WO1997004828A1

WO1997004828A1 - Device and method for insulating contaminated indwelling catheters

Info

Publication number: WO1997004828A1
Application number: PCT/IL1996/000061
Authority: WO
Inventors: Gad Porat; Dalit Doron
Original assignee: Novadent Ltd.
Priority date: 1995-07-26
Filing date: 1996-07-23
Publication date: 1997-02-13
Also published as: IL114748A0; EP0840632A1; AU6629096A

Abstract

A device (10) and method for substantially preventing contamination of the patient environment by contact thereof with contaminating material associated with the outer surface of an indwelling catheter (70) when extracting same from the patient body, comprising: a collecting duct (20) comprising a distal inlet end (24), having a rigid edge (11), and a proximal outlet (27); an extensible protecting sleeve (86), having a distal open end (83) sealingly attached onto said collecting duct (20) in open communication with said proximal outlet (27) and a proximal open end (87) sealingly attached onto said catheter (70) at or near to the proximal end of the same, said sleeve (86) extending to cover the external surface of said catheter (70) as the same is passed through said proximal outlet (27) of said collecting duct (20); and catheter guiding means (30) mounted by suitable mounting means (31) within said collecting duct (20) at or near said distal inlet end (24) for guiding said catheter (70) towards said proximal outlet (27) of said collecting duct (20) as said catheter (70) is passed through said collecting duct (20), said catheter guiding means (30) being in a spaced relationship with respect to said rigid edge (11) to define a clearance (77) between said catheter (70) or at least a portion thereof adjacent to said distal edge (11) for substantially preventing contact between said contaminating material and said edge (11), and said mounting means (31) minimising runoff of contaminating material that may become attached to said guiding means (30) towards said rigid edge (11).

Description

DEVICE AND METHOD FOR INSULATING CONTAMINATED

INDWELLING CATHETERS

Technical Field

The present invention relates to a device and method for preventing contact of contaminating material associated with the outer surface of an indwelling medical catheter with the patient's environment when extracting the catheter from the patient body.

Background

Indwelling catheters have a variety of applications in human medicine, and also in veterinary medicine. The term catheter is used herein to include a plurality of catheters, as well as a probe or a plurality of probes. Medical drains for example, are used mainly to prevent the accumulation of blood, plasma or other fluids or semi fluids within body cavities such as the stomach, or wounds, by removing them outside of the body. The drains consist of single or multiple tubes with a hole located at the distal end thereof, and/or aperture/s along their distal part. (The terms "proximal" and "distal" are relative positional terms, and refer to being away from and near to (or within) the body, respectively.) These apertures allow the passage of fluids and semi fluids into the drains and therefrom out of the body. In some systems, such as nasogastric drains, the drains may be used, alternatively, to dispense fluids or semi fluids into the body for feeding, irrigation and drug administration purposes. Some types of medical catheters may be used, for example, in angiography for injecting diagnostic contrast media into the blood supply for a particular organ such as the heart prior to X-raying same, wherein a catheter is inserted up the aorta and into the openings of the coronary arteries. Urinary catheters are used for removing urine from the bladder of incontinent, geriatric and/or post-operative patients. Endoscopes are typical probes used for visualizing the interior of hollow organ, such as the duodenum or stomach, or a body cavity or part, such as the rectum or urethra. While medical probes, such as endoscopes, are typically non- disposable highly-reusable expensive items, medical catheters are disposed of after one use.

Very often, body secretions of different consistencies adhere to the external surface of indwelling catheters or probes, and after removal from a patient's body, they act as a source of physical, bacterial and viral contamination, polluting the patient environment including attending medical personnel as well as the patient, bed linen, furniture, the floor and peripheral medical equipment. For example, in nasogastric drains, about 10 to 15 milliliters of body secretions may be associated with the outer surface thereof, so that even if gloves are worn by the attending medical staff, drippage inevitably occurs, with the ensuing contamination ofthe patient environment.

With the growing awareness of infection of body fluids with the HIV, Hepatitis-B virus and other pathogenic micro-organisms, it is becoming increasingly important to provide adequate protection against such infection. In fact, the U.S. Occupational Safety and Health Administration (OSHA) has issued specific regulations (Federal Register/Vol. 56 No. 235; December 6, 1991; Rules and Regulations, Part 1910) regarding :-

1. Protection from contact with potentially infectious body fluids. 2. Protection by reducing the amount of contaminated laundry.

3. Protection by providing engineering and work practice controls to minimize exposure to potentially infectious body fluids.

Prior art indwelling catheters and probes do not include any mechanism that adequately protects against the aforesaid contamination and ensuing infection.

