WO2006097935A2 - Apparatuses for the amelioration of urinary incontinence in females - Google Patents
Apparatuses for the amelioration of urinary incontinence in females Download PDFInfo
- Publication number
- WO2006097935A2 WO2006097935A2 PCT/IL2006/000346 IL2006000346W WO2006097935A2 WO 2006097935 A2 WO2006097935 A2 WO 2006097935A2 IL 2006000346 W IL2006000346 W IL 2006000346W WO 2006097935 A2 WO2006097935 A2 WO 2006097935A2
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- WIPO (PCT)
- Prior art keywords
- support
- insert
- optionally
- section
- exemplary embodiment
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Definitions
- the present invention relates generally to treating feminine medical conditions, for example by providing devices for the prevention of female incontinence and/or prolapse.
- Surgical treatment may involve securing the paraurethal tissues to the periosteum of the pubic bone or the rectus facia in order to elevate the bladder neck above the pelvic floor and thereby distribute pressure equally to the bladder, the bladder neck, and the mid-urethra.
- TVT Treatment Free Vaginal Tape
- a mesh tape is implanted underneath the mid-urethra, creating a hammock on which the urethra may kink during a rise in intra-abdominal pressure.
- surgery is only suitable for severe cases, and the majority of women experiencing incontinence do not need, and certainly would rather avoid, surgical solutions.
- One modality of non-surgical treatment involves the use of devices that are inserted into the vagina, either by a medical practitioner or by the woman herself. Most devices are designed to apply pressure against the bladder neck so as to inhibit or completely block the flow of urine through the urethra.
- a variety of such devices are known in the art. For example, refer to U.S. Publication No. 2002/0183711 to Moser, entitled, “Urinary Incontinence Device”; U.S. Patent No. 6,739,340 to Jensen, et al., entitled, "Device for prevention of involuntary urination"; U.S. Patent No.
- vaginal devices have been developed having specialized shapes that do not completely block the urethra but these devices tend to be large, uncomfortable, and intrusive. They also tend to cause irritation or soreness to the vagina.
- An aspect of some exemplary embodiments of the invention relates to providing • incontinence devices with inserts adapted to provide resilient reinforcement to at least a portion of the device.
- the incontinence devices are provided with support arms.
- an insert is used in conjunction with the support arms of the incontinence device to provide urethral support to a patient.
- the insert urges the support arms to expand radially (radially outwards from a central axis of the device) for providing urethral support.
- radial expansion is up to 20% of the previous radial profile of the device.
- radial expansion is up to 50% of the previous radial profile of the device.
- the insert is conical shaped.
- the insert is geometrically locking.
- the insert is of varying geometry.
- the insert is bi-stable.
- the insert is an o-ring.
- the insert is comprised of a plurality of components removably fitted together.
- at least a portion of the insert is elastic.
- the insert locks into at least one position on the incontinence device.
- the insert removably locks into position on the incontinence device.
- the insert is positioned in relation to the incontinence device such that support and/or pressure are rendered to the anchor arms of the device.
- an incontinence device is provided with tension reducing arms.
- tension is reduced by providing the arms with a folding section.
- the tension reducing arms are folded while in storage within an applicator, however upon deployment, the arms expand to render support and/or anchoring.
- an incontinence device is provided with a component which is at least bi-stable.
- the bi-stable component is provided with a first stable position, which does not cause the device to expand radially, and at least a second stable position, which causes the device to expand radially.
- the bi-stable component transfers from the first stable position to the second stable position without substantially moving in relation to the incontinence device.
- the bi-stable component transfers from the first stable position to the second stable position by moving in relation to the incontinence device.
- An aspect of some exemplary embodiments of the invention relates to providing at least a portion of an incontinence device with elasto-mechanical radial expansion.
- force is supplied for elasto-mechanical radial expansion by an elastic central member.
- the elastic central member is operationally connected to expanders (which in some embodiments are mechanical, hence the name "elasto- mechanical") which cause radial expansion of the device.
- the device is provided with support arms, which constitute a portion of the device which is radially expanded.
- the device is provided with anchor arms, which constitute a portion of the device which is radially expanded.
- the device is provided with a removal device which dislodges the pivot piece allowing for device contraction and/or easier removal of the device.
- the elastomeric ring is a component of a bi- stable incontinence device.
- the elastomeric ring is not flexible.
- the elastomeric ring is not ring shaped; it is optionally square, rectangular, triangular, ovoid, or u-shaped, for example.
- An aspect of some exemplary embodiments of the invention relates to providing at least one tensile element to an incontinence device for providing radial expanding force, but not compressive force, to the device.
- at least one tensile element extends between an arm of an anchor section and a corresponding arm of a support section of the incontinence device.
- the at least one tensile element is elastic.
- the at least one tensile element is stretched prior to deployment and while being stored in an applicator.
- the at least one tensile element substantially unstretches upon being deployed, setting providing expansion force to the incontinence device as a function of the natural unstretched length of the connector.
- the at least one tensile element helps to resist movement of the support section and/or the anchor section after deployment of the device in the vagina.
- the flexibility of the support section and/or anchor section are adjusted depending on the desired response to the at least one tensile element.
- an aspect of some exemplary embodiments of the invention relates to an incontinence device which scrolls in order to increase and/or decrease its size profile.
- the incontinence device is rolled up around its central axis to reduce the diameter of the device.
- the reduced diameter device is stored in an applicator prior to deployment.
- the scrolling device is provided with a plurality of protrusions for offering support and/or anchoring.
- scrolling sections are provided with a plurality of protrusions for offering support and/or anchoring.
- scrolling sections roll around the central axis of the device to reduce their radial profile.
- the reduced radial profile device is stored in an applicator.
- scrolling sections upon deployment of the incontinence device, scrolling sections unroll to assume a larger diameter to provide support to a patient's urethra.
- support is mid-urethral.
- An aspect of some exemplary embodiments of the invention relates to providing lubrication at least to the external surface of an applicator.
- the applicator is for inserting an incontinence device.
- lubrication is provided by a reservoir ring positioned around the circumference of the applicator.
- the reservoir ring is porous.
- the reservoir ring is hollow.
- lubrication is provided by a layer on the applicator which is revealed when a cover is removed.
- lubrication is provided by a movable sleeve positioned on the applicator and wherein the lubricant is located.
- the applicator is lubricated prior to insertion into the patient's vagina.
- the ring is removed after lubrication but prior to insertion.
- the sleeve is removed after lubrication but prior to insertion.
- an indicator such as a ring
- an indicator is used on the applicator to indicate the proper depth for insertion of the applicator in order to achieve effective device deployment.
- the ring physically stops the applicator at the proper depth for insertion of the applicator in order to achieve effective device deployment.
- An aspect of some exemplary embodiments of the invention relates to providing applicators for extending the shelf life of incontinence devices.
- any radially expandable device is used with the shelf life extending applicators.
- an applicator is provided with a flared section for storage of at least the support section of an incontinence device. The flared section allows the support section to remain at least partially unstressed during storage.
- the applicator contacts a central portion, such as the node, of the incontinence device to deploy it from the applicator.
- the applicator deploys the incontinence device by contacting at least one support arm.
- at least part of the applicator, such as the plunger is used to help place the support arm into a deployed position.
- an apparatus for treating urinary incontinence comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; an insert, a portion of which is adapted to be positioned proximal to the support section; and, wherein the insert selectively provides at least support to the support section of the apparatus.
- the insert is adapted to provide pressure to the support section, causing radial expansion of the support section.
- the support section is flexible.
- the support section is comprised of at least one support arm.
- the insert is an o-ring.
- the insert is flared.
- the urethral support is mid-urethral support.
- the apparatus further comprises a cover.
- the insert is conical.
- the insert is comprised of a plurality of geometrically interlocking elements.
- the insert is comprised of at least a supporting protrusion and a locking protrusion.
- the insert is an invertible membrane.
- the insert is a ringed insert.
- the apparatus further comprises a resilient support member.
- the resilient support member biases at least the support section towards a central axis of the apparatus.
- the resilient support member biases at least the support section away from a central axis of the apparatus.
- the insert is comprised of a plurality of components removably fitted together.
- the insert urges the support section radially outwards from a central axis of the apparatus.
- the insert is provided with an expanded end which provides radial expansion to the anchoring section.
- the apparatus further comprises a cover.
- the cover substantially encapsulates the apparatus.
- at least the support section and the anchoring section are flexible.
- the apparatus is flexible.
- the apparatus further comprises a removal device.
- the urethral support is mid-urethral support.
- the support section is comprised of at least one support arm.
- an apparatus for treating urinary incontinence comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; at least one expander node, provided with at least one expander connected to the apparatus; an elastic member which passes through the at least one expander node; a removable safety catch provided to an expanded end of the elastic member which prevents expanded end from passing through the at least one expander node, and, wherein when the elastic member is substantially unstretched, the at least one expander causes radial expansion of the apparatus.
- the apparatus further comprises a cover.
- the cover substantially encapsulates the node, support section and the anchoring section.
- the apparatus further comprises a removal device provided to the safety catch.
- the urethral support is mid-urethral support.
- the support section is comprised of at least one support arm.
- an apparatus for treating urinary incontinence comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; a first groove; an elastomeric ring positioned on an exterior surface of the apparatus within the first groove; and, wherein the elastomeric ring provides compression force to at least a portion of the apparatus.
- the elastomeric ring applies compression force to the support section to effectuate radial contraction of the support section.
- the apparatus further comprises a second groove located between the first groove and the support section.
- the apparatus further comprises a pivot piece located in a third groove.
- the apparatus further comprises a removal device attached at least to the pivot piece.
- the apparatus further comprises a cover.
- the support and anchoring sections are flexible.
- an apparatus for treating urinary incontinence comprising: a support section adapted for providing urethral support; an anchoring section for resisting movement of the apparatus; and, a tensile element, the tensile element attached to the support section and the anchoring section and adapted to provide radial expansion to the apparatus.
- the tensile element is elastic.
- the apparatus further comprises a first groove associated with the first stable position and a second groove associated with the second stable position.
- the ring is slidable on an exterior of the apparatus from the first groove to the second groove.
- the apparatus further comprises a removal device.
- a removal device is attached to the bi-stable component for changing the second stable position to the first stable position.
