CA2741926C

CA2741926C - A catheter containing device, a dressing for a catheter and a kit comprising both thereof

Info

Publication number: CA2741926C
Application number: CA2741926A
Authority: CA
Inventors: Gianni Pecorari
Original assignee: Emodial Srl
Current assignee: Emodial Srl
Priority date: 2008-10-29
Filing date: 2009-10-27
Publication date: 2017-03-07
Anticipated expiration: 2029-10-27
Also published as: ITBO20080661A1; CA2741926A1; WO2010049417A1; IT1391498B1

Abstract

Catheter containing device, of a type constituted by a pouch (11), externally accessible via an opening (12), the pouch (11) being constituted by two facin walls (13,13'), characterised in that at least one of the walls (13,13') affords a slit (14) destined to receive the catheter contained in the pouch (11) in a free coupling.

Description

A CATHETER CONTAINING DEVICE, A DRESSING FOR A CATHETER
AND A KIT COMPRISING BOTH THEREOF
TECHNICAL FIELD
The invention relates to the field of medical devices, in particular container devices for containing catheters and dressings for catheters.
BACKGROUND ART
Catheters are vascular access devices used in the medical field for liquid infusion and intravenous administration of pharmaceutical drugs. In some pathologies these vascular accesses can be kept open for rather long times.
In particular the central venous catheter (CVC) is an external vascular access that is tunnelled over a long period of time (for example in oncology and peritoneal dialysis) or for obtaining an immediate access in emergency situations.
The central venous catheter is constituted by a variable-length catheter of about 20 centimetres with a diameter of the order of a few millimetres, which is tunnelled below the skin by inserting the terminal part thereof into the path of a central vein (subclavian, jugular, femoral). One or more connections for infusion devices are located In the proximal part of the catheter, external of the skin.
Once the catheter has been implanted, the access point must be closed as quickly as possible without getting infected; if not a further implant will have to be made in a different position.
The long-term complications of the catheter are occlusion of the catheter, venous thrombosis and infections. For these reasons careful and frequent maintenance is required, at each use of the catheter heparin has to be

- 2 -administrated in order to prevent occlusion and thrombosis, and the zone adjacent to the exit point of the catheter from the body must be periodically medicated with disinfectants and covered with packs of antiseptic material.
The portion of catheter which projects from the body has to be fixed to the body or collected in a pouch which has the function of protecting the catheter from external agents and which can be fixed to the body by a plaster.
At present, the medical field uses dressings, the surface layer of which is made of aluminium or in which the fibres of the surface layer are covered with aluminium, in order to facilitate haemostasis and to prevent infection. For example, in a tracheostomy, an operation which creates a permanent opening between the trachea and the cervical skin, dressings are applied in which the fibres of the surface layer are clad with aluminium. In the post-operative period these tracheostomy dressings are placed around the zone of the throat adjacent to the tracheostomy tube in order to facilitate cicatrisation.
In some cases the tracheostomy dressings have a slit which is suitable for surrounding the tube and therefore adhere more satisfactorily as the zone in which the tracheostomy tube projects from the body. The slits consist of a cut terminating in a circular hole of diameter 8-12 mm suitable for locating the tracheostomy dressing in strict adherence to the tracheostomy tube, the external dimensions of which correspond. To fix the tracheostomy dressing to the skin a length of plaster is used. Cicatrisation of the wound of the tracheostomy takes a couple of months. The portion of tube which projects from the neck is of a minimal length, so that it does not cause traumas over a long time to the entry zone due to accidental impacts or proximal displacements, and once the wound has cicatrised there is no further need for dressing.
Patients having recourse to peritoneal dialysis or chemotherapy, to whom a central venous catheter has been fixed, have to keep the catheter up to the end of therapeutic treatment. For this reason, when the central venous catheters are obstructed or when the zone they are implanted in gets infected,