For example, U.S. Patent Number 4,735,607 relates to an anti-reflux valve of a filter on a secondary vent lumen used with double and multiple lumen drains, particularly nasogastric drains. However, this valve is designed to prevent leakage from the secondary vent lumen during a stomach evacuation process, but does not prevent leakage of contaminated fluids or semi fluids from the main lumen, nor does the valve offer any solution for removing contaminated material adhering to the external drain surface, which is likely to soil the bed site upon removal of the drain from the body and its disposal into the waste receptacle.

U.S. Patent Number 5,375,589 discloses a catheter having an annular brush at its distal end for cleaning a retractable fibre optic probe housed therein while the catheter is still inside the body. There are no means provided nor suggested for cleaning the external surface of the catheter, nor for ensuring its dripless removal from the body.

The prior art also includes a number of devices, for example as disclosed in U.S. Patent Numbers 3,606,889, 4,525,157, 4,563,176 and 5,059,186, which are essentially directed to provide a sterile environment for a catheter prior to its insertion into the body; however, none of these references addresses the problem of contamination of the patient environment after removal from the body, nor do they suggest a solution to this problem.

The prior art further includes a number of devices which, while primarily attempting to provide a sterile environment for a catheter prior to its insertion into the body, also refer to its removal therefrom, though none of the devices is directed towards achieving - nor enables - dripless removal ofthe catheters from the body to avoid contaminating the patient environment. Much less so, none of these devices discloses nor suggests the device of the present invention.

For example, U.S. Patent Number 5,149,326 discloses an adjustable shield having a distal fitting and a proximal fitting with inlet and outlet openings respectively, wherein the shield may be expanded in a controlled manner by the user. A catheter may be removed from a blood vessel and into the shield via an introducer sheath which is embedded in the vessel and rigidly sutured to the patient, the distal fitting having been locked previously onto the introducer sheath. The system is limited for use with a specific introducer sheath, and is therefore unsuitable for many applications which do not require a sheath, e.g. indwelling nasogastric drains. Moreover, the sheath itself may still contaminate the environment as it is removed from the blood vessel, whether or not it is still connected to the shield, and no means are disclosed to prevent this contamination. Even if the shield were used without any sheath at all, the removal of a catheter from the blood vessel and into the shield via the distal fitting would result in drippage of contaminating material from the external surface of the catheter. Inevitably, the catheter would scrape against the outer free edge of the distal fitting while being inserted into the shield. Furthermore, contact between the external surface of the catheter and the distal edge of the distal fitting opening or bore would result in the accumulation of contaminating material inside the distal fitting and subsequent runoff into the patient environment. Thus, this reference does not provide a solution for the removal of catheters from the body while adequately protecting against contamination ofthe patient environment.

U.S. Patent Number 5,274,874 relates to a sponge arrangement for cleaning and defogging endoscopes by wiping against a sponge impregnated with a cleaning agent prior to insertion into the body. In one embodiment, the sponge is packaged in a container which can be attached to an endoscopic trocar cannula, having entrapment means for preventing the cleaning agent from seeping into the body cavity via the cannula. This reference therefore does not address the problem of dripless removal of catheters which are not threaded through a specific cannula embedded in the patient, nor to the contamination which may ensue when removing the cannula from the body. Indeed, removal of catheters using the disclosed device in the absence of its connection to the cannula (as would have to be in the case, e.g. if the container were used for the extraction of nasogastric drains) would inevitably result in contact between the external surface of the catheter and the edge of the container, with the ensuing drippage of contaminating material onto the patient environment. Furthermore, contact between the external surface ofthe catheter and the edge ofthe distal opening in the container would result in the drippage of contaminating material thereat and subsequent runoff into the patient environment.

U.S. Patent Number 5,325,850 discloses a suction catheter assembly wherein an aspirator catheter is enclosed in a protecting sleeve connected to the patient connecting end, which is connected to a tracheal tube. The catheter may be inserted into, and removed from, the patient connecting end and the tracheal tube. This reference addresses the question of providing an adequate seal between the catheter and the sleeve for preventing the latter from inflating when the catheter is periodically removed from the body. As with U.S. Patent Numbers 5,149,326 and 5,274,874, this reference discloses a device which is limited in its application, requiring the same to be connected to a component which is in direct contact with the patient, in this case the tracheal tube, with the consequent contamination problems which ensue when removing the said component. Furthermore, even if used without the tracheal tube, contaminating matter would be scraped onto the edge of the patient connecting end, and also accumulate therein and runoff into the patient environment to contaminate same, in a similar manner to the said two references.

