|Publication number||US2533924 A|
|Publication date||Dec 12, 1950|
|Filing date||Jun 28, 1948|
|Priority date||Jun 28, 1948|
|Publication number||US 2533924 A, US 2533924A, US-A-2533924, US2533924 A, US2533924A|
|Inventors||Frederic E B Foley|
|Original Assignee||Frederic E B Foley|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (4), Referenced by (75), Classifications (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Dec. 12, 1950 F. E. B. FOLEY 2,533,924
ARTIFICIAL SPHINCTER Filed June 28, 1948 FEEDER/C E. E. FOLEY Patented Dec. 12, 1950 UNITED STATES PATENT OFFICE ARTIFICIAL SPHINCTER Frederic E. B. Foley, St. Paul, Minn.
Application June 28, 1948, Serial No. 35,625
1 This invention relates to improvements in artificial sphincters for controlling the involuntary escape of urine in the male and the primary object is to provide means for this purpose which is simple, practical and sanitary and which admirably meets the problems of persons suffering from this afiliction. 1
The term involuntary escape of the urine is 7 here used generically to describe both the permaunder remote control, thus making it particularly useful where the condition is a temporary one, or does not justify more technical or complicated procedures, or possibly surgery, for its care.
As an example of such devices, applicable without surgery, the most widely known heretofore is probably the so-called Cunningham incontinence clamp which comprises hinged jaws which are placed across the penis and operate to compress all of the structures therein, including its erectile bodies as well as the contained urethra. This device is, however, objectionable as to size, difiiculty of operation and the discomfort which it causes the wearer. It is particularly undesirable due to its tendency to cause partial erection distal to the site of application.
In accordance with my invention I provide a sphincter, which may also be applied to the intact penis, with an inflatable, or rather distensible, element located in intimate contact with the ventral area immediately about the contained urethra, and tubularly connected to an inflating means which may be carried in a trousers pocket or other convenient location. Said distensible element may then be normally expanded or distended as necessary by fluid pressure'to compress the urethra and completely close its lumen to positively prevent the escape of the urine. In this connection and in furtherance of the objects of my invention the location of the distensible element on the ventral area, proximate to the urethra itself, results in exertion of the maximum pressure per unit of area at and about this desired point and minimum pressure on the -cir- '5 Claims. (01. 128-346) cumferential quadrants of the organ and particularly about the cavernous bodies thereof. Thus the tendency towards partial erection, distal to the location of the artificial sphincter, is to a large extent eliminated. Of course, the pressure of the fluid may be released Whenever required and in practice it is found that the patient may exercise control over his urine equally well, if not better, than the person not afflicted, and with the very minimum of discomfort in the wearing of the device.
These and other more detailed and specific objects will be disclosed in the course of the following specification reference being had to the accompanying drawings, in which- Fig. 1 is a perspective view of my improved artificial sphincter as applied to the penile organ, including the remotely operable inflating means and tubular connecting means.
Figs. 2 and 3 are elevations of the sphincter element in its applied position, showing it respectively in inoperative and operative, or urethra closing, conditions.
Fig. 4 is a perspective view of the sphincter alone.
Fig. 5 is an enlarged detail cross sectional view of the inflation pump and control element alone.
Referring now more particularly and by reference characters to the drawing A designates generally a section of the penile organ, wherein are the corpora cavernosa B and the urethra C contained within the corpus spongiosum D, the whole being within the outer surrounding skin E.
The artificial sphincter of my present invention is designated generally at I 0 and comprises a parted ring or clamp l l of spring material having oppositely turned lips or flanges l2 and is at its ends adapted to hook together and hold the clamp closed as clearly shown in Figs. 2 and 3. When unhooked the clamp will spring apart to facilitate its removal as will be readily understood. The clamp has a lining designated at It on its inner side and while this lining is yieldaible to provide maximum comfort to the wearer it is not, however, inflatable. In its preferred form the lining is made of a strip of soft sponge rubber 15 which is enclosed in a thin cover It of latex or the like, the purpose being to protect the spongy center portion, necessary for softness, with a smoother outer surface which may be readily kept in a sanitary condition. The lining thus formed is cemented to the inside of the clamp to hold them together and it will be noted that the lining terminates short of one' of the clamp ends and projects loosely past the other as indicated'at H to completely cover the inside of the clamp while allowing the lips l2 and i3 to be manipulated in applying or removing the device.