- an apparatus for treating urinary incontinence comprising: a support section adapted to render support to a urethra; an insert, the insert comprising a first material which exhibits first material properties and at least a second material which exhibits second material properties; and, wherein the insert selectively expands the support section.
- the first material is flexible.
- the second material is more rigid than the support section.
- an apparatus for treating urinary incontinence comprising: a central node, wherein the central node is a rolled sheet; a plurality of support protrusions located on the node; and, a plurality of anchor protrusions located on the node.
- the central node when rolled has a larger diameter on one end than the other end.
- an apparatus for treating urinary incontinence comprising: a connector; and, a plurality of scrolling sections.
- the connector is flexible.
- the scrolling sections are provided with a plurality of protrusions for rendering urethral support.
- the scrolling sections are provided with a plurality of protrusions for rendering anchoring.
- the plurality of scrolling sections means two sections.
- each of the two sections is located on an opposite end of the connector.
- an apparatus for inserting a vaginal device comprising: an enclosure for containing the vaginal device; and a lubricating element located externally of the enclosure.
- the lubricating element is a ring located around a circumference of the enclosure.
- the lubricating element is a layer of lubricant applied to the enclosure which is revealed when a cover to the layer is removed.
- the lubricating element is a movable sleeve located around a circumference of the enclosure.
- the lubricating element is a layer of lubrication on the enclosure.
- the lubrication is highly viscous such that once lubrication is located on the enclosure it substantially remains in place until use.
- an apparatus for extending the shelf life of a vaginally insertable device comprising: an enclosure adapted for receipt of at least a first portion of the device and vaginal insertion; a section adapted for receipt of at least a second portion of the device such that the second portion is at least partially expanded.
- the section is a flared enclosure.
- the section is provided with a plurality of slots.
- the slots are sized and numbered to accommodate the second portion of the device.
- the apparatus further comprises a slidable sleeve located externally of the enclosure for repositioning the second portion of the device prior to insertion of the device into a vagina.
- an apparatus for motivating a vaginally insertable device comprising: an outer section, adapted for insertion into a vaginal applicator; and, an inner section, capable of insertion into and movement within the outer section.
- the apparatus further comprises a ring, wherein the ring is located on the outer section such that friction is created by ring when there is movement of the apparatus relative to the applicator.
- a collapsible apparatus for inserting a vaginal device comprising: an enclosure for containing the vaginal device; and a plunger adapted to coaxially fit within the enclosure.
- the plunger is substantially located within the enclosure during storage.
- an insert is provided to the vaginal device.
- the insert is attached to a removal/activator device.
- the removal activator device is removably latched to the plunger.
- movement of the plunger out of the enclosure moves the insert at least partially through the vaginal device.
- Fig. IA is a profile view of an incontinence device with a conical insert in accordance with an exemplary embodiment of the invention
- Fig. IB is a profile view of an incontinence device with a conical insert during device removal in accordance with an exemplary embodiment of the invention
- Fig. 2A is a profile view of an incontinence device with a geometric locking insert in an applicator in accordance with an exemplary embodiment of the invention
- Fig. 2B is a profile view of an incontinence device with a geometric locking insert being deployed in accordance with an exemplary embodiment of the invention
- Fig. 2C is a profile view of an incontinence device with a geometric locking insert in a deployed position in accordance with an exemplary embodiment of the invention
- Fig. 2D is a profile view of an incontinence device with a geometric locking insert showing device removal in accordance with an exemplary embodiment of the invention
- Fig. 3 C is a profile view of an incontinence device with a varying geometry insert during removal in accordance with an exemplary embodiment of the invention
- Fig. 4A is a profile view of an incontinence device with an inverting insert located in an applicator in accordance with an exemplary embodiment of the invention
- Fig. 4B is a profile view of an incontinence device with an inverting insert deployed in accordance with an exemplary embodiment of the invention
- Fig. 4C is a profile view of an incontinence device with an inverting insert during removal in an exemplary embodiment of the invention
- Fig. 5 is a profile view of an incontinence device with an integrated resilient support member in accordance with an exemplary embodiment of the invention
- Fig. 7B is a profile view of a scrolling incontinence device with a flared proximal end in accordance with an exemplary embodiment of the invention
- Fig. 7C is a top and/or bottom view of a scrolling incontinence device in accordance with an exemplary embodiment of the invention.
- Fig. 7D is a top view of a scrolling incontinence device in an applicator in accordance with an exemplary embodiment of the invention.
- Fig. 8 is a profile view of a connected, double-sided, scrolling incontinence device in accordance with an exemplary embodiment of the invention
- Fig. 9A is a cross sectional view of an applicator with a lubricating ring in accordance with an exemplary embodiment of the invention
- Fig. 9B is a cross sectional view of an applicator with a removable cover in accordance with an exemplary embodiment of the invention.
- Fig. 1OB is a cross sectional view of an applicator with a lubricating sleeve in accordance with an exemplary embodiment of the invention
- Fig. 1 IA is a cross sectional view of an applicator and a loosely loaded incontinence device in accordance with an exemplary embodiment of the invention
- Fig. HB is a cross sectional view of a flared proximal end applicator loaded with an incontinence device in accordance with an exemplary embodiment of the invention
- Fig. 12C is a cross sectional view of a slotted applicator with a sliding sleeve loaded with an incontinence device in accordance with an exemplary embodiment of the invention
- Fig. 12D is a side view of a slotted applicator with a sliding sleeve wherein a sliding sleeve is in a proximal position in accordance with an exemplary embodiment of the invention
- Fig. 13 is a cross sectional view of a telescoping plunger in accordance with an exemplary embodiment of the invention
- Fig. 14A is a cutaway view of an applicator containing a bi-stable incontinence device within accordance with an exemplary embodiment of the invention
- Fig. 14B is a bi-stable incontinence device in a deployed configuration in accordance with an exemplary embodiment of the invention
- Fig. 15A is a cross-sectional view of an incontinence device with an o-ring insert, in accordance with an exemplary embodiment of the invention
- Fig. 15B is a cross-sectional view of an incontinence device with an o-ring insert being removed, in accordance with an exemplary embodiment of the invention
- Figs. 15C and 15D are top views of exemplary configurations of an o-ring insert, in accordance with an exemplary embodiment of the invention.
- Fig. 16A is a cross-sectional view of an incontinence device with a plurality of components removably fitted together in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 16B is a cross-sectional view of an incontinence device with a plurality of components removably fitted together in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 16C is a cross-sectional view of an incontinence device with a plurality of components removably fitted together in a removal configuration, in accordance with an exemplary embodiment of the invention
- Fig. 16D is a cross-sectional view of an alternative incontinence device with a plurality of components removably fitted together in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 17A is a cross-sectional view of an incontinence device with a plurality of components removably fitted together including an elastic component in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 17B is a cross-sectional view of an incontinence device with a plurality of components removably fitted together including an elastic component in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 17C is a cross-sectional view of an incontinence device with a plurality of components removably fitted together including an elastic component in a removal configuration, in accordance with an exemplary embodiment of the invention
- Fig. 17D is a cross-sectional view of an alternative incontinence device with a plurality of components removably fitted together including an elastic component in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 18A is a cross-sectional view of a deployed incontinence device which uses an interlocking keystone insert, in accordance with an exemplary embodiment of the invention
- Fig. 18B is a cross-sectional view of an incontinence device which uses an interlocking keystone insert being removed, in accordance with an exemplary embodiment of the invention
- Fig. 19A is a cross-sectional view of an elasto-mechanically expanding incontinence device in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 19B is a cross-sectional view of an elasto-mechanically expanding incontinence device in a deployed configuration, in accordance with an exemplary embodiment of the invention.
- Fig. 19C is a cross-sectional view of an elasto-mechanically expanding incontinence device in a removal configuration, in accordance with an exemplary embodiment of the invention.
- Fig. 2OA is a cross-sectional view of an incontinence device provided with an elastomeric ring in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 2OD is a cross-sectional view of an alternative incontinence device provided with an elastomeric ring in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 21A is a cross-sectional view of an incontinence device provided with dimension setting connectors in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 21B is a cross-sectional view of an incontinence device provided with dimension setting connectors in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 22A is a cross-sectional view of an exemplary arm configuration, in accordance with an exemplary embodiment of the invention.
- Fig. 22C is a cross-sectional view of an exemplary arm configuration, in accordance with an exemplary embodiment of the invention
- Fig. 23A is a cross-sectional view of an incontinence device provided with a leaf spring support section, in accordance with an exemplary embodiment of the invention
- Fig. 27A is a profile view of an incontinence device with an expandable insert in a deployed configuration, in accordance with an exemplary embodiment of the invention
- Fig. 27B is a profile view of an incontinence device with an expandable insert in a removal configuration, in accordance with an exemplary embodiment of the invention
- Fig. 28A is a profile view of an incontinence device with a ringed insert in a storage configuration, in accordance with an exemplary embodiment of the invention
- Fig. 28B is a profile view of an incontinence device with a ringed insert in a deployed configuration, in accordance with an exemplary embodiment of the invention.
- Fig. 28C is a perspective view of a ringed insert, in accordance with an exemplary embodiment of the invention.
- support is generated at a mid-urethral location.
- the bottom supporting section 110 provides at least one form of anchoring to help anchor device 100 in position.
- the entire length of device 100 is between 30mm and 50mm. optionally, device 100 is larger or smaller depending on the individual needs of the patient.
- the various sections, parts and/or elements described are optional.
- the functions the various sections, parts and/or elements perform are optional.
- a central section 108, or node is provided which optionally connects anchoring 106 and supporting 110 elements.
- a node which is short relative to the entire length of the device allows for more flexibility in varying the stiffness, the comfort, and the size of device 100.
- the node is not provided with one axis longer than the other, the axes are equal in length (e.g. a sphere or a cube).
- a small node in relation to the overall length of the device allows for greater control over the behavior of the anchoring and support arms, described below. This is because the overall length of the device is somewhat determined by the topography of the vagina. If, for example, the central node was a significant portion of the overall length of the device, then the arms would be short in length and at an angle to the central node close to 90°. This configuration does not have the advantage of being able to take advantage of the flexibility that is possible with longer arms at a lower angle of incidence to the central node.
- a cover 120 is provided to device 100.
- the elements of the device 100 optionally function as an internal support structure for a cover 120.
- the tension of cover 120 is increased by the arms of device 100.
- the anchoring element 106 and the supporting element 110 have four (4) arms each or arm sets 112 and 114, respectively.
