset

Background technology

The urinary incontinence is the women the problem of.It is estimated that up to 50% women's occasional not automatically leakage of urine, and And medical advice is sought by about 25% women's federation, to solve the problems, such as this.Stress incontinence is that the urine of most common type loses Prohibit, it refers to not autonomous leakage of urine caused by being increased by abdominal pressure.When there is not automatic micturition, it is frequently due to the pressure in bladder Power increases and occurs, and for the pressure, the compensatory back-pressure from neck of urinary bladder or urethra is not present.This be typically neck of urinary bladder and Urethra drops to lower position and extremely far from the result of intraabdominal pressure system.This is referred to as " hyperkinesia ", it may be to branch Caused by some injuries of support mechanism, which usually makes urethra and neck of urinary bladder be maintained at raising along the back side of pubis Position at.

Such as the decline of the neck of urinary bladder and urethra occurred when women cough, sneezing or laugh can cause involuntary leakage Urine.Although many difference factors can contribute to the development of stress incontinence, age 35-65 women and had more In the women of secondary vaginal delivery, it is most common.

For women, stress incontinence is disagreeable, offending, and is also likely to be embarrassing.Perhaps More women wear sanitary napkin with the answering pressure urinary incontinence, but this is not the real solution of problem, and it may right and wrong It is often inconvenient and insecure.Operative treatment may relate generally to raise anterior vaginal wall (anterior wall colporrhaphy), will be by urethra Tissue is fixed to the periosteum (Marshall-Marchetti-Krantz operations) of pubis or is lifted to anterior vaginal wall by uterine neck Thus tough take (the Burch Colpo suspensions) of Coopers will press so that neck of urinary bladder to be lifted on the height at pelvis bottom Power is equally distributed among on bladder, neck of urinary bladder and mid-urethral.Recently, having developed a kind of referred to as " TVT ", (" no-station pole canopy vagina is hung Band ") operation form hammock wherein lengths are implanted in below urethra (usually in mid-urethral), increased in intraabdominal pressure Period urethra can be twisted together on the hammock.However, surgical operation is suitable only for serious situation, and live through stress incontinence Most of women do not need and surgery solution would rather be avoided far and away.

A kind of form of non-surgical treatment, which is related to using, to be inserted into either by medical practitioner or by women oneself in vagina Vaginal inset.Most of vaginal insets are designed to apply pressure against neck of urinary bladder, to forbid or to stop completely Urine is flowed across urethra.One problem of such device is that they fully block urethra, therefore in order to allow women Urination needs to remove these devices or these devices is made to collapse.In order to overcome the disadvantage, develop with specific shape Vaginal inset, the insert will not fully stop urethra, but these vaginal insets are often larger, uncomfortable and carry It is invasive.They also tend to cause stimulation or pain to vagina.

Another common disadvantage be to be inserted into and/or remove most of vaginal insets also tend to be difficult, pain Or it is uncomfortable.In order to correctly prevent uroflow, need vaginal inset being properly positioned in vaginal canal.Therefore, may be used Doctor can be needed correctly to position the vaginal inset.In most of situations, vaginal inset is suitable for keeping in vagina The time of one elongated segment is (this is because need trained medical professional to be inserted into vaginal inset the time it takes And expense).However, when being located in the time of an elongated segment in vagina, vaginal inset may cause vagina infection, pressure Ulcer and/or bleeding.

Vaginal inset for treating the urinary incontinence should have size appropriate and shape configurations so that it is being inserted into and is moving Except can be comfortable during process.Vaginal inset for treating the urinary incontinence there is a need for being able to after being inserted into vagina and wear Period expands, and is protected in order to provide the effective urinary incontinence.Need a kind of vaginal inset for treating the urinary incontinence, the insert It can be comfortable wearing under static state, and urinary incontinence prevention can be provided during high stress event.Need a kind of manufacture Method for this vaginal inset for treating the urinary incontinence.A kind of manufacturing method for providing vaginal inset is needed, it should Vaginal inset can have suitable size and shape configurations so that vaginal inset can be comfortable during insertion, be somebody's turn to do Vaginal inset can be expanded after such insertion to provide urinary incontinence prevention, and the vaginal inset can collapse, to allow from the moon Vaginal inset is cosily removed in road.

Invention content

A method of manufacture vaginal inset, this approach includes the following steps：There is provided core, the core include anchoring element, Support component and the node for connecting anchoring element and support component；Covering blank is provided；By the way that covering blank is inserted into It is inserted into covering blank on core and by core, generates core and the combination of covering blank；Element will be removed and be attached to covering blank； And convert covering blank to covering.In various embodiments, covering blank includes the first layer material and with first Layer material the second layer material in face-to-face relationship and by the first layer material be attached to the second layer material the first side seams and Second side seams.In various embodiments, covering blank include when in flat two dimensional configurations observe when rectangle, it is trapezoidal or The trapezoidal shape of class.In various embodiments, this method further includes the steps that the formation support component seam in covering blank. In various embodiments, the support component seam of covering blank can be located at the support component of core.In various embodiments In, will remove the step of element is attached to covering blank further includes the steps that rotary core and covering blank combine.Various In embodiment, this method further includes the steps that covering is made to conform to core.In various embodiments, covering is made to conform to core Step further includes the steps that the band of material is attached to covering.

A method of manufacture vaginal inset, this approach includes the following steps：There is provided core, the core include anchoring element, Support component and the node for connecting anchoring element and support component；Covering blank is provided, which includes first layer Material and it is attached to the second layer material with the first layer material the second layer material in face-to-face relationship and by the first layer material First side seams and the second side seams；Support component seam is formed in covering blank；Covering blank is overturn on core To form core and the combination of covering blank；Element will be removed and be attached to covering blank；And form anchor in covering blank Gu element seam is to convert covering blank to covering.In various embodiments, covering blank is included in flat two Rectangle, trapezoidal or trapezoidal class shape in dimension configuration.In various embodiments, element will be removed and is attached to covering blank Step further includes the steps that rotary core and the combination of covering blank.In various embodiments, element will be removed and is attached to covering The step of blank further includes that will remove element to be attached in the region of covering blank of the side seams not comprising covering blank The step of.In various embodiments, this method further includes the steps that covering is made to conform to core.In various embodiments, make to cover It further includes the steps that the band of material is attached to covering that cover material, which conforms to the step of core,.

A method of manufacture vaginal inset, this approach includes the following steps：Core is provided；Covering blank is provided, it should Covering blank include the first layer material and with the first layer material the second layer material in face-to-face relationship, by the first layer material knot It closes to the first side seams of the second layer material and the second side seams, the first layer material and the second layer material in unbonded configuration Top edge and the first layer material and the second layer material in unbonded configuration bottom margin；Make covering blank Bottom margin at pleat；Support component seam is formed in the bottom margin at pleat of covering blank；Covering blank is existed It overturns on core and is combined with forming core and covering blank；Make the top edge of covering blank at pleat；And in covering blank The top edge at pleat in formed anchoring element seam, convert covering blank to covering.In various embodiments, Covering blank is included in the rectangle in flat two dimensional configurations, trapezoidal or trapezoidal class shape.In various embodiments, the party Method further includes the steps that attachment removes element.In various embodiments, the step of element is attached to covering blank will be removed to wrap The step of including rotary core and the combination of covering blank.In various embodiments, removal element is attached to the step of covering blank Rapid further includes the step in the region for will remove the covering blank that element is attached at the side seams not comprising covering blank. In various embodiments, this method further includes the steps that covering is made to conform to core.

A method of so that covering is conformed to vaginal inset, this approach includes the following steps：Core is provided, which includes Anchoring element, support component and the node for connecting anchoring element and support component；Covering blank, the covering blank packet are provided Include the first layer material and the second layer material with the first layer material in face-to-face relationship；And the first layer material is attached to second The first side seams and the second side seams of layer material；Core is inserted into covering blank and is combined with forming core and covering blank； Convert covering blank to covering；And covering is made to conform to core in the region of the node of core.In various embodiments In, covering blank is included in the rectangle in flat two dimensional configurations, trapezoidal or trapezoidal class shape.In various embodiments, The step of making covering conform to core further includes the steps that the size for reducing covering at the node of core.In various embodiments In, the step of size for reducing covering, may also include one of following：The band of material is wrapped in around covering；Formation is covered The part torsion of the material of cover material；Heat treatment is applied to covering；Or change the elasticity and/or ductility of covering Matter.In various embodiments, the step of size for reducing covering, may additionally include and be wrapped in the band of material at the node of core The step of around covering.In various embodiments, this method further includes the anchoring element of compressed core and makes the band of material in core Compression anchoring element on the step of sliding.In various embodiments, this method further includes the ruler for the reduction for keeping covering Very little step.

A method of so that covering is conformed to vaginal inset, this approach includes the following steps：Core is provided, which includes Anchoring element, support component and the node for connecting anchoring element and support component；Covering blank, the covering blank are provided The second layer material including the first layer material and with the first layer material in face-to-face relationship；And the first layer material is attached to The first side seams and the second side seams of two layer materials；Core is inserted into covering blank to form core and covering blank group It closes；Convert covering blank to covering；The band of material is provided；Make the band of material be looped around at the position of the node of core to cover Around cover material；And the band of material is attached to covering at the position of the node of core.In various embodiments, covering base Material is included in the rectangle in flat two dimensional configurations, trapezoidal or trapezoidal class shape.In various embodiments, core is inserted into and is covered Step in object blank further includes the steps that overturning covering blank on core.In various embodiments, this method further includes The anchoring element of compressed core simultaneously makes the band of material the step of being slided on the anchoring element of the compression of core.

A method of so that covering is conformed to vaginal inset, this approach includes the following steps：Core is provided, which includes Longitudinal axis and around longitudinal axis it is symmetrical；Covering blank is provided, which includes longitudinal axis and work as It is symmetrical around longitudinal axis when being observed in flat two dimensional configurations；Core is inserted into covering blank；Covering blank is converted For covering；Covering is set to conform to core.In various embodiments, core further includes anchoring element, support component and connection anchoring The node of element and support component.In various embodiments, covering blank further include rectangle, trapezoidal or trapezoidal class shape. In various embodiments, the step of making covering conform to core further includes the step for the size for reducing covering at the node of core Suddenly.In various embodiments, the step of size for reducing covering, may also include one of following：The band of material is wrapped in covering Around object；The part torsion of the material of covering will be formed；Heat treatment is applied to covering；Or change the bullet of covering Property and/or extending property.In various embodiments, the step of size for reducing covering may additionally include will at the node of core The step of band of material is wrapped in around covering.In various embodiments, this method further include the anchoring element of compressed core simultaneously Make the band of material the step of being slided on the anchoring element of the compression of core.In various embodiments, this method further includes keeping covering The step of size of the reduction of cover material.

A method of so that covering is conformed to core, this approach includes the following steps：Core is provided；Covering blank is provided； It is inserted into core in covering blank；Convert covering blank to covering；Reduce the size of covering；And keep covering Reduction size.In various embodiments, the size of covering reduces at the narrowest part of core.In various embodiments, Core includes anchoring element, support component and the node for connecting anchoring element and support component.In various embodiments, covering Size reduces at the node of core.In various embodiments, the step of size for reducing covering, may also include one of following：It will The band of material is wrapped in around covering；The part torsion of the material of covering will be formed；Heat treatment is applied to covering； Or change the elastic and/or extending property of covering.In various embodiments, the step of size for reducing covering, may be used also Include the steps that the band of material is wrapped in around covering.In various embodiments, the size of the reduction of covering is kept Step may also include the step of band is attached to covering.

A kind of core insertion module, the module include：Bottom level comprising core compresses pallet；And push rod, it is located in Core compresses below pallet；Top-level comprising the second tray platform；And pre- pleating bar, it is located in above the second tray platform； And intermediate level, between bottom level and top-level and include roller.In various embodiments, core compresses pallet Including at least one opening for receiving core wherein.In various embodiments, core compression pallet includes a pair of of jaw, phase The angle that module deviates 45 ° is inserted into for core, with core of the compression-loaded in core compression pallet.In various embodiments, roller 180 ° can be rotated.In various embodiments, the second tray platform further includes transfer pipe.

A kind of core insertion module, the module include：Bottom level comprising closed configuration can be converted to from open configuration Core compress pallet；And push rod, it is located in below core compression pallet；Top-level comprising can be in moving up and down The second mobile tray platform；And pre- pleating bar, it is located in above the second tray platform；And intermediate level, in bottom layer Between grade and top-level and it include roller；And core places tool.In various embodiments, core compression pallet includes at least one It is a to be open for receiving core wherein.In various embodiments, core compression pallet includes a pair of of jaw, is inserted into relative to core Module deviates 45 ° of angle, with core of the compression-loaded in core compression pallet.In various embodiments, roller can rotate 180°.In various embodiments, the second tray platform further includes transfer pipe.

A kind of compression pallet, the compression pallet include：Preceding jaw；Jaw afterwards；Guide block；At least one opening, for connecing Receive article to be compressed；And a pair of jaw bindiny mechanism spaced apart, connect preceding jaw and rear jaw.In various embodiments In, the angle of 45 ° of preceding jaw and rear jaw offset, with compression-loaded to the core in compression pallet.In various embodiments, preceding pincers Mouth and rear jaw offset relative to each other and keep the aspect ratio of the opening of compression pallet.In various embodiments, jaw connects Connection mechanism can be one of rack and pinion gear arrangement, sliding block, guide rail or linear bearing.

It is a kind of threading and knotting module, the module include：Thread module comprising line block；Line block fixture is located at line block It is internal；Needle；Bracing wire clamp mechanism；And wire holder, it is associated with bracing wire clamp mechanism；Knotting module comprising top is beaten Caking, lower part knotting block and the first funnel and the second funnel, in the first and second funnels each with lower part knotting block It is associated.In various embodiments, threading module further includes providing the source of air pressure difference.In various embodiments, module is threaded Further include cutting assemblies.In various embodiments, knotting block in knotting module top further includes upper part, low portion and positioning Centrepin in the upper part of top knotting block.In various embodiments, the upper and lower part part of top knotting block can It moves independently of one another.In various embodiments, knotting block in knotting module lower part further includes upper part, low portion and positioning Centrepin in the upper part of lower part knotting block.In various embodiments, the upper and lower part part of lower part knotting block can It moves independently of one another.In various embodiments, knotting module further includes thread path, the lower part of the thread path and lower part knotting block It is associated with the lower part and upper part of upper part and top knotting block.In various embodiments, with top knotting block phase A part of in 90 ° angle of the part for associated thread path relative to thread path associated with lower part knotting block.

It is a kind of threading and knotting module, the module include：Thread module comprising line block；Line block fixture is located at line block It is internal；Needle；Bracing wire clamp mechanism；Wire holder, it is associated with bracing wire clamp mechanism；And a pair of of covering blank fixture；It beats Tie module comprising top knotting block, lower part knotting block and the first funnel and the second funnel, in the first and second funnels Each is associated with lower part knotting block；And tension disk.In various embodiments, threading module further includes providing air pressure The source of difference.In various embodiments, threading module further includes cutting assemblies.In various embodiments, the top of top knotting block It can be moved independently of one another with low portion.In various embodiments, the upper and lower part part of lower part knotting block can each other solely On the spot move.In various embodiments, knotting module further includes thread path, the lower part and top of the thread path and lower part knotting block The lower part and upper part of part and top knotting block are associated.In various embodiments, associated with top knotting block A part of in 90 ° angle of the part for thread path relative to thread path associated with lower part knotting block.

A kind of knot module, the module include：Top knotting block comprising upper part, low portion are located in top and beat Centrepin in the upper part of caking；Lower part knotting block comprising upper part, low portion are located in lower part knotting block Upper part in centrepin；Thread path, it is associated with the lower part of lower part knotting block and upper part and beaten with top The lower part of caking and upper part are associated.In various embodiments, but the upper part of top knotting block and low portion that This is independently moved.In various embodiments, the upper part of lower part knotting block and low portion can move independently of one another. In various embodiments, a part for thread path associated with top knotting block is relative to circuit associated with lower part knotting block A part of angle in 90 ° of diameter.

A kind of band shaping module, the module include：First web guiding piece；A pair of of feed roller；Second fiber is net guided Part；Shear mechanism；And mandrel.In various embodiments, mandrel can be rotated by 360 °.In various embodiments, mandrel includes Hollow at least one end.In various embodiments, mandrel is connected to vacuum.In various embodiments, mandrel is included in it On vacuum sectional hole patterns.In various embodiments, band shaping module further includes servo motor, for driving in feed roller extremely It is one few.In various embodiments, band shaping module further includes combining mechanism.

A kind of band shaping module, the module include：First web guiding piece；A pair of of feed roller；Second fiber is net guided Part；Compressed air supplies；Shear mechanism；And mandrel.In various embodiments, mandrel can be rotated by 360 °.In various realities It applies in example, mandrel includes hollow at least one end.In various embodiments, mandrel is connected to vacuum.In various embodiments In, mandrel includes vacuum sectional hole patterns on it.In various embodiments, band shaping module further includes servo motor, for Drive at least one of feed roller.In various embodiments, band shaping module further includes combining mechanism.

Description of the drawings

Fig. 1 is the perspective view of the exemplary embodiment of vaginal inset.

Fig. 2-3 is the perspective view of the exemplary embodiment of core.

The sectional view of the exemplary embodiment of the support arm for the core that Fig. 4-6 is.

Fig. 7 is the perspective view of the exemplary embodiment of core.

Fig. 8 is the plan view of the exemplary embodiment of the possibility relationship of the longitudinal axis of support arm and core.

Fig. 9 is table, shows and is deflected and rotated horizontally (from centre axis according to the inside of the exemplary embodiment of core Left/right) exemplary performance range.

Figure 10 is the perspective view of the exemplary embodiment of the applicator of vaginal inset.

Figure 11 is the sectional view of the applicator of Figure 10.

Figure 12 is the perspective view of the applicator of Figure 10.

Figure 13 is the side view of the exemplary embodiment of the component part of the product packaging of vaginal inset.

Figure 14 A -14C are a series of charts for showing Exemplary cores specification.

Figure 15 is vaginal inset performance coordinate diagram, and the power of application is associated with core size, diameter and hardness.

Figure 16 is table, shows the performance characteristics of illustrative basic core configuration.

