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Publication numberUS3903894 A
Publication typeGrant
Publication date9 Sep 1975
Filing date26 Jul 1974
Priority date26 Jul 1974
Publication numberUS 3903894 A, US 3903894A, US-A-3903894, US3903894 A, US3903894A
InventorsIsaac Michael Rosen, Owen James Tassicker, David John Angus
Original AssigneeIsaac Michael Rosen, Owen James Tassicker, David John Angus
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Implantable clamp
US 3903894 A
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Description  (OCR text may contain errors)

United States Patent 1191 Rosen et al.

1451 Sept. 9, 1975 1 IMPLANTABLE CLAMP [76] Inventors: Isaac Michael Rosen, 3 Northwood Rd., Mt. Ousley, New South Wales, Australia, 2519; Owen James Tassicker, 1 l9 Heaslip St, Mangerton, New South Wales, Australia, 2500; David John Angus, l5l Northcliff Dr, Lake Heights, New South Wales, Australia 2502 [22] Filed: July 26, 1974 [2]] Appl. No.: 492,328

52 us. (:1. llllllllllll 128/346; l28/DlG1 25; 251 5 51 lm. c1? A6lB 19/00 581 Field of Search 128/1 R, 34o D10. 25;

[56] References Cited UNITED STATES PATENTS Foley 1. 128/346 Balaban 1. l28/l R Giori et a] l28/l R FOREIGN PATENTS OR APPLICATIONS l l74 8l4 l2/l969 United Kingdom l28/DIG. 25

Primary Examiner-Dalton L. Truluck Attorney, Agent, or FirmMcGlew and Tuttle [5 7 ABSTRACT An implantable prosthetic clamp comprising a fluid filled actuating bulb operately connected through a fluid duct to an operating balloon affixed to the clamp, actuation of the bulb serving to expand the balloon which transposes the clamp from an open" to a closed" condition or vice versa.

4 Claims, 5 Drawing Figures IMPLANTABLE CLAMP The present invention relates to a clamp which is implantable in the body of a human, or of another animal, to restrict the flow of a liquid along a vessel or duct of the body.

Urinary incontinence has been recognised as a condition occurring in both males and females. Various surgical procedures have been proposed to treat this condition; however, these still remains a proportion of patients who do not respond. The device according to this invention is designed, inter alia, to provide a prosthetic device for persons suffering urinary incontinence. It will be clear to persons skilled in the art, however, that the implantable clamp according to this invention may be used in numerous applications other than for the correction of urinary incontinence.

The present invention consists in an implantable prosthetic device comprising a compressible fluid reservoir, jaw means moveable between an open" and a closed" condition, the jaw means being biased towards one of these conditions, and a fluid expandable actuating member connected to the reservoir by a fluid duct, the actuating member being adapted to move the jaw means to the other of said conditions upon being expanded by the compression of the fluid reservoir.

The jaw means may either be biased towards an open or a closed position and inflation of the actuating member serves to force the jaw means towards the other position, e.g. if the jaw means are normally biased to a position closely adjacent one another, i.e. a closed position, the actuating member will be so disposed that its expansion will cause the jaw means to be forced apart to the open position. ln the converse situation the jaw means may be biased to an open position and compression of the reservoir will move the jaw means to a closed position. In this latter case valve means will be required on the reservoir to allow the jaw means to be maintained in a closed position for a prolonged period. The valve means may conveniently comprise an operable one way flap valve fitted between the reservoir and the fluid duct.

The clamp according to this invention is designed to be totally implanted in the body with the jaw means extending transversely of the vessel or duct to be controlled.

