EP1648549A1 - Catheter pour traitement cerebral au moyen de substances radioactives - Google Patents

Catheter pour traitement cerebral au moyen de substances radioactives

Info

Publication number
EP1648549A1
EP1648549A1 EP03817747A EP03817747A EP1648549A1 EP 1648549 A1 EP1648549 A1 EP 1648549A1 EP 03817747 A EP03817747 A EP 03817747A EP 03817747 A EP03817747 A EP 03817747A EP 1648549 A1 EP1648549 A1 EP 1648549A1
Authority
EP
European Patent Office
Prior art keywords
catheter
internal
external
balloon
treatment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03817747A
Other languages
German (de)
English (en)
Inventor
Arturo Chiti
Paolo Gaetani
Riccardo Rodriguez Y Baena
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Humanitas Mirasole SpA
Original Assignee
Humanitas Mirasole SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Humanitas Mirasole SpA filed Critical Humanitas Mirasole SpA
Publication of EP1648549A1 publication Critical patent/EP1648549A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014—Intracavitary radiation therapy
    • A61N5/1015—Treatment of resected cavities created by surgery, e.g. lumpectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019—Sources therefor
    • A61N2005/1021—Radioactive fluid

Definitions

  • the present finding relates to a catheter for cerebral treatment with radioactive substances and a method for cerebral treatment with radioactive therapeutic substances employing said catheter.
  • the finding relates to a catheter insertable at the level of the encephalon in places where there have been, even partial, neoplasia removals.
  • catheters used during surgical therapy to deliver drugs locally or to drain areas of the human body of liquids or unwanted secretions are known.
  • a particular type of catheter is represented by catheters which are used at the level of the encephalon following tumour removal operations .
  • a catheter is inserted into the cavity which forms following said removal, directly into the partially removed neoplasia.
  • the catheter will then be filled with a pharmacological substance such as for example a radiodrug or a chemotherapeutic agent, so as to allow local treatment, particularly targeted to the area attacked by the tumour.
  • This area can in fact contain residual tumour cells despite the removal of the tumour mass itself, which can give rise to new malignant proliferation.
  • the U.S. patent US 5,429,582 describes a catheter of the type just indicated in which an inflatable balloon is inserted into a cavity in the encephalon created by the removal of a tumour mass and is connected through a tube to a reservoir implanted subcutaneously in the patients head. Following the filling of the reservoir with a syringe containing a treatment liquid, the balloon connected thereto is inflated until its external wall adheres to the wall of said cavity.
  • the catheter can comprise a dual walled balloon which delimits an internal chamber and an external chamber connected to respective tubes and subcutaneous reservoirs.
  • the innermost balloon is filled with a radioactive treatment substance, whilst the outermost balloon is filled with a chemotherapeutic agent which can permeate through the membrane of the corresponding balloon to come into direct contact with the cerebral matter to be treated.
  • a catheter for cerebral infusion such as that just described however has some drawbacks.
  • the problem at the heart of the present invention is therefore that of devising a catheter for cerebral treatment which allows the treatment of cerebral areas from which a tumour, or part of it, has been removed with radioactive substances, in a safe and functional manner.
  • a catheter for cerebral treatment as stated in the independent claim which allows overcoming the above mentioned known art drawbacks and satisfies the needs just set out.
  • Figure 1 represents a schematic plan and sectional view of a catheter for cerebral treatment according to the invention
  • Figure 2 represents a schematic view of a partial section of the cranium of a patient with the catheter of figure 1 inserted therein
  • Figure 3 represents a schematic view of a partial section of the cranium of a patient, with the catheter of figure 1 in operative conditions, inserted therein.
  • the catheter 1 comprises a proximal section 2, an intermediate section 3, having a substantially cylindrical shape, and a distal section 4 having a substantially balloon-like shape.
  • the proximal section 2 consists of two hollow cylinder coaxially arranged one around the other, so as to form two portions of two internal 5 and external 6 tubes having their respective lumens 7 and 8 open.
  • the external tube 6 can be provided with a flange (not shown in the figures) turned towards the exterior of its lumen 8 having the function of allowing easy anchorage of the entire catheter 1 onto the skin on the cranium of the patient.
  • said flange will allow easy gripping for the extraction of the catheter 1 once the treatment has finished, as will be better described below.
