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
  • A61F13/00—Bandages or dressings; Absorbent pads
  • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
  • A61F13/20—Tampons, e.g. catamenial tampons; Accessories therefor
  • A61F13/2051—Tampons, e.g. catamenial tampons; Accessories therefor characterised by the material or the structure of the inner absorbing core
• • 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

Definitions

• the present invention relates to an intravaginal device for treating
• urinary stress incontinence in females which provides mechanical support for the bladder neck and absorbs incidental urinary spillage from the urethra
• urinary incontinence To achieve urinary continence under normal conditions, the urinary
• bladder acts as a passive reservoir for fluid filtrate accumulating from the kidneys. Contraction waves leading to micturition originate in the proximal
• bladder must exceed that within the urethra] lumen to permit fluid to flow
• urethral resistance mediated in part by the musculus dilator urethrae system
• the musculus dilator urethrae system opposes the action of the musculus sphincter
• the urinary bladder contracts via the detrusor smooth muscle and actively
• Contraction of the abdominal muscles and a lowering of the diaphragm elevate intra-abdominal pressure to help force urine from the bladder.
• external urethral sphincter is situated within the urethral wall, and is
• the pelvic floor musculature provides additional
• periurethral muscles which are skeletal muscles related to but structurally distinct from the urethral wall
• Urinary incontinence is defined as any involuntary leakage of urine.
• control permits the detrusor muscle to contract prematurely when relatively
• Overflow incontinence may arise in an obstructed or atonic urinary bladder.
• Diabetes may also result in an atonic bladder.
• estrogenic activity leads to thinning of the vaginal wall and reduced vaginal secretions. Consequently, vaginal smooth muscle mass is decreased, thereby
• the bladder neck is closely related to the anterior vaginal wall.
• anterior wall of the vagina is related to the urethra, which is
• intra-abdominal pressure increases intravesical pressure above ambient
• the urethra cannot benefit from added abdominal pressure due to poor positioning. Thus, the urethra actually moves out of the sphere of
• U.S. Patent No. 5,618,256 to Rei er discloses an intravaginal device with flexible legs attached to a main
• intravaginal urinary incontinence device composed of a resilient circular base
• an intravaginal device having an arched central base portion connecting forward and rearward portions.
• the forward portion has a projection means to
• U.S. Patent 5,609,559 to Weitzner discloses an intravaginal device including an anterior inflatable body having a hose attached thereto for the purpose of inflating the anterior body upon positioning the device within the
• a source of pressurized air is releasably attached to a distal end of the hose to facilitate inflation of the anterior body, disposing the body to apply pressure to the urethra through the vaginal wall.
• an object of the invention is to provide a device designed
• Another object of the invention is to provide a device as described
• a further object of the invention is to provide a device as described
• Yet another object of the invention is to provide a device as described
• involuntary urination comprising:
• Devices according to the invention can further include:
• the string member may be of the same material as, or a different
• involuntary urination comprising an absorbent pessary member for absorbing
• absorbent pessary member having proximal and distal ends, a
• pessary member being insertable into a
• vaginal canal with an orientation in which one of protrusions support at least one of the bladder neck and bladder in the vaginal canal, while at least one
• the invention further provides a process for preventing involuntary
• the distal end is that end which is directed toward the
• the removal string member extends out of the
• FIGs. 1, 2 and 3 are side elevational, cross-sectional views of three
• FIG. 4 is a side elevational view of a modified version of the
• FIG. 5 is a side elevational view of a further embodiment of the
• FIG. 6 is an end view of the device of FIG. 5, in the direction of arrow
• FIG. 7 is a plan view of a component of the device of FIGs. 5 and 6
• FIG. 8 is an end view of another embodiment of a device according to the present invention.
• FIG. 9 is a side view, in the direction of arrow IX of FIG. 8, of one
• FIG. 10 is a perspective view of an element of a modified version of the embodiment of FIGs. 8 and 9.
• FIG. 11 is a side elevational view of an other embodiment of the
• FIG. 12 is a bottom plan view of the embodiment of FIG. 11.
• FIG. 13 is a plan view of a component of the embodiment of FIGs. 11
• FIG. 14 is a top plan view of an intravaginal device according to the invention inserted into an applicator.
• FIG. 15 is a side elevational view of an intravaginal device according
• FIG. 16 is a side elevational view of the intravaginal device according
• FIG. 17 is a side elevational view of an intravaginal device according
• FIG. 18 is a side elevational view of an intravaginal device according
• FIG. 19 is a side elevational view of an intravaginal device according
• FIG. 20 is a side elevational view of an intravaginal device according
• FIGs. 21 A and 21B are plan views of expanded spring-out disks which can be employed in the devices of FIGs. 15 and 18.
• FIG. 22 is a perspective view of a further embodiment of the invention.
• FIGs. 1, 2 and 3 show embodiments of the invention in which a pessary member 2 is provided with one or two flexible arcuate support members 4.