While I herein use the term clamp in describing my device, for convenience in descrip-' tion, it is to be understood that it does not act as a clamp in the sense that it compresses the organ with sufficient pressure to close the contained urethra C as does the Cunningham clamp previously mentioned. Instead my clamp is made of such size and is so shaped and arranged as merely to hold itself in position on the particular organ to which it is applied. 7 a
On'the lower part of the clamp, or the part which in use will be applied across the ventral quadrant of the organ there is formed a downwardly or outwardly rounded distension bag seat or socket is having a centrally located distension tube opening l9, this seat being here shown as formed by means of a hemispherical shell 20 soldered or otherwise secured about an opening in the clamp. See Figs. 2 and 3. The aforesaid lining Ii traverses this opening into the seat and protects against contact with the edge thereof. For use with this clamp I provide a distension bag 2| formed of latex at the end of a flexible distension tube 22 of the same material and the bag is in its uninflated condition also substantially control unit designated generally at 23 which is attached to the other end of the tube and due to theflexibility and length of the tube this unit may be carried in a trousers pocket (not shown) or other location prepared for it and where it may be operated by one hand as will presently appear.
The control unit 23 includes a ump for supplying a fluid (air in this case) under pressure to'the distension bag and valve means for holding the air in the bag or exhausting it therefrom as'the case may be. Referring particularly to Fig. 5 it will be seen that this unit comprises a barrel or cylinder 24 telescopically fitted over a plunger 25 around which is placed a small conventional O-ring 26 to make an air tight cirg;
cumferential seal between these parts. An expansion coil spring 2? is placed inside the cylinder 24 and braced between its closed end 28 and them apart to the position shown. A stop screw 29,is threaded inwardly through the cylinder wall.
and plays in a longitudinal groove 35 in the plunger to limit the relative motion between the parts. Air may enter the chamber inside the cyl inder. 24 through an opening 3| in its end .28
' and it will be noted that this end of the cylinder sageway 34 from end to end and a projecting needle portion 35 on the exposed end permits the convenient application of the distension tube 22 thereto in communication with said passageway. The opposite end portion of the passageway is enlarged and is threaded at 36 to re- 7 ceive a conventional pneumatic tire inflation valve 3'1 which operates to open upon. the building up of suificient pressure within the cylinder the 'end of the plunger 25 thus to normally urge will'be readily appreciated.
In the use and operation of the device, with the sphincter clamp or rin in place the ,wearer operates the control unit 23 by hooking two fingers over the plunger flange 33 and placing the thumb over the flanged cylinder end 32 covering the opening 3|. Then by squeezing the fingers and thumb together the cylinder 24 and plunger 25 will be telescoped and the air trapped in the chamber of the cylinder will be compressed until it reaches a point at which it will open or unseat the valve 31. The air will then pass through the distension tube 22 into the distension bag 2| which will be expanded to the bulbous shape shown in Fig. 3. When pressure on the control unit is relieved by the hand operating it the air will be held in the distension tube and bag by the valve 31 without further effort. As clearly 7 shown this distension of the bag 2| forces the lining l4 immediately thereadjacent against the ventral part of the penile organ to squeeze the urethra closed, and: completely obliterates its lumen to positively prevent the unwanted escape V of the urine. When urination is necessary the user again grasps the control unit and telescopes it, but this time with his thumb not covering the air opening 3 it being the purpose of the flange 32 to provide purchase space for the thumb in this operation. The end of the cylinder will now strike and mechanically open the valve 31 sothat the air may escape in a rush from the distension bag allowing it to collapse and the urethra to open and start the flow. When urination is completed the bag is against distended as described above. r
It is an important feature of my invention that the urethra is compressed by the distension bag 2| only and this bag being small and located in-. timate to the ventral surface of the organ below the urethra delivers the maximum pressure per 7 unit of area at this point with a minimumpres sure upon the other circumferential areas of the organ. See Fig. 3 particularly. The liner engaging or pressure wall of the bag has a transverse dimension of about 10% of the circumference of the clamp shown and, no matter how small a clamp is used, in any case the transverse dimension of the wall should be less than 25%ofthecircumferential dimension of the'clamp. The
pressure on the erectile bodies of the organ is thus Y minimized andthetendency towards partial erection, distal to the location of the device is largely if not completely eliminated. In this connection itwill be noted that the sphincter'is not circular but is elongated laterally and engages only the dorsal and ventral areas of the organ. Lateral pressure against the ventral area of the organ,
thuslimiting the pressure area to that strictly" necessary for my purpose." All of these factors contribute to the comfort of the patient and to the elimination of the tendency toward erection as It is understood that suitable modifications J may be made in the structure as disclosed, pro-' j vided such modifications come'within the spirit and scope of the appended claims; Having now therefore'fully illustrated and described my invention, what I claim to be newand'desire to able lining, and a fluid actuated distension bag separate from the said lining but operative between the lining and the clamp to urge only a circumferentially small portion of the former into pressure engagement with the organ.
