AU673839B2 - Sealable external access catheter - Google Patents

Description

OIPI OAT[ 29/11/93 A0JIP DATE 10/02/94 APPI N. 10 '11111113 I I~l I 1111 111111111111111111111 1111il PCT NUMBER PCT/FR93/00412I1111IlfiIl1111111111111i li AU9342873 l)1NMANOLW INII,,INAIIONALI, PU Lill [N v['RT DlU TRAITI DL1 (0 RITJMON I N WWIII RU I 11IUVIS O( T) Classification Internationale des brevels-5 (I I)Nuniiro do publicaion Internationale: WO 93/21972' A61M 1/00 All (43) Dale do polillcadlon Wnnuitonate: I I novemhre 1993 (11.11.93) (21) Num~ro do In dernande Internationale: PCT F 193 00412 EtaK dUslgnts: AU, CA. J1P. NO. US, brewe curopcen (AT,I 11F. D, F. S. Fit. OR, 11L, IT, LU, MC, (22) Date do -p~t Interntional: 2.8 avril 1993 (2tK04.93) NL. [IT. SU).

Donnics relatives i In prIorlt6* Publi~c 92/05307 29 avr1I 199.2 (29.04.92) FR Ai'ee rapport tic rcherche internaooIWl.

(71) 1)6posant fposir tous lv Fiats tkiign&s saif USI: (1 IRONO- IliC S.A.R.L. (FR FRI; 1499, chemnindo S.-Mayrnes. F- 06600 Antibes (Fit).

(72) Jrnvnleur; of Jnventeur/D61posant WLS seutemntz: HAUSER, lean-Luc 1499, chermin do 5.-Maymes, F-00600 Antibes

(FR).

(74) Nlandatatre: CABINET BONNEAU; Les Lauricts, 6, avenuc des Aigles, r-06600 Antibes (FR1).

67 38b39 (54)Thite: SCALABLE EXTERNAL ACCESS CATHETER (54)111re: CATHETER EXTERNALISE FERME A ACCES ETANCHL (57) Abstract A sealable external access catheter including a portion (10) implanted in the body of the patient, an anchoring sleeve (14) extending through the skin, and a portion (12) located outside the patient and provided at its free end with a self-healing septum made of a material which is repeatably and se-dably pierceable by an infusion instrument. The septum may comprise two fins (18) forming a flat base enabling it to be easily attached to the patient's skin. Said catheter is provided with a sealing plug whereby any danger ofr infection is avoided, unlike in unsealed external access catheters.

(57) Abrig6 L'invention concerne un cath~ter externalis 6 f ermoturo 6tanche comprenant une partie (10) implant~e dans Ie corps du patient, un manchon d'ancrage (14) A Ia travers~e de, Ia poau, et une partie (12) externo au patient munie d son extr~mit6 fibre d'un septum auto-cicatrisant (20) rialisi en un mat~riau pouvant Wte travers6 do nombreuses fois par un instrument de perfusion sans pordre son 6tanch~it&. Le septum pout comporter deux ailettes (18) formant une embase plate pormettant une fixation ais~e sur la peau du patient. Le catheter selon l'invention, du fait do l'existonce d'un bouchon 6tanclie, no pr~sente pas do risquos d'infection comme un cath.~ter oxtornalis& ouvort.

Closed external catheter with leakproof access Technical sphere The present invention concerns catheters which are Intended for implanting into the bodies of patients so as to be able to carry out Infusions, and1 more especially a closed external catheter with leakproof access.

State of the art Catheters which can be Implanted under the skin of patients and the inlets of which consist of an "access site", have existed for a long time. The latter usually consists of a rigid chamber which is provided with a septum located immediately under the skin of the patient. Ilion the patient is to be given infusions in the course of a periodical chemotherapeutic treatment, the physician or the nurse locate the septum by palpation so as to be able to insert the infusion needle. The septum is made of a material which the needle can easily penetrate, but which regains leak tightness as soon as the needle is withdrawn. Usually the septum needs to be replred after a certain number of infusions, of the order of several hundred, because the large number of infusions carried out will weaken it and make it lose its leak tightness.