- four arms are provided to each section in which two are generally projected towards the bladder, and two are generally projected towards the vaginal floor adjacent the bowels.
- the two support arms which project towards the bladder fit within natural slots on either side of the urethra in some embodiments of the invention.
- the anchoring and supporting elements are provided with more or less arms.
- the anchoring element could have more arms if there is concern about unwanted movement of device 100.
- the arms are provided at varied angles with respect to the node 108 and/or each other.
- arms which is capable of supporting the urethra, in the case of the support section, or preventing the device from unintentionally moving, in the case of the anchor section.
- at least one cone, protrusion, and/or extension attached to the node could be used for anchoring and support.
- the anchoring arms of the device prevent the device from moving unintentionally out of position.
- the anchor element arms 112 resist motion of the device towards the uterus because the arms increase their angle to the node 108.
- anchor element arms 112 are provided with a large angle to the node to enhance this anchoring effect. It should be noted that this enhanced anchoring effect is observed only up until a maximum angle.
- a narrowed node 108 increases the flexibility and the possible ranges of movement for the overall device 100 in some embodiments of the invention.
- devices such as wires and/or springs are embedded in the neck in order to enhance flexibility for device 100. This additional flexibility can enhance the comfort of the woman while wearing the device 100.
- the additional flexibility of device 100 enables more comfortable defecation in comparison to prior art devices. Any of the embodiments described herein are optionally utilized in conjunction with a narrowed node 108.
- the arms are flexible, it should be noted that they are rigid enough to prevent unwanted motion of the device towards the entrance of the vagina.
- the arms are rigid but the node is flexible, the node thus providing flexible anchoring and support. Movement towards the vaginal opening is resisted by the arms which position themselves in the vagina towards the cervix and which, in some exemplary embodiments of the invention are held in place by pressure exerted on them by the vaginal wall, see for example the description of "tenting" below.
- An additional feature of the anchoring arms of the device 100 is that they operate remotely from the support arms. This reduces the amount of pressure applied to the urethra by the device because in some exemplary embodiments of the invention, the support arms do not need to render anchoring functions in addition to support.
- the urethral support is mid-urethral support. Such a configuration increases comfort to the wearer, prevents unnecessary damage to the tissues adjacent to the device, increases the anchoring function of the device, and in some optional embodiments of the invention allows the wearer to void voluntarily without having to remove the device to urinate.
- the arms 112 of the anchoring element 106 force the device 100 to remain in situ within the vagina, unable to substantially move inwards or outwards, or to rotate.
- the arms of the device cause "tenting" of the walls on top of them with resultant sagging of the walls around the node 108, thereby stabilizing the device 100.
- the arms 114 of the supporting element 110 cause relative elevation of the tissues around mid- urethra, acting as a hammock. This hammock supports mid-urethra in a tension free manner, much like the TVT operation.
- the urethra sags down but meets the hammock in its mid part.
- the meeting of the urethra and the hammock causes an elevation of the intra-urethral pressure with resultant urinary continence.
- the radiating support a ⁇ ns 114 of device 100 create an overall device radial diameter of 25mm to 50mm within the vaginal cavity.
- the diameter is larger or smaller depending on the individual needs of the patient.
- the described devices herein can also be used as a treatment for prolapse.
- arms which are expanded to a certain radius for incontinence treatment can optionally expand to a larger radius for prolapse treatment.
- prolapse treating configurations optionally exhibit a diameter of up to 100mm.
- arms are manufactured so that they are biased towards a central axis of device 100.
- storage e.g. storage in an applicator, such as described below
- the arms are optionally placed in an expanded configuration during or after deployment, such as by using the inserts described herein.
- removal of the insert causes the arms to return to the contracted state for easy removal from the user's vagina.
- anchoring and/or support elements e.g. arms
- Inserts are generally used to provide the support arms with additional support against pressure exerted on the support arms by the vaginal wall and/or with radial expansion.
- removable inserts such as those described herein, enable the incontinence devices to render effective incontinence treatment while avoiding some of the storage stresses that would normally come with devices which render such effective treatment.
- the insert is stored in a non-deployed position, the non-deployed position not exerting treatment level pressure on the support arms.
- the inserts and device configurations described in reference to Figs. IA-B, 2A-D, 3A-C, 15A-D, 16A-D, 17A-D, 18A-B, 23A-B, 27 A-B and 28A-C are exemplary only, and that different configurations are optionally used depending on the needs of the patient.
- the insert is optionally shaped to urge the support arms to different radial expansion diameters, as measured from a central axis of the device.
- incontinence device 100 is provided with a conical insert 118.
- Conical insert 118 is designed such that upon insertion into a conical recess 122, located just proximal of node 108, conical insert 118 applies outward radial pressure to support arms 114, thereby causing them to diverge and support the urethra.
- conical insert 118 is inserted into conical recess 122 upon deployment from an applicator, via pressure from a plunger.
- conical insert 118 is prepositioned in conical recess 122 prior to deployment.
- varying sizes of conical insert 118 are used depending on the spread desired from support arms 114.
- conical insert 118 once deployed into conical recess 122 is removably fixed there by friction and/or pressure. Friction is created between the outer surface of conical insert 118 and the surface facing conical insert 118 of conical recess 122. This friction resists movement of conical insert 118 from conical recess 122, especially with the addition of pressure exerted on conical insert 118 by support arms 114. In an exemplary embodiment of the invention, pressure on conical insert 118 by support arms 114 is ultimately derived from pressure on device 100 from the vaginal wall.
- conical insert 118 is constructed from any material capable of urging support arms 114 outward.
- device 100 is positioned beneath the mid-urethra to render support.
- any of the devices described herein render mid-urethral support.
- Conical insert 118 is optionally constructed of the same material as device 100.
- conical insert 118 is constructed of a harder and/or stiffer and/or denser material than device 100 to provide enhanced resistance to the counter-pressure of the vaginal wall.
- a removal device 116 such as a string, is attached to conical insert 118.
- a profile view of incontinence device 100 with conical insert 118 is shown during device 100 removal, in accordance with an exemplary embodiment of the invention.
- application of a downward force, a force away from the cervix dislodges conical insert 118 from conical recess 122.
- the support rendered to support arms 114 is removed by removing conical insert 118, they are more easily able to converge towards central axis 150 facilitating easier and/or more comfortable removal of device 100 than if the arms 114 were fully deployed with conical insert 118 reinforcement.
- conical insert 118 remains within cover 120 upon detachment from conical recess 122.
- a removal device is attached to cover 120 wherein upon a downward force exercised on the removal device causes cover 120 to collapse on support arms 114, forcing them towards central axis 150 and therefore reducing the radial profile of device 100 for easier removal.
- Fig. 2A shows a profile view of an incontinence device 200 with a geometric locking insert 202 in accordance with an exemplary embodiment of the invention.
- Device 200 is slightly different than device 100 in that it is optionally comprised of more than one piece. The addition of at least one additional piece allows for part of the insert to lock with device 200, and for part of the insert to be removable to assist with device 200 removal.
- an external ring 206 of device 200 is capable of mechanically locking into the support arms.
- Device 200 is shown in an applicator 204 which can optionally be used to deploy device 200 in the vagina.
- device 200 is comprised of a plurality of components.
- external ring 206 is provided which is adapted to be locked into a slot 208 located on the inner surfaces of support arms 210.
- a plurality of slots are located on the inner surfaces of support arms 210, external ring 206 being pushed from slot to slot until the desired radial expansion of support arms 210 is achieved.
- an internal insert 212 adapted to geometrically mate with the inner surface of external ring 206 such that internal insert 212 can be inserted through external ring 206.
- more than external ring 206 and internal insert 212 comprise geometric locking insert 202.
- a connecting device 214 is provided which maintains internal insert 212 in close proximity to external ring 206 in a suitable orientation for insertion of internal insert 212 through external ring 206.
- device 200 is stored in applicator 204 in a partially assembled state, such as shown in Fig. 2A.
- maintaining device 200 in a partially assembled state particularly where external ring 206 is not locked into slot 208, the device adapted to better withstand storage stresses while not in use, allowing for longer storage and/or greater efficacy of device 200.
- Deployment of device 200 is illustrated in Fig. 2B where internal insert 212 is urged through external ring 206 by a plunger 216 (depicted in Fig. 2A), in an exemplary embodiment of the invention.
- Fig. 2C illustrates device 200 in a deployed mode according to an exemplary embodiment of the invention.
- external ring 206 is locked into slot 208, which is shaped to mate with a predetermined external ring profile.
- multiple slots are provided which are capable of receiving external ring 206, with each slot defining a different configuration for device 200.
- external ring 206 is shaped to avoid misapplication, for example with grooves to accommodate support arms 210.
- Internal insert 212 is removably positioned within external ring 206.
- internal insert 212 is held in place by frictional forces between external ring 206 and internal insert 212.
- internal insert 212 is held in place by compression forces from support arms 210.
- Fig. 2D is a profile view of device 200 showing removal of device 200, in accordance with an exemplary embodiment of the invention. Removal of device 200 is optionally achieved by pulling on removal device 218 away from the cervix. Optionally, removal device 218 is attached to internal insert 212. Additionally or optionally, removal device 218 is attached to device 200. Sufficient force on removal device 218 in a direction away from the cervix dislodges internal insert 212 from external ring 206, in accordance with an exemplary embodiment of the invention.
- sufficient force is such that it is enough to remove internal insert 212 from its friction fit to external ring 206, accounting for at the very least the pressure rendered to internal insert 212 from the vaginal wall via device 200 and external ring 206.
- support arms 210 are allowed to converge towards the central axis of device 200 enabling easier and/or more comfortable removal of device 200.
- a cover is used in conjunction with device 200.
- the cover may also contribute to converging support arms 210 towards the central axis during removal.
- a removal device is attached to the cover.
- an incontinence device 300 with a varying geometry insert 302 is shown, in accordance with an exemplary embodiment of the invention.
- device 300 is different from device 100 and device 200 in that varying geometry insert 302 traverses the length of the central node of device 300, as opposed to staying essentially within the confines of the support section.
- Varying geometry is provided to insert 302 in order to perform at least three basic functions with respect to device 300.
- the distal protrusion is used to prevent insert 302 from being pulled out of device 300 from the proximal side of device 300, in an exemplary embodiment of the invention.
