AU668182B2 - Infusion system having a multi-chamber implantable access device - Google Patents

Abstract

A perfusion system comprising an implantable access device with two separate chambers (10, 12) accessed via a septum (16, 18), said chambers being arranged one above the other so that when the infusion or sampling needle is inserted into the lower chamber (10) by passing it through the respective septum (16), said needle also passes through the septum (18) of the upper chamber (12). The system further comprises an infusion device consisting of two rigidly connected parallel needles (36, 38) having different lengths, such that when the longer needle (38) is inserted into the lower chamber, the shorter needle (36) is also inserted into the other chamber. The infusion device with two rigidly connected needles avoids any danger of tearing which may lead to extravasation.

Description

OI DATE 29/11/93 APPLN. ID 42645/93 AOJP DATE 10/02/94 PCT NUMBER PCT/FR93/00415 DEi (51) Classlflcation Internationale des brevets A61M 39/02 lNurnkto de Publication Internationale; N'/O 93/21 988 (43 Date do publication Internationale, I I novembre 1993 (11 11.93) (21) Num6ra o la I deniando Internationale., PCT/FR93 f004I1 (22) Date dIc dkp~t International: 28 avril 1993 (28.04.93) (81) Etats d~slgn~s: AU, CA, J 11 NO. US, brevet curopeen (AT, BE1, CHI, DEi, DK, ES, FR, G11, GR, IF, IT, LU, MC, NL, IT, SQ).

l'ubit.0 Arec rapport die rchewrdc inirnationale.

Donn~es relatives A to prlorih6: 92/05311 29 avril 1992 (29.04.92) FR (7 1) Dt-posant (pour tostv k's Emas dWsign~s satif USI: CH RONO.

TEC SA.R.L. [FR/FRI; 1499, chemin dIc S.-Maymes, F.

06600 Antibes (17R), (72) Inventcur;, et Inventeur/D~posant (US scukenent) :HAUSER, lean-Luc [FR/FR]; 1499, chemnin doc S.-Maymes, F-06600 Antibes

(FR).

(74) Nlnndatalrc: BONNEAU, G6rard-; Les Laundcrs, 6, avenue des Algies, P.06600 Antibes (FR).

668182 (54)TMtle: INFUSION SYSTEM HAVING A MULTI-CHAMBER IMPLANTABLE ACCESS DEVICE (54)Tltre: SYSTEME DE PERFUSION A DISPOSITIF D'ACCES IMPLANTABLE MULTICHAMBRE (57) Abstract3 A perfusion system comprising an implantable acccss device with two separate chambers (10, 12) accessed via a septum (16, 18), said chambers being arranged one above the other so that when the infusion or sampling needle is inserted into the lower chamber (10) by 3 4 passing it through the respective septum said needle also passes through the septum (18) of the upper chamber The system further comprises an infusion device con. 36'=03 sisting of two rigidly connected parallel needles (36, 38) having different lengths, such that when the longer needle (38) is inserted into the lowver chamber, the shorter needle8 (36) is also inserted into the other chamber. The infusion 3 device with two rigidly connected needles avoids any danger of tearing which may lead to extravasation.

(57) Abrkg6 L'invention concerne un syst~me de perfusion comportant un dispositir d'acc~s implantable comprenant deux chambres ind~pendantes (10, 12) dont l'acc~s se fait par un septum (16, 18), les chatnbres 6tant superpos~es de sorte que lors de l'acc~s 6i la chambre inr~rieure (10) apr~s travers6e du septum associ6 l'aiguille de perfusion ou pr~1~vement traverse 6galement le septum (18) de la chambre sup~rieure et un dispositif de perfusion compos6 de deux aiguilles (36, 38) solidaires, paral1~les, de longucur diff~rente de mani~re 5 cc que 1'acc~s A Ia chainbre inf~rieure par 1'aiguille la plus longue (38) entraine l'a=8~ Ai lautre chambre par l'aiguille la plus courte Le dispositif dec perfusion Ai deux aiguilles solidaires emp~che tout risque d'arrachemcnt pouvant entrainer une extravasation.

if 1 !i Znfusa n system with a multi-chamber implantable access I device '9 5,9 Field of the invention:.

An infusion system with a multi-chamber implantable i' access device which may be implanted in an accessible Ssubcutaneous zone of a patient's body so as to form an access site for the infusion of pharmaceutical drugs or Sfor the sampling of physiological liquid from the patient's I body.

