Catheters and other tubular medical devices are designed for insertion into canals, vesses, passageways or body cavities so as to permit injection or withdrawal of fluids or substances from the body. Commonly used examples are urinary catheters, which are used by some 30- 40% of elderly people, both men and women. Such a catheter is inserted into the urinary tract, the other end of the catheter opening into a urine collection bag which is commonly strapped to the user's leg.

Urinary catheters are commoniy worn by the user for extended periods and it is vital that the catheter be held securely in position so as to prevent movement which might lead to the catheter becoming dislodged, or to pain or discomfort for the user.

There is therefore a need for a device by which a catheter may be secured against unwanted movement. Such a device should be easy to use, particularly bearing in mind that many users may be elderly and/or lacking in dexterity. The device should be capable of being worn comfortably. Ideally, the device should prevent lateral movement of the catheter completely or substantially completely, but may permit a limited degree of longitudinal movement. The device should ideally also be capable of accommodating a range of conventionally used catheter sizes without occlusion, yet maintaining secure positioning of the catheter. In addition, the device should permit easy removal of the catheter and should be reusable.

There has now been devised a clamp for a catheter or the like which enables these objectives to be met.

According to the invention, a clamp for securing a catheter or the like to an object comprises

a base affixe, in use, to the object, a flap connecte at one end thereof to the base, and securing means for securing the flap to the base so as to retain the catheter or the like therebetween, wherein a portion of the base and/or the flap which, in use, encloses the catheter or the like carries a resilient pad coated with a non-adhesive synthetic resin.

The clamp according to the invention is advantageous primarily in that it can be used to secure a catheter or the like to an object such as a user's leg or abdomen, thereby preventing unwanted movement of the catheter during normal use. The clamp holds the catheter or the like in place, without occluding or substantially distorting the internal bore of the catheter.

The non-adhesive synthetic resin enhances the frictional engagement of the clamp with the catheter without adhering to the catheter. The catheter may nonetheless be easily removed from the clamp, which is reuseable.

The securing means are preferably cooperating fastening means, most preferably cooperating male and female parts of a touch-and-close or hook-and-loop (VELCRO-type) fastener.

The synthetic resin is most preferably a silicone rubber. A variety of synthetic resins, in particular silicones, may be employed, including those known for use in enhancing fiictional contact with the body, eg in hosiery. In general, the synthetic resin should be such that when it contacts a catheter the coefficient of friction is sufficient to resist slippage of the catheter.

It is particularly preferred for two or more strips of synthetic resin to be applied across the surface of the resilient pad, most preferably parallel to the longitudinal axis of the catheter when the catheter is held between the flap and the base.

In other embodiments, in addition to the non-adhesive synthetic resin, a part of the flap may have an adhesive surface. More particularly, an adhesive strip may be provided at a location which, when the flap surrounds the catheter or the like, is diametrically opposite to the non- adhesive synthetic resin. Such an arrangement provides increased fixation of the catheter or the like without permanently closing the clamp and hence retaining relative ease of removal

of the catheter or the like from the clamp.

The resilient pad is most preferably of a plastics foam. Preferably, the pad is conformable around a range of catheter diameters yet is sufficiently resilient to urge the synthetic resin into sufficiently firm contact with a catheter to prevent slippage. One particularly preferred material for the resilient pad is a closed cell polyester foam. The foam preferably has, for most applications, a thickness of less than 5mm, say 3-4mm, and preferably has a density of 30-40 kg/m3, say 34-38 kg/m3.

The base may be affixed directly to the object, eg the patient's skin, by adhesive. In such embodiments of the invention, the base may be self-adhesive, the adhesive being masked prior to use by a pelable paper or film.

In other embodiments, the base may be affixed to the object by being wrapped around the object. Such an arrangement may be suited, for example, to a clamp for securing a catheter to a patient's limb. In such embodiments, the base is preferably a strap, most preferably a knitted and elasticated strap. The surface of the strap is preferably formed with a loop pile which serves as the female part of a touch-and-close fastener, and one end of the strap is provided with a corresponding male fastener. The flap is preferably stitched to the strap.

