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WO1995034253A1 - Traitement de l'incontinence - Google Patents

Traitement de l'incontinence Download PDF

Info

Publication number
WO1995034253A1
WO1995034253A1 PCT/US1995/007548 US9507548W WO9534253A1 WO 1995034253 A1 WO1995034253 A1 WO 1995034253A1 US 9507548 W US9507548 W US 9507548W WO 9534253 A1 WO9534253 A1 WO 9534253A1
Authority
WO
WIPO (PCT)
Prior art keywords
expansion member
urethra
state
plug
catheter
Prior art date
Application number
PCT/US1995/007548
Other languages
English (en)
Inventor
Mark B. Knudson
Robert E. Buuck
Dezso K. Levius
Original Assignee
Iotek, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Iotek, Inc. filed Critical Iotek, Inc.
Priority to AU27051/95A priority Critical patent/AU2705195A/en
Publication of WO1995034253A1 publication Critical patent/WO1995034253A1/fr

Links

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
    • A61F2/0022—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening
    • A61F2/0027—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed deep in the body opening inflatable

Definitions

  • This invention pertains to an apparatus and method of treatment for incontinence. More particularly, this invention pertains to a plug for insertion into the urethra to seal fluid flow through the urethra.
  • Incontinence is defined as the involuntary loss of urine. Incontinence affects a large percentage of the population. - For example, among women, incontinence is estimated to affect 25 to 41% of all women. From 6 to 8.3% are so troubled by incontinence that they must wear incontinence absorption pads or the like. See, e.g. , "The Urethral Plug: A New Treatment Modality for Genuine Urinary Stress Incontinence in Women",- The Journal of Urolocry, Vol. 144, November 1990, pages 1199-1201.
  • U.S. Patent No. 3,372,695 to Belliveau dated March 12, 1968 teaches a plug for insertion in the urethra.
  • the plug includes a retainer member which engages the wall of the bladder.
  • U.S. Patent No. 3,503,400 teaches a urethral valve as does U.S. Patent No. 3,642,004.
  • U.S. Patent No. 3,841,304 to Jones dated October 15, 1974 teaches an inflatable balloon-like bulb. The bulb end is inserted into the bladder and inflated. The bulb is inflated by a pumping bulb shown as element 18 in Figure 1 of the '304 patent. More recently, U.S. Patent No.
  • Urethral plugs seal within the bladder at the entrance to the urethra with the sealing occurring above the sphincter.
  • a urethral plug may seal within the urethra against the urethral wall.
  • urethral plugs should be comfortable and easy to use.
  • Prior art devices such as U.S. Patent No. 3,841,304 require the use of external apparatus to inflate the plug. This requires user manipulation as well as a user determining the degree of inflation. Such requirements for user interaction can result in user error. Further, such devices require manipulation which may be difficult for certain patients due to other physiological factors (for example, arthritis and the like) . It is desirable to provide incontinence devices which are easy to use and are automatically actuated to seal.
  • an incontinence control apparatus having an expansion member formed at least in part of a material having a rest state and an enlarged swell state.
  • the material is characterized by changing from a rest state to the swell state in response to predetermined characteristics of an environment of the material.
  • the member is inserted at least partially into the urethra and the member expands to its swelled state to block fluid flow through the urethra.
  • FIG. 1 is a perspective view of an urethral plug according to the present invention.
  • Fig. 2 is a side cross-section view of the plug of Fig. 1;
  • Fig. 3 is an enlarged view of a distal end of the plug of Fig. 1;
  • Fig. 4 is a side sectional view of an alternative plug according to the present invention
  • Fig. 5 is an enlarged view of a distal end of the plug of Fig. 4;
  • Fig. 6 is an end view of the plug of Fig. 4;
  • Fig. 7 is a side sectional view of a further alternative plug according to the present invention
  • Fig. 8 is an enlarged view of a proximal end of the plug of Fig. 7;
  • Fig. 9 is an enlarged view of a distal end of the plug of Fig. 7.
  • a urethral plug 10 is shown.
  • the urethral plug 10 will be shown with representative sizes and configuration for use in treating female incontinence. It will be appreciated that a urethral plug for male incontinence according to the present invention is also contemplated and can be fabricated according to the teachings of the present invention while changing the relative dimensions necessary to properly size the plug with reference to male anatomy.
  • the plug 10 includes catheter 12 which is generally tubular in shape and has a hollow bore 14 extending along its axial length.
