Indwelling device

Abstract

A medical device for insertion into a body having a surface covered by a detachable cover. The cover may be detached from the surface and removed from the body while the device is inserted in the body. The device may be, for example, a catheter, cannula, drain, stent, pacemaker, or electrode.

Description

FIELD OF THE INVENTION [0001] The present invention is in the field of medical devices, and more specifically relates to indwelling medical devices. BACKGROUND OF THE INVENTION [0002] There are many medical devices that are inserted into the body and left indwelling for a prolonged period of time. These include, for example, various types of catheters, cannulae, drains, implants, stents, pacemakers, electrodes and other devices. Some of these devices, such as a urinary catheter, when in use, extend from the exterior of the body into the body interior, passing through an orifice on the body surface. The orifice may be a natural orifice (e.g. mouth, meatus, nostrils, etc.) or an artificial orifice (e.g. a hole formed in the skin by a surgical incision). Other indwelling devices, such as a pacemaker or stent, are completely enclosed inside the body during use. Accessing these devices typically requires surgical incising or other invasive approaches. [0003] Although using indwelling dev...

AI Technical Summary

Benefits of technology

[0006] It has now been found that it is possible to prevent the build-up of biofilm on the surfaces of indwelling medical devices by means of providing removable covers. By means of this arrangement, biofilm components become deposited on the surface of a cover instead of on the surface of the medical device itself. This cover may then be removed without disturbing the positioning or functioning of the indwelling device to which said cover was attached, thereby removing the built-up biofilm from the region of the device, and from the body. The act of removing the cover exposes either a further cover, enabling the removal process to be repeated, or, the external surface of the indwelling device itself. Unexpectedly, the inventors have found that it is possible to construct a covered device, such that the desired functioning thereof (for example the passage of fluids through a catheter or the mechanical dilatory action of a stent) is not affected or influenced by the presence of one or more covers on the surface of the device.

[0008] The present invention is thus primarily directed to indwelling medical devices having an outer surface, at least a portion of which is protected by a manually detachable cover. During insertion, the cover is attached to the surface so as to prevent relative movement of the surface and the cover. This allows the integrity of the device and cover to be maintained during insertion. Once the covered device (e.g. catheter, stent, drain etc.) has been inserted into the desired operating location, said device may be manipulated or operated in the normal manner, without any hindrance or loss of functionality arising from the presence of the cover. At any time after insertion, the cover may be detached from the shaft and removed from the body, leaving the device in place. Removing the cover from the device removes the biofilm and contamination that has accumulated on the cover.

[0021] A detachable cover may be made from an elastic material. An elastic cylinder may be stretched over the shaft of a catheter or over detachable covers already present on the shaft and allowed to contract with the shaft and any previously existing detachable covers in its lumen. In this case, a reversible attachment is formed between the new cover and an adjacent member by the elastic forces of the new outermost cover. The attachment may be broken by making a longitudinal cut along the outermost cover. The cover may have one or more lines of preformed perforations that are easily torn by splaying apart an end of the coating.

[0023] The space between the device and a cover or between two adjacent covers may contain material to reinforce the attachment or to enhance relative sliding. The material may repel deposits, and / or contain pharmaceutically-active agents, including but not limited to anti-microbial agents such as antibiotics. The interface material can be the same or different, for each pair of adjacent members. For example, mineral oil may be present to enhance sliding and prevent penetration of contamination between the members.

[0024] In a particularly preferred embodiment of the device of the present invention, sealing elements are present at the distal and / or proximal extremities of the covered device. The presence of these sealing elements prevents the ingress of liquids such as blood, urine, tissue fluid and so on into the space between pairs of adjacently-disposed covers or into the space between the innermost cover and the external surface of the medical device itself. In another aspect, the present invention is also directed to indwelling medical devices having an inner or luminal surface, at least a portion of which is protected by either one manually detachable cover or a stack of two more sequentially detachable covers. This particular embodiment of the device of the invention is particularly suitable for use in applications where it is desirable to prevent the formation and growth of blood clots on the luminal surface of indwelling devices such as venous and arterial catheters. During insertion, the cover is attached to the surface so as to prevent relative movement of the surface and the cover. This allows the integrity of the device and cover to be maintained during insertion. Once the covered internal device (e.g. internal surface of a catheter or drain) has been inserted into the desired operating location, said device may be manipulated or operated in the normal manner, without any hindrance or loss of functionality arising from the presence of the cover. At any time after insertion, the cover may be detached from the shaft and removed from the body, leaving the device in place. Removing the cover from the device removes any blood clots, contamination and other biofilm deposits that may have accumulated on the cover. All of the various different embodiments and technical features described above in relation to the devices having external covers also apply to the devices having internal covers as described immediately hereinabove.

Problems solved by technology

This may cause inflammation and further infection around the device.

In certain locations and in certain circumstances the biofilm and associated inflammatory processes may lead to undesirable blood clot formation.

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