WO2010057934A1 - Cathéter flexible - Google Patents

Cathéter flexible Download PDF

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Publication number
WO2010057934A1
WO2010057934A1 PCT/EP2009/065419 EP2009065419W WO2010057934A1 WO 2010057934 A1 WO2010057934 A1 WO 2010057934A1 EP 2009065419 W EP2009065419 W EP 2009065419W WO 2010057934 A1 WO2010057934 A1 WO 2010057934A1
Authority
WO
WIPO (PCT)
Prior art keywords
tip
elongated body
catheter
flexible catheter
veins
Prior art date
Application number
PCT/EP2009/065419
Other languages
English (en)
Inventor
Rudi Devers
Original Assignee
F Care Systems
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 F Care Systems filed Critical F Care Systems
Priority to EP09759714A priority Critical patent/EP2367494A1/fr
Publication of WO2010057934A1 publication Critical patent/WO2010057934A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating

Definitions

  • the present invention relates to a flexible catheter for thermal coagulation of veins according to the preamble of the first claim.
  • Thermal coagulation is a technology for treating varicose veins based on thermal-based destruction of the veins.
  • catheters or needles are used to penetrate the veins and these catheters or needles are consequently heated by means of radiofrequency waves. The increase in temperature will make the vein coagulate after which the bleeding stops and the vein will finally disappear.
  • a very high radiofrequency energy pulse is delivered into the varicose vein via an ultra-fine needle with a diameter of 0.075 which is protected by a specific isolating layer. These needles are made of nickel. This set-up allows that an amount of energy is delivered where needed.
  • the elongated body is provided to be inserted in and coagulate veins having a diameter of between 1 - 4 mm.
  • the varicose vein is thermally coagulated surprisingly without damaging effects on the epidermis and surrounding tissue.
  • the inventor moreover found that the thermal coagulation-based therapy with the catheter according to the current invention can be performed all year round because the treated areas may, surprisingly, be exposed to the sun.
  • the comfort of the patient is much higher as it has been found that there is no need to ware supporting stockings after the treatment.
  • the success rate using the catheter of the current invention is higher than existing treatments for varicose veins between 1 - 4 mm.
  • a preferred embodiment is characterized in that the layer of insulating material, the insulating layer, along at least part of its length mainly consists of a single layer of insulating material.
  • the single insulating layer can be sufficient to shield the radiofrequency waves from the surrounding tissue during transport to the tip along the conductor and that the radiofrequency waves do not need to be shielded from the surrounding tissue or be transported back from the tip to the radiofrequency source by additional conductive layers surrounding the conductor.
  • the current invention also relates to a method for coagulating a vein having a diameter of between 1 - 4mm, preferably 1 - 3mm, using the flexible catheter according to the current invention by inserting the conductive tip of the flexible catheter according to present invention into the vein until the tip reaches the vein location which needs to be coagulated after which the vein is coagulated at the vein location at the tip by sending a radiofrequency signal along the conductor to the tip.
  • Figure 1 shows a first embodiment of the catheter according to the invention.
  • Figure 2 shows a different embodiment of the catheter according to the invention.
  • Figure 1 shows a flexible catheter for thermal coagulation of veins comprising an elongated body with a proximal end 1 and a distal end 2.
  • the distal end 2 of the elongated body comprises a tip 3 in a conductive material.
  • the elongated body further comprises a conductor 4 which makes contact with the tip and extends between the distal end 2 and the proximal
  • the outside of the elongated body is provided over at least part of its length, but not at the tip with a layer of insulating material 5.
  • the elongated body is provided to be inserted in and coagulate veins having a diameter of between 1 - 4 mm.
  • the tip 3 preferably is rounded, as for example shown in figure 2. This improves the gliding in the vein and avoids perforation of the vein wall by the catheter. However, the tip 3 can also be sharp, as for example shown in figure 1.
  • the tip 3 preferably is made from a conductive material which conducts radiofrequency waves and which heats up under influence of appropriate radiofrequency waves.
  • the conductive material is chosen from the group comprising nickel and gold.
  • the tip 3 is made from nickel.
  • the diameter of the tip 3 preferably ranges from 0,3 -
  • the diameter from the tip 3 ranges from 0,3 - 1 ,4 mm.
  • the length of the tip 3 ranges from 1 ,5 - 5 mm. Most preferably, the length of the tip 3 ranges from 2 - 4 mm.
  • the conductor 4 preferably comprises several twisted wires of a conductive material, as for example shown in figure 2.
  • the inventor has found that by increasing the number of twisted wires, while maintaining the diameter of the conductor 4 substantially the same, flexibility increases. Thus, in other words, the number of wires used, determines the flexibility of the catheter. Depending on the diameter of the catheter, between 4 and 10 wires are used.
  • the diameter of the tip 3 is larger than or, more preferably, substantially equal to the outer diameter of the part of the elongated boy comprising the conductor, more preferably, the outer diameter of the insulating layer 5, more preferably the single insulating layer, surrounding the conductor 4 so that the tip 3 and the insulating layer 5 can be substantially seamlessly inserted in the catheter.