U.S. Patent Number 5,140,983 discloses a catheter assembly having a T- shaped part, one end which is inserted into the patient's mouth, and a second end of which accommodates a sponge behind a wall having a closable aperture. As the catheter is withdrawn from the patient and through this aperture, the extemal walls of the catheter tend to scrape against the edge of the aperture resulting in drippage of contaminating material at least through the lower arm of the T-shaped part into the patient environment. Furthermore, additional contamination may result from the contact of the T- shaped part with the mouth of the patient. Thus, this reference fails to provide, nor does it suggest, a device for the dripless removal of a catheter from the body.

U.S. Patent Number 4,878,762 discloses a device which is detached from the catheter, essentially comprising a collecting bag which is closed at one end. The open end is attached to a rigid canister that houses the bag prior to use and also serves as a non-collapsible mouth. Upon removal of the catheter from the body it is manually introduced into the bag, through the canister. Once the entire catheter is contained within the bag and canister, the device is sealed with a lid and disposed of. However, the device disclosed by this reference does not prevent contact of contaminating material associated with the outer surface of the catheter with the patient environment when the catheter is extracted from the patient's body. As the catheter is passed through the free edge of the canister, no means are provided for preventing contact therebetween, thereby resulting in contamination of the edge. Thus, there exists a substantial probability and therefore high risk of contact of contaminating material with the outer surface of the device and thus the patient environment, particularly in view of the difficulty in controlling precise motion and path taken by catheter - specially the distal end thereof - during extraction from the body. Furthermore since the device comprises a collecting bag which is closed at the proximal end thereof, it can only be used exclusively for catheters which have been totally disconnected to peripheral medical equipment, i.e., having a free proximal end, thus increasing the risk of spillage of contaminated material from the inner lumen of the catheter. The device being independent to the catheter renders its use optional, thus requiring a high degree of compliance by medical and ancillary staff, which may be difficult at times of high workload and stress, for example. Furthermore, users are required to maintain separate stocks of devices and catheters, which may be not be possible at times to match.

An aim of the present invention is to provide a device which overcomes the limitations of prior art devices and enables an indwelling catheter to be removed from the patient body while substantially preventing contamination of the patient environment by contact thereof with contaminating material associated with the outer surface of the catheter. The device of the present invention thus comprises :-

i) a collecting duct comprising a distal inlet end, having a rigid edge, and a proximal outlet;

ii) an extensible protecting sleeve, having a distal open end sealingly attached onto said collecting duct in open communication with said proximal outlet and a proximal open end sealingly attached onto said catheter at or near to the proximal end of the same, said sleeve extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct;

and is characterised in further comprising:-

iii) catheter guiding means mounted by suitable mounting means within said collecting duct at or near said distal inlet end for guiding said catheter towards said proximal outlet of said collecting duct as said catheter is passed through said collecting duct, said catheter guiding means being in a spaced relationship with respect to said rigid edge to define a clearance between said catheter or at least a portion thereof adjacent to said distal edge for substantially preventing contact between said contaminating material and said edge, and said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge. It is another aim of the present invention to provide such a device wherein the catheter guiding means comprises an annular support.

It is another aim of the present invention to provide such a device wherein the mounting means for the guiding means comprises a suitable proximal extension extending from the catheter guiding means to the proximal outlet and suitably attached thereto.

It is another aim of the present invention to provide such a device wherein the mounting means for the guiding means comprises a radial strut.

It is another aim of the present invention to provide such a device wherein the catheter guiding means and/or the mounting means are integral with the duct.

It is another aim of the present invention to provide such a device which may be used for extracting an indwelling catheter from the body, whether or not the proximal end of the catheter is still connected to peripheral medical equipment, e.g., vacuum pumps and feeders.

It is another aim of this invention to provide such a device which may furthermore be integrally mounted onto a proximal part of the catheter and is thus readily available for immediate use, thereby negating the constant need, in all applications, for an independent supply of said devices. Thus catheters may be extracted from the body without the need to disconnect peripheral medical equipment, e.g., vacuum pump and feeders. Furthermore the need is also eliminated for users themselves to mount the device onto a catheter prior to its extraction, since it can be mounted to the catheter at source. It is another aim of this invention to provide such a device optionally further comprising a housing for protecting the unextended portion of the extensible sleeve.

It is another aim ofthe present invention to provide such a device optionally further comprising adjunct clamping means at a proximal end ofthe catheter for blocking the inner lumen of the catheter, and thereby substantially preventing leakage ofthe contents therein during extraction ofthe catheter.

It is another aim ofthe present invention to provide such a device optionally further comprising a distal lid for sealing the contaminating material in said device.

