Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2001-01-09
2003-10-14
Lo, Weilun (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S544000, C604S355000
Reexamination Certificate
active
06632204
ABSTRACT:
INTRODUCTION
The present invention relates to an external urinary catheter device for the relief of male urinary incontinence, comprising a contact member which is adapted to be engaged with at least the extreme portion of a penis; an opening formed in a distal end section of the contact member and positioned substantially opposite the urethral orifice in the position of use, and a discharge conduit connected with the opening to provide a sealed urine flow passage extending in a substantial axial direction towards the exterior of the catheter device. The invention also pertains processes for manufacture of an external urinary catheter device for the relief of male urinary incontinence as well as uses of catheters of this kind.
BACKGROUND ART
For the relief of male urinary incontinence external catheters are generally used in the form of condom-like tubular sheaths to be placed externally on penis and having a discharge spout which via a hose is connected with a urine collection bag. Such external catheters are known in numerous designs and in many cases serve as a satisfactory solution of male incontinence problems. However, the complete envelopment of penis may give rise to trouble, partly because the application which is effected by unrolling the catheter requires a certain length of penis, partly in use due to the fact that the envelopment of the full length of penis with the catheter, which is generally fastened adhesively either by means of a separate adhesive strip or by means of an internal adhesive layer, involves strain of the skin of penis. Furthermore, the constant humid environment from the delivered urine may cause skin problems, such as allergy and maceration and even ulceration.
In recent years various suggestions have been presented in the prior art concerning the use in a urinary catheter of an inner member or a contact member, which in a position of use is positioned between the surface of the corona and the foreskin of the penis.
Thus, from GB-A-2 075 847 an device is known, which comprises a relatively short funnel-like uridom devise to be placed directly against the corona of the penis and to be kept in place under the foreskin. Around a discharge conduit of the device an external sheathing body is fastened in an inverted position to be brought into engagement with the external side of the foreskin after application of the uridom device to maintain the device in place by means of the sandwich position of the foreskin between the contact member and the external sheathing body.
Another design is disclosed in GB-A-2 126 483, wherein a more safe retainment of the device in the position of use is implemented by use of a tubular urine ducting device, e.g. of silicone rubber, arranged outside the corona in extension thereof, so that a rather severe extension of the foreskin is required to keep the tubular device in place by arrangement of an adhesive strip or strap member on the external side of the foreskin. Evidently, the rather severe extension of the foreskin required to keep the tubular device in place causes considerable discomfort in use.
In EP-B-0 706 355 and EP-B-0 706 356 external urinary catheters are disclosed in which a safe retainment in the position of use is obtained with considerably less discomfort to the user by means of a short inner contact member designed with improved form stability in its distal end part. Aiming at keeping the contact member safely in place under the foreskin the catheter is provided with a separate substantially bowl-shaped outer holder member displaceably surrounding a discharge conduit of the catheter device. The outer holder member is movable between an application position and a position of use.
Urinary catheters are generally connected via a hose to a urine collection bag. The wearer of the urinary catheter suitably places the urine collection bag in a position lower than the position of the urinary catheter to ensure that the urine effectively is drained off by gravity. To allow free movement of the wearer of the urinary catheter the urine collection bag is generally positioned at a part of the leg. Generally, it is preferred to position the urine collection bag at the shin to drain off urine in a standing as well as a sitting position. Furthermore, this position of the urine collection bag provides for the possibility of hiding it behind a trouser leg.
When using the prior art catheters mentioned above the problem arise, following a discharge of urine, that the unbroken column of urine in the hose give rise to a considerable built-up of sub-pressure at the surface of the corona. The wearer of the urinary catheter is subjected to discomfort, especially on extended exposure to the sub-pressure. Suction marks have been observed on the corona due the exposure to sub-pressure. In severe cases, oedema and subsequent infection has been developed.
It has been suggested to overcome this problem by incorporating a vent or a valve in the urine collection bag or the lower part of the hose allowing the surrounding air to communicate with the interior of the catheter-hose-bag environment. Reference is made to e.g. U.S. Pat. Nos. 3,800,857, 3,835,857, and 5,622,183. However, the position of a vent or valve in the bag or the lower part of the hose entails the potential risk that urine, when the bag is full or about to be full, will escape the urine collection bag.
Another suggestion is disclosed in U.S. Pat. No. 5,897,540 wherein a slit-shaped opening is provided in a condom-like device for drainage of uncontrolled urine release. The opening is provided for ventilation of the space entrapped between the device and the penis and is placed in the position of use at the main body of the penis well behind the corona. The opening is not provided with a filter or similar means. A further suggestion is disclosed in U.S. Pat. No. 4,656,675, which describes a condom-like device for draining off urine. The device is provided with a filter covering a hole positioned at a point close to the source of urine. The filter is capable of passing air but impervious to liquid at relative low pressures. A major drawback of this suggestion is that the filter is placed at an exposed position. The wearer of the device must be careful since the filter easily can be ripped off by abrasion or accident and the urine will tend to be conveyed through the hole in the device and not as intended through the hose.
It is the object of the present invention to avoid all or some of the above discussed problems and drawbacks of the prior art urinary catheters. Especially, it is an object of the present invention to provide a urinary catheter device having an enhanced reliability and durability due to reduced risk of deterioration.
DESCRIPTION OF THE INVENTION
Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.
The external urinary catheter device of the kind disclosed in the introduction is, according one aspect of the invention, characterized in that an aperture is provided in a distal part of the contact member or in the discharge conduit; a membrane is fastened to the surface surrounding said aperture, the membrane being capable of selectively passing gases but retaining urine; a shield is at least partly protecting the membrane; and at least one vent is arranged for allowing gases to be in substantially unhindered contact with the external surface of the membrane.
The contact member and optionally also further components of the catheter device according to the invention, such as the discharge conduit and the shield, may be made from any material which is suitable for engagement with the sensitive skin of the corona and the foreskin. Suitable materia
Guldfeldt Signe Uhre
Nielsen Henrik Lindenskov
Tanghoj Allan
Bogart Michael G.
Coloplast A/S
Jacobson & Holman PLLC
Lo Weilun
LandOfFree
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