Implantation of thle septum under the skin can present a number of problems. Thus, a failure of the leak tightness of the septum, or a displacement of the needle during an infusion, can be the cause for a subcutaneous leak. The use of an agressive drug in the infusion liquid can also prove dangerous for the patient because of the penetration of the skin by the needle.

There are external catheters with open external ends. They are usually closed by a rigid external stopper. This stopper is not a septum and cannot be penetrated by an infusion needle. When the infusion is to be carried out, the stopper is withdrawn and the source of the infusion liquid is connected to the catheter, for example by means of a syringe without needle of the "cone luer lock" type as described in patent EP-.A-2666.243. Such systems, which are called open systems, carry great infection risks because -1Athe inlet to the catheter is open to air each time an infusion is to be administered.

There are also external catheters such as the one described in patent EP- A143.- 18 the external end with respect to the patient is closed by a septum. But this closing off septum of the catheter is of the pre-existing opening type which permits the introduction of the pharmaceutical drug by means of an instrument of the cannula type, and not by means of a needle as is the case with a self sealing septum. In contrast to a self sealing septum, this type of septum with a pre-existing opening cannot be used a large number of times without the opening enlarging and allowing the catheter to communicate with the exterior, with the attendant infection risks.

Throughout the description and claims of this specificatior, the word "comprise" and variations of the word, such as "comprising" and "comprises", is not intended to exclude other additives or components or integers.

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a* o a* 3 D0 i19z e3tzztztri n tc to be administered.

There are also external catheters such as the e described in patent ERP-A143. 518 the external end with r ect to thle patient is closed by a septum. But this closing septum of the catheter is of the pre-existing opening typ ich permits rhv introduction of the pharmaceutical drug b cans of an Instrument of the canulla type, and not by means a needle as is the case with a selfsealing septum. In contra. to a selfsealing septum, this type of septum with a pre-e sting opening cannot be used a large number of times withou- e opening enlarging and allowing the catheter to communicate Summary of the invention The aim of the invention is, therefore, to produce an external catheter which is leak tight and does not present the infection risks of an open external catheter.

Another aim of the invention is to produce an external catheter containing one or more lines, each terminating in a selfsealing septum.

Yet another aim of the invention is to produce an external catheter with several lines, one of which carries a connection support for control signals for ani infusion carried out by means of another line.

Its aim is an external catheter, comprising an internal part which can be implanted into the patient and a part external to the patient, through which a needle or another instrument can penetrate, making it possible to carry out an infusion, a sampling or any other appropriate intervention, the external part being provided at its free end with a leak tight stopper made of a material which can be penetrated repeatedly in a leak tight manner, by the said instrument.

According to another characteristic of the invention, the caLheter may comprise several lines, each being closed off in the part external with respect to the patient, by means of a septum which can be I penetrated by an infusion needle.

Brief description The aims, objects and characteristics of the invention will be better understood by reading the description below which was prepared with reference to the drdwings in which: figure 1 represents the catheter of the invention with its sleeve and the septum at the external end, figure 2 is a cross sectional view of the external end of the catheter of the invention, figure 3 represents a catheter comprising several lines, figure 4 represents a catheter provided with optical fibres and sensors, and figure 5 represents a catheter with two lines one of which contains optical fibres for the transmission of signals supplied by a sensor for control of the infusion while it is being administered.

Detailed description As shown in figure 1, the catheter of the invention comprises a part 10, which is implanted into the body of the patient, usually into a blood vessel. The catheter penetrates the skin of the patient by way of the anchorage sleeve 14 and terminates in an external part 12. This external part comprises at its end a leak tight stopper 16 which contains a self sealing septum made of a known material such as silicone, through which the infusion needle can be inserted to administer infusion of a pharmaceutical drug into the patient.

