WO2000066029A1 - Dispositif de controle de la vessie et procede pour traiter l'incontinence urinaire chez la femme - Google Patents
Dispositif de controle de la vessie et procede pour traiter l'incontinence urinaire chez la femme Download PDFInfo
- Publication number
- WO2000066029A1 WO2000066029A1 PCT/US2000/011604 US0011604W WO0066029A1 WO 2000066029 A1 WO2000066029 A1 WO 2000066029A1 US 0011604 W US0011604 W US 0011604W WO 0066029 A1 WO0066029 A1 WO 0066029A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- distal
- members
- sleeve
- female
- intraurethral device
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 23
- 206010046543 Urinary incontinence Diseases 0.000 title claims abstract description 12
- 210000003708 urethra Anatomy 0.000 claims abstract description 34
- 238000007915 intraurethral administration Methods 0.000 claims description 87
- 239000000463 material Substances 0.000 claims description 12
- 239000013536 elastomeric material Substances 0.000 claims 1
- 238000003780 insertion Methods 0.000 abstract description 10
- 230000037431 insertion Effects 0.000 abstract description 10
- 229920001971 elastomer Polymers 0.000 description 19
- 239000000806 elastomer Substances 0.000 description 19
- 241001313288 Labia Species 0.000 description 6
- 239000002344 surface layer Substances 0.000 description 5
- 210000002700 urine Anatomy 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 210000003813 thumb Anatomy 0.000 description 4
- 238000003825 pressing Methods 0.000 description 3
- 230000002745 absorbent Effects 0.000 description 2
- 239000002250 absorbent Substances 0.000 description 2
- 229960003333 chlorhexidine gluconate Drugs 0.000 description 2
- YZIYKJHYYHPJIB-UUPCJSQJSA-N chlorhexidine gluconate Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O.C1=CC(Cl)=CC=C1NC(=N)NC(=N)NCCCCCCNC(=N)NC(=N)NC1=CC=C(Cl)C=C1 YZIYKJHYYHPJIB-UUPCJSQJSA-N 0.000 description 2
- 210000003811 finger Anatomy 0.000 description 2
- 239000000017 hydrogel Substances 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- 206010046479 Urethral valves Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 239000004599 antimicrobial Substances 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 239000013043 chemical agent Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 229920002674 hyaluronan Polymers 0.000 description 1
- 229960003160 hyaluronic acid Drugs 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 229940100890 silver compound Drugs 0.000 description 1
- 150000003379 silver compounds Chemical class 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 210000005070 sphincter Anatomy 0.000 description 1
- 229920002725 thermoplastic elastomer Polymers 0.000 description 1
- 239000012815 thermoplastic material Substances 0.000 description 1
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
- A61F2/0036—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 implantable
Definitions
- the present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.
- a bladder flow control device may be positioned in the urethra of a patient to control the flow of urine out of the bladder. It is desirable for the placement of the bladder flow control apparatus in the urethra to be performed easily and non-surgically. Once the bladder flow control device is placed, it is desirable that it be safely and securely retained in the urethra. Optimally, the device surfaces which contact the human body will be formed of biocompatible materials, to lessen chances of inflammation in patients.
- the present invention relates generally to devices and methods for treating female urinary incontinence. More particularly, the present invention relates to intraurethral devices and methods for controlling urine flow.
- An intraurethral device in accordance with the present invention includes a sleeve having a distal portion and a proximal portion.
- a proximal retainer is fixed to the proximal portion of the sleeve and a plurality of distal members are disposed at the distal end of the sleeve.
- each distal member is preferably shaped so that the distal members combine to form a generally conical distal tip.
- the proximal portion of each distal member is fixed to the distal portion of the sleeve by a linking means.
- the linking means includes a ring and elastomer hinges.
- the elastomer hinges may be deformed to allow the distal members to assume a variety of positions.
- An actuating means may be used to selectively place the distal members in a number of positions. When the actuating means is not acting upon the distal portions of the distal members, the elastomer hinges are free to assume a natural, undeformed state. When the elastomer hinges are in a natural, undeformed state, the distal members assume a position adjacent to each other. In this position, the distal members form a generally conical distal tip.
