WO2001008739A1

WO2001008739A1 - Securing device for spinal or venous catheters

Info

Publication number: WO2001008739A1
Application number: PCT/EP2000/007283
Authority: WO
Inventors: Pasquale Mastronardi; Fiorentino Fraganza; Antonio Ercole Rossi
Original assignee: COMENDULLI BRUNO GIUSEPPE
Current assignee: COMENDULLI BRUNO GIUSEPPE
Priority date: 1999-08-03
Filing date: 2000-07-28
Publication date: 2001-02-08
Anticipated expiration: 2002-02-03
Also published as: ITMI991739A1; AU6831800A; ITMI991739A0; IT1313591B1

Abstract

A securing device for spinal or venous catheters, comprising a body (1) with a self-adhesive base (2) for securing to the patient's skin, the said body (2) presenting a through inner cavity designed for the passage of a catheter (100), which said cavity presents an anti-constriction entry guide consisting of an inclined tube (5) connected axially to a housing (7) designed to house a rubber lining (9) with a central channel (10) of a gauge proportional to that of the catheter to be secured, which said lining is designed to secure catheter (100) by means of the pressure exerted by a screw stopper (11), which said stopper also presents a central channel (12) for the exit of the catheter.

Description

SECURING DEVICE FOR SPINAL OR VENOUS CATHETERS

The subject of this invention is a catheter securing device designed to be inserted in the spinal column or in the venous blood vessels.

Access via suitable spinal catheters (inserted in the spinal column) or venous catheters (inserted in venous blood vessels) has led to breakthroughs in medical treatment.

In fact, if a catheter is positioned in the spinal column, local anaesthetics and other drugs can be administered to perform surgical anaesthesia or combat pain. If a catheter is inserted in a blood vessel, drugs can be instilled continuously for therapeutic purposes. As both approaches (venous and spinal) require the catheter to remain in place for a long period, sometimes for several months, one of the major problems is obviously constituted by the need to secure the catheter firmly to prevent displacement which, apart from nullifying the therapeutic effects, would also expose the patient to the risk of administration of drugs in tissues other than those in which the catheter was originally positioned.

The purpose of the invention is to solve this problem by supplying a catheter securing device which provides firm, long-term securing with no possibility of catheter displacement.

This aim is achieved in accordance with the invention, which presents the characteristics described in the annexed independent claim 1.

Advantageous embodiments of the invention are described in the dependent claims.

Basically, the catheter securing device in accordance with the invention comprises a substantially flattened body with a self-adhesive base that can be applied firmly to the patient's body, and an anti-constriction entry guide for the catheter.

Inside the said body there is a through tube with different diameters designed to house a rubber lining having a central channel of a gauge proportional to that of the catheter to be secured, which firmly holds the catheter inserted in the body as a result of the pressure exerted by an external screw stopper, causing it to exit through a channel in the said stopper. Further characteristics of the invention will appear more clearly from the detailed description that follows, which is given by way of example but not of limitation, and is illustrated in the annexed drawings, in which: figure la is a plan view of the body of the catheter securing device in accordance with the invention - figure lb is a view from above of the device shown in figure la figure 1 c is a cross-section in accordance with plane II shown in figure la figure 2a is a cross-section of a rubber lining designed to fit into the body shown in figures la-c - figure 2b is a view from above of the rubber lining shown in figure 2a figure 3a is a cross-section of a stopper suitable to close from above the body shown in figures la-c figure 3b is a view from above of the stopper shown in figure 3a figure 4 is a cross-section of the assembled device like the one appearing in figure lc, showing the body appearing in figures la-c, complete with the rubber lining shown in figures 2a-b and the stopper shown in figures 3a-b. With reference to those figures, and in particular to figures la-c for the time being, a body 1 , which is conveniently made of plastic, with a fairly flattened shape, presents a flat face 2 and a substantially convex opposite face 3, faces 2 and 3 being joined by side walls 4 which have rounded edges.

Flat face 2, which corresponds to the lower or rear face of body 1, is self- adhesive, or has double-sided adhesive tape applied to it to ensure firm anchorage to the patient's skin after insertion of catheter 100, shown schematically by a dotted line in figure 4 only.

Body 1 presents an inner cavity which passes from one end to the other, made with different sections, which will now be described in more detail.

