MX2007011339A - Apparatuses for the amelioration of urinary incontinence in females. - Google Patents
Apparatuses for the amelioration of urinary incontinence in females.Info
- Publication number
- MX2007011339A MX2007011339A MX2007011339A MX2007011339A MX2007011339A MX 2007011339 A MX2007011339 A MX 2007011339A MX 2007011339 A MX2007011339 A MX 2007011339A MX 2007011339 A MX2007011339 A MX 2007011339A MX 2007011339 A MX2007011339 A MX 2007011339A
- Authority
- MX
- Mexico
- Prior art keywords
- insert
- optionally
- support
- exemplary embodiment
- incontinence
- Prior art date
Links
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Classifications
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
An apparatus for treating urinary incontinence is disclosed. The apparatus includes a support section for providing urethral support, an anchoring section for resisting movement of the apparatus and an insert. The insert is positioned where the support section attaches to a node attached to the support section. Together, the insert urges the support section outward in a radial direction from a central axis of the apparatus.
Description
APPARATUS FOR IMPROVING URINARY INCONTINENCE IN WOMEN FIELD OF THE INVENTION The present invention relates generally to the treatment of female medical conditions, for example by providing devices for the prevention of incontinence and / or female prolapse. BACKGROUND OF THE INVENTION Urinary incontinence is a widespread problem among women. It is estimated that up to 50% of women occasionally leak urine involuntarily, and that approximately 25% of women will seek medical advice at some point in order to deal with the problem. Stress incontinence, the much more common type of urinary incontinence, refers to the involuntary loss of urine that results from the elevation of abdominal pressure that occurs during exercise, coughing, sneezing, laughing, etc. While many different factors may contribute to the development of stress incontinence, it is much more prevalent among women ages 35-65 and those who have had multiple vaginal deliveries. Stress incontinence is both annoying and unpleasant for women and can also be painful. Many women use sanitary pads or diapers to deal with incontinence, although this is not a real solution to the problem and can be
very inconvenient and unreliable. The surgical treatment may involve securing the tissues to retrace the periosteum of the pubic bone or the rectus abdominus to elevate the neck of the bladder above the pelvic floor and through which it distributes the pressure equally to the bladder, the neck of the the bladder and the middle urethra. Recently, he developed a procedure known as "TV?" ("Vaginal Tape ..lb.re of Tension"), in which a mesh tape is implanted under the middle urethra creating a hammock on which the urethra can be twisted during a rise in intra-abdominal pressure. However, surgery is only suitable for several cases, and most women who experience incontinence do not need it and certainly would avoid surgical solutions. A non-surgical treatment modality involves the use of devices that are inserted into the vagina, either by a medical professional or by the woman herself. Most devices are designed to apply; pressure against the neck of the bladder to inhibit or completely block the. Urine flow through the urethra. A variety of such devices are known in the art. For example, refer to the North American publication No. 2002/0183711 of Moser, entitled, "Urinary Incontinence Device"; American patent No.
6,739,340 to Jenscn et al., "Device for prevention of involuntary urina Lion"; U.S. Patent No. 6,679,831 to Z? nkcr et al Intitulada, "Resiíienien incontinence inserí, and method of making the same"; U.S. Patent No. 6,460,542 to James, entitled "Female Incontinence Control Device"; U.S. Patent No. 6,413,206 to Biswas, entitled, "? ntra-vaginal device"; U.S. Patent No. 5,785,640 to Kresch, entitled "Method for 'J'reating Female Incon tinence"; U.S. Patent No. 5,771,899 to Mertclíy et al, entitled, "Pessary"; U.S. Patent No. 5,618,256 to Reimer, entitled "Device for Change in the Vagina for Prevention of Involuntary Urination with Emiseds and an Applicator for Use in Insertion of the Device"; U.S. Patent 5,417,226 to Juma, entitled "Female Anti-Incontinence Device"; U.S. Patent No. 5,386,836 to Biswas, entitled, "Urinary Incontinence Device"; U.S. Patent No. 5, 00 '/, 894 of Enhorning, entitled, "émale Incontinence Device"; and U.S. Patent No. 4,920,986 to Biswas, entitled, "Urinary Incontinence Device," the descriptions of which are incorporated herein by reference. A problem with many of the devices listed above is that they completely block the urethra and thus need to be removed or collapsed in order to allow the
woman urinating To overcome this disadvantage, vaginal devices have been developed having specialized forms that do not completely block the urethra but these devices tend to be large, uncomfortable and intrusive. They also tend to cause irritation or pain to the vagina. Another common deficiency is that most devices known in the art also tend to be difficult or painful to insert and / or remove. In order to properly inhibit the flow of urine, the device needs to be properly placed in the vaginal canal. As a result, a doctor may be required to properly position the device. In most cases, the device is adapted to remain in the vagina for a prolonged period of time (due to the time and cost to require a trained medical professional to insert the device). However, when placed in the vagina for a prolonged period of time, the device can cause infections, necrosis or bleeding from the vagina. BRIEF DESCRIPTION OF THE INVENTION One aspect of some exemplary embodiments of the invention relates to the provision of incontinence devices with inserts adapted to provide resilient reinforcement to at least a portion of the device. Optionally, incontinence devices
They are provided with support arms. In some exemplary embodiments, an insert is used in conjunction with the sopote arms of the incontinence device to provide urethral support to a patient. In an exemplary embodiment of the invention, the insert pushes the support arms to expand radially (radially outwardly from a central axis of the device) to provide urethral support. Optionally, the radial expansion is up to 20% of the previous radial profile of the device. Optionally, the radial expansion is up to 50% of the previous radial profile of the device. In some embodiments, the radial expansion is more than 50% prior radial profile of the device. In some exemplary embodiments of the invention, an insert is located at the convergence of the support arms at a central node of the incontinence device. In some exemplary embodiments of the invention, the insert penetrates the central node of the incontinence device. In some exemplary embodiments of the invention, the insert is placed on a device surface, an interior surface, which is located opposite a vaginal wall. In an exemplary embodiment of the invention, the insert is conical in shape. Optionally, the insert is geometrically of appraisement. Opel ona] men te, the insert is of variant geometry. Optionally, the insert is
bistable Optionally, the insert is an o-ring. Optionally, the insert is comprised of a plurality of components remotely fixed together. Optionally, at least a portion of the insert is elastic. In some exemplary embodiments of the invention, the insert is stuck in at least one position on the incontinence device. In some exemplary embodiments of the invention, the insert is removably stuck in a position on the incontinence device. In some exemplary embodiments of the invention, the insert is positioned in relation to the incontinence device such that the support and / or pressure is subjected to the fixation arms of the device. In some exemplary embodiments of the invention, the incontinence device is deployed using an applicator, such as those described herein and in the related applications. The incontinence device is optionally provided with a removal device to remove the device from the vagina after use. In some exemplary embodiments of the invention, the incontinence device is provided with a cover. Optionally, the urethral support is the middle urethral support. In some exemplary embodiments of the invention, an incontinence device is provided with a member
of internal and / or external support. Optionally, the resilient support member biases the arms of the incontinence device. Optionally, the support member res i 1 icntc biases the arms of the incontinence device radiating I amount towards a central axis of the contingency device. It biases the arms of the incontinence device radially inward toward a central axis of the incontinence diaphragm. Choice of mount, or support member, is used for at least the supporting arms of the incontinence device. Optionally, the support member 1 i lens is used for at least the fixing arms of the incontinence device. Option 1 ment, the insert is placed in relation to an incontinence device such that the support and / or pressure are given to the support arms of the device I n some exemplary embodiments of the invention, or I support given by the insert to the device is support against the forces exerted on the arms by a vagmal wall. In some exemplary embodiments of the invention, the pressure pushes the arms radially outward from a central axis of the device, causing the radial expansion of the spool. In some exemplary embodiments of the invention, a di espos it ívo of incontinence with arms of
voltage reduction. Optionally, the tension is reduced by providing the arms with a folding section. In some exemplary embodiments of the invention, the tension reduction arms are folded while in storage within an applicator, however in ei. deployment, the arms expand to give support and / or fixation. One aspect of some exemplary embodiments of the invention relates to providing an incontinence device with multiple stable configurations. In some exemplary embodiments of the invention, an incontinence device is provided with a component that is bistable monkeys. Optionally, the bisable 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. Optionally, the bistable component is transferred from the first stable position to the second stable position without moving substantially in relation to the incontinence device. Optionally, the bistable component is transferred from the first stable position to the second stable position when moving relative to the incontinence device. In some exemplary embodiments of the invention, the device is provided with a removal device that
it is possible to change the second position to the first stable position. Optional 1 ment, the device is used with a cover. Optionally, the device is deployed in a vagina by using an api icator. An aspect of some exemplary embodiments of the invention relates to providing an incontinence device that is comprised of different components with different material properties in order to achieve a particular operational profile. For example, in some exemplary embodiments of the invention, an insert is provided to the incontinence device where the insert is partially clastic and / or partially rigid. Option I ment, a partially rigid insert is used to apply expansion and / or selective retraction of the support and / or fixation sections of the incontinence device. Optionally, different components with different material properties are used to distribute forces exerted on and / or by the incontinence device. In some exemplary embodiments of the invention, the incontinence device is comprised of different materials with different material properties in order to provide effective treatment. One aspect of the exemplary modalities of the invention is related to providing at least a portion of an incontinence device with expansion.
radia] elasfo-mechanics. In some exemplary embodiments of the invention, force is provided for the elasto-mechanical radial expansion by a central elastic member. Optionally, the central elastic member is operatively connected to the expanders (which in some embodiments are mechanical, hence the name "to-mechanical") that causes the radial expansion of the device. Optionally, the device is provided with support arms, which constitute a portion of the device that is radially extended. Optionally, the device is provided with clamping arms, which constitute a portion of the device that is racially extended. In some exemplary embodiments of the invention, radial expansion of the incontinence device occurs in the ejection of an applicator device. In some exemplary embodiments of the invention, the device is provided with a removal device that stops the elastic central member from exerting force on the expanders in this manner causing a radial contraction of the device and / or allowing easier removal of the device. One aspect of some exemplary embodiments of the invention relates to providing an incontinence device with an elastomeric ring to assist with radial expansion and / or contraction of the device. In some
II
exemplary embodiments of the invention, the elastomeric ani is the one hoisted in a plurality of positions in relation to the device in order to provide radial expansion and / or contraction to the device. Optionally, the elastomeric ring sc slides along an exterior of the device in order to assume the plurality of positions. In some exemplary embodiments of the invention, the forms of the incontinence device and / or a pivot member assist in the expansion and / or contraction of the incontinence device. In some exemplary embodiments of the invention, the device is provided with a removal device which dislodges the pivot piece allowing contraction of the device and / or easier removal of the device. In some exemplary embodiments of the invention, the elastomeric ring is a component of a bi-stable incontinence device. In some exemplary embodiments of the invention, the elastomeric ring is not flexible. Optically, the ring and the astomoteric ring is not in the form of a ring; It is optionally square, rectangular, triangular, ovoid, or u-shaped, for example. One aspect of some exemplary embodiments of the invention relates to providing at least one tension element to an incontinence device to provide radial expansion force, but does not force
compressive to the device. In some exemplary embodiments of the invention, at least one tension member extends between an arm of a fastening section and a corresponding arm of a support section of the incontinence device. Opti ona At least one tension element is elastic. In some exemplary embodiments of the invention, the at least one tension element is stretched before unfolding and while stored in an applicator. Optionally, the at least one tension element is not stretched substantially when deployed, by adjusting supply expansion force to the incontinence device as a function of the natural unstretched length of the connector c. In some exemplary embodiments of the invention, the at least one tension member helps resist movement of the support section and / or fixation section after the release of the device into the vagina. Optically, the flexibility of the support section and / or fastening section are adjusted depending on the desired response to the at least one tension element. An aspect of some exemplary embodiments of the invention relates to an incontinence device which moves in order to increase and / or decrease its size profile. In some embodiments and emplares of the invention, the incontinence device is wound around its central axis to reduce the diameter of the device.
Optionally, the reduced diameter device is stored in an applicator before deployment. In some exemplary embodiments of the invention, when the displaced incontinence device is deployed from the applicator, it is at least partially unwrapped to assume a larger diameter to provide support to the patient's urethra. Optionally, the displacement device is provided with a plurality of protuberances to provide supports and / or fixation. In some exemplary embodiments of the invention, the device is adapted so that the arms and / or protuberances of the position of the device by themselves on either side of the urethra; either directly in the deployment or after the movement by the user causes slight rotation of the device. Optionally, the displacement device is cylindrical. Optionally, the displacement device has a larger diameter at one end than the other end. In an exemplary embodiment of the invention, sc provides an incontinence device with a plurality of connected displacement sections. Optionally, two displacement sections are provided for the incontinence device. Optionally, the displacement sections are connected by a flexible member. In some modalities
of the invention, a displacement section is located at each end of the flexible member. Optionally, the displacement sections are provided with a plurality of protuberances to provide support and / or fixation. In some exemplary embodiments of the invention, the displacement sections are wound around the central axis of the device to reduce its radial profile. Optionally, the device with reduced radial profile is stored in an applicator. In some exemplary embodiments of the invention, in the deployment of the incontinence device, the displacement sections unwind to assume a larger diameter to provide support to the urethra of a patient. Optionally, the support is medium urethral. One aspect of some exemplary embodiments of the invention relates to providing lubrication at least to the external surface of an applicator. Optionally, the applicator is for inserting an incontinence device. Optionally, the lubrication cs provided by a reservoir ring placed around the circumference of the applicator. Optionally, the reservoir ring is porous. Optionally, the reservoir ring is hollow. Optionally, lubrication is provided by a coating on the applied surface which is revealed when a cover is removed. Optionally, lubrication is
provided by a movable sleeve placed on the applicator and where the Lubricant is located. In an exemplary embodiment of the invention, the applicator is lubricated prior to insertion into the vagina of a patient. Optionally, the ring is removed after lubrication but before insertion. Optionally, the sleeve is removed after lubrication but before insertion. Optionally, an indicator such as a ring is used on the applicator to indicate the appropriate depth for the insertion of the applicator in order to achieve the deployment of the effective device. Optionally, the ring physically stops the applicator at the proper depth for insertion of the applicator in order to achieve the deployment of the effect device. One aspect of some exemplary embodiments of the invention is related to providing apicers to extend the shelf life of incontinence devices. Optionally, any radially extendable device is used with the shelf life extension applicators. In an exemplary embodiment of the invention, an applicator is provided with a flared section for storage of at least the support section of an incontinence device. The enlarged section allows the support section to remain at least partially de-energized during storage.