2. Apparatus for controlling involuntary escape of urine, comprising in combination, a clamp for application to the male ongan, a yieldable lining for the inside of the clamp, the said clamp having a seat, a bulbous fluid actuated distension bag positioned in said seat, and means for inflating the bag to distend it and force the immediate area of the said 1ining against the ventral quadrant of the organ.
2. Apparatus for controlling involuntary escape of urine, comprising in combination, a clamp for application to the male organ, a yieldable lining for the inside of the clamp, the said clamp having a seat forming means and an opening therein, a distension bag seated in the seat forming means and a distension tube leading from the bag out through the said opening, and means attached to the tube for distending the bag.
4. An apparatus for controlling involuntary escape of urine comprising a clamp for the male organ, said clamp having a seat adjacent the ventral portion of the organ, a bulbous distensible element positioned in the seat, and a distension means on the apparatus for distending the element towards said ventral portionj 5. A device for controlling the involuntary escape of urine from the male organ which comprises a member adapted to encircle the organ and engage the ventral portion thereof, a distensible element on said member adjacent the point of ventral engagement, said element having a pressure Wall adapted to be moved radially inward toward the ventral portion of the organ as the element is distended, said wall being less in transverse dimension than 25% of the circumferential dimension of the member whereby the upper side portions of the organ will not be com pressed by said distension, and means on the device for distending the element.
FREDERIC E. B. FOLEY.
REFERENCES CITED The following references are of record in the file of this patent:
UNITED STATES PATENTS Number Name Date 678,943 Davis H July 23, 1901 1,728,322 Badrian Sept. 17, 1929 1,827,241 Kempf Oct. 13, 1931 2,045,750 Buschenfeldt June 3t), 1936
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US678943 *||Apr 22, 1901||Jul 23, 1901||John C Davis||Compress.|
|US1728322 *||Feb 21, 1929||Sep 17, 1929||Badrian Max||Device for elastically clamping off the male urethra|
|US1827241 *||Oct 24, 1929||Oct 13, 1931||Kempf Arthur R||Tourniquet|
|US2045750 *||Feb 8, 1935||Jun 30, 1936||Buschenfeldt Karl W||Tourniquet|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US2839062 *||Jun 23, 1953||Jun 17, 1958||Kidde Mfg Co Inc||Pneumatic tourniquet cuff|
|US3155096 *||Aug 8, 1963||Nov 3, 1964||Edson S Outwin||Male incontinence clamp|
|US3675656 *||May 26, 1969||Jul 11, 1972||Salomon Hakim||Fluid operatable hemostat|
|US3744063 *||Oct 12, 1971||Jul 10, 1973||Kendall & Co||Artifical sphincter for controlling urinary incontinence|
|US3815576 *||Jan 26, 1973||Jun 11, 1974||D Balaban||Artificial sphincter|
|US4167952 *||Mar 9, 1978||Sep 18, 1979||Parker-Hannifin Corporation||Control device for prosthetic urinary sphincter valve|
|US4209010 *||Jul 26, 1978||Jun 24, 1980||The Kendall Company||Artificial sphincter|
|US4210131 *||Jul 26, 1978||Jul 1, 1980||The Kendall Company||Artificial sphincter with collection bag|
|US4210132 *||Jul 26, 1978||Jul 1, 1980||The Kendall Company||Artificial sphincter|
|US4222377 *||Jun 27, 1977||Sep 16, 1980||American Medical Systems, Inc.||Pressure regulated artificial sphincter systems|
|US4256093 *||Oct 12, 1978||Mar 17, 1981||The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration||Prosthetic urinary sphincter|
|US4406281 *||Apr 14, 1981||Sep 27, 1983||Tecnol, Inc.||Fluid impermeable cover for operating room tourniquet|
|US4419985 *||Mar 24, 1982||Dec 13, 1983||Medical Engineering Corporation||Apparatus for reversibly closing a body passage|