• a pessary member 2 is provided with one or two flexible arcuate support members 4.
• FIG. 1 there is only one flexible arcuate support member 4 positioned substantially near the proximal end of the absorbent pessary member for
• FIG. 2 two flexible arcuate support members 4 are depicted in series disposed in the same plane of the absorbent pessary
• a single flexible arcuate support member 4 is dimensioned to extend along
• Each embodiment is further provided with a removal string member 6
• The, or each, upper flexible arcuate support member 4 may be made of
• a plastic strip or other biocompatible material having a width, perpendicular to
• Support member 4 is positioned on the absorbent pessary member 2 for applying pressure to the
• Each support member 4 is configured to support the bladder neck, proximal urethra, and/or the bladder.
• support member 4 to pessary member 2 may be achieved by adhesion with an inert, biocompatible polymer composition or by plastic strips wrapped around pessary member 2 and the ends of each support member 4.
• FIG. 4 shows an alternative version of the embodiment of FIG. 1,
• support member 4 is replaced by an annular support member 14 that surrounds absorbent pessary member 2.
• Annular support member 14 may be
• each member 4 made of .the same material as each member 4 and is molded or shaped to have
• pessary member 2 may be radially compressed in
• a suitable sleeve which has a diameter less than the inner diameter of annular support member 14 and then inserted into pessary member 2. Then the sleeve
• pessary member 2 expands radially so as to contact annular support member
• support member 14 may be provided with a suitable inner surface of support member 14.
• annular support member 14 may be slit longitudinally
• FIGs. 2 and 3 can be constructed in a manner similar to that of FIG. 4.
• Absorbent pessary member 2 may have the same form as a
• FIGs. 5 and 6 show a further embodiment of an incontinence device according to the invention composed of absorbent pessary member 2 and a unit 20 that provides an upper vertical flexible arcuate support member 24 for
• Unit 20 further includes two annular bands 28 and 30 which are
• Adhesive may be provided between bands 28 and 30 and
• Pessary member 2 may be inserted into unit 20
• Unit 20 may be a molded, semirigid plastic part which is suitably
• FIG. 6 shows the device of FIG. 5 in an inserted state.
• FIG. 7 shows an embodiment of unit 20 that may be produced by
• support member 24 and arcuate wing members 26 are postforming to give support member 24 and arcuate wing members 26 the
• This postforming will reduce the distance between bands 28 and 30, relative to that illustrated in FIG. 7, and allow the free end of support member 24 to be attached to band 30. This attachment may be
• bands 28 and 30 may be secured to one another, again by application of an adhesive, or
• thermowelding etc.
• FIGs. 8 and 9 are, respectively, an end view of another embodiment of
• component 32 is
• one of these parts is a one-piece part which includes two arcuate wing
• arcuate central element 40 which extends around approximately two-thirds of
• component 32 is made of two semirigid
• Armature 41 has two opposed arcuate segments 42 that will be bonded to the arcuate edges of wing members 36 and two opposed circular arcuate segments 43 that extend between segments 42 and that will be bonded
• FIGs. 1 1 and 12 A further embodiment of the invention is shown in FIGs. 1 1 and 12
• pessary member 2 is provided with one support member 44
• molded plastic tube can be cut to create members 44 and 46 and bands 48 and
• Pessary member 2 may be inserted into the space enclosed by bands 48 and 50 in the manner described above with reference to the embodiment of
• FIG. 4 Alternatively, as shown in FIG. 13, members 44 and 46 and bands 48
• bands 48 and 50 can be wrapped around pessary member 2 and the free
• ends of bands 48 and 50 can be bonded together by any suitable means, such as
• bands 48 and 50 can optionally be attached to
• the component providing members 44 and 46 and bands 48 may be any suitable material.
• wing members 46 made of a flexible plastic, such as an elastomer, permitting wing members 46
• this component is
• insertion may be effected with greater
• outer tube 56', and the distal end of inner tube 56" may then be in contact with the proximal end of pessary member 2, all as shown in FIG. 14.
• tubes 56' and 56" are withdrawn together from the vagina.
• support member 44 to support, in this embodiment, the bladder neck.
• incontinence device or a portion thereof, such as the insertion end, may be
• Absorbent pessary member 2 as shown has an elongated circular cylinder shape, but could be configured in any other shape that allows it to be
• the vagina such as an elongated
• Member 2 may be made of any material or materials that are biocompatible, or nontoxic, and that are capable of maintaining the shape of member 2 when inserted in
• Member 2 may be composed entirely or partially of any absorbent
• member 2 may comprise a mass of
• materials include a combination of cotton batting and cotton gauze.
• member 2 comprises a compressed cotton material suitable for a wide range of applications.
• member 2 comprises a compressed cotton material suitable for a wide range of applications.
• member 2 may comprise a
• Member 2 serves to absorb urine which may leak from the urethra, despite the
• Member 2 may
• the absorbent pessary material may be impregnated with a deodorant
• Deodorants safe for contact with vaginal membranes are well known in the art of feminine hygiene products.