Optionally, a central node of the incontinence device is also located in the enlarged section. Optionally, the flared section is sized to accommodate at least the partially expanded arms of the incontinence device. Optionally, the enlarged section is used to indicate the appropriate depth for the insertion of the applicator in order to achieve the deployment of the effective device. In some exemplary embodiments of the invention, an applicator is provided with a plurality of slots adapted and constructed to accommodate the arms of an incontinence device such that when the incontinence device is located within the applicator the arms protrude outwards and / or they are not compressed. Optionally, a movable sleeve is used to place the protruding arms outwardly into the applicator in preparation for deployment. Optionally, an indicator, such as a ring, is used on the applicator to indicate the appropriate depth for the applicator insertion in order to achieve the deployment of the effective device. One aspect of some exemplary embodiments of the invention relates to minimizing the size of a plunger used to deploy an incontinence device of an applicator. In an exemplary embodiment of the invention,
provides a telescopic plunger. Optionally, the plunger is folded. Optionally, the telescopic plunger is comprised of at least two sections. Optionally, the plunger in a closed condition is approximately half its size when in an unfolded condition. In an exemplary embodiment of the invention, a ring is located on the plunger to provide friction between the plunger and an applicator during relative movement therebetween. Optionally, the ring resists the inadvertent dislodging of the plunger of the applicator. In an exemplary embodiment of the invention, the applicator makes contact with a central portion, such as the node, of the incontinence device to deploy it from the applicator. Optionally, the applicator deploys the incontinence device when making contact with at least one support arm. In an exemplary embodiment of the invention, at least part of the applicator, such as the plunger is used to assist in positioning the support arm in a deployed position. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence comprising: a support section adapted to provide urethral support; a fixing section to resist movement of the apparatus; an insert, a portion of which is adapted to be possible placed
next to the support section; and, where I heard the insert selectively provides at least support to the support section of the apparatus. Optionally, the insert is adapted to provide pressure to the support section, causing "radial expansion of the support section." Optionally, the support section is flexible In an exemplary embodiment of the invention, the support section is comprised of by at least one support arm Optionally, the insert is an o-ring Optionally, the insert is enlarged Optionally, the urethral support is middle urethral support In an exemplary embodiment of the invention, the apparatus further comprises a cover. Optionally, the insert is conical Optionally, the insert is comprised of a plurality of elements geometrically of in tera toramieto Optionally, the insert is comprised of at least one supporting protrusion a bulge of bulge Optionally, the insert is a Invertible membrane Optionally, the insert is a ring insert In an exemplary embodiment of the invention, the apparatus furthermore comprises of a resilient support member. Optionally, the resilient support member biases at least the support section on a central axis of the apparatus. Optionally, the resilient support member biases at least the support section away from a central axis of the apparatus. Optionally, the support section and
the fixing section are comprised of at least two arms, respectively. Optionally, the arms are provided with a folding section. Optionally, the cover spontaneously encapsulates the apparatus. Optionally, at least the support section and the fastening section are flexible. Optionally, the device is flexible. In an exemplary embodiment of the invention, the apparatus further comprises a removal device. This is provided in accordance with an exemplary embodiment of the invention, an apparatus for treating urinary incontinence, comprising: a support section adapted to provide urethral support .; a fixing section to resist the movement of the apparatus; and, an insert, adapted to provide at least support to the support section and at least a portion of the insert that is elastic. Optionally, the insert is comprised of a plurality of removably adjusted components together. Optionally, the insert pushes the support section radially outward from a central axis of the apparatus. Optionally, the insert is provided with an expanded end which provides radial expansion to the fixing section. In an exemplary embodiment of the invention, the apparatus further comprises a cover. Optionally, the cover encapsulates its apparatus. Optionally, at least the support section and
The fixing section are flexible. Optionally, the apparatus is flexible. In an exemplary embodiment of the invention, the apparatus further comprises a removal device. Optionally, the urethral support is the middle urethral support. Optionally, the support section is comprised of at least one support arm. Thus, according to an exemplary embodiment of the invention, an apparatus for treating urinary incontinence is provided; comprising: a support section adapted to provide urethral support; a fixing section to resist 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 pin provided to an expanded end of the elastic member which prevents the expanded end from passing through at least one expander node, and, where when the elastic member is substantially unstretched, the at least one Expander causes the radial expansion of the apparatus. In an exemplary embodiment of the invention, the apparatus further comprises a cover. Optionally, the cover substantially encapsulates the node, the support section and the fixing section. Optionally, at least the support section and the fixing section are flexible. In an exemplary embodiment of the invention, the apparatus also
comprises a removal device provided to the safety pin. Optionally, the urethral support is the middle urethral support. Optionally, the support section is comprised of at least one support arm. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide urethral support. A fixing section to resist the. movement of the apparatus; a first to slit; an elastomeric ring placed on an outer surface of the apparatus within the first slit; and, wherein the ring the astommer provides compression force to at least a portion of the apparatus. Optionally, the elastomeric ring applies compression force to the support section to effect radial contraction of the support section; In an exemplary embodiment of the invention, the apparatus further comprises a second groove located between the first groove and the support section. In an exemplary embodiment of the invention, the apparatus further comprises a pivot part located in a third slot. Optionally, in the deployment the elastomeric ring passes from the first slit to the second slit causing the radial expansion of the support and the fixing sections. In an exemplary embodiment of the invention, the apparatus further comprises a
Removal device attached to at least the pivot part. In an exemplary embodiment of the invention, the apparatus further comprises a cover. Optionally, the support and fixing sections are flexible. Thus, an apparatus for treating urinary incontinence is provided in accordance with an exemplary embodiment of the invention, comprising: a support section adapted to provide urethral support .; a fixing section to resist movement of the apparatus; and, a tension element, the tension element positioned to the support section and the attachment section and adapted to provide radial expansion to the apparatus. Optionally, the tension element is elastic. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a support section adapted to provide urethral support; and, wherein the apparatus is provided with a first stable position and a second stable position, such that when the apparatus is in the second stable position the support section supports the urethra. Optionally, the support section is provided with a plurality of support t5.raz.os. In an exemplary fashion of the invention, the apparatus further comprises a bistable component wherein the bistable component is attached to the support section. Optionally,
The stable bi component is a flexible membrane. Optionally, the flip-flop component is a gauging element. Option I ent e, the stable bi component is ani l it. In an exemplary embodiment of the invention, the adorning apparatus comprises a first slit associated with the prunera stable position and a second slit associated with the second stable position. Option Lmen t e, the ring is removable on an outside L from the first slit to the second slit. In an exemplary embodiment of the invention, the apparatus further comprises a removal device. Optional, a removal device is attached to the bistable component to change the stable position to the first stable position. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for treating the urinary incontinence, comprising: a support section adapted to support a urethra; an insert, the insert comprising a first material which exhibits properties of first material and at least one second material that exhibits the second material properties; and, wherein the insert selectively expands the support section. Optional, the first material is flexible. Opc ona 1 men t c, the second material is stiffer than the support section. This is provided according to a modality
exemplary of the invention, an apparatus for treating urinary incontinence, comprising: a central node, wherein the central node is a rolled sheet; a plurality of support protuberances located on the node; and, a plurality of fixing protuberances located on the node. Optionally, the central node when rolled has a larger diameter on one end than the other end. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for treating urinary incontinence, comprising: a connector; and, a plurality of displacement sections. Optionally, the connector is flexible. Optionally, optionally, the displacement sections are provided with a plurality of protuberances to provide urethral support. Optional Lonaimente, the displacement sections are provided with a plurality of protuberances to give fixation. Optionally, the plurality of displacement sections means two sections. Option 1, each of the two sections is located on an opposite end of the connector. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for inserting a vaginal device, comprising: an enclosure for containing the vaginal device; and a lubrication element
located externally of the enclosure. Optionally, the lubrication element is a ring located around a circumference of the enclosure. Optionally, the lubrication element is a layer of lubricant applied to the enclosure which is revealed when a cover to the layer is removed. Optionally, the lubrication element is a movable sleeve located around a circumference of the enclosure. Optionally, the lubrication element is a lubrication layer on the enclosure. Optionally, the lubrication is highly viscous such that once the lubrication is localized, the enclosure remains in place until use. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for extending the shelf life of a vaginally insertable device, comprising: an enclosure adapted to receive at least a first portion of the device. device and vaginal insertion; a section adapted to receive at least a second portion of the device such that the second portion cs is at least partially expanded. Optionally, the section is a widened enclosure. Optionally, the section is provided with a plurality of slots. Optically, the slots are dimensioned and numbered to accommodate the second portion of the device. In a
In an exemplary embodiment of the invention, the apparatus further comprises a slidable sleeve located externally of the enclosure for positioning the second portion of the device prior to insertion of the device into a vagina. Thus, according to an exemplary embodiment of the invention, there is provided an apparatus for motivating a vaginally insertable device, comprising: an external section, adapted for insertion into a vaginal applicator; and, an internal section, capable of insertion into and movement within the internal section. In an exemplary embodiment of the invention, the apparatus further comprises a ring, wherein the ring is located on the outer section such that friction is created by the ring when there is movement of the apparatus relative to the applicator. This is provided according to an exemplary embodiment of the invention, a collapsible device for inserting a vaginal device, comprising: an enclosure for containing the vaginal device; and a plunger adapted to fit coaxially within the enclosure. Optionally, the plunger is located substantially within the enclosure during storage. Optionally, an insert is provided to the vaginal device. Optionally, the insert is attached to a removal / activator device. Optionally, the device
removal / activator is removably attached to the plunger. Optionally, the movement of the plunger outside the enclosure moves the insert at least partially through the vaginal device. BRIEF DESCRIPTION OF THE FIGURES Non-limiting modes of the invention will be described with reference to the following description of the exemplary embodiments, in conjunction with the figures. The figures are generally not shown to scale and any of the measurements are only proposed to be exemplary and not necessarily limiting. In the figures, structures, elements or identical parts appearing in more than one figure are preferably marked with the same or similar number in all the figures in which they appear, in which: Fig. 1A is a profile view of a incontinence device with a conical insert according to an exemplary embodiment of the invention; Fig. IB is a profile view of an incontinence device with a conical insert during removal of the device in accordance with an exemplary embodiment of the invention; Fig. 2A is a profile view of an incontinence device with a geometric gauging insert in an applicator according to an exemplary embodiment of the
invention; Fig. 213 is a profile view of an incontinence device with a geometric gauging insert that is detached according to an exemplary embodiment of the invention; Fig. 2C is a profile view of an incontinence device with a geometric gauging insert in a deployed position according to an exemplary embodiment of the invention; Fig. 2D is a view of perf.il. of an incontinence device with a geometric gauging insert showing the removal of the device in accordance with an exemplary embodiment of the invention; Fig. 3A is a profile view of an Incontinence device with an Insert of variant geometry as in an applicator according to an exemplary embodiment of the invention; The L'i g. 313 is a profile view of an incontinence device with an insert of variant geometry as spaced according to an exemplary embodiment of the invention; the fi . 3C is a profile view of an incontinence device with an insert of vanishing geometry during removal according to an exemplary embodiment of the invention;
Fig. 4A is a profile view of an incontinence device with an inversion insert located in an applicator according to an exemplary embodiment of the invention; Fig. 413 is a profile view of an incontinence device with a reversal insert deployed in accordance with an exemplary embodiment of the invention; Fig. 4C is a profile view of an incontinence device with an inversion insert during removal in an exemplary embodiment of the invention; the IJ'ig. 5 is a profile view of an incontinence device with a resilient support member integrated in accordance with an exemplary embodiment of the invention; Fig. 6 is a profile view of an incontinence device provided with tension reduction arms according to an exemplary embodiment of the invention; FIG. VA is a profile view of a displacement incontinence device according to an exemplary embodiment of the invention; Fig. 713 is a profile view of a displacement incontinence device with a proximal end enlarged according to an exemplary embodiment of the invention;
the Fig. 7C is a top and / or bottom view of a displacement incontinence device according to an exemplary embodiment of the invention; Fig. 7D is a top view of a displacement incontinence device in an applicator according to an exemplary embodiment of the invention; the Fig. 8 is a profile view of a double-sided displacement incontinence device connected in accordance with an exemplary embodiment of the invention; Fig. 9A is a cross-sectional view of a apiicator with a lubrication ring according to an exemplary embodiment of the invention; Fig. 9B is a cross-sectional view of an applicator with a removable cover according to a first-order fashion of the invention; Fig. 10A is a side view of an applicator with a lubrication sleeve according to an exemplary embodiment of the invention; Fig. 10B is a cross-sectional view of an applicator with a lubrication sleeve according to a modal. exemplary nature of the invention; Fig. 11A is a cross-sectional view of an applied /: and a loose-loaded incontinence device according to an exemplary embodiment of the invention;
Fig. 1113 is a cross-sectional view of a widened proximal end applicator loaded with an incontinence device in accordance with an exemplary embodiment of the invention; Fig. 12A is a side view of a slotted applicator with a sliding sleeve in a distal position according to an exemplary embodiment of the invention; the L'lg. 12B is a side view of a slotted applicator with a sliding sleeve loaded with an incontinence device with arms protruding out of the slots of the applicator according to 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 according to an exemplary embodiment of the invention; the Fl. 13 is a cross-sectional view] of a telescopic plunger in accordance with an exemplary embodiment of the invention; Fig. 1A is a cutaway view of an applicator containing a bistable incontinence device within
in accordance with an exemplary embodiment of the invention; Fig. 14B is a bistable incontinence device in a deployed configuration according to an exemplary embodiment of the invention; Fig. IbA is a cross-sectional view of an incontinence device with an o-ring insert, according to an exemplary embodiment of the invention; ia F.i g. 1513 is a cross-sectional view of an incontinence device with an o-ring insert that is 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. 16? is a cross-sectional view of an incontinence device with a plurality of components remotely adjusted 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 that are individually adjusted together in a deployed configuration, in accordance with an exemplary embodiment of the invention; Fig. 16C is a cross sectional view dc
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 cs a cross-sectional view of an alternative incontinence device with a plurality of components readily adjusted 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 removably-adjusted components that include an elastic component in a storage configuration, in accordance with an exemplary embodiment of the invention; FIG. 1713 is a cross-sectional view of an incontinence device with a plurality of removably-adjusted components together that include an elastic component in a deployed configuration, in accordance with an exemplary embodiment of the invention; the Fl g. 17C is a cross-sectional view of an incontinence device with a plurality of removably-adjusted components together that include an elastic component in a configuration of
removal, 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 removably-adjusted components together that include an elastic component in a deployed configuration, in accordance with an exemplary embodiment of the invention; FIG. 18A is a cross-sectional view of an expanded incontinence device utilizing a trapezoidal infeasor insert, in accordance with an exemplary embodiment of the invention; Fig. 1.8B cs a cross-sectional view of an incontinence device using a trapezoidal insertion insert which is removed, in accordance with an exemplary embodiment of the invention; FIG. 19A is a cross-sectional view of an incontinence device that expands elastically-mechanically in a storage configuration, in accordance with an exemplary embodiment of the invention; the Fig. 1913 is a cross-sectional view of an incontinence device that expands elastically-mechanically in a deployed configuration, in accordance with an exemplary embodiment of the invention; Fig. 19C is a cross-sectional view of
an incontinence device that expands elastically-mechanically in a removal configuration, in accordance with an exemplary embodiment of the invention; the ivi. 20A 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; the F.i g. 20B is a cross-sectional view of an incontinence device provided with an elastomeric ring in a deployed configuration, in accordance with an exemplary embodiment of the invention; FIG. 20C is a cross-sectional view of an incontinence device provided with an elastomeric ring in a removal configuration, in accordance with an exemplary embodiment of the invention; Fig. 20D 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. 20E is a cross-sectional view of an alternative incontinence device provided with an elastomeric ring in a removal configuration, in accordance with an exemplary embodiment of the invention; Figs. 20F-I are cross-sectional views of alternative inserts that can be used with
incontinence devices described herein, in accordance with an exemplary embodiment of the invention; Fig. 217 \ is a cross-sectional view] of an incontinence device provided with dimension adjustment connectors in a storage configuration, in accordance with an exemplary embodiment of the invention; Fig. 2113 is a cross-sectional view of an incontinence device provided with dimension adjustment connectors in a deployed configuration, according to 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; the Fi g. 2213 is an exemplary cross-sectional view of an incontinence device, 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; ia Fig. 23? 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. 23B is a cross-sectional view of
an expanded incontinence device provided with a Lioja spring support section, according to an exemplary embodiment of the invention; Fig. 24 is a cross-sectional view of an applicator with a lubrication layer, in accordance with an exemplary embodiment of the invention; and Fig. 25A is a cross-sectional view of a slotted applicator with a sliding sleeve in a dlstal position according to an exemplary embodiment of the invention; Fig. 2513 is a cross-sectional view of a slotted applicator with a sliding sleeve in a position prepared in accordance with an exemplary of the invention; Fig. 25C is a cross-sectional view of a slotted applicator with a sliding sleeve in an imminent deployment position according to an exemplary embodiment of the invention; the IJ'ig. 26A is a cross-sectional view of a collapsible applicator in a collapsed configuration, in accordance with an exemplary embodiment of the invention; Fig. 2613 is a cross-sectional view of a collapsible applicator cn an expanded configuration, according to 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, according to an exemplary embodiment of the invention; Fig. 287 is a profile view of an incontinence device with a ring insert in a storage configuration, according to an exemplary embodiment of the invention; the Flg. 2813 is a profile view of an incontinence device with a deployed configuration ring insert, according to an exemplary embodiment of the invention; and Fig. 28C is a perspective view of a ring insert, according to an exemplary embodiment of the invention. DETAILED DESCRIPTION OF EXEMPLARY MODALITIES Irrigation With reference to FIG. 1A, a profile view of an exemplary embodiment of the incontinence device 100 is shown. In an exemplary embodiment of the invention, the device 100 is arranged around a central axis.