Figure 17 is the graphical representation of exemplary of a part for the process of the embodiment for manufacturing covering blank.

Figure 18 is the example of a part for the process of multiple covering blanks of the sequence manufacture in flat two dimensional configurations Property diagram.

Figure 19-20 is the vertical view of the exemplary embodiment of the covering blank in flat two dimensional configurations.

Figure 21 is the front view of a part for the exemplary embodiment of the first tray, and covering blank can be loaded into the tray On.

Figure 22 is the vertical view of a part for the first tray of Figure 21.

Figure 23 is the side view of a part for the first tray of Figure 21.

Figure 24 is the front view of a part for the exemplary embodiment of loads fixture, and covering blank can be loaded into the load On fixture.

Figure 25 is the side view of a part for the loads fixture of Figure 24.

Figure 26 is the front view of the exemplary embodiment for the covering blank being loaded into a part for the first tray.

Figure 27 is the front view of the exemplary embodiment for the covering blank being loaded into a part for loads fixture.

Figure 28 is the exemplary reality for the process that the first tray is loaded with the covering blank being loaded into before this in loads fixture Apply the front view of example.

Figure 29 is that there are two the examples of a part for the first tray of covering blank for band before covering blank is at pleat The front view of property embodiment.

Figure 30 is the vertical view of the illustrative diagram of the covering blank in open configuration before at pleat.

Figure 31 is the vertical view at the illustrative diagram of covering blank during pleat in covering.

Figure 32 is the vertical view of the illustrative diagram of the covering blank before withdrawing from into pleat item.

Figure 33 is the vertical view of the illustrative diagram of the covering blank at pleat in position to be combined.

Figure 34 is the side view of the illustrative diagram of the example process for removing corner areas from covering blank.

Figure 35 is the front view for the exemplary embodiment that core is inserted into module.

Figure 36 be core be inserted into module intermediate level and lower part level exemplary embodiment perspective view, wherein roller and Core compression pallet can be at open position.

Figure 37 be core be inserted into module intermediate level and lower part level exemplary embodiment perspective view, wherein roller and Core compression pallet can be at closed position.

Figure 38 A and 38B are the perspective views of the exemplary embodiment of core compression pallet.

Figure 39-42 is the schematic diagram for the exemplary process steps that core is inserted into covering blank.

Figure 43 is the front view of the exemplary embodiment of the vaginal inset with the part manufacture for removing element.

Figure 44-46 is the schematic diagram that will be removed element and be attached to the exemplary process steps of covering.

Figure 47-50 is the schematic diagram for the exemplary process steps that will remove element knotting.

Figure 51 is the schematic diagram of exemplary circuit diameter.

Figure 52-55 is the schematic diagram for the exemplary process steps that will remove element knotting.

Figure 56 is the perspective view of the exemplary embodiment of the core and covering blank in the second tray.

Figure 57 is the perspective view of the exemplary embodiment of the core and covering blank in third tray.

Figure 58-64 is core and the combination of covering blank exemplary into the transfer process of third tray from the second tray The schematic diagram of process steps.

Figure 65 is the perspective view of the exemplary embodiment of tray shift module.

Figure 66 is the front view of the exemplary embodiment of tray shift module.

Figure 67 is the perspective view of the exemplary embodiment of compressor reducer.

Figure 68 is the front view of the exemplary embodiment of a part for the third tray combined with core and covering blank.

Figure 69 is the vertical view of the third tray of Figure 68.

Figure 70 is the schematic diagram of exemplary process steps during covering blank is at pleat.

Figure 71 is the schematic plan of the process steps of Figure 70.

Figure 72 is the schematic diagram of exemplary process steps during covering blank is at pleat.

Figure 73 is the schematic plan of the process steps of Figure 72.

Figure 74 is the schematic diagram of exemplary process steps during covering blank is at pleat.

Figure 75 is the schematic plan of the exemplary process steps in the cohesive process of covering blank.

Figure 76 is the schematic diagram of the exemplary process steps in the cohesive process of covering blank.

Figure 77 is the schematic diagram of exemplary process steps during forming the band for covering.

Figure 78 is the schematic diagram of the exemplary patterns of the vacuum hole on mandrel.

Figure 79 is the schematic diagram for the example process being arranged in band on covering.

Figure 80 is the schematic diagram for the example process that tape welding is connected to covering.

Specific implementation mode

The disclosure relates generally to a kind of method manufacturing the vaginal inset for treating the urinary incontinence in women.Vagina Insert can provide the no-station pole canopy treatment of urinary incontinence support perpendicular to urethra (that is, across urethra).It should also be noted that for For certain women, described vaginal inset also is used as the treatment of prolapsus or a part for treatment.

Vaginal inset：

In various embodiments, vaginal inset may be adapted to stablize in vagina, without significantly longitudinal in intravaginal And/or moving in rotation.For example, the support of vaginal inset and anchor arm may be designed to resist the longitudinal movement in intravaginal.Make For another example, the top of support and/or anchor arm may be designed to coordinate (for example, passing through by the non-human act with vaginal wall Dimensioned and/or it is configured to that vaginal wall is caused to be at least partially enveloping top, to prevent moving in rotation) resist rotation fortune It is dynamic.It in vaginal inset and is spatially positioned at around the vaginal inset on vaginal wall by using support and/or anchor arm Multiple points between contact is provided, can also enhance stability.In one embodiment, the correct support of vaginal inset provides Positioning can be considered as following scenario described：Two support arms by self poisoning at each one in every side of urethra, while work as the two Support arm is at least one other when being subjected to the power from urethra during the high stress event fallen in vagina under causing urethra Support arm provides opposite power to vaginal inset.

In various embodiments, vaginal inset may be adapted to be disposable, only wear relatively short a period of time, then It abandons and is replaced with new vaginal inset (if necessary).Alternatively, vaginal inset can be by disappearing between use twice Poison and recycle.Vaginal inset can be using simple and convenient, and can be optionally for example by using application Device by intermenstrual period insert the tampon into vagina it is identical it is user friendly in a manner of be inserted into.In one embodiment, vagina is inserted Entering object can be inserted into any orientation, because vaginal inset can naturally be migrated into due to the geometry of vaginal inset Correct treatment position.Vaginal inset can be small exemplary size described below, comfortable, and once be inserted into, There is no need to consider further that it before the removal by women.It is the same with being inserted into, removal can for example by drawing removal element with Tampon similar mode is realized.

In various embodiments, vaginal inset may include core and remove element.In various embodiments, vaginal inset It may include core, covering and remove element.Each in these components is described in more detail below.In Fig. 1 it can be seen that The example of vaginal inset 10 with core 12, covering 14 and removes element 16.

Referring to Fig. 2, the saturating of the exemplary embodiment of the core 12 for treating vaginal inset 10 used in the urinary incontinence is shown View.It arranges for ease of description, core 12 can surround longitudinal axis 24 and is divided into three primary elements.It may be provided in dotted line frame The top section 18 in portion can be used as " anchoring " element for stablizing vaginal inset 10 in intravaginal.It may be present three kinds At least one of anchoring of type：Axial anchor may act on the direction along the central axis of vagina；Radial anchor Gu can be acted on abreast or substantially perpendicular to the central axis of vagina；And/or rotation anchoring, it will hereinafter more in detail Carefully describe.In one embodiment, anchoring element 18 do not apply significant pressure to wearer vagina and/or urethra, because This can lead to the comfort of enhancing.May be provided in the base segment 20 inside dotted line frame, can be used as " supporting " element with In generation support force.In various embodiments, support force can generate at the position (for example, mid-urethral) below urethra.It is standby Selection of land, additionally and/or alternatively, support force can generate at neck of urinary bladder.In various embodiments, support component 20 can provide The anchoring for stating at least one type, it is in place to help to anchor vaginal inset 10 in intravaginal.In various embodiments, it anchors The effect of element 18 and support component 20 is changeable or shared.In one embodiment, the anchoring element 18 of core 12 and support member Part 20 may act as the inner supporting structure of covering 14.

In one embodiment, it is possible to provide intermediate section can be used as " node " 22, and can connect anchoring element 18 and branch Support element 20.The node 22 of core 12 can have the length of the sub-fraction for the total length that can be core 12.In various embodiments, The length of node 22 is smaller than about 15%, 20% or 30% of the total length of core 12.In various embodiments, when with longer When the core 12 of the equal length of node 22 is compared, there is node 22 length shorter relative to the total length of core 12 can change core 12 rigidity, comfort level and size aspect assigns greater flexibility.

Each design aspect of core 12 can help to stability of the vaginal inset 10 in vagina, including：Core 12 is indulged To design, may be incorporated into suitable for preventing vaginal inset 10 to the anchor arm 26 of the deeper movement of intravaginal and/or suitable for preventing Support arm 28 of the vaginal inset 10 towards the movement of introitus vaginae；The arm top technically adjusted, such as top 30 and 32, can The moving in rotation for resisting vaginal inset 10, because they can be at least partially enveloping by vaginal wall；Master-plan, can profit Phenomenon is swelled with the tent like of vagina；And in terms of multidimensional, the various arms 26 of permissible core 12 and/or 28 contact simultaneously it is multiple And/or opposite vagina surface.

In one exemplary embodiment, anchoring element 18 and support component 20 can be respectively provided with four arms 26 and 28. In such exemplary embodiment, each two arms 26 in anchoring element 18 and support component 20 and 28 can generally court Anterior vaginal wall applies pressure, and two arms 26 of each in anchoring element 18 and support component 20 and 28 can generally court The posterior vaginal wall of neighbouring enteron aisle applies pressure.The distal part of urethra extends into vagina, is formed in urethra bulge and vagina Recess portion between wall.Stressed arm 26 is applied forward and/or 28 can be coordinated in these natural recess portions on urethra either side. In various embodiments, anchoring element 18 and support component 20 can respectively have more or fewer arms 26 and 28.For example, if load The non-required movement of heart vaginal inset 10, anchoring element 18 can have more anchor arms 26.

Support arm 28 can cause the raising of the tissue around urethra (optionally mid-urethral and/or neck of urinary bladder), to use Make hammock.The hammock can support urethra in a manner of no-station pole canopy.(for example, when the abdominal pressure raising during cough, sneezing etc. When) during stress events in the women of leakage of urine, urethra is sagging, but meets with hammock in the middle.Urethra and hammock meet Intraurethral pressure can be caused to increase, and lead to the urinary incontinence.

In one embodiment, anchor arm 26 can force vaginal inset 10 to keep in situ in intravaginal, substantially cannot It moves in or out in intravaginal or is rotated in intravaginal.A reason for such case occur may be due to vaginal wall Collapse and formed the trend of closed tube chamber.The arm 26 of core 12 and/or 28 it can cause " tent shape of the vaginal wall on the top of arm Protuberance ", and lead to sagging of the vaginal wall around core 12, therefore this can be such that core 12 stablizes.In addition, in various embodiments, anchor Gu arm 26 can be flexible and/or elasticity and/or it is with resilience.This flexibility, which can enhance anchor arm 26, prevents vagina The ability that insert 10 is further moved to intravaginal.When power attempts its own being applied on vaginal inset 10 and makes vagina When insert 10 is further moved to intravaginal, anchor arm 26 flexible can tend to spread.This extension of anchor arm 26 is dynamic Make that the friction between vaginal inset 10 and vaginal wall can be increased, to prevent further moving to intravaginal.Although anchor arm 26 may be flexible, it should be understood that they can be sufficiently rigid, and/or can be configured for expanding, to prevent Non-required movement of the vaginal inset 10 towards introitus vaginae.In one embodiment, anchor arm 26 can be rigid, but be saved Point 22 can be flexible, to allow node 22 to provide anchorage support flexible.Movement towards vaginal opening can also be supported arm 28 resist, and support arm 28 tends to be radial in outside drawing and broadens.The tent shape of these features and vaginal wall swells behavior cooperation, The behavior also contributes to vaginal device 10 being held in place.

Referring to Fig. 2, anchor arm 26 can have top 30, and support arm 28 can have top 32.In various embodiments, The top 30 of anchor arm 26 can be rounding or spherical in itself, to provide the flat of the tent shape protuberance for vaginal wall Sliding surface (that is, without turning or tip).In various embodiments, the top 32 of support arm 28 and/or the turning of core 12 can be by Along anchor arm 26 and support arm 28 and the chamfered edge at top 32 (for example, shown in figs 2 and 3) passivation.Each In kind embodiment, top 32 can be slightly rounded and/or with chamfered edge.In one embodiment, relative to working as core The chamfered edge of full spherical cross section when in compact model to be packaged in applicator, support arm 28 can reduce core 12 Overall circumference.It can be seen in figures 4 and 5 with the core 12 for chamferring cross section and with the difference between the core 12 of spherical cross section Go out.Fig. 6 shows the vaginal inset in applicator 40 with beveling cross section.

Also show channel 34 in figure 3, can crosscutting core 12, so as to by being disposed through the bar in channel 34 in core " holding " core 12 during 12 manufacture and/or assembling.In one embodiment, channel 34 can be circular shape.At one In embodiment, channel 34 can be quadrangle form.As shown in fig. 6, when being compressed to be packaged in applicator 40, channel 34 can be that the quadrangle tunnel 36 that is formed by the chamfered edge by support arm 28 is enterable.In one embodiment, lead to Road 34 can be not more than tunnel 36 on perimeter and/or size.

In various embodiments, the core 12 of all sizes can all have arm, and both anchor arm 26 and support arm 28, they can To be equal length.In various embodiments, when being inwardly compressed completely, the core 12 of all sizes all can be having the same Total length.In the figure 7 it can be seen that the example for the core 12 being inwardly compressed.In one embodiment, anchor arm 26 is than support arm 28 It is short.In such embodiments, when core 12 is inwardly compressed completely, the longitudinal length of anchoring element 18 can shorter than support member The longitudinal length of part 20.In such embodiments, node 22 is not necessarily located in the midpoint of longitudinal axis 24.In such reality It applies in example, it is symmetrical that core 12 can surround longitudinal axis 24；However, core 12 not necessarily surrounds, lateral axes are symmetrical, which can position In the midpoint of longitudinal axis 24.In one embodiment, in row's core 12 with different sizes, anchor arm 26 can have Consistent size, although support arm 28 can change on size and/or performance.In various embodiments, anchor arm 26 can have There is identical size, is considered with simplifying manufacture.In various embodiments, the anchor arm 26 of core 12 can be relative to the longitudinal axis of vagina Line is operating independently from support arm 28.

In various embodiments, the difference between the size of core 12 can be composed view, and support arm 28 is relative to core 12 longitudinal axis 24 is protruded outward with the angle.In various embodiments, the core 12 of " larger " size can have radial expansion Angle larger support arm 28, therefore, when being placed on the core 12 of smaller size (that is, differently its support arm 28 of radial expansion Core 12) side when, they may " shorter ".One potential advantage of this design can be that all cores 12 are (no matter radial expansion Angle is how) it can all be inserted into a kind of applicator 40 of size.

In one embodiment, the flexibility of the various parts of the core 12 of vaginal inset 10 can be designed to function and Both comforts of user.In various embodiments, the core 12 of vaginal inset 10 may be designed to have flexible four At least one of aspect, this can contribute to realize these functions and comfort target.For example, the node 22 of core 12 may energy Enough flexibilities realized between anchoring element 18 and support component 20, this permissible vaginal inset 10 are adjusted to the arch of vagina Shape structure, and adjust to any position (for example, stand, take a seat, buckling etc.) taken during daily routines by wearer. By can be bent at node 22, the pressure applied on the vaginal wall can be inserted relative to the vagina that cannot be bent at node 22 Enter the reduction of object 10.

Another flexibility of core 12 can relate to provide effect and comfort across different vaginal planes, such as Arm 26 and/or 28 is suitable for contacting in the position of variation and/or with the entry angle relative to each other changed far from longitudinal axis 24 In the case of vaginal wall (for example, as shown in Figure 8), the core 12 of this permissible vaginal inset 10 passes through the central shaft from each arm Line rotates and can adapt to vagina shape characteristic/geometry in variation to the left or to the right.

Another flexible related fields can relate to the ability that each in arm 26 and/or 28 executes inside flexure, Wherein each arm 26 and/or 28 can be when being compressed by vaginal wall towards 24 deflection of longitudinal axis, so as to realize the moon Adjustment of the road insert 10 to various vagina diameters.

4th flexibility can be following characteristics：Each arm 26 and/or 28 can be operated individually, for example, each arm 26 and/or 28 can surround the axis both clockwise of its own and/or torsion counterclockwise, to allow 12 grams of the core of vaginal inset 10 A contact point is obeyed to next vagina structural fluctuation.

It is noted that in various embodiments, at least one of this flexible four characteristic aspects allow vagina The core 12 of insert 10 provides effective support, without considering vagina size, vaginal shape, vagina depth and/or passing through multiple Plane.

Fig. 9 is table, shows that (top of one or more arms is towards core according to the deflection of the inside of the exemplary embodiment of core 12 The distance that 12 longitudinal axis 24 is advanced) and horizontal rotation (perpendicularly to the longitudinal axis 24 move left and right) exemplary performance model It encloses.Shown number is millimeter.It should be appreciated that rotating horizontally means the rotation on the axis perpendicular to the longitudinal axis of vagina Turn, particularly when in vagina from from the longitudinal axis that vaginal opening to cervix extends " right side " and " left side ".Shown in Fig. 9 Range is the amount that each arm can deviate relative to the longitudinal axis 24 of core 12 from its physical slot, in terms of millimeter.About interior lateral deviation Turn, it should be noted that when arm deflects inwardly, there is also that deflection (but can inwardly on the other side of core 12 in many cases Can not be identical amount) corresponding arm, therefore in one embodiment, inside devlation (in terms of mm) divided by two, to force The inside deflection of nearly single arm.It should also be noted that the numerical value of the inside deflection in the table of Fig. 9 indicates to assume that corresponding arm is basic The whole amount of the deflection of single arm in the case of not moving.In addition, in some embodiments, the maximum of inside deflection depends on Two opposite arms being in contact with each other, to prevent further inside deflection.In various embodiments, it can be achieved that minimum core 12 A diameter of 12mm, each arm indicate the parts 6mm of the sum.