The compressible fluid reservoir is preferably provided with a wall which is at least in part flexible such that pressure applied to that portion of the wall will be transmitted to the fluid therein; the fluid pressure in the reservoir is transmitted to the actuating means to cause the jaw means to be re-oriented. The reservoir is preferably a flexible bulb which can be compressed by pressure from any direction such that the bulb may be implanted in the body in any orientation without affecting the ability of the reservoir to be compressed to create a source of fluid pressure to actuate thejaw means. The bulb is preferably implanted in the body intermediate the skin and a firm underlayer such as an area of hard muscle, cartilage or bone or alternatively in the scrotum ofa male patient.

The fluid duct interconnecting the fluid reservoir and the activating member is preferably formed integrally with the reservoir and the actuating means. The system being filled, most preferably, with a liquid such as a non-toxic silicone oil. In an alternative embodiment of the invention, the system may be filled with air or with some other fluid such as an isotonic saline solution.

The reservoir, actuating member and duct as well as the jaw members are preferably made of a silicone elastomer such as that sold under the trade name SlLAS- TIC. This material is advantageous in being nonirritating to the tissues of humans or other animals as well as being subject to negligible deterioration or structural degradation. The reservoir and the jaw means and/or the actuating member are preferably provided with a covering of dacron velour, or with some other means, into which the surrounding tissues may grow to anchor the various members in place in the body. If desired a stitch or stitches may be provided to anchor the parts of the clamp in place until the surrounding tissue has had a chance to grow into the anchoring means.

The jaw means itself is preferably so constructed and arranged that on one side of the duct there are a pair of spaced apart arms while there is on the other side of the duct a single arm spaced, in a longitudinal sense, intermediate the arms on the one side of the duct.

The jaw means are preferably formed integrally with a resiliently flexible bight portion, the actuating member being disposed adjacent the bight portion between arms of the jaw means. Expansion of the actuating members will serve to bias the arms apart with a consequent flexing of the bight portion. When the actuating member is allowed to contract, the resilience of the bight portion will return the arms of the jaw means to their initial positions.

In another embodiment of the invention, the actuating means is formed as an elongate balloon extending along one of the arms of the jaw means, the compression of the reservoir serving to expand the balloon such that the duct is constricted between the expanded balloon and the outer arm or arms of the jaw means.

The surgical procedure for the implantation of the clamp will depend upon the vessel or duct to be controlled and the manner in which fluid pressure is to be generated in the reservoir. If the device is to be used to control urinary incontinence in males it is envisaged that perineal and supra-pubic incisions would be required to allow placement of the clamp across the urethra and the reservoir in a position ventrally of the pelvis. Alternatively, the device could be inserted via one incision with the reservoir located in the scrotum. In females the device according to the invention could be used for, inter alia, the treatment of failed stress incontinence in which case the clamp could be placed across the urethra from a retropubic approach and the whole device inserted via the one incision, again with the reservoir placed in the pelvic region.

If the reservoir is placed in the pubic region or the scrotum as discussed above, it may be operated digitally. In another embodiment of the invention, the reservoir may be mounted for operation by some other part of the body, e.g. it could be mounted behind the knee for operation by a bending of the knee or it could be mounted on the hip for actuation by the elbow of a patient. These latter arrangements would be of obvious advantage to incapacitated persons without the use of hands.

Hereinafter given by way of example only is a preferred embodiment of the invention which is described with reference to the accompanying drawings in which:

FIG. 1 shows a clamp device according to this invention in an open position.

FIG. 2 shows a cross sectional view along A A of FIG. 1 when the clamping device is closed.

FIG. 3 shows a cross sectional view along A A of FIG. 1 when the clamping device is open, and

FIGS. 4 and 5 depict two surgical procedures for implantation of a clamp according to this invention.

The implantable clamp comprises a bulbous reservoir 11, and actuating balloon l2 and jaw means 13.