150 and divided into three parts. Optionally, the device has more or less parts. An upper section 106 is
provided which serves as the "fixation" element, to stabilize the device inside the vagina. There are two types of fixation, axial fixation which acts in the direction along the central axis of the vagina, and radial fixation acting from side to side or substantially perpendicular to the central axis of the vagina. A bottom section 110 is provided which serves as the "support" element, to generate urethral support. In some embodiments of the invention, the support is generated in a middle urethral location. In some embodiments of the invention, the bottom support section 110 provides at least one form of attachment to assist in fixing the device 100 in position. In some embodiments of the invention, the entire length of the device 100 is between 300 mm and 50 mm. Optionally, the device 100 is larger or smaller depending on the individual needs of the patient. In some exemplary embodiments of the invention, the various sections, parts and / or elements described are optional. In some exemplary embodiments of the invention, the functions performed by the various sections, parts and / or elements are optional. In some exemplary embodiments of the invention, there is provided a central section 108, or node, which optionally connects the fixing elements 106 and support 110. The node 108 of this and many other devices described in FIG.
the present have a length that is only a small portion of the entire length of the device, in some embodiments of the invention. In some embodiments of the invention, the length of the node is less than 15% of the entire length of the device. In some embodiments of the invention, the length of the node is less than 20% of the entire length of the device. In other embodiments of the invention, the length of the node is less than 30% of the entire length of the device. In an exemplary embodiment of the invention, the length of the complete invention is up to 75mm. Optionally, the length of the complete device is up to 60 mm. Optionally, the length of the complete device is 50 m. In some exemplary embodiments of the invention, the complete arrangement is not less than 30 mm in length. In some embodiments of the invention, a node that is relatively short to the entire length of the device allows for more flexibility in varying stiffness, comfort, and size. device 100. Optionally, the node is not provided with one axis longer than the other, the axes are equal in length (for example a sphere or a cube). In an exemplary embodiment of the invention, a small node in relation to the full length of the device allows greater control over the composition of the fixing and support arms described below. This is because the entire length of the device is of some
way determined by the topography of the vagina. If, for example, the central node was a significant portion of the full length of the device, then the arms would be short in length and cn an angle to the central node near 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 .. In some embodiments of the invention, a cover 120, described in greater detail below, the device 100 is provided. The elements of the device 100 optionally function as an internal support structure for a cover 120. Optionally, the tension of the cover 120 is increased by the arms of the device 100. F, in an exemplary embodiment, the element of fixation 106 and support element: 110 have four (4) arms each or sets of arms 112 and 114, respectively. In an exemplary embodiment of the invention, four arms are provided for each section in which two project generally toward the bladder, and two project generally to the vaginal floor adjacent to the intestines. The two support arms projecting towards the bladder fit within the natural grooves on either side of the urethra in some embodiments of the invention. Optionally,
the fastening and support elements are provided with more or less arms. For example, the fastening element could have more arms if there is concern about the unwanted movement of the device 100. In other embodiments of the invention, the arms are provided at varying angles with respect to the node 108 and / or to each other. Optionally arms 112 and 114 are flexible or rigid and are constructed of a biocompatible material c. Optionally, each of the arms reacts individually to the forces exerted on them by the vaginal wall, similar to the independent suspension in a car. Optionally, each of the support arms operates separately to support the urethra. Optionally, the pad elements adapted for contact are provided to the areas where they are likely to contact the vaginal wall of the user in order to increase the contact surface area and thereby increase comfort to the user. The pad elements also reduce the likelihood of necrosis due to the reduced pressure exhibited between the device and the vaginal wall, as a result of the increase in the contact surface area between the two. In an exemplary embodiment of the invention, the fixation element does not apply significant pressure to the vagina and / or urethra of the user, thereby increasing comfort.
In some embodiments of the invention, another structure is provided in place of the arms that is capable of supporting the urethra, in the case of the support section;, or preventing the device from unintentional movement, in the case of the section Fixing. For example, at least one cone, p otube and / or extension attached to the node could be used for fixation and support. The fixing arms of the device prevent the device from unintentional movement out of position. In an exemplary embodiment of the invention, the fixation element arms 112 resist movement of the device toward the uterus because the arms increase their angle to the node 308. This effective increase in the radius operates to cont arrest the movement of the device further. in the vagina. In some embodiments of the invention, the fixing element arms 112 are provided at a large angle to the node to increase this fixing effect. It should be noted that: this increased fixing effect is observed only up to a maximum angle. A reduced node 108 increases the flexibility and possible ranges of movement for the complete device 100 in some embodiments of the invention. Optionally, devices such as wires and / or springs are embedded in the neck in order to increase flexibility for the device 100. This flexibility
additional may increase the comfort of the woman while using the device 100. Optionally, the additional flexibility of the device 100 enables more conformable defecation compared to prior art devices. Any of the embodiments described herein are optionally used in conjunction with a reduced node 108. While the arms are flexible, it should be noted that they are rigid enough to prevent unwanted movement of the device toward the entrance of the vagina. Optionally, the arms are rigid but the node is flexible, the node in this way provides fixation and flexible support. The movement towards the opening of the vagina is restricted by the arms that are placed by itself in the vagina towards the cervix and, in some exemplary embodiments of the invention are kept in place by the pressure exerted on them by the vaginal wall, see for example the description of "cover" right away. These characteristics work independently of and in conjunction with the vaginal wall covering behavior described below, which also help to maintain the device in the proper place. An additional feature of the fixing arms of the device 1.00 is that they operate remotely from the support arms. This reduces the amount of pressure
applied to the urethra by the device because some exemplary embodiments of the invention, the support arms do not need to provide fixation functions in addition to support. Optionally, the urethral support is the middle urethral support. Such a configuration increases user comfort, prevents unnecessary damage to tissues adjacent to the device, increases the fixation function of the device, and in some exemplary embodiments of the invention, allows the user to avoid it voluntarily without having to remove the urinating device. . The arms 1.12 of the. fastening element 106 forces device 100 to remain in place within the vagina, unable to move substantially inwardly or outwardly, or to rotate. One reason for this to occur is as a result of the special tendency of the walls of the vagina to collapse and form an occluded lumen. The arms of the device cause the "cover" of the walls of the upper part of them with the resulting softening of the walls around the node 1.08, in this way stabilizing the device 100. The arms 114 of the supporting element 110 causes the lifting relative of the tissues around the urethra measured, acting as a hammock. This hammock supports the middle urethra in a stress-free manner, very similar to the TV operation. In a woman who lets out urine during an event of exertion (when she raises the pressure
abdominal during coughing, sneezing, etc.), the urethra sc buckles down but finds the hammock in its middle part. The encounter of the urethra and the hammock causes an elevation of intraurethral pressure with resultant urinary continence. In some embodiments of the invention the radial support arms 114 of the. device 100 create a complete device radial diameter of 25mm to 50mm inside the vaginal cavity. Optionally, the diameter is larger or smaller depending on the individual needs of the patient. It should also be noted that for certain women, the devices described herein can also be used as a treatment for the. prolapse. For example, arms that are expanded to a certain radius for the treatment of incontinence may optionally be expanded to a larger radius for the treatment of prolapse. For example, the configurations treating the prolapse optionally exhibit a diameter of up to 100 mm. Various embodiments of incontinence device are described in the present, many of which use inserts to assist with radial expansion of the continence device. It should be noted that many of these inserts optionally have multiple stopping positions corresponding to multiple incontinence device configurations. The specific positions are selected
optionally depending on the needs of the patient. In addition, although a certain nomenclature used (for example, "fixation" and "support") it should be understood that these are for ease of reference only, and in some embodiments of the invention a "fixation" section could be used to provide support urethral and / or vice versa.
Disposi tives E empia es with an Insert to Treat ía
Incontinence In some exemplary embodiments of the invention, the traces are manufactured so as to be skewed towards a central axis, of the device 100. In such an embodiment, storage (eg, storage in an applicator, as described below) is expected. in a contracted configuration it imposes less stress on the device 100 than if it were manufactured with slanted arms in an expanded configuration. The arms are optionally placed in an expanded configuration during or after deployment, such as when using the inserts described herein. In an exemplary embodiment of the invention, it is conceived that the removal of the insert causes the arms to return to the contracted state for easy removal of the user's vagina. Many of the exemplary incontinence devices described herein are optionally manufactured with fixation and / or support elements (e.g. arms) that are skewed in a
undeployed configuration, contracted. The qs. 1A-B, 2A-D, 3A-C, 15? -D, 16A-D, 14A-D, 18? -D, 23? -B, 27? -I3 and 28? -C show different exemplary embodiments of inserts which are optionally hoisted with an incontinence device. The inserts are generally used to provide the support arms with additional support against the pressure exerted on the supporting arms by. the vaginal wall, and / or with radial expansion. In addition, the removable inserts, such as those described herein, have provided incontinence devices with effective incontinence treatment while avoiding some of the storage efforts that would normally come with the devices that give such effective treatment. In an exemplary embodiment of the invention, storage efforts are avoided because the insert is stored in an undeployed position, the undeployed position does not exert treatment level pressure on the support arms. It should be understood that the methods and device configurations described in the reference to Figs. 1? -B, 2A-D, 3A-C, 15? -D, 16A-D, 17? -D, 18A-B, 23A-B, 27? -I3 and 28A-C are exemplary only, and that Different configurations are used optionally depending on the needs of the patient. For example, the insert is optionally formed to push the support arms to expansion diameters.
different radials, as measured from a central axis of the device. Optionally, the insert is provided with a plurality of removably-gauging positions on the device, with each gauging position corresponding to a slightly different configuration, such as a radial expansion diameter of the device. In the exemplary embodiment of the invention shown in FIG. 1A, the incontinence device 100 is provided with a conical insert 118. The conical insert 118 is designed such that in the insertion in a conical recess 122, located precisely next to the node 108. , the conical insert 11.8 applies radial pressure outwards to the support arms 114, thereby causing them to diverge and support the urethra. Choice .1 mind, cl. conical insert 118 is inserted into the conical recess 1.22 in the deployment of an applicator, via the pressure of a plunger. Optionally, the conical insert 11.8 is pre-positioned in the conical recess 122 before deployment. Optionally, the varying sizes of the conical insert 118 are used depending on the desired extension of the support arms 114. In an exemplary embodiment of: the invention, the conical insert 118 once deployed in the conical recess 1.22 is removably attached by friction and / or pressure. The friction is created between the outer surface of the insert
conical 118 and the surface facing the. conical insert 118 of the conical recess 122. This friction resists the. movement of the conical insert 118 of the conical recess 122, especially with the addition of pressure exerted on the conical insert 118 with the support arms 1.14. In an exemplary embodiment of the invention, the pressure on the conical insert 11.8 by the support arms: 1.14 is ultimately derived from the pressure on the device 100 of the vaginal wall. In some embodiments of the invention, the conical insert 118 is constructed of any material, capable of pushing the support arms 114 Liacia out. Optionally, the device 100 is placed below the middle urethra to support. Optionally, any of the devices described in the present gives medium urethral support. The conical insert 118 is optionally constructed of the same material as the device 100. Optionally, the conical insert 1.1.8 is constructed of a material, harder and / or stiffer and / or denser than the device 100 to provide increased resistance. to the back pressure of the vaginal wall. In some exemplary embodiments of the invention, a removal device 116, such. Like a string, it is attached to. conical insert 11.8. With reference to Fig. IB, a profile view of the incontinence device 100 with the conical insert 118 is shown during the removal of the. device 100, of
according to an exemplary embodiment of the invention. In some embodiments, the application of a downward force, a force away from the cervix, dislodges the conical insert 118 from the conical recess 122. Once the support has given it to the support arms 114 it is removed. removing the conical insert 118, are more easily able to converge towards the central axis 150 facilitating easier and / or more comfortable removal of the device 100 than if the arms 11.4 were fully deployed with the reinforcement of the. conical insert 118. Optionally, the. conical insert 1.18 remains: within cover 120 in the detachment from conical gap 122. Optionally, alternatively, alternatively, a removal device is attached to cover 120 where a downward force exerted on it. The removal device causes the cover 120 to collapse on the support loops 114, leading them towards the central axis 150 and thereby reducing the radial profile of the device 100 for easier removal. Fig. 2A shows a profile view of an incontinence device 200 with a geometrical gaging insert 202 according to an exemplary embodiment of the invention. The device 200 is slightly different than the device 100 in that it is optionally comprised of more than one piece. The addition of at least one additional piece allows part of the insert to close with it.