- a locking protrusion 316 is used to secure insert 302 to device 300 when in a deployed condition, in accordance with an exemplary embodiment of the invention.
- a support protrusion is used to provide support to the support arms of device 300 in accordance with an exemplary embodiment of the invention.
- device 300 is depicted in an applicator 304 adapted for deployment of the device 300 into a vagina to render urethral support.
- urethral support includes mid-urethral support.
- device 300 is used in conjunction with a cover 306.
- a plunger 308 is provided to proximal end of applicator 304 to facilitate deployment of device 300, where proximal end is towards the vaginal opening and distal is towards the cervix.
- proximal end is towards the vaginal opening and distal is towards the cervix.
- only two distinct protrusions are present.
- at the distal end of insert 302 is a distal protrusion 310 located in a recess located at the convergence of the anchoring arms 312.
- distal protrusion 310 is adapted and constructed to resist, optionally prevent, passage of the entire insert 302 away from the cervix through a canal 314 which passes through device 300 and which accommodates insert 302.
- a locking protrusion 316 is optionally located between the distal and proximal ends of insert 302 and is shaped, in accordance with some exemplary embodiments of the invention, to mate with a locking recess 318 located in canal 314.
- a support protrusion 320 is located at the proximal end of insert 302 in an exemplary embodiment of the invention.
- device 300 is a device with multiple stable configurations, such as described below.
- Fig. 3B illustrates incontinence device 300 in an exemplary deployed configuration, wherein insert 302 is advanced through canal 314 such that locking protrusion 316 is removably locked in locking recess 318.
- locking protrusion 316 and/or locking recess 318 are positioned sufficiently away from support protrusion 320 such that when in a removably locked condition, support protrusion 320 is in a position to render reinforcement to support arms 322.
- support protrusion 320 urges support arms 322 radially outwards into a predefined position, optionally depending on the shape of support protrusion 320.
- support arms 322 support the mid-urethra.
- Removal of device 300 is optionally accomplished by unlocking insert 302 from locking recess 318 and dislodging supporting protrusion from its deployed position at the convergence of support arms 322.
- removal of incontinence device 300 is effectuated by pulling on a removal device 324, depicted in Fig. 3C away 326 from the cervix.
- sufficient applied force to removal device 324 causes locking protrusion 316 to become dislodged from locking recess 318, unlocking locking protrusion 316 and permitting movement of insert 302 towards the vaginal opening.
- distal protrusion 310 halts downward motion of insert
- removal device 324 when it reaches the recess marking the convergence of anchoring arms 312 because it is sized larger than canal 314.
- removal device 324 is attached to insert 302 which is not removable from device 300.
- a removal device 324 is attached to cover 306.
- removal is assisted by cover 306 which urges support arms 322 towards the central axis of device 300, allowing for easier and/or more comfortable removal.
- a deployed incontinence device 1500 is shown which is provided with an o-ring shaped insert 1502, examples of which are shown in more detail in Figs. 15C and D, in accordance with an exemplary embodiment of the invention.
- o-ring insert 1502 is removably positioned in at least one groove 1504 located on a surface, shown more clearly in Fig. 15B, of the support arms 1506 located opposite the vaginal wall and adapted to receive o-ring insert 1502 and removably hold insert 1502 there during use of incontinence device 1500.
- incontinence device 1500 While in use, support arms 1506 of incontinence device 1500 are urged radially outwards by o-ring insert 1502 to render support to a urethra.
- the mid-urethra is supported by support arms 1506.
- incontinence device 1500 is provided with a cover 1508, which functions similarly to other covers described herein.
- o-ring insert 1502 is not located in groove 1504 prior to deployment of incontinence device 1500 into a vagina, and is placed there during deployment using, for example, a plunger such as described with respect to other embodiments.
- FIG. 15B shows a cross-sectional view of incontinence device 1500 during removal, in accordance with an exemplary embodiment of the invention.
- a removal device 1510 is used to dislodge o-ring insert 1502 from groove 1504.
- Removal device 1510 is attached to o-ring insert 1502 and is also optionally attached to incontinence device 1500 to enable removal device 1510 to assist with extraction of incontinence device 1500 from the vagina in which it is being used and/or to prevent loose objects from floating around inside the user's body.
- removal device 1510 is secured to incontinence device 1500 by threading a portion of removal device 1510 through the central node of incontinence device.
- an enlarged portion 1512 is used to prevent removal device 1510 from pulling through the central node during removal. Force exerted on removal device 1510 in a direction away from the cervix of the user will result in dislodgment of o-ring insert 1502 from device 1500 and eventually incontinence device 1500 as a whole from vagina, in some exemplary embodiments of the invention.
- an insert 1602 which is at least partially elastic is provided to an incontinence device 1600, such as shown in Fig 16A. Fig.
- FIG. 16A shows incontinence device 1600 in a storage configuration, for example if device 1600 was in an applicator.
- elastic insert component 1604 is stretched such that it is longer than the device 1600, such as shown in Fig. 16A.
- the flared nature of insert 1602 does not significantly cause radial expansion of support 1608 and/or anchor arms 1610 of device 1600, such as shown in Fig. 16B.
- This is primarily due to stretchable nature of elastic insert component 1604 allowing insert 1602 to remain outside the realm of support 1608 and/or anchor arms 1610 of device 1600.
- insert 1602 is comprised of a plurality of component parts, for example elastic insert component 1604 and an addition inner insert component 1606.
- inner insert component 1606 is adapted to removably mate with elastic insert component 1604.
- inner insert component 1606 exhibits different material properties than elastic insert component 1604, for reasons described below.
- an elastic insert component 1604 and an inner insert component 1606 are used in combination to provide radial expansion during deployment to support arms 1608 and anchor arms 1610 of the incontinence device 1600.
- inner insert component 1606 is attached to elastic insert component 1604 with a string, which penetrates the length of elastic insert component 1604 and which is secured to elastic insert component 1604 with an expanded end 1612 at the anchoring side of device 1600.
- expanded end 1612 is a knot formed by knotting and/or melting the string. It should be noted that in some exemplary embodiments of the invention the string has to be long enough to allow the stretching of elastic insert component 1604, which cups inner insert component 1606, to be longer than device 1600.
- incontinence device 1600 is shown in a deployed configuration, in accordance with an exemplary embodiment of the invention.
- the support 1608 and anchor 1610 arms are free to expand radially.
- this freedom of movement is sufficient to allow the stretched insert 1602 to return to its nominal state.
- Insert 1602 unstretches causing a flared anchor end 1614 of elastic insert component 1604 to force anchor arms 1610 radially outwards and flared inner insert component 1606, cupped within elastic insert component 1604, to force support arms 1608 radially outwards as they collapse in towards the center of device 1600.
- inner insert component 1606 is held within elastic insert component 1604 by friction between the two components.
- elastic insert component 1604 is provided wit a slight lip around its opening which helps retain inner insert component 1606 within elastic insert component 1604. In such an embodiment, the lip is not sufficient to withstand removal forces exerted on inner insert component 1606, as described below, thereby releasing inner insert component 1606 and allowing device 1600 removal.
- Fig. 16C shows an exemplary removal configuration of incontinence device 1600, in accordance with an exemplary embodiment of the invention.
- Inner insert component 1606 is optionally dislodged by pulling on a removal device 1616 in order to facilitate device 1600 removal, in some exemplary embodiments of the invention. Dislodgment of inner insert component 1606 reduces the outward radial force exerted on support arms 1608 allowing support arms 1608 to return to a nominal, less expanded state for easier removal.
- support arms 1608 squeeze elastic insert component 1604, causing it to deform, when support arms 1608 return to their nominal state.
- device 1600 is provided with a cover 1618.
- incontinence device 1600 is provided with a jointed central node.
- the interface at the joint is like a ball joint.
- the jointed nature of the central node results in an anchor section 1620 and a support section 1622 of device 1600 being able to move somewhat independently as a result of stresses being applied to them by movement of the wearer.
- support section 1622 and anchor section 1620 are held in a friction causing relationship by elastic insert component 1604.
- the insert is comprised of more than one material.
- the insert is comprised of more than one material.
- the insert is made of a first material which is at least partially flexible and/or a second material which is rigid enough to expand the support section of the incontinence device when in the proper position to do so.
- the insert is at least more rigid than the support section of the incontinence device.
- the first material is used for the elastic insert component 1604 and/or the second material is used for the inner insert component 1606.
- a more rigid material is optionally used for elastic insert component 1604 if upon removal of inner insert component 1606 it is desired that the support section still remains at least partially expanded.
- a less rigid material is used for inner insert component 1606 if it is desirable to increase the comfort to the wearer and/or reduce the degree of radial expansion of the device.
- an incontinence device 1700 which also has an insert 1702 which is essentially a plurality of components removably fitted together.
- a difference between the incontinence device 1700 depicted in Fig. 17 and the incontinence device 1600 depicted in Fig. 16 is the anchor end 1704 of insert 1702 is not flared to cause radial expansion of the anchor arms 1706.
- anchor end 1704 of insert 1702 because anchor end 1704 of insert 1702 is not flared, it does not have to be outside of anchor arms 1706 during storage, which is reflected in the embodiment depicted in Fig. 17 A. It can be seen that in storage, anchor end 1704 of insert 1702 does not exert radial expansion force on anchor arms 1706.
- Fig. 17B shows incontinence device 1700 during deployment and Fig. 17C shows device 1700 during removal.
- Device 1700 is optionally provided with a cover 1714.
- anchor arms 1706 are not radially expanded
- storage stress on insert 1702 is reduced in relation to the embodiment depicted in Figs. 16A-D because insert 1702 does not need to be stretched as far for the same sized device when in storage.
- only one side of insert 1702 needs to unstretch in order to cause radial expansion as opposed to two sides of insert 1602 (anchor and support) as shown in Figs. 16A-D, avoiding a two stage deployment (first the anchor arms as they become free of applicator, then support arms) of device 1700.
- FIG. 17D An alternate embodiment of incontinence device 1700 in which the support arms 1708 are configured to accommodate the elastic insert component 1710 cupping the inner insert component 1712 without them having to be outside support arms 1708 during storage, is shown in Fig. 17D. In some exemplary embodiments of the invention, this allows a shorter string connecting inner insert component 1712 to elastic insert component 1710, and also allows for a shorter elastic insert component 1710.