The entrance to body 1, located in the lower part in the annexed drawings, consists of a tube 5 having an angle of approximately 30 degrees from the vertical, and constitutes a guide for catheter 100, preventing the said catheter from bending or being pulled out in the passage from the patient's body to the securing device in accordance with the invention.

After the angled section, the entry tube 5 continues with a straight vertical section 6 which leads to a cylindrical housing 7 of larger diameter in the centre of body 2. Cylindrical housing 7 terminates with a threaded upper section 8 of slightly larger diameter.

Cylindrical housing 7 is designed to house a rubber lining 9, shown in figures 2a and 2b, which presents a central channel 10. Rubber lining 9 is retained inside body 1 by a stopper 11 , shown in figures 3a and 3b, which also presents a central through channel 12.

Stopper 11 presents a basically cross-shaped head 13 to facilitate grip and manipulation, a threaded central section 14 designed to engage with terminal threaded section 8 of the cavity in body 1 , and a lower section 15 destined to be inserted, wholly or partially, in cylindrical housing 7 inside body 1.

By suitably screwing stopper 11 into body 1 , rubber lining 9 is compressed to such an extent as to reduce the gauge of its channel 10, possibly with the aid of two washers 16 positioned at either end of the rubber lining, as shown in figure 4, to even the pressure exerted by stopper 11 so as to make lining 9 adhere so strongly to the catheter that the latter is firmly secured without being constricted.

Catheter 100, which exits from channel 12 of stopper 11, as schematically shown in the overall view in figure 4, can usually be connected to the classic infusion systems. The measurements shown in the annexed drawings are naturally given by way of example only; in particular, channel 10 of lining 9 will be produced in various diameters, depending on the gauge of catheter 100.

The securing device in accordance with the invention can be replaced in case of need without removing catheter 100 from the site of implantation; it is sufficient to loosen stopper 11 by unscrewing it and gently detach adhesive base 2, then remove body 1 from the free catheter and insert a new securing device if necessary.

If catheter 100 is removed, the securing device in accordance with the invention will be directly removed with the catheter. Suitable materials for the catheter of the invention include silicones, PVC, polyethylene, EVA, polyurethanes, polypropylene for medical uses, rubbers, thermosetting polymers for medical uses and the like.

The advantages of the invention, which fully achieves the intended aims, clearly appear herein. The invention is obviously not limited to the particular form of embodiment described above and illustrated in the annexed drawings; numerous details could be modified without departing from the ambit of the invention as defined in the claims below.

Claims

1. Securing device for spinal or venous catheters, comprising a body 1 with a substantially flat face 2 that can be secured to the patient's skin by adhesive means, presenting a through inner cavity designed for the passage of a catheter 100, the said cavity having a variable diameter and comprising in particular a housing 7 for a rubber lining 9 with a central channel 10, and an upper section 8 designed to engage with a stopper 11, which said stopper also presents a central channel 12, and is designed to compress the said rubber lining 9 so that it holds catheter 100 firmly without constricting it.

2. Securing device as claimed in claim 1, characterised in that the said through cavity in body 1 constitutes an anti-constriction entry guide for catheter 100, and comprises an inclined tube 5 which continues with an axial tube 6 aligned with channels 10 and 12 in lining 9 and stopper 11 respectively.

3. Securing device as claimed in claim 2, in which the said inclined tube 5 has an inclination of approximately 30 degrees from the axis of body 1.

4. Device as claimed in claim 1, characterised in that the said central channel 10 of lining 9 has a gauge proportional to that of catheter 100 to be secured.

5. Securing device as claimed in any of the preceding claims, characterised in that the said stopper 11 engages by screwing with a terminal section 8 of the said cavity in body 1, and presents an end section 15 designed to be inserted at least partly in the said cylindrical housing 7 of body 1 to compress lining 9.

6. Securing device as claimed in any of the preceding claims, characterised in that the said stopper 11 presents a cross-shaped head 13.

7. Securing device as claimed in any of the preceding claims, characterised in that washers 16, designed to even the pressure exerted by stopper 11, are fitted at the ends of the said lining 9.

8. Securing device as claimed in any of the preceding claims, characterised in that the said adhesive means are integral with base 2 of body 1.