In various embodiments, core 12, which can be manufactured into multiple sizes and/or display, has specific performance characteristics, example Such as, support arm 28 is radially expanded.In various embodiments, the diameter for the anchoring element 18 being radially expanded can be from about 30 to about In the range of 33mm.In various embodiments, the diameter for the support component 20 being radially expanded can be from about 34mm to about 52mm's In range.In various embodiments, core 12 also can have different performance characteristics (for example, hard by different materials and/or display Degree) material be made.In various embodiments, core 12 can be by that can show one or more materials with 30-80 Xiao A hardness Material is configured to.In various embodiments, core 12 may be produced that multiple Xiao A hardness, including but not limited to 40,50 and 70.

In various embodiments, core 12 can be configured to by single-piece (Monoblock).In various embodiments, core 12 can have The anchoring element 18 and support component 20 of individual part (bipolar) can be provided as by having, these parts are attachable to form core 12.Each In kind embodiment, each element (support component 20 or anchoring element 18) can be configured to by two or more parts.

Referring to Fig. 1, the core 12 of the exemplary embodiment according to vaginal inset 10 being encapsulated in covering 14 is shown Perspective view, covering 14 be equipped with remove element 16.Covering 14 can be optionally in the covering described in following patent It is any：PCT/IL2004/000433；PCT/IL2005/000304；PCT/IL2005/000303；PCT/IL2006/ 000346；PCT/IL2007/000893；PCT/IL2008/001292；U.S. Provisional Patent Application the 60/719,422nd；It is beautiful State's Provisional Patent Application No. 60/762,059；And U.S. Provisional Patent Application the 60/960th, 492.

In various embodiments, covering 14 can be smooth.In various embodiments, covering 14 can by weaving or Non-woven material is formed.Weaving material may include but be not limited to fabric, can by artificial silk, cotton, polyolefin or other synthesize yarn Line is made.Synthetic can be staple fiber or continuous filament yarn.Non-woven material may include but be not limited to spunbond, bonded carded fiber Net and spun lacing web.In various embodiments, covering 14 can be configured to by viscose non-woven material.In various implementations In example, covering 14 can be handled with aqueous solution, be removed from vagina with reducing frictional resistance and enhancing the vagina neutralization of insertion women The easness gone out.In various embodiments, covering 14 can be non-woven by such as 33gsm(production number Non-woven material 097YLJO09P) is configured to.In various embodiments, covering 14 can be configured to by non-woven material, example Such as, it is configured to by about 50% polypropylene and about 50% polyethylene.In various embodiments, covering 14 can be by nylon construction At.In various embodiments, covering 14 and removal element 16 can be by identical integral materials and/or simultaneously and/or identical It constructs in the process.In various embodiments, covering 14 and removal element 16 can be configured to by individual more than one piece material.Various In embodiment, covering 14 can be configured to by non-absorbing material.In various embodiments, covering 14 can be flexible and/ Or it is stretchable.In various embodiments, covering 14 can be formed by heat-shrinkage material.In various embodiments, covering 14 It can be by that can be that extendable and/or elastic material is formed.In various embodiments, the element of covering 14 can be combined, It sews up, suture and/or welds together.In various embodiments, tieing, stitch, suture and/or weld seam can be located at and vaginal wall Inside opposite covering 14.In various embodiments, covering 14 and/or core 12 may be adapted to allow vaginal fluid free flow It is dynamic.

In various embodiments, removing element 16 can be configured to by cotton material, but can be configured to by other materials.Various In embodiment, removing element 16 can be configured to by the permissible material for absorbing fluid, or can be by the material that does not allow to absorb fluid Material is configured to.In various embodiments, it can be the line or belt shape object made of 100% cotton fiber to remove element 16.Various In embodiment, removing element 16 can be configured to by nonabsorbable polyurethane, optionally the coating with organosilicon membrane, which can Smooth surface is provided to remove element 16.In various embodiments, it can apply organosilicon, woollen yarn knitting polyester to remove element 16, Its example is manufactured by Ashaway.

In various embodiments, the removal element 16 of vaginal inset 10 can be length from about 14cm to about 16cm, But length can change in different 10 configurations of vaginal inset.In one embodiment, removing element 16 can be such Covering 14 is fixed at position：It can wherein be shown in the support arm 28 for making core 12 when intravaginal is collapsed towards the pulling force of introitus Work is evenly distributed on covering 14.In one embodiment, which can be in the covering in 20 region of support component 14 center, such as shown in Fig. 1.

In various embodiments, covering 14 can reduce the friction between vaginal inset 10 and vaginal wall.Drawing removes Element 16 can cause the tensioning of covering 14.The tensioning of covering 14 can lead to stretching for vaginal wall, therefore this can mitigate above The tent like effect, and reduce the tension for being applied to vaginal inset 10 so that it can be easy from vagina and smoothly move Except vaginal inset 10.In addition, drawing, which removes element 16, can cause at least slightly the collapsing towards longitudinal axis 24 of support arm 28, this It is to reduce the radial diameter of core 12, and to allow to from vagina caused by the power that covering 14 is applied to them Remove easily and smoothly vaginal inset 10.

Other than as the supplementary means for removing vaginal inset 10, the additional purpose of covering 14 can act as The sling stretched between support arm 28 can provide suburethral no-station pole canopy support for urethra.

Referring to Figure 10-12, the perspective view of applicator 40 is shown, which can be used to dispose for treating the urinary incontinence Vaginal inset 10.In one embodiment, applicator 40 may include shell 42 and plunger 44.Shell 42 may be adapted to receive And/or storage vaginal inset 10.In various exemplary embodiments, plunger 44 can be used to be deployed to the moon in vaginal inset 10 Vaginal inset 10 is discharged from shell 42 during in road.Figure 11 is the sectional view of Figure 10, which can more clearly illustrate application The configuration of device 40, the interface being included between shell 42 and plunger 44.In various embodiments, shell 42 can be equipped with outlet 46. In various embodiments, outlet 46 can be equipped with multiple flexible flaps (" valve "), when vaginal inset 10 is discharged from applicator 40 When, fin can be open.Outlet 46 more clearly illustrates in fig. 12.

In applicator 40, vaginal inset 10 can be oriented so that the anchoring element 18 of core 12 first from applicator 40 Out enter vagina, followed by the support component 20 of core 12, support component 20 comes out at the end of deployment process.Implement at one In example, vaginal inset 10 can be disposed to provide support to urethra.In one embodiment, vaginal inset 10 can be disposed To provide support to neck of urinary bladder.

In one embodiment, vaginal inset 10 can be received in individual packaging 50 shown in such as Figure 13 by user In.In one embodiment, the different sizes and/or packaging 50 with the vaginal inset 10 with different characteristic can have Color encodes, to facilitate the user of vaginal inset 10 to identify.Figure 13 is 10 institute of vaginal inset for treating the urinary incontinence With the side view of the component part of product packaging 50.Product packaging 50 may include applicator shell 42, core 12, covering 14, move Except element 16, applicator plunger 44 and product wrappage 52.In one embodiment, product wrappage 52 can be wrapped in applicator Around 40, applicator 40 may include the vaginal inset 10 in shell 42 in packaging.Therefore, it is in the production of its assembling form Product packaging 50 can be the shape of tampon more or less cylindrical or similar to package.

In one embodiment, vaginal inset 10 can be similar to the insertion of tampon to the insertion of intravaginal.User can With a hand by longinymph, the front of applicator 40 is directed to intravaginal, and with another hand compression plunger 44, to Vaginal inset 10 is deployed to intravaginal from applicator 40.In one embodiment, since core 12 surrounds the longitudinal axis of core 12 The design of 24 general symmetry of line, need not be specifically oriented vaginal inset 10.The insertion of vaginal inset 10 can be any It is executed from anywhere in orientation in 360 ° of longitudinal axis 24 that is lower and/or surrounding core 12 in applicator 40.

In various embodiments, although core 12 can be designed symmetrically, since each in arm 26 and 28 is when in place It can be bent independently of other arms 26 and 28, and each vagina is slightly different in shape, vaginal inset 10 is real when in use May not have symmetrical form on border (referring to Fig. 8).Referring to Fig. 8, plan view is shown, the figure shows work as vaginal inset 10 it is in place when support arm 28 and core 12 longitudinal axis 24 possibility relationship.It should be pointed out that not each vagina is with identical Profile and internal structure, although some summaries can be carried out to vaginal anatomy feature.For this purpose, being made according to vaginal inset 10 User, core 12 may be designed to the vagina feature for being adaptable to the variation that it is likely encountered.For example, every in the support arm 28 of core 12 One can independently work.This allows the maximum flexibility of realization, to any vaginal shape (cross section) And/or the maximum adjustment of vagina size.Accordingly, it is possible to such situation occur：In given cross section, the support arm of core 12 28 longitudinal axis 24 that will not surround core 12 are symmetrically unfolded, such as shown in Fig. 8 like that.

Core 12 can with a variety of sizes manufacture and/or it is commercially available, wherein each size show with different performance characteristics, grasp Make size, weight etc..In various embodiments, the core 12 of different sizes can be made of identical material.In various embodiments, Different materials and/or different materials ratio can be used in the core 12 of different sizes.Figure 14 A -14C are to show 12 size of Exemplary cores A series of charts.As can be seen in the chart of Figure 14 A -14C, core 12 can be produced as at least four sizes, for It is most preferably adjusted for various vagina sizes and/or according to the severity of the urinary incontinence.Various sizes can be in the exhibition of support arm 28 Open it is diametrically different, and therefore can be different on the total length at deployment (that is, support arm 28 is unfolded).In various embodiments In, anchor arm 26 can in all sizes deployment size and/or performance characteristics having the same.

In various embodiments, core 12 can be configured to by injection molding by liquid silicone resin (LSR).It can be used His material, for example, TPE, non-liquid silicones and the other materials for the core 12 with identical size.In one embodiment In, show that the material with various Xiao A hardness can be used to produce softer or more rigid core 12.

It should be appreciated that various size combinations can be made by changing size and/or Xiao A hardness.For example, size 1 and 2 It may be produced that with 70 Xiao A hardness, and size 3 and 4 can be with 40 Xiao A hardness.In various embodiments, Suo Youxin 12 sizes can all show Xiao A hardness having the same.In various embodiments, each individual size may be produced that a variety of productions Product form, each product form, which is shown, has different Xiao A hardness.In short, the feature of various combination and permutation, size, property Energy characteristic and/or building material can be used to apply support force under required urethra under some operating angle.

In various embodiments, the radial support arm 28 of core 12 can be transversal in widest support component 20 in vaginal canal 12 overall diameter of core from about 34mm to about 52mm is formed at face.In various embodiments, which can be according to the individual character of user Demand is greater or lesser.

Figure 15 is the performance coordinate diagram of core 12, will be in the expansive force (y-axis) applied by support arm 28 and Figure 14 A -14C The amount (x-axis) and hardness (hachure) of the inside of each deflection in shown four kinds basic sizes are associated, wherein interior lateral deviation Turn be longitudinal axis 24 from the natural swelling state of support arm 28 towards core 12 distance (in terms of mm).

The expansive force applied by support arm 28 generally depends on the hardness level of each and/or phase in support arm 28 For the inside degree of flexibility (inside deflection) of longitudinal axis 24.If using specific material in the construction of core 12, for example, Liquid silicone resin can be the core of any given diameter then in the case of the performance characteristics of the known used specific material 12 support arm 28 measures these power.Utilize being somebody's turn to do in coordinate diagram (wherein x-axis indicates that 12 diameter of core, y-axis indicate power) Data can show the power applied by support arm 28 for given 12 size of core and its material hardness grade.Slope indicates Ratio between power (gram) and the amount (mm) of inside deflection.

During designing and/or selecting core 12 for using, it may be considered that considering in certain performances.It should refer to Go out, the support of core 12 is by support arm 28 at least slightly by vaginal wall compression (that is, the deflection of longitudinal axis 24 towards core 12 or " inside Deflection ") come " startup ".In general, the compressing force on support arm 28 is stronger, applies go back to vaginal wall/lower section by support arm 28 Support force on urethra is stronger.For example, support arm 28 must be compressed some minimum, carried in order to provide being enough to allow support arm 28 For the reaction force of support.That is, if vaginal inset 10 is inserted into vagina and core 12 is too small or be radially expanded Angle it is too small, then do not have enough power and be applied to support arm 28 from vaginal wall so that support arm 28 using provide it is suitable and Power needed for effective support carrys out reaction.Fail on support arm 28 to realize that this is most under static state during stress events The compression (being shown as the minimum application line of force 60 of the level at the power of about 10g in fig.15) of small value will reduce vaginal inset 10 effects.It is noted that in some embodiments, the minimum line of force 60 that applies at 10g is approximation, and can change ± 3 grams.

Similarly, when vaginal inset 10 remains static in vagina and/or when removing vaginal inset 10, Apply maximum, force on the vaginal wall in the presence of by core 12, exceeds the power, user will feel under the weather.Therefore, implement at one In example, core 12 can be designed and/or be chosen to use no more than the maximum, force.The maximum, force indicates in fig.15 For the thick horizontal line 62 at the power of about 50g.In one embodiment, 50 grams are approximation, and can change ± 5 grams. For example, if being radially expanded for support arm 28 is too big, it will generate excessive power on the vaginal wall, and user may feel Uncomfortable, this will be avoided.

In various embodiments, the coordinate diagram of Figure 15 may be used to determine 12 configuration of specific core and specific vagina size made Use potentiality.For example, the D1 in coordinate diagram indicates the vagina of the diameter with 33mm.Referring to Figure 15, it can be seen that have S40 The user is not suitable for the core 12 of the size 1 of the Xiao A hardness of S50, because they cannot be provided under static state Support effective enough.However, other multiple 12 sizes of core and Xiao A hardness are considered acceptable：

1 device of size (power for providing about 21 grams) with Xiao A hardness 70

2 device of size (power for providing about 25 grams) with Xiao A hardness 50

2 device of size (power for providing about 20 grams) with Xiao A hardness 40

3 device of size (power for providing about 38 grams) with Xiao A hardness 50

3 device of size (power for providing about 28 grams) with Xiao A hardness 40

4 device of size (power for providing about 48 grams) with Xiao A hardness 50

4 device of size (power for providing about 35 grams) with Xiao A hardness 40

As another example, the D2 in coordinate diagram indicates the vagina of the diameter with 42.5mm.Due to the user's The size of vagina can provide less selection and be supported with the vagina for obtaining ideal effect.In this example, possible selection will Including：

3 device of size (power for providing about 22 grams) with Xiao A hardness 70

4 device of size (power for providing about 45 grams) with Xiao A hardness 70

4 device of size (power for providing about 22 grams) with Xiao A hardness 50

4 device of size (power for providing about 18 grams) with Xiao A hardness 40

It should be pointed out that in one exemplary embodiment, the size 4 made of low Xiao A hardness (such as 40) material Core 12 can be used for various vagina diameters (about 30mm to 45mm).

Show that 12 size of various cores deflects (one in the inside of different level in the coordinate diagram of 62 or more the maximum line of force, Figure 15 Straight 12 diameter of total core for being decreased to about 12mm) at power apply it is horizontal.In one embodiment, each arm width is about 6mm, Because possible minimum diameter distance is in two opposite arm contacts or at 12mm (6mm+6mm).Show with reference to Figure 16 Go out and be more fully described the specific number of 12 size of selected core.

Figure 16 is table, shows the specific performance water of exemplary 12 size of basic core and Xiao A hardness described in Figure 15 It is flat.Minimum diameter lists two opposite contacts of arm 28 (to be essentially prevented any further inside deflection of arm 28) When diameter (in terms of mm).In one embodiment, maximum, force applies when core 12 is compressed most or at minimum diameter.Most The maximum of the power applied in 12mm diameter levels by each 12 size of core listed and Xiao A hardness is listed energetically.

It should be pointed out that some in information shown in Figure 16 are also included in the table of Figure 14 A -14C.In INFORMATION OF INCOMPLETE one In the case of cause, it should be understood that widest value will belong to embodiment described herein.For example, a certain range of value may be The upper limit of the lower limit of range from a table and range obtains in the case of another table.It should also be noted that these values are only It provides by way of example, and 12 performance characteristics of core can be according to the material and/or 12 size of core and/or Shore A for construction Hardness and change.

In various embodiments, many in the possible size of core 12 to be suitble to specific user, and without departing from Enough supports can be provided in the case of uncomfortable threshold value.This is for the core 12 with low Xiao A hardness and medium slope It is especially true.For example, the core 12 (support diameter 45mm) of the size 3 made of the soft silicones with 40 Xiao A hardness can To be suitble to large-scale vagina diameter：Diametrically apply 12 grams of power in 40mm, in the power for diametrically applying 21 grams of 35mm, And the power for diametrically applying 31 grams in 30mm.In other words, in some embodiments, 12 size of single core can be a variety of the moon Road size provides support.In one embodiment, core 12 may be adapted to be used by various users, such as by the way that core 12 to be designed to With relatively low or medium slope.

It is possible that the core 12 of only one size is suitble to the women with some vagina diameter, especially in her the moon When road size is more than average value.In some embodiments, only size 3 or 4 is suitable, and smaller size will not apply institute The minimum support power needed.It is noted that all power such as the applied, the size of vaginal inset 10 and/or selected vaginal inset The characteristic of 10 general comfort degree is highly dependant on each individual user, and can also depend on by being used for each list Pathological reaction caused by the vaginal inset 10 of only user.

In one exemplary embodiment, reduce between the support top end 32 of support arm 28 and the longitudinal axis 24 of core 12 Distance will increase the power that is applied in support top end 32 by core 12.Such operation importance may is that, compared to insertion phase Smaller vaginal inset 10 in same vagina, the relatively large vaginal inset 10 being inserted into vagina will be applied on the vaginal wall Add higher power.Using the identical principle, if the external force being applied on vaginal inset 10 reduces in its 28 He of support arm Inner distance (for example, during cough, jump, sneezing etc.) between longitudinal axis 24, will be by support arm 28 in vaginal wall The upper reaction force for applying bigger, to the efficiency for enhancing urethral support He preventing leakage of urine.Therefore, in an exemplary embodiment In, vaginal inset 10 can be designed in the case of the reaction tension force that consideration activity generates.

The manufacturing method of vaginal inset：

As described above, in one embodiment, vaginal inset 10 can have core 12, covering 14 and remove element 16. Manufacturing process for producing vaginal inset 10 may include such as providing covering blank 68, core 12 be encapsulated in covering base In material 68 and the step of removal element 16 are provided.In various embodiments, manufacturing process, which may also comprise, makes covering 14 conform to The step of core 12.