- Fig. 18A an incontinence device 1800 is shown which is provided with an insert seat 1802 adapted to removably receive an insert 1804, in accordance with an exemplary embodiment of the invention.
- insert seat 1802 connects an anchoring section 1806 and a support section 1808 of incontinence device 1800 together.
- insert 1804 is flared to provide radial expansion to insert seat 1802 and/or support section 1808 when insert 1804 is fitted into insert seat 1802.
- An integrated resilient support member 1820 is shown in use with incontinence device 1800. It can be seen from Fig. 18B that in some exemplary embodiments of the invention, integrated resilient support member 1820 is adapted to cause radial expansion of support section 1808 when insert 1804 is fitted into insert seat 1802. The flared sides of insert 1804 exert pressure on the exposed ends of integrated resilient support member 1820 forcing it radially outwards, and thus support section 1808 and/or a support arm 1816 radially outwards.
- the slope of the flared ends, and optionally their length determines the quantity of this effect.
- Fig. 18A shows incontinence device 1800 in a deployed configuration
- insert 1804 is optionally not fitted to insert seat 1802 while in storage.
- insert 1804 is pushed into a position fitted to insert seat 1804 by a plunger, such as described elsewhere herein, during deployment from an applicator.
- Fig. 18B shows incontinence device 1800 in a removal configuration, in accordance with an exemplary embodiment of the invention.
- incontinence device 1800 is provided with a removal device 1812.
- Sufficient force applied on removal device 1812 pulling away from the user's cervix causes insert 1804 to dislodge from insert seat 1802, thereby removing the source of increased radial expansion of support section 1808 and easing the removal of device 1800.
- pulling on removal device 1812 causes a collapse of at least support section 1808 and/or seat 1802 of device.
- seat 1802 is predisposed to collapse inwards towards a central axis of device 1800.
- device 1800 is provided with a cover 1810, 1822.
- an incontinence device 2300 is shown which is provided with a resilient, biased support section in accordance with an exemplary embodiment of the invention.
- Device 2300 is comprised of at least an anchoring section 2302, a support section 2304 and an insert 2306, in an embodiment of the invention.
- device 2300 includes a central node, providing an intersection and/or bridging structure between anchoring section 2302 and support section 2304.
- support section 2304 is comprised of a plurality of arms 2310, two of which are shown in Figs. 23 A-B.
- anchoring section 2302 is formed of a biocompatible material and operates similar to other anchoring sections described herein. Anchoring section 2302 is attached to support section 2304, for example using a tucker 2308 as shown in Fig. 23A.
- support section 2304 is formed such that it maintains a nominal compressed configuration (which is biased towards a central axis of device 2300), but is flexible enough to be placed into an expanded configuration by insert 2306 (as shown in Fig. 23B).
- support section 2304 applies a modicum of support when in the compressed configuration.
- support section 2304 is a leaf spring which is biased towards a central axis of device 2300.
- support section 2304 is formed with an integrated resilient support member, such as shown in Fig. 5.
- support section 2304 is comprised of metal.
- support section 2304 is comprised of plastic.
- the ends of arms 2310 are capped with a biocompatible material in order to provide enhanced comfort to the user.
- the material capping arms 2310 is flexible, such as rubber or plastic.
- insert 2306 is capable of use with a device 2300 with only two support section 2304 arms 2310.
- insert 2306 is forced upwards towards tucker 2308 with a plunger (not shown). Continued pressure using the plunger in this direction causes device 2300 to eventually deploy out of an applicator (not shown), assuming the deployed position depicted in Fig. 23B.
- Fig. 23B shows insert 2306 within support section 2304 which is flexed at flex points 2312 during the positioning of insert 2306 therein. Reconfiguration of support section 2304 to render support is a result of the positioning of insert 2306 within in an exemplary embodiment of the invention.
- insert 2306 is maintained within support section 2304 by the compressive force applied to it by the biased support section 2304.
- removal of device 2300 is via downward force on removal device 2314 away from cervix and towards the vaginal opening.
- Insert 2306 is dislodged from support section 2304 by this force on removal device 2314 allowing arms 2310 to contract to the compressed configuration and permitting comfortable removal of device 2300.
- device 2300 is provided with a cover 2316 similar to those described elsewhere herein.
- an incontinence device 2700 is depicted with an expandable insert 2702, in accordance with an exemplary embodiment of the invention.
- Device 2700 is shown deployed, for example as it would be in a user's vagina.
- An insert head 2706 is expanded by an insert expander 2704 in a deployed configuration and in a removal configuration insert head 2706 is contracted, or contracts of its own volition, by the removal of insert expander 2704, in accordance with an exemplary embodiment of the invention.
- insert expander 2704 is positioned within a slot in insert head 2706.
- insert head 2706 is expanded by insert expander 2704, causing insert head 2706 to exert pressure on support arms 2708 of device 2700.
- insert head 2706 the pressure exerted by insert head 2706, as a result of insert expander 2704, causes radial expansion of support arms 2708 and subsequently treatment for incontinence.
- insert expander 2704 is not positioned in insert head 2706 during storage.
- insert head 2706 is flexible.
- expandable insert 2702 has an expanded portion which prevents expandable insert 2702 from being pulled through device 2700 during removal, as shown in Fig. 27B.
- Fig. 27B shows incontinence device 2700 in a removal configuration, in accordance with an exemplary embodiment of the invention. Removal is initiated by pulling on removal device 2710 which dislodges insert expander 2704 from insert head 2706, in some exemplary embodiments of the invention. Upon the dislodgment of insert expander 2704 from insert head 2706, insert head 2706 substantially releases the force exerted on support arms 2708, allowing them to contract, or at the minimum making them less resistant to collapsing towards a cerntral axis of device 2700, for easier and more comfortable removal of device 2700.
- device 2700 is used with a cover 2712 which is provided with an opening which is sized such that removal device 2710 can pass, but not insert expander 2704, due to the larger size of insert expander 2704.
- a cover 2712 which is provided with an opening which is sized such that removal device 2710 can pass, but not insert expander 2704, due to the larger size of insert expander 2704.
- an incontinence device 2800 with a ringed insert 2802 is shown in a storage configuration, in accordance with an exemplary embodiment of the invention.
- An exemplary ringed insert 2802 can be seen in perspective in Fig. 28C.
- Support arms 2806 of the device pass through openings 2850 between the ring and the central portion of ringed insert 2802, in accordance with an exemplary embodiment of the invention.
- ringed insert 2802 is not positioned within device 2800 while device 2800 is in storage, extending life and improving performance.
- a removal/activator device 2812 is fastened to a removal/activation plate 2814 . located distally from a central portion of device 2800.
- deployment of device 2800 is commenced by pulling down on removal/activator device 2812, causing device 2800 to move towards the proximal end of the applicator 2808, and affecting a pulling of the ringed insert 2802 into incontinence device 2800.
- activation ledges 2816 are provided to applicator 2808 to provide a counter-force to the pulling of device 2800 onto insert 2802.
- plunger 2804 is used to force insert 2802 into device 2800 to apply radial expansion force to the support arms 2806, which will assume their deployed configuration upon device 2800 ejection from applicator 2808. Deployment out of applicator 2808 and into vagina is performed as described with respect to other embodiments herein.
- ringed insert 2802 is positioned through device 2800 such that an insert head 2810 is located at the distal side of device 2800.
- insert head 2810 is shaped, for example like an arrow-head, to allow its passage through device 2800 during deployment, but to prevent passage of insert 2802 back through device 2800, to the original configuration, thereafter.
- ringed insert 2802 applies force to support arms 2806 causing them to expand radially outwards.
- device 2800 is provided with removal/activator device 2812, which, in addition to activating the incontinence device 2800, can be used like other removal devices described herein.
- device 2800 is provided with a cover.
- incontinence devices are provided with multiple stable configurations for treating incontinence.
- a bi-stable component is used to provide incontinence devices with a first stable position, for storage and/or removal, and a second stable position, for rendering incontinence treatment.
- the bi-stable component is sometimes referred to as an insert, a locking element and/or an elastomeric ring.
- Figs. 4A-C and 14A-B show exemplary embodiments of bi-stable inserts used with incontinence devices which do not substantially move in relation to the incontinence device in order to transfer from the first stable position to the second.
- FIGS. 20A- C show an exemplary embodiment of a bi-stable device where the bi-stable component moves in relation to the incontinence device when transferring from the first stable position to the second stable position.
- deployment of the bi-stable devices occurs after the devices are properly positioned within the vagina, "popping" into their second stable position when the bi-stable insert is switched to the second position.
- popping deployment is more comfortable than other forms of deployment described herein because the support arms do not exert pressure against the vaginal wall until the incontinence device is already in a position to render incontinence treatment.
- Fig. 4A is a profile view of an incontinence device 400 with an inverting, bi-stable insert 402 located in an applicator 406 in accordance with an exemplary embodiment of the invention.
- Inverting insert 402 resembles a flexible bowl-shaped membrane, in an exemplary embodiment of the invention.
- Insert 402 is constructed such that when membrane is biased towards the proximal end of device 400 in a first configuration, insert 402 membrane is flaccid. However, when the membrane is pushed through the center of insert 402 towards the distal end of device 400, the insert 402 membrane exerts radially expanding pressure on the support arms 404 of device 400 and the arms 404 "pop" into position.
- insert 402 membrane has variable wall width, and therefore, different tension at every point.
- insert 402 is located between support arms 404 of device 400.
- insert membrane 402 is pushed through its own center, thereby deploying device 400 into a second configuration, by a plunger 408 located at the proximal end of applicator 406.
- Fig. 4B is a profile view of incontinence device 400 with an inverting insert 402 deployed, in accordance with an exemplary embodiment of the invention. It can be seen in this exemplary embodiment that during deployment plunger 408 pushed insert 402 membrane through its center, biasing it towards the distal end of device 400. As described herein, the membrane is constructed so that when it is biased towards the proximal end of device 400 it is flaccid, and when it is biased towards the distal end of device 400 it is sufficiently rigid to apply radial pressure to support arms 404 causing them to increase their diameter for urethral support. Optionally, the urethral support is mid-urethral.
- FIG. 4C shows a profile view of incontinence device 400 with an optional removal device 410, such as a string.
- Force on removal device 410 in a proximal direction, away from the cervix, causes insert 402 membrane to re-invert transforming membrane from at least semi-rigid to flaccid.