Description of prior art: i The recent technique of implanting access sites, usually during an operation under local anesthetic, consists of placing a chamber under the subcutaneous tissue so that it is accessible through the skin; said chamber is Sconnected to a catheter which releases a substance directly into the body area concerned. Access sites may remain in the patient's body for long periods of time and peimit elimination of repeated intravenous, intra-arterial, i ntraspinal, into the cerebral ventricle or intraperitoneal injections in that they may be replaced SI with simple subcutaneous injections.

The access sites are preferably formed by a chamber accessed via a thick membrane or septum through which an infusion needle is inserted. The septum is self-repairing, i.e. the substance it is made of, silicone for example, Scloses together as soon as the infusion needle is withdrawn so that the chamber remains sealed.

i The above technique has been improved by the use of Saccess sites comprising two septa. Indeed, it is sometimes necessary to simultaneously carry out two infusions using two immiscible pharmaceutical drugs. In order to do .this, we had the idea of implanting an access site comprising two chambers placed side by side which lead into two ducts or tubes in the catheter. This type of access site may also be used to simultaneously carry out an infusion through one septum and a sampling of physiological liquid through the other septum, be it because said sampling is to be used for tests or because it is necessary to take certain physiological measures while carrying out the infusion. Whether the aim is that of .examination or analysis, maximum use is made of the installed catheter rather than taking sample through intravenous, intraarterial, intraspinal or other channels.

However, the disadvantage of the double septum access site as described above lies fn the substantial size of the device as a result of the juxtaposition of the chambers.

Implantation requires a relatively large surface, thus a larger subcutaneous pocket, which may lead to complications such as higher risks of infection, not to mention a rather large scar as a wider cut has to be made in the epidermis..

This is why double septum access sites now exist comprising two chambers arranged one above the other as described in patents US-A-4.705.501, WO-A-89/10149 and WO-A-89/10157. But.said devices have the disadvantage of using either two separate needles, or one needle with two lumina.

Indeed, the major disadvantage of two separate needles, apart from the danger of one of the needles moving and coming out during infusion (extravasation), as well as the dangers of subcutaneous leaks which may result from this, lies in the fact that the needle which must reach the lower septummay not be sufficiently inserted. In this event, the two medications to be infused will mix and there is a risk of reaction or incompatibility between them thus putting the patient in danger,or, in the case of sampling carried out simultaneously with infusion, the infusion S medication and the physioligical liquid sample will mix.

The use of a single needle comprising two lunina.

.combines both disadvantages mentioned above, namely the risk of extravasation due to the needle inopportunely 1' I r 3 Scoming out as well as a mixing of the liquids in the chambers caused by such during infusion.

ii SSUMMARY OF THE INVENTION 5 The purpose of the invention therefore is to remedy the above two disadvantages with the aid of a multi-chamber implantable access device which poses no more problems when .I|i [implanted than a single chamber access device.

S 10 Another of the invention's aims is to 'proyide an implantable access device with several chambers placed one above the other combined with an infusion device with several rigidly connected needles which avoids any danger of the needles coming out and causing extravasation.

S 15 The invention consists therefore of an infusion system Sin which the infusion device comprises a number f needles corresponding to the humber of chambers in the access device, the needles being rigidly connected, parallel, placed next to one another and of different lengths, so that when the longest needle is inserted into the lower chamber, each of the other needles is also respectively inserted into the other chambers.

BRIEF DESCRIPTION The aims, objects and characteristics of the invention will be better understood upon reading, the following S description given with references to diagrams in which figure 1 represents a cross-section of a double chamber access device according to the invention, figure 2 represents a device with two needles for S infusion or 'sampling used jointly with the access device illustrated in figure i.

DETAILED DESCRIPTION The device represented in figure 1 is an access device with two chambers according to ofie preferred embodiment of the invention. Said device or access site, generally implanted under the patient's skin during an operation under local anesthetic, has two chambers 10 and 12 arranged one above" the other in a structure 14, preferably made of plastic. The lower chamber 10 is closed off by a thick membrane or septum 16, and the upper chamber 12 is closed off by a thick membrane or .septum 18. The access site is connected to a catheter 20 which is also in the patient's body, by ducts 22 and 24 opening respectively into the lower chamber 10 and the upper chamber 12. The two ducts 22 and 24 are continued into the catheter 20 by two Snon-communicating tubes.