  • the proximal portion 2 further comprises a non return valve 9 located within the lumen 7 of the internal tube 5.
  • the valve 9 is arranged in such a manner as to allow the admission of treatment fluid through the internal tubing 5 for example by means of a syringe 19 (shown schematically in figure 3) entirely conventional within the medical- surgical sector. Said valve 9 would prevent the treatment fluid from spontaneously discharging, or returning, once the syringe is retracted from the lumen 7.
  • the same valve 9 however allows for the emptying of the treatment substance, as will be described below.
  • the valve 9 can consist of a "duck bill" type valve.
  • the lumen 7 can be simply provided with a septum, consisting of a material known in the sector, which readily reseals following the extraction of a syringe needle introduced therethrough in order to inject the treatment substance.
  • the intermediate portion 3 constitutes a longitudinal extension of the proximal section 2 of the catheter 1 along the axis X-X. Consequently, the intermediate portion 3 comprises an internal tube and an external tube each of them being the extension of internal tube 5 and external tube 6 of the proximal portion 2.
  • the distal portion 4 has the appearance of a kind of sheath or bag comprising an internal balloon 10 enclosed within an external balloon 11.
  • the internal balloon 10 joins with the internal tube 5 of the proximal 2 and intermediate 3 portions so as to form an end container or chamber 12 and, hence, in such a way as to make the lumen 7 of said internal tube 5 communicate with said chamber 12 of said internal balloon 10.
  • the external balloon 11 joins with the external tube 6 so as to form an end chamber 13 and, hence, in such a way as to make the lumen 8 of said external tube 6 communicate with said chamber 13 of said external balloon 11.
  • the proximal 2 and intermediate 3 portions are made of a sufficiently rigid plastic material so as to not allow, above all, the lumen 7 of the internal tube 5 to collapse during the entire treatment period until the removal of the catheter 1 from the cranium of the patient .
  • the plastic material can be therefore any of the materials normally used in the sector for the manufacture of catheters, such as for example nylon, polyethylene, polyurethane, PET or the like.
  • the internal 10 and external 11 balloons are made of an elastic, or at least flexible, plastic material, since it must allow the expansion of the balloons following their filling up with air or treatment fluid and their return to the relaxed state following their emptying. Furthermore, it is fundamental that this material be impermeable to fluids and, in particular, to gas with reference to at least the external balloon 11.
  • the internal balloon 10 is filled with a radioactive treatment substance such as for example a radionuclide, generally in liquid solution. It is understood that such a substance must absolutely not be able to permeate out from the internal balloon 10. Consequently, its material must be impermeable to liquids, preferably also impermeable to gas.
  • the external balloon 11 must be made from a material that is also impermeable to gas in such a way as to create a safety cover around the internal balloon 10 which contains the treatment substance.
  • Materials which meet the above mentioned requirements can be for example latex, latex-similar, flexible siliconised plastic and the like.
  • the proximal 2 and intermediate 3 portions can have lengths between 10 cm and 20 cm, preferably the length is 11.5 cm, whilst the diameter of the internal lumen 7 and the external lumen 8 are between 1.5 mm and 3 mm and between 0.5 mm and 1 mm, respectively.
  • the external diameters of the internal 10 and external 11 balloons are between 0.5 cm and 4 cm, under filled conditions . [0019] .
  • the proximal portion 2 protrudes from the cranium of the patient once the catheter is inserted into the encephalon for therapeutic treatment of at least 2-3 cm in order to facilitate the operations of the admission of air to the inside of the external balloon 11 and the therapeutic substance to the inside of the internal balloon 10.
  • the proximal 2, intermediate 3 and distal 4 portions can be made in one piece creating a single unit with appropriate adaptations at the level of the tubes so as to avoid the collapse of the respective lumens.
  • said sections can be made of the same elastic plastic material in a single piece with the addition of sufficiently rigid sleeves applied to the walls of the lumens of the tubes so as to keep them open.
  • the materials can be sealingly joined together by for example, melting or gluing with biocompatible glues.