- the distal members form a generally conical distal tip to aid insertion of the device into a patient's urethra.
- the actuating means may selectively place the distal members in an outwardly extending position.
- the distal members When the distal members are deployed in an outwardly extending position, the distal members serve to prevent proximal motion of the intraurethral device out of the patient by contacting the bladder floor. Distal motion of the intraurethral device into the patient is prohibited by the proximal retainer fixed to the proximal end of the sleeve. This proximal retainer contacts the urethral labia.
- the intraurethral device is held within the urethra by distal members and the proximal retainer acting at opposite ends of the urethra.
- the applicator for use in inserting an intraurethral device into a patient's urethra is also disclosed.
- the applicator includes a housing having a distal end and a proximal end.
- the proximal end of the housing includes a housing flange.
- the housing further includes a wall defining a lumen.
- An applicator rod is disposed in the lumen of the housing.
- the applicator rod includes a distal end and a proximal end.
- a means for selectively connecting the distal end of the applicator rod to the proximal end of an intraurethral device is disposed at the distal end of the rod.
- -An actuating pad is fixed to the proximal end of the applicator rod.
- the applicator rod also includes at least one flange.
- a spring is disposed in the lumen of the housing, the distal end of the spring being seated on the distal tip member, and the proximal end of the spring being seated on the flange rod. In a presently preferred embodiment, the spring urges the applicator rod in a proximal direction.
- a method of positioning an intraurethral device in a urethra utilizing the applicator typically begins with the steps of urging the applicator rod in a distal direction and connecting the distal end of the applicator rod to the proximal end of the intraurethral device.
- the housing flange is adapted to receive two of the physician fingers and the pad is adapted to receive the physicians thumb.
- the thumb is used to apply pressure to the pad urging the applicator rod in a distal direction relative to the applicator housing. Applying pressure to the pad also has the effect of compressing the applicator spring. This presently preferred embodiment allows for simple, one-handed operation of the applicator.
- the pressure applied to the pad may be released.
- the release of the pressure on the pad allows the applicator spring to expand.
- the applicator spring expands it acts upon the actuating means of the intraurethral device.
- the applicator causes the distal members of the intraurethral device to assume a position in which the distal members form a generally conical distal tip.
- the intraurethral device is held in this desirable position by the applicator.
- the distal tip may now be inserted into the urethra.
- the generally conical shape of the distal tip allows for easy insertion.
- the remainder of the intraurethral device may be urged into the urethra until the proximal retainer is disposed proximate the urethral labia. Having placed the intraurethral device in the urethra, the applicator may now be disengaged from the urethral device. When the applicator is removed, the actuating means of the intraurethral device will be free to act upon the proximal end of the distal members of the intraurethral device. The actuating means of the intraurethral device causes the distal members to assume a deployed position in which the distal members extend away from the sleeve of the intraurethral device.
- the distal members serve to prevent proximal motion of the intraurethral device out of the patient by contacting the bladder floor. Distal motion of the intraurethral device into the patient is prohibited by the proximal retainer fixed to the proximal portion of the sleeve. In this manner, the intraurethral device is held within the urethra by the distal members and the proximal retainer acting at opposite ends of the urethra.
- Figure 1 is a cross-sectional plan view of an intraurethral device in accordance with an exemplary embodiment of the present invention
- Figure 2 is a cross-sectional plan view of the intraurethral device of Figure 1;
- Figure 3 is a perspective view of an assembly including an intraurethral device and an applicator in accordance with an exemplary embodiment of the present invention;
- Figure 4 is a perspective view of an applicator rod in accordance with an exemplary embodiment of the present invention.
- Figure 5 is a cross-sectional perspective view of a valve housing in accordance with an exemplary embodiment of the present invention.
