Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2001-01-25
2002-12-10
Shaver, Kevin (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
Reexamination Certificate
active
06491623
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject disclosure relates to systems for artificially constricting body conduits, and more particularly to an improved artificial sphincter for preventing fecal incontinence.
2. Background of the Related Art
In the medical field, colostomies, Krohn's disease, short-gut syndrome in children, bowel resections for colorectal carcinoma and a variety of other circumstances can cause an individual to become incontinent. To accommodate such conditions, it is desirable to artificially constrict a body conduit or otherwise stop the flow of biological material therethrough.
Several devices have been developed to perform this function. For example, U.S. Pat. No. 3,750,194 to Summers discloses an apparatus for reversibly closing a body passage which includes a pump activated by an external switch to fill or empty a band, which acts as an artificial internal sphincter. U.S. Pat. No. 4,428,365 to Hakky discloses an anti-incontinent prosthesis which includes a strip of silicone rubber which has three bladders which are connected to tubing. The tubing connects the bladders to a flexible bulb. A non-return valve, between the bulb and the tubing, can be deformed to open the valve allowing the bladders to deflate. Pinching the flexible bulb fills the bladders with fluid.
Further examples include U.S. Pat. No. 4,634,443 to Haber, which discloses an elastofluidic sphincter having an occlusion cuff surrounding an expandable chamber. Primary and secondary fluid paths communicate with inlets and outlets of the expansible chamber. The fluid paths consist of several tube connectors and manually manipulatable one way check valves communicating with patient controlled hemispheric fluid reservoir-actuators. Depression of the fluid reservoirs increases pressure in the expansible chamber and manual manipulation of the check valves relieves pressure within the expansible chamber. A physician control port connected to the primary path facilitates adding more fluid to the system at any time.
Still further, U.S. Pat. No. 4,222,377 to Burton discloses a pressure regulated artificial sphincter having cuff member which encircles an affected vessel. A variable volume chamber, communicating with the cuff member, regulates system pressure. The cuff member receives fluid from hoses attached to a pump. Squeezing the pump introduces fluid into the cuff and chamber. A check valve prevents backflow when the pump is not being squeezed. To release the pressure within the cuff member, a tip portion of stem is depressed to overcome a spring tension against a blocking plug to unblock the check valve. U.S. Pat. No. 4,351,322 to Prager discloses a stoma control device having a ring for surgical implantation around an emerging bowel. The ring can be a gel filled skin containing a balloon which inflates to block the stoma.
Also, U.S. Pat. No. 4,994,020 to Polyak discloses an artificial sphincter which includes a cuff having a non-elastic backing and an inflatable inner cushion. The cuff is in fluid communication with a pump bulb by means of a tube. The tube has a one way check valve and a deactivation valve. U.S. Pat. No. 5,893,826 to Salama discloses an artificial sphincter. The artificial sphincter includes an inflatable balloon cuff which receives fluid through a tube from a syringe-type bulb pump connected to a one-way valve. The patient squeezing the valve with their fingers opens the valve and allows the cuff to deflate. The bulb pump is constructed of rubber or plastic with sufficient memory to allow it to maintain shape.
In light of the foregoing, a need exists for an artificial sphincter which is simple, reliable, cost-effective and which will not fail or damage the adjoining tissue.
SUMMARY OF THE INVENTION
The present disclosure provides an device for controlling the flow of matter through a body including a cuff portion configured to substantially encircle a section of a body conduit. An inlet conduit is operatively connected to the cuff portion for delivering fluid. The inlet conduit has a first flow control device operatively associated therewith. An outlet conduit is operatively connected to the cuff portion for releasing fluid therefrom. The outlet conduit has a second flow control device. A pumping reservoir is in fluid communication with the inlet conduit and the outlet conduit, wherein actuation of the pumping reservoir causes fluid to ingress into the cuff portion such that the cuff portion radially contracts and actuation of the second flow control device causes fluid to egress from the cuff portion such that the cuff portion radially expands. A lumen surrounds the cuff portion for admitting a fluid to provide rigidity and balance the pressure between the cuff portion and the pumping reservoir.
Another embodiment of the present disclosure is an artificial sphincter having an inflatable cuff for occluding a body passageway. The inflatable cuff has an interior wall portion and an exterior wall portion, wherein a first lumen is defined between the exterior wall portion and the interior wall portion, and a second lumen is defined by the interior wall portion. A pumping reservoir is in fluid communication with the inflatable cuff for controlling the ingress and egress of fluid to and from the second lumen to cause the inflatable cuff to radially contract and expand relative to the body passageway.
Still another embodiment of the present disclosure includes an implantable device for reversibly closing a body passageway. The device includes a coil having an elastic radially inner portion configured to be positioned about a body passageway such that when pressure within the coil increases, the elastic radially inner portion expands radially inward to block the body passageway. When pressure decreases, the elastic radially inner portion contracts and the body passageway opens. An outer housing provides structural support to the coil and a port is provided to inject fluid into the outer housing to adjust the rigidity of the outer housing. A reservoir stores fluid to reversibly inflate the coil by way of the at least one tube operatively connecting the coil to the reservoir. The tube has a valve to prevent backflow of fluid from the at least one coil into the reservoir and allow opening to allow fluid to flow from the coil into the reservoir.
Yet another embodiment of the present disclosure includes an artificial sphincter for controlling incontinence which has a cuff in the form of at least part of a turn of a coil. The cuff has an outer wall, an intermediate wall and an elastic inner wall. The outer wall and intermediate wall define a first lumen therebetween and the intermediate wall and the elastic inner wall define a second lumen therebetween. An injection port is provided to allow a surgeon to inflate the first lumen to set shape and rigidity but not to occlude the bowel and a pumping reservoir allows the patient to reversibly inflate and deflate the second lumen.
These and other unique features of the system disclosed herein will become more readily apparent from the following description, the accompanying drawings and the appended claims.
REFERENCES:
patent: 3863662 (1975-02-01), Zehr
patent: 4417567 (1983-11-01), Trick
patent: 4584990 (1986-04-01), Haber et al.
patent: 4634443 (1987-01-01), Haber
patent: 4643169 (1987-02-01), Koss et al.
patent: 4682583 (1987-07-01), Burton et al.
patent: 4878889 (1989-11-01), Polyak
patent: 4881939 (1989-11-01), Newman
patent: 4994019 (1991-02-01), Fernandez et al.
patent: 5509888 (1996-04-01), Miller
patent: 5562598 (1996-10-01), Whalen et al.
patent: 6045498 (2000-04-01), Burton et al.
patent: 6074341 (2000-06-01), Anderson et al.
Fellows Harriet A.
Snyder Daniel R.
Cadugan Joseph A.
Cummings & Lockwood
Harridan Medical
Shaver Kevin
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