  • a cranioto y operation for the removal of neoplasia is carried out by firstly lifting an area 14 of the skin from the head of a patient and making a hole 18 in the bone of the cranium allowing access to the encephalon 15 at the level of the neoplasia (figure 2) . At this point the tumour mass is identified and removed which will leave a "virtual" cavity 16. This cavity may contain remains from tumour cells on its wall 17 which have not been removed together with the identified tumour mass or macroscopic residues of the partially removed neoplasia. Following this operation it is hence possible to insert a catheter 1, such as that described above for treating residual neoplasia, into the cavity.
  • the piston of the syringe 19 is left free to move outwards in such a manner that the syringe can act as a means of deflation for the air contained within the external balloon 11 and compressed by the expansion of the internal balloon 10.
  • said means of deflation can themselves be represented by a "duck bill" type valve having the respective laps arranged into a circular ring. In this manner, the air can be deflated by simply pressing on the external walls of the proximal portion 2. [0027] .
  • the internal balloon 10 is filled with a radionuclide suitable for such types of treatments, until its external wall come into contact with the internal wall of the external balloon 11.
  • the catheter 1 of the invention works through two chambers, one inside the other, which are inflated, in succession from the outer to the inner, with air and with a liquid solution containing a radionuclide, respectively, in such a away as to form a single dual walled chamber which substantially adheres to the internal wall of the cavity.
  • the treatment substance finds itself substantially in contact with the area to be treated thus favouring its effectiveness against the residual tumour cells.
  • the treatment substance, or the radionuclide finds itself inside an impermeable dual walled chamber. It is understood therefore that the catheter 1 according to the invention is much safer with respect to prior art catheters which use a radioactive substance as the treatment substance.
  • the syringes 19 and 20 are retracted from the respective tubes and the catheter 1 is fixed onto the skin of the patient through suture stitches at the level of the previously described flange.
  • the end of the proximal portion 4 can be closed with a suitable stopper.
  • the catheter described in said patent provides the use of a subcutaneous reservoir which serves as an intermediate between the operator and the balloon containing the treatment substance.
  • the operator is thus forced to act with extreme precision and control on the reservoir by means of a needle of a syringe.
  • the operator must first of all insert the needle underneath the skin of the patient in a very delicate manner to give as little discomfort as possible to the patient, and in addition, he must appreciate however that the subcutaneous reservoir has limited thickness.
  • the structure of the catheter in the U.S. patent is a rather complicated since it provides the above mentioned subcutaneous reservoirs, which are by no means necessary in the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un cathéter (1) à utiliser pour un traitement cérébral au moyen de substances thérapeutiques radioactives. Ce cathéter, comprend une partie proximale (2), une partie intermédiaire (3), laquelle partie distale (4) comprend elle-même un ballonnet intérieur (10) et un ballonnet extérieur (11). Ce cathéter se caractérise en ce que lesdits ballonnets intérieur (10) et extérieur (11) sont faits d'un matériau imperméable aux liquides. L'invention concerne également une méthode de traitement cérébral par des substances radioactives avec recours audit cathéter.
EP03817747A 2003-07-29 2003-07-29 Catheter pour traitement cerebral au moyen de substances radioactives Withdrawn EP1648549A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2003/000471 WO2005011793A1 (fr) 2003-07-29 2003-07-29 Catheter pour traitement cerebral au moyen de substances radioactives

Publications (1)

Publication Number Publication Date
EP1648549A1 true EP1648549A1 (fr) 2006-04-26

Family

ID=34113394

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03817747A Withdrawn EP1648549A1 (fr) 2003-07-29 2003-07-29 Catheter pour traitement cerebral au moyen de substances radioactives

Country Status (3)

Country Link
EP (1) EP1648549A1 (fr)
AU (1) AU2003253284A1 (fr)
WO (1) WO2005011793A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5429582A (en) * 1991-06-14 1995-07-04 Williams; Jeffery A. Tumor treatment
US5616114A (en) * 1994-12-08 1997-04-01 Neocardia, Llc. Intravascular radiotherapy employing a liquid-suspended source
US6149575A (en) * 1998-07-07 2000-11-21 World Medical Manufacturing Corporation Radiation delivery catheter
US7056274B2 (en) * 2001-07-13 2006-06-06 Apple Marc G Catheter with concentric balloons for radiogas delivery and booster radiosources for use therewith

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005011793A1 *

Also Published As

Publication number Publication date
AU2003253284A1 (en) 2005-02-15
WO2005011793A1 (fr) 2005-02-10

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