device 100 and part of the insert be removed to assist in the removal of the device 200. Further, in some exemplary embodiments of the invention, an outer ring 206 of the device 200 is capable of mechanically closing on the support arms. The device 200 is shown in an applicator 204 which can optionally be used to deploy the device 200 in the vagina. In some exemplary embodiments of the invention, the device 200 is comprised of a plurality of components. Optionally, the. outer ring 206 is provided which is adapted to be closed in a groove 208 located on the inner surfaces of the support arms 210. Optionally, a plurality of grooves are located on the inner surfaces of the support arms 21.0, the outer ring 206 that is pushed from the slot to the slot until the desired radial expansion of the support arms 202 is achieved. Optionally, an internal insert 212 adapted to geometrically couple with the inner surface of the outer ring 206 is provided such that the inner insert 212 can be inserted through the. outer ring 206. Optionally, more than outer ring 206 and inner insert 212 comprise the geometric gauging insert 202. Optionally, a connecting device 214 is provided which maintains inner insert 212 in close proximity to outer ring 206 in an orientation
suitable for the insertion of internal insert 212 through the. outer ring 206. In an exemplary embodiment of the invention, device 200 is stored in an applicator 204 in a partially assembled state, such. as shown in Fig. 2A. In some exemplary embodiments of the invention, the maintenance device 200 in a partially assembled state, particularly where the outer ring 206 is not closed in the slot 208, the device adapted to better support the storage efforts while not in use, allow longer storage and / or greater efficiency of the device 200. The deployment of the. device 200 is illustrated in Fig. 2B where the. inner insert 202 is pushed through outer ring 206 by a plunger 216 (shown in FIG. 2A), in an exemplary embodiment of the invention. In the coupling of the outer ring 206 by the internal insert 21 ?, the outer ring 206 is pushed towards the slot 208 by the continuous pressure towards the cervix on the plunger 216. The device 200 eventually closes itself in the slot 208, which in turn pushes the radially reliable support arms 210 out in a position deployed in this manner by exerting a predefined support tension in an exemplary embodiment of the invention. Fig. 2C illustrates a device 200 in a mode
deployed according to an exemplary embodiment of the invention. It can be seen that the outer ring 206 is stuck in the groove 208, which is formed to engage with a predetermined outer ring profile. Optionally, the multiple slots are provided which are capable of receiving the outer ring 206, with each slot defining a different configuration of the device 200. Optionally, the outer ring 206 is formed to prevent misapplication, for example with slots for accommodating the support arms 210. The inner insert 212 is removably positioned within the outer ring 206. Optionally, the inner insert 202 is held in the right place by frictional forces between the outer ring 206 and the inner insert 212. Optionally , the internal insert 212 e: s maintained in the precise place by compression forces of the support arms 210. FIG. 2D is a view of perf. vi of the device 200 showing the removal of the device 200, according to an exemplary embodiment of the invention. The removal of the device 200 is optionally removed by pulling on the removal device 216 away from the cervix. Optionally, the removal device 218 is attached to the internal insert 212. Additionally or optionally, the removal device 218 is attached to the device 200. Sufficient force on the removal device 218 in a
direction away from the cervix dislodges the inner insert 212 from the outer ring 206 in accordance with an exemplary embodiment of the invention. In an exemplary embodiment of the invention, the sufficient force is such that it is enough to remove the inner insert 212 from its friction fit to the outer ring 206, taking into account finally the pressure given to the inner insert 212 of the vaginal wall by the via. device 200 and outer ring 206. Once the at least partially flexible outer ring 206 is no longer reinforced by internal insert 212, support arms 21.0 are left to converge towards it. central axis of the device 200 allowing easier and / or more comfortable removal of the device 200. Optionally, a cover is used in conjunction with the device 200. In an exemplary embodiment of the invention, the cover can also contribute to converge the arms of the device. support 210 towards the central axis during the removal. Optionally, a removal device is attached to the cover. With reference to Fig. 3A, an incontinence device 300 is shown with an insert of variant geometry 302, according to an exemplary embodiment of the invention. In some exemplary embodiments of the invention, the device 300 is different from the device 100 and the device 200 in that the variant geometry insert 302 traverses the length of the. central node. device 300,
as opposed to staying essentially within the confines of the support section. The variant geometry is provided to the insert 302 in order to perform at least three basic functions with respect to the device 300. First, the distal protrusion is used to prevent the insert 302 from being pulled out of the 300 device. next side of. device 300, in an exemplary embodiment of the invention. Second, a bulge extrusion 316 is used to secure the insert 302 al. device 300 when in an unfolded condition, in accordance with an exemplary embodiment of the invention. Third, a support protrusion is used to provide support to the support arms of the device 300 in accordance with an exemplary embodiment of the invention. In an exemplary embodiment of the invention, the device 300 is represented in an applicator 304 adapted for deployment of the device 300 in a vagina to provide urethral support. Optionally, the urethral support includes the urethral support, medium. Optionally, the device 300 is used in conjunction with a cover 306. In an exemplary embodiment of the invention, a plunger 308 is provided to the proximal end of the applicator 304 to facilitate deployment of the device 300, where the proximal end is toward the vaginal opening and the Dysstal end is towards the cervix. Optionally, only two different protuberances
they are present. In an exemplary embodiment of the invention, the distal end of the insert 302 is a distal protrusion 310 located in a recess located at the convergence of the fixation arms 31.2. Optionally, the distal protrusion 310 is adapted and constructed to resist, optionally, the. passage of the complete insert 302 away from the cervix through a channel 314 which passes through the device 300 and accommodates the insert 302. A bulge protrusion 316 is optionally located between the distal and proximal ends of the insert 302 and is formed, in accordance with some exemplary embodiments of the invention, to be coupled with a catcher baffle 218 located on channel 314. A support boss 320 is located at the proximal end of insert 302 in an exemplary embodiment of the invention. In some exemplary embodiments of the invention, the device 300 is a device with multiple stable configurations, as described below. Fig. 3B illustrates the incontinence device 300 in an exemplary deployed configuration, wherein the insert 302 is advanced through the channel. 314 such that the bump protrusion 316 is removably stuck in the gauging hole 318. In some exemplary embodiments of the invention, the mating protrusion 316 and / or el. Gap hole 318 are placed
sufficiently far from the support protrusion 320 such that when in the removably jammed condition, the support protrusion 320 is in a position to reinforce the support arms 322. In an exemplary embodiment of the invention, the support protrusion 320 pushes the support arms 322 radially outward in a predetermined position, optionally depending on the shape of the support protrusion 320. Optionally, the support arms 322 support the middle urethra. The removal of. device 300 is optionally achieved in undoing the insert 302 of the gauging recess 318 and dislodging the support protrusion from its deployed position at the support convergence 322. Optionally, the removal of the support. incontinence device 300 is effected by pulling a removal device 324, shown in FIG. 3C away 326 from the cervix. In an exemplary embodiment of the invention, sufficient force applied for the removal of the device 324 causes the gaging protrusion 316 to become dislodged from the gauging hole 318, undoing the gaging protrusion 316 and allowing movement of the insert 302 toward the vaginal opening. In an exemplary embodiment of the invention, the distal protuberance. 310 stops the downward movement of the insert 302 when it reaches the gap making the convergence of the fixing arms 312 because it is larger in size
that the channel 314. The downward force continued on the removal device 324 causes the. device 300 be removed from the vagina as the removal device 324 is attached to the insert 302 which is not removable from the device 300. Optionally or additionally, a removal device 324 is attached to the cover 306. Optionally, the removal is aided by the cover 306 which pushes the support arms 322 towards the central axis of the device 300, allowing easier and / or more comfortable removal. With reference to Fig. 15A, an expanded incontinence device 1500 is shown which is provided with an o-ring-shaped insert 1502, examples of which is shown in more detail in Figs. 15C and D, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, the 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 wall. vaginal and adapted to receive the o-ring insert and removably contain the insert 1502 there. during use of the incontinence device 1500. While in use, the support arms 1506 of the incontinence device 1500 are pushed radially outwardly by
the amllo-o 1502 insert to support an urethra. Optionally, the middle urethra is supported by the support arms 1506. In some exemplary embodiments of the invention, the incontinence device 1500 is provided with a cover 1508, which operates similiarly to other covers described herein. In some exemplary embodiments of the invention, the amlLo-1502 insert is not located in the slit 1504 prior to deployment of the incontinence device 1500 into a vagina, and is placed there during the use of the deployment, for example, a plunger as described with respect to other embodiments. The Fi g. 15B shows a cross-sectional view of the incontinence device 1500 during removal, in accordance with an exemplary embodiment of the invention. In order to facilitate the removal of the incontinence device 1500, in some exemplary embodiments of the invention, a retraction device 1510 is provided to dislodge the insertion of amllo-o 1502 from the recess 1504. The removal device 1510 is attached to ring insert 1502 and is also optionally attached to incontinence device 1500 to allow removal device 1510 to assist with removal of incontinence device 1500 from the vagina in which it is being used and / or for Produce loose objects to float around inside the user's body. In some
Exemplary embodiments of the invention, the removal device 1510 is secured to the incontinence device 1500 by threading a portion of the removal device 1510 through the central node of the incontinence device. In some exemplary embodiments of the invention, an enlarged portion 1512 is used to prevent the removal of L device 1510 from the run through the central node during removal. The force exerted on the removal device 1510 in a direction away from the user's cervix will result in the removal of the insert from the ring 1502 of the ilioptrum 1500 and eventually the incontinence device 1500 as a whole from the vagina. in some exemplary embodiments of the invention. In some exemplary embodiments of the invention, an insert 1602 is provided which is at least partially elastic to an inconsistency device 1600, as shown in FIG. 16 ?. The ig. 16? shows the incontinence meter 1600 in a storage configuration, for example if the device 1600 was in an api icator. In the storage configuration, the elastic insert component 1604 is stretched such that it is longer than the device 1600, as shown in Tig. 16A. In such a configuration, the enlarged nature of the insert 1602 does not cause the radial expansion of the support 1608 and / or the fixation arms 1610 of the
device 1600, as shown in Fig. 1.6B. This is mainly due to the stretchable nature of the component of the elastic insert 1604 which allows the insert 1602 to remain outside the area of the support arms 1608 and / or fixation 1 1.0 of the device 1600. In some exemplary embodiments of the invention, the insert 1,602 is comprised of a plurality of component parts, for example the elastic insert component 1604 and an internal insert insert component 1606. In some exemplary embodiments of the invention, the internal insert component 1606 is adapted to be removably coupled with the elastic insert component 1604. Optionally, internal insert component 1606 exhibits different material properties than elastic insert component 1604, for the reasons described below. In an exemplary embodiment of the invention, an elastic insert component 1604 and an internal insert component 1606 are used in combination to provide radial expansion during deployment of the support arms 1,608 and the fixation arms 1610 of the incontinence device 1600. In some exemplary embodiments of the invention, the internal insert component 1606 is attached to the elastic insert component 1604 with a cord, which penetrates the length of elastic insert component 1604 and which is secured to the component: of elastic insert 1604 with a
expanded end 1612 at the attachment site of device 1600. Optionally, expanded end 1612 is a knot formed by knotting and / or fusing the cord. It should be noted that in some exemplary embodiments of the invention the string has to be quite long to allow stretching of the elastic insert component 1604, which hollows the internal insert component 1606, to make it longer than the device 1600. With reference to the Fig. 1613, the incontinence device 1600 is shown in a deployed configuration, in accordance with an exemplary embodiment of the invention. In the deployment of the device 1600 outside of an applicator, the support arms 1608 and fixation arms 161.0 are free to expand radially. In an exemplary embodiment of the invention, this freedom of movement is sufficient to allow the stretched insert 1602 to return to its nominal state. Ei. Insert 1602 is not: stretched from: to a fixing end camping 1614 del. Elastic insert component 1.604 leads clamping arms 1610 radially outwardly and enlarged internal insert component 1604, aligns within elastic insert component 1604, to bring support arms 1608 radially outward as they collapse inwardly toward each other. center of the device 1600. In some exemplary embodiments of the invention, the. internal insert component
1606 is maintained within the elastic component 1604 by friction of the two components. In some exemplary embodiments of the invention, the elastic insert component 1604 is provided with a slight flange around its opening which helps retain the internal insert component 1606 within the elastic insert component 1604. In such an embodiment, the flange does not it is sufficient to withstand the removal forces exerted on the internal insert component 1.606, as described hereinafter, thereby releasing the. inner insert component 1606 and allowing removal of device 1600. Fig. 16C shows an exemplary removal configuration of incontinence device 1600, in accordance with an exemplary embodiment of the invention. The internal insert component 1606 is optionally dislodged by pulling a removal device 1616 in order to facilitate the 1600 removal device, in some exemplary embodiments of the invention. The evacuation of the internal insert component 1606 reduces the outward radial force exerted on the support arms 1608 allowing the support arms 1608 to return to a less expanded, nominal state for easier removal. In some exemplary embodiments of the invention, the support arms 1608 compress the elastic insert component 1604, causing it to deform, when the support arms 1608 return to their
nominal state. As with other incontinence devices described herein, the force on the removal device 1616 away from the cervix of the user causes the internal insert component 1606 to dislodge and the continued force finally removes the 1600 device from the vagina. exemplary embodiments of the invention, the device 1600 is provided with a cover 1618. 1 n a modality to the alternative, represented in the] ** i. 16D, sc provides the incontinence device 1600 with a central node attached. Optionally, the interface in the umon is similar to a ball joint. In some exemplary embodiments of the invention, the nature attached to the central node results in a fastening section 1620 and a support section 1626 of the device 1600 that is capable of moving in a manner independently as a result of the efforts that are applied to them. through the movement of the user. In some exemplary embodiments of the invention, the support section 1622 and J to the fixing section 1620 are maintained in a friction causing the relationship by the elastic insert component 1604
It should be noted that in some exemplary embodiments of the invention, such as those shown in FIGS. 16 and 1 /, at least part of the incontinence device is comprised of more than one bad waste. Optionally, the insert is comprised of more than one
In some exemplary embodiments of the invention, the insert is made of a first material that is at least partially flexible and / or a second material that is rigid enough to expand the support section of the incontinence device when it is in the appropriate position to do it. In some exemplary embodiments of the invention, the insert is at least more rigid than the support section of the. incontinence device. In an exemplary embodiment of the invention, the first material is used for the elastic insert component 1604 and / or the second material is used for the internal insert component 1606. The selection of various materials is optionally based on the objectives for the operation of the incontinence device. For example, a stiffer material is optionally used for the elastic insert component 1604 if it is desired in the removal of the insert component nl.cr.no 1606 that the support section still remain partially expanded. Optionally, a less rigid material is used for the internal insert component 1606 if it is desirable to increase comfort to the user and / or reduce the comfort. degree of radial expansion of the d ive po rt. With reference to Figs. 17A-C, there is shown an incontinence device 1700 which also has an insert 1/02 which esenc ally a plurality of
rcmov components i bly adjusted together. A difference between the incontinence device 1700 shown in Fig. 1 / and the incontinence device 1600 shown in L Fig. 16 is the attachment end 1704 of moterto 1/02 is not widened to cause expansion. of the fixing arms 1 / 06. In an exemplary embodiment of the invention, because the fixing end 1704 of the insert 1702 is not widened, it does not have to be external to the fixing arms 1706 during storage, which It is reflected in the embodiment shown in Fig. 17A It can be seen that in storage, the fixing end 1704 of the insert 1702 does not exert radial expansion force on the fixing arms 1/06. 1700 incontinence device during deployment and Fig. 17C shows device 1700 during removal.The device 1/00 is optionally provided with a cover 1714. In addition to providing a modality in which the lasso If the fixing support 1706 is not radially expanded, the storage force on the insert 1/02 is reduced in relation to the embodiments shown in FIGS. 16A-D because the insert 1702 does not need to be stretched as much by the same device when it is in storage. Also, in the deployment, only one side of insert 1702 needs
de-stretched in order to cause radial expansion as opposed to the two sides of the insert 1602 (fixing and support) as shown in Figs. 16A-D, avoiding a two-stage deployment (first the fixation arms as they become free of the applicator, then the support arms :) of the device 1700. An alternate mode of the incontinence device 1700 in which the support arms 1708 are configured to accommodate the elastic insert component 1710 by recessing the inner insert component 1712 without them having to be outside of the support arms 1708 during: the. storage, is shown in Fig. 17B. In some exemplary embodiments of the invention, this allows a shorter string to connect the inner insert component 171.2 to the elastic insert component 1710, and also allows a shorter elastic insert component 1710. With reference to Fig. 18A, an incontinence device 1800 is shown which is provided with an insert seat 1,802 adapted to removably receive an insert 1804 in accordance with an exemplary embodiment of the invention. Optionally, the insert seat 1802 connects a fastening section 1806 and a support section 1608 of the incontinence device 1800 together. In an exemplary embodiment of the invention, the insert 1804 is
flared to provide radial expansion to the insert seat 1802 and / or to the support section 1800 when the insert 1804 is fitted in the insert seat 1802. An integrated resilient support module 1820, described in more detail below with with respect to Fig. 5, it is shown in use with the incontinence device 1800. It can be seen from Fi. 1813 that in some exemplary embodiments of the invention, the integral support member 1 and integrated lens 1820 is adapted to cause radial expansion of the support section 1808 when the insert 1804 is fitted in the insert seat 1802. The widened sides of the Insert 1804 exerts pressure on the opposite ends of the integrated resilient support member 1820 by carrying it radially outward, and thus the support section 1808 and / or a support arm 1816 radially outward. In an exemplary embodiment of the invention, the slope of the widened extensions and optionally their length determines the amount of this effect. While Fig. 18A shows the incontinence device 1800 in a deployed configuration, it should be understood that optionally the insert 1804 is not optionally fitted to the insert seat 1802 while in storage. For example, the insert 1804 is pushed into a position fitted to the mote 1804 seat by a plunger, as described elsewhere in FIG.