|US4531519 *||Jun 18, 1984||Jul 30, 1985||Dunn David C||Vascular clamp|
|US4534353 *||Mar 24, 1983||Aug 13, 1985||Leur Eric J A De||Accessory for counteracting the consequences of vesical incontinence with males|
|US4549530 *||Aug 29, 1983||Oct 29, 1985||Medical Engineering Corporation||Male urinary incontinence device and method|
|US4587954 *||Jan 27, 1984||May 13, 1986||Habley Medical Technology Corporation||Elastomeric prosthetic sphincter|
|US4641638 *||Oct 10, 1985||Feb 10, 1987||Perry Robert D||Sexual erection prothesis and method of use|
|US4773419 *||Apr 14, 1987||Sep 27, 1988||Scanlan International, Inc.||Method and apparatus for limiting blood flow to a distal portion of an extremity|
|US4800900 *||Sep 25, 1987||Jan 31, 1989||Vance Products, Inc.||External strap incontinence control device|
|US4880016 *||May 13, 1988||Nov 14, 1989||E. R. Squibb And Sons, Inc.||Penile clamp|
|US5184629 *||Apr 25, 1991||Feb 9, 1993||Dacomed Corporation||Male urinary anti-incontinence device and method|
|US5421808 *||Jul 30, 1993||Jun 6, 1995||Osbon Medical Systems, Ltd.||Battery-operated male organ conditioning appliance|
|US5483976 *||May 17, 1993||Jan 16, 1996||Uromed Corporation||Mechanically actuated urethral plug assembly and method for controlling urinary incontinence|
|US5653218 *||Oct 28, 1994||Aug 5, 1997||Hitachi Koki Co., Ltd.||Electric-powered stone cutter|
|US5857960 *||Sep 26, 1997||Jan 12, 1999||Boutos; David||Pneumatic apparatus for controlling certain bodily insertion devices and collapsible seating apparatus|
|US5893826 *||Aug 14, 1997||Apr 13, 1999||Salama; Fouad A.||Artificial sphincter urinary control system|
|US5984910 *||Nov 25, 1997||Nov 16, 1999||Berke; Joseph J.||Urinary incontinence device and method|
|US6039750 *||Apr 10, 1997||Mar 21, 2000||Mentor Corporation||Urethral occlusion device for maintaining urinary bladder retention and method of use|
|US6138678 *||Sep 30, 1997||Oct 31, 2000||Nilsson; Leif||Male incontinence guard|
|US6470890 *||Sep 18, 2000||Oct 29, 2002||Ananias Diokno||Device and a method for mechanical installation and removal of inflatable vaginal pessary|
|US6659937||Oct 11, 2001||Dec 9, 2003||M. Sheldon Polsky||Continent bladder access device|
|US6663653 *||Sep 20, 2001||Dec 16, 2003||Radi Medical Systems Ab||Adjustable radial artery compressor|
|US7658196||Apr 25, 2007||Feb 9, 2010||Ethicon Endo-Surgery, Inc.||System and method for determining implanted device orientation|
|US7775215||Mar 7, 2006||Aug 17, 2010||Ethicon Endo-Surgery, Inc.||System and method for determining implanted device positioning and obtaining pressure data|
|US7775966||Mar 7, 2006||Aug 17, 2010||Ethicon Endo-Surgery, Inc.||Non-invasive pressure measurement in a fluid adjustable restrictive device|
|US7844342||Feb 7, 2008||Nov 30, 2010||Ethicon Endo-Surgery, Inc.||Powering implantable restriction systems using light|
|US7918782||Nov 17, 2008||Apr 5, 2011||Ams Research Corporation||Prosthesis with bladder that adjusts girth|
|US7927270||Jan 29, 2007||Apr 19, 2011||Ethicon Endo-Surgery, Inc.||External mechanical pressure sensor for gastric band pressure measurements|
|US8016744||Mar 7, 2006||Sep 13, 2011||Ethicon Endo-Surgery, Inc.||External pressure-based gastric band adjustment system and method|
|US8016745||Apr 6, 2006||Sep 13, 2011||Ethicon Endo-Surgery, Inc.||Monitoring of a food intake restriction device|
|US8034065||Feb 26, 2008||Oct 11, 2011||Ethicon Endo-Surgery, Inc.||Controlling pressure in adjustable restriction devices|
|US8057492||Feb 12, 2008||Nov 15, 2011||Ethicon Endo-Surgery, Inc.||Automatically adjusting band system with MEMS pump|
|US8066629||Feb 12, 2007||Nov 29, 2011||Ethicon Endo-Surgery, Inc.||Apparatus for adjustment and sensing of gastric band pressure|