The reservoir 11 is a flexible bulb made of a SILAS- TIC material and is formed integrally with a duct 14 which interconnects the reservoir 11 and the actuating balloon 12. The duct 14 is itself made of a flexible SI- LASTIC material. The actuating balloon 12 is connected to the duct 14 in a fluid tight manner and is also made of a flexible grade of SILASTIC. The reservoir 11, duct 14 and actuating balloon 12 are completely filled with a silicone oil of low viscosity such that the application of pressure to the reservoir 11 will result in the expansion of the actuating balloon 12. An operable one way flap valve 20 is provided between the reservoir 11 and the fluid duct 14. The valve is so arranged as to enable the balloon 12 to be maintained in an inflated condition. When it is desired to deflate the balloon the valve is squeezed to render it inoperative and the natural resilience of the material of the balloon 12 will force the fluid back into the reservoir 11.

The actuating balloon 12 is disposed along the arm 16 of the clamping device 15 and faces towards the spaced apart arms 16a and 16b. The arms 16 are connected t) gether by a bight portion 16. The arms of the clamping device are formed from stainless steel with a coating of a resilient grade of SILASTIC material which is thickened to form cushions 19 on those portions of the arms in contact with the duct.

The provision of the silastic cushions on the arms and the 3 arm construction of the jaw means eliminates possible crushing of the duct and instead closes the duct by FIGS. 4 and 5 show alternative method for the insertion of the device according to this invention for the purpose of controlling urinary incontinence in males. In the arrangement of FIG. 4 the clamping device 15 is inserted through a perineal incision such that it extends transversely of the urethra. By tunnelling through the groin and into the suprapubic region a passage is formed for placement of the duct. A suprapubic incision is made to assist placement of the reservoir and to allow it to be fastened to the fascia over the rectus muscle. in the arrangement shown in FIG. 5 the reservoir is placed in the scrotum which allows placement of the device through a single incision.

Actuation of the device is achieved by manually pressing the area over the reservoir, or by squeezing the scrotum, to cause the actuating balloon to expand with consequent actuation of the jaws. Thus a person fitted with the implant can readily control urination.

The claims defining the invention are as follows:

1. An implantable prosthetic device comprising a compressible fluid reservoir, jaw means transportable between an open and a closed condition, the jaw means being biased towards one of these conditions, and a fluid expandable actuating member connected to the reservoir by a fluid duct, the actuating member being adapted to transpose the jaw means to the other of said conditions upon being expanded by the com pression of the fluid reservoir, said jaw means comprising three spaced apart parallel arms, the arms being connected together by a bight portion and being so disposed as to be, when viewed in cross-section, at the apices of a notational equilateral triangle.

2. An implantable clamp as claimed in claim 1, in which the actuating member comprises a balloon disposed along one arm of the jaw means, the jaw means being biased to the open position by the elasticity of the balloon.

3. An implantable clamp as claimed in claim I, in

kinking it. This arrangement prevents pressure necrosis 4() which an pe able n way valve is provided between the reservoir and the fluid duct.