present, during the deployment of an api icator. The lig. 1813 shows the incontinence device 1800 in a removal configuration, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, incontinence device 1800 is provided with a removal device 1812. The sufficient force applied to the removal device 1812 away from the user's cervix causes the insert 1804 to be dislodged from the insert seat 1802. , thereby removing the source of increased radial expansion of the support section 1800 and facilitating the removal of the LVO 1800 device. Alternatively, pulling the removal device 1812 causes a collapse of at least one support section 1808 and / or the 1802 seat of the device. Optionally, the seat 1802 is predisposed to collapse inward towards a central axis of the device 1800. The force away from the user's cervix is held in order to pull it. 1800 device out of the user's vagina. An expanded end 1814 of the removal device 1812 is used to prevent removal of the device 1812 from being pulled from the incontinence device 1800 during the removal and also to prevent separation of the insert 1804 from the rest of the device 1800. In some exemplary embodiments of the invention, the 1800 device is provided with a
cover 1810, 1822. With reference to Fig. 23A, an incontinence device 2300 is shown which is provided with a resilient, biased support section, in accordance with an exemplary embodiment of the invention. The device 2300 is comprised of at least one fastening section 2302, a support section 2304 and an insert 2306, in one embodiment of the invention. Optionally, the device 2300 includes a central node that provides an intercept and / or bridging structure between the fastening section 2302 and the support section 2304. In some exemplary embodiments of the invention, the support section 2304 is comprised of a plurality of arms 2310, two of which are shown in Figs. 23A.B. In an exemplary embodiment of the invention, the fastening section 2302 is formed of a biocompatible material and operates similar to other fastening sections described herein. The fastening section 2302 is attached to the support section 2304, for example using a retainer 2308 as shown in Fig. 23A. In an exemplary embodiment of the invention, the support section 2304 is formed such that it maintains a nominal compressed configuration (which is biased toward a central axis of the device 2300), but is flexible enough to be placed in an expanded configuration by the
insert 2306 (as shown in Fig. 2313). In some exemplary embodiments of the invention, the support secund 2304 applies to a certain degree of support when in the compressed configuration. Optionally, the support section 2304 is a leaf spring which is biased towards a central axis of the. device 2300. Optionally, the support section 2304 is formed with an integrated resilient support member, as shown in F g. 5. Option 1, the support section 2304 is comprised of a metal. Alternatively or additionally, the support section: 2304 is comprised of plastic. In an exemplary embodiment of the invention, the ends of the arms 2310 are capped with a tibial or soft material in order to provide increased comfort to the user. Optionally, the material covering the arms 2310 is flexible, such as rubber or plastic. In some embodiments of the invention, the insert 2306 is capable of being used with a device 2300 with only two support sections 2304 and the arms 2310. In the operation, the insert 2306 is brought up towards the. retainer 2308 with a plunger (n shown). The continued pressure that the plunger uses in this direction causes the device 2300 to eventually deploy outside of an applicator (not shown), assuming the deployed position shown in F.i g. 13B. Fig. 2313 shows the insert
2306 within the support section 2304 which is flexed at the flexion points 2312 during the position of the insert 2306 therein. The reconfiguration of support section 2304 that supports is a result of the. positioning of the insert 2306 within an exemplary embodiment of the invention. In an exemplary embodiment of the invention, the insert 2306 is maintained within the support section 2304 by the compressive force applied to it by the skew support section 2404. In one embodiment of the invention, the removal of the device 2300 is by the force path down on the 2314 removal device away from the cervix and toward the vaginal opening. The insert 2306 is: dislodged from the support section 2304 by this force on the removal device 2314 leaving the arms 2310 collapsed to the compressed configuration and allowing comfortable removal of the device 2300. In one embodiment of the invention, the device 2300 is provides a cover 2316 similar to those described elsewhere herein. With reference to Fig. 27A, an incontinence device 2700 is shown with an expandable insert 2702, in accordance with an exemplary embodiment of the invention. The device 2700 is shown deployed, for example as it would be in a vagina of the user. An insert head 2706 is expanded by an insert expander 2704 in a
The unfolded configuration and in an insert head of removal configuration 2706 is contracted, or contracted of its own accord, by removing the insert expander 2704, in accordance with an exemplary embodiment of the invention. In an exemplary deployed configuration, the insert expander 2704 is positioned within a slot in the insert head 2706. In some exemplary embodiments of the invention, the insert head 2706 is expanded by the insert expander 2704, causing the head of the insert 2704 to expand. insert 2706 exert pressure on support arms 2708 of device 2700. In an exemplary embodiment of the invention, the pressure exerted by insert head 2706, as a result of insert expander 2704, causes radial expansion of the support arms 2708 and subsequently the. treatment for incontinence. In an exemplary embodiment of the invention, the insert expander 2704 is not placed in the insert head 2706 during storage. Optionally, the insert head 2706 is flexible. In an exemplary embodiment of the invention, the expandable insert 2702 has an expanded expansion that prevents the expandable insert 2702 from being pulled through the device 2700 during removal, as shown in Fig. 2713. Fig. 27B shows the device of Incontinence 2700 in a removal configuration, according to a
exemplary embodiment of the invention. The removal is initiated by pulling the. removal device 271.0 which dislodges the insert expander 2704 from the insert head 2706, in some exemplary embodiments of the invention. In the eviction of. insert expander 2704 of insert head 2706, insert head 2706 substantially releases the force exerted on support arms 2708 allowing them to contract, or at least making them less resistant to collapse towards a central axis of device 2700, for easier and more comfortable removal of the device 2700. In one embodiment of the invention, the device 2700 is used with a cover 2712 which is provided with an opening that is dimensioned such that the removal device 2710 can pass but not the expander of insert 2704, due to the larger size of the insert expander 2704. The downward force continued on the removal device 2/10 away from: the cervix towards the vaginal opening will eventually cause the insert expander 2704 to capture on the cover 2712 near of the opening (since it can not pass through the opening) and pull the 2700 device out of the vagina. As described elsewhere herein, the force applied to the cover 2712 using the removal device 2710 also aids in the contraction of the support arms 2708 facilitating the removal of the. 2700 device.
With reference to Fig. 28A, an incontinence device 2800 with a ring insert 2802 is shown in a storage configuration, in accordance with an exemplary embodiment of the invention. An exemplary ring insert 2802 can be seen in perspective in Fig. 28C. The support arms 2806 of the device pass through the openings 2850 between the ring and the central portion of the ring insert 2802, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, the ring insert 2802 is not placed within the 2800 device while the 2800 device is in storage, extending life and improving performance. In an exemplary embodiment of the invention, a removal / activating device 281.2 is attached to a removal / activation plate 2814 located distally from a central portion of the device 2800. In an exemplary embodiment of the invention, the deployment of the 2800 device is started when pulling down on the removal / activating device 2812, causing the device 2800 to move toward the proximal end of the applicator 2808, and affecting a roll of the. ring insert 2802 in the incontinence device 2800. In an exemplary embodiment of the invention, the activation projections 2816 are provided to the applicator 2808 to provide a counterforce to the chuck of the device.
2800 on the insert 2802. Optionally, the plunger 2804 is used to force the. insert 2802 in the device 2800 to apply the radial expansion force to the support arms 2806, which will assume its deployed configuration in the ejection of the. 2800 device 2808. The. deployment outside the. apiicador. 2808 and within the vagina is performed as described with respect to other embodiments herein. An exemplary deployed configuration of the device 2800 is shown in Fig. 2813. In an exemplary embodiment of the invention, the anchor insertion Lo 2802 is placed through the device 2800 such that an insert head 2810 is located on the side. Dista! of the device 2800. Optionally, the insert head 2810 is formed, for example similar to an arrow head, to allow its passage through the device 2800 during deployment, but to prevent passage of the insert 2802 back through the device 2800, to the original configuration, later. In an exemplary embodiment of the invention, in a deployed ring insert 2802 applies force to the support arms 2806 causing them to radiate radiantly outwardly. Optionally, the 2800 device is provided with the. removal / activating device 2812, which, in addition to activating incontinence device 2800, may be useful similar to other removal devices described herein. Optionally, the
disposit i vo 2800 is provided with a cover. Di esposi ti es Exemplary with Multiple Configurations
Stable for 1 rat r the Incontinence. In some exemplary embodiments of the invention, incontinence devices are provided with multiple stable coni raciones ions to treat incontinence. Optionally, a stable bi component is used to provide incontinence devices with a first stable position, for storage and / or removal, and a second stable position, for incontinence treatment. As used herein, the stable bi component is sometimes referred to as an insert, a gauging element and / or a ring and asymmetry. The 1 ígs. 4? -C and 14A-B show modalities and methods of the bistable inserts used with incontinence devices that do not move their tannins at the same time in relation to the incontinence device in order to transfer from the first stab position to the second. The igs. 3? -C, in the foregoing, and Fig. 20A-C, described immediately in another section, show an exemplary embodiment of a bistable device where the stable bi component moves relative to the incontinence device when transferred from the first stable position to the second stable position. It should also be noted that in an exemplary embodiment of the invention, the deployment
of the bistable devices occurs after the devices are properly placed inside the "vaulted" vagina in its second stable position when the bistable insert is changed to the second position. In an exemplary embodiment of the invention, jumped deployment is more comfortable than other forms of deployment described hereinbefore because the support arms do not press against the vaginal wall until the incontinence device is ready in a position to give incontinence treatment. FIG. 4A is a profile view of an incontinence device 400 with a bistable, reversing insert 402 located in an applicator 406 in accordance with an exemplary embodiment of the invention. The insert insert 402 resembles a flexible bowl-shaped membrane, in an exemplary embodiment of the invention. The insert 402 is constructed such that when the membrane is biased towards the proximal end of the device 400 in a first configuration, the insert membrane 402 is flaccid. However, when the membrane is pushed through the center of the insert 402 towards the distal end of the device 400, the insert membrane 402 exerts pressure that expands radially on the support arms 404 of the device 400 and the arms 404"jump" in the position. In an exemplary embodiment of the invention, the insert membrane 402 has
variable wall width, and therefore, different voltage at each point. Optionally, the insert 402 is located between the support arms 404 of the device 400. Optionally, the insert membrane 402 is pushed through its own center, thus deploying the device 400 in a second configuration, by means of a plunger. 408 located at the proximal end of the applicator 406. FIG. 413 is a profile view of the incontinence device 400 with an inverted insert 402 deployed, in accordance with an exemplary embodiment of the invention. It can be seen in this exemplary embodiment that during plunger 408 pushed insert membrane 402 through its center, biasing it towards the distal end of device 400. As described herein, the membrane is constructed so that when it is bias towards the proximal end of the device 400 is flaccid, and when biased towards the distal end of the device 400 is sufficiently rigid to apply radial pressure to the support arms 404 causing them to increase their diameter for the urethral support. Optionally, the urethral support is the middle urethral. The removal of the device 400 is shown in Fig. 4C, which shows a profile view of the incontinence device 400 with an optimal removal device.
410, such as a line The force on the removal device 410 in a proximal direction, away from the cervix causes the membrane of the insert 402 to reinvest the transformation of the membrane from at least semi-rigid to flaccid. The reduced radial pressure exerted by the insert membrane 402 facilitates the movement of the support arms 404 towards the central axis of the device 400 for ease of removal. In some exemplary embodiments of the removal, the continued force on the removal device 410 pulls the support arms 404 toward the central axis of the device 400 and toward the vaginal opening. Adjacent, alternative or optionally, the removal device 410 is fastened to a cover 412 which, when the downward force is applied to the removal device 410, exerts pressure on the support arms 404 towards the central ee of the device 400 for more ease of removal. l modality represented in the Tigs. 4A-C is optionally used with an integrated resilient support, as described below with respect to FIG. 5. With reference to the lig. 14A, a cropped view of an applier 1402 is shown, depicting a bistable incontinence device 1400 herein, in accordance with an exemplary embodiment of the invention. The bicsfablc insert of the I gs. 14? -I3 cs different from that of the Ligs. 4A-C in which before uL i 1 / r a membrane exhibiting the
First and second stable positions depending on their biases, the mechanical arms are provided exhibiting the first and second stable positions. As described with respect to the other embodiments of the incontinence device herein, the bistable incontinence device 1400 is configured in a reduced diameter shape for storage within the applicator 1402. The applicator 1.402 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. In an exemplary embodiment of the invention, the bistable incontinence device 1400 is provided with a bistable gauging member 1508 which is attached to a support arm restraining element 1,606. The bistable gauging element 1408 is optionally configured such that in a first stable position, where the bistable gauging element 1508 is biased towards the support arms 1404 of the device 1400, the bistable gauging element 1208 does not substantially push the element. of reinforcement of support arm 1406 radially outwards. However, in a second stable position, where the bistable gauging element 1408 is biased toward the clamping arms 1420, shown in Fig. 1413, of the incontinence device 1400. In some exemplary embodiments of the invention, a
plurality of arms of rc forzami in to are attached to the support arms 1404 of incontinence device 1400 such that when the bistable gauging member 1408 is in the second stable position the arms of to force in push the support arms 1404 It extends outwardly from a central axis of the il- ious beam 1400. Optionally, each support arm 1404 is provided with a reinforcing arm. Optionally, the selected support arms 1404 are supplied with reinforce arms, for example, if the forced deployment of the support arms 1404 is only desired along a single axis. In some exemplary embodiments of the invention, the support arm reinforcement element 1406 has a center portion L with a male gauging cylinder 1416. Alternatively, the bistable seal member 1508 is provided with a central female gauging cylinder receiver, which allows the bistable element 1408 to be clamped brazed to the support arm recess element 1406. The bistable gauging element which is bilently attached to the reinforcing element i on to support arm counteracts. The pressure of the vaginal wall which acts to bring the device 1400 in the first stable position. Optionally, the gauge cylinder 1416 is provided with a flange which is dimensioned
slightly larger than an inner circumference of the bucket cylinder receiver, which, optionally, is a hole located on the bistable buoyancy element, such. that when the throttle cylinder 1416 is pushed against it. 1416 gauging cylinder with sufficient force the receiver passes over it. the flange and becomes removably attached to the arm reinforcement element 1406. Optionally, the bistable gauging element 1408 is biased that when pushing the support arm reinforcing element 1406, the gauging element bistable 1408 abuts removably in a reposition position without the need to maintain the atorable. gauging cylinder 1416 with the. Reciprocating cylinder receiver. In some exemplary embodiments of the invention, the bistable gauging element 1408 is urged towards the support arm restraining element 1,406 by a plunger 1410. Optionally, the clamping force provided by the clamping arms 1520 is more than the force required to change the support arm forcing element 1408 from the first stable position to the second stable position such that at the insertion of the. device 1400 in the vagina, when the fixing arms 1420 are in position, prevent the device 1400 from moving towards the cervix since the pressure to "jump" in the
second stable position is exerted on the re-arm element on support arm 1406 by the plunger. Optionally, the incontinence device 1400 is provided with a removal device 1412 which is attached to the bistable gauging member 1408 such that it can change the position of the bistable gauging member 1508 from the second stable position to the first posi- tion. stable:. With reference to Eig. 1413, e: 1 bistable 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 the bistable mounting element 1408 is urged against the support arm retention element 1406, urging the biasing arms radially outward, and consequently the support arms 1404 radially outwardly from a central axis. of device 1400. In an exemplary embodiment of the invention, support arms 1404 provide support to an urethra. Optionally, the support is the medium urethral support. Optionally, the device 1400 is used in conjunction with a cover 1418, such as that described herein. The removal of the device 1400 is optionally facilitated by exerting a downward force on the removal device 1412 toward a vaginal opening. This force towards
below causes the biasing biasing element 1408 to change from the second stable position to the first stable position, removing the re-orientation of the support arms 1404 and allowing them to converge on a central axis of the device 1400. The reduction in the radial diameter of the device 1400 due to its convergence enables a more easy and / or more comfortable removal than if the support arms 1404 had remained deployed. In an exemplary embodiment of the invention, the flip-flop element 1408 is provided with reinforcing arms and the central portion of the bracket arm re-arm element 1406 is omitted. Ring Inconti ng Devices The astorne rico Example
Some of the modalities described in this section are provided with multiple stable configurations, for example those represented in the bigs. 20? -C. In some exemplary embodiments of the invention, an elastomeric ammo is used to provide an incontinence device 2000 with radial expansion and / or contraction, depending on whether the annulus 2002 is in the first stable position or the second stable position. Optionally, the radial expansion and / or contraction is caused by the properties and / or configuration of the material of an incontinence device and an element is selectively placed to prevent specific configurations of