|US8100870||Dec 14, 2007||Jan 24, 2012||Ethicon Endo-Surgery, Inc.||Adjustable height gastric restriction devices and methods|
|US8114345||Feb 8, 2008||Feb 14, 2012||Ethicon Endo-Surgery, Inc.||System and method of sterilizing an implantable medical device|
|US8142452||Dec 27, 2007||Mar 27, 2012||Ethicon Endo-Surgery, Inc.||Controlling pressure in adjustable restriction devices|
|US8152710||Feb 28, 2008||Apr 10, 2012||Ethicon Endo-Surgery, Inc.||Physiological parameter analysis for an implantable restriction device and a data logger|
|US8187162||Mar 6, 2008||May 29, 2012||Ethicon Endo-Surgery, Inc.||Reorientation port|
|US8187163||Dec 10, 2007||May 29, 2012||Ethicon Endo-Surgery, Inc.||Methods for implanting a gastric restriction device|
|US8192350||Jan 28, 2008||Jun 5, 2012||Ethicon Endo-Surgery, Inc.||Methods and devices for measuring impedance in a gastric restriction system|
|US8221439||Feb 7, 2008||Jul 17, 2012||Ethicon Endo-Surgery, Inc.||Powering implantable restriction systems using kinetic motion|
|US8233995||Mar 6, 2008||Jul 31, 2012||Ethicon Endo-Surgery, Inc.||System and method of aligning an implantable antenna|
|US8337389||Jan 28, 2008||Dec 25, 2012||Ethicon Endo-Surgery, Inc.||Methods and devices for diagnosing performance of a gastric restriction system|
|US8377079||Dec 27, 2007||Feb 19, 2013||Ethicon Endo-Surgery, Inc.||Constant force mechanisms for regulating restriction devices|
|US8545391||Dec 22, 2009||Oct 1, 2013||Ams Research Corporation||Penile prosthesis implantation device|
|US8591395||Jan 28, 2008||Nov 26, 2013||Ethicon Endo-Surgery, Inc.||Gastric restriction device data handling devices and methods|
|US8591532||Feb 12, 2008||Nov 26, 2013||Ethicon Endo-Sugery, Inc.||Automatically adjusting band system|
|US8864651||Sep 26, 2013||Oct 21, 2014||Ams Research Corporation||Penile prosthesis implantation device|
|US8870742||Feb 28, 2008||Oct 28, 2014||Ethicon Endo-Surgery, Inc.||GUI for an implantable restriction device and a data logger|
|US9005111||Jul 22, 2014||Apr 14, 2015||Ams Research Corporation||Penile prosthesis implantation device|
|US9089426||Mar 14, 2013||Jul 28, 2015||Ams Research Corporation||Automated implantable penile prosthesis pump system|
|US9402723||Mar 13, 2015||Aug 2, 2016||Ams Research, Llc||Penile prosthesis implantation device|
|US9522065||Jul 22, 2015||Dec 20, 2016||Boston Scientific Scimed, Inc.||Automated implantable penile prosthesis pump system|
|US20040242956 *||Jul 29, 2003||Dec 2, 2004||Scorvo Sean K.||System for controlling fluid in a body|
|US20090132043 *||Nov 17, 2008||May 21, 2009||George Stephanie A||Prosthesis with Bladder that Adjusts Girth|
|US20090204144 *||Feb 5, 2009||Aug 13, 2009||De Francesco Juan Carlos||Device for the control of urinary incontinence|
|US20100016652 *||Sep 25, 2009||Jan 21, 2010||Aram Bonni||Patient-adjustable incontinence device (aid)|
|US20100160722 *||Dec 22, 2009||Jun 24, 2010||Ams Research Corporation||Penile prosthesis implantation device|
|USRE31121 *||Aug 8, 1980||Jan 11, 1983||Parker-Hannifin Corporation||Control device for prosthetic urinary sphincter cuff|
|EP0228532A1 *||Nov 1, 1986||Jul 15, 1987||Karl Dr. Aigner||Implantable catheter with a vein clamp|
|EP2087855A2||Feb 5, 2009||Aug 12, 2009||Donati, Ricardo Roberto||Device for the control of urinary incontinence|
|WO1987002570A1 *||Nov 1, 1986||May 7, 1987||Karl Aigner||Implantable catheter with container throttle|
|WO1990011063A1 *||Mar 19, 1990||Oct 4, 1990||Dacomed Corporation||Male urinary anti-incontinence device and method|
|WO1998014146A1 *||Sep 30, 1997||Apr 9, 1998||Radojevic, Borka||A male incontinence guard|
|U.S. Classification||128/885, 128/DIG.250|
|Cooperative Classification||Y10S128/25, A61F2/0054|