- 3 -they have to be replaced.
There emerges, therefore, a need to avoid or reduce the catheter replacements which require periodical and discomfiting operations on the patient.
DISCLOSURE OF INVENTION
An aim of the present invention is to provide a medical device enabling a reduction of the catheter replacements, in particular to provide a container device for a catheter which both contains the portion of catheter external of the body and facilitates the healing and reduces the probability of infection of the wound, both in the post-operative period and during the time the catheter is attached, thus reducing the number of implanting procedures to which a patient has to be subjected.
The invention further has an objective of providing a kit comprising at least a device as described herein and at least a catheter dressing as described herein.
In view of the above-cited aims the present invention provides a system constituted by a catheter container device of a type constituted by a pouch which is accessible from the outside by means of an opening, the pouch being constituted by two facing walls, in which at least one of the walls affords an opening 12 for freely couplingly receiving the catheter contained in the pouch; and a dressing for catheters comprising: at least a surface layer destined to be laid on the skin, the layer being blood-permeable and permeable to bodily fluid; at least an internal absorbent layer; at least an internal absorbent layer; in which at least one from among the surface layer and the internal absorbent layer comprises

- 4 -at least a substance selected from a group consisting of silver, aluminium and derivatives thereof; and at least a slit selected from a group comprising:
an upturned-Y-shaped slit, starting from an edge of the dressing with a first cut and terminating in a bifurcation defined by two further cuts originating at an end of the first cut and identifying an angle; or a fissure-shaped cut, starting from an edge of the dressing and terminating with a hole, which single cut is of a length comprised between 0 and 6 cm and which hole is circular with a diameter comprised between 1.5 mm and 7 mm, preferably between 5-6 cm.
According to an aspect of the present invention there is provided a catheter containing device for containing the portion of catheter external of the body, of a type constituted by a pouch, externally accessible via an opening, the pouch being constituted by two facing walls, wherein at least one of the walls affords a slit destined to receive the catheter contained in the pouch in a free coupling, and wherein the slit is:
upturned-y-shaped, starting with a first cut and terminating in a bifurcation defined by two further cuts originating at an end of the first cut and identifying an angle; or fissure-shaped, starting with a single cut and terminating with a hole.
The special conformation and dimensions of the slits enable the catheter dressing of the invention to be better adapted to the profile of the catheter at the point in which it emerges from the body, and thus to be placed in contact with the whole zone surrounding the point. The presence of silver or aluminium or derivatives thereof in the catheter dressing facilitates haemostasis and thus both reduces healing times and antibacterial characters, reducing the probability of infection in the wound.
The catheter dressing as disclosed herein can be used singly in the post-operative period, or can be applied on the catheter container device such as to be located in contact with the skin when the slit of the device receives the catheter, the slits corresponding to the device and the dressing being - 4a -superposed. The catheter dressing is applied on the container device at each application and will be periodically replaced during the course of the application of the dressing while the catheter container device can be re-utilised more than once if in good condition and clean.
Thus a kit comprising at least one of the catheter container devices and at least a catheter dressing as described above of the invention is advantageous.
The present invention also provides a kit comprising at least the device as described herein.

- 5 -BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of an embodiment of the invention;
figure la is an alternative slit to the one shown in the embodiment of the invention of figure 1;
figure 2 is a perspective view of a further embodiment of the invention.
In figures 1 to 2 identical components used for the various embodiments of the invention are denoted using the same numbers, and have similar characteristics to unless otherwise indicated.
BEST MODE FOR CARRYING OUT THE INVENTION
Figure 1 illustrates a catheter container device 10 of the invention. The device 10 is constituted by two walls 13, 13' facing one another and having one of the walls 13' exhibiting a slit 14 destined to freely couplingly receive the catheter contained in the pouch 11.
Figures 1 and 2 show particular preferred embodiments of the invention in which the walls 13, 13' of the catheter container device have a different extension and define, as shown in figures 1 and 2, a flap 15 adjacent to the opening 12, and in which the slit 14 involves the flap 15. This embodiment is particularly preferred in that it enables application of the catheter dressing of the invention and makes the arrangement of the device 10 about the catheter easier to accomplish.
In all the embodiments of the invention the slit 14 of the catheter container device 10 can originate from:
a point of the portion of the edge of the opening 12 in the wall 13, 13';
or

