Surgery – Devices transferring fluids from within one area of body to...
Reexamination Certificate
2002-09-30
2004-12-28
Snow, Bruce Edward (Department: 3738)
Surgery
Devices transferring fluids from within one area of body to...
C604S009000, C623S023660
Reexamination Certificate
active
06835183
ABSTRACT:
TECHNICAL FIELD
The invention relates generally to urethral prostheses and methods of insertion into a body. More particularly, the invention relates to a urethral prosthesis having a bladder/prostate segment and a penile urethra segment connected by a bridge segment, which crosses the urinary sphincter.
BACKGROUND INFORMATION
Urinary retention in males is often caused by neurological disorders or by obstructions in the urinary tract. Neurogenic urinary retention is a condition in which a person is unable to empty his urinary bladder voluntarily due to a neurological dysfunction of the urinary bladder and/or of the urinary sphincter. Neurogenic urinary retention is due to an inability of the bladder to contract and/or of the urinary sphincter to relax. Patients with spinal cord injuries, multiple sclerosis, Parkinson's disease, or trauma to the pelvic region may suffer from neurogenic urinary retention on a permanent or transient basis.
Patients suffering from neurogenic urinary retention generally have limited options for draining their bladders. These include using a Foley catheter, intermittent catheterization, and a suprapubic drainage tube. All three options have high infection rates, are inconvenient for the patient and/or care giver, are uncomfortable for the patient, and cause the patient emotional distress.
Urinary retention is also caused by obstructions in the urethra, such as prostatic obstructions. The prostate gland encircles the urethra immediately below the urinary bladder. A common affliction among older males is benign prostatic hyperplasia (BPH), or the nonmalignant enlargement of the prostate. When the prostate becomes enlarged, it may restrict the urethra and thereby obstruct the flow of urine from the bladder.
A common treatment of BPH is surgical resection of the prostate and urethral tissue, but this option is not suitable for many patients. BPH afflicts primarily older males, so other health problems, such as cardiovascular disease, may prevent surgical intervention. Furthermore, potential complications associated with surgery, such as urinary infection, dysuria, and incontinence, may make a patient unwilling to undergo the surgery.
SUMMARY OF THE INVENTION
It is an object of the invention to relieve the symptoms of urinary retention in males without the high infection rates and other potential complications associated with current treatments. It is another object of the invention to provide a urethral prosthesis that resides within a bladder and urethra of a patient and that provides the patient control over drainage of the bladder without the discomfort and emotional distress associated with conventional treatments.
In one aspect, the invention relates to a urethral prosthesis including a first tubular element, a second tubular element, a bridge segment for joining the first and second tubular elements, and a valve. The first tubular element includes a distal portion with a drainage hole for receiving urine, a proximal end and a lumen, which extends from the drainage hole through the first tubular element to the proximal end of the first tubular element. At least a portion of the first tubular element is adapted for residing in a urethra of a patient. The second tubular element is adapted for residing in a penile urethra of a patient. The second tubular element includes a lumen extending from the bridge segment to its proximal end. The bridge segment has a diameter that is smaller than the diameter of the first tubular element and has a lumen for providing a permanent urine flow channel from the first tubular element through the urinary sphincter. The valve is disposed within the lumen of the second tubular element for controlling a flow of urine through the lumen of the second tubular element.
Embodiments according to this aspect of the invention can include the following additional features. The first and second tubular elements and the bridge segment may all be made of a pliable, biocompatible material, such as silicone rubber, for example. In another embodiment, the bridge segment comprises a spring disposed within the pliable, biocompatible material. In another embodiment, the proximal end of the second tubular element contains a suture wire to aid in removing the prosthesis from the urethra of a patient. The first and second tubular elements may also have an external surface coated with a coating including a plurality of gas bubbles therein.
In this aspect of the invention, the valve may be a magnetically-actuatable valve. In this embodiment, the valve includes a ferromagnetic valve seat, which has an aperture for the passage of fluid therethrough, and a valve element. The valve element includes a magnet encapsulated in a non-magnetic capsule. The capsule has a top portion and a base portion, which is wider than the top portion. The valve element is magnetically attracted to the valve seat so that it blocks the flow of fluid through the aperture in the valve seat.
In a second aspect, the invention relates to a urethral prosthesis including a first tubular element, a second tubular element, and a bridge segment of suture wires connecting the first and second tubular elements. The bridge segment resides within the urinary sphincter. The first tubular element has a drainage hole for receiving urine in its distal portion, a lumen extending from the drainage hole to its proximal end, and an external surface coated with a coating including a plurality of gas bubbles disposed therein. The first tubular element is adapted for residing at least partially in the urethra of a patient. The second tubular element is adapted for residing in a penile urethra of the patient and has a lumen.
Embodiments according to this aspect of the invention can include the following additional features. The second tubular element may also have an external surface coated with a coating including a plurality of gas bubbles. The first and second tubular elements may be composed of a pliable, biocompatible material, such as silicone rubber, for example. The second tubular element may include a suture wire attached to its proximal end to aid in removing the prosthesis from the patient. Finally, the second tubular element may include an optical lens embedded in its wall.
In a third aspect, the invention relates to a urethral prosthesis including a first tubular element, a second tubular element, and a bridge segment of suture wires connecting the first and second tubular elements. The bridge segment resides within the urinary sphincter. The first tubular element has a drainage hole for receiving urine in its distal portion, and a lumen extending from the drainage hole to its proximal end. The first tubular element is adapted for residing at least partially in the urethra of a patient. The second tubular element is adapted for residing in a penile urethra of the patient and has a lumen and includes an optical lens embedded in its wall.
Embodiments according to this aspect of the invention can include the following additional features. The first and second tubular element may also have an external surface coated with a coating including a plurality of gas bubbles. The first and second tubular elements may be composed of a pliable, biocompatible material, such as silicone rubber, for example. The second tubular element may include a suture wire attached to its proximal end to aid in removing the prosthesis from the patient.
The invention also relates to systems and methods for treating urinary retention. A system of the invention includes a urethral prosthesis of any of the above-described embodiments, an inflation cannula, and an inflatable balloon. The inflation cannula includes a lumen, which is in communication with the inflatable balloon for passage of fluid or gas to the balloon, so as to inflate the balloon. In one embodiment, the balloon covers at least a portion of the first tubular element when inflated. In another embodiment, the balloon covers the second tubular element when inflated.
A method of using such a system in which the balloon covers at least a portion of
Godshall Douglas E.
Lamport Ronald B.
Lennox Charles D.
Levine Andrew H.
Nordstrom Steven
Sci-Med Life Systems, Inc.
Snow Bruce Edward
Testa, Ilurwitz & Thibeault, LLP
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