WO2010054456A9 - Catheter for endoluminal laser with centralizer and apical sensors of temperature - Google Patents

Catheter for endoluminal laser with centralizer and apical sensors of temperature Download PDF

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Publication number
WO2010054456A9
WO2010054456A9