- 6 -a point on the edge of the flap 15, as shown in figures 1, la.
The slit 14 of the catheter container device 10 can preferably originate from a point of the edge portion of the opening 12 relative to the wall 13 or 13'.
The slit 14 of the container device 10 destined to receive the catheter in free coupling is advantageously:
in an upturned Y-shape, as shown in figures la and 2; the slit begins with a first cut 20 and terminates in a bifurcation defined by two further cuts 21, 21' which originate from an end of the first cut 20 and identify and angle 22;
or in a shape of a slit starting from a single cut 23 and terminating with a hole 24, as shown in figure 1. Preferably the single cut 23 has a length comprised between 0 and 6 cm and the hole is circular with a diameter comprised between 1.5 and 7 mm, in particular comprised between 5 and 6 mm.
The conformations enable the area of the device in contact with the skin surrounding the entry point of the catheter to be maximised.
Particularly preferred are the slits 14, both in the container device 10 and the catheter dressing 100, in which the first cut 20 has a length comprised between 0.5-8 cm, the further two cuts 21, 21' having a length comprised between 1 and 3 cm. and the angle 22 is comprised between 85 -95 , preferably 900.
These configurations enable the zone adjacent to the slit to strictly adhere to the catheter, further maximising the area of the device in contact with the skin surrounding the entry point of the catheter, which will thus be entirely in contact with the anti-bacterial and haemostatic agents.
Figure 1 also shows a further advantageous aspect of the invention which enables fixing the container device 10 to the patient's skin. The illustrated container device 10 further comprises an auxiliary adhesive strip coupled to

7 the container device 10 in proximity of or at the area 30 adjacent to the slit 14.
The auxiliary adhesive layer possesses at least an adhesive side and a portion 41 of surface not superposed on the area 30 and arranged such that the adhesive side is placed in contact with the skin when the slit 14 receives the catheter. Obviously, in the case in which the auxiliary adhesive layer superposes the slit 14, the adhesive layer will also have a slit 14 of equal conformation and dimensions.
As shown in figure 2, the extension of the surface of the auxiliary adhesive layer is advantageously greater than the area 30 adjacent to the slit 14, entirely covers the area 30 and extends distally to the opening 12 along the longitudinal axis 42 of the device beyond the flap 15.
Optionally the portion of surface of the auxiliary adhesive layer extending distally could also have a slit superposing the slits 14 of the container device 10 and/or the catheter dressing 100, and which proceeds up to the edge of the auxiliary adhesive layer.
Figure 2 further illustrates a particularly advantageous embodiment of a catheter container device 10 in which a catheter dressing according to the invention is applied to the area 30 adjacent to the slit 14 destined to be located in contact with the skin surrounding the catheter. The surface layer 110 thereof is arranged such as to be located in contact with the skin when the slit 14 of the device receives the catheter and the slits 14 of the device 10 and the dressing 100 are superposed.
When the catheter dressing 100 is not applied to the container device 10, preferably at least the area 30 adjacent to the slit 14 and destined to be located in contact with the skin surrounding the catheter comprises at least a substance selected from a group comprising silver, aluminium and derivatives thereof.
In at least an embodiment the area 30 of the catheter container device adjacent to the slit 14 is destined to be located in contact with the skin surrounding the catheter, or the surface layer 110 of the catheter dressing

- 8 -are made of a non-stick textile, a non-stick textile fabric having knit weft, a non-woven non-stick textile selected from a group comprising:
a) a textile having fibres made of silver or aluminium;
b) a slim perforated layer of silver or aluminium;
c) a textile the fibres of which are covered with silver or aluminium and wherein the aluminium or silver fibres are situated on the surface destined to be placed in contact with the skin (i.e. a textile metallized with silver or aluminium).
Obviously, in the case of a catheter dressing 100, the surface is the external surface of the surface layer 110 destined to be placed in contact with the skin.
It is preferable to metallise an anti-stick support permeable to blood and other bodily fluids with silver and/or aluminium, the support being a knit, a textile, a non-woven textile made of polyethylene, polyester, viscose, or another material used pharmaceutically. Metallisation can be performed either with classic techniques or using modern and innovative methods such as micro- or nano-deposition. The metallisation of the support reduces the quantity of metal used with respect to the embodiments of a) or b) and is therefore preferable thereto.
In a further embodiment, silver and/or aluminium derivatives or particles of silver and/or aluminium are used, which can be situated either on the area 30 adjacent to the slit 14 and destined to be located in contact with the skin surrounding the catheter and/or on the surface layer 110 and/or in the absorbent layer 120 of the catheter dressing.
Thus, there is a particular preference for catheter container devices 10 and catheter dressings 100 comprising at least one of the following derivatives of aluminium and silver selected from a group constituted by aluminium sulphate (anhydrous aluminium sulphate and in various forms of hydration thereof) cas numbers 10043-01-03, 16828-11-8, 16828-12-9 and 7784-31-8), aluminium