4. An implantable clamp as claimed in claim 1 in which the reservoir, the fluid duct and the actuating means are filled with a silicone oil.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2455859 *13 May 19467 Dec 1948Frederic E B FoleyArtificial sphincter and method
US3815576 *26 Jan 197311 Jun 1974D BalabanArtificial sphincter
US3854469 *31 Oct 197217 Dec 1974Electro Sciences For MedicineEpiurethral valve
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US4019499 *22 Apr 197626 Apr 1977Heyer-Schulte CorporationCompression implant for urinary incontinence
US4178915 *16 Aug 197718 Dec 1979Gerhard SziniczSelectively operatable blocking device for tubular body organs
US4209010 *26 Jul 197824 Jun 1980The Kendall CompanyArtificial sphincter
US4210131 *26 Jul 19781 Jul 1980The Kendall CompanyArtificial sphincter with collection bag
US4210132 *26 Jul 19781 Jul 1980The Kendall CompanyArtificial sphincter
US4246893 *5 Jul 197827 Jan 1981Daniel BersonInflatable gastric device for treating obesity
US4549530 *29 Aug 198329 Oct 1985Medical Engineering CorporationMale urinary incontinence device and method
US4552128 *29 Dec 198312 Nov 1985Haber Terry MElastomechanical sphincter
US4553533 *8 Nov 198319 Nov 1985Leighton Stephen BIntra-urethral prosthetic sphincter valve
US4556050 *2 May 19843 Dec 1985Hodgson Darel EArtificial sphincter including a shape memory member
US4566446 *8 Apr 198328 Jan 1986Mentor CorporationPenile prosthesis device
US4587954 *27 Jan 198413 May 1986Habley Medical Technology CorporationElastomeric prosthetic sphincter
US4641860 *25 Jun 198410 Feb 1987Berkley And Company, Inc.Coupling for flexible tubing
US4708140 *8 May 198624 Nov 1987Baron Howard CAtraumatic vascular balloon clamp
US4786276 *1 Jul 198722 Nov 1988Habley Medical Technology CorporationTriple cushion sphincteric web
US4846784 *1 Jul 198711 Jul 1989C. R. Bard, Inc.Manually adjustable sphincteric system
US4909785 *2 Nov 198820 Mar 1990American Medical Systems, Inc.Method for valving body fluids
US5088980 *31 May 199018 Feb 1992The United States Of America As Represented By The Department Of Health And Human ServicesIntra-urethral valve with integral spring
US5593443 *31 Oct 199514 Jan 1997Nph Ltd.Prosthetic anal sphincter
US5792042 *8 Aug 199611 Aug 1998Cohen; Kenneth L.Apparatus for treating incontinence in females
US5795288 *8 Aug 199618 Aug 1998Cohen; Kenneth L.Apparatus with valve for treating incontinence
US6908473 *23 Mar 200121 Jun 2005Jeffry B. SkibaTissue anchoring devices, biological vessel suspending devices and systems and methods utilizing same
US7727140 *21 Jun 20051 Jun 2010Department Of Veterans AffairsSurgically implantable perineal urinary incontinence device
US80074292 Jul 200830 Aug 2011Gt Urological, LlcVessel occlusive device and method of occluding a vessel
EP0019644A1 *23 May 197910 Dec 1980Werner TrawögerImplantable apparatus for closing natural or artifical tubular body organs
EP0274517A1 *2 Jul 198720 Jul 1988Habley Medical Technology CorpHypodermically implantable genitourinary prosthesis.
EP0274518A1 *2 Jul 198720 Jul 1988Habley Medical Technology CorpAssembly for hypodermically implanting a genitourinary prosthesis.
EP0275310A1 *2 Jul 198727 Jul 1988Habley Medical Technology CorpApparatus for hypodermically implanting a genitourinary prosthesis.
WO1989000030A1 *1 Jul 198812 Jan 1989Bard Inc C RManually adjustable sphincteric system
WO2010148504A1 *22 Jun 201029 Dec 2010Antoine TrubianoSurgically implantable urethra pressure control valve
Classifications
U.S. Classification600/31, 251/5, 128/DIG.250
International ClassificationA61F2/00
Cooperative ClassificationA61F2/004, Y10S128/25
European ClassificationA61F2/00B6B2
Legal Events
DateCodeEventDescription
6 Apr 1984ASAssignment
Owner name: BONNY KENNETH
Free format text: POWER OF ATTORNEY BY ASSIGNOR APPOINTING ASSIGNEE TO REPRESENED HIM IN ALL MATTERS UNDER SAID PATENTS;ASSIGNOR:AMERICAN HOSPITAL SUPPLY CORPORATION;REEL/FRAME:004281/0965
Effective date: 19840322
Owner name: MENTOR CORPORATION
Owner name: MENTOR CORPORATION, MINNEAPOLIS, MN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:AMERICAN HOSPITAL SUPPLY CORPORATION, AN IL CORP;REEL/FRAME:004281/0961
Effective date: 19840330
Owner name: PAIGE STEPHEN B.