WO1999021606A1

WO1999021606A1 - Tube device and use thereof

Info

Publication number: WO1999021606A1
Application number: PCT/SE1998/001926
Authority: WO
Inventors: Elisabeth Svanberg; Kent Lundholm; Mats Asztely
Original assignee: A+ Science Invest Ab
Priority date: 1997-10-28
Filing date: 1998-10-26
Publication date: 1999-05-06
Also published as: AU9770698A; SE9703925D0

Abstract

The invention concerns a tube device designed to be inserted into human tissue, said device comprising a tube (1) and a stop means (3) arranged to releasably engage the surrounding tissue once the tube device is inserted into said tissue. The tube in accordance with the invention preferably is a dialysis tube having a dialysis membrane (2) at the end thereof intended to be placed in the body tissue. Preferably, the stop means (3) consists of at least one barb (3', 3'). The tube device also may comprise pulling means (4) for retraction of the tube from the body tissue. The invention also concerns the use of a tube device as defined above for insertion of drugs into and/or withdrawal of samples from the body tissue, above all for the introduction of cytotoxic drugs or other drugs directly into a limited area, such as a tumour.

Description

TUBE DEVICE AND USE THEREOF

Field of the invention

The present invention relates to a tube device designed to be inserted into human or animal body tissue, especially into parenchymatous organs, and to use of such a tube device, especially for treatment of tumours.

Background of the invention At present, various tumour treatment methods exist. For example, the tumour may be removed surgically. Above all in the case of cancer of the liver, transplantation is also a possible remedy, which is employed for large localised tumours, as is also injection of alcohol, using a thin needle which is inserted straight into the tumour. In accordance with prior-art technology cytotoxic drugs are used in many cases. Such cytotoxic drugs are often necessary in the treatment of tumours but unfortunately they also frequently have undesired side-effects, among them a negative effect on the patient' s immunologi- cal defence. In order to reduce such harmful and unde- sired side-effects one is often forced to using low doses of the administered cytotoxic drug, with consequential less efficient treatment results than desired, or to prolonging the treatment over extended periods.

In the case of liver tumours another technique is used today according to which the cytotoxic drug is administered surgically directly into the affected liver. Although this method reduces the harmful side-effects it may cause liver damage to the patient. Furthermore, this surgical operation is expensive and complicated, and the patient must be anaesthetised during this quite serious operation.

Available on the market are tubes known as dialysis tubes comprising a dialysis membrane at one of its ends, as do for example the tubes manufactured by CMA Mi- crodialysis, Stockholm, Sweden. Presently, these tubes are used mainly in connection with various types of adipose tissue. They cannot be used for example for introducing drugs into various types of tissue in the abdomen, because the patient's breathing and other motions cause ejection of these prior-art dialysis tubes.

Catheters for different purposes have been described earlier, and also catheters which may be anchored once in place in the body. The design of such catheters vary de- pending on their intended use. For example US 5,267,960 and US 3,938,529 describe catheters that are intended for placement in hollow organs surrounded by muscles; trachea in US 5,267,960 and ureter in US 3,938,529. The catheters described herein are relatively hard and stiff. They can not be used for placement in parenchymatous organs, such as liver and kidney, since these catheters, and especially their anchoring means, would cause extensive and serious damage to the organ tissue. However, they are suitable for use in hollow, muscle surrounded organs since this type of organs are much more resistant to violence .

Summary of the invention The object of the invention is thus to provide a tube device suitable for use in parenchymatous organs. Said tube device should further comprise means for anchorage of the device when it is in position in a parenchymatous organ; said anchorage means should, however, not prevent removal of the device from the organ. Thus, the present invention relates to a tube device intended for insertion into body tissue, especially into a parenchymatous organ, characterised in that it comprises a tube and a stop means which is attached to the tube and which is arranged to releasably engage the sur- rounding tissue once the tube device is inserted into said tissue. The invention also relates to the use of such a tube device for introducing drugs into and/or withdrawing samples from body tissue, especially parenchymatous organs. The tube device in accordance with the present in- vention could be regarded as a modification of a dialysis tube .

Generally speaking, a dialysis tube is one tube placed inside another. Both tubes terminate at one end in a dialysis membrane common to both. The substance to be administered is introduced into one of the tubes, passes through the dialysis membrane and further into the surrounding tissue. The other tube is used for withdrawal of body fluids, allowing the content therein of the administered substance to be measured and thus making it possi- ble to establish the amounts of the substance that the patient has received.

With the aid of the tube device in accordance with the invention it is e.g. possible to introduce a cytotoxic drug or some other drug directly into a limited area, such as a tumour or a cancerous cell, without affecting surrounding tissue or normal cells.

By the expression "tube device" should be understood both in the description and in the claims a device of a tube-like or tubular configuration. By the expression "body tissue" is to be understood all types of tissue in the human or animal body.

By the expression "stop means" should be understood all types of means able to maintain the tube device in the correct position once the latter is placed in the body tissue.