- 9 -and potassium dodecahydrate. cas 7784-24-9, metallic aluminium, metallic silver, ionic silver, an inorganic silver salt, in particular silver nitrate, cas 7761-88-8; and an organic compound of silver, in particular protein silver, cas 42-8; vitellinate silver, cas 9015-51-4, silver alginate and silver sulfadiazine.
In the catheter dressing 100 these compounds can be comprised in at least one of the surface layer 110 and absorbent layer 120. In a case in which the metal particles of sliver and/or aluminium or the silver derivatives and/or aluminium derivatives are exclusively contained in the absent layer 120 of the dressing 100, the surface layer 110 will have a perforated structure or a structure with openings which will allow the absorbent layer 120 to come into contact with the patient's skin. However the structure of the surface layer will retain the fibres of the absorbent layer internally of the dressing even during the stage of removal thereof from the skin. An expert in the field, according to the type of absorbent material used and the length of the fibres, will be perfectly able to establish the shape of the holes or the openings. In these embodiments the surface layer can be constituted by a textile or a woven cotton material, or polyester, or another material used in the manufacturing of the surface layers of the absorbent medical devices well known to an expert in the field.
The use of silver or its derivatives is preferable to the use of aluminium or its derivatives as silver has greater anti-bacterial and haemostatic powers than aluminium and its derivatives. Therefore catheter container devices and catheter dressings of the invention preferably comprise silver or its derivatives.
Dressings for catheters of the invention can be manufactured in any geometric shape, for example: square, circular, rectangular, hexagonal, octagonal, oval, triangular, and more besides. Square catheter dressings are particularly suitable, having a side length comprised between 3 and 8 cm, or rectangular with sides comprised between 2.5 and 8 cm or circular with a diameter comprised between 2.5 and 8 cm.
Similarly, the pouch 11 too can be of various shapes and sizes, according to

- 10 -the type and length of the catheter, which they will contain, through preferably rectangular or square, as these are easier to make.
Also particularly advantageous are embodiments in which the catheter dressing 100 is applied on a plaster, an elastic bandage, a self-adhesive bandage, as they enable fastening the single catheter dressing 100 to the body.
The above-mentioned surface layer of the dressing 100 is preferably anti-stick, and without projecting fibrous particles.
The absorbent layer can be constituted by a gauze absorbent made of hydrophilous cotton, or non-woven textile or expandable dressings constituted by a single spongy material such as synthetic felt or ribbon polypropylene or viscose for pharmaceutical use. An absorbent layer made of viscose or viscose-polypropylene is preferred, having a thickness comprised between 0.1 and 15 mm or greater, according to the clinical situation. More preferable is a thickness comprised between 1 and 4 mm and having an absorbent power of 500-1500% in a second, and even more preferable is 700-1500% in a second.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A catheter containing device for containing the portion of catheter external of the body, of a type constituted by a pouch, externally accessible via an opening, the pouch being constituted by two facing walls, wherein at least one of the walls affords a slit destined to receive the catheter contained in the pouch in a free coupling, and wherein the slit is:
upturned-y-shaped, starting with a first cut and terminating in a bifurcation defined by two further cuts originating at an end of the first cut and identifying an angle;
or fissure-shaped, starting with a single cut and terminating with a hole.

2. The device of claim 1, wherein the walls are of a different size and define a flap adjacent to the opening, the slit being afforded in the flap.