- Figure 6 is a perspective view of a crown in accordance with an exemplary embodiment of the present invention
- Figure 7 is a plan view of an intraurethral device in accordance with an exemplary embodiment of the present invention disposed in the urethra of a patient;
- Figure 8 is a perspective view of an assembly in accordance with an exemplary embodiment of the present invention
- Figure 9 is a perspective view of an assembly in accordance with an exemplary embodiment of the present invention.
- FIG. 1 is a cross sectional plan view of an intraurethral device 20 in accordance with the present invention.
- Intraurethral device 20 includes a sleeve 22 having a distal portion 26 and a proximal portion 24.
- a proximal retainer 28 is fixed to proximal portion 24 of sleeve 22.
- Proximal retainer 28 serves to prevent distal motion of sleeve 22 into the patient by lying against the urethral labia.
- Sleeve 22 includes a sleeve wall 32 defining a central lumen 30 and a proximal orifice 33.
- a valve housing 40 is disposed in lumen 30 of sleeve 22.
- Naive housing 40 includes a distal portion 42 and a proximal portion 46 having a proximal orifice 48.
- Valve housing 40 is adapted to contain a flow control valve assembly (not shown in Figure 1).
- flow control valve assemblies which are suitable for inclusion in valve housing 40 are described by Kulisz et al. in U.S. Patent No. 5,437,604 entitled NONSURGICAL INTRAURETHRAL BLADDER CONTROL DEVICE, and U.S. Patent Application Serial No. 09/207,821 by Migachyov and entitled VALVE FOR BLADDER CONTROL DEVICE, the disclosure of each being hereby incorporated by reference.
- Those of skill in the art will appreciate that other flow control valves may be used in conjunction with intraurethral device 20 without departing from the spirit or scope of the present invention.
- Intraurethral device 20 also includes a plurality of distal members 50 each having a distal portion 52 and a proximal portion 54.
- distal members 50 are adjacent to each other.
- the distal portion 52 of each distal member 50 is preferably shaped so that distal members 50 combine to form a generally conical distal tip 102 when they are positioned as shown in Figure 1.
- distal members 50 are positioned as shown in Figure 1 to aid in inserting intraurethral device 20 into the urethra of a patient.
- linking means 60 includes elastomer hinges 62 and a ring 64. Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figure 1. The position of distal members 50 in Figure 1 is labeled with element number 100.
- FIG. 2 is a cross sectional plan view of intraurethral device 20 of Figure 1 with distal members 50 in a second position 200.
- First position 100 of distal members 50 is shown with phantom lines in Figure 2.
- Distal members 50 may be urged from position 100 to position 200 by an actuating means 300.
- Actuating means 300 applies a force to proximal portions 54 of distal members 50 causing the angular position of distal members 50 to change.
- Elastomer hinges 62 deform to allow the angular position of distal members 50 to change.
- actuating means 300 includes a crown 310 and a spring 304.
- Crown 310 includes a base 312 and an engaging member 314.
- Spring 304 is biased to act distally upon proximal end 46 of valve housing 40.
- Valve housing 40 transfers the force of spring 304 to crown 310.
- Engaging member 314 of crown 310 acts upon proximal portions 54 of distal members 50.
- crown 310 is fixed to a distal portion 42 of valve housing 40.
- Distal portion 42 of valve housing 40 includes a plurality of grooves or recesses 44.
- Recesses 44 are adapted to receive a base 312 of crown 310 and/or engaging member 314 of crown 310.
- Other methods of fixing crown 310 to distal portion 42 of valve housing 40 may be used without deviating from the spirit or scope of the present invention. Examples of methods which may be suitable in some applications include a threaded joint, a welded joint, and an adhesive joint. Embodiments of the present invention have also been envisioned in which crown 310 is an integral part of valve housing 40.
- Proximal portion 24 of sleeve 22 includes recesses or slots 144. Recesses 144 are adapted to receive a retaining member 320. Retaining member 320 supports spring 304. Spring 304 is biased to act upon both retaining member 320 and proximal end 46 of valve housing 40. Distal portion 26 of sleeve 22 includes a distal stop 46. Distal stop 46 is adapted to arrest the distal movement of valve housing 40 and crown 310.