- the reduced radial pressure exerted by insert 402 membrane facilitates the movement of support arms 404 towards the central axis of device 400 for easier removal.
- continued force on removal device 410 pulls support arms 404 towards the central axis of device 400 and towards the vaginal opening.
- removal device 410 is fastened to a cover 412 which, when downward force is applied to removal device 410, exerts pressure on support arms 404 towards the central axis of device 400 for easier removal.
- the embodiment depicted in Figs. 4A-C is optionally used with an integrated resilient support, as described below with respect to Fig. 5.
- Fig. 14A a cutaway view of an applicator 1402 is shown, depicting a bistable incontinence device 1400 therein, in accordance with an exemplary embodiment of the invention.
- the bi-stable insert of Figs. 14A-B is different from that of Figs.
- bi-stable incontinence device 1400 is configured in a reduced diameter form for storage within applicator 1402.
- Applicator 1402 is, optionally, similar to any of the applicators described herein and in related applications, known to those skilled in the art or not yet invented.
- bi-stable incontinence device 1400 is provided with a bi-stable locking element 1408 which is attached to a support arm reinforcing element 1406.
- Bi-stable locking element 1408 is optionally configured such that in a first stable position, wherein the bi-stable locking element 1408 is biased towards support arms 1404 of device 1400, bi-stable locking element 1408 does not substantially urge support arm reinforcing element 1406 radially outwards. However, in a second stable position, wherein bi-stable locking element 1408 is biased towards the anchoring arms 1420, shown in fig. 14B, of device 1400, bi-stable locking element 1408 applies force to support arm reinforcing element 1406 causing support arms 1404 to urge radially outwards from a central axis of incontinence device 1400.
- a plurality of reinforcing arms are attached to the support arms 1404 of incontinence device 1400 such that when bi-stable locking element 1408 is in the second stable position reinforcing arms urge support arms 1404 radially outward from a central axis of device 1400.
- each support arm 1404 is provided with a reinforcing arm.
- selected support arms 1404 are supplied with reinforcing arms, for example if forced deployment of support arms 1404 is only desired along a single axis.
- support arm reinforcing element 1406 has a central portion with a male locking cylinder 1416.
- bi-stable locking element 1408 is provided with a central female locking cylinder receiver, which allows for bistable locking element 1408 to be removably fastened to support arm reinforcing element 1406. Removably fastening bi-stable locking element to support arm reinforcing element counters pressure from the vaginal wall which acts to force device 1400 into the first stable position.
- locking cylinder 1416 is provided with a lip which is sized slightly larger than an inner circumference of the locking cylinder receiver, which is optionally a hole located on bistable locking element, such then when locking cylinder 1416 is urged against locking cylinder 1416 with sufficient force the receiver passes over the lip and becomes removably fastened to support arm reinforcing element 1406.
- bi-stable locking element 1408 is biased such that when urged towards support arm reinforcing element 1406, bi-stable locking element 1408 removably locks into a reinforcing position without the need for lockably mating locking cylinder 1416 with locking cylinder receiver.
- bi-stable locking element 1408 is urged towards support arm reinforcing element 1406 by a plunger 1410.
- the anchoring force provided by anchoring arms 1420 is more than the force required to switch support arm reinforcing element 1406 from the first stable position to the second stable position such that upon the insertion of device 1400 into the vagina, when anchoring arms 1420 are in position, they prevent device 1400 from moving towards the cervix as pressure to "pop" into the second stable position is exerted on support arm reinforcing element 1406 by plunger.
- incontinence device 1400 is provided with a removal device 1412 which is attached to bi-stable locking element 1408 such that it can change the position of bi-stable locking element 1408 from the second stable position to the first stable position.
- bi-stable incontinence device 1400 is shown deployed in the second stable position, in accordance with an exemplary embodiment of the invention. It can be seen that bi-stable locking element 1408 is urged against support arm reinforcing element 1406, urging the reinforcing arms radially outwards, and hence support arms 1404 radially outwards from a central axis of device 1400. hi an exemplary embodiment of the invention, support arms 1404 provide support to a urethra. Optionally, the support is mid-urethral support.
- device 1400 is used in conjunction with a cover 1418, such as those described herein.
- Removal of device 1400 is optionally facilitated by exerting a downward force on removal device 1412 towards a vaginal opening.
- This downward force causes bi-stable locking element 1408 to change from the second stable position to the first stable position, removing reinforcement from support arms 1404 and allowing them to converge on a central axis of device 1400.
- the reduction in radial diameter of device 1400 due to this convergence enables an easier and/or more comfortable removal than if support arms 1404 had remained deployed.
- bi-stable locking element 1408 is provided with reinforcing arms and the central portion of support arm reinforcing element 1406 is omitted.
- an elastomeric ring 2002 is used to provide an incontinence device 2000 with radial expansion and/or contraction, depending on whether ring 2002 is in the first stable position or the second stable position.
- radial expansion and/or contraction is caused by material properties and/or configuration of an incontinence device and a ring is selectively positioned to prevent specific configurations from manifesting themselves. Referring to Fig. 20A 5 incontinence device 2000 is shown in a first stable position, or a storage configuration, in accordance with an exemplary embodiment of the invention.
- Elastomeric ring 2002 is initially located in a first groove 2004, situated between an anchor section 2006 of incontinence device 2000 and a second groove 2008 in some exemplary embodiments of the invention, is used to help maintain device 2000 in a storage configuration.
- first groove 2004 is situated on body of device 2000 where when elastomeric ring 2002 applies pressure to device 2000 from first groove 2004 support 2010 and anchor 2012 arms are not urged radially outwards.
- elastomeric ring 2002 is comprised of latex, rubber, silicone, polyurethane or nylon.
- elastomeric ring 2002 is constructed of any at least slightly elastic material.
- the elastomeric ring is not elastic and/or flexible.
- elasticity and/or flexibility aid elastomeric ring 2002 in moving from first groove 2004 to second groove 2008 and/or remaining in the grooves 2004, 2008.
- ring 2002 uses its elastic ability, like a rubber band, to apply pressure to device 2000 while ring 2002 is in a groove, thereby helping to retain ring 2002 in the groove and also in the case of first groove 2004 holding device in a storage configuration and in the case of second groove 2008 helping the radial expansion of support 2010 and anchor 2012 arms.
- the elastomeric ring is not ring shaped, it is optionally square, rectangular, triangular, ovoid, or u-shaped, for example.
- Deployment of incontinence device 2000 transitions elastomeric ring 2002 from a first stable position where ring 2002 is located in a first groove 2004 to a second stable position, where ring 2002 is located in a second groove 2008, in accordance with some exemplary embodiments of the invention.
- elastomeric ring 2002 hits a transition element 2018 located on the interior surface of applicator 2014.
- Device 2000 is subjected to sustained pressure for deployment, urging device 2000 out of applicator 2014, while elastomeric ring 2002 is pushed by transition element 2018 down the exterior surface of device 2000 until it settles into second groove 2008.
- second groove 2008 is adapted to prevent further movement of elastomeric ring 2002 as a result of transition element 2018, and further pressure on device 2000 deploys device 2000 into position, optionally in the user's vagina.
- first groove 2004 and/or second groove 2008 are adapted to allow movement of ring 2002 out of first groove 2004 as a result of encountering transition element 2018 but to prevent movement of ring 2002 out of second groove 2008.
- second groove 2008 is deeper than first groove 2004 in some exemplary embodiments of the invention.
- Fig. 2OB shows incontinence device 2000 in the second stable position, or in a deployment configuration, where elastomeric ring 2002 is located in second groove 2008, in accordance with an exemplary embodiment of the invention.
- anchor arms 2012 are urged radially outwards in part because of the compressive force exerted by elastomeric ring 2002 at its second groove 2008 position towards a central axis of device 2000 and because of a pivot point 2020 created by the curvature of device 2000 at first groove 2004 location.
- the pivot point is created by the meeting of the two points on at least two of the anchor arms which are the lowest in the curvature of first groove 2004.
- the support arms 2010 do not derive the benefit of a curved groove, like first groove 2004, therefore a pivot point is provided by positioning a pivot piece 2022 between elastomeric ring 2002 and support arms 2010.
- pivot piece 2022 is a ball.
- pivot piece 2022 is situated in a third groove 2024 adapted to receive pivot piece 2022 and prevent it from falling out prior to ' removal. As above, the pressure exerted by elastomeric ring 2002 and pivot piece 2022 causes support arms 2010 to expand radially.
- the pressure exerted on device 2000 by elastomeric ring 2002 is varied depending on the length of the lever between ring 2002 and a pivot point (pivot point 2020 and/or pivot piece 2022) and/or the effect desired to be achieved on device 2000. Additionally or alternatively, the flexibility of the material from which device 2000 is constructed is also taken into consideration.
- incontinence device 2000 is shown in a removal configuration, in accordance with an exemplary embodiment of the invention.
- the radial profile of at least a portion of incontinence device 2000 is reduced to ease removal of device 2000, in some exemplary embodiments of the invention.
- reduction of the radial profile is accomplished by dislodging pivot piece 2022 using a removal device 2026 attached to pivot piece 2022.
- force applied on removal device 2026 away from cervix and towards the direction of the user's vaginal opening causes pivot piece 2022 to dislodge from third groove 2024.
- pivot piece 2022 removes a part of the mechanism from which support arms 2010 were deriving radial expansion, allowing support arms 2010 to return to a reduced radial profile configuration.
- Sustained force on removal device 2026 away from the cervix eventually removes device 2000 from the user's vagina.
- Removal device 2026 is optionally secured to incontinence device 2000 by threading it through the central node of device 2000 and provided an enlarged end 2028 to prevent removal device 2026 from being pulled out of device during removal.
- device 2000 is provided with a cover 2030.
- the device depicted in Fig. 2OD shows another exemplary embodiment of an incontinence device 2050 which uses an elastomeric ring 2052 to selectively apply pressure to device 2050.
- Incontinence device 2050 depicted in Fig. 2OD is similar to many of the other embodiments described herein, which use an insert 2054 to radially expand support arms 2056 and/or to provide support to support arms 2056 against the counter-pressure exerted by the vaginal wall, and in this embodiment elastomeric ring 2052, when device 2050 is deployed.
- Optional insert configurations which could be used with any of the embodiments described herein are depicted in Figs. 20F-I.
- the hollow passage traversing the center of the inserts is to allow the passage of a removal device.