In order to make vaginal inset 10 efficiently reduce the leakage of urine situation caused by the urinary incontinence, vaginal inset 10 needs foot It is enough small, to be inserted into vagina and to remove from vagina, it also requires can be radially expanded after the insertion with during wearing.Cause This, the core 12 of vaginal inset 10 should can change in compressed configuration and between being radially expanded configuration.In order to avoid being limited in This transformation between configuration, covering 14 should size be designed to it is sufficiently large, to allow core 12 to be expanded to it during wearing Size needed for maximum.Although covering 14 is sufficiently large to allow the expansion of core 12, covering 14 that should also be designed to correctly Size is to help to remove vaginal inset 10.As described herein, drawing, which removes element 16, can lead to pulling force essentially homogeneously It is distributed on covering 14, this can be used to make the support arm 28 of core 12 to collapse towards the longitudinal axis 24 of core 12, to reduce core 12 Radial diameter and allow smooth from vagina and easily remove vaginal inset 10.Therefore, covering 14 does not answer size Design it is too much so that support arm of the covering 14 to core 12 when drawing removes element 16 during removing vaginal inset 10 28 almost without effect.

In one embodiment, covering 14 can conform to the shape and/or size of core 12.As described above, in various realities It applies in example, covering 14 may act as the sling stretched between the arm (such as support arm 28) of core 12.In such embodiments, Covering 14 can provide the support of the no-station pole canopy below urethra for urethra.Same as described herein, core 12 can change from compressed configuration To configuration is radially expanded, to provide support for urethra.Covering 14 can conform to the size and/or shape of core 12, so as to for Covering 14 provides required tension, to allow covering 14 to be enough to serve as sling and support urethra.Without being bound by theory can To believe, the size of core 12 is not conformed to and/or shape or does not conform to the size of core 12 and/or covering for shape sufficiently Cover material 14 will be excessively loose for the encapsulation piece as core 12, and enough supports will not be provided for urethra.However, such as Upper described, covering 14 should not exceedingly conform to the size and/or shape of core 12, because this can prevent core 12 from being expanded radially into Degree needed for enough supports is provided for urethra.In various embodiments, covering 14 can be conformed to by a process Core 12, the process can reduce the size of covering 14 and keep the size of the reduction of covering 14.In various embodiments, it covers Cover material 14 can conform to core 12 by a process, which can reduce covering 14 in the narrowest part of core 12 (for example, section Put the size at 22) place.In various embodiments, the size of covering 14 can be subtracted by such as, but not limited to following process It is small：The band of material is wrapped in around covering 14 with " tensioning " covering 14；The material torsion of covering 14 will be formed；It will be hot Processing is applied to covering 14, for example, the covering 14 formed by heat-shrinkage material；And/or change covering 14 elasticity and/ Or extending property.In one embodiment, 14 shape of covering and/or size can be substantially similar to shape after the expansion of core 12 Shape and/or size.In one embodiment, the internal volume of covering 14 can be substantially similar to the volume of the core 12 of expansion.

Covering 14 can be formed by covering blank 68.Covering blank 68 can pass through at least one of two methods shape At.The first method for forming covering blank 68 may include：Into two by single folding of material；By the two half blocks to face Face relationship simultaneously arrives together；And at least part of the two half blocks is combined together to form at least one calmodulin binding domain CaM. The second method for forming covering blank 68 may include：Two individual materials are provided together with face-to-face relationship；And At least part of the two individual materials is combined together to form at least one calmodulin binding domain CaM.By any just described At least one calmodulin binding domain CaM that kind method generates can be that covering 14 be ultimately provided to a few seam.In various embodiments In, covering blank 68 can have at least one calmodulin binding domain CaM.In various embodiments, covering blank 68 can have at least two A calmodulin binding domain CaM.In various embodiments, covering blank 68 can have at least three calmodulin binding domain CaMs.Once covering blank 68 Complete encapsulating core 12 and the material for forming covering blank 68 have sewed up together completely to prevent core 12 to be detached from covering base The constraint of material 68, so that it may to say that covering blank 68 has been converted into covering 14.In various embodiments, covering 14 can have At least one seam.In various embodiments, covering 14 can have at least two seams.In various embodiments, covering 12 can have at least three seams.In various embodiments, covering 12 can have at least four seams.

Term " in conjunction with " and " in conjunction with " in this article refer to engagement, adherency, connection, the attachment etc. of two elements.When it Engage, adhere to indirectly directly to each other or each other, connection, attachment etc. whens, such as in each element is bonded directly to Between element when, two elements will be considered being combined together.In conjunction with adhesive, pressure combination, thermal, ultrasonic wave knot can be passed through It closes, splicing, suture and/or weld progress.

Figure 17 provides the graphical representation of exemplary of the method for manufacturing covering blank 68.As shown in figure 17, list can be used A material 90.Material 90 in deployed configuration can have that there are two opposite and spaced apart longitudinal edges, such as edge 92 and 94. Material 90 can enter folding region 96, herein, material 90 can be folded so that can forming material 90 two half blocks, wherein one Another half block of a half block and material 90 is in face-to-face relationship.The folding of material 90 can be come real by using such as folded sheet It is existing.The folding of material 90 can make edge 94 be in the position substantially adjacent to edge 92.The folding part 98 of gained in material 90 Edge 92 can be remained parallel to and 94 and be spaced apart with the edge, and folding part 98 and edge 92 and 94 can in the longitudinal direction after Continuous movement.The material 90 of folding can be extended to combined area 100, and herein, at least one of the half block of the material 90 of folding can It is attached at least part of another half block of the material 90 of folding.In conjunction with can for example, by but be not limited to following method come It realizes：Adhesive, pressure combination, thermal, ultrasonic wave combine, splicing, suture and/or weld.

At least part of combination of two half blocks of the material 90 of folding or in various embodiments two individual materials At least part of material, which is combined together, can form at least one calmodulin binding domain CaM.At least one calmodulin binding domain CaM can be provided finally At least one seam of covering 14.Calmodulin binding domain CaM can have the gained seam for thinking to be adapted to hold calmodulin binding domain CaM and covering 14 Integrality width.In various embodiments, calmodulin binding domain CaM can have from about 0.1,0.2,0.3,0.4 or 0.5mm to about 0.6, the width of 0.7,0.8,0.9 or 1.0mm.

Referring to Figure 17, in the exemplary embodiment of shown method, two basic change region 84 and 86 can be formed.Due to such as The calmodulin binding domain CaM of calmodulin binding domain CaM 84 and 86 can be that covering 14 finally provides seam, and calmodulin binding domain CaM 84 and 86 can provide covering base A part for the shape of material 68.In various embodiments, covering blank 68 can have to work as and be observed in flat two dimensional configurations When rectangle, trapezoidal or trapezoidal class shape.The trapezoidal shape of class can have at least two parallel sides, and other two side can To be not parallel, there can be camber line, or there can be any other required shape.It such as can in the graphical representation of exemplary of Figure 17 See, established calmodulin binding domain CaM 84 and 86 can be provided for that there can be trapezoidal shape when being observed in flat two dimensional configurations The covering blank 68 of shape.

In various embodiments, needed for the covering blank 68 in flat two dimensional configurations at its most wide size most Big width can be narrower than the width of (multiple) material 90 for providing and being combined together to form covering blank 68.Such In various embodiments, the region of scrap material can be located at such as calmodulin binding domain CaM of calmodulin binding domain CaM 84 and 86 and be used for manufacturing covering Between the edge and/or folding part of the material 90 of blank 68.In the exemplary embodiment shown in Figure 17, calmodulin binding domain CaM 84 and 86 Can be located at material 90 edge 92 and 94 with the inside of folding part 98.Therefore, leftover pieces region 102 can be located at the combination of material 90 Between region 84 and 86 and edge 92 and 94 and folding part 98.Since material 90 can be further processed into covering blank 68, Leftover pieces region 102 can be used as leftover bits 110 and be detached with calmodulin binding domain CaM 84 and 86.The shifting of leftover bits 110 is discussed below It removes.

Material 90 can enter perforated zone 104, herein, can apply perforation 106 on material 90.Perforation 106 can be by making With thinking that suitable any punch-cuts device formed.Perforation 106 can be the perforation 106 for being extended across material 90 in the horizontal. Perforation 106 can provide separation between two final covering blanks 68.In various embodiments, perforation 106 can not prolong Extend into leftover pieces region 102, the region be located at material 90 calmodulin binding domain CaM 84 and 86 with edge 92 and 94 and folding part 98 it Between.In various embodiments, without being bound by theory it is believed that so that perforation 106 is not extended into leftover pieces region 102 can Allow effective removal in the leftover pieces region 102 during manufacturing process.

In order to remove leftover pieces region 102, material 90 can enter leftover pieces and remove area 108, and herein, longitudinal sectional device can be used to Leftover pieces region 102 is set to be detached from material 90 as leftover bits 110.Leftover bits 110 can think suitable side by any Method (such as vacuum) is pulled away from material 90.After leftover pieces region 102 has been used as leftover bits 110 to be removed, calmodulin binding domain CaM 84 The seam for becoming covering blank 68 with 86, such as side seams 72 and 74.

It is noted that in various embodiments, providing the longitudinal direction of (multiple) material 90 for manufacturing covering blank 68 Length can be enough to manufacture single covering blank 68；Alternatively, in various embodiments, the longitudinal direction of (multiple) material 90 provided Length can be enough to manufacture multiple covering blanks 68, for example, the ribbon 112 of the covering blank 68 manufactured in a sequential manner. Figure 17 and 18 provides the graphical representation of exemplary of the ribbon 112 of covering blank 68.Figure 17 may be provided in leftover pieces region 102 and divide Ribbon 112 from the covering blank after preceding and separation.Figure 18 may be provided in the covering base before leftover pieces region 102 detaches The ribbon 112 of material 68.

Referring to Figure 18, the exemplary embodiment of a part for the ribbon 112 of covering blank 68 can be shown.In Figure 18 In, two individual materials 90 can and at face-to-face relationship.Each in material 90 can be parallel with extending in the longitudinal direction And edge spaced apart, such as edge 92 and 94.At least part of two individual materials 90 may then bond together, and can shape At calmodulin binding domain CaM 84 and 86.Leftover pieces region 102 can be located between the calmodulin binding domain CaM 84 and 86 and edge 92 and 94 of material 90.Such as It can be seen in the exemplary embodiment of Figure 18, the width W3 for forming the material 90 of covering blank 68 can be more than covering base The most wide degree of material 68, for example, the width W2 of covering blank 68.

As shown in the exemplary embodiment of Figure 17 and Figure 18, the ribbon 112 of covering blank 68 is shown as：First covers The maximum width W2 of cover material blank 68 is sequentially adjacent to the maximum width W2 of next covering blank 68, and the first covering base The most narrow width W1 of material 68 is sequentially adjacent to the most narrow width W1 of next covering blank 68.Without being bound by theory can phase The most narrow width W1 of two covering blanks 68 is kept neighbouring relations and by the most wide degree of two covering blanks 68 by letter W2 keeps neighbouring relations to can help between covering blank 68 more effectively be incorporated to perforation 106 and contributes to leftover pieces area More effective removal of the domain 102 as leftover bits 110.

In the manufacturing process for sequentially manufacturing covering blank 68, the connected ribbon 112 of covering blank 68 Can exist before leftover pieces region 102 is detached as leftover bits 110, such as shown in Figure 18.It is covered being manufactured for sequence In the manufacturing process of cover material blank 68, the connected ribbon 112 of covering blank 68 can be used as corner in leftover pieces region 102 Exist after the separation of waste material 110, such as shown in Figure 17.By destroying the perforation between two adjacent covering blanks 68 106, the connected ribbon 112 that single covering blank 68 can be with covering blank 68 detaches.

Figure 19 and 20 provides the graphical representation of exemplary of the covering blank 68 in flat two dimensional configurations, which can be with The ribbon 112 of covering blank 68 detaches.Due to covering blank 68 can by fold to itself single material 90 or by with Face-to-face relationship is simultaneously manufactured into two materials 90 together, and the covering blank 68,70 and 80 of material 90 has overlying such as One layer of another layer of such as layer 70 of layer 80.In the exemplary embodiment shown in Figure 19 and 20, layer 70 is towards observer. Covering blank 68 can have the side seams combined, for example, side seams 72 and 74.Covering blank 68, which can have, is not joined to that This each layer 70 and 80 top edge 76.Covering blank 68 can have the bottom for being not joined to mutual each layer 70 and 80 Portion edge 78.In various embodiments, when being observed in flat two dimensional configurations, covering blank 68 can have such as in Figure 19 Exemplary embodiment shown in rectangular configuration.In various embodiments, when being observed in flat two dimensional configurations, covering Object blank 68 can have the trapezoidal configuration as shown in the exemplary embodiment in Figure 20.In various embodiments, when flat Two dimensional configurations in when observing, covering blank 68 can have class trapezoidal configuration.In various embodiments, when in flat two dimension When being observed in configuration, covering blank 68 can have any other structure for thinking to be adapted to provide for the covering 14 for encapsulating core 12 Type.

During manufacturing process, the top edge 76 of each layer 70 and 80 and the bottom margin 78 of each layer 70 and 80 can be tied It is combined, to ultimately form the covering 14 of the core 12 for vaginal inset 10.When joined, 70 He of each layer 80 bottom margin 78 can form calmodulin binding domain CaM 168, can be located near the support component 20 of core 12.When joined, The top edge 76 of each layer 70 and 80 can form calmodulin binding domain CaM 318, can be located near the anchoring element 18 of core 12.

In various embodiments, when being observed in flat two dimensional configurations, covering blank 68 can have such as Figure 19 Shown in rectangular configuration.Covering blank 68 can have initial longitudinal length L1, be measured as the top from layer 70 and 80 Edge 76 arrives the distance of bottom margin 78.Each (top edge 76 and bottom margin in the edge of corresponding layer 70 and 80 78) original top border width W1 and original bottom border width W2 can be respectively provided with.A reality shown in such as Figure 19 It applies in example (wherein covering blank 68 can have rectangular configuration), original top border width W1 and original bottom border width W2 It can be identical.

In one embodiment, core 12 can surround the longitudinal axis 24 of core 12 symmetrically and around the lateral axes of core 12 Symmetrically, the lateral axes of core 12 can be located at the midpoint of the longitudinal axis 24 of core 12.When core 12 can be at compressed configuration With when core 12 can be at being radially expanded configuration, these symmetry may be present.In such embodiments, it is possible to provide covering base Material 68, can be around covering blank 68 longitudinal axis 82 it is symmetrical and/or can express out it is right around longitudinal axis 82 Claim, and can be around covering blank 68 lateral axes it is symmetrical and/or can express out symmetrical around lateral axes , wherein the lateral axes of covering blank 68 can be positioned over the midpoint of the longitudinal axis 82 of object blank 68.Work as covering When blank 68 can be observed in flat two dimensional configurations, for example, before core 12 is encapsulated in covering blank 68, it can be seen that cover These symmetry of cover material blank 68.Figure 19 provides the diagram of the covering blank 68 in flat two dimensional configurations, and Covering blank 68 can have the longitudinal axis 82 around covering blank 68 and around the symmetrical configurations of both lateral axes, side The midpoint of the longitudinal axis 82 of object blank 68 is positioned over to axis.

In various embodiments, when being observed in flat two dimensional configurations, covering blank 68 can have such as Figure 20 Shown in trapezoidal configuration.Covering blank 68 can have initial longitudinal length L1, be measured as the top from layer 70 and 80 Edge 76 arrives the distance of bottom margin 78.Each (top edge 76 and bottom margin in the edge of corresponding layer 70 and 80 78) original top border width W1 and original bottom border width W2 can be respectively provided with.A reality shown in such as Figure 20 It applies in example (wherein covering blank 68 can have trapezoidal configuration), original top border width W1 can be wide with original bottom edge Degree W2 is differed.In such embodiments, width W1 in top edge is smaller than bottom margin width W2.

In one embodiment, core 12 can surround the longitudinal axis 24 of core 12 symmetrically；However, core 12 can not surround core 12 lateral axes are symmetrical, and the lateral axes of core 12 can be located at the midpoint of the longitudinal axis 24 of core 12.When core 12 can be located When compressed configuration and when core 12 can be at being radially expanded configuration, may be present core 12 around core 12 longitudinal axis 24 it is symmetrical Property.In such embodiments, it is possible to provide covering blank 68, can with when around covering blank 68 longitudinal axis 82 it is right Claim, and/or can express out symmetrical around longitudinal axis 82.When covering blank 68 can be observed in flat two dimensional configurations When, for example, before core 12 is encapsulated in covering blank 68, it can be seen that covering blank 68 is around the vertical of covering blank 68 To the symmetry of axis 82.Figure 20 provides the diagram of the covering blank 68 in flat two dimensional configurations, and covering Blank 68 can be around covering blank 68 longitudinal axis 82 it is symmetrical, but can not surround and be positioned over object blank 68 The lateral axes of the midpoint of longitudinal axis 82 are symmetrical.

As described herein, Figure 14 provide when core 12 can be at disposing/be radially expanded configuration when 12 structure of illustrative core Type.Covering blank 68 can be by suitably size design, to encapsulate all cores as described herein 12.It is noted that due to core 12 Various sizes are may be provided in, covering blank 68 can also provide into various initial sizes to conform to the size of core 12.Each In kind of embodiment, covering blank 68 (in flat two dimensional configurations and before the encapsulating of core 12) can have from about 90,92, 94, the initial longitudinal length L1 of 96,98,99 or 100mm to about 101,102,104,106,108 or 110mm.In one embodiment In, covering blank 68 (in flat two dimensional configurations and before the encapsulating of core 12) can be with the initial of about 100mm ± 1mm Longitudinal length L1.In various embodiments, covering blank 68 (in flat two dimensional configurations and before the encapsulating of core 12) Can have from about 40,42,44,46,48,50,52,54,56,58 or 60mm to about 70,72,74,76,78,80,82,84,86, The original top border width W1 and bottom margin width W2 of 88 or 90mm.In one embodiment, it is in flat two-dimentional structure The covering blank 68 of type can be rectangular shape, and top edge width W1 can be identical as bottom margin width W2. In one embodiment, the covering blank 68 in flat two dimensional configurations can have such as trapezoidal shape, and top sides Edge width W1 can be different from (for example, being less than) bottom margin width W2.