  • This is for example illustrated in figures 1 and 2.
  • the conductor 4 preferably is made of a conductive material able to conduct radiofrequency waves.
  • the conductive material is chosen from the group comprising nickel, silver and gold. Most preferably, nickel is used. Nickel has the advantage being a good conductor for radiofrequency waves and having a good flexibility to generate the twisted wires used to make the conductor.
  • the layer of insulating material 5 next to substantially electrically isolating the conductor from the surrounding tissue preferably is also able to isolate against radiofrequency waves to prevent heating of tissue surrounding the conductor.
  • the layer of insulating material 5 preferably is made of polytetrafluoroethylene (PTFE), medical PTFE or another insulating material.
  • the layer of insulating material 5 preferably consists of a single layer of insulating material.
  • this single layer of insulating material comprises one or more layers of the same insulating material.
  • This single layer of insulating material may also be composed of different types of insulating material possible, but not necessarily superimposed in different layers.
  • the layer of insulating material 5 coaxially covers the outside of the conductor 4 of the elongated body of the flexible catheter extending between the distal 2 and the proximal 1 end of the elongated body.
  • the layer of insulating material 5 is provided over at least part of the length of the elongated body, but not at the tip 3. This results in a thermal coating of the elongated part of the catheter, but not of the tip 3.
  • the radiofrequency waves are transported from the conductive material of the conductor 4, which is insulated by the insulating material 5, to conductive tip 3. There the radiofrequency waves are able to heat the tip and to thermally coagulate the vein.
  • the conductive tip 3 of the flexible catheter according to present invention is inserted into the vein that needs to be coagulated.
  • This catheter is connected to a thermal coagulation device, capable of sending a radiofrequency signal into the cable connected to the catheter according to present invention.
  • a radiofrequency signal is sent into this flexible catheter.
  • a radiofrequency signal having a wavelength between 2 MHz and 12 MHz is used.
  • the catheter transports the temperature to the exact place in the vein where coagulation is desired.
  • only the tip 3 of the catheter is not insulated, only tissues making contact with the tip 3 are heated. Tissues making contact with the conductor 4 coated with insulating material 5 of the catheter are not heated and radiofrequency waves are not transported through these tissues.
  • the insulated catheter with a non-insulated tip 3 makes sure that when a radiofrequency signal is sent into the catheter, the temperature along the catheter remains the same, so that the vein does not heat up alongside the catheter.
  • the vein Due to the local increase in temperature, the vein will be locally coagulated and will therefore be sealed. This will lead to rejection of the vein by the patient's body and eventually the vein will disappear.
  • the temperature at the non-insulated tip 3 of the insulated catheter, generated by the radiofrequency signal is preferably at least 50 C°, more preferably at least 60 C° and most preferably at least 70 C°.
  • the flexibility of the catheter according to present invention is preferred so that the catheter can follow the vein even when the vein is not straight, but for example curved.
  • the insulated catheter with a non-insulated tip 3 according to present invention is preferably used for thermal coagulation of veins of 1 - 4 mm in size, in particular for treatment by means of thermal coagulation of varicose veins of 1 - 4 mm in size.
  • the insulated catheter with a non-insulated tip 3 according to present invention is more preferably used for thermal coagulation of veins of 1 - 3 mm in size, in particular for treatment by means of thermal coagulation of varicose veins of 1 - 3 mm in size.
  • Thermal coagulation using the catheter of present invention may replace the currently used sclerotherapy for small varicose veins between 1 - 4 mm. Indeed, thermal coagulation has not been performed yet for small varicose veins between 1 - 4 mm but exhibits multiple advantages related to the comfort of the patients when compared to sclerotherapy.
  • Effectiveness of this treatment by means of thermal coagulation using catheter of present invention is expected to be between 55 and 100 %.
  • Substantially improved disappearance of the coagulated varicose veins by use of the insulated catheter with a non-insulated tip according to present invention is expected around 60 days after treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Cathéter flexible pour une coagulation thermique des veines comportant un corps allongé présentant une extrémité proximale (1) et une extrémité distale (2), l'extrémité distale (2) du corps allongé comportant un bout (3) dans un matériau conducteur. Selon l'invention, le corps allongé comporte un conducteur (4) qui vient en contact avec le bout (3) et s'étend entre l'extrémité distale et l'extrémité proximale du cathéter flexible, et l'extérieur du corps allongé s'étend au moins sur une partie de sa longueur, mais pas jusqu'au niveau du bout (3) muni d'une couche de matériau isolant (5). L'invention est également caractérisée en ce que le corps allongé à insérer dans les veines a un diamètre de l'ordre de 1 à 4 mm.
PCT/EP2009/065419 2008-11-18 2009-11-18 Cathéter flexible WO2010057934A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09759714A EP2367494A1 (fr) 2008-11-18 2009-11-18 Cathéter flexible

