IL120286A

IL120286A - Connections for catheter tubes

Info

Publication number: IL120286A
Application number: IL12028697A
Authority: IL
Original assignee: Badia Marcelo Segura; Inst Mun Assist Sanitaria
Priority date: 1996-02-23
Filing date: 1997-02-21
Publication date: 2001-09-13
Also published as: PL318604A1; CZ290922B6; CA2197898C; PL186078B1; IL120286A0; ES2112784B1; BR9701057A; ES2112784A1; CA2197898A1; CZ53997A3; MX9701134A

Abstract

A disinfecting connection for a catheter tube, of the type comprising a central body (1) which receives, at one end, the terminal for connection to the perfusion container and, at the other end, the terminal of the duct carrying the catheter, the central body of which carries a disinfecting element (2) which is to be traversed by the needle (5) incorporated in the terminal associated with the perfusion container, characterised in that the needle- carrying terminal part (6) of the connection associated with the perfusion container is provided with external guide means arranged symmetrically with respect to the needle, in a position encasing the needle and capable of being guided in the central body carrying the disinfecting element, which is connected to said central body in a non-releasable manner. 2149 כ" ה באלול התשס" א - September 13, 2001

Description

Connections for catheter tubes Marcelo SEGURA BADIA L'Institut Municipal d'Assistencia Sanitaria C. 105594 IMPROVEMENTS TO DISINFECTING CONNECTIONS FOR CATHETER TUBES DESCRIPTION The present invention relates to improvements introduced into disinfecting connections for catheter tubes for medical use, providing substantial features of novelty and inventive step.

In the field of medical care, connections for catheters are already known which comprise an intermediate disinfecting element incorporated in the connection in such a manner that, on introducing a needle attached to the feed duct of the container carrying the perfusion liquid, the needle penetrates and passes through the mentioned disinfecting element in such a manner that, as a necessary part of the connecting operation, as is customarily achieved by the screwing-up of the inserted parts, a high level of asepsis is achieved in the assembly of members which make up the connection to the catheter.

In this field of the art, mention may be made of the applicants' patent No. 91 00239 which provides that the disinfecting connection comprises a central body formed by two parts which are connected in a releasable manner and carry an exchangeable disinfecting element, the central body having an opening which is to permit the passage of the connecting needle of the corresponding terminal of the duct connected to the container carrying the perfusion liquid.

Although that arrangement satisfactorily achieves the function of disinfecting the needle at the moment of its penetration through the disinfecting element, the long distance covered by the needle, which is necessary in order to pass through the disinfecting element correctly, in some cases creates certain disadvantages because the guiding of the needle is not sufficiently accurate owing to the existence of only one passage opening in the body carrying the disinfecting element. The result of this is that, in some cases, the connecting operation has to be repeated, with the inconvenience and loss of time which this involves, especially in the case of surgical interventions. It also gives rise to the unfavourable phenomenon that, when the connecting needle strikes against the body of the connector, when the guiding operation is not correct, the needle may be blunted and the plugs and cap may be eroded, which may partially pull away the material of the resilient plugs when the needle is withdrawn or when a further attempt at connection is made, giving rise to possible progressive degradation of the resilient closure element .

An object of the present invention is to provide improvements to connections for catheters and the like of the type mentioned above, by means of which the disadvantages previously mentioned are overcome.

Likewise, another object of the present improvements is to obtain a higher degree of asepsis in the central element carrying the means for disinfecting the needle.

In order to achieve these objects, the present improvements provide a connection for catheters and the like of the type indicated in the introduction to the description, in which the terminal part carrying the needle is provided with an external guide casing, the axis of symmetry of which coincides with that of the needle and which semi-surrounds the needle and is to coincide in sliding manner with the periphery of an end portion of the part carrying the disinfecting element, in such a manner that, on introducing the needle in order to effect the connection, guiding is effected automatically by the external casing with respect to the body carrying the disinfecting element, so that the needle is automatically centred without the operator having to pay express attention to the introduction of the connecting needle, thus preventing incorrect connections.