  • catheter 12 is formed of a flexible material which is smooth on its external surfaces to permit insertion of the catheter 12 into the urethra such that the catheter 12 may conform with the shapes of the urethra upon insertion and with minimized trauma to the urethral wall.
  • An axial distal end 15 of the catheter 12 is provided with a cap 16 which is secured to the catheter 12.
  • the catheter has a length of about 2.69 inches.
  • the diameter of the catheter 12 is about .158 inches (12 Fr.) .
  • the proximal end 13 of the catheter is provided with a flange 18.
  • the flange 18 has a hole 19 which is axially aligned with the bore 14.
  • the catheter has a reduced diameter portion 20 (shown best in Fig. 3) , such that the wall thickness of the catheter in reduced diameter portion 20 is substantially narrowed.
  • a flexible push rod 24 extends through the bore 14 and terminates at an end abutting cap 16.
  • the push rod 24 has a handle 26 external of the bore 14 and opposing the flange 18.
  • the catheter is preferably formed of silicon rubber or polyurethane with a hardness of 20 to 60 durometer such that the catheter is both flexible and stretchable along its axial length.
  • the diameter is 12 french (about 4.0 millimeters) .
  • the reduced diameter portion 20 separates the catheter 12 into an upper portion 21 and a lower portion 23.
  • An expansion member 30 connects the portions 21,23.
  • Expansion member 30 is substantially tubular surrounding the catheter 12 at the upper portion 21 and surrounding portion 23 as well as surrounding reduced diameter portion 20.
  • the bonding of the member 30 (through adhesive or the like) to the upper portion 21 occurs along a length or bonding area 40 which is preferably 2 to 3 millimeters long and immediately adjacent the reduced diameter portion 20.
  • a terminal end 31 of the expansion member 30 is bonded in a region 42 to lower portion 23. Again, the bonded portion 42 is approximately 2 to 3 millimeters long and immediately adjacent the reduced diameter portion 20.
  • Figs. 2 and 3 show the expansion member 30 in a rest state in which the expansion member 30 is substantially tubular and of generally equal diameter to the catheter 12. Accordingly, with expansion member 30 in the rest state, the device 10 may be inserted into the urethra without interference.
  • the expansion member 30 is expandable to an expanded shape shown by phantom lines 50 in Figs. 2 and 3 and shown in Fig. 1.
  • the expansion member In the expanded shape or swelled shape, the expansion member has a diameter substantially greater than the outside diameter of catheter 12.
  • the expansion member 30 In the swelled state, the expansion member 30 preferably has an outside diameter of about .59 inches (about 30 french) with a volume of about 2 to 5 cubic centimeters.
  • the preferred expansion member 30 is formed, at least in part, from a so-called "smart polymer". Smart polymers are recognized in the polymer technologies as polymers which substantially change in volume or dimension in response to changes in the environment of the polymer. Examples of smart polymers are discussed in POLYMER GELS FUNDAMENTALS AND
  • BIOMEDICAL APPLICATIONS Derossi et al. editors, Plenum Press, New York, New York, 1991.
  • a preferred polymer is polyacrylonitril (PAN) discussed on p. 269 of the aforementioned publication. Further examples are also found in an article entitled “Reports Collapse of Gels in an Electric Field", SCIENCE, Vol. 218, pages 467-469 (1982) . Smart polymers may expand from a rest state to a swelled state showing an increase in volume of one hundred times over the rest state. In the aforementioned article "SCIENCE”, the change in volume is activated by a voltage applied to the polymer.
  • smart polymers can also show a change in size in response to other environmental factors including temperature, moisture, pH and other factors including the presence of preselected ions (e.g. , Na+, K+, C1-) .
  • the smart polymer of expansion member 30 responds to moisture to change from the rest state to the swelled state. The moisture is provided by contact with the urethral wall and the moisture within the urethra or bladder.
  • Expansion member 30 may be either completely formed of the smart polymer or may be an elastomeric tube having inner woven or encapsulated threads of the smart polymer along its length or helically around the tubular ' expansion member 30.
  • the amount and geometry of the smart polymer may be varied to provide an expansion member 30 having any one of a number of desired characteristics.
  • the amount of expansion and balloon pressure of the swelled expansion member 30 may be varied for a wide variety of sizes and applications of the plug 10.
  • the expansion member 50 expands to an outside diameter of about 30 french. It is believed such an expansion member 30 may seal against 100 mm Hg of water pressure in the urethra.