- the inserts are configured to achieve various radial expansion effects on the support arms of the incontinence device.
- the inserts are configured to be removably attached to the incontinence device.
- elastomeric ring 2052 acts in concert with the removal of insert 2054 to force radial contraction of support arms 2056 in order to ease removal of device 2050.
- force applied to a removal device 2058 as shown in fig. 2OE, dislodges insert 2054.
- An Exemplary Integrated Resilient Support Member Embodiment Fig. 5 is a profile view of an incontinence device 500 with an integrated resilient support member 502, in accordance with an exemplary embodiment of the invention.
- device 500 is any of the devices described herein.
- resilient support member 502 is used to bias the support arms 504 of device 500.
- support arms 504 are biased in an expanded radial configuration.
- support arms 504 are biased in a compact radial configuration.
- integrated support member 502 is embedded within device 500.
- integrated support member 502 is located externally of the device 500, like an exoskeleton.
- integrated support member 502 is used in conjunction with the support arms 504 of device 500.
- Integrated support member 502 is optionally constructed of a material with an enduring shape memory (such as stainless steel or polymers, such as nylon or silicone based materials).
- a shape memory integrated support member 502 imparts to device 500 an extended shelf life since compressed in the applicator for an extended time will not substantially diminish the integrated support member's 502 spring coefficient.
- Integrated support member 502 is designed such that when device 500 is deployed from an applicator, integrated support member 502 forces support arms 504 to deploy radially outwards from the central axis of device 500 for urethral support.
- an integrated support member is used with the anchor arms 508.
- Removal of device 500 is assisted by attaching a removal device 506 to support arms 504. Downward force on removal device 506 away from the cervix causes support arms 504 to converge on the central axis of device 500 enabling easier and/or more comfortable removal.
- removal device 506 and integrated support member 502 are constructed of the same material.
- removal device 506 and integrated support member 502 are manufactured simultaneously.
- integrated support members are used which bias support and/or anchor arms towards the central axis of device 500 instead of away from the central axis. Such a configuration is optionally used to provide better arm convergence for easier incontinence device removal.
- a profile view of an incontinence device 600 provided with tension reducing support and/or anchor a ⁇ ns 602 is shown, in accordance with an exemplary embodiment of the invention.
- Reduction in tension in support and/or anchor arms 602 extends the shelf life of device 600.
- the area of an incontinence device which undergoes the most stress and/or tension, the joint between the support and/or anchor arms and the node is reconfigured to distribute that stress and/or tension.
- the stress and/or tension are reduced by spreading it out of a greater area of the device.
- tension is optionally reduced on support and/or anchor arms 602 by providing them with an accordion-like section 604 which folds in on itself when compressed within an applicator.
- folding is accomplished without the use of hinges and/or other mechanical means.
- other devices such as described herein are provided with tension reducing arms such as shown in Fig. 6.
- support and/or anchor arms 602 deploy themselves to expand radially from the central axis of device 500.
- arms 602 deploy to render mid-urethral support.
- device 600 is used in conjunction with a cover, such as those described herein.
- anchor arms 706 located at the distal end of devices 700, 720 are variable in length depending on the requirements of the patient.
- support and/or anchor arms are sufficiently long to prevent vaginal tissue from becoming caught in the crease between the two ends of central member 702.
- the support and/or anchor arms are up to 10 mm in length.
- the arms are longer than lOmms.
- the arms are less than 5mm in length.
- support is rendered to the mid-urethra.
- security catch 1918 is tied in a looseable knot, which comes undone upon the application of sufficient force away from the cervix.
- security catch 1918 is comprised of a breakaway portion which causes catch 1918 to become unfastened to support section enlarged end 1916 when sufficient force is applied to catch 1918 by removal device 1920.
- a cover 1924 is provided to incontinence device 1900.
- removal device 1920 is affixed to cover 1924 to aid in removal of device 1900. In such an embodiment, sustained force on removal device 1920 applied away from the user's cervix subsequently causes the reduced profile device 1900 to be pulled out of the user's vagina along with cover 1924.
- anchor section 2104 is not expected to display much radial expansion, it would be suitable to decrease the flexibility of anchor section 2104 so it would not respond to at least one tensile element 2102 as it would have if it were more flexible. It should be understood that at least one tensile element 2102 can be used in conjunction with any of the incontinence devices described herein in order to assist with incontinence device deployment.
- lubrication is provided to the applicator used for inserting a device into the vagina. Lubrication of the applicator eases its insertion and/or removal from the vagina and/or enhances the comfort to the user.
- lubricating ring 902 is provided to lubricate the external surface of applicator 900.
- ring 902 is slidable over the length of applicator in order to provide lubrication at least over the area to be inserted into the vagina.
- lubrication is directed towards at least the distal end of the applicator near the exit.
- ring 902 is hollow. Materials located within ring 902 are optionally squeezed out from ring 902 via a plurality of small holes (not shown) located on ring 902.
- Ring 902 moves along applicator 900, the material is deposited on applicator 900 in accordance with the speed of movement of ring 902, pressure on ring 902, amount of material within ring 902 and/or other variables.
- Ring 902 is optionally removed from applicator 900 before applicator 900 is used to deploy a device.
- ring 902 remains on applicator 900 during device deployment and then is disposed of, along with applicator 900.
- a lubricating applicator 2400 is shown in accordance with an exemplary embodiment of the invention.
- Applicator 2400 operates in a similar fashion to deploy an incontinence device 2408 as other applicators described herein, by applying pressure on a plunger 2404 to expel device 2408 from an enclosure 2402 and into a vagina, in an embodiment of the invention.
- a lubricating layer 2406 is applied to applicator 2400, optionally towards a proximal end 2410 of applicator to ease insertion of applicator 2400 into a user's vagina.
- lubricating layer 2406 is comprised of a lubricant which is highly viscous.
- the highly viscous lubricant is applied at the proximal end of applicator 2400 at the time of manufacture and remains in place during storage. At the time of use, the viscous lubricating layer 2406 eases insertion of applicator 2400 into the user's vagina.
- the lubricating layer 2406 is comprised of silicone oil.
- the lubricating layer 2406 is comprised of glycerin.
- the lubricating layer 2406 is comprised of a petroleum jelly.
- lubricating layer 2406 is comprised of a viscous, water based material.
- viscous lubricating layer 2406 is applied to any of the applicators described herein.
- FIGs. HA-B, 12A-D and 25 A-C depict exemplary embodiments which allow for at least a portion of the device .to remain in a substantially uncompressed condition during storage. It is believed that reduction of the storage stresses on at least a portion of the device enhances performance and/or shelf life of the device.
- Fig. 1 IA a cross sectional view of an applicator 1100 and a loosely loaded incontinence device 1102 is shown, in accordance with an exemplary embodiment of the invention.
- incontinence device 1102 is any of those described herein or radially expandable and known in the art.
- storage of an at least partially elastic device in a compressed state reduces the efficacy of the device somewhat.
- an incontinence device such as some of those described herein, is only loosely loaded into applicator 1100 in order to avoid degradation of incontinence device 1102 as a result of compression during storage within applicator 1100.
- loosely loaded comprises loading only an anchor section 1104 of incontinence device 1102 into applicator 1100, while support section 1106 and optionally central node 1108 remain outside of applicator 1100.
- a loading device 1110 is provided which is connected to incontinence device 1102 and which extends through the applicator 1100 and out via an exit 1112 located at a distal end of applicator 1100.
- loading device 1110 is removably connected to incontinence device 1102 so that after loading device 1102 into applicator 1100, loading device 1110 is removed from applicator 1100.
- loading device 1110 is string-like and is looped around incontinence device 1102 such that the two ends of the string are accessible at exit 1112, as depicted in Fig. 1 IA.
- a plunger (not shown) is applied to the proximal end of applicator 1100 (where incontinence device 1102 was loaded) in order to deploy incontinence device 1102 into a patient's vagina.
- the plunger is provided separately from applicator 1150, shown in Fig. HB, and is used only when deployment of incontinence device 1102 is desired.
- Fig. 1 IB shows a cross sectional view of a flared proximal end applicator 1150 which is loaded with an incontinence device 1102, in accordance with an exemplary embodiment of the invention.
- Applicator 1150 is provided with a flared section 1152 towards its proximal end.
- incontinence device 1102 is only partially loaded into a narrow portion of applicator 1150, whereas the remainder of incontinence device 1102 is positioned within flared section 1152.
- flared section 1152 is sized to allow full expansion of the support section 1106 of incontinence device 1102.
- flared section 1152 is provided with flared segments in number and size to accommodate each arm of support section 1106.
- flared section is at least partially conical shaped, and not provided with specific flared segments, but a generally flared, conical shape for accommodation of device 1102 irrespective of rotational orientation.
- Deployment of incontinence device 1102 is accomplished by using a plunger 1154 to urge incontinence device 1102 towards an exit 1156 located at the distal end of applicator 1150.
- plunger 1154 is provided with a shaped head 1158 in order to stimulate convergence of support section 1106 towards the central axis of device 1102.
- plunger 1154 is provided separately from applicator 1150, and is used only when deployment of incontinence device 1102 is desired.
- flared section 1152 begins its flare at the proper place on the applicator to indicate correct insertion depth.
- applicator 1150 is substantially open on the proximal end (not substantially closed as shown in Fig. 1 IB).
- the open proximal end is provided with a lip, which corresponds to a lip on plunger 1154, designed to prevent plunger 1154 from dislocating from applicator 1150.
- Fig. 12C is a cross sectional view of slotted applicator 1200 with sliding sleeve 1202 loaded with incontinence device 1206, in accordance with an exemplary embodiment of the invention. From this perspective, it can be seen that incontinence device 1206, while within applicator 1200, is partially located outside of applicator 1200 and avoids compression on the support arms 1208 during storage.
- sliding sleeve 1202 is provided with a reservoir 1210, from which substances may be deposited onto surface of applicator 1200.
- reservoir 1210 is provided with a plurality of openings between itself and applicator 1200 to deposit substances stored within onto surface of applicator 1200.
- a lubricant is a substance which is stored in reservoir 1210.
- a pharmaceutical is a substance stored within reservoir 1210.
- Substances in reservoir 1210 are optionally deposited on applicator 1200 by moving sliding sleeve 1202 up and/or down the length of applicator's 1200 surface.