- actuating means 300 are possible without deviating from the spirit and scope of the present invention.
- actuating means which may be suitable in some applications include elastomer springs, flat springs, and other materials known to those skilled in the art.
- distal members 50 When actuating means 300 is not acting upon the proximal portions 54 of distal members 50, elastomer hinges 62 are free to return to a natural, undeformed state. When elastomer hinges 62 are in a natural, undeformed state, distal members 50 assume position 100 as shown in Figure 1. First position 100 may be referred to as an insertion position; and second position 200 may be referred to generally as a deployed position. It will be appreciated from the above discussion, that distal members 50 may be selectively placed in a number of positions in addition to the exemplary positions illustrated in Figures 1 and 2.
- a force F is acting upon proximal end 46 of flow control valve 40.
- Force F has the effect of holding crown 310 in a proximal position and holding spring 304 in a compressed state.
- elastomer hinges 62 are free to assume their natural position when force F is applied to distal end 46 of valve housing 40.
- intraurethral device 20 is placed in position 100 to aid in inserting intraurethral device 20 into a patient's urethra.
- intraurethral device 20 assumes deployed position 200 as shown in Figure 2.
- distal members 50 serve to prevent proximal motion of sleeve 22 out of the patient by contacting the bladder floor.
- distal member 50, elastomer hinge 62, and ring 64 are all comprised of the same material.
- a presently preferred method of manufacturing this preferred embodiment is injection molding. Materials which may be suitable for this preferred embodiment include silicone rubber, and thermoplastic rubber.
- sleeve 22 is comprised of a thermoplastic material.
- Figures 8 and 9 are both perspective views of an exemplary embodiment of distal members 50 and ring 64, in accordance with the present invention.
- Distal members 50 each have a distal portion 52 and a proximal portion 54.
- distal members 50 are adjacent to each other.
- the distal portion 52 of each distal member 50 is preferably shaped so that distal members 50 combine to form a generally conical distal tip 102 when they are positioned as shown in Figure 8.
- Proximal portions 54 of distal members 50 are linked to ring 64 by elastomer hinges 62 which are best shown in Figure 9.
- elastomer hinges 62 are shown in a natural, undeformed position. Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figures 8 and 9.
- Elastomer hinges 62 define a slot 66 as shown in Figure 9 (not visible in Figure 8). In this exemplary embodiment of elastomer hinges 62, slot 66 allows engaging member 314 of crown 310 to pass through ring 64 and contact distal portions 54 of distal members 50.
- Embodiments of intraurethral device 20 have also been envisioned which include a surface layer 90.
- Surface layer 90 may include an anti-microbial chemical agent such as chlorhexidine gluconate (CHG) or silver compounds to reduce the likelihood of infection during use.
- Surface layer 90 may also include materials such as hyaluronic acid, a hydrogel, or other materials to mimic mucous.
- Surface layer 90 may also include a lubricious material such as a hydrophilic hydrogel or a hydrophobic silicone to facilitate insertion and removal. It is envisioned that one or more of the above described surface layer materials can be used.
- Embodiments of intraurethral device 20 have also been envisioned in which the materials which comprise distal members 50 and sleeve 22 include one or more of the materials described immediately above.
- a method of inserting intraurethral device 20 in accordance with the present invention may now be described with reference to Figures 1 and 2. It should be understood that steps may be omitted from this process and/or, the sequence of the steps may be changed without deviating from the spirit or scope of the invention.
- a first step desirable in some applications is to pre-lubricate and pre-dilate the urethra of the patient. It may also be desirable to apply a lubricant to the outer surfaces of intraurethral device 20. A force F may then be applied to distal end 46 of valve housing 40 so that it assumes insertion position 100 as shown in Figure 1.
- Generally conical distal tip 102 comprising distal members 50 is inserted into the patients urethra.
- the remainder of intraurethral device 20 including sleeve 22 may then be urged into the urethra until proximal retainer 28 contacts the urethral labia.
- the application of force F on valve housing 40 may be discontinued.