manifest themselves With reference to Lig. 20A, The incontinence device 2000 is shown in a first stable position, or a storage configuration, in accordance with an exemplary embodiment of the invention. The elastomeric ring 2002 is initially located in a first slit 2004, located between a section of fixation 2002. of the incontinence device 2000 and a second slit 2008 in some exemplary embodiments of the invention, is used to help maintain the device 200 in a storage configuration, in an exemplary manner of the invention, the first slit 2004 is located on the body of the device 2000 where when the elastomepco ring 2002 applies pressure to the device 2000 from the first slit 2004 the support and fixing arms 2012 do not push radially outwards. In some exemplary embodiments of the invention, the 2002 wave ring is comprised of Latex, rubber, if 1 Leone, polyurethane or naleon. Optionally, the 2002 elastomepco ring is constructed of at least slightly elastic material. In some exemplary embodiments of the invention, the elastomeric ring is not elastic and / or flexible. In some exemplary embodiments of the invention, the elasticity and / or fl exibility aids the olastomeric ring 2002 in the movement of the first slit 2004 the second slit 2008 and / or remains in the
slits 2004, 2008. In some exemplary embodiments of the invention, the 2002 ring uses its elastic ability, similar to a garter, to apply pressure to the 2000 device while the 2002 ring is in a slit, thereby helping to retain the ring 2002 in the slit and also in the case of the first slit 2004 maintaining the device in a storage configuration and in the case of the second slit 2008 helping the radial expansion of the support arms 2010 and fixation 2012. Optionally, the Elastomeric ring is not ring-shaped, it is optionally square, rectangular, triangular, ovoid or u-shaped, for example. The deployment of the incontinence device 2000 transitions the elastomeric ring 2002 from a first stable position where the ring 2002 is located in a first groove 2004 to a second stable position, where the ring 2002 is located in a second groove 2008, according to some exemplary embodiments of the invention. As the device 2000 moves in an applicator 201.4 towards an outlet of the applicator 2016, the elastomeric ring 2002 hits a transition element 2018 located on the interior surface of the applicator 2014. The device 2000 is subjected to the sustained pressure for the deployment, pushing the device 2000 outside of. 2014 applicator, while the elastomeric ring 2002 is pushed
per transition element 2018 down the outer surface of the. device 2000 until it seats in the second groove 2008. In some exemplary embodiments of the invention, the second groove 2008 is adapted to prevent further movement of the elastomeric ring 2002 as a result of the transition element 2018, and by further pressing on it. device 2002 deploying device 2000 in one position, optionally in the vagina of the user. Optionally, the first slit 2004 and / or the second slit 2008 are adapted to allow the movement of the ring 2002 out of the first opening 2004 as a result of the meeting of the transition element 2018 but to prevent the movement of the ring 2002 out of the second. slit 2008. For example, the second slit 2008 is deeper than the first slit 2004 in some exemplary embodiments of the invention. Fig. 20B shows the incontinence device 2000 in the second stable position, or in a deployment configuration, where the elastomeric ring 2002 is located in the second slit 2008, in accordance with an exemplary embodiment of the invention. When the elastomeric ring 2002 is located in the second slit 2008, the fixing arms 2012 are pushed radially outward partly because the compressive force exerted by the elastomeric ring 2002 in its second
slit position 2002 towards a central axis of device 2000 and due to a pivot point 2020 created by the curvature of the device 2000 at the first location of the slit 2004. In some exemplary embodiments of the invention, the pivot point is created by the coupling of the two points on at least two of the fixing arms which are the lowest in the curvature of the first slit 2004. In an exemplary embodiment of the invention, the support arms 2010 do not derive from the benefit of a slit curve, similar to the first slit 2004, therefore a pivot point is provided by placing a pivot piece 2022 between the elastomeric ring 2002 and the support arms 2010. Optionally, the pivot piece 2022 is a ball. In some exemplary embodiments of the invention, the pivot piece 2022 is located in a third slot 2024 adapted to receive the pivot piece 2022 and prevent it from falling before removal. As in the above, the pressure exerted by the elastomeric ring 2002 and the pivot piece 2022 causes the support arms 2010 to expand radially. In some exemplary embodiments of the invention, the pressure exerted on the device 2000 by the elastomeric ring 2002 is varied depending on the length of the leveler between the ring 2002 and a pivot point (pivot point 2020 and / or pivot part 2022) I the
desired effect to be achieved on the device 2000. Additionally or alternatively, the flexibility of the material from which the device 2000 is constructed is also taken into consideration. With reference to Fig. 20C, the 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 the incontinence device 2000 is reduced for easy removal of the device 2000, in some embodiments of the invention. Optionally, the reduction of the radial profile is achieved by dislodging the pivot piece 2022 using a removal device 2026 attached to the pivot piece 2022. In an exemplary embodiment of the invention, the force applied on the removal device away from the cervix and in the direction of: the user's vaginal opening causes the pivot part 2022 to disengage from the third slit 2024. This evacuation of the pivot part 2022 removes a part of the mechanism from which the support arms 2010 were deriving radial expansion, allowing the 2010 support arms to return to a reduced radial profile configuration. The force held on him. Removal device 2026 away from the cervix eventually removes the vagina device 2000 from. user. The removal device 2026 is optionally secured to the device
incontinence 2000 by screwing it to the central node of device 2000 and providing an enlarged end 2028 to prevent removal of device 2026 from being pulled out of the device during removal. In some exemplary embodiments of the invention, the device 2000 is provided with a cover 2030. While not necessarily a bistable device in some embodiments of the invention, the LVO device shown in FIG. 20D shows another exemplary embodiment of an incontinence device 2050 which utilizes a non-elastomeric ani 2052 to selectively apply pressure to the device 2050. The incontinence device 2050 shown in FIG. 2013 is similar to many of the other embodiments described herein, which use an insert 2054 to radically expand the support arms 2056 and / or provide support to the support arms 2056 against the back pressure exerted by the vaginal wall, and in this In the embodiment of the elastomeric ring 2052, when the device 2050 is deployed, the optional insert configurations which could be used with any of the modalities described herein are shown in FIGS. 201"" -]. In some exemplary embodiments of the invention, the hollow passage through the center of the inserter is to allow the passage of a removal device. In some exemplary modalities
In the invention, the inserts are configured to achieve several radial expansion electives on the support arms of the incontinence device. Optionally, the inserts are configured to make the incontinence device remotely attached. In an exemplary embodiment of the invention, the elastomeric ring 2052 acts in conjunction with the removal of the insert 2054 to force the radial contraction of the support arms 2056 for easy removal of the device 2050. In an exemplary embodiment of the invention, the force applied to a removal device 2058, as shown in fig. 201, dislodges the insert 2054. This allows the support arms 2056 to be free to convert to the central axis of the device 2050, and the elastomer ring 2052 applies pressure to the support arms 56 to reinforce this contraction movement. In an exemplary embodiment of the invention, in the sustained force away from the user's head, the 2050 device is removed from the user's vagina. A Modality as an Integrated Resilient Support Member Sample Eig. 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. Option 1 mind, the 500 device is any of
the devices described in the present. In an exemplary embodiment of the invention, the resilient support member 502 is used to bias the support arms 504 of the device 500. Optionally, the support arms 504 are biased in a radial configuration. expanded. Optionally, the support arms 504 are biased in a compact radial configuration. Optionally, the integrated support member 502 is embedded within the device 500. Optionally, the integrated support member 502 is located externally of the device 500, similar to a skeleton. In some exemplary embodiments of the invention, the integrated support member 502 is used in conjunction with the support arms 504 of the device 500. The integrated support member 502 is optionally constructed of a material with a permanent memory (such as steel). stainless or polymers, such as nylon or silicone-based materials). In an exemplary embodiment of the invention, an integrated shape memory support member 502 imparts to the device 500 an extended shelf life since it is compressed in the applicator for an extended time will not substantially decrease the spring coefficient of the integrated support member. 502. The integrated support member 502 is designed such that when the device 500 is deployed from an applicator, the integrated support member 502
it forces the support cups 504 to deploy radially outwardly from the central axis of the device 500 for the urethral support. Optionally, an integrated support member is used with the fixing arms 508. Removal of the device 500 is aided by joining a removal device 506 for the support arms 504. The force down on the removal device 506 away from the cervix, cause the support arms 504 to converge on the central axis of the device 500 enabling easier and / or more comfortable removal. Optionally, the removal device 506 and the integrated support member 502 are constructed of the same material. Optionally, the removal device 506 and the integrated support member 502 are manufactured simultaneously. In other exemplary embodiments of the invention, the integrated support members are used which skew the support and / or fixation arms. central axis of device 500 instead of away from the central axis. Such configuration is optionally used to provide better arm convergence for the removal of the incontinence device easier. Modality of Exemplary Voltage Reduction Arms With reference to Fig. 6, a profile view of an incontinence device 600 provided with support arms and / or reduction fixation 602, is shown.
according to an exemplary embodiment of the invention. The reduction in tension in the support and / or fixation arms 602 extends the shelf life of the device 600. In an exemplary embodiment of the invention, the area of an incontinence device which is subjected to the most stress and / or tension, the union between the support and / or fixation arms and the node, is reconfigured to distribute the stress and / or tension. Optionally, the effort and / or tension are reduced by extending them out of the greater area of the device. In an exemplary embodiment of the invention, the tension is optionally reduced on the support and / or fixing arms 602 by providing them with a section similar to an accordion 604 which folds within itself when compressed within an applicator. Optionally, folding is achieved without the use of articulations and / or other mechanical means. Optionally, other devices as described herein are provided with the tension reduction arms as shown in Fig. 6. However, in the deplnt of the applicator, in an exemplary embodiment of the invention, the arms of Support and / or fixation 602 deploy on their own to expand radially from the central axis of device 500. In an exemplary embodiment of the invention, arms 602 are deployed to provide medium urethral support. Optionally, the device 600 is used in conjunction with a cover,
such as that described herein. In some exemplary embodiments of the invention, the removal of the device is facilitated by applying a downward force, away from the cervix, to a removal device attached to the cover that encapsulates the device 600. As described in other embodiments herein , this force causes the device arms 600 to converge3 towards the central axis of the device 600, enabling easier and / or more comfortable removal than without the arm convergence. In an exemplary embodiment of the invention, an additional benefit of some embodiments of the stress reduction devices is the greater flexibility in device size and / or size of the applicator. Optionally, the voltage reduction configuration described herein allows the use of an incontinence device that has a larger diameter than would normally: be suitable for use with an applicator, for example in the use of prolapse devices, which generally require a larger diameter. Alternatively, a narrower applicator may be used for a voltage reduction device that when deployed exhibits a radius similar to a non-voltage reduction mode. In an exemplary embodiment of the invention, this is due to the folding nature of the arms 602 that occupy less space when folded than when
the arms 602 are in full expansion. In another exemplary embodiment of the invention, the folding of the arms enables the use of a larger central node that would typically be adjusted in an applicator, by increasing the length to fold the accordion section 604. Exemplary Displacement Incontinence Devices In some Exemplary embodiments of the invention, incontinence devices are provided which comprise at least one displacement section. Exemplary embodiments are shown in Figs. 7A-D and 8. These devices 700, 800 are distinguishable in at least one aspect of other incontinence devices described herein, in that before the support and / or fixation arms converge towards a central axis in order to to reduce the radial profile of the device, the displacement sections are provided with the ability to roll up to reduce the radial profile of the device. With reference to Fig. 7A; a profile view of a displacement incontinence device 700 is shown, in accordance with an exemplary embodiment of the invention. The device 700 is comprised of a central member 702, which when deployed optionally has a generally cylindrical shape. Optionally, located at or near the proximal and distal ends of the central member 702 are the arms of
support 704 (proximal end) and fixation arms 606 (at the distal end). In some exemplary embodiments of the invention, the central member 702 is comprised of a rolled sheet provided with arms 704, 706, as described more in detail with respect to Fig. 7C. In some exemplary embodiments of the invention, a removal device 708 is attached to the device 700 to facilitate removal. The removal device 708 is optionally attached to the device 700 such that when a downward force is applied to the removal device 708 away from the cervix, the device 700 exhibits a deformation behavior towards the vaginal opening thereby reducing its profile to the easiest removal. For example, a removal force on the removal device 708 optionally the proximal end of the device 700 in a conical-like manner with the peak pointed toward the vaginal opening. Fig. 713 is a profile view of another device modality of: displacement incontinence 720, wherein the device 720 has a proximal enlarged end, in accordance with an exemplary embodiment of the invention. A widened proximal end is optionally desirable in the incontinence treatment in order to provide additional support with the support arms 722 on the device 700, which does not have a proximal end enlarged. In a
exemplary embodiment of the invention, an enlarged proximal end allows the length of the support arms 722 to be made shorter, reducing a source of potential discomfort in the deployment and / or the use of the 720 slider. Mental option, The arms of support / 04, 722 are variable in length depending on the requirements of the patient. Optionally, the fixation arms / 06 located at the distal end of: the devices / 00, 720 are variable in length depending on the requirements of the patient. Optionally, the support and / or locking arms are long enough to prevent the vagina l from becoming caught in the crease between the two ends of the central member / 02. In some exemplary embodiments of the invention, the support and / or fixing arms are up to 10 mm in length. Opc ona 1 ment e, the arms are longer than 10 mm. Optionally, the arms are less than 5 mm in length. Optional, the support is given to the urethra measured. A top or bottom view of the displacement incontinence device / 00, according to an exemplary embodiment of the invention, is shown in Fig. 7C. It can be observed that when it is seen in conjunction with Mg. The central member 702 is optional, generally cylindrical in shape. In some exemplary embodiments of the invention, the central member 702 is
comprised of a sheet, which is rolled to provide the generally cylindrical shape. Optionally, the sheet is comprised of a material that is biased to cause the sheet to open from the cylindrical shape but which is prevented from doing so that way when it is in an applicator or in a vagina, for example. Therefore, in an exemplary application, the device 700 is wound similar to a roll of paper and placed in an applied 730, shown in Fig. 7D. The device 700 is wound up such that its natural biases to open will cause the device 700 to expand in its generally cylindrical shape, and also exert at least some radially outward bearing pressure, in the deployment of the applicator 730. Optionally, the pressure of the support : it is directed towards the middle urethra. Optionally, the device 720 is used as described herein with respect to the device 700. Referring to Fig. 8, a double-sided displacement incontinence device 800 is shown, in accordance with an exemplary embodiment of the invention. . The device 800 is optionally comprised of a connection node 802 which is provided with the spring-like, displacement-like arms sections located on the proximal and distal ends of the connection node 802. A support arm section 804 and a support arm section 804 are provided.
fixing arm 806 optically comprise the arm sections provided for connecting node 802. In an exemplary embodiment of the invention, an arm section is comprised of a roll-up wire 808 which defines a generally circular profile around of connection node 802, as shown in Lig. 8. Optionally, a winding strip 808 has protuberances 810 located therein to provide support and / or fixation. 1, n some exemplary embodiments of the invention, at least the winding lug 808 of the arm section is flexible, the flexibility of the winding strip 808 allows compression of the strip in order to fit the device 800 in a api icor In addition, the flexible nature of the winding strip 808 provides optionally enhanced comfort to a patient using the device 800 as it tends to fit the patient better during movement than a rigid device. Optionally, the connection node 802 is flexible. Optionally, the protuberances 810 are flexible. Optionally, the protuberances 810 are provided in varied lengths, as described in conjunction with Figs. /? - D. Optionally, the winding strips that define larger and / or smaller radio circles are used with the incontinence device 800, depending on the patient's needs.
Incontinence Device Exemplary Mechanical Incontinence With reference to Figs. 19A-C, an incontinence device 1900 is shown which is provided with an operation of the tomcanics to achieve radial expansion and / or contraction, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one expander 1904 is provided to the device 1900 connected to a fixation arm 1908 or to a support arm 1910 of the device 1900. An elastic member 1902 is provided to the incontinence device 1900 which, in some exemplary embodiments of the invention, it selectively causes the expanders 1904 to radially expand and / or contract the device 1900. FIG. 19A shows the incontinence device 1900 in a storage configuration (eg, while in an applicator). , according to an exemplary embodiment of the invention. The expanders 1904 are connected on one end to an expander node 1906 and on the other end to any fixing arm 1908 or support arm 1910, such that both ends of the expanders 1904 can rotate from a pivot with respect to any which are attached . In a storage configuration, the elastic member 1902 is stretched, allowing the expanders 1904 to rotate from a pivot, allowing the support arms and the attachment arms to assume a reduced radial profile.