  • the plug 10 is sized such that the catheter 12 may be inserted in the urethra with the flange 18 abutting the urethra meatus (i.e. , the entrance to the urethra) .
  • the length of the catheter 12 is selected such that the expansion member 30 resides within the bladder at the bladder neck. Accordingly, when the expansion member 50 expands in response to the environmental conditions within the bladder, the expanded expansion member seals the bladder neck to prevent urine from passing through the urethra. Also, the swelled expansion member 30 within the bladder together with the flange 18 abutting the urethra meatus results in the plug 10 being securely anchored within the urethra.
  • the smart polymer of the expansion member 30 can be selected so that its expansion occurs over a controlled amount of time.
  • the full expansion of the expansion member 30 can be controlled to occur after a predetermined time following insertion (e.g. , 10 seconds to 5 minutes) .
  • the plug 10 When a user desires to evacuate, the plug 10 may be removed by simply depressing handle 26 against flange 18. This causes the rod 24 to urge the plug 16 away from the flange 18. In response to this force, the reduced diameter portion 20 stretches resulting in the expansion member 30 being forced against its expanded state back to a tubular state in which the entire plug 10 may be easily removed through the urethra and disposed.
  • the urethra is sealed from urine flow automatically following insertion of the expansion plug 10. There is no need for alternative mechanisms (such as syringes or the like) to expand the member.
  • Figs. 4-6 show an alternative embodiment of the present invention where a plug 10a includes a catheter 12a secured to a flange 18a.
  • a push rod in the form of a flexible spring 24a is disposed within the catheter bore 14a and terminates at an exposed handle 26a.
  • the catheter 12a includes an elastomeric expansion end 80 which is a well-known melicot expansion end in the form of four ribs 81.
  • the elastomeric expansion member 80 stretches to the outside diameter of the catheter 14a or an expanded state as shown in Figs. 4-6.
  • the expanded member 80 is connected to the catheter 12a by means of a tubular expansion member 30a which is a smart polymer such as expansion member 30 of the embodiment of Fig. 1.
  • a tubular expansion member 30a which is a smart polymer such as expansion member 30 of the embodiment of Fig. 1.
  • the plug 10a is inserted into the urethra by depressing the handle 26a such that the expanded anchor 80 is of the outside diameter of the catheter 12a.
  • the plug 10a is inserted into the urethra with the anchor portion_ 80 positioned within the bladder. Pulling back on the handle 26a, the spring 24a forces the anchor 80 to its expanded state such that the device is anchored within the bladder by reason of anchor 80.
  • the expansion member 30a responds to moisture or other preselected environmental factors within the urethra to expand to an expanded state shown in the phantom lines 50a. The expansion member 30 then seals against the urethral wall.
  • the embodiment of Figs. 1-3 provides the smart polymer expansion member 30 to both seal and anchor the plug 10.
  • the plug 10a is anchored within the urethra by means of the mechanical melicot expansion anchor 80 positioned within the bladder.
  • the sealing of the urethra is provided by the expansion member 30a sealing against the urethra wall directly.
  • the handle 26a is further depressed which both forces both the expansion anchor 80 and the expansion member 30a to the tubular configuration such that the plug 10a may be removed through the urethra.
  • Figs. 7-9 show a further embodiment 10b.
  • the plug 10b includes an outer catheter 12b having a bore 14b.
  • the proximal end of the catheter is provided with a flange 18b which includes a battery housing 100.
  • the distal end of the catheter includes the smart polymer expansion member 30b.
  • the smart polymer of the expansion member 30b (instead of responding to moisture) responds to an electro-magnetic field provided by a coil 106 connected to the battery 102 housed in housing 100.
  • Electrical leads 103,104 extend from the battery to the coil 106 such that the voltage of the battery 102 may be applied against the coil 106 to generate a magnetic field to expand the polymer to the expanded shape 50b.
  • the polymer of expansion member 30b is positioned within the bladder neck to both anchor and seal.
  • the plug 10b is removed by simply rotating the battery housing 100 about its axis to change the polarity of the battery 102 causing the magnetic field to reverse resulting in the smart polymer 30b to revert to its rest state.
  • a smart polymer which responds to a magnetic field is acid- acrylamide copolymer gel (PAAM) discussed on p. 238 of the aforementioned Polymer Gels Fundamentals publication.