- distal members 50 assume position 200 as shown in Figure 2.
- intraurethral device 20 assumes retention position 200, distal members 50 serve to prevent proximal motion of sleeve 22 out of the patient by contacting the bladder floor.
- Figure 7 is a plan view of intraurethral device 20 disposed in the urethra of a patient.
- the urethra and bladder are shown in cross-section.
- intraurethral device 20 is shown after distal members 50 have been allowed to assume deployed position 200.
- FIG 3 is a perspective view of an assembly including an intraurethral device 20 and an applicator 400.
- Intra-urethral device 20 includes a sleeve 22 shown in partial cross section.
- Sleeve 22 includes a distal portion 26 and a proximal portion 24.
- a proximal retainer 28 is fixed to proximal portion 24 of sleeve 22.
- a ring 64 is fixed to distal portion of 26 of sleeve 22.
- Sleeve 22 includes a sleeve wall 32 defining a central lumen 30.
- a valve housing 40 is disposed in lumen 30 of sleeve 22.
- Intraurethral device 20 also includes a plurality of distal members 50 which are shown in cross-section in Figure 3.
- Distal members 50 each include a proximal portion 54 and a distal portion 56.
- Proximal portions 54 of distal members 50 are fixed to ring 64 by elastomer hinges 62 (not shown).
- Elastomer hinges 62 may be deformed to allow distal members 50 to assume positions other than the position shown in Figure 3.
- Intraurethral device 20 includes an actuating means 300 which may selectively apply force to proximal portions 54 of distal members 50 causing the angular position of distal members 50 to change.
- actuating means 300 includes a spring 304 which is biased to act distally upon proximal portions 54 of distal members 50.
- Applicator 400 includes a housing 402 having a distal end 406 and a proximal portion 404.
- Proximal portion 404 of housing 402 includes a housing flange 408 having a stop 418.
- An applicator tip 410 is fixed to distal end 406 of housing 402.
- Housing 402 further includes a wall 432 defining a lumen 430.
- An applicator rod 440 is disposed in lumen 430 of housing 402.
- Applicator rod 440 includes a distal end 446 and a proximal end 444.
- One or more keys 450 is disposed proximate distal end 446 of applicator rod 440.
- An actuating pad 446 is fixed to proximal end 444 of applicator rod 440.
- Applicator rod 440 also includes a first rod flange 452 and a second rod flange 454. The travel of applicator rod 440 in a proximal direction is limited by stop 418 of housing flange 408. As shown in Figure 3, stop 418 of housing flange 408 is adapted to make contact with second rod flange 454 of applicator rod 440.
- Applicator 400 includes an applicator spring 460 disposed in lumen 430 of housing 402. A proximal end 464 of spring 460 seats againsi- first rod flange 452 of applicator rod 440. A distal end 466 of applicator spring 460 seats against applicator tip 410 of applicator 400. Applicator spring 460 is positioned between first rod flange 452 and applicator tip 410 so that it urges applicator rod 440 in a proximal direction.
- intraurethral device 20 includes a spring 304 which is biased to act distally upon proximal portions 54 of distal members 50.
- applicator rod 440 and spring 460 are acting proximally upon proximal end 46 of valve housing 40.
- the force applied to proximal end 46 of valve housing 40 is sufficient to compress spring 304 of intraurethral device 20.
- applicator 400 may be utilized to selectively place distal members 50 in the position shown in Figure 3.
- distal end 446 of applicator rod 440 is adapted to be inserted into a proximal orifice 48 of valve housing 40.
- the elements of applicator rod 440 and valve housing 40 are best shown in Figures 4 and 5.
- FIG 4 is a perspective view of applicator rod 440
- Figure 5 is a cross-sectional perspective view of valve housing 40.
- applicator rod 440 includes a distal end 446 and a proximal end 444.
- applicator rod 440 includes a first rod flange 452, and a second rod flange 454.
- Keys 450 are disposed proximate distal end 446 of applicator rod 440. Keys 450 are adapted to selectively engage the proximal portion of valve housing 40.