By the expression "releasably" should be understood that the restraining force of the stop means can be overcome when the tube device is to be removed from the body tissue . The tube in accordance with the invention preferably is configured as a dialysis tube. Furthermore, it should be appreciated that the tube as also the stop means pref- erably are made from one or several biocompatible materials, i.e. materials that are suitable for introduction in human or animal body tissue. Suitable materials for this purpose are different types of biocompatible plastics ma- terials, such as polyethylene or polyurethane .

The stop means is configured so as not to obstruct the introduction of the tube into the patient's body but, once the tube is in position, to prevent the tube from being dislodged unintentionally, either by falling out of or being ejected from the body tissue. It is suitable to configure the stop means in such a manner that it may be compressed while being introduced into the body tissue to thereafter expand when the device is in position and again be compressed when the tube device is to be removed from the body. This feature may be obtained for instance by using a stop means which is spring-biased in the direction away from the tube.

Preferably, the stop means is in the form of at least one barb, preferably 2-3 barbs and most preferably 2 barbs. The barb/barbs preferably are made from stainless steel. Should a barb made from such steel for any reason separate from the tube while the latter is in situ in the patient, this causes the patient no harm, nor is it necessary to remove the barb.

The barbs are provided on the tube in such a manner as to be movable at least in a plane coinciding with the tube and the barbs. The movability may be achieved e.g. by means of different types of articulated joints or hinges. If the barbs, as is preferred, are formed by thin stainless steel wires, no separate articulation means need to be provided, since the material as such is sufficiently pliable to provide the desired movability.

Obviously, the stop means preferably is arranged on the part of the tube device which, when in use, will be positioned inside the body tissue in question. Furthermore, the tube in accordance with the invention preferably comprises pulling means intended to facilitate withdrawal of the tube from the body tissue and from the patient's body. These means could consist e.g. of at least one steel wire suture which is attached to the tube and/or to the stop means in any suitable manner, for instance by being glued and/or tied thereto.

The tube in accordance with the invention may be introduced into the patient' s body via a simple incision, made in the patient's body under local anaesthetic. Thus, in the treatment of liver tumours this is a considerable advantage over the comparable prior-art technique according to which cytotoxic drugs were administered in connection with surgical operations, necessitating anaesthetis- ing the patient. In addition, the tube can be left inside the patient for a long period of time, up to a week or more, and consequently drugs may be administered continuously or discontinuously to the area in question for prolonged periods, which for obvious reasons is not possible when the above-mentioned surgical method is used.

The tube in accordance with the invention is inserted with the aid of conventional so called introduces, i.e. insertion sleeves for angiography, well known in the technical field concerned. In order to allow the end of the tube to be placed in the area to which one wishes to administer the drug in question it is possible to employ the technique used for PTC (percutaneous trans-hepatic cholangiography) , which is an established method in in- terventional radiology. It is likewise possible to introduce more than one tube into the patient. For instance, one tube may be placed in the area or in the tumour to be treated, and another tube externally thereof, in healthy tissue. By means of the second tube the content of the drug in the healthy area may be measured, and consequently any leakage from the area to be treated may be minimised as may also possible negative side-effects. Local anaesthetics are not even necessary when the tube is to be withdrawn from the patient. It is sufficient to exert a pulling force of a certain magnitude on the tube, or preferably on the pulling means provided to facilitate removal of the tube from the patient's body.

The tube device in accordance with the invention may be used for treatment of and interventions in diseases affecting for example the liver, kidneys, muscles and osseous tissue. Furthermore, the tube device in accordance with the invention may be used in other contexts where one wishes to retain a tube-like or tubular device in body tissue over a prolonged period.

Brief description of the drawings:

The invention will be described in closer detail in the following by way of a preferred embodiment thereof and with reference to the accompanying drawings, wherein: Fig. 1 illustrates a preferred embodiment of the tube device in accordance with the invention;

Fig. 2 illustrates the tube device of Fig. 1 placed in the liver of a patient;

Fig. 3 illustrates the manner of removal of the tube device of Fig. 2 from the patient.

Detailed description of preferred embodiments The preferred embodiment of the tube device in accordance with the present invention comprises a dialysis tube 1 one end of which is provided with a dialysis mem- brane 2. The tube device also comprises stop means 3, consisting of two steel-wire barbs 3', 3". In order to facilitate the manufacture, the steel-wire barbs 3' , 3" may be formed from one single steel wire bent to the form of an M-shaped spring wire. The wire may be attached to the tube in the following manner: the spring wire is fixed to the tube and a drop of glue is applied, when the glue has spread over the surface a hardener is applied on top of the glue surface, and finally the front part of the tube device is rinsed in hot water. The preferred embodiment also includes pulling means 4 consisting of at least one and preferably two long stainless steel wire sutures 4', 4" the function of which is to facilitate removal of the tube device from out of the patient's body. The steel wire sutures 4', 4" preferably are attached to the stop means 3, and consequently, in addition to facilitating removal of the device from the patient, the sutures also contribute to lowering the risk that the stop means 3 separate from the tube 1 during removal of the tube device. When the stop means consists of an reshaped spring wire as indicated above the steel wire suture preferably is passed through he centre loop of the spring wire and glued to the tube together with the spring wire.