Fig. 1913 shows the incontinence device 1900 deployed, in accordance with an exemplary embodiment of the invention. The elastic member 1902, previously stretched while storing, contracts to its normal state by trapping the expander nodes with the enlarged ends 1912 of the elastic member 1902 and carrying the expanders 1904 in an expanded configuration. In an exemplary embodiment of the invention, the expanders 1904 push their respective arms causing the device 1900 to expand its radial profile. The arms are connected to the central node 1914 such that they can rotate from a pivot to assume various configurations ope.racional.es (for example, storage, unfolding, removal). In an exemplary embodiment of the invention, the enlarged end of support section 1916 is dimensioned so that it is passed through the expander node only to the safety pin 1918, which is removable as seen in Fig. 19C. In Fig. 19C, the incontinence device 1900 is shown in a removal configuration, in accordance with an exemplary embodiment of the invention. The removal of the device 900 is optionally facilitated by reducing the radial profile of the 1,900 device. In an exemplary embodiment of the invention, the reduction of the radial profile of the device 1900 is achieved by removing the safety pin 1918, which nominally prevents the end
Enlarged section of the 1916 support to pass through the expander node. Once the enlarged end of the support section 1916 passes through the expander node, the expanders for that node are free to collapse the support arms toward a central axis of device 1900, at least in response to the pressure exerted on them. by the vaginal wall. Optionally, expanders 1904 are at least partially elastic. Optionally, the safety pin 1918 is removed by applying force on a removal device 1920 in a direction opposite to the user's seat 7 and toward the vaginal opening. Optically, the. 1918 safety pin is tied in a releasable knot, which is reached by applying enough force away from the cervix. Optionally, the safety pin 1918 is comprised of a separation portion that causes the pin 1918 to become unattached to the enlarged end of the support section 1916 when sufficient force is applied to the pin 1918 by removing the pin. device 1920. In some exemplary embodiments of the invention, a cover 1924 is provided to the incontinence device 1900. Optionally, the removal device 1920 is attached to the cover 1924 to aid in the removal of the device. device 1900. In such an embodiment, the force held on the removal device 1920 applied away from the user's cervix causes subfrequently to the
device: reduced profile 1,900 to be pulled out of the user's vagina together with the cover 1924. Exemplary Modality of an Incontinence Device Provided with a Teaching Element With reference to Fig. 21A, an incontinence device 2100 is shown which it is provided with at least one tension element 2102, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one tension element 2102 extends between the arms of a fastening section 21.04 and the corresponding arms of a support section: 2106 of the incontinence device 2100. Optionally, at least one Tension element 2102 is elastic. In some exemplary embodiments of the invention, at least one tension member 2102 is stretched prior to deployment and / or while it is stored in an applicator 2108 in order to reduce the radial profile of the device 2100 and optionally, provide force to expand the arms of the support section 2106 during deployment. Fig. 2 IB shows the incontinence device 2100 in a deployed configuration, according to an exemplary embodiment of the invention. In some exemplary embodiments of the invention, at least one tension member 2102 is stretched substantially when deployed,
providing a deployment force for the support section 2106 and, optionally, the fastening section 2104 of the incontinence device 2100. Optionally, the flexibility of the fixation section 2104 and / or the support section 2106 is varied in order to control the response to at least one tension element 2102. For example, in a mode where the fastening section 2104 is not expected to exhibit much radial expansion, it would be appropriate to decrease the flexibility of the fastening section 2.104 so that it does not respond to at least one tension element 2102 since this would have if it were more flexible. It should be understood that at least one tension element 2102 can be used in conjunction with any of the incontinence devices described herein in order to assist with the deployment of the incontinence device. Exemplary Lubrication Applicator Modes In some exemplary embodiments of the invention, lubrication is provided to the applicator used to insert a device into the vagina. The lubrication of the applicator facilitates its insertion and / or removal of the vagina and / or increases user comfort. Figs. 9A-B, 10A-B and 24 represent exemplary embodiments of lubrication applicators. Fig. 9A is a cross-sectional view of an applicator 900 with a lubrication ring 902, in accordance
with an exemplary embodiment of the invention. The applicator 900 serves for the insertion of an incontinence device into the vain of a patient. The insertion is achieved using this applicator in a manner similar to inserting a regular monthly tampon. In an exemplary embodiment of the invention, the incontinence device is maintained within the distal end 904 of the applicator 900 which is inserted into the vagina. When the push on a piston 906 located in the. The proximal end of the applicator 900, the incontinence device is pushed through the outlet 908, allowing the use of the incontinence device once the applicator 900 is removed from the vagina. It should be noted that in an exemplary embodiment of the invention, the outlet 908 remains closed until the plunger 906 is pushed and the incontinence device is carried out of the applied one! 900. Optionally, the output 908 is comprised of a plurality of sections. While in the introduction an incontinence device in a vagina with ei. 900 applicator, the insert is optionally provided by the lubrication applicator 900. In an exemplary embodiment of the invention, the lubrication ring 902 is provided to lubricate the external surface of the applicator 900. Option I, ring 902 is desiizabie on the length of the applicator in order to provide lubrication at least on the area to
be inserted in the vagina. Optionally, the lubrication is directed towards at least the far end! of the api idor near the exit. Optionally, ring 902 is hollow. The locator materials within the ring 902 are optionally compressed outside the ring 902 via a plurality of small holes (not shown) located on the ring 902. In an exemplary embodiment of the invention, the ring 902 is 1 Dazed with lubricant. Optional, the ani I lo 902 is filled with a pharmaceutical formulation. Optionally, the small holes face the applicator 900 such that when the slender materials of the anchor 902 are deposited mainly on the applicator 900. Optionally, the ring 902 is constructed of a flexible material, such as silicone. In an exemplary embodiment of the invention, the ring 902 is pulled along the applicator 900 while applying at least slight pressure to the ring 902 in order to eject the materials therein through the plurality of holes. As the indigo Lo 902 moves along the applicator 900, the material is deposited on the applicator 900 in accordance with the speed of movement of the ring 902, the pressure on the ring 902, the amount of the material within the ring 902 and / or other variables. 1 1 902 ring is optional 1 removed from the 900 applicator before the 900 application is used to deploy a device. Optionally, ring 902
remains on the applicator 900 during the deployment of the device and is then discarded from, together with the applicator 900. Referring to Fig. 913, a cross-sectional view of an applicator 950 with a removable cover 952 is shown, in accordance with an exemplary embodiment of the invention. The applicator 950 is optionally circumferentially enclosed by a removable cover 952. In an exemplary embodiment of the invention, the removable cover 952 seals between it and the applicator 950 a layer 954 of a material such as a lubricant and / or a formulation pharmaceutical Optionally, the removable cover 952 is manufactured from a substance, such as polymers, nylon or aluminum foil, which retains the layer of lubricating and / or pharmaceutical material 954 for an extended period of time. Prior to insertion of the applicator 950 into the patient's vagina, the removable cover 952 is removed from the applicator 950 to reveal the material layer 954. Optionally, the removable cover 952 and / or the material layer. 954 cover only a portion of the applicator 950. FIG. 10A illustrates a side view of an applicator 1000 with a lubrication sleeve 1002 in accordance with an exemplary embodiment of the invention. Similar to the modality of the lubrication ring described with respect
to Fig. 9A, the lubrication sleeve 1002 is used for easy insertion of the applicator 1000 into the vagina of a patient for the deployment of the incontinence device by spreading a lubricant on the exterior surface of the applicator 1000. Optionally, the sleeve lubrication 1002 is used to dispense a pharmaceutical formulation onto the applicator 1000. A cross-sectional view of the applicator 1000 is shown in Fig. 1.013. In an exemplary embodiment of the invention, the lubrication sleeve 1002 is provided with a reservoir 1004 that is used for the storage of lubricant and / or a pharmaceutical formulation. The lubrication sleeve 1002 is optionally provided with a plurality of outlets by which in the lubricant release through the outlets, at least a portion of the applicator 1000. It receives the cover. In an exemplary embodiment of the invention, the lubrication sleeve 1002 is moved along the surface of the applicator 1000 to deposit the lubricant. Optionally, the lubrication sleeve 1002 is removed from the applicator 100 by sliding it over the distal end. of the applicator before insertion of the applicator 1000 into the patient's vagina. With reference to Fig. 24, a lubrication applicator 2400 is shown in accordance with an exemplary embodiment of the invention. The 2400 applicator operates in a
similar manner for deploying an incontinence device 2408 as other applicators described herein, by applying pressure on a plunger 2404 for expelling device 2408 from an enclosure 2402 and in a vagina in an embodiment of the invention. A lubrication layer 2406 is applied to the applicator 2400, optionally to a proximal end 2410 of the applicator for easy insertion of the applicator 2400 into a vagina of the user. In some exemplary embodiments of the invention, the lubrication layer 2406 is comprised of a lubricant that is highly viscous. The highly viscous lubricant is applied to the proximal end of the 2400 applicator in the. moment of manufacture and remains in place during storage. At the time of use, the viscous lubrication layer 2406 facilitates the insertion of the applicator 2400 into the vagina of the user. Optionally, the lubrication layer 2406 is comprised of silicone oil. Optionally, the lubrication layer 2406 is comprised of glycerin. Optionally, the lubrication layer 2406 is comprised of petrolatum. Optionally, the lubrication layer 2406 is comprised of a water-based, viscous material. Optionally, the viscous lubrication layer 2406 is applied to any of the applicators described herein. Exemplary Applicator Modalities to Improve
Storage Conditions of Incontinence Devices In some exemplary embodiments of the invention, methods and apparatus are provided for storing and applying incontinence devices. Figs. 11A-B, 12A-D and 25A-C depict exemplary embodiments that allow at least a portion of the device to remain in a substantially uncompressed condition during storage. It is believed that reducing storage efforts on at least a portion of the device increases the performance and / or shelf life of the device. Referring to Fig. HA, a cross-sectional notice of an applicator 1100 and a loosely loaded incontinence device 1102 is shown, in accordance with an exemplary embodiment of the invention. Optionally, the incontinence device 1102 is any of those described herein or radially expandable and known in the art. Typically, storage of a device at least partially elastic in a compressed state reduces the efficiency of the device in some way. In an exemplary embodiment of the invention, an incontinence device, such as some of those described herein, is only loosely loaded on the applicator 1100 in order to prevent degradation of the incontinence device 1102 as a result of the
compression during storage within the applier 1100. Loosely loaded option comprises loading only a fixation section 1104 of the incontinence device 1102 in the applier 1100, while the support section 1106 and the optional inode 1 node The central 1108 remain outside the applicator 1100. In an exemplary embodiment of the invention, a loading device 1110 is provided which is connected to the incontinence 1102 and which is extended through the 1100 applier and out the path of a leak 1112 located at a distal end of the applicator 1100. Optionally, the charging device 1110 is removed and connected to the incontinence device 1102 so that after the charging device 1102 in the applicator 1100, the loading device 1110 is removed from the applier 1100. Option Iment e, the caga 1110 device is similar to a string and is wound around the LVO device of incontinence 1102 such that the two ends of the cord are accessible at outlet 1112 as shown in g. 11A. The loading incontinence device 1102 in the applicator is achieved by pulling the loading device 1110 towards the far end of the api ictor which in turn pulls the device away from the 1102 in the ap 1100. Optionally, the print run is done with the hands cleaned to maintain the quality of the applicator. Optionally,
A release layer is provided to the applicator which is removed after the device 1102 is loaded in the applicator 1100. In the embodiment shown in Fig. HA, both ends of the loading device 1110 are pulled simultaneously to achieve loading. Removal of the loading device 1110 from the applicator 1100 is optionally achieved by pulling one end of the loading device 1110 available at the outlet 1112 until the full loading device 1110 is pulled out of the applicator 1100. In an exemplary embodiment of In the invention, a plunger (not shown) is applied to the proximal end of the applicator 1100 (where the incontinence device 1.102 was loaded) in order to deploy the incontinence device 1.102 in the vagina of a patient. Optionally, the plunger is provided separately from the applicator 11.50, shown in Fig. 1.1.13, and is used only when the deployment of the incontinence device 1102 is desired. Fig. 1113 shows a cross-sectional notice of a widened proximal end applicator 1.1.50 which is loaded with an incontinence device 1.102, in accordance with an exemplary embodiment of the invention. The applicator 1150 is provided with an enlarged section 1152 toward its proximal end. In the embodiment described with respect to Fig. HA, the incontinence device 1102 is only partially loaded in a narrow portion of the
applicator 1150, while the remainder of incontinence device 1102 is positioned within flared section 1152. Optionally, flared section 1152 is dimensioned to allow complete expansion of support section 1106 of incontinence device 1102. In an exemplary embodiment of the invention, the flared section 1152 is provided with segments enlarged in number and size to accommodate each arm of the support section 1106. Optionally, the flared section is at least partially conical in shape, and is not provided with specific flared segments , but a conical shape, generally enlarged for the accommodation of the device 1102 and respective of the rotational orientation. The deployment of the incontinence device 1102 is achieved by using a plunger 1154 to push the incontinence device 1,102 toward an outlet 1156 located at the distal end of the applicator 11.50. Optionally, the plunger 1154 is provided with a formed head 1158 in order to stimulate the convergence of the support section 1106 towards the central axis of the device 11.02. Optionally, the plunger 1154 is provided separately from the applicator 1150, and is used only when the deployment of the incontinence device 1102 is desired. Optionally, the flared section 1152 begins its widening at the appropriate place on the applicator to indicate the depth of
correct insertion In an exemplary embodiment of the invention, the applicator 1150 is substantially open on the proximal end (not substantially closed as shown in Fig. 1113). In some embodiments of the invention, the open proximal end is provided with a flange, which corresponds to a flange on the plunger 1154, designed to prevent the plunger 11.54 from dislocating the applicator 1150. With reference to FIG. 12A, shows a side view of a slotted applicator 1200 with a sliding sleeve 1202, in accordance with an exemplary embodiment of the invention. The sliding sleeve 1202 is optionally located on the external surface of the applicator 1200 and is capable of moving up and / or down the length of the applied /; 1200. It can be seen that the applicator 1200. It can be seen that the applicator 1200 is provided with a plurality of slots 1204 in an exemplary embodiment of the invention. Optionally, slots 1204 correspond in shape and / or in number to support the arms of an incontinence device. In an exemplary embodiment of the invention, the shelf life of an incontinence device is prolonged by preventing storage of the device in a compressed configuration within an applicator. Instead, the support arms in an incontinence device 1206 projecting
optionally out of the slots 1204 prior to deployment in a patient's vagina, as shown in Fig. 12B. The Fi g. 12C is a cross-sectional view of a 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 the incontinence device 1206, while inside the applicator 1200, is partially located outside the applicator 1200 and prevents compression on the support arms 1208 during storage. In some exemplary embodiments of the invention, the sliding sleeve 1202 is provided with a reservoir 1210, from which the substances can be deposited on the surface of the applicator 1200. Optionally, the reservoir 1210 is provided with a plurality of openings therebetween same and the applicator 1200 for depositing substances stored inside on the surface of the. applicator 1200. Optionally, a lubricant is a substance that is stored in the reservoir 1210. Optionally, a pharmaceutical formulation is a substance stored within the reservoir 1210. The substances in the reservoir 1210 are optionally deposited on the applicator 1200 when the sleeve is moved. slider 1202 up and / or down the length of the surface of the
applied r 1200. In some exemplary embodiments of the invention, the lubricant is deposited on the applicator 1200 of the reservoir 1210 prior to the insertion of the applicator 1200 into a vagina in order to facilitate the insertion of the applicator 1200 into the vagina and the deployment of the incontinence device 1206 stored inside it. Referring to FIG. 12D, a side view of the slotted applicator 1200 is shown with the slide sleeve 1202 where the deflection sleeve 1202 is in a deployed position, in accordance with an exemplary embodiment of the invention. Before the incontinence device 1206 is deployed, the dislodging sleeve 1202 is disengaged. Lance along the applicator 1200 to its proximal end
(closer to the vaginal opening when inserted into the vagina) where the disengaging sleeve 1202 I is to be stuck in the deployment position. The movement of the sliding sleeve 1202 pushes the arms 1208 into the slot 1204, ready for the release. Once the sliding sleeve 1202 reaches the deployment position, it is held in place by a tooth: 1212 to prevent further slippage to the distal end. 1214 of the applicator 1200. When the deflection sleeve 1202 is in the deployment position, the arms 1208 are completely converged towards the central part of the incontinence device 1206 such that the device is
Deployment of the dispenser 1200. In some exemplary embodiments of the invention, the sleeve does not depend on the sliding to move: instead it is screwed down and up the applicator 1200 along threads located on the external surface of the applicator 1200. The F'ig. 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. The applicator 2500 includes an enclosure 2502, a slotted section 2504, and a plug 2506 in an embodiment of the invention. The slotted section 2504 is substantially cylindrical and is provided with grooves (similar to the slots in the apiicator 1200) corresponding to the approximate number and size of the support arms 2512 of the device 2508. While the device 2508 is in storage, the support arms 2512 protrude from the slots provided to the slotted section 2504, thereby reducing the compressive stress forces on the device 2508 and improving the shelf life and performance of device 2508. Optionally, the support arms 251.2 are protected for a bag or cover while they are exposed. In an exemplary embodiment of the invention, the
The slotted section 2504 is coaxially mounted on the inner circumference of the enclosure 2502 such that the slots remain exposed, thereby enabling the support arms 2512 of a device 2508 located therein projecting. The plunger 2506 is mounted coaxially on the internal circumference of the slotted section 2504, optionally with a protrusion 2518 in contact with an insert 2510, the insert 2510 which is used to cause the support arm 2512 to expand for the treatment that the deployment provides. . In one embodiment of the invention the. piston 2506 is slidable.e within slotted section 2504 and slotted section 2504 is slidable within enclosure 2502. In one embodiment of the invention, slotted section 2504 adjusts friction and fits within the. enclosure 2502 such that it requires more force on the plunger 2506 to cause the slotted section 2504 to slide within the enclosure 2502 that attaches the insert 2510 to the device 2508. In the operation, shown in Fig. 2513, the plunger is moved by the user towards a distal end 2514 of the enclosure 2502 that deposits the insert 251.0 in the device 2508, but without substantially moving the slotted section 2504. Once the insert 2510 is deposited, the force continued on the plunger 2506 towards the distal end 2514 cause the reaction.