It is another aim ofthe present invention to provide such a device optionally further comprising arrester means which prevents the distal end of the catheter from exiting the device, thus locking together the device and catheter to provide easier handling.

It is another aim ofthe present invention to provide such a device optionally further comprising wiping means for wiping the extemal surface of the catheter and absorbing liquid as it is passed through said device.

It is another aim of the present invention to provide a method for the dripless extraction of an indwelling catheter from the body.

Description of Figures

Figure 1 shows in side elevational cross-sectional view, a preferred embodiment ofthe present invention. Figure 2 shows in side elevational cross-sectional view, another embodiment ofthe present invention.

Figure 3 illustrates a transverse section along XX of the embodiment of Figure 2.

Figure 4 illustrates a transverse section along YY of the embodiment of Figure 1.

Figure 5 shows in side elevational cross-sectional view, optional features of another embodiment ofthe present invention

Figure 6 illustrates use of an embodiment of the present invention in extracting an indwelling catheter from the body.

Disclosure of Invention

The present invention relates to a device for substantially preventing contamination of the patient environment by contact thereof with contaminating material associated with the outer surface of an indwelling catheter when extracting same from the patient body, comprising:-

(i) a collecting duct comprising a distal inlet end, having a rigid edge, and a proximal outlet;

(ii) an extensible protecting sleeve, having a distal open end sealingly attached onto said collecting duct in open communication with said proximal outlet and a proximal open end sealingly attached onto said catheter at or near to the proximal end of the same, said sleeve extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct;

and characterised by further comprising:-

(iii) catheter guiding means mounted by suitable mounting means within said collecting duct at or near said distal inlet end for guiding said catheter towards said proximal outlet of said collecting duct as said catheter is passed through said collecting duct, said catheter guiding means being in a spaced relationship with respect to said rigid edge to define a clearance between said catheter or at least a portion thereof adjacent to said distal edge for substantially preventing contact between said contaminating material and said edge, and said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge.

The invention will be better understood from a number of embodiments thereof, with reference to the appended figures, beginning with a description of each component of each embodiment.

The relative positional terms "proximal" and "distal", respectively designated (P) and (D) in the Figures, refer to directions away from and near to (or within) the body, respectively.

With reference to Figure 1 , a preferred embodiment of the device of the present invention is generally designated (10) and comprises a collecting duct (20), catheter guiding means (30) and protecting sleeve (86), the device being mounted onto a catheter (70), as hereinafter described. The device (10) and all components thereof are preferably made from medically compatible materials. In particular, the collecting duct (20) and catheter guiding means (30) are made from a liquid-impermeable material, preferably a rigid plastic material such as polypropylene, PVC or high density polyethylene, and the sleeve (86) is made from a flexible liquid- impermeable material such as low density polyethylene.

In a preferred embodiment, the collecting duct (20) comprises a preferably rigid frusta-conical wall (22), comprising a larger distal inlet end (24) having a rigid edge (11). The frusta-conical wall (22) further comprises a smaller proximal outlet end (26), comprising a preferably integral annular end wall (28) with a proximal outlet (27). Said end wall (28) is optional and may be absent, in which case the proximal outlet (27) is at the said proximal outlet end (26). The profile of the outlet (27) may be adapted to correspond to the cross-section of the catheter, though preferably it is circular having a diameter (S) which is substantially greater than the outer diameter of an envelope (72) around the cross-section of the catheter comprising, for example, a plurality of lumens (76), as illustrated in Figure 4.

Optionally, the collecting duct (20) may further comprise at the said proximal outlet end (26) an elongate first tubular wall part (not shown) of substantially equal diameter thereto, wherein said end wall (28) comprising outlet (27) is herein located proximal to said first tubular wall part.

Optionally, the collecting duct (20) may further comprise at said distal inlet end (24) a second tubular wall part (not shown) of substantially equal diameter thereto, wherein said edge (11) is herein located distal to said second tubular wall part. Altematively, said collecting duct (20) may be tubular, funnel-shaped, polyhedral or of any other suitable shape, having a rigid edge at its inlet end and a suitable proximal outlet.

In the preferred embodiment, the catheter guiding means (30) comprises an annular support (32), the intemal diameter thereof being greater than that of the said envelope (72), for example (S), to permit unobstructed and smooth sliding passage of the said catheter (70) therethrough. The said annular support (32) is mounted within said collecting duct (20) by suitable mounting means (31). Said mounting means (31) is configured to minimise runoff of contaminating material that may become attached to the said annular support (32) towards the rigid edge (11) and out ofthe device (10).