The tube is made from a very soft material and consequently a condition for successful introduction thereof into the organ in question is that a path is created by the insertion of an introducer sleeve.

When the tube is inserted into a patient' s body the barbs 3' , 3" are directed rearwards relative to the direction of insertion. They are also compressed somewhat owing to the pressure exerted on the barbs by the sur- rounding tissue and therefore they do not impede the insertion of the tube device.

Once the tube device is in position inside the patient and the introducer sleeve has been retracted, which is the situation illustrated in Fig. 2 wherein the tissue in question is a liver 5, the barbs 3' , 3" will again flex somewhat outwards. The ends 3a, 3b of the barbs then will abut against the liver tissue and in doing so oppose ejection tendencies that might arise due to the pressure generated by the patient's movements and breathing. As the tube is pulled outwards by a millimetre or two with the aid of the pulling means, the barbs flex further outwards, thus securing the anchorage?. The dialysis mem- brane 2 at one end of the tube device is positioned in accordance with the exemplary embodiment inside a tumour 6 to be treated by e.g. cytotoxic drugs. The opposite end of the tube device, comprising two tube end pieces 1' and 1", are positioned externally of the patient's body as are also the pulling means 4 that are provided for the purpose of facilitating the removal of the tube from the patient, once the treatment is completed. The cytotoxic drug to be administered may be introduced through one tube end piece 1' while fluid samples are withdrawn for analysis through the other piece 1".

In order to establish communication between the outside and the dialysis membrane it is necessary to withdraw the rigid introducer sleeve from out of the body. The lengths of the tube device and of the introducer, respectively, must be chosen to make such withdrawal possible. The removal of the introducer may be facilitated by the use of an introducer of so called peel-sheet type, i.e. an introducer that is peeled off as it is being pulled out.

Once the treatment is completed, which depending on the clinical picture may vary from between some hours to several days, the tube is removed in response to a pull exerted on the steel wire sutures 4', 4". This situation is illustrated in Fig. 3, according to which the tube device is removed from the patient when a pulling force is exerted in the direction of the arrow. In response to a pulling force exerted on the steel wire sutures 4', 4" and/or on the tube 1, the barbs 3' , 3" will be forced by the surrounding tissue to pivot rearwards relative to the direction of movement of the tube device, and consequently they will no longer obstruct removal thereof.

As examples of suitable dimensions of a tube device of a preferred type, for example the one illustrated in Fig. 1, for treatment of liver tumours, the following may be mentioned, viz.: length of tube about 5 - 8 cm, length of dialysis membrane about 1-3 cm, length of barbs about 2-3 cm, barb diameter about 0.2 mm, length of steel wire sutures serving as pulling means, about 6 - 8 cm and diameter thereof about 0.08 mm.

Claims

1. A tube device intended for insertion into body tissue, characterised in that it comprises a tube (1) and a stop means (3) which is attached to the tube and which is arranged to releasably engage the surrounding tissue once the tube device is inserted into said tissue.

2. A tube device according to claim 1, wherein said body tissue is a parenchymatous organ.

3. A tube device according to claim 1 or 2, made from a flexible material.

4. A tube device according to any one of the claims 1-3, made from a material of a biocompatible type.

5. A tube device according to any one of the claims 1-4, wherein said tube (1) is configured as a dialysis tube .

6. A tube device according to any one of the claims 1-5, wherein said stop means (3) is biased in the direction away from the tube.

7. A tube device according to any one of the claims 1-6, wherein said stop means (3) is configured as at least one barb (3', 3") which is arranged on the tube (1) so as to be movable at least in a plane coinciding with the tube (1) and the barb (3', 3").

8. A tube device according to claim 7, wherein said stop means (3) is configured as two barbs (3', 3") .

9. A tube device according to any one of the claims 7-8, wherein said barb/barbs (3', 3") is/are made from stainless steel.

10. A tube device according to any one of the claims 1-9, wherein said stop means (3) is arranged on the part of the tube (1) that is intended to be placed in the body tissue .

11. A tube device according to any one of the claims 1-10, further comprising pulling means (4) attached adjacent the stop means (3) and serving to withdraw the tube from the body tissue.

12. A tube device according to claim 11, wherein said pulling means (4) consist of at least one steel wire suture (4' , 4") .

13. Use of a tube device according to any one of the claims 1-12 for introducing drugs into and/or withdrawing samples from the body tissue.

14. Use according to claim 13 for the treatment of tumours .

15. Use according to claim 14, wherein said tumour is a tumour in a parenchymatous organ.

16. Use according to claim 15, wherein said organ is the liver.