• Absorbent pessary member 2 may also be impregnated with a
• the therapeutic agent for intravaginal delivery.
• the therapeutic agent may be an
• antimicrobial appropriate for controlling local vaginal infections due to fungi
• the therapeutic agent may comprise an
• anti-inflammatory agent such as a nonsteroidal anti-inflammatory compound
• Antineoplastic compounds may be delivered intravaginally to vaginal tissues
• hormones particularly estrogen or
• derivatives thereof may be administered intravaginally by impregnating the
• Dosages may be titrated by adjusting the length of time the absorbent urinary incontinence device is left within the
• pessary member may permit distribution of the agents beyond the vaginal region. For example, combining the mechanical support of the absorbent
• urinary incontinence device of the invention with delivery of estrogen to pelvic musculature may afford a synergistic approach to relieving urinary
• Estrogen absorbed across the vaginal wall may serve to activate estrogen receptors responsible for improving the tone of the musculature of the pelvic floor.
• One such preparation may be a 1 % estrogen cream marketed under the
• At least one flexible arcuate wing member is provided for
• the flexible arcuate wing members may be curved differently from the forms
• Flexible wing members may be integrally molded
• the flexible wing members may be covered with the absorbent material of the pessary for cushioning purposes. Cushioning may be effected by making the wing members of a soft polymer, in lieu of an absorbent cover.
• the flexible arcuate wing members may be positioned in several configurations around pessary member 2.
• the flexible arcuate wing members extend radially from adjacent to the proximal end of the absorbent pessary member 2.
• the flexible wing members extend over substantially the full length of pessary member 2.
• the flexible wing members extend over a substantial portion of the length of pessary member 2.
• Full extension along substantially the full length of pessary member 2 imparts optimal stability to the device upon insertion into the vagina. In general, the flexible wing members should prevent rolling or displacement of the device.
• two or four flexible arcuate wing members are disposed to extend from the absorbent pessary member, forming an angle between about 30° to about 45° relative to
• Removal string member 6 is
• Removal string member 6 may be made of natural or
• the flexible arcuate wing members of FIGs. 11-13 are oriented so that
• the arcuate form of the wing members assures easy removal of the device.
• the intravaginal urinary incontinence device of the invention may be any suitable intravaginal urinary incontinence device of the invention.
• Water soluble lubricants or petroleum-based jellies may be used.
• Individual intravaginal urinary incontinence devices may be worn
• FIGs. 15-2 IB are illustrated in FIGs. 15-2 IB.
• FIGs. 15 and 16 is composed of an
• absorbent pessary member 1 10 made of any one of the absorbent materials
• Each sleeve 1 12 made of a relatively rigid material. Each sleeve 1 12 houses a
• Spring-out disks may be solid disk 1 14', as shown in FIG. 21 A, or segmented disks 1 14", as shown in FIG. 21B.
• Each disk 114 is made of a suitable
• resiliently deformable material typically metal or semirigid plastic, and has a
• String member 104 is movable
• disks 114 spring open into the positions shown in FIG. 16, with the result that portions of member 110 are forced radially outwardly in order to produce annular bulging portions 116. These bulging portions, since they extend
• annular bulging portions 1 16 are formed and each of these presses against a respective one of the bladder neck and the bladder within the vaginal canal.
• member 110 is to be removed, this can be achieved by pulling on string
• Sleeve 124 contains a spring-out disk 126 that is smaller than each of disks 114 of FIGs.
• removal string member 104 is fastened at its
• String member 104 passes through core 122 and is secured to disk 126.
• portion 128 that protrudes radially outwardly at a location to bear against either the bladder or the bladder neck within the vaginal canal.
• bulging portion 128 performs the functions of both the support member and
• hollow core 122 such that the bulge occurs in a predetermined, limited area.
• pessary member 140 may contain an initially compressed ball 142 made from,
• member 140 will be inserted with the aid of an applicator
• Outer tube 144 is
• member 140 Prior to being packaged for sale, member 140 will be inserted into tube
• Tube 145 has a diameter which causes it to abut against the proximal end
• tube 144 is inserted into the vagina and the applicator will be operated in the same manner as the applicator of FIG. 14.
• embodiment is constituted by a one-piece absorbent body 150 having three
• Protrusions 152 extend radially outwardly from
• the center of body 150 and also extend uniformly along the length of body 150.
• one protrusion 152 will serve as a support member against the bladder, or bladder neck, while the other two protrusions 152 will serve as wing members
• Body 150 may be inserted with the aid of an applicator, in the same
• the absorbent member of all of the devices disclosed herein may be any absorbent member of all of the devices disclosed herein.

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Family Applications (1)

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Cited By (21)

Citations (11)

• 2000
  • 2000-05-09 WO PCT/US2000/012515 patent/WO2000067662A1/en active Application Filing
  • 2000-05-09 AU AU47069/00A patent/AU4706900A/en not_active Abandoned

Patent Citations (11)

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