In the preferred embodiment, said mounting means (31) comprises a preferably annular proximal extension (33) of said annular support (32), extending from the distal end of the same, suitably connected to, or, preferably, integral with the end wall (28). Altematively, said extension (33) may be frusta-conical, wherein the proximal larger end is suitably attached proximally to the inner surface (21) of the duct (20). Optionally, said extension (33) may further comprise at least one radial web (35), suitably attached to said inner surface (21) and/or to said end wall (28). Thus, contaminating material that may become attached to the said annular support (32) will tend to flow along the said extension (33) and collect in the volume enclosed by the same, the inner surface (21) and the endwall (28), rather than run out ofthe duct (20).

In a different embodiment, said mounting means (31) comprises a preferably rigid radial strut (34) suitably attached to, or integral with, said annular support (32) and the inner surface (21) of the said collecting duct (20), as illustrated in Figures 2 and 3. Thus, the single strut (34) of this embodiment minimises the available routes for contaminating material to flow from the annular support (32) to the inner surface (21). In the preferred form of this embodiment, the said single radial strut (34) is inclined to the longitudinal axis (100) of the collecting duct, and is proximal-facing towards the said annular support (32); furthermore, the said strut (34) is located approximately vertically above the said annular support (32) during use of the device (10). Altematively, said mounting means (31) may comprise a plurality of said radial struts (34), though preferably not exceeding three said struts (34).

The catheter guiding means (30) may be furthermore optimally located both longitudinally and transversely within said collecting duct (20) in order to minimise the risk of contaminating material spilling outside said device (10) as the contaminated distal portion of said catheter (70) is passed into the distal inlet end (24). Transversely, the guiding means (30) is preferably located at the centre of the duct (20), as illustrated in Figure 3, for example. Longitudinally, the optimal location (A) of the guiding means (30) with respect to the rigid edge (11) of collecting duct (20) may be determined by considering an envelope (78) defined by the locus of the maximum flexing (70a) of the said catheter (70) about a fixed location defined at the said annular support (32). It is then ensured that the mounting means (31) support the said annular support (32) sufficiently close to the said rigid edge (11), so that a suitable clearance (77) is maintained between the said rigid edge (11) and the said envelope (78), and therefore the contaminated distal portion of the said catheter (70). Thus, the risk of contaminating material contaminating the patient environment outside of the device (10), by virtue of contact between the catheter (70) and the rigid edge (11), is at least minimised. At the same time, said catheter guiding means (30) is not located too close to the said rigid edge (11) of said device (10), so that any contaminating material that is removed at the annular support (32) will not tend to directly contaminate the patient environment outside of the device (10).

Thus, both the location of the annular support (32) and the configuration of the mounting means (31) may be optimised to minimise risk of contaminating the patient environment with contaminating material as the contaminated distal portion of said catheter (70) is passed through said annular support (32).

In a different embodiment, and with reference to Figure 5, said mounting means (31) comprises a frusta-conical wall (36) having a distal larger end sealingly mounted to the inner surface (21) of the collecting duct (20), said annular support (32) being mounted to the smaller proximal end of said wall (36). Said frusta-conical wall (36) is perforated by a plurality of slots or orifices (37) which allow any contaminated material deposited on the distal surface of the said frusta-conical wall (36) to flow into a proximal part of the collecting duct, and thus minimise runoff of said contaminating material out of the distal end of said collecting duct (20). Initially, said contaminating material may become attached to the said annular support (32) by virtue of contact ofthe extemal contaminated surface ofthe catheter (70) with said annular support (32), and then flow onto the wall (36).

The said device (10) further comprises an extensible protecting sleeve (86), having a distal open end (83) which is sealingly attached onto the outer surface of said collecting duct (20), preferably said annular end wall (28), said distal end (83) being in open communication with said proximal outlet (27). In the preferred embodiment, said distal open end (83) is sealingly attached to said collecting duct (20) by means of a suitable adhesive which sealingly bonds the distal end (83) of the sleeve (86) to the collecting duct (20), though altematively a suitable clamp or clip may be used. Said sleeve (86) also has a proximal open end (87) which is sealingly attached onto said catheter (70) at or near to the proximal end (74) ofthe same. In the preferred embodiment, said proximal end (87) is sealingly attached onto said catheter by means of adjunct clamping means (85), as hereinafter described, though altematively, other suitable clamps or clips may be used, or a suitable adhesive. Thus, prior to use of the device (10), the protecting sleeve (86) is in a retracted, i.e. unextended, configuration, together with the collecting duct (20), over a proximal portion of the catheter (70) distal of the said end (74), the said catheter (70) having been threaded through the said annular support (32). Since the proximal end ofthe sleeve (86) is only attached onto the external surface of the catheter (70), rather than enclosing its end, it is not necessary to disconnect the proximal unenclosed end ofthe catheter (70) from peripheral medical equipment prior to extracting the catheter from the body. In normal use, the device (10) is installed on the corresponding catheter (70) prior to inserting the catheter into the body. In the preferred embodiment, the installation is effected at source by the catheter supplier, though altematively, the device (10) may be installed onto the catheter (70) by a user. Altematively, the device may be installed onto the catheter (70) after the same has been inserted into the body by first disconnecting the proximal end of the catheter (70) from peripheral medical equipment: the free proximal end of the catheter (70) is threaded into the annular support via the distal inlet end (24) and out ofthe proximal outlet (27) including the proximal outlet end (87) of the substantially unextended sleeve (86). The proximal end (87) is then sealingly attached onto a proximal part of the catheter (70) as hereinbefore described. The said sleeve (86) then extends to cover the extemal surface of said catheter (70), particularly the contaminated distal end thereof, as the catheter (70) is passed through said proximal outlet (27) of said collecting duct (20). In the preferred embodiment, said sleeve (86) in the fully extended state is of a longitudinal length sufficient to enclose the full length ofthe catheter.