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08169373 2008-11-18
EP08169373.1 2008-11-18

Publications (1)

Publication Number Publication Date
WO2010057934A1 true WO2010057934A1 (fr) 2010-05-27

Family

ID=41559096

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/065419 WO2010057934A1 (fr) 2008-11-18 2009-11-18 Cathéter flexible

Country Status (2)

Country Link
EP (1) EP2367494A1 (fr)
WO (1) WO2010057934A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2501034A1 (fr) * 1981-03-06 1982-09-10 Francis Brunelle Procede et electrode pour l'electrocoagulation de vaisseaux sanguins
DE19734506A1 (de) * 1997-08-08 1999-02-25 Stockert Gmbh Vorrichtung für die Hochfrequenzbehandlung von Körpergewebe
WO1999011185A1 (fr) * 1997-08-30 1999-03-11 Steffen Hoffmann Appareil pour traiter des lesions vasculaires, notamment des varices
GB2333964A (en) * 1999-03-04 1999-08-11 Falah Hasan Ali Intravenous coagulation catheter for treatment of varicose veins
DE102006047366A1 (de) * 2006-10-04 2008-04-10 Celon Ag Medical Instruments Biegeweicher Katheter zur Hochfrequenztherapie von biologischem Gewebe
EP1967154A1 (fr) * 2007-03-02 2008-09-10 F-CARE SYSTEMS, naamloze vennootschap Aiguille ou cathéter pour la coagulation thermique des vaisseaux sanguins

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2501034A1 (fr) * 1981-03-06 1982-09-10 Francis Brunelle Procede et electrode pour l'electrocoagulation de vaisseaux sanguins
DE19734506A1 (de) * 1997-08-08 1999-02-25 Stockert Gmbh Vorrichtung für die Hochfrequenzbehandlung von Körpergewebe
WO1999011185A1 (fr) * 1997-08-30 1999-03-11 Steffen Hoffmann Appareil pour traiter des lesions vasculaires, notamment des varices
GB2333964A (en) * 1999-03-04 1999-08-11 Falah Hasan Ali Intravenous coagulation catheter for treatment of varicose veins
DE102006047366A1 (de) * 2006-10-04 2008-04-10 Celon Ag Medical Instruments Biegeweicher Katheter zur Hochfrequenztherapie von biologischem Gewebe
EP1967154A1 (fr) * 2007-03-02 2008-09-10 F-CARE SYSTEMS, naamloze vennootschap Aiguille ou cathéter pour la coagulation thermique des vaisseaux sanguins

Also Published As

Publication number Publication date
EP2367494A1 (fr) 2011-09-28

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