The stopper 16 is located several centimetres from the sleeve 14.

It can be constructed in such a manner that it can be taken to pieces, which permits the replacement and also the adjustment of the length of the external part 12 of the catheter after its implantation or the facilitation of the introduction procedure of the catheter, for example in the case of a subcutaneous intravenous access way.

As has been said previously, the replacement of the self-sealing septum is necessary only after many introductions of the infusion needle, say several hundred times.

~1_ In order to make possible easy fixing on the patient's skin, the stopper 16 is preferably provided with fins 18 which form a smooth base.

Figure 2 represents a section of the end of the external part 12 of the catheter. As can be seen on the figure, the stopper 16 consists of a septum 20 across which the infusion needle is inserted.

The septum 20 is extended by a connection box 22 which serves as a reservoir for receiving the infusion liquid. The whole is inserted into the catheter. Two circular threads of the stopper 16 permit its adjustment inside the catheter. A sleeve 26 (different from the fixing sleeve 14), with a conical internal profile permits the strong tightening of the box 22 inside the catheter, and to ensure in this manner the leak tightness of the assembly.

As shown on figure 3, the catheter according to the invention can consist of several lines or lumen permitting several infusions or independent manipulations. As in the case of a catheter with a single conduit, the catheter of figure 3 comprises a part 10 which is implanted in the body of the patient. A sleeve 14 permits penetration of the patient's skin. The catheter and in particular its part 10 comprise three conduits or lumen, the external part comprises three leak tight stoppers or septa 32 which are located at the ends ot the three external parts 34 which are the extension of the three catheter conduits. The three conduits being independent and equivalent to three catheters can have different diameters, which are appropriate to the infusion or to the manipulation one wishes to carry out through the septum at the end cf the said conduit.

Thus, on figure 3 it can be seen that one of the external parts has a greater diameter than the two other external parts and it is to be understood that the same applies to the correaponding septa.

It should be noted that the septa corresponding to different conduits can also be located in a single leak tight stopper of the same type as stopper 16 which is shown in figures 1 and 2.

Figure 4 represents a particular mode of execution of the invention. In effect, the catheter of figure 4 certainly contains an internal part 10 which is implanted in the body of the patient, a sleeve 14 for insertion through the skin and an external part provided with a leak tight stopper or septum at its end. But in this mode of execution one of the conduits (or lumen) of the catheter is used for holding one or more optical fibres 44. The optical fibres 44, which can be removable, make it possible to visualise, owing to an appropriate visualisation device (not shown), the vascular state of the patient, to pin point a thrombosis, or they can be used for the transmission of signals to/or to receive them from a control device which is located at the distal end of the catheter. Another conduit or lumen can be used for holding two wires 46 which connect at the other end of the catheter to a sensor.

Such a sensor can, owing to an appropriate surveillance device, serve for the measurement or analysis of certain physiological constituents such as the oxygen content in the blood, the calcium content...

An example of execution of a catheter with two conduits is shown on figure 5. One of the conduits terminates, at its external end at the patient, at the outlet of sleeve 14, in a self-sealing septum 50. A second conduit containing optical fibres ends in a connecting piece 52 which lets the connection 54 of the optical fibres of the conduit appear. An enlargement of the cross section of the distal end 56 of the catheter is also shown on figure As can be seen, the conduit intended for injection of the pharmaceutical drug into the body of the patient comprises an opening 58 for the flow of the substance. The second conduit, which is separated from the first, contains one or more optical fibres which are directly connected to a device 62 which contains a photovoltaic cell of the gallium arsenide type and a miniaturised light source, a device which is in its turn connected to a sensor 64 of the piezo-electric type. The energy supply for the device 62 and for the sensor 64 can thus be produced by illuminating the photovoltaic cell, by way to the optical fibres. The signals supplied by the sensor 64 are transformed into optical signals and transmitted by the optical fibres to the end where they are collected and analysed in a manner so as to modify the parameters of the infusion if it so happens.