Optionally said device (10) further comprises a housing (84) for the unextended portion of the said protecting sleeve (86). In the preferred embodiment said housing (84) is tubular, having a distal end (88) suitably attached to the collecting duct (20), e.g., with a suitable adhesive or via a snap-fit arrangement, preferably at or near the proximal outlet end (26) of the duct. Altematively, said distal end (88) is integral with the collecting duct (20). The housing (84) further comprises a proximal open end (89) out of which the said sleeve (86) may be extended to cover the catheter (70) as the same is passed through the collecting duct (20).

Optionally, the said device (10) may further comprise adjunct clamping means (85) such as a simple clamp (82) or any other type of device that blocks the inner lumen (73) ofthe said catheter (70) at or near the proximal end thereof, thereby substantially preventing leakage of material that may be contained in the lumen of said catheter (70) from either the distal or proximal ends of the catheter (70), particularly if the same has been disconnected from peripheral medical equipment. Such clamps (82) are well-known in the art and do not require further description. In the preferred embodiment, said adjunct clamping means (85) is mounted on the said catheter (70) in a proximal relationship with respect to the said device (10), and is actuated prior to extraction ofthe catheter (70) from the body.

In the preferred embodiment, said device (10) optionally further comprises a distal sealing lid (80) which may be used to seal the distal end of the device (10) after extraction ofthe distal end ofthe catheter (70) from the body into the device (10) has been completed. Further, the said lid (80) may optionally be tethered to said device (10) via a suitable connecting part (81) such as a string or film hinge.

Optionally, said device (10) further comprises arrester means (60) for preventing the distal end of the said catheter (70) from being accidentally pulled through the duct (20) and exiting same. The arrester means (60) thus minimises the risk of the catheter (70) being fully contained within the sleeve (86) and subsequently of puncturing the same with the distal end of the catheter (70) during handling; furthermore, said arrester means (60) facilitates handling of the device (10) after full extraction of the catheter (70) from the body. In one embodiment, said sleeve (86) is also said arrester means (60), wherein sleeve (86) has a predetermined fully-extended length shorter than the said catheter (70) distal from the proximal end (87), such that the distal end of the catheter (70) is still within the duct (20), and remains substantially locked therein, after full extension of the sleeve (86). Further relative movement between the distal end of the catheter (70) and the duct (20) is not possible as the proximal end of the catheter (70) is sealingly attached to the proximal end of the sleeve (86), the same being relatively inelastic. If the said sleeve (86) is made from a relatively elastic material, the said predetermined length is calculated to incorporate the elasticity of said material, so that when fully stretched, the distal end of the catheter (70) is still within the duct. In such a case, the said predetermined length preferably enables the distal end of the catheter (70) to be just inside the duct (20) when the sleeve (86) is fully extended but unstretched.

In a different embodiment, arrester means may comprise a modification at or near the distal end of the catheter (70) to comprise thereat a ring or protrusions, the diameter of which is greater than the outer diameter of the annular support (32) or outlet (27). Thus, when the catheter (70) is passed through said device (10), it is prevented from exiting the duct (20) and remains locked therein.

In a different embodiment, particularly for the extraction of drain catheters or the like from the body wherein the catheter comprises at least one side orifice (79) at or near the distal end thereof, said arrester means (60) comprises at least one pin (62), located within the collecting duct (20), generally proximal with respect to the catheter guiding means (30) (Figure 5). One end of each of the said pins (62) is suitably mounted to or integral with the said inner surface (21), and the other engaging end of each pin is distal facing and presses against the outer surface of the said catheter (70). Said at least one pin (62) is engaged into said orifice (79) when the distal end ofthe catheter (70) is passed through said device (10), locking the same onto the distal end ofthe said catheter (70).