As the illustrative examples that core 12 and covering blank 68 combine, core 12 can have anchoring element 18, support component 20 and the node 22 between anchoring element 18 and support component 20.It is disposing/is being radially expanded in configuration, the anchor of core 12 Gu element 18 can have the radial diameter of about 41mm ± 1mm with the radial diameter of about 32mm ± 1mm, support component 20, and And the length of core 12 can be about 42mm ± 1mm.When being observed in flat two dimensional configurations, and the encapsulating of core 12 it Before, the covering blank 68 for such core 12 can have trapezoidal configuration, and can have following original dimension：About 100mm ± The longitudinal length L1 of 1mm；The top edge width W1 of about 50mm ± 1mm；And the bottom margin width W2 of about 61mm ± 1mm.

As another illustrative examples that core 12 and covering blank 68 combine, core 12 can have anchoring element 18, branch Support element 20 and the node 22 between anchoring element 18 and support component 20.It is disposing/is being radially expanded in configuration, core 12 anchoring element 18 can have the radial direction of about 50mm ± 1mm straight with the radial diameter of about 32mm ± 1mm, support component 20 Diameter, and the length of core 12 can be about 37mm ± 1mm.When being observed in flat two dimensional configurations, and in the packet of core 12 Before envelope, the covering blank 68 for such core 12 can have trapezoidal configuration, and can have following original dimension：About The longitudinal length L1 of 100mm ± 1mm；The top edge width W1 of about 50mm ± 1mm；And the bottom margin of about 80mm ± 1mm Width W2.

It should be appreciated that when covering blank 68 undergoes procedure of processing described herein, the size size of covering blank 68 It can change, for example, becoming less than the original dimension of covering blank 68.For example, covering blank 68 can have initial size Size, for example, initial longitudinal length L1.When covering blank 68 is further processed, for example, layer 70 and 80 it is at least one When edge (for example, top edge 76) is combined together and/or removes leftover bits, core 12 is being inserted into covering blank 68 It is interior, core 12 is encapsulated in covering blank 68 and/or when covering blank 68 final sews up covering blank 68 it is final Longitudinal length is smaller than initial longitudinal length L1.

During manufacturing process, covering 14 can be manipulated, and required configuration is presented, which depends on the institute of core 12 Need configuration.Therefore, covering 14 can conform to core 12.As described herein, core 12, which can have, is located at anchoring element 18 and support member Node 22 between part 20.The midpoint of longitudinal axis 24 of the core 12 around the longitudinal axis 24 of core 12 and positioned at core 12 wherein The symmetrical embodiment of both lateral axes in, node 22 can be located at the midpoint of the longitudinal axis 24 of core 12.Core 12 wherein Symmetrical around the longitudinal axis 24 of core but not around the midpoint of the longitudinal axis 24 positioned at core 12 lateral axes are symmetrically real It applies in example, node 22 can not be located at the midpoint of the longitudinal axis 24 of core 12.In such embodiments, support arm 28 can be grown In anchor arm 26, and node 22 can be closer to the anchoring top 30 of core 12 and the support top end 32 of farther off-chip 12.Any In a embodiment, by fastening covering 14 in the region residing for the node 22 of core 12, covering 14 can conform to core 12 Required configuration.

In order to which core 12 to be encapsulated in covering blank 68, covering blank 68 can be converted into three from flat two dimensional configurations Configuration is tieed up, to provide space between two layers 70 of the material 90 of covering blank 68 and 80, to be inserted into core 12 in it.It will The process that covering blank 68 is converted into 3-d modelling from two dimensional configurations may include covering blank 68 being loaded into the first tray On, the first tray can have contact pin 124 and 126, to open covering blank 68.It can show can there is contact pin in Figure 21-23 The exemplary embodiment of 124 and 126 the first tray 120.

Figure 21 provides the illustrative examples of the front view of a part for the first tray 120, with base portion 122 and can incite somebody to action The position 118 that covering blank 68 is loaded into.Figure 22 provides the vertical view of the first tray 120, and having can be by covering base At least one position 118 that material 68 is loaded into.Figure 23 provides the side view of the first tray 120, and having can be by covering base The position 118 that material 68 is loaded into.It should be pointed out that the first tray 120 can have 68 required amount of position of load covering blank 118, to be converted into 3-d modelling from two dimensional configurations.In various embodiments, the first tray 120 can have at least 1,2,3,4,5, 6,7,8,9 or 10 positions 118, for receiving the two-dimensional covering blank for being converted into three-dimensional covering blank 68 68.In various embodiments, the first tray 120 can have from about 1,2,3,4 or 5 position 118 to about 6,7,8,9 or 10 positions Set 118.

Referring to Figure 21-23, each position 118 on the first tray 120 can have a pair of of mounting bracket, such as mounting bracket 128 and 130.In mounting bracket 128 and 130 each can by thinking that suitable any material is made, such as, but not limited to steel, Aluminium, plastics etc..Mounting bracket 128 and 130 can have and be converted to open configuration (institute in Figure 23 (shown in Figure 22) from closed configuration Show) ability.Mounting bracket 128 and 130 can be hingedly connected to each other so that a mounting bracket of such as mounting bracket 128 Movement can cause the movement of such as another mounting bracket of mounting bracket 130.For example, for example by pressing mounting bracket 128 Base portion and causing mounting bracket 128 to be converted to open configuration from closed configuration can cause mounting bracket 130 to complete identical turn Become.Each mounting bracket 128 and 130 can be operatively connected in a manner of thinking suitable with the first tray 120, so that energy It is enough that open configuration is for example converted to from closed configuration by using hinge.Each mounting bracket 128 and 130 can be in its corresponding face Inside side have hemispherical shape so that when the two mounting brackets 128 with 130 can in closed configuration and together with When (such as shown in Figure 22), two hemisphere can form the complete circle around open area 132.Mounting bracket 128 and 130 In each can have height H1, this highly can be think be suitble to manufacturing process described herein any height.

Referring to Figure 21-23, each mounting bracket 128 and 130 can be associated with a pair of of contact pin 124 and 126.For example, installation Bracket 128 can be associated with a pair of of contact pin 124, and mounting bracket 130 can be associated with a pair of of contact pin 126.A pair of of contact pin 124 Can respectively have base segments with 126, it can be associated with the inward-facing side of each mounting bracket 128 and 130 respectively.Often It can be by thinking that suitable any mode (for example, welding or use screw) is corresponding to its to the base segments of contact pin 124 and 126 Mounting bracket 128 and 130 it is associated.Each pair of contact pin 124 and 126 respectively can exceed mounting bracket 128 and 130 with extensible Height H1 part so that covering blank 68 may be mounted to a pair of of the contact pin 124 for extending beyond mounting bracket 128 and 130 On 126 part.

In various embodiments, each pair of contact pin of such as contact pin 124 can be the identical phase with such as mounting bracket 128 The associated two individual components of mounting bracket answered.In such embodiments, each position on the first tray 120 118 can have there are two mounting bracket 128 and 130 and four individual contact pins, and each contact pin has its corresponding mounting bracket Frame 128 and 130 its associated own base portion are (for example, two individual contact pins 124, each contact pin 124 and mounting bracket 128 is associated；And two individual contact pins 126, each contact pin 126 are associated with mounting bracket 130).In various embodiments In, each pair of contact pin of such as contact pin 124 can be made of single material, and be shaped so that two contact pins of such as contact pin 124 The configuration extended from identical material base portion.In such embodiments, each position 118 on the first tray 120 can have There are two mounting bracket 128 and 130 and four individual contact pins, two of which contact pin 124 is from associated with mounting bracket 128 Single common base extends, and two contact pins 126 extend from single common base associated with mounting bracket 130.

As described above, mounting bracket 128 and 130 can respectively have the hemispherical shape on its inward-facing side, make When proper mounting bracket 128 and 130 is in closed configuration, hemispherical shape can form the complete circle around open area 132 Shape.The base material of contact pin 124 and 126 can be configured so that they follow the identical curvature of mounting bracket 128 and 130. It should be pointed out that the inward-facing side of mounting bracket 128 and 130 is not necessarily hemispherical shape, with formed it is complete round and Open area 132.Open area 132 allows the various bars of such as push rod and/or pre- pleating bar to pass through tray (described herein the One, second and third tray).Open area in each tray can be any shape for thinking to be suitble to that various bars is allowed to pass through Shape.In various embodiments, open area can be round, square, oval (overall) and rectangle etc..Open zone The shape in domain can be limited by tray, for example, the shape of open area 132 can be by the inward-facing side of mounting bracket 128 and 130 It limits.

Contact pin 124 and 126 can be by thinking that suitable any material is made, such as, but not limited to steel, aluminium, plastics etc..Contact pin 124 and 126 can allow contact pin 124 and 126 to exist with suitable any shape and configuration, any shape and configuration is thought It is attached during being converted into three-dimensional covering blank 68 from flat planar cover object blank 68 and being provided for covering blank 68 It is opened and closed during the seam added and keeps covering blank 68.During the process, contact pin 124 and 126 should not hinder Any other activity in the fabrication process or process steps.In various embodiments, contact pin 124 and 126 can be mutual Mirror image.Contact pin 124 and 126 can respectively have the height H2 for extending beyond mounting bracket 128 and 130.The height of contact pin 124 and 126 Degree H2 is smaller than the overall initial longitudinal length L1 of covering blank 68 so that contact pin 124 and 126 can not interfere covering base Material 68 further processing, for example, the layer 70 of covering blank 68 and 80 bottom margin 78 combination.

As noted above, mounting bracket 128 and 130 can be converted to for example from closed configuration for example in fig. 22 in Figure 23 In open configuration.Since contact pin 124 and 126 can respectively have and mounting bracket 128 and 130 associated base portions, contact pin 124 The transformation (that is, from closed configuration to open configuration) on identical configuration can be undergone with 126.Referring to Figure 22,128 He of mounting bracket 130 can be at closed configuration.The base portion of contact pin 124 and 126 can be associated in this way with mounting bracket 128 and 130, I.e. so that the contact pin 124 and 126 of mounting bracket 128 and 130 is extended beyond when mounting bracket 128 and 130 is in closed configuration Part can be closely adjacent to each other.In various embodiments, when mounting bracket 128 and 130 is in closed configuration, 124 He of contact pin 126 can be in contact with each other (for example, 124 contact insert pin 126 of contact pin).Referring to Figure 23, when mounting bracket 128 and 130 is converted to opening When configuration, open configuration can be also converted to by extending beyond mounting bracket 128 and 130 contact pin 124 and 126 part, and be inserted Needle 124 and 126 can be moved directionally away from each other.Contact pin 124 and 126 this movement away from each other can cause covering blank 68 are converted into the 3-d modelling of opening from flat two dimensional configurations, are covered because contact pin 124 and 126 movement away from each other can force The layer 70 of cover material blank 68 and 80 is away from each other.

As described above, in various embodiments, the ribbon 112 of covering blank 68 can be manufactured.In various embodiments In, such as embodiment shown in Figure 18, the covering blank 68 in the ribbon 112 of covering blank 68 can have trapezoidal structure Type, and the layer 70 of two covering blanks 68 and 80 top edge 76 can be adjacent to each other, and two covering blanks 68 The bottom margin 78 of layer 70 and 80 can be adjacent to each other.As set forth above, it is possible to it is believed that, which can be used as leftover bits removing Higher efficiency is provided during 110 leftover pieces region 102.In order to will each individual covering blank 68 from two-dimentional structure Type is converted into 3-d modelling, and individual covering blank 68 can detach with the ribbon 112 of covering blank 68 and with slotting It is loaded at the position 118 of needle 124 and 126 on first tray 120.

In various embodiments, it can be advantageous that tied after being loaded into covering blank 68 on first tray 120 Close 68 layer 70 of covering blank and 80 bottom margin 78.The combination of the layer 70 of covering blank 68 and 80 bottom margin 78 Calmodulin binding domain CaM 168 can be formed, seam, such as support component seam 174 can be ultimately formed, which can be located at the support of core 12 Near element 20.In such embodiments, covering blank 68 can be loaded on the first tray 120 so that covering base Expect 68 layer 70 and 80 top edge 76 near mounting bracket 128 and 130, and the layer 70 of covering blank 68 and 80 Bottom margin 78 is near the topmost part of contact pin 124 and 126.Covering blank 68 can have initial longitudinal length L1, should Length, which is more than, extends beyond mounting bracket 128 and 130 contact pin 124 and the height H2 of 126 part.Extend beyond contact pin 124 It can be coupled to together to form calmodulin binding domain CaM 168 with the part of the covering blank 68 of 126 height H2, calmodulin binding domain CaM 168 can Seam is ultimately formed, for example, the support component seam 174 of covering 14.

As noted above, covering blank 68 can manufacture in the ribbon 112 of covering blank 68, two of which sequence The top edge 76 of covering blank 68 can be adjacent to each other, and the bottom margin 78 of the covering blank 68 of two sequences can Adjacent to each other.Therefore, covering blank 68 can be said to be manufacture in the alternate sequence of covering blank 68.Due to covering Blank 68 may be in the alternate sequence in the ribbon 112 of covering blank 68, by will be near mounting bracket 128 It is placed on the first tray 120 with the layer 70 of 130 covering blank 68 and 80 top edge 76, it is every in ribbon 112 Every the ready configuration that a covering blank 68 may be at being loaded on the first tray 120.In order to contribute in manufacturing operation Efficiency, may be not at the alternate covering blank 68 for the ready configuration being loaded on the first tray 120 can be placed to In 68 loads fixture 134 of covering blank shown in such as Figure 24 and 25.Figure 24 provides 68 loads fixture of covering blank 134 front view, Figure 25 provide the side view of 68 loads fixture 134 of covering blank.68 loads fixture 134 of covering blank There can be 68 support element 138 of clamp base 136 and covering blank.As described above, in various embodiments, covering blank 68 There can be trapezoidal configuration.Since covering blank 68 can have trapezoidal configuration, 68 support element 138 of covering blank that can also have ladder Shape configuration.68 loads fixture 134 of covering blank can provide alternative position, work as load and will be loaded into the first tray The ribbon 112 of covering blank 68 on 120 may be not at the covering blank 68 of ready configuration when detaching.

Referring to Figure 26-28, covering blank 68 can be shown on the first tray 120 and covering blank 68 is to covering base Expect the load in 68 loads fixtures 134.In one embodiment, when covering blank 68 can be with the ribbon of covering blank 68 112 separation, covering blank 68 can be connected to covering blank via the layer 70 of covering blank 68 and 80 bottom margin 78 When 68 ribbon 112 and layer 70 and 80 top edge 76 are the leading edges of ribbon 112 of covering blank 68, covering Blank 68 can considered to be in the ready configuration for being loaded on the first tray 120.In such embodiments, pass through disconnection The bottom of covering blank 68 and next adjacent covering blank 68 in ribbon 112 in ribbon 112 being connected Perforation 106 between portion edge 78, covering blank 68 can be detached with ribbon 112.The covering blank 68 of separation can be It is loaded directly at one available position 118 on first tray 120.

Referring to Figure 26, the covering blank 68 of the separation can be loaded on the first tray 120 so that covering blank 68 Layer 70 and 80 top edge 76 near mounting bracket 128 and 130, and the bottom of the layer 70 and 80 of covering blank 68 Edge 78 extends beyond contact pin 124 and 126.Covering blank 68 can be oriented so that the side seams of such as seam 74 perpendicular to The plane of first tray 120.Covering blank 68 is located so that side seams 74 can perpendicular to the plane of the first tray 120 It is rotated including making covering blank 68 surround contact pin 124 and 126 in the clockwise or counterclockwise direction, until side seams 74 can hang down Directly in the plane of the first tray 120.The side seams of such as seam 74 are positioned perpendicularly to the plane of the first tray 120 to be prevented It is associated with the vaginal inset 10 in side seams 72 and 74 to remove element 16.If removed in element 16 and side seams 72 and 74 Vaginal inset 10 it is associated, drawing, which removes element 16 and can weaken vagina, during removing vaginal inset 10 from vagina inserts Enter the side seams 72 and 74 of object 10, this can weaken the integrality of vaginal inset 10.

Covering blank 68 manufactures the ribbon 112 in the alternate sequence with covering blank 68 (for example, figure wherein Shown in 17 and 18) in embodiment in, the first covering blank 68 from ribbon 112 detach and be loaded into the first goods After on disk 120, next adjacent covering blank 68, which can detach from ribbon 112 and be loaded into covering blank 68, to be added It carries on fixture 134, for example, shown in Figure 27.As shown in figure 27, covering blank 68 can be loaded into the support of covering blank 68 On part 138 so that base portion 136 of the bottom margin 78 of layer 70 and 80 near 68 loads fixture 134 of covering blank.With reference to figure 28, in order to which covering blank 68 is transferred to the first tray 120, covering blank 68 from 68 loads fixture 134 of covering blank 134 rotatable 180 ° of loads fixture, to navigate to the covering blank 68 being positioned in 68 loads fixture 134 of object blank Correctly it is orientated to be loaded on the first tray 120.It initially will covering when the ribbon 112 with covering blank 68 detaches The layer 70 of object blank 68 and 80 bottom margin 78 are as its up-front covering blank 68 at this time by the layer of covering blank 68 70 and 80 top edge 76 is used as its leading edge, and on correct be orientated, by the layer 70 of covering blank 68 and 80 Top edge 76 is aligned closest to the mounting bracket 128 and 130 of the first tray 120.