Preferred embodiments of the invention will now be described in greater detail, by way of illustration only, with reference to the accompanying drawings, in which Figure l is a side view of a first embodiment of a catheter clamp according to the invention, prior to use; Figure 2 is a plan view of the clamp of Figure 1; Figure 3 is a side view of the clamp of Figure l, in use;

Figure 4 is a side view of a second embodiment of a clamp according to the invention; and Figure 5 is a partial plan view of the clamp of Figure 4, in use.

Referring first to Figures 1 to 3, a first embodiment of a clamp according to the invention is generally designated 10. The clamp 10 comprises a woven tape 11. A region of the tape 11, near one end thereof, has upstanding therefrom the male part 12 of a touch-and-close or hook-and-loop fastener. The corresponding female part 13 of the fastener is provided near the other end of the tape 11. The central part of the tape 11 carries, on the same side as the male and female fastener parts 12,13 a resilient foam pad 14, the upper surface of which carries two stripes 15 of silicone rubber.

The tape 11 has an adhesive undersurface. The underside of that end of the tape 11 which carries the male fastener part 12 is provided with a first masking paper 16.

A second tape 17, having one adhesive surface, is folded approximately in half and the adhesive side of one half is pressed into contact with the adhesive undersurface of that part of the first tape 11 which carries the female fastener part 13. The underside of the other half carries a second masking paper 18.

The arrangement is thus such that the part of the first tape 11 which carries the male fastener 12, to which is applied the first masking paper 16, and the part of the second tape 17 which carries the second masking paper 18 together constitute a base for the clamp 10. The other part of the first tape 11, which is affixed to the other half of the second tape 17, constitutes a flap.

In use, the first and second masking papers 16,18 are gripped at their free edges (16a, 18a respectively) and peeled off. The exposed adhesive undersurfaces of the clamp 10 are then affixed to a patient's skin 20 (see Figure 3) at the position at which a catheter 21 is to be secured. The catheter 21 is then laid on the foam pad 14 and the flap is folded over such that

the female part 13 of the fastener engages the male part 12. The catheter 21 is thus captivated by the flap. The resilience of the foam pad 14 accommodates the catheter 21 without causing occlusion of the internal bore of the catheter 21. The silicone stripes 15 engage the surface of the catheter 21 and further prevent any displacement of the catheter 21, either longitudinally or laterally. Nonetheless, the catheter 21 can readily be released from the clamp 10, simply be separating the male and female fastener parts 12,13.

Referring now to Figures 4 and 5, a second form of clamp according to the invention is generally designated 30. The clamp 30 comprises a knitted and elasticated strap 31 of generally conventional form. One surface of the strap 31 is formed with an upstanding loop pile 32 which constitutes the female part of a touch-and-close fastener. One end of the strap 31 is stitched to a tab 33 which carries the male part 34 of the fastener, such that the strap 31 may be wrapped around the limb of a patient and held by engagement of the male part 34 with an appropriate part of the loop pile 32.

A tape 35, which is generally similar to the first tape 11 of the first embodiment described above, is affixed to the strap 31 near the end which carries the tab 33. The tape 35 is secured by two lines of stitching, one 36 positioned centrally of the tape 35 and the other 37 being close to one end of the tape 35. The part of the tape 35 which is secured to the strap 31 carries the male part 38 of a touch-and-close fastener, and the other part of the tape forms a flap 39 which carries a corresponding female part 40. The central part of the tape 35 carries a resilient foam pad 41, to the surface of which are applied two stripes 42 of silicone rubber.

The second embodiment is used by wrapping the strap 31 around a patient's limb, eg a thigh, and engaging the tab 33 with the loop pile 32. A catheter 43 is then laid across the foam pad 41 and the flap 39 is folded over the catheter 43 so that the male part 38 of the fastener engages the female part 40. The catheter 43 is thus held in a similar fashion to that described for the first embodiment.