The mentioned guide, which is an extension of the terminal carrying the needle, may be constituted by a frustoconical , cylindrical or similar structure, such as a frustopyramidal structure, or even by elongate elements in the form of rods, or by sheet-form elements or the like, which are symmetrical with respect to the axis of the needle and each of which is to establish contact with the body carrying the disinfecting element in order to achieve the mentioned effect of automatically centring the needle during its introduction.

In a particular embodiment, the guide casing will be substantially frustoconical with longitudinal internal ribs which are to act as guide means. Said ribs will be shorter than the total length of the guide casing since, after introducing the connection body, with the needle penetrating through the disinfecting element, the said part has to be screwed up, for which purpose the casing has to be able to rotate and therefore it is necessary to interrupt the fitting between guide ribs and the corresponding area of the body. In order to improve the leakproofness of the connection, the terminal connected to the catheter may have an extension which is to receive in abutment the edge of the casing of the needle, preventing any ingress of impurities into the interior of the connection, such impurities being of the aeriform type as well as of the solid or liquid type.

Likewise, in order to achieve the object of improved asepsis in the central portion carrying the disinfecting element, the present improvements provide for the production of the central portion of the body in a non-releasable form by means of a central cylindrical body which is to carry the disinfecting solution and which is closed at both ends by respective plugs penetrable by the connecting needle and which receives the two parts intended for connection to the tube coming from the bottle carrying the perfusion liquid and to the catheter, respectively, the mentioned elements being fixedly joined in a non-releasable manner to the central cylindrical body, for example, by cold-welding or any other type of welding which achieves the mentioned features of non-releasable joining and leakproofness .

Therefore, to summarise, the improvements applicable to connections of the type comprising a central body which receives, at one end, the terminal for connection to the perfusion container and, at the other end, the terminal of the duct carrying the catheter are characterised in that the needle-carrying terminal part of the duct associated with the perfusion container is provided with external guide means arranged symmetrically with respect to the needle, in a position encasing the needle, and capable of being guided in the central body carrying the disinfecting element, which is joined to the terminals connected, respectively, to the duct connected to the perfusion container and to the duct connected to the catheter in a leakproof and non-releasable manner. Preferably, the guide means are formed by a body which encases the needle and the axis of symmetry of which coincides with that of the needle and which can be guided, by the end near the body carrying the disinfecting element, by providing the encasing guide body internally with a large number of longitudinal ribs which can be guided in external grooves of the body carrying the disinfecting element.

A variant of the method of guiding the needle for obtaining correct penetration thereof through the resilient elements closing the disinfecting element is obtained in accordance with the present improvements by forming the external protuberance of the disinfecting element, which protuberance is to indicate the minimum level of liquid, in such a manner that it projects substantially in the radial direction, thus providing the casing with two guide points during introduction, i.e. the end of the external body to which the terminal connected to the perfusion container is secured and the mentioned central rib.

The present improvements also provide that the connection terminal connected to the container carrying the perfusion liquid may be formed in one piece with the duct for connection to the said container and in addition that, in order to adapt the connection to the volumes necessary for the care of the patient, the insertion needle may optionally be changed in order to vary the diameter thereof.

An embodiment of the improvements of the present invention will be described hereinafter by way of non-limiting example with reference to the appended drawings, in which: Figures 1 and 2 are each complete longitudinal sections through a connector which incorporates the improvements of the present invention, representing states of complete and partial filling of the disinfecting element ; Figure 3 is a longitudinal section similar to that of Figures 1 and 2 representing the introduction of the connection element carrying the needle; Figure 4 is a cross-section on the plane indicated in Figure 3 ; Figure 5 is a longitudinal section through a connecting element carrying the needle with a smooth frustoconical guide casing; Figure 6 is a longitudinal section similar to Figure 5 with the frustoconical casing being provided internally with guide ribs; Figure 7 is a detailed side view of the end of the connection element of Figure 6 in the portion corresponding to the connection to the perfusion bottle; Figures 8 and 9 are each cross-sections on the planes indicated in Figure 6 ; Figure 1 0 is a longitudinal section showing the relative position of the terminal carrying the needle and a protector for the needle; Figure Ί 1 is a view similar to Figure 10 showing the needle-protector completely mounted; Figure 12 is a cross-section through the assembly shown in Figure 11 on the plane indicated; Figures 13, 14 and 15 are cross-sections and a longitudinal section, respectively, through the central element of the connection carrying the disinfecting body; Figure 16 is a plan view of the end of the body carrying the disinfecting element that is to guide the element carrying the needle; Figure 17 is a sectional view showing the various members making up the body carrying the disinfecting element; Figure 18 is a sectional view showing the relative positions of the various members of Figure 17 once assembled; Figure 19 is a longitudinal section through the terminal for connection to the perfusion container, showing the detachable needle; Figures 20 and 21 are each longitudinal sections, one complete and one a detail, of a connection which comprises two guide points for the terminal carrying the needle; and Figures 22 and 23 each show versions of the implementation of the improvements which provides for the leakproof closure of the interior of the connection once the connection has been made.