Landscapes

  • 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)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

Appareil utilisé pour gérer l'incontinence, comprenant un élément de dilatation polymère intelligent qui se dilate dans l'urètre ou la vessie pour bloquer l'écoulement de fluide dans l'urètre.
PCT/US1995/007548 1994-06-14 1995-06-14 Traitement de l'incontinence WO1995034253A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU27051/95A AU2705195A (en) 1994-06-14 1995-06-14 Incontinence treatment

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25952694A 1994-06-14 1994-06-14
US08/259,526 1994-06-14

Publications (1)

Publication Number Publication Date
WO1995034253A1 true WO1995034253A1 (fr) 1995-12-21

Family

ID=22985309

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/007548 WO1995034253A1 (fr) 1994-06-14 1995-06-14 Traitement de l'incontinence

Country Status (2)

Country Link
AU (1) AU2705195A (fr)
WO (1) WO1995034253A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10304614A1 (de) * 2003-02-05 2004-08-26 Willital, Günter Heinrich, Prof. Dr.med. Kontinenz-Vorrichtung
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
WO2014191002A1 (fr) * 2013-05-29 2014-12-04 Magcath Aps Dispositif de régulation de l'écoulement urinaire, tel qu'un dispositif pour l'incontinence
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
US10857324B2 (en) 2014-08-26 2020-12-08 C. R. Bard, Inc. Urinary catheter
US11547599B2 (en) 2017-09-19 2023-01-10 C. R. Bard, Inc. Urinary catheter bridging device, systems and methods thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3447533A (en) * 1964-09-14 1969-06-03 Richard J Spicer Closure means for artificial body openings
US3642004A (en) * 1970-01-05 1972-02-15 Life Support Equipment Corp Urethral valve
EP0193406A2 (fr) * 1985-02-28 1986-09-03 Medtronic, Inc. Dispositif pour contrôler l'incontinence
EP0265207A1 (fr) * 1986-10-20 1988-04-27 Vance Products Incorporated Dispositif trans-urétral pour l'incontinence
US5030199A (en) * 1989-12-11 1991-07-09 Medical Engineering Corporation Female incontinence control device with magnetically operable valve and method
WO1992011826A1 (fr) * 1990-12-31 1992-07-23 Uromed Corporation Procede et dispositif amovible utilise dans le traitement auto-administre d'infections des voies urinaires et d'autres troubles en tant que bouchon urethral
WO1992019192A1 (fr) * 1991-04-25 1992-11-12 Coloplast As Un dispositif permettant de prevenir les mictions involontaires, surtout chez la femme
WO1994026215A1 (fr) * 1993-05-17 1994-11-24 Uromed Corporation Tampon uretral expansible