- valve housing 40 includes a proximal portion 46 and a distal portion 42.
- Proximal portion 46 of valve housing 40 includes a proximal orifice 48, a shoulder 49, and one or more key slots 45.
- Key slots 45 are adapted to act as a passageway for keys 450 of applicator rod 440 when distal end 446 is inserted into proximal orifice 48 of valve housing 40. Once distal end 446 of applicator rod 440 is disposed inside valve housing 40, applicator rod 440 may be rotated so that keys 450 are no longer in alignment with key slots 45. With keys 450 in a misaligned position relative to key slots 45, keys 450 may apply a proximal force upon shoulder 49.
- Valve housing 40 of Figure 5 also includes a plurality of recesses 44 proximate distal portion 42 which are adapted to receive crown 310. Crown 310 is best shown in Figure 6.
- FIG. 6 is a perspective view of one embodiment of a crown in accordance with the present invention.
- crown 310 includes a base 312 and an engaging member 314.
- valve housing As described previously, valve housing
- 40 includes a plurality of recesses 44 which are adapted to receive base 312 and/or engaging member 314 of crown 310.
- a method of positioning intraurethral device 20 into a urethra utilizing applicator 400 may now be described with reference to Figures 4-7.
- a first step desirable in some applications is to pre- lubricate and pre-dilate the urethra of the patient. In many cases it is desirable to apply a lubricant to the exterior surfaces of intraurethral device 20 prior to insertion.
- applicator 400 typically begins with the steps of urging applicator rod 440 in a distal direction and inserting distal end 446 of applicator rod 440 into proximal proximal orifice 33 of sleeve 22.
- housing flange 408 is adapted to receive two of the physicians fingers and pad 446 is adapted to receive the physicians thumb.
- the thumb is used to apply pressure to pad 446, urging applicator rod 440 in a distal direction relative to applicator housing 402. Applying pressure to pad 446 also has the effect of compressing applicator spring 460.
- This presently preferred embodiment allows for simple, one handed operation of applicator 400.
- applicator rod 440 may be rotated until keys 450 are aligned with key slots 45. Distal end 446 of applicator rod 440 may then be inserted through orifice 48 of valve housing 40. Once distal end 446 of applicator rod 440 is disposed inside valve housing 40, applicator rod 440 may be rotated so that keys 450 are no longer in alignment with key slots 45. With keys 45 in a misaligned position relative to key slots 45, keys 450 may apply a proximal force upon shoulder 49.
- distal end 446 of applicator rod 440 is selectively linked to proximal portion 46 of valve housing 40.
- the connection formed between applicator rod 440 and valve housing 40 may be generally referred to as a bayonet connection.
- Those of skill in the art will appreciate that other methods of selectively linking applicator rod 440 to valve housing 40 may be used with out deviating from the spirit or scope of the present invention.
- applicator rod 440 Once applicator rod 440 is placed in the desired position, the pressure applied to pad 446 is release, allowing applicator spring 460 to expand. When applicator spring 460 expands it will urge valve housing 40 in a proximal direction compressing spring 304 of intraurethral device 20. When spring 304 of intraurethral device 20 is compressed, distal members 50 are free to assume insertion position 100 as shown in Figure 1. When distal members 50 assume insertion position 100, they form a generally conical tip 102.
- Distal tip 102 may now be inserted into the urethra.
- the generally conical shape of distal tip 102 allows for easy insertion.
- the remainder of intraurethral device 20 may be urged into the urethra until proximal retainer 28 is disposed proximate the urethral labia.
- applicator 400 may now be disengaged from intraurethral device 20. This may be accomplished by applying pressure to pad 446 causing applicator rod 440 to move in a distal direction. Applicator rod 440 may then be rotated so that keys 450 are in alignment with key slots 45. The pressure applied to pad 446 is then release, allowing applicator spring 460 to expand. As applicator spring 460 expands it will pull applicator rod 440 in a proximal direction, causing keys 450 to pass through key slots 45. Once keys 450 have passed through key slots 45, applicator 400 may be moved in a proximal direction away from intraurethral device 20.