Referring to Fig.1 7-28, in one exemplary embodiment, the first tray 120 can have and can load two dimension above and cover Six positions 118 of cover material blank 68, and 68 loads fixture 134 of covering blank can have planar cover can be loaded above Six covering blanks, 68 support element 138 of object blank 68.In such exemplary embodiment, by covering from alternate sequence Multiple covering blanks 68 of the ribbon 112 (for example, shown in Figure 17 and 18) of cover material blank 68 are loaded into the first tray 120 On process may include following steps：In the case where the top edge 76 of layer 70 and 80 is near mounting bracket 128 and 130, Covering blank 68 from ribbon 112 is alternately loaded on the first tray 120；Then in the bottom sides of layer 70 and 80 Edge 78 is in the case of the base portion 136 of 68 loads fixture 134 of covering blank, by next covering in ribbon 112 Object blank 68 is loaded into 68 loads fixture 134 of covering blank.These process steps can continue, until the first tray 120 All six 68 support elements 138 of covering blank of 68 loads fixture 134 of all six positions 118 and covering blank all have The covering blank 68 of load.Therefore, in such embodiments, 12 covering blanks 68 can be with covering blank 68 Ribbon 112 detaches.Once all six positions 118 of the first tray 120 are all loaded with covering blank 68, covering blank 68 It can be oriented so that side seams 72 and 74 can be perpendicular to the plane of the first tray 120.Mounting bracket 128 and 130 can be operated At mounting bracket 128 and 130 is made open configuration is converted to from closed configuration with contact pin 124 and 126.Mounting bracket 128 and 130 Transformation from closed configuration to open configuration can be by depressing such as base portion of the mounting bracket of mounting bracket 128 and keeping it hinged It opens to realize.The movement can cause the mounting bracket 130 of hinged attachment to be also converted to open configuration.Inserting in open configuration Needle 124 and 126 can be apart from one another by the layer 70 and 80 of covering blank 68, to make covering blank 68 enter open configuration. Load above can be moved into next station of manufacturing process there are six the first tray 120 of covering blank 68, and can be with Obtain " empty " first tray 120 (therefore another first tray 120).68 loads fixture 134 of covering blank can be " empty " 180 ° of the top of the first tray 120 overturning, and it has been loaded into the covering blank 68 of 68 loads fixture 134 of covering blank Covering blank 68 on support element 138 68 support element 138 of covering blank and can drop to " empty " by the way that they slip away It is transferred to " empty " first tray 120 on the contact pin 124 and 126 of first tray 120.In six covering blanks 68 from covering 68 loads fixture 134 of cover material blank is transferred to after " empty " first tray 120, and 68 loads fixture 134 of covering blank will not With covering blank 68, the first tray 120 " emptied " fills covering blank 68 at this time, and can be moved to manufacture Next station of process, and the sequence for loading covering blank 68 can be directed to another empty first tray 120 and sky 68 loads fixture 134 of covering blank restarts.

Next station in manufacturing process may include the layer 70 of covering blank 68 and 80 bottom margin 78 at pleat And sealing.The formation that can lead to calmodulin binding domain CaM 168 at pleat and sealing of the layer 70 of covering blank 68 and 80 bottom margin 78, Calmodulin binding domain CaM 168 can ultimately form seam, for example, the support component seam 174 of covering 14.

As described above, covering blank 68 can be positioned on the first tray 120 so that 70 He of layer of covering blank 68 80 top edge 76 can be positioned so that the mounting bracket 128 and 130 near the first tray 120.Therefore, covering blank 68 The bottom margin 78 of layer 70 and 80 extensible exceed contact pin 124 and 126.The bottom margin 78 of layer 70 and 80 can be coupled to together To form calmodulin binding domain CaM 168.Calmodulin binding domain CaM 168 can eventually become support component seam 174, and can be eventually located at the branch of core 12 It supports near element 20.

Figure 29-34 provides the graphical representation of exemplary of exemplary process steps, wherein the layer 70 of covering blank 68 and 80 Bottom margin 78 at pleat and can combine, to form calmodulin binding domain CaM 168.Three-dimensional at least one opening on it First tray 120 of covering blank 68 can enter into pleat device module.Covering blank 68 can be at open configuration, because first The contact pin 124 and 126 of tray 120 can be at open configuration.Layer 70 and 80 can be made together at pleat at pleat device module, to form knot Close region 168.Calmodulin binding domain CaM 168 can eventually become the support component seam 174 of covering 14, and can be located close to vagina insertion At the support component 20 of the core 12 of object 10.

As described in above in association with Figure 26 and 28, planar cover object blank 68 can be loaded on the first tray 120 and determine Position is at so that side seams 72 and 74 can be perpendicular to the plane of the first tray 120.First tray 120 can be transported into pleat device mould Block, and the side seams 72 and 74 of covering blank 68 are perpendicular to the plane of the first tray 120.

Figure 29 provides the graphical representation of exemplary of a part for the first tray 120, and covering base is loaded on the first tray 120 Expect 68 and open configuration is maintained at by a pair of opposite contact pin (such as contact pin 124).It should be appreciated that contact pin 126 and contact pin 124 Cooperation by covering blank 68 to be maintained at open configuration；However, for observer, the only contact pin in the diagram of Figure 29 124 is visible.There can be tucker bar 150 at pleat device module, can be operated with pair wise.For example, referring to Figure 29, it can be seen that be in Two covering blanks 68 of open configuration, and five tucker bars 150 can be seen.Tucker bar 150 may extend past open cover The bottom margin 78 of cover material blank 68, and close to together, to form the layer 70 and 80 pleats of covering blank 68.Work as pleating When the immigration of bar 150 gets out the position for making covering blank 68 at pleat, the tucker bar 150 in a pair of of tucker bar 150 can be positioned On the side of covering blank 68, and another tucker bar 150 in a pair of of tucker bar 150 can be positioned in covering base On the opposite side of material 68.After this declines tucker bar 150 in place, each tucker bar 150 moves into the side of covering blank 68 Face is to form pleats.Figure 30 provides the vertical view diagram of covering blank 68 and two tucker bars 150, two tucker bars 150 It is located in ready position with relationship relative to each other so that covering blank 68 is at pleat.Direction arrow may indicate that each tucker bar 150 The mobile direction for the offer pleats in covering blank 68.Although being noted that Figure 30 is vertical view, in order to carry For being clearly illustrated that, the diagram of the first tray 120 is invisible in fig. 30.

As tucker bar 150 is moved toward each other to form pleats in covering blank 68, contact pin 124 and 126 is collapsible Together and covering blank 68 is clamped, to prevent from pulling out pleats.When observing in a top view, at the covering blank of pleat 68 can be presented " H " configuration.Figure 31, which is provided, have been made the layer 70 of covering blank 68 in a pair of of tucker bar 150 and 80 one-tenth pleats and has inserted Needle 124 and 126 from open configuration be converted to closed configuration after covering blank 68 " H " configuration vertical view.Referring to Figure 32, it can be seen that holder bar 152 may move into close to the position of the covering blank 68 at pleat, will be at the covering of pleat Blank 68 is maintained at into " H " configuration of pleat, and/or ensures that contact pin 124 and 126 has collapsed in one before tucker bar 150 is withdrawn from It rises.Tucker bar 150 can be withdrawn by, and can be transported to coupling unit at the covering blank 68 of pleat, for being combined into pleat Layer 70 and 80.Holder bar 152 can also be withdrawn from before, during or after the first tray 120 is delivered to coupling unit.Covering The combination of the layer 70 and 80 at pleat of object blank 68 materials at two layers can at least will be combined together.In various embodiments, due to A pair of of tucker bar 150 can fold inwardly and towards each other layer 70 and 80, in conjunction with can be realized by least four layer materials.Figure 31 and 32 The diagram of the layer 70 of covering blank 68 and 80 four layer materials can be respectively provided, these materials may then bond together to form knot Close region 168.The pleats center 158 in " H " configuration also can be seen in Figure 31 and 32.Pleats center 158 can be into pleat Covering blank 68 position, in the position, the material of layer 70 and 80 can become tight each other due to moving for tucker bar 150 It is adjacent.In various embodiments, the layer 70 in pleats center 158 and the gap less than 10mm may be present between 80 material. In various embodiments, the layer 70 in pleats center 158 and may be present between 80 material from about 0,1,2,3,4 or 5mm to about 6, the gap of 7,8,9 or 10mm.

Figure 33 provides the vertical view of the covering blank 68 at pleat in coupling unit.In conjunction with can be by thinking suitable Any means carry out, and such as, but not limited to adhesive, pressure combination, thermal, ultrasonic wave combine, splicing, suture and/or weld It connects.In exemplary embodiment shown in fig. 33, it can undergo ultrasonic wave at the covering blank 68 of pleat and combine to form combination Region 168 (shown in Figure 34).Ultrasonic bonders can have internal solenoid valve, when being triggered in conjunction with cycle, the solenoid valve Soldering tip can be moved in and out position.Think that suitable any wave welding head of ultrasonic wave 154 and anvil 156 can be adopted to form calmodulin binding domain CaM 168。

Once the combination of each covering blank 68 on the first tray 120 is completed, the first tray 120 can be advanced to Leftover pieces remove station.Figure 34 provides the diagram that leftover pieces remove the exemplary embodiment of station.The layer of covering blank 68 70 and 80 combination can be happened in the region of the layer 70 and 80 for the height H2 for extending beyond contact pin 124 and 126.In various implementations In example, all material for extending beyond the layer 70 and 80 of the covering blank 68 of the height H2 of contact pin 124 and 126 all may be incorporated in Together to form calmodulin binding domain CaM 168.In various embodiments, the covering blank of the height H2 of contact pin 124 and 126 is extended beyond 68 layer 70 and 80 may then bond together all or fewer than material to form calmodulin binding domain CaM 168.In such embodiments, corner Between the bottom margin 78 for expecting the layer 70 and 80 that region 164 can be located at calmodulin binding domain CaM 168 and covering blank 68.Leftover pieces region 164 can remove station in leftover pieces is removed.Station is removed since the first tray 120 can advance through leftover pieces, such as from branch The trimming wheel 162 of the suspended trimming wheel 162 of bracketing frame 172 can cut leftover pieces region 164, and by leftover pieces region 164 pull up, so that leftover pieces region 164 is detached with calmodulin binding domain CaM 168.In various embodiments, trimming wheel 162 can be A pair of of friction pulley.It leftover pieces region 164 can be by thinking that suitable any means (for example, vacuum 166) are pulled further away from combination Region 168.Pressure roller 160 can prevent covering blank 68 to be drawn out contact pin 124 and 126.Depressing roller 160 can be from mounting bracket 170 is suspended.

After the edge 78 of the layer 70 and 80 of covering blank 68 is at pleat and combination, covering blank 68 can have single A part for a opening, at least one edge in middle level 70 and 80 keeps unbonded.Core, which is inserted into module 180, to pass through core 12 The opening of covering blank 68 is inserted into covering blank 68.In various embodiments, core 12 is inserted into covering blank 68 Can simply it make in the space between layer 70 and 80 of the movement of core 12 by being open and entering covering blank 68.In such reality It applies in example, support component seam 174 can be on the outer surface of covering 14.In various embodiments, core 12 is inserted into and is covered It may include overturning covering blank 68 in object blank 68 and then make the movement of core 12 by being open and entering covering blank The step in open space between 68 layer 70 and 80.In such embodiments, support component seam 174 can be located at vagina On 10 inner surface of insert.In various embodiments, the step that core 12 is inserted into covering blank 68 may include moving in core 12 Covering blank 68 is turned over while in space between the dynamic layer 70 and 80 by being open and entering covering blank 68 The step of coming and being turned on core 12.During the process that core 12 is inserted into covering blank 68, core is inserted into module 180 Core 12 and the combination of covering blank 68 can be transferred to the second tray 188.

Figure 35 provides the front view diagram that core is inserted into the exemplary embodiment of module 180.Core is inserted into module 180 can be by core 12 are received in core compression pallet 190, and core 12 is transferred to from core compression pallet 190 in covering blank 68 and (is arranged first On tray 120) and by core 12 and 68 integrated positioning of covering blank in the second tray 188.Core 12 compresses pallet 190 from core Transfer into covering blank 68 may include that core 12 is inserted into covering base by any one of insertion method described above In material 68.A kind of such insertion method-while covering blank 68 overturn by core 12 move into covering blank 68 it is interior- It can be described further herein.In order to realize insertion and core 12 and covering blank 68 of the core 12 in covering blank 68 Combine the transfer to the second tray 188, core, which is inserted into module 180, can have that there are three main levels.Top-level 182 can provide can be The position for wherein loading the second tray 188, to receive core 12 and covering after core 12 is inserted into covering blank 68 Blank 68 combines.Top-level 182 may include that platform 198, the second tray 188 can be positioned on platform 198.In various embodiments, Platform 198 can be inserted into module 180 in up and down motion in core and move.For example, the case where the second tray 188 are located on it Under, platform 198 can drop to core and be inserted into the intermediate level 184 of module 180 so that closer to the first tray 120, the first tray 120 can quilt Core is located in be inserted into the intermediate level 184 of module.Top-level 182 may also comprise pre- pleating bar 202, and pre- pleating bar 202 can The initial rivel of covering blank 68 is provided on core 12.Intermediate level 184 may include roller 194 and roller shank 196.The One tray 120 can be positioned in roller 194, and roller shank 196 can be used to rotating cylinder 194 with by the first tray 120 Overturning.First tray 120 can have at least one covering blank 68 being positioned on.Covering blank 68 can connect with side Seam 72 and 74 and support component seam 174.Covering blank 68 can have at the top of the layer 70 and 80 of covering blank 68 Opening between edge 76.The top edge 76 of layer 70 and 80 can be positioned so that the installation close to the position 118 of the first tray 120 Bracket 128 and 130.Intermediate level 184 may also comprise core and place tool 204, can be used to core 12 being placed to core compression pallet In 190.Core 12 can be placed into core compression pallet 190 in opening 220 in, and core place tool 204 can be used to by core 12 into In one step push-in opening 220 so that core 12 can be positioned in 224 lower section of top surface of core compression pallet 190.Core places tool 204 can help to keep being loaded into the uniform depth of (multiple) core 12 in core compression pallet 190.Lower part level 186 can wrap Include core compression pallet 190.Core 12 can be placed into the opening of core compression pallet 190, to be ready for insertion into covering blank 68. Core, which compresses pallet 190, can have shank 192, shank 192 to can be used to the mobile core compression support between open configuration and closed configuration Disk 190.Lower part level 186 may also comprise push rod 200, and core 12 can be upwardly into covering blank 68 by push rod 200 goes forward side by side one In step the second tray 188 of push-in.

Figure 36 provides the perspective that core is inserted into the intermediate level 184 of module 180 and the exemplary embodiment of lower part level 186 Figure.Core compresses pallet 190 and roller 194 each in open configuration, and waits for and load core 12 and the first tray 120 respectively. Figure 37 provides the perspective view that core is inserted into the intermediate level 184 of module and the exemplary embodiment of lower part level 186, core pressure Contracting pallet 190 and roller 194 are in closed configuration.Core compression pallet 190 has been pushed into core and has been inserted into module 180, and rolls Cylinder 194 is by 180 ° of rotation.180 ° of rotations of roller 194 can overturn the first tray 120 in roller 194.Figure 38 A are carried The perspective view of the exemplary embodiment in open and uncompressed configuration core compression pallet 190 is supplied, and Figure 38 B are provided Core in closing and compressed configuration compresses the perspective view of the exemplary embodiment of pallet 190.Core compression pallet 190 can have core Compression pallet shank 192, preceding jaw 206 and rear jaw 208, guide block 210 will be loaded into for receiving in core compression pallet 190 The opening 220 of (multiple) core 12, at least one jaw bindiny mechanism (for example, rack-and-pinion arrangement 222) and guide rail 212.Jaw bindiny mechanism can connect jaw 206 and 208 so that jaw 206 and 208 can move in tandem.Jaw connects The additional example of mechanism includes but not limited to sliding block, guide rail and linear bearing.When being converted to closing and compression from open configuration When configuration, core compression pallet 190 can keep the shape (that is, the aspect ratio between axis can be kept) of opening 220, and jaw 206 and 208 can be compressed to identical degree.

When being loaded into core 12 in core compression pallet 190, core 12 can be placed into the opening 220 between guide block 210. When core compresses pallet 190 by from core insertion module 180 pull-out and push-in core insertion module 190, guide rail 212 can help to guide Core compresses pallet 190.In various embodiments, after core compression pallet 190 to be moved into core and is inserted into module 180, core compression Compressible (multiple) core 12 being loaded into core compression pallet 190 of pallet 190.In various embodiments, pallet 190 is compressed in core When being pushed into core insertion module 180, compressible (multiple) core 12 being loaded into core compression pallet 190 of core compression pallet 190. In order to which compression-loaded is to (multiple) core 12 in core compression pallet 190, preceding jaw 206 and rear jaw 208 can be inserted into relative to core Module 180 deviates 45 °, with compressed core 12.Jaw 206 and 208 is in order to compress (multiple) core 12 and movement towards each other can be by gas Cylinder, pneumatic power, hydraulic power or core compress the manually handle of pallet 190 and cause.Core compression pallet 190 is pulled out core to insert Enter module 180 and pulling in open configuration can cause jaw 206 and 208 to discharge its compression.In various embodiments, core compresses pallet 190 can have at least one opening 220 for receiving core 12.In various embodiments, core compression pallet 190 can have from 1, 2,3,4 or 5 openings, 220 to 6,7,8,9 or 10 openings 220.In various embodiments, core compression pallet 190 can have with The equal number of opening in position 118 on first tray 120 220.

Referring to Figure 39-42, it can show that operation core is inserted into the schematic diagram of the process of module 180.Since these figures are schematic diagrames And for clearly illustrating purpose, many surrounding details that core is inserted into module 180 are removed from diagram.It can be seen such as in Figure 39 It arrives, the second empty tray 188 can be loaded into core and be inserted into the top-level 182 of module 180.Second tray 188 can have Base portion 214 and at least one clamper 216 for keeping core 12 and covering blank 68 to combine.Although the second tray 188 shows Go out for tool there are one clamper 216, but the second tray 188 can have from 1,2,3,4 or 5 clamper 216 to 6,7,8,9 or 10 A clamper 216.In various embodiments, the second tray 188 can have and 118 same number of position on the first tray 120 Clamper 216.The second empty tray 188 can be loaded on the second tray platform 198, can on the second tray platform 198 First be moved downward to from the top-level 182 of core insertion module 180 in the intermediate level 184 that core is inserted into module 180 Tray 120.Second tray platform 198 can have transfer pipe 218, and the second tray is converted in core 12 and the combination of covering blank 68 During in 188,218 bootable core 12 of transfer pipe and covering blank 68 combine.It is inserted in core in pre- pleating bar 202 and push rod 200 Enter in module 180 it is corresponding it is mobile during, transfer pipe 218 also bootable pre- pleating bar 202 and push rod 200.It loads on it There is the first tray 120 of at least one covering blank 68 also to be brought into core to be inserted into the intermediate level 184 of module 180. The load that first tray 120 is inserted into core in the intermediate level 184 of module 180 may include the first tray 120 being put into roller 194 It is internal so that support component seam 174 can be upwardly-directed on the direction of the second tray 188.When the first tray 120 leaves into pleat When device module, the contact pin 124 and 126 of the first tray 120 is in closed configuration.Since the first tray 120 can be moved and be loaded It is inserted into core in the intermediate level 184 of module 180, contact pin 124 and 126 can be converted to open configuration from closed configuration.It should refer to Go out, only contact pin 124 is visible in Figure 39；However, two pairs of contact pins 124 and 126 can be all converted in open configuration.124 He of contact pin 126 opening also causes moving layer 70 and 80 on the direction of the opening of covering blank 68 away from each other and therefore.Covering The opening of blank 68 can form the flat surfaces of covering blank 68 above the support component 20 of core 12.