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3447533A (en) * 1964-09-14 1969-06-03 Richard J Spicer Closure means for artificial body openings
US3642004A (en) * 1970-01-05 1972-02-15 Life Support Equipment Corp Urethral valve
EP0193406A2 (fr) * 1985-02-28 1986-09-03 Medtronic, Inc. Dispositif pour contrôler l'incontinence
EP0265207A1 (fr) * 1986-10-20 1988-04-27 Vance Products Incorporated Dispositif trans-urétral pour l'incontinence
US5030199A (en) * 1989-12-11 1991-07-09 Medical Engineering Corporation Female incontinence control device with magnetically operable valve and method
WO1992011826A1 (fr) * 1990-12-31 1992-07-23 Uromed Corporation Procede et dispositif amovible utilise dans le traitement auto-administre d'infections des voies urinaires et d'autres troubles en tant que bouchon urethral
WO1992019192A1 (fr) * 1991-04-25 1992-11-12 Coloplast As Un dispositif permettant de prevenir les mictions involontaires, surtout chez la femme
WO1994026215A1 (fr) * 1993-05-17 1994-11-24 Uromed Corporation Tampon uretral expansible

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10304614B4 (de) * 2003-02-05 2005-02-24 Willital, Günter Heinrich, Prof. Dr.med. Kontinenz-Vorrichtung
DE10304614A1 (de) * 2003-02-05 2004-08-26 Willital, Günter Heinrich, Prof. Dr.med. Kontinenz-Vorrichtung
US8864730B2 (en) 2005-04-12 2014-10-21 Rochester Medical Corporation Silicone rubber male external catheter with absorbent and adhesive
US9248058B2 (en) 2005-04-12 2016-02-02 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Male external catheter with absorbent and adhesive
US9707375B2 (en) 2011-03-14 2017-07-18 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US11607524B2 (en) 2011-03-14 2023-03-21 Rochester Medical Corporation Catheter grip and method
US10569051B2 (en) 2011-03-14 2020-02-25 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter grip and method
US9872969B2 (en) 2012-11-20 2018-01-23 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Catheter in bag without additional packaging
US10092728B2 (en) 2012-11-20 2018-10-09 Rochester Medical Corporation, a subsidiary of C.R. Bard, Inc. Sheath for securing urinary catheter
US10780244B2 (en) 2012-11-20 2020-09-22 Rochester Medical Corporation, a subsidiary of C. R. Bard, Inc. Catheter in a bag without additional packaging
US11730919B2 (en) 2012-11-20 2023-08-22 Rochester Medical Corporation Catheter in bag without additional packaging
CN105358094B (zh) * 2013-05-29 2017-07-18 玛格凯斯有限公司 诸如失禁装置的尿液流动控制装置
US10350043B2 (en) 2013-05-29 2019-07-16 Magcath Aps Urine flow control device, such as an incontinence device
CN105358094A (zh) * 2013-05-29 2016-02-24 玛格凯斯有限公司 诸如失禁装置的尿液流动控制装置
WO2014191002A1 (fr) * 2013-05-29 2014-12-04 Magcath Aps Dispositif de régulation de l'écoulement urinaire, tel qu'un dispositif pour l'incontinence
US10857324B2 (en) 2014-08-26 2020-12-08 C. R. Bard, Inc. Urinary catheter
US10874825B2 (en) 2014-08-26 2020-12-29 C. R. Bard, Inc. Urinary catheter
US11850370B2 (en) 2014-08-26 2023-12-26 C. R. Bard, Inc. Urinary catheter
US11547599B2 (en) 2017-09-19 2023-01-10 C. R. Bard, Inc. Urinary catheter bridging device, systems and methods thereof

Also Published As

Publication number Publication date
AU2705195A (en) 1996-01-05

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