slide to the far end! 2514 of the enclosure 2502. It should be noted that although the insert 2510 is giving radial expansion force to the support arms 2512 while the device 2508 is still inside the. Applicator 2500, the flexible nature of device 2508, and optionally the insert 2510, allows temporary compression of device 2508 prior to ejection of applicator 2500 and release within the vagina of the user. In an exemplary embodiment of the invention, the device 2508 is deployed shortly after the. insert 2510 is deposited in device 2508. As shown: Fig. 25C, the slotted section 2504 continues to move within the enclosure 2502 until a circumferential ring 2516 around the distal end of the slotted section 2504 collects into the enclosure 2502. Optionally, by. at least one protrusion is used in place of the circumferential ring 251.6. The continued application of force over 2506 exercises the. device 2508 from the applicator 2500 and the force of the insert 2510 on the support arms 2512 cause them to expand radially in place of the vagina of the user, thereby providing urethral support to the user. Optionally, the support is the middle urethral. Exemplary Collapsible Applicator Modality With reference to Fig. 26 ?, an applicator 2500 is shown that in some modalities is capable of assuming
an axially collapsed configuration before use. In addition, the applicator 2600 prepares an incontinence device 2604 for use during deployment, in some embodiments of: the invention. A collapsible applicator would be desirable for more convenient storage (it takes less space), for example. An enclosure 2602 is provided to the applicator 2600 which contains the incontinence device 2604 (device 2604 shown in those of Figs 27A-B) therein and while a collapsed configuration, a large portion of a plunger 2606. In an embodiment exemplary of the invention, an insert 2612 used to assist in unfolding the device 2604 is attached to the activation / removal device 2608, for the reasons described below. Optionally, the activation / removal device 2608 is removably attached to the applicator 2600 by a latch 261.0. In an exemplary embodiment of the invention, prior to the use of the applicator 2600 for deploying the incontinence device 2604, the plunger 2606 is pulled down to a configuration shown in Figure 26B. In the protrusions of the interface 261.4 are provided on the plunger 2606 and the enclosure 2602 to prevent the plunger 2606 from dislodging the applicator 2600, in some embodiments of the invention. The pulling action on the plunger 2606 causes the insert 2612 to partially pass through the device 2604
since the insert 2612 is attached to an activation / removal device 2608 and the activation / removal device 2608 is attached to i. plunger 2606 by bolt 2610. A distal, enlarged end of insert 2612 prevents Insert 2604 from completely passing through device 2604. The proximal end of insert 261.2 is adapted to cause radial expansion of the support arms of device 2604 , particularly in the deployment of the device 2604 outside the applicator 2600 and as described with reference to Figs. 27A-B. In an exemplary embodiment of the invention, the latch 2610 is removed from the activation / removal device 2608 to allow deployment of the device 2604 of the applicator 2600. The deployment is optionally effected by advancing the plunger 2606 toward the distal end. of the. 2600 applicator and push the 2604 device out of the applicator. An Exemplary Plunger Fig. 13 is a cross-sectional view of a telescopic plunger 1300, in accordance with an exemplary embodiment of the invention. In some situations, it is desirable to minimize the package size of the complete incontinence device, which generally comprises an applicator, an incontinence device and / or a plunger, in some exemplary embodiments of the invention. The plunger, for example, is long enough to expel a device from
incontinence of an applicator but also has enough length that can be manually operated by the patient. In an exemplary embodiment of the invention, the plunger is reduced in size during storage by providing the telescopic plunger 1300. In order to shorten the package of devices without changing the dimensions of the applicator, the plunger is optionally supplied in a "closed" position. or folded that is expanded for the deployment of an incontinence device. In an exemplary embodiment of the invention, the telescopic plunger 1300 is provided with two parts, one inside the other. The outer part 1302 of the plunger 1300 is partially maintained within the body of the applicator as with a non-telescopic plunger while the internal part 1304 of the plunger 1300 is at least partially located within the outer part 1302. The deployment of the piston 1300 In An exemplary embodiment of the invention involves keeping the inner part 1304 and pulling it away from the outer part 1302 in an "open" position. Continuous throwing of the inner part 1304 away from the outer part 1302 results in the inner part 1304 being stuck on the outer part 1302 by way of an insert 1,306 located on the inner part 1304 which fits into an adapted hole 1308 to receive and / or interatorate with the insert 1306 on the external part 1302. The plunger 1300 is optionally fitted with the
ring 1310 which when inserted into an applicator provides at least slight friction between the plunger 1300 and the applicator during the relative movement between the two and also to prevent the plunger from bringing out freely from the applicator. Optionally, the ring 1310 is comprised of rubber. Optionally, the anion is comprised of a polymer-based substance. Optionally, ring 1310 is flexible. In some exemplary embodiments of the invention, an applicator is provided with a flange as its proximal opening where: the plunger is to be. inserted. This flange is adapted to resist the passage of the plunger 1300 and the ring 1310 without at least some degree of force provided by the person inserting the plunger 1300 into the applied r. In an exemplary embodiment of the invention, once the plunger 1300 is inside the applicator, this flange resists the movement of the plunger 1300 to exit behind the applicator, preventing inadvertent dislodging of the plunger from. api idor .. Additional Sample Modes It should be noted that a circular ring (not shown in any of the Figures), but previously described in PCT / IL2005 / 000304, which is incorporated herein by reference, can be located on any applicator in order to mark the appropriate depth of insertion of the applicator into the vagina. Optionally, the. ring can be
provide with selected positions that correspond women of different size for personalization. Other, any of the incontinence devices described herein may be used in conjunction with a cover. In an exemplary embodiment of the invention, a cover is made of a soft, flexible mesh material. Optionally, the cover is porous. Optionally, the cover is designed as a small pouch that encapsulates the incontinence device, which acts as an internal support structure for the cover. The use of the cover can potentially provide one or more benefits in the use of the device. For example, the cover optionally reduces friction between the applicator and the device in the insert. In addition, the cover optionally reduces friction between the vagina and the device during insertion and / or removal. In some embodiments of the invention, the cover mesh, which is stretched between the arms of the device, serves as a support similar to a sling for the urethra. In a woman who lets out urine during an event of exertion (when the abdominal pressure rises during coughing, sneezing, etc.), the urethra buckles down but finds the cover in its middle part. This causes an elevation of intraurethral pressure with resultant urinary continence. Optionally, the cover provides support to
the urethra. In an exemplary embodiment of the invention, the device does not place pressure against the urethra or neck of the bladder, but only provides support where there is an elevation in abdominal pressure, as described above. Optionally, the device applies direct pressure to the urethra and / or neck of the bladder. In some embodiments of the invention, the cover is disposable. Optionally, the cover is sterilized between uses and is reusable. Optionally, the cover is decorated. In some embodiments of the invention, the cover aids in the removal of the device from the vagina. First, the cover optionally reduces friction between the incontinence device and the vaginal wall. Second, the cover is optionally provided with a removal device, such as a cord. Optionally, the cover and the removal device are constructed of the same unit piece of material. The removal device optionally aids with the removal of the device in a number of ways. The throw of the removal device causes the tightening of the cover. The tightening of the cover causes the straightening of the vaginal walls. The straightening of the vaginal walls reduces the similar effect to the cover described in the above and mitigates the tension applied to the device, allowing an easy and smooth removal of the device from the vagina. In addition, the circulation on the
Removal device causes optional between the support and fixation arms to fold slightly towards the central axis of the incontinence device, thereby reducing the radial size of the incontinence device and allowing easy easy removal of the device from the vagina. In an exemplary embodiment of the invention, the device can be "moved" out of the vagina by pulling on the removal device causing the support arms to move: toward the opening of the vagina (and thus pulling the attachment section). along), releasing the string unexpectedly, and then repeating the process. In some exemplary embodiments of the invention, the lubricant is supplied by the incontinence device in response to a configuration change and / or during the removal of the device. Optionally, the lubricant is contained within the device of continuation. Figs. 22A-C show cross-sectional views of the incontinence devices, which are by way of example only. In some exemplary embodiments of the invention, different cross-sectional configurations are used to manipulate the stresses applied to the incontinence devices during storage, deployment, use and / or
removal. Optionally, different cross-sectional configurations are used to reduce the resistance to certain movements of! incontinence device and / or increased resistance to other movements. Optionally, different configurations are used to prevent necrosis and / or discomfort to the user. These figures are used to show some of the many possibilities available for the shape and configuration of the devices described herein. For example, the quadrilateral and ovo Ldes shapes for the arms are not shown, but they are also capable of being used with current inventions. The present invention has been described using detailed descriptions of embodiments thereof which are provided by way of example and are not intended to limit the scope of the invention. The described modalities comprise different characteristics, not all of which are required in all the modalities of the invention. Some modalities of the present invention utilize only some of the characteristics or possible combinations of features. Variations of embodiments of the present invention that are described and embodiments of the present invention that comprise different combinations of features noted in the embodiments described will occur to those skilled in the art. When they are used in
the following claims, the terms "comprises", "includes", "has" and their conjugates mean "including but not limited to". The scope of the invention is limited only by the following claims.
Claims (1)
- CLAIMS 1. An apparatus for treating urinary incontinence, characterized in that it comprises: a support section adapted to provide urethral support; a fixation section adapted to resist movement of the apparatus in a vagina; an insert separated from the support section, a portion of which is adapted to be placed proximate to the support section; and wherein the insert selectively provides at least support to the support section of the apparatus. An apparatus according to claim 1, characterized in that the insert is adapted to provide pressure to the support section, causing radial expansion of the support section. 3. An apparatus according to any of the preceding claims, characterized in that the support section is flexible. 4. An apparatus according to any of the preceding claims, characterized in that the support section is comprised of at least one support arm. 5. An apparatus according to any of the preceding claims, characterized in that the Insert is an o-ring. 6. An apparatus according to any of claims 1-4, characterized in that the insert is widened. 7. An apparatus according to any of claims 1-4, characterized in that: the insert is conical. 8. An apparatus according to any of claims 1-4, characterized in that the insert is comprised of a plurality of geometrically infeasible elements. 9. An apparatus according to any of claims 1-4, characterized in that the insert is comprised of at least one support protrusion and a bulge protrusion. 1.0. An apparatus according to any of claims 1-4, characterized in that the insert is an invertible membrane. 1.1. An apparatus according to any of claims 1-4, characterized in that the insert is a ring insert. 12. An apparatus according to any of claims 1-4, characterized in that it further comprises a resilient support member. 13. An apparatus in accordance with claim 12, characterized in that the resilient support member biases at least the support section towards a central axis of the apparatus. 14. An apparatus in accordance with the rei indication 12, characterized in that the resilient support member biases at least the support section away from a central axis of the apparatus. 15. An apparatus according to any of the preceding claims, characterized in that the support section and the fastening section are comprised of at least two arms, respectively. 16. An apparatus according to claim 15, characterized in that the arms are provided with a folding section. 17. An apparatus according to any of the preceding claims, characterized in that at least the support section and the fi xing section are flexible. 18. An apparatus according to claim 17, characterized in that the apparatus is f Lex i b I e. 19. An apparatus according to any of the preceding claims, characterized in that it also comprises a removal device. 20. An apparatus in accordance with any of the preceding claims, characterized in that the urethral support is the middle urethral support. 21. An apparatus according to any of the preceding claims, characterized in that it also comprises a cover. 22. Apparatus according to claim 21, characterized in that the cover encapsulates its apparatus substantially. 23. An apparatus according to any of the preceding claims, characterized in that the insert portion is adapted to fit within the support section, when the selective support is provided.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 | |
| US76205906P | 2006-01-25 | 2006-01-25 | |
| PCT/IL2006/000346 WO2006097935A2 (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2007011339A true MX2007011339A (en) | 2007-11-23 |
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|---|---|---|---|
| MX2007011339A MX2007011339A (en) | 2005-03-17 | 2006-03-16 | Apparatuses for the amelioration of urinary incontinence in females. |
Country Status (7)
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| EP (1) | EP1863399B1 (en) |
| KR (1) | KR20070117676A (en) |
| AU (1) | AU2006224158B9 (en) |
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| CA (1) | CA2600988C (en) |
| MX (1) | MX2007011339A (en) |
| WO (1) | WO2006097935A2 (en) |
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| JP4175662B2 (en) | 1996-01-08 | 2008-11-05 | インパルス ダイナミクス エヌ．ヴイ． | Electric muscle control device |
| US9289618B1 (en) | 1996-01-08 | 2016-03-22 | Impulse Dynamics Nv | Electrical muscle controller |
| US9713723B2 (en) | 1996-01-11 | 2017-07-25 | Impulse Dynamics Nv | Signal delivery through the right ventricular septum |
| US9101765B2 (en) | 1999-03-05 | 2015-08-11 | Metacure Limited | Non-immediate effects of therapy |
| US9931503B2 (en) | 2003-03-10 | 2018-04-03 | Impulse Dynamics Nv | Protein activity modification |
| US11439815B2 (en) | 2003-03-10 | 2022-09-13 | Impulse Dynamics Nv | Protein activity modification |
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| US4212301A (en) * | 1978-08-14 | 1980-07-15 | Kimberly-Clark Corporation | Digital tampon |
| US4726805A (en) * | 1986-06-26 | 1988-02-23 | Tambrands Inc. | Tampon applicator |
| US5479945A (en) * | 1990-12-31 | 1996-01-02 | Uromed Corporation | Method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders |
| US5671755A (en) * | 1994-06-29 | 1997-09-30 | Uromed Corporation | Assembly and method for controlling urinary incontinence in humans |
| US6110099A (en) * | 1995-11-13 | 2000-08-29 | Benderev; Theodore V. | Devices and methods for assessment and treatment of urinary and fecal incontinence |
| US5785640A (en) * | 1996-05-23 | 1998-07-28 | Kresch; Arnold J. | Method for treating female incontinence |
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| US6558370B2 (en) * | 2001-06-05 | 2003-05-06 | Kimberly-Clark Worldwide, Inc. | Urinary incontinence device |
| DE60213757T2 (en) * | 2002-02-05 | 2007-08-16 | Birchbob International Sa | tampon |
| US6808485B2 (en) * | 2002-12-23 | 2004-10-26 | Kimberly-Clark Worldwide, Inc. | Compressible resilient incontinence insert |
| US7044928B2 (en) * | 2003-04-04 | 2006-05-16 | Platex Products, Inc. | Tampon applicator assembly having an improved plunger and methods of making |
| CA2560877C (en) * | 2004-03-18 | 2014-07-29 | Contipi Ltd. | Apparatus for the prevention of urinary incontinence in females |
-
2006
- 2006-03-16 WO PCT/IL2006/000346 patent/WO2006097935A2/en not_active Ceased
- 2006-03-16 BR BRPI0609831-2A patent/BRPI0609831A2/en not_active Application Discontinuation
- 2006-03-16 AU AU2006224158A patent/AU2006224158B9/en active Active
- 2006-03-16 CA CA2600988A patent/CA2600988C/en active Active
- 2006-03-16 EP EP06711327.4A patent/EP1863399B1/en active Active
- 2006-03-16 MX MX2007011339A patent/MX2007011339A/en active IP Right Grant
- 2006-03-16 KR KR1020077023731A patent/KR20070117676A/en not_active Withdrawn
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| CA2600988A1 (en) | 2006-09-21 |
| BRPI0609831A2 (en) | 2011-10-11 |
| AU2006224158A1 (en) | 2006-09-21 |
| EP1863399A2 (en) | 2007-12-12 |
| CA2600988C (en) | 2014-09-23 |
| WO2006097935A3 (en) | 2007-03-01 |
| KR20070117676A (en) | 2007-12-12 |
| AU2006224158B2 (en) | 2012-01-19 |
| WO2006097935A2 (en) | 2006-09-21 |
| EP1863399B1 (en) | 2022-08-17 |
| AU2006224158B9 (en) | 2012-02-09 |
| EP1863399A4 (en) | 2013-11-20 |
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