Each septum, 16 or 18, is self-7repairing i.e. after having been penetrated by an infusion or sampling needle, it reseals itself once the needle' is withdrawn. Said property of the septum, which is well known in the profession, enables each chamber to remain impervious and thus avoids the mixing of pharmaceutical drugs in the chambers after infusion or during sampling.

Although figure I represents a preferred embodiment of the invention it is clear that different modifications may be made to it without going outside the scope of the invention. Thus, even if the existence of two chambers constitutes the preferred embodiment, three or more chambers arranged one above the other may be envisaged, or two groups placed side by side of two (or more) chambers arranged one above the other, or two chambers arranged one above the other and placed side by side to one single chamber. Said formations, known .to the professional, have not been represented in the drawings. In the same way, although the chambers represented in figure 1 have a constant depth, chambers with variable depths may be envisaged, thus sloping the access site (from left to right in figure 1) towards the catheter.

4I Figure 2 shows the multi-needle device which is specifically usable with the access device illustrated in figure 1. Said device comprises a rigid frame preferably in metal, containing two ducts one of which is connected to an infusion or sampling tube via an access outlet 32; and the other is connected to another infusion or sampling tube via access outlet 34. The rigid frame is curved to 90% at the other end which is extended by two needles 36 and 38 respectively connected to access outlets 32 'and 34.

With the frame 30, the two needles 36 and 38 form an interdependent unit. They are preferably parallel, approximately 3 to 5 mm apart and of different lengths.

They could equally be wider apart for insertion into chambers placed side by side. Needle 36 is shorter than needle 38 so that when the needles are inserted into the access site in figure 1, the longer needle 38 passes through the septum 16 and its point enters chamber 10 while the shorter needle 36 passes through septum 18 and its point enters chamber 12. In this way, two infusions may be made simultaneously, for example, for the simultaneous injection of two immiscible substances. The device in figure 2 may also be used to take two simultaneous *samplings, and especially to take a sample of physiological liquid 'for analysis or examination via one of the two chambers, while an infusion is carried out via the other chamber.

The main advantage of an infusion system with a multichamber access device and a multi-needle device as in this invention, is due to the presence of two (or several) rigidly connected needles combined with the 'fact that the longer needle passes through both septa in order to enter S* the lower chamber. Indeed, a septum made of plastic such as silicone exerts a certain pressure around the needle.

-However, with the access sites of the earlier technique using either two separate needles or one single needle with two tubes, lateral movement of the needle is always possible with a risk of resulting extravasation. By contrast, the infusion device with two needles shown in figure 2 is held in position by the forces of friction exerted on each of the needles (the longer needle is held not only at the end but also in the middle where it passes through the septum of the upper chamber), so avoiding any possible displacemeit of the two needles. Said support is due to greater forces of friction and is reinforced by the impossibility of rotation by.'the needles which often leads to extravasation in devices using the former technique.

Although the invention is described in reference to an/ embodiment in which the device is implanted in the patient's body, it is evident that the principles of the invention are equally applicable to an external catheter.

Claims (5)

1. Infusion system including a multi-chamber access device implantable in the human body so that an infusion, sampling or any other appropriate intervention by means of an infusion device with needles may be carried out, said multi-chamber access device including a number of independent chambers arranged one above the other, each chamber being accessed via a septum; wherein said infusion device incudes a number of needles corresponding to said number of chambers in the access device, said needles being rigidly connected, parallel, next to one another and of different lengths so that when the longest needle is inserted through each above chamber of the multi-chamber access device into the lowermost chamber, each of the other needles is also respectively inserted into the other chambers.

2. Infusion system according to claim 1, wherein the access device includes two initial chambers arranged one on top of the other.

3. infusion system according to claim 2, wherein the access device includes two further chambers arranged one on top of the other and placed side by side to said initial two chambers.

4. Infusion system according to claim 2, wherein the access device includes a chamber placed side by side to said initial two chambers. 20

5. Infusion system substantially as herein described with reference to the accompanying drawings. DATED 15 February, 1996 PHILLIPS ORMONDE FITZPATRICK 25 Attorneys for: CHRONOTEC S.A.R.L. .9* iO•• •0