- intraurethral device 20 When applicator 400 is removed, spring 304 of intraurethral device 20 will be free to expand causing distal members 50 to assume deployed position 200 as shown in Figure 2. When intraurethral device 20 assumes position 200, distal members 50 serve to prevent proximal motion of intraurethral device 20 out of the patient by contacting the bladder floor. Distal motion of intraurethral device 20 into the patient is prohibited by proximal retainer 28.
- distal members 50 serve to prevent proximal motion of intraurethral device 20 out of the patient by contacting the bladder floor. Distal motion of sleeve 22 into the patient is prohibited by proximal retainer 28 which contacts the labia of the urethra. In this manner, intraurethral device 20 is held within the urethra by distal members 50 and proximal retainer 28 acting at opposite ends of the urethra.
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- Health & Medical Sciences (AREA)
- Urology & Nephrology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
L'invention concerne un dispositif (20) et un procédé permettant de traiter l'incontinence urinaire chez la femme. Le dispositif (20) de cette invention comprend une gaine (22) qui présente une extrémité distale (26) et une partie proximale (24), une lumière (30) s'étendant entre celles-ci. De plus, une pluralité d'éléments distaux (50) est disposée au niveau de l'extrémité distale (26) de ladite gaine (22), ces éléments distaux (50) pouvant être sélectivement placés en position d'insertion, dans laquelle ils forment un embout distal généralement conique (102). Enfin, ces éléments distaux (50) peuvent également être sélectivement placés dans une seconde position, dans laquelle ils maintiennent le dispositif dans l'urètre par un contact avec le fond de la vessie.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US30285599A | 1999-04-30 | 1999-04-30 | |
US09/302,855 | 1999-04-30 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000066029A1 true WO2000066029A1 (fr) | 2000-11-09 |
Family
ID=23169493
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/011604 WO2000066029A1 (fr) | 1999-04-30 | 2000-04-28 | Dispositif de controle de la vessie et procede pour traiter l'incontinence urinaire chez la femme |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2000066029A1 (fr) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2831051A1 (fr) * | 2001-10-22 | 2003-04-25 | Johnson & Johnson Internat | Mini soutenement sous urethro-cervical |
EP1551492A2 (fr) * | 2002-10-02 | 2005-07-13 | Civco Medical Instruments Corporation | Catheter |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3683928A (en) * | 1970-03-25 | 1972-08-15 | David H Kuntz | Urethral catheter applicator |
WO1996018431A1 (fr) * | 1994-12-12 | 1996-06-20 | Influence, Inc. | Dispositif de fixation de cathether |
US5989179A (en) * | 1997-07-07 | 1999-11-23 | Hk Medical Technologies Incorporated | Bladder control device housing and method |
-
2000
- 2000-04-28 WO PCT/US2000/011604 patent/WO2000066029A1/fr active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3683928A (en) * | 1970-03-25 | 1972-08-15 | David H Kuntz | Urethral catheter applicator |
WO1996018431A1 (fr) * | 1994-12-12 | 1996-06-20 | Influence, Inc. | Dispositif de fixation de cathether |
US5989179A (en) * | 1997-07-07 | 1999-11-23 | Hk Medical Technologies Incorporated | Bladder control device housing and method |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2831051A1 (fr) * | 2001-10-22 | 2003-04-25 | Johnson & Johnson Internat | Mini soutenement sous urethro-cervical |
WO2003034939A1 (fr) * | 2001-10-22 | 2003-05-01 | Johnson & Johnson International | Mini soutenement sous urethro-cervical |
US7628751B2 (en) | 2001-10-22 | 2009-12-08 | Johnson & Johnson International | Mini sub-urethral-cervical support |
EP1551492A2 (fr) * | 2002-10-02 | 2005-07-13 | Civco Medical Instruments Corporation | Catheter |
EP1551492A4 (fr) * | 2002-10-02 | 2008-03-05 | Civco Medical Instr Co Inc | Catheter |
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