As shown in the Figures, the complete connection incorporating the present improvements comprises a central cylindrical body 1 which carries the disinfecting liquid 2 and which receives at its ends the resilient closure plugs 3 and 4 penetrable by the connecting needle 5 secured to the terminal 6 which is connected to the container carrying the perfusion liquid. The central body of the connection also comprises two parts 7 and 8 which are to be connected to the body 1 in a non-releasable manner, for example by cold-welding or another type of welding to the said tubular body 1.

As shown in Figures 17 and 18, the tubular element 1 is assembled by the successive connection of the various parts mentioned above, there being shown by way of example the arrangement of layers of adhesive, such as 9, 10 and 11, for rendering the various elements integral after assembly, as can be seen in Figure 18 which shows the assembly already formed and the liquid 2 filling the tubular part 1.

The terminal 6, which may correspond to a cone of the "luer" type, has an external guide body 12, shown frustoconically - in the drawings, which has an axis of symmetry coinciding with that of the needle 5 which is integral with the terminal 6 and which is to pass through the disinfecting element until it projects into the central tubular element 14 of the part 8 connectable to the catheter. The terminal 14 may be in the form of a "luer" cone.

The external guide casing 12 is to be guided by the body carrying the disinfecting element, preferably the region 15 of the part 7, which region may, if desired, be provided with external grooves 16, Figures 4 and 14, which guide the internal longitudinal ribs 17 of the external guide casing 18 in the version shown in Figures 6, 9, 10 and 11. As will be appreciated, the mentioned ribs 17 start at the edge 19 of the external casing 20 but do not reach the end of the latter, the region 21 remaining free of the ribs so that, after the complete introduction of the needle, the screwing-up operation can be carried out, which requires that there be no interference between the ribs and their guide grooves.

In order to improve the guide characteristics, the upper part 7 has a wide radius 22 in the region where the needle enters. Likewise, the part 7 has a narrowed portion 23 near the region where the needle 5 enters, Figure 1 , with reduced clearance with respect to the base 24 for securing the needle in order to improve the guide characteristics .

A protective cap 27 may be mounted under pressure on the base 13 carrying the needle, protecting the tip thereof.

As will be readily appreciated, by the implementation of the improvements described, it is possible to obtain improved characteristics of asepsis in the central connection assembly carrying the disinfecting element, and improved guiding for the needle.

As indicated, the present improvements provide that the disinfecting element is not exchangeable per se but that, in order to avoid all classes of possible contamination, a unitary central assembly carrying the disinfecting element is used which is formed by the parts which have been explained and represented in the Figures, for example in Figures 17 and 18. In order that the operator can readily see the level of liquid 2 inside the tubular element 1 , showing him that the assembly must be exchanged, the present improvements provide for the production of a very visible mark on the outside of the body 1 , such as, for example, a greatly projecting peripheral rib 25 or other similar marks or points so that, when the liquid 2 reaches the level 26, as shown in Figure 2, the necessity of exchanging the disinfecting element is readily observed.

In order to improve the guiding of the needle in the introduction stage, the present improvements provide for the embodiment illustrated in Figures 20 and 21 which show that the central tubular element 1 carrying the disinfecting liquid has a peripheral rib 27 which, radially, is capable of establishing contact with the internal face of the casing 12 in such a manner that, when the needle is introduced, the terminal carrying it is guided by the end 15 of the body and by the rib 27, thus substantially improving guiding.

