Catheter valve

Valves and valve actuation – Tube compressors

Reexamination Certificate

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Details

C251S096000, C604S248000, C604S349000

Reexamination Certificate

active

06270053

ABSTRACT:

FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a catheter valve and, more particularly, to a catheter valve of a mechanically simple design which can be attached to, or integrated into, a urinary catheter, for providing self control over urine outflow.
Catheter valves are well known in the art and a great number of configurations are commercially available as either catheter integral, or catheter plug-in, valves.
The valves employed by urinary catheters, such as for example, drainage catheters, incontinence catheters or other indwelling catheters are typically positioned out of the body so as to allow an individual to control urine outflow from the catheter.
The function and extra-body placement of such urinary catheter valves necessitates that the valve is ergonomically shaped and of small size, such that it does not cause any discomfort or physical damage to a patient even in cases where a patient is confined to a bed for a long time as is the case with older patients. In addition, since the motor functions of older patients are often reduced, a catheter valve must be extremely simple and easy to operate. Finally, in cases of long-term use, the valve must be configured so as to minimize the risk of contamination and therefore infection to the patient.
A number of urinary catheter valves which attempt to meet these requirements have been described in the prior art.
For example, U.S. Pat. No. 4,570,898 describes a catheter and closure device in the form of a valve which remains in place at the drainage funnel of a catheter during normal urination and has to be separated from the funnel only for flushing out. The catheter valve includes a conical part serving for the insertion into the drainage funnel. Additionally, the valve includes on its inside a rubber-elastic valve hose adapted to be influenced from the outside, which during actuation of the valve is opened uninterruptedly but is closed in the non-actuated rest position by a single or multiple kink, fold or twist. The valve includes a fixed part with a through-bore as well as the rubber-elastic hose in extension of this bore. A sleeve with a spring is placed over these parts, whereby the kinked hose is straightened out by the axial displacement of the sleeve opposite the spring force.
U.S. Pat. No. 5,522,806 describes a self-closing catheter valve having a housing with an oval cross section and a conical hose attachment connector which can be inserted into a catheter drainage funnel. A valve hose piece partially extends through the housing. A V-shaped spring element deforms and constricts the valve hose piece by pressing the valve hose piece against a wall of the housing. An actuation member is positioned within the housing for bringing the self-closing catheter valve into an open position.
Although the above described catheter valves substantially improve comfort and ease of operation over other prior art valves, they are inherently limited by a mechanically complex configuration which utilizes spring elements for retaining a closed position. In addition, since such valves are designed to self close, an individual must physically maintain an open position to allow urine outflow, thus increasing the risk of valve contamination and therefore infection and severely limiting ease of operation.
There is thus a widely recognized need for, and it would be highly advantageous to have, a catheter valve which is mechanically simple and ergonomic and which can be operated with ease even by older patients with reduced motor functions.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a catheter valve comprising a housing engaging at least a portion of a tubular member, the tubular member having distal and proximal open ends defining a flow-through passage therebetween, the tubular member further having a proximal portion of a deformable and therefore twistable structure and a distal portion of a more rigid structure, the proximal portion being partially and circumferencially attached to an inner surface of the housing, wherein dimensions of the housing, of the proximal portion and of the distal portion are selected such that when the distal portion is rotated, the proximal portion is twisted so as to block passage of fluid through the tubular member and therefore through the catheter valve and the distal portion is secured by the housing so as to prevent self untwisting of the proximal portion.
According to another aspect of the present invention there is provided a method of controlling urine outflow from a urinary catheter, the method comprising the steps of: (a) attaching a catheter valve to a distal portion of the urinary catheter, the catheter valve including a housing engaging at least a portion of a tubular member, the tubular member having distal and proximal open ends defining a flow-through passage therebetween, the tubular member further having a proximal portion of a deformable and therefore twistable structure and a distal portion of a more rigid structure, the proximal portion being partially and circumferencially attached to an inner surface of the housing; (b) rotating the distal portion so as to twist the proximal portion to thereby block passage of fluid through the tubular member and therefore through the catheter valve; and (c) securing the distal portion within the housing so as to prevent self untwisting of the proximal portion.
According to further features in preferred embodiments of the invention described below, the housing is of a tapering inner cross section, and as such step (c) is effected by translation of the distal portion within the housing in a proximal direction during or following rotation thereof.
According to still further features in the described preferred embodiments the proximal and distal portions of the tubular member are formed from a single material of variable thickness, whereas the proximal portion is thinner than the distal portion.
According to still further features in the described preferred embodiments the proximal and distal portions of the tubular member are formed from different materials wherein a Shore value of the proximal portion is lower than a Shore value of the distal portion.
According to still further features in the described preferred embodiments the housing is of a tubular shape.
According to still further features in the described preferred embodiments following twisting of the proximal portion, the distal portion is secured in the housing via frictional forces.
According to still further features in the described preferred embodiments the housing of the catheter valve is configured so as to be attachable to a drainage funnel of a urinary catheter.
According to still further features in the described preferred embodiments the distal portion is rotated at least 180 degrees relative to the housing.
According to still further features in the described preferred embodiments the housing is of a tapering inner cross section, such that translation of the distal portion within the housing in a proximal direction during or following rotation thereof secures the distal portion within the housing so as to prevent untwisting of the proximal portion.
According to still further features in the described preferred embodiments there is provided a urinary catheter comprising the catheter valve described herein.
According to still further features in the described preferred embodiments the catheter valve forms an integral part of the urinary catheter.
According to another aspect of the present invention, there is provided a catheter valve comprising a tubular element being engaged within a tubular housing, the tubular element and the tubular housing being designed and constructed so as to restrict flow through the catheter valve when the tubular element is twisted relative to the tubular housing and to allow flow through the catheter valve when the tubular element is at least partially pulled out of the tubular housing.
The present invention successfully addresses the shortcomings of the presently known configuratio

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