Core 12 can be loaded into core compression pallet 190 in, and the support arm 28 of core 12 on the direction of the second tray 188 to Upper orientation.Core places tool 204 and can be used to be pushed further into core 12 in the opening 220 that core compresses pallet 190 so that core 12 exists Core compresses 224 lower section of top surface of pallet 190.Core compression pallet 190 can be pushed into core and be inserted into module 180.In various realities It applies in example, core compression pallet 190, which is pushed into core and is inserted into module 180, can cause core to compress pallet 190 from open and unpressed Configuration is converted to the configuration of closing and compression.In various embodiments, it has been pushed into core in core compression pallet 190 and has been inserted into module After in 180, core compression pallet 190 can be converted to the configuration of closing and compression from open and unpressed configuration.Any In the case of, the compression that core compresses pallet 190 all can be by the hand of cylinder, pneumatic power, hydraulic power or core compression pallet 190 It is dynamic to manipulate to activate.It is noted that when the configuration in closing and compression, core compression pallet 190 compresses from the top to the bottom Entire core 12.For compressed core 12, the guide block 210 of preceding jaw 206 and rear jaw 208 can be inserted into module 180 with 45 ° relative to core Angle move toward each other.In wherein core compression pallet 190 from open and do not press after being pushed into core and being inserted into module 180 In the various embodiments of the configuration transformation of contracting, the compression of (multiple) core 12 can be happened at any one of following time place： Two trays 188 drop to core from top-level 182 and are inserted into before, during or after the intermediate level 184 of module 180；Or Pre- pleating bar 202 from top-level 182 drop to intermediate level 184 with by before in covering blank 68 pre- pleating to core 12, During or after.

The roller shank 196 for being used for overturning roller 194 can be used to overturn 180 ° for roller 194.The overturning of roller 194 can cause The support component seam 174 of covering blank 68, which changes, to be orientated so that support component seam 174 may be oriented in the direction of core 12 On, and can be closer to core 12.The overturning orientation of covering blank 68 can be seen in Figure 40.

Referring to Figure 40, the second tray platform 198 can drop to intermediate level 184 from top-level 182 so that the second tray 188 can be closer to the first tray 120.Although transfer pipe 218 can show that (such as in Figure 40) is that length makes transfer pipe 218 lean on The base portion of nearly first tray 120, but in various embodiments, transfer pipe 218 can have such length：It makes when the second goods When dish platform 198 drops to intermediate level 184 from top-level 182, transfer pipe 218 can extend across opening in the first tray 120 Region 132 is put, and same distant place can be extended to the support component seam 174 of covering blank 68.In various embodiments, turn It moves pipe 218 and may extend into covering blank 68 so that it can be closer to the support component seam 174 of covering blank 68.

Referring to Figure 41, once the second tray 188 drops to intermediate level 184 with closer to the first goods from top-level 182 Disk 120, the top-level 182 that pre- pleating bar 202 can be inserted into module 180 from core decline and may move through the second tray clamper Open area in 216 passes through the open area in the first tray 120 by the open area in the second tray transfer pipe 218 132, and between the contact pin of the first tray 124 and 126, to push the branch of covering blank 68 against the support arm 28 of core 12 Support element seam 174.In various embodiments, pass through the support component of the promotion covering of support arm 28 blank 68 against core 12 Covering blank 68 can be inserted partially into the support component 20 of core 12 by seam 174, pre- pleating bar 202 so that when process is complete Cheng Shi, covering blank 68 can relax on core 12.After in the support component 20 of 68 partial insertion core 12 of covering blank, Pre- pleating bar 202 can bounce back.

Referring to Figure 42, after pre- pleating bar 202 can bounce back, push rod 200 can be inserted into the bottom level of module 180 from core 186 move up.Push rod 200 can move upwardly through the opening 220 of core compression pallet 190, pass through the opening of the first tray 120 Region 132, and pass through the guide pipe 218 of the second tray platform 198.Push rod 200 can upwardly extend so that compressed core 12 towards second Tray 188 moves.By making the movement of compressed core 12 by the opening in covering blank 68 and covering blank 68 being made to compress It is overturn on core 12, compressed core 12 is inserted into covering blank 68 by this promotion of compressed core 12 towards the second tray 188.12 He of core The combination of covering blank 68 can be also upwardly into the second tray clamper 216 of the second tray 188, such as can be seen in Figure 42 It arrives.After core 12 and the combination of covering blank 68 arrived the second tray clamper 216, push rod 200 and the second tray platform 198 can bounce back to its corresponding initial position.In other words, push rod 200 can decline, and the second tray platform 198 can increase.

It is loaded into the second goods after core 12 is inserted into covering blank 68 and in core 12 and the combination of covering blank 68 After in disk 188, extensible second tray that is higher by of the support arm 28 of core and 20 region of support component of vaginal inset 10 is clamped The top surface of device 216.As described herein, at 20 region of support component of vaginal inset 10, removing element 16 can be with the moon Road insert 10 is associated.The second tray 188 combined with core 12 and covering blank 68 can be transported to threading and knotting Module.In various embodiments, threading and knotting module can will remove 20th area of support component of element 16 and vaginal inset 10 Domain is associated, and two knots are formed in removing element 16.Removing the binode of element 16 can be such that removal element 16 is inserted in vagina Enter and be held in place on object 10, and can be carried for the wearer of vaginal inset 10 during withdrawing from vaginal inset 10 from vagina The place of element 16 is removed for grasping.

Core 12 and the combination of covering blank 68 in the second tray 188 can enter threading and knotting module, and support member Part seam 174 is exposed to 216 top of the second tray clamper.By thread and knotting module processing after, covering blank 68 The top edge 72 of layer 70 and 80 can still be not associated with, and removing element 16 can be attached in the region of support component seam 174 It is connected to covering blank 68 and knots twice.Figure 43 provides schematically showing after product is processed in threading and knotting module Example property embodiment.

Threading and knotting module can will remove element 16 and be attached to covering blank 68, and can on removing element 16 shape At lower junction 230 and top knot 232.When removing element 16 measured, cutting and knotting, threading and knotting module can be used several Kind mechanical component and air/vacuum remove element 16 to control.Include with threading and the associated component of knotting process：Knotting block Component, needle assemblies, cutting assemblies and covering blank 68 and removal members clamp component.

In threading and knotting mould whole process tool in the block, there are two key steps.First step can will remove element 16 are inserted into core 12 and the combination of covering blank 68, and second step can be that two knots are formed in removing element 16.Figure 44-46 Provide the implementation for the removal element 16 of such as line 244 to be inserted into the process steps in core 12 and the combination of covering blank 68 Example schematic diagram, Figure 47-54 provide for will remove element 16 beat binode process steps embodiment schematic diagram.

Referring to Figure 44, the schematic diagram of threading module can be shown.Threading module may include the spool 246 of line 244.Line 244 Spool 246 can be located on unwinding frame, and line 244 can be allowed to flow freely from spool 246 during entire threading process. In various embodiments, mechanical counterweight could attach to line 244 to keep the tension in line 244.Line 244 may move through line block 240, Line block 240 can move and return towards needle 238.In various embodiments, line 244 passes through the movement of line block 240 that can pass through draught head It realizes.In various embodiments, draught head can make the region of elevated pressures be located at what core 12 and covering blank 68 combined In region.In various embodiments, line 244 can be by being realized across the movement of line block 240 with air drag wire 244.Each In kind embodiment, line 244 can be carried out across the movement of line block 240 via using vacuum drag wire 244.Since line block 240 can It is moved towards needle 238, the movement of line block 240 can make line 244 move amount identical with the movement of line block 240.In line block 240 Internal wire holder 242 can be used to prevent line 244 from moving when wishing that line 244 does not move.Middle empty needle 238 allows line 244 to move Pass through needle 238.In various embodiments, provided by line 244 channel any kind of component can all replace in empty needle 238 make With.It is opposite with needle 238, and on the other side that core 12 and covering blank 68 combine, bracing wire clamp mechanism 234 can be determined Position.Bracing wire clamp mechanism 234 can be with the forward/backward movement of 238 mechanisms of needle.Covering blank 68 has been pierced through in needle 238 and by line After 244 push through covering blank 68, the wire holder 236 in bracing wire/clamp mechanism 234 can be used to keep line 244.

Referring to Figure 45, the schematic diagram for providing the basic process of line 244 can be shown.Although it should be pointed out that not showing in Figure 45 Go out, but covering blank 68 threading before two funnels 256 associated with lower part knotting block 262 can fall into place and On the either side of covering blank 68.More details about funnel 256 and knotting process will be provided later.Keep core 12 The second tray 188 combined with covering blank 68 can be indexed the removal for offer for example in the form of line 244 in place Element 16.Since the second tray 188 can be indexed in place, core 12 and the combination of covering blank 68 can be rotated.Rotation can ensure that Needle 238 and line 244 will not pierce through support component seam 174, because the puncture of support component seam 174 can weaken entire support member Part seam 174.

Air can be pushed up from 188 lower section of the second tray towards the second tray base portion 214.Air can move further through Second tray clamper 216, it can make covering blank 68 " heaving " and tent like is swelled above the support arm of core 12 28. After " the heaving " of covering blank 68 and tent like protuberance, 68 fixture 248 and 250 of covering blank can be closed covering blank 68 and core 12.The closure of covering blank fixture 248 and 250 can make the support arm 28 of core 12 and covering blank 68 collapse.By Covering blank 68 " heaving " and tent like protuberance, covering blank before the closure in covering blank fixture 248 and 250 The extensible height for being higher by covering blank fixture 248 and 250 of 68 part.Therefore, the air below the second tray 188 Moving can cause 68 tent like of covering blank to be swelled and provide needle 238 incite somebody to action with the closure of covering blank fixture 248 and 250 Line 244 connect by position.

Two funnels 256 associated with lower part knotting block can decline, and in the covering blank 68 of tent like protuberance A funnel 256 on per side.In order to make the movement of line 244 by covering blank 68, needle 238 can be towards covering blank 68 forward It is mobile.Needle 238 may move through the opening in the first funnel 256, four layers of covering blank 68 swelled at pleat and tent like, and And the opening by being positioned in the second funnel 256 on the opposite side of object blank 68.Xian Kuai mechanisms 240 can be towards needle 238 Rear portion is moved, and can about 1/2 inch of line 244 be fed through needle 238.The first funnel 256, four is fed through by needle 238 The line 244 for the covering blank 68 and the second funnel 256 that layer is swelled at pleat and tent like can be by bracing wire clamp mechanism 234 Wire holder 236 captures, and wire holder 236 can also be moved forward towards covering blank 68.Bracing wire fixture 236 can clamping line 244 end Portion, and Xian Kuai mechanisms 240 can be released.

Referring to Figure 46, needle 238 and bracing wire clamp mechanism 234 move and are back to its initial position.Since line 244 can be by Wire holder 236 in bracing wire clamp mechanism 234 is clamped and is kept, and line 244 can be pulled by bracing wire clamp mechanism 234, and bracing wire The distance that clamp mechanism 234 moves backward can set the length of line 244.The covering blank 68 that line 244 can be swelled in tent like Position be in it is intermediate clamped by tension disk 254, to prevent it from being slided during knotting process.Chucking power in line 244 can quilt It keeps, until the first knot is formed.Once the line 244 and line 244 of length needed for obtaining are clamped by tension disk 254, so that it may by Positioned at 252 cutting line of thread cutter at needle 238, and push away line fixture 242 can be clamped to as subsequent cycle ready line 244。

When line 244 by the first funnel 256, the covering blank 68 swelled at pleat and tent like by four layers and passes through When second funnel 256 is fed to bracing wire clamp mechanism 234, the knotting of line 244 can be started simultaneously at.Knotting may include when core 12 and cover Top knotting block 260 and lower part knotting block 262 are declined into step in place with funnel 256 when cover material blank 68 is clamped first. Before the movement of needle 238 is by core 12 and covering blank 68, funnel 256 can be in place.Such as shown in Figure 47, line 244 can quilt Two funnels 256 are fed through, the two funnels 256 are located at every side of the covering blank 68 swelled at pleat and tent like On.It should be pointed out that funnel 256 can be used to navigate to line 244 in knotting block.When they are in thread position, funnel 256 can It is opened by following mechanical cam.When knotting block 260 and 262 is moved up from threading apparatus module, funnel 256 leaves machine Tool cam is simultaneously closed.In various embodiments, funnel 256 can be remained turned-off by using small magnet.In knotting block 260 and 262 Each can be moved independently of another knotting block 260 and 262.In knotting block 260 and 262 each can have top and Low portion, upper and lower part part can also independently move.Top knotting block 260 can have upper part 228 and lower part portion Divide 226.Lower part knotting block 262 can have upper part 278 and low portion 276.

Once line 244 is cut off, such as shown in Figure 47, knotting block 260 and 262 and funnel 256 just move up with Line is stretched, such as shown in Figure 48.Line 244 is still clamped by tension disk 254, but line 244 can be released from bracing wire clamp mechanism 234 It puts.The inlet point 258 that line enters lower part knotting block 262 can be at the bottom of lower part knotting block 262.On funnel 256 and top While knotting block 260 and lower part knotting block 262 are elevated, tension disk 254 can continue to keep line 244.

Referring to Figure 49, once moving up by funnel 256 and top knotting block 260 and lower part knotting block 262 Line 244 is lifted up, wick gripper 270 just can be used to temporarily maintain line 244, and prevent it from collapsing towards product.Wire clamp is held Device 270 can support the weight of line 244, until line 244 can be introduced into knotting block 260 and 262.From now on, funnel 256 can be It is remained turned-off in the remaining time of process.

Referring to Figure 50, knotting block 260 and 262 can drop to wick gripper 270, and vacuum can be used to pull on line 244 Pass through knotting block 260 and 262.Knotting block 260 and 262 can have thread path 274, thread path 274 that can form such as center of surrounding The knot lantern ring of the centrepin of pin 264 and 266.Centrepin 264 and 266 can be used to force and be formed at the specified point on knot online 244. In various embodiments, centrepin 264 and 266 can be located separately in the upper part 228 and 278 of knotting block 260 and 262.Example Such as, centrepin 264 can be located in the upper part 278 of lower part knotting block 262, and centrepin 266 can be located at top knotting block 260 In upper part 228.Once line 244 can be fed through thread path 274 and surround centrepin 264 or 266, fixture 268 can For keeping line 244 while forming knot.Thread path 274 can be shown in Figure 51.For clarity, knotting block details does not exist It is shown in the diagram of Figure 51, but shown thread path 274 can show that line 244 can surround 264 He of centrepin in lower part knotting block 262 The path that centrepin 266 in top knotting block 260 follows.Thread path 274 can be knotted in top knotting block 260 and lower part " overhand knot " path in 262 the two of block.In various embodiments, 260 part of top knotting block of thread path 274 can be relative to 262 parts of lower part knotting block of thread path 274 are in 90 °.

Referring to Figure 50, line 244 can follow thread path 274, and thread path 274 can be such that line 244 surrounds and be located at lower part knotting block 262 Upper part 278 in centrepin 264.Line 244 can continue to follow thread path 274 to the low portion of top knotting block 260 226, herein, line 244 can be clamped by the wire holder 268 in the low portion 226 of top knotting block 260.

As can be seen in the figure in the signal of Figure 52, top knotting block 260 can move up, this can cause lower part knotting block 262 upper part 278 and low portion 276 is opened.The upper part 278 of lower part knotting block 262 and beating for low portion 276 Open the retraction of permissible centrepin 264.Since top knotting block 260 can continue to move up, line 244 can be tensioned, and wrap Lower junction 230 can be formed by being rolled in the part of the line 244 around centrepin 264.Lower junction 230 can be by top knotting block 260 and upper Wire holder 268 in the low portion 226 of portion's knotting block 260 moves up tensioning.Lower part knotting block 262 can be in the surplus of process It is stayed open in remaining part point.Tension disk 254 can be also released at this moment.

After the completion of lower junction 230, top knotting block 260 can be moved down to receive line 244 again, to form the Two knots 232.As lower junction 230, line 244 follows thread path 274, and line 244 can be wrapped in top knotting block by thread path 274 Around centrepin 266 in 260 upper part 228.Figure 53 provides the schematic diagram of such process steps.Referring to Figure 54, Once line 244 has been wrapped in around the centrepin 266 in the upper part 228 of top knotting block 260, top knotting block 260 Wire holder 268 in upper part 228 just can be used to keep line 244 while knot 232 is tensioned.Top knotting block 260 Upper part 228 can move up and open upper part 228 from the low portion 226 of top knotting block 260, to allow Centrepin 266 bounces back.Since the upper part 228 of top knotting block 260 can continue to move up, line 244 can be tensioned, and Top knot 232 can be formed by being wrapped in the part of the line 244 around centrepin 266.Top knot 232 can be by top knotting block 260 Upper part 228 move up tensioning.

Figure 55 is schematic diagram, which can show：Once knot 230 and 232 can be formed, knotting block 260 and 262 can be upward It is moved to its initial position.Indexable and 248 He of covering fixture in next part of the second tray 188 towards manufacturing process 250 it is retractable line traffic control mechanism 272 can be moved forward with captured line simultaneously, and prevent them towards in the second tray 188 Core 12 and the combination of covering blank 68 are broken.It should be pointed out that although knotting module can be described as with top knotting block 260 under Portion's knotting block 262, but in various embodiments, knotting module can have only one knotting block.In such embodiments, it knots Module middle online can generate the first knot, line is repositioned in identical knotting block, and the second knot of online interior formation.