Equally, in order to permit improved asepsis of the connection, the present improvements provide for the closure of the internal portion of the connection as soon as the needle has penetrated, as shown in Figures 22 and 23 . In both cases, the terminal 8 connectable to the catheter has a wide extension, indicated by the numeral 28 in Figure 22 in which the extension has a conical external surface and by the numeral 29 in Figure 23 in which the extension has a cylindrical external surface, both being intended to receive the free edge of the casing 1 2 of the needle, which edge has been indicated by the numeral 30 in Figure 22 and by the numeral 31 in Figure 23 . When the edge 30 , 31 abuts the extensions 28 , 29 of the terminal connected to the catheter, complete isolation of the inside of the connection is obtained, preventing the ingress of any impurity of the aeriform, solid or liquid type .

The present improvements also provide for the possibility of adapting the needle 5 to different diameters according to the patient's requirements. To that end, as shown in Figure 1 9 , the needle may be detachable with respect to an internal cone 32 of the terminal 6 .

Claims

10 120286/2 CLAIMS:

1. A disinfecting connection for a catheter tube, of the type comprising a central body which receives, at one end, the terminal for connection to the perfusion container and, at the other end, the terminal of the duct carrying the catheter, the central body of which carries a disinfecting element which is to be traversed by the needle incorporated in the terminal associated with the perfusion container, characterised in that the needle-carrying terminal part of the connection associated with the perfusion container is provided with external guide means arranged symmetrically with respect to the needle, in a position encasing the needle and capable of being guided in the central body carrying the disinfecting element, which is connected to said central body in a non-releasable manner.

2. A disinfecting connection for a catheter tube according to Claim 1, characterised in that the guide means are formed by a body which encases the needle and the axis of symmetry of which coincides with that of the needle and which can be guided by the end near the body carrying the disinfecting element.

3. A disinfecting connection for a catheter tube according to the preceding claims, characterised in that the encasing guide body is provided internally with a large number of longitudinal ribs which can be guided in external grooves of the body carrying the disinfecting element.

4. A disinfecting connection for a catheter tube according to Claim 3, characterised in that the longitudinal ribs provided on the inside of the encasing guide body start at the mouth of the encasing body and terminate in a region separated from the bottom of the body in order to enable the terminal to rotate, after it has been introduced, so that it can be screwed up.

5. A disinfecting connection for a catheter tube according to Claim 1, characterised in that the central body carrying the disinfecting element is formed by a cylindrical body which is provided with resilient end plugs, contains the disinfecting liquid, and receives at the outside, at its respective ends and in a leakproof and non-releasable manner, the terminals connected, 1 1 120286/2 respectively, to the duct for communication with the perfusion container and the duct connected to the catheter.

6. A disinfecting connection for a catheter tube according to Claims 1 and 5, characterised in that the cylindrical body containing the disinfecting liquid is provided externally with regions indicating the minimum acceptable level for the disinfectant contained in its interior.

7. A disinfecting connection for a catheter tube according to Claim 6, characterised in that the cylindrical body carries a projecting external rib indicating the minimum level of disinfecting liquid.

8. A disinfecting connection for a catheter tube according to the preceding claims, characterised in that the terminal associated with the catheter has an external extension having a face which receives in abutment the free edge of the body encasing the needle in order to seal the inside of the connection when the needle has penetrated completely.

9. A disinfecting connection for a catheter tube according to the preceding claims, characterised in that the central body carrying the disinfecting element is provided with a radially projecting rib which is capable of establishing contact with the internal surface of the casing of the needle, permitting guiding of the terminal carrying the needle as it is introduced and additionally guiding of the end of the central body.

10. A disinfecting connection for a catheter tube according to the preceding claims, characterised in that the terminal carrying the needle has an internal cone for the releasable connection of standardised needles having different diameters.

11. A disinfecting connection for a catheter tube according to the preceding claims, characterised in that the terminal carrying the needle is integral with the duct for communication with the container carrying the perfusion liquid. For the Applicants REINHOLD C AND PARTNERS 105594-6/claims/DD-jg/08/03/01