Optionally, said device (10) further comprises wiping means (40) for wiping the extemal surface of the said catheter (70) as the same is passed through said collecting duct (20). Wiping means (40) provides further protection to the patient environment by minimising the possibility of issue of contaminating material if the sleeve (86) is punctured, particularly, when a large amount of contaminating liquid is associated with the catheter (70) as in, e.g., femoral coronary catheters.

In one embodiment, said wiping means (40) comprises a plug (52) having a bore with an absorbing surface (42). Said plug (52) is mounted inside the said collecting duct (20), proximal with respect to the catheter guiding means (30), and preferably comprises a profile which is complementary with respect to that of the inner surface (21). Preferably, said plug (52) comprises an annular proximal wall (55) which abuts against said annular end wall (28). Said absorbing surface (42) is in close sliding contact with said catheter (70) and is preferably contoured to complement the extemal contour of the said catheter (70). Thus, if the said catheter (70) comprises a single circular tube, for example, the said absorbent surface (42) is cylindrical. Contaminating liquid on the extemal surface ofthe catheter (70) is absorbed at the surface (42) by contact therebetween, and retained in the body of the plug (52). Preferably, said plug (52) and surface (42) are made from a medically compatible high capacity absorbent material, many examples of which are well known in the art, being used in numerous applications including sanitary napkins, diapers and tampons.

Said wiping means (40) may altematively or additionally comprise an annular wiper (44) concentrically supported within said collecting duct (20) by means of at least one radial strut (45), and is preferably located proximal to said catheter guiding means (30), and distal to said plug (52) if same is also mounted in said collecting duct (20). Preferably, said annular wiper (44) presents a relatively shaφ distal annular edge (43) in close scraping contact with the extemal surface of the said catheter (70), so that when the same is passed through the said annular wiper (44), contaminating material is wiped off the said extemal surface. Said annular edge (43) may be made from a rigid material, such as metal or plastic, or from a semi-rigid material such as hard rubber.

The present invention also relates to a method for substantially preventing contamination of the patient environment by contact thereof with contaminating material associated with the outer surface of an indwelling catheter when extracting same from the patient body, characterised in comprising the step of providing a device as hereinbefore described, comprising :-

ii) an extensible protecting sleeve, having a distal open end sealingly attached onto said collecting duct in open communication with said proximal outlet and a proximal open end sealingly attached onto said catheter at or near to the proximal end of the same, said sleeve extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct; and

iii) catheter guiding means mounted by suitable mounting means within said collecting duct at or near said distal inlet end for guiding said catheter towards said proximal outlet of said collecting duct as said catheter is passed through said collecting duct, said catheter guiding means being in a spaced relationship with respect to said rigid edge to define a clearance between said catheter or at least a portion thereof adjacent to said distal edge for substantially preventing contact between said contaminating material and said edge, and said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge;

wherein the contaminated distal end of the said catheter is extracted out of the patient body and passed through the said collecting duct, said catheter guiding means guiding said catheter towards the distal outlet of the collecting duct and providing a clearance between the said rigid edge and the said catheter, said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge, and said protecting sleeve automatically extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct.

The device (10) ofthe present invention may be used as follows. The device (10) may be manually mounted onto the proximal end of the said catheter (70) (either by the user or at source) prior to insertion of same into the body, in which case the catheter (70) need not be disconnected from peripheral medical equipment such as a collection vessel or a suction outlet. Altematively, said device (10) may be mounted onto the catheter (70), after insertion of same into the body, in the manner hereinbefore described. Advantageously, the optional adjunct clamping means (85) is actuated prior to extraction of the catheter (70) from the patient body to prevent drippage from the lumen of the said catheter (70), particularly if this has been disconnected from peripheral medical equipment. Referring to Figure 6, the device (10) is first distally slid along the extemal surface ofthe said catheter (70) until the said rigid edge (11) is reasonably close to the point of entry (49) of the catheter (70) into the body, e.g. a nostril. At the same time, a portion of the sleeve (86) automatically extends from the device (10) to cover a corresponding potion of the catheter (70) that has passed through the device (10). The said catheter (70) is then pulled in a proximal direction while retaining the said device (10) fixed in position relative to the said point of entry (49) until the distal end of the said catheter (70) is fully extracted from the body. Concurrently, a portion of the sleeve (86) automatically extends from the device (10) to cover a corresponding potion of the catheter (70) that has passed through the device (10). In one embodiment of the device (10), the same is held so that the single radial strut (34) is vertically above the annular support (32). Advantageously, the said device is held with the said distal inlet end (24) facing the point of entry (49) and particularly skywards, so that the lowermost point ofthe said edge (11) is higher than the lowermost point on the said distal outlet end (26). During the extraction procedure, the catheter guiding means (30) substantially ensures an adequate clearance (77) between the said catheter (70) and the said rigid edge (11), thereby substantially preventing contact between said contaminating material and said edge (11), and the mounting means (31) minimises runoff of contaminating material that may become attached to said guiding means (30) towards said rigid edge (11). The optional lid (80) then seals the catheter within the device (10), preferably irreversibly.