- lubricant is deposited on applicator 1200 from reservoir 1210 prior to insertion of applicator 1200 in a vagina, in order to ease insertion of applicator 1200 into vagina and the deployment of incontinence device 1206 stored within. Referring to Fig.
- sliding sleeve 1202 Prior to incontinence device 1206 deployment, sliding sleeve 1202 is slid along applicator 1200 to its proximal end (closest to the vaginal opening when inserted in the vagina) where sliding sleeve 1202 becomes locked into deployment position. The motion of sliding 1202 sleeve pushes arms 1208 into slots 1204 readying them for deployment.
- sliding sleeve 1202 Once sliding sleeve 1202 reaches deployment position, it is held in place by a dent 1212 to prevent it from sliding back to the distal end 1214 of applicator 1200.
- arms 1208 When sliding sleeve 1202 is in deployment position, arms 1208 are forcefully converged towards the central axis of incontinence device 1206 such that the device is deployable from applicator 1200.
- the sleeve does not rely on sliding for movement but instead screws up and down applicator 1200 along threads located on external surface of applicator 1200.
- Fig. 25A depicts an applicator 2500 which is comprised of a three part slotted applicator designed to reduce stress on an incontinence device 2508 located therein during storage, in accordance with an exemplary embodiment of the invention.
- Applicator 2500 includes an enclosure 2502, a slotted section 2504, and a plunger 2506 in an embodiment of the invention.
- Slotted section 2504 is substantially cylindrical and is provided with slots (similar to the slots of applicator 1200) which correspond to the number and approximate size of support arms 2512 of device 2508. While device 2508 is in storage, support arms 2512 jut out of the slots provided to slotted section 2504, thereby reducing compressive stress forces on device 2508 and improving shelf life and performance of device 2508.
- support arms 2512 are protected by a bag or cover while they are exposed.
- slotted section 2504 fits friction fits within enclosure 2502 such that it requires more force on plunger 2506 to cause slotted section 2504 to slide within enclosure 2502 than it does to attach insert 2510 to device 2508.
- plunger is moved by the user towards a distal end 2514 of enclosure 2502 depositing insert 2510 in device 2508, but without substantially moving slotted section 2504. Once insert 2510 is deposited, continued force on plunger 2506 towards distal end 2514 causes slotted section 2504 to slide towards distal end 2514 of enclosure 2502.
- an applicator 2600 is shown which in some embodiments is capable of assuming an axially collapsed configuration prior to use.
- applicator 2600 prepares an incontinence device 2604 for use during deployment, in some embodiments of the invention.
- a collapsible applicator could be desirable for more convenient storage (takes up less space), for example.
- An enclosure 2602 is provided to applicator 2600 which contains incontinence device 2604 (device 2604 shown is that of Figs. 27 A-B) therein and while in a collapsed configuration, a large portion of a plunger 2606.
- Deployment of plunger 1300 in an exemplary embodiment of the invention involves holding inner part 1304 and pulling it away from outer part 1302 into an "open" position. Continued pulling of inner part 1304 away from outer part 1302 results in inner part 1304 locking into outer part 1302 via an insert 1306 located on inner part 1304 which fits into a recess 1308 adapted to receive and/or interlock with insert 1306 on outer part 1302.
- a circular ring (not shown in any figures), but previously described in PCT/IL2005/000304, which is herein incorporated by reference, may be located on any applicator in order to mark the proper depth of insertion of the applicator into the vagina.
- the ring can be provided with selectable positions corresponding to different sized women, for personalization.
- any of the incontinence devices described herein can be used in conjunction with a cover.
- a cover is made of a flexible, smooth mesh material.
- the cover is porous.
- the cover is designed as small sack which encapsulates an incontinence device, which acts as an internal support structure for the cover.
- Use of the cover can potentially provide one or more benefits in using the device.
- the cover optionally reduces friction between the applicator and the device upon insertion.
- the cover optionally reduces friction between the vagina and the device during insertion and/or removal.
- the mesh of the cover being stretched between the arms of the device, serves as a sling-like support for the urethra.
- the urethra In a woman who leaks urine during a stressful event (when abdominal pressure rises during coughing, sneezing, etc.), the urethra sags down but meets the cover in its mid part. This causes an elevation of the intra urethral pressure with resultant urinary continence.
- the cover provides support to the urethra.
- the device does not put pressure against the urethra or the bladder neck, but only provides support when there is a rise in abdominal pressure, as described above.
- the device applies direct pressure to the urethra and/or bladder neck.
- the cover is disposable.
- the cover is sterilized between uses and is reusable.
- the cover is decorated.
- pulling on the removal device optionally causes the support and anchor arms to fold slightly towards the central axis of the incontinence device, thereby reducing the radial size of the incontinence device and allowing for an easy and smooth removal of the device from the vagina.
- the device can be "walked" out of the vagina by pulling on removal device causing the support arms to move towards the vaginal opening (and thereby pulling the anchor section along), releasing the string suddenly, and then repeating the process.
- lubricant is delivered by the incontinence device in response to a configuration change and/or during removal of the device.
- lubricant is contained within the incontinence device.
- Figs. 22A-C show cross-sectional views of incontinence devices, which are by way of example only.
- different cross-sectional configurations are used for manipulating the tension and compression stresses applied to incontinence devices during storage, deployment, use and/or removal.
- different cross-sectional configurations are used for reducing resistance to certain motions of the incontinence device and/or increasing resistance to other motions.
- different configurations are used for preventing necrosis and/or discomfort to the wearer.
- Figures are used to show some of the many possibilities available for the shape and configuration of the devices described herein. For example, quadrilateral and ovoid shapes for the arms are not shown, but are also capable of use with the current inventions.
Abstract
Description
Claims
Priority Applications (13)
Application Number | Priority Date | Filing Date | Title |
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AU2006224158A AU2006224158B9 (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
MX2012012106A MX345807B (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females. |
MX2007011339A MX2007011339A (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females. |
US11/886,248 US8617047B2 (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
EP06711327.4A EP1863399B1 (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
CA2600988A CA2600988C (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
CN2006800172622A CN101287422B (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
JP2008501489A JP2008537497A (en) | 2005-03-17 | 2006-03-16 | Urinary incontinence improvement device for women |
BRPI0609831-2A BRPI0609831A2 (en) | 2005-03-17 | 2006-03-16 | mechanism for improvement of urinary incontinence in women |
IL176883A IL176883A (en) | 2005-09-22 | 2006-07-16 | Apparatus for the amelioration of urinary incontinence in females |
IL219989A IL219989A0 (en) | 2005-09-22 | 2006-07-16 | Apparatuses for the amelioration of urinary incontinence in females |
IL219988A IL219988A0 (en) | 2005-09-22 | 2012-05-24 | Apparatuses for the amelioration of urinary incontinence in females |
US14/078,586 US9549798B2 (en) | 2005-03-17 | 2013-11-13 | Apparatuses for the amelioration of urinary incontinence in females |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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ILPCT/IL2005/000304 | 2005-03-17 | ||
PCT/IL2005/000304 WO2005087154A2 (en) | 2004-03-18 | 2005-03-17 | Apparatus for the prevention of urinary incontinence in females |
US71942205P | 2005-09-22 | 2005-09-22 | |
US60/719,422 | 2005-09-22 | ||
US76205906P | 2006-01-25 | 2006-01-25 | |
US60/762,059 | 2006-01-25 |
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PCT/IL2005/000304 Continuation-In-Part WO2005087154A2 (en) | 2003-05-22 | 2005-03-17 | Apparatus for the prevention of urinary incontinence in females |
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US11/886,248 A-371-Of-International US8617047B2 (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
US14/078,586 Continuation US9549798B2 (en) | 2005-03-17 | 2013-11-13 | Apparatuses for the amelioration of urinary incontinence in females |
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EP (1) | EP1863399B1 (en) |
KR (1) | KR20070117676A (en) |
AU (1) | AU2006224158B9 (en) |
BR (1) | BRPI0609831A2 (en) |
CA (1) | CA2600988C (en) |
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- 2006-03-16 BR BRPI0609831-2A patent/BRPI0609831A2/en not_active Application Discontinuation
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US9931503B2 (en) | 2003-03-10 | 2018-04-03 | Impulse Dynamics Nv | Protein activity modification |
US7771344B2 (en) | 2003-05-22 | 2010-08-10 | Contipi Ltd. | Device for the prevention of urinary incontinence in females |
US9737389B2 (en) | 2003-05-22 | 2017-08-22 | Kimberly-Clark Worldwide, Inc. | Apparatus for the prevention of urinary incontinence in females |
US10405959B2 (en) | 2003-05-22 | 2019-09-10 | Kimberly-Clark Worldwide, Inc. | Apparatus for the prevention of urinary incontinence in females |
US11779768B2 (en) | 2004-03-10 | 2023-10-10 | Impulse Dynamics Nv | Protein activity modification |
US10352948B2 (en) | 2004-03-10 | 2019-07-16 | Impulse Dynamics Nv | Protein activity modification |
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US9339361B2 (en) | 2006-07-16 | 2016-05-17 | Kimberly-Clark Worldwide, Inc. | Apparatuses for the amelioration of urinary incontinence in females |
US8302608B2 (en) | 2006-12-21 | 2012-11-06 | Oz Harmanli | Vaginal pessary |
US10507094B2 (en) | 2006-12-21 | 2019-12-17 | Oz Harmanli | Vaginal pessary |
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WO2009044394A3 (en) * | 2007-10-01 | 2009-05-22 | Contipi Ltd | Management of urinary incontinence in females |
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US8221374B2 (en) | 2008-03-31 | 2012-07-17 | Mcneil-Ppc, Inc. | Urinary incontinence device applicator |
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Also Published As
Publication number | Publication date |
---|---|
CA2600988A1 (en) | 2006-09-21 |
MX2007011339A (en) | 2007-11-23 |
AU2006224158B9 (en) | 2012-02-09 |
AU2006224158A1 (en) | 2006-09-21 |
WO2006097935A3 (en) | 2007-03-01 |
AU2006224158B2 (en) | 2012-01-19 |
EP1863399A4 (en) | 2013-11-20 |
EP1863399A2 (en) | 2007-12-12 |
CA2600988C (en) | 2014-09-23 |
BRPI0609831A2 (en) | 2011-10-11 |
EP1863399B1 (en) | 2022-08-17 |
KR20070117676A (en) | 2007-12-12 |
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