Although a sleeve is used in the mode of execution preferred in the invention, it is possible to conceive a catheter which does not contain a sleeve without leaving the framework of the invention.

It should be noted that during the time an infusion is administered to the patient, the infusion line is connected to the catheter during for a certain time. Because of this fact it is advisable to provide a blocking off device for the connection (not shown on the figures) of the external part of the catheter to the infusion line.

The catheter according to the invention can be used for any pharmaceutical drug infusion or not, as well as for sampling a human body fluid or for carrying out any examination or any appropriate manipulation. It combines the advantages of the implantable access site and of the external catheter without having their disadvantages.

Thus, its leakproof access, even during the process of connection to an infusion line, minimises the infection risks. This advantage is besides reinforced of a interdermal puncture.

An extravasation is very improbable owing to an easy and assured connection between the catheter and the infusion line. Furthermore, the septum pesents no difficulty in being located and then pricked.

Many advantages derive from the present invention, such as: the possibility of discovering any leak appearing at the connection, which minimises the damage inflicted on the patient, the absence of intradermal puncture constitutes an advantage for certain patients whom punctures cause anxiety, a possible occlusion of the catheter (thrombosis, precipitation,...) can be eliminated by the introduction of a stylus, chuck or other device appropriate to the interior of the catheter, through the septum or after removal of the septum.

The septum can be replaced in case of damage without having to have recourse to a surgical intervention, while leaving the catheter in place.

Claims (11)

1. External catheter, comprising an internal part which can be implanted into the body of the patient and a part external to the patient through which a needle or other instrument can penetrate permitting the administration of an infusion, sample taking or any other appropriate manipulation, characterised in that the said external part is provided at its fee end with at least one self sealing septum, which is made of a material which can be penetrated in a leakproof manner by the said instrument, as well as an operation in which the said instrument is located permanently in the said septum, and i~ an operation in which the said septum is penetrated repeatedly and frequently by the said instrument.

2. Catheter according to claim 1, characterised in that the said catheter is provided V. Whtc.IA ax-k'O'S tV%"tng with a fixing sleeve the skin of the patient.

3. Cahee A 3. Catheter according to claims 1 or 2 characterised in that it comprises several conduits, each terminating at its part outside the patient, in a septum which can be penetrated in a leakproof manner by an infusion needle.

4. Catheter according to claims 1 or 2, characterised in that it contains several conduits connecte4 to a single leakproof stopper, in which each of the said conduits is closed off by a septum.

5. Catheter according to any one of claims 1,2,3 or 4, characterised in that the septum, being located at the external end of the catheter or of each of the conduits, can be taken to pieces so that it can be replaced after the said septum has been considered unfit for further service.

6. Catheter according to any of the preceding claims, characterised in that it is equipped with optical fibres which permit the visualisation of the vascular system of the patient.

7. Catheter according to claim 6, characterised in that the said optical fibres are removable.

8. Catheter according to any of the preceding claims, characterised in that it comprises in the said part which is implanted in the body of the patient, at least one piezo-electric sensor which is connected to the part external to the patient by optical jA -8- fibres which are intended to transmit the signals supplied by the said sensor by way of a miniaturised optical signal generating device.

9. Catheter according to any of the preceding claims, characterised in that it comprises in the said part. which is implanted in the body of the patient, at least one sensor connected to the said part by means of conducting wires.

Catheter according to claim 9, characterised in that the said sensor is removable.

11. A catheter substantially as hereinbefore described as illustrated in any one of the figures. iS DATED: 21 February, 1996 PHILLIPS ORMONDE FITZPATRICK Attorneys for: CHRONOTEC S.A.R.L. lI1A c NRAL JDEEEP279.O MR -~s