In an embodiment comprising said wiping means (40), the said absorbent surface (42) absorbs into said plug (52) contaminating liquid from the extemal surface ofthe said catheter (70). In an embodiment comprising said arrester means (60), the same substantially prevent the distal end of the said catheter (70) from being pulled automatically through the collecting duct (20) in the course of extracting the catheter (70) from the body, as hereinbefore described.

Although only a few embodiments have described in detail in the foregoing description, the present invention is not limited thereto, and is only defined by the scope ofthe claims.

Claims

Claims :-

1. A device for substantially preventing contamination of the patient environment by contact thereof with contaminating material associated with the outer surface of an indwelling catheter when extracting same from the patient body, comprising:-

i) a collecting duct comprising a distal inlet end, having a rigid edge, and a proximal outlet; ii) an extensible protecting sleeve, having a distal open end sealingly attached onto said collecting duct in open communication with said proximal outlet and a proximal open end sealingly attached onto said catheter at or near to the proximal end ofthe same, said sleeve extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct; and characterised by further comprising:-

iii) catheter guiding means mounted by suitable mounting means within said collecting duct at or near said distal inlet end for guiding said catheter towards said proximal outlet of said collecting duct as said catheter is passed through said collecting duct, said catheter guiding means being in a spaced relationship with respect to said rigid edge to define a clearance between said catheter or at least a portion thereof adjacent to said distal edge for substantially preventing contact between said contaminating material and said edge, and said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge.

2. A device as claimed in claim 1, wherein said collecting duct is frusta- conical having a larger distal end and a smaller proximal end.

3. A device as claimed in claim 1, wherein said collecting duct is substantially tubular.

4. A device as claimed in any one of claims 1 to 3, wherein said catheter guiding means comprises a suitable annular support.

5. A device as claimed in any one of claims 1 to 4, wherein said mounting means comprises a suitable proximal extension extending from the said catheter guiding means to the said proximal outlet and suitably attached thereto or integral therewith.

6. A device as claimed in any one of claims 1 to 4, wherein said mounting means comprises a radial strut connecting said guiding means to the inner surface of said collecting duct.

7. A device as claimed in any one of claims 1 to 6, further comprising a housing for the unextended portion of said protecting sleeve.

8. A device as claimed in any one of claims 1 to 7, further comprising adjunct clamping means mounted at or near a proximal end of said catheter, wherein said clamping means substantially prevents leakage from at least one lumen of said catheter.

9. A device as claimed in any one of claims 1 to 8, further comprising a distal lid, wherein said lid for substantially sealing the said distal end of said device.

10. A device as claimed in claim 9, wherein said distal lid is suitably tethered to said device at least prior to sealing same with said distal lid.

11. A device as claimed in any one of claims 1 to 10, further comprising arrester means for locking the distal end of the said catheter distal to said sleeve.

12. A device as claimed in claim 11, wherein said arrester means comprises at least one suitable pin which engages into a corresponding orifice at or near the distal end of the said catheter, locking same with respect to said device.

13. A device as claimed in any one of claims 1 to 12, further comprising wiping means for wiping the extemal surface of the said catheter as the same is passed through said device.

14. A device as claimed in claim 13, wherein said wiping means comprises a high capacity absorbent material.

15. A method for substantially preventing contamination of the patient environment by contact thereof with of contaminating material adhered to the outer surface of an indwelling catheter when extracting same from the patient body, characterised by comprising the step of providing a device as claimed in any one of claims 1 to 14, wherein the contaminated distal end of the said catheter is passed through the said collecting duct, said catheter guiding means guiding said catheter towards the distal outlet of the collecting duct and providing a clearance between the said rigid edge and the said catheter, said mounting means minimising runoff of contaminating material that may become attached to said guiding means towards said rigid edge, and said protecting sleeve automatically extending to cover the extemal surface of said catheter as the same is passed through said proximal outlet of said collecting duct.