After it can form the line 244 for removing element 16 and be attached, core 12 and the combination of covering blank 68 are transferred to third Tray 280 may be beneficial.Core 12 and covering blank 68 combine to the transfer of third tray 280 and allow core 12 and covering The combination of object blank 68 overturns and makes it possible to the top edge 76 of the layer 70 and 80 in conjunction with covering blank 68, to encapsulate completely Core 12 simultaneously converts covering blank 68 to covering 14.Figure 56 provides the exemplary reality that core 12 and covering blank 68 combine The perspective view of example is applied, core 12 is positioned in covering blank 68, and is removed element 16 and be attached at 20 region of support component Place, but one end of covering blank 68 keeps unbonded.Figure 57 provides the perspective of the exemplary embodiment of third tray 280 Figure, core 12 and the combination of covering blank 68 can be reverse from configuration shown in Figure 56.In other words, in the second tray 188 Core 12 and covering blank 68 combination contribute to remove element 16 be attached to covering blank 68 and in the second tray 188 It is external visible.Figure 57 core 12 and covering blank 68 combination display, from the second tray 188 be transferred to third tray 280 it Afterwards, the support component 20 that removal element 16 is combined with core 12 and covering blank 68 is in the inside of third tray 280, and anchor Gu element 18 extends beyond the outer surface of third tray 280.

The schematic diagram for the process that core 12 and the combination of covering blank 68 are transferred to third tray 280 from the second tray 188 can It is shown with further reference to Figure 65-67 about shift module 300 in Figure 58-64.Shift module 300 can have the second tray 188 loading zones 302, removal element scraper 288,280 loading zone 304 of third tray, turner 308 and turner shank 322, Compressor reducer 284 and compressor reducer shank 286, push rod 292 and push rod shank 294 and foot pedal 306.Turner 308 is rotatable 180 °, and can also raise and reduce the second tray 188 that (that is, after the rotation of turner 308) is orientated in its overturning. It removes element 16 to be attached to after covering blank 68, the second tray that the second tray 188 can be transported to shift module 300 adds Carry area 302.When the second tray 188 to be transported in the second tray loading zone 302, the second tray 188 can be passed through one Group removes element scraper 288, to ensure to remove any part for the shift module 300 that element 16 will not be trapped in such as guide rail In.Second tray 188 can be loaded on turner 308, and the second tray 188 can be turned to for shifting core by turner 308 12 and covering blank 68 combine position.Second tray loading zone 304 and turner 308 can be positioned on compressor reducer 284 Side.Empty third tray 280 can be loaded into third tray loading zone 304.Third tray loading zone 304 may include promoting support Third tray 280 can be lifted up by disk towards compressor reducer 284.Therefore, third tray loading zone 304 can be positioned in compression 284 lower section of device.Third tray 280 can have the position 290 for receiving core 12 and covering blank 68 to combine.Third tray 280 can have think suitably to count destination locations.In one embodiment, third tray 280 can have at least one position 290.In one embodiment, third tray can have from 1,2,3,4 or 5 position 290 to 6,7,8,9 or 10 positions 290. In various embodiments, third tray 280 can have and the 118 equal number of position 290 of position on the first tray 120.

Referring to Figure 58, the second tray 188 can be loaded into the second tray loading zone 302, the second tray loading zone 302 Above compressor reducer 284 and it is placed on turner 308；And third tray can be loaded into positioned at 284 lower section of compressor reducer Third tray loading zone 304 in.Second tray can be loaded with the core 12 to face upward far from compressor reducer 284 and covering blank 68 Combination.Referring to Figure 59, by grasping turner shank 322 and turner being rotated 180 °, the second tray 188 can be reversed, directly It is not downwardly oriented on the direction of compressor reducer 284 to core 12 and the combination of covering blank 68.Referring to Figure 60, turner 308 and Two trays 188 can drop to its extreme lower position so that support component 20 and removal element 16 are positioned in compressor reducer 284.Very Sky can be used in the opening for helping that the sucking compressor reducer 284 of element 16 will be removed.Using foot pedal 306, foot pedal 306 can be pressed Under, this can cause associated rod piece to ramp up third tray 290 towards compressor reducer 284.Referring to Figure 61, compressor reducer shank 286 can activated so that the jaw of compressor reducer 284 collapse and by the compression blocks 298 in 284 base portion 296 of compressor reducer towards each other It is mobile.Compression blocks 298 can deviate 45 ° of angle relative to shift module 300.In order to realize that offset, compressor reducer 284 can have There are jaw bindiny mechanism, such as, but not limited to sliding block, guide rail, linear bearing or rack and pinion gear to arrange.Compression can make core 12 It collapses with the combination of covering blank 68, so that core 12 and the combination of covering blank 68 can be transferred to the from the second tray 188 Three trays 290.In various embodiments, the compression of compressor reducer 284 can pass through cylinder, pneumatic power, hydraulic power or compressor reducer 284 manually handle activates.Referring to Figure 62, push rod 292 can be actuated to opening in the mobile base portion by the second tray 188 Region is put, and core 12 and the combination of covering blank 68 are released into the second tray 188 and are pushed into third tray 280.Referring to figure 63, in core 12 and the combination of covering blank 68 after the second tray 188 is transferred to third tray 280, push rod 292 can bounce back, And the second tray 188 can be reversed and be back to the initial start position of the second tray 188.Compressor reducer shank 286 can be caused It moves to discharge compressor reducer 284, and third tray 280 can be declined by discharging foot pedal 306.Third tray 280 can continue Manufacturing process, such as shown in Figure 64.

Third tray 280 can be by core 12 and 68 combination transfer of covering blank at pleat device module.Due to covering blank 68 may have side seams 72 and 74 and support component seam 174, can be that covering blank 68 provides at pleat device module Anchoring element seam.Similar to the formation of the pleats in the layer 70 and 80 of covering blank 68 before this in the fabrication process, cover The top edge of the layer 70 and 80 of cover material blank 68 can be " H " configuration at pleat, as observed by the top of covering blank 68 's.After covering blank 68 can be by pleat, the layer 70 of covering blank 68 and 80 can complete covering in combination with to be formed Core 12 can be completely enclosed in covering 14 by 14 anchoring element seam.

Referring to Figure 68-76, it can make the layer 70 of covering blank 68 at pleat device module and 80 one-tenth pleats and combine to form anchoring Abutted seam.Figure 68 provides front view, and Figure 69 provides third tray 280 (when it is transported into pleat device module) Vertical view.The anchoring element 18 of core 12 is extensible to be higher by third tray 280, and a part for 68 material of covering blank can prolong It stretches and exceeds anchoring element 18.Figure 70 can provide front view, and Figure 71 can provide pin 310 decline inside covering blank 68 and Vertical view of the tucker bar 312 towards the movement of the side of covering blank 68 and middle part.In one embodiment, four pins 310 can Assist in keeping the open configuration of covering blank 68.Figure 72 can provide front view, and Figure 73 can provide tucker bar 312 in pin The vertical view of movement between 310 into covering blank 68.This movement of tucker bar 312 can form " H " configuration of pleats. Figure 74 can provide illustrated below：Once having formed pleats, so that it may remove pin 310 in from covering blank 68.In pin 310 from covering After being removed in object blank 68, the layer 70 and 80 of covering blank 68 is combinable, for example, such as being surpassed like that shown in Figure 75 Sound wave welds.Once the layer 70 of covering blank 68 and 80 combination are completed, tucker bar 312 can bounce back to its initial position, And covering blank 68 can have calmodulin binding domain CaM 318, calmodulin binding domain CaM 318 that can eventually become the anchoring element of covering blank 68 Seam.Once the anchoring element seam of covering blank 68 can be formed, core 12 can be completely enclosed in covering 14.Such as It can be seen in exemplary embodiment in Figure 76, leftover pieces region 320 can be formed during cohesive process.The leftover pieces area Domain 320 can be removed in a manner of similar to previously for the method for removing leftover pieces region description.

Although core 12 can be encapsulated in it by covering 14, it may be advantageous that covering 14 is made to conform to the total of core 12 Shape and configuration.The reason of making covering 14 conform to core 12 and method are discussed before this.It herein can further in detail A kind of method is stated, such as forms band and attachment strip.Band 344 can be applied to the covering 14 of vaginal inset 10 with shaping module On.In various embodiments, band 344 can be configured to by the material of such as non-woven material.In various embodiments, band 344 can It is configured to by the material of such as film.In various embodiments, band 344 can be configured to by weaving material.In various embodiments, band 344 can be by that can be configured to for the material that constructs covering 14 with identical material.

Small material strips 344 can be generated with forming process, can be placed on the covering 14 of vaginal inset 10.It is formed It can be shown in Figure 77 with 344 process.Material 330 for band 344 can be from involving in and can drawing via mechanical fiber net Guiding element 332 is sent to feed roller 334.Material 330 can have from about 3,4 or 5mm to the width of about 6,7 or 8mm.Implement at one In example, material 330 can be with the width of about 6mm.In one embodiment, one in roller 334 can be controlled by servo motor, And another in feed roller 334 can pass through friction-driven.Each friction-driven roller can have adjustable spring tightener, To increase or decrease the power of roller 334.In various embodiments, material 330 passes through the movement of web guiding piece 332 that can pass through gas Pressure difference is realized.In various embodiments, draught head can make the region of lower pressure be located in the region of mandrel 340.One In a embodiment, material 330 can be pushed over by using compressed air and mobile by the net guided part of mechanical fiber 332.Each In kind embodiment, material 330 can be carried out across the movement of web guiding piece 332 via material 330 is pulled using vacuum.Into Material 330 can be fed into the second web guiding mechanism 336 by material roller 334.Second web guiding mechanism 336 can utilize pressure Material 330 is fed on mandrel 340 by contracting air.Material 330 can be fed to mandrel 340, once and material 330 be placed On mandrel, vacuum just can be used to control material 330 in mandrel.Once the material 330 of required length is fed to mandrel 340 On, the cutter of such as scissors 338 in the second web guiding mechanism 336 can cutting material 330.Mandrel 340 can revolve Turn, and material 330 can be wrapped in around mandrel 340.Figure 78 provides the diagram of the vacuum sectional hole patterns 350 on mandrel 340, For 344 material therefor 330 of band to be held in place on mandrel 340.Pattern 350 can have on the left of " C " towards rear A series of lateral apertures.Material 330 can be placed in the right-hand side (that is, three vertical holes in pattern 350) of " C " on mandrel, and And mandrel 340 and pattern 350 can continue to rotate, three vertical holes weights in the end of cutting material 330 and pattern 350 It is folded.Once material 330 itself will overlap on mandrel 340, material 330 just can be coupled to itself, for example, by using ultrasonic wave Soldering tip 342 or any other combined method-for being mentioned above are for example, adhesive, thermal and/or pressure combine.Material 330 arrives The combination of itself can be happened in the open area of " C " backward in pattern 350.Material 330 can form band to the combination of itself 344, it can be placed on the covering 14 of vaginal inset 10.

Once band 344 is manufactured, it can be placed on the covering 14 of vaginal inset 10.Figure 79 can show by The process being placed on 344 on the covering 14 of vaginal inset 10.Mandrel 340 can have there are two section：Top section can connect It is connected to vacuum source, and can be material 330 can be wrapped in around mandrel 340 to form the position of band 344.The base portion of mandrel Section can be hollow, to allow vaginal inset 10 being pushed into inside mandrel, so that band 344 can be slid onto vagina insertion On the covering 14 of object 10.The anchoring element 18 of vaginal inset 10 can be compressed.In the anchoring element 18 of vaginal inset 10 After compression, the third tray 280 where vaginal inset 10 can be raised, and the anchoring member of the compression of vaginal inset 10 Part 18 can be positioned in inside mandrel 340.Band stripper 356 on mandrel 340 and above band 344 can along mandrel 340 to It moves down and towards vaginal inset 10.Since band stripper 356 can be moved down along mandrel, band stripper 356 will can exist Band 344 in place is moved down on the anchoring element 18 of the compression of vaginal inset 10 on mandrel 340.Third tray 280 can Decline, the anchoring element 18 of vaginal inset can be removed from 340 inside of mandrel, and band 344 can be on vaginal inset 10 In place.

Band 344 can be welded to vaginal inset 10 by rivet hot weldering process on both the front side of vaginal inset 10 and rear side Covering 14.Figure 80 provides the schematic diagram of the example process of rivet hot weldering band 344.Heated element 358 can be by briefly The band 344 being compressed on the covering 14 of vaginal inset 10, to form weld seam, which can be by band 344 in vaginal inset It is held in place on 10 covering 14.

The manufacture of vaginal inset 10 and covering 14 and the core 12 of vaginal inset 10 it is conformal after, vagina is inserted into Object 10 can be placed into all applicators as described herein 40, in order to which vaginal inset 10 to be inserted into vagina.

Although it should be pointed out that the description herein provide manufacture vaginal inset 10 process exemplary embodiment, But it is also envisaged that other embodiment.For example, the exemplary embodiment of manufacturing process described herein can be generally described core 12 are inserted by the opening between two layers 70 of covering blank 68 and 80 top edge 76 in covering blank 68.It answers When pointing out, in various embodiments, insertion of the core 12 into covering blank 68 can pass through two layers 70 of covering blank 68 Opening between 80 bottom margin 78 or the opening passed through between the layer 70 of covering blank 68 and 80 lateral edges carry out. It is further contemplated that although the description herein generally describes the top edge 76 of the layer 70 and 80 in covering blank 68 Combination before combine covering blank 68 layer 70 and 80 bottom margin 78, but in various embodiments, covering blank 68 layer 70 and 80 top edge 76 can be tied before the combination of the bottom margin 78 of the layer 70 and 80 of covering blank 68 It closes.

Although it should also be noted that the description herein generally provide core be inserted into module 180, threading and knotting module, Shift module 300, at pleat device module and with the finishing die exemplary embodiment of each in the block, but it is it is also envisaged that other Embodiment.For example, in some parts of the description herein, some component representations of various modules be equal modules its His component " top " or " lower section ", and in some parts of the description herein, some component representations are the spy in module In fixed " level ", for example, " top-level ", " intermediate level " or " bottom level ".It is contemplated that the orientation of module can overturn, So that for example presently described component in another component " top " can be in the component in the embodiment of various imaginations " lower section ", and presently described some components in " top-level " can be in " bottom in the embodiment of various imaginations In level ".

In order to for the sake of succinct and simplicity, in the disclosure shown in the range of any value consider institute in the range There is value, and should be interpreted the claim for supporting to enumerate any subrange, the endpoint of the subrange is in the rule considered Determine whole numerical value in range.By the example of hypothesis, range, which is 1 to 5 disclosure, should be considered as supporting any following range Claim：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.

Dimensions and values disclosed herein is not understood as being strictly limited to the exact the exact numerical.On the contrary, unless another It indicates outside, otherwise each such size is intended to indicate that described value and the functionally equivalent range around the value.For example, open It is intended to indicate that " about 40mm " for the size of " 40mm ".

The All Files quoted in " specific implementation mode " are herein incorporated by reference in relevant part；It is right The reference of any file is not necessarily to be construed as recognizing that it is prior art with regard to the present invention.Term in this written document Any meaning or definition with any meaning of the term in the file being incorporated by reference or define conflict in the case of, answer When being subject to the meaning for assigning the term in this written document or definition.

Although having shown and described the particular embodiment of the present invention, pair it will be apparent to those skilled in the art that , various other change and modification can be made without departing from the spirit and scope of the present invention.Therefore, appended It is intended to cover all such change and modification within the scope of the present invention in claims.

Claims

1. a kind of band shaping module, the module include：

A. the first web guiding piece；

B. a pair of of feed roller；

C. the second web guiding piece；

D. shear mechanism；And

E. mandrel, with vertical direction, horizontal direction, peripheral surface and the vacuum sectional hole patterns in the peripheral surface, Described in vacuum sectional hole patterns around the mandrel, and the vacuum sectional hole patterns include：

I. first part comprising extend along at least two row vacuum holes of horizontal direction extension and along the vertical direction A line vacuum hole, wherein the row vacuum hole extended along the vertical direction includes at least three vacuum holes and with regard to the level of mandrel It is located at the first side of horizontally extending vacuum hole, and the horizontally extending at least two row vacuum for direction Uppermost vacuum hole in close row vacuum hole vertically extended of the first row in hole, and it is horizontally extending Nethermost vacuum hole of second row in the row vacuum hole vertically extended in vacuum hole, wherein mandrel surface The position between horizontally extending vacuum hole of embarking on journey do not contain vacuum hole；With

Ii. second part comprising horizontally extending a line vacuum hole, wherein the vacuum hole of the second part is with regard to core It is located at second of the horizontally extending vacuum hole of embarking on journey in the vacuum hole of the first part for the horizontal direction of axis Side, horizontally extending row vacuum hole of the second part of the vacuum sectional hole patterns is close to mandrel surface along water Square to the position without containing vacuum hole between two row vacuum holes of extension.

2. band shaping module according to claim 1, wherein the mandrel can be rotated by 360 °.

3. band shaping module according to claim 1, wherein the mandrel includes hollow at least one end.

4. band shaping module according to claim 1, wherein the mandrel is connected to vacuum.

5. band shaping module according to claim 1, further includes servo motor, for driving in the feed roller extremely It is one few.

6. band shaping module according to claim 1, further includes combining mechanism.

7. a kind of band shaping module, the module include：

A. the first web guiding piece；

B. a pair of of feed roller；

C. the second web guiding piece；

D. compressed air supplies；

E. shear mechanism；And

F. mandrel, with vertical direction, horizontal direction, peripheral surface and the vacuum sectional hole patterns in the peripheral surface, Described in vacuum sectional hole patterns around the mandrel, and the vacuum sectional hole patterns include：

8. band shaping module according to claim 7, wherein the mandrel can be rotated by 360 °.

9. band shaping module according to claim 7, wherein the mandrel includes hollow at least one end.

10. band shaping module according to claim 7, wherein the mandrel is connected to vacuum.

11. band shaping module according to claim 7, further includes servo motor, for driving in the feed roller It is at least one.

12. band shaping module according to claim 7, further includes combining mechanism.