3. The device of claim 2, wherein the slit originates from:
a point on a portion of edge of the opening in the wall, or a point on an edge of the flap.

4. The device of claim 1, wherein the first cut is of a length comprised between 0.5 and 8 cm, and the two further cuts are of lengths comprised between 1-3 cm, and the angle is comprised between 85° and 95°.

5. The device of claim 1, wherein the single cut has a length comprised between 0 cm and 6 cm and in that the hole is circular with a diameter comprised between 1.5 mm and 7 mm.

6. The device of any one of claims from 1 to 5, wherein at least the area adjacent to the slit and destined to be located in contact with a skin area surrounding the catheter comprises at least a substance that is silver, aluminium or any derivative thereof.

7. The device of claim 6, wherein the area adjacent to the slit is made of a non-stick textile, a non-stick textile fabric having knit weft, a non-woven non-stick textile that is:
a textile having fibres made of silver or aluminium;

a textile having fibres covered with silver or aluminium; or a slim perforated layer of silver or aluminium.

8. The device of claim 6, wherein the area adjacent to the slit comprises a derivative of aluminium or silver that is anhydrous aluminium sulphate or any hydrated form thereof, aluminium or potassium dodecahydrate, metallic aluminium, metallic silver, ionic silver, an inorganic silver salt, an organic compound of silver, silver nitrate, protein silver, vitellinate silver, silver alginate or silver sulfadiazine.

9. The device of any one of claims from 1 to 8, wherein it further comprises an adhesive auxiliary layer coupled to the containing device in proximity of or at the area adjacent to the slit, the auxiliary adhesive layer having at least an adhesive side and a portion of surface not superposed on the area adjacent to the slit arranged such that the adhesive side is placed in contact with the skin when the slit receives the catheter.

10. The device of claim 9, wherein the extension of the surface of the auxiliary adhesive layer is greater than the area adjacent to the slit, entirely covers the area adjacent to the slit, and extends distally of the opening along a longitudinal axis of the device beyond the flap, the auxiliary adhesive layer affording a slit which superposes the corresponding slit of the containing device and/or a corresponding slit of a dressing for a catheter application.

11. The device of any one of claims from 1 to 5, and 9 to 10, wherein a dressing for a catheter application is applied on the area adjacent to the slit, the surface layer of which is arranged such as to be located in contact with the skin when the slit of the device receives the catheter, with the slit of the device and the slit of the dressing being superposed, wherein the dressing comprising:
at least a surface layer for resting on the skin, the layer being permeable to blood and body fluids;
at least an internal absorbent layer;
wherein at least one of the surface layer and the absorbent layer comprises a substance that is silver, aluminium or any derivative thereof, wherein it comprises at least a slit that is:
an upturned-y-shaped slit, starting from an edge of the dressing with a first cut and terminating in a bifurcation defined by two further cuts originating at an end of the first cut and identifying an angle; or a fissure-shaped slit, starting from an edge of the dressing and terminating with a hole, which single cut is of a length comprised between 0 and 6 cm and which hole is circular with a diameter comprised between 1.5 mm and 7 mm.

12. The device of claim 11, wherein the first cut is of a length comprised between 0.5 and 8 cm, and the further two cuts are of lengths comprised between 1 cm and 3 cm, and the angle is comprised between 85° and 95°.

13. The device of claim 11 or 12, wherein the first surface layer is non-stick textile, a non-stick textile fabric having knit weft, a non-woven non-stick textile that is:
a textile having fibres made of silver or aluminium;
a slim perforated layer of silver or aluminium; or a textile having fibres covered with silver or aluminium and in which the aluminium or silver fibres are situated on the external surface of the surface layer destined to be placed in contact with the skin.

14. The device of any one of claims 11 to 13, wherein at least one of the surface layer and the absorbent layer comprises at least one derivative of aluminium or silver that is anhydrous aluminium sulphate or any hydrated form thereof, aluminium or potassium dodecahydrate, metallic aluminium, metallic silver, ionic silver, an inorganic silver salt, an organic compound of silver, silver nitrate, protein silver, vitellinate silver, silver alginate or silver sulfadiazine.

15. A kit comprising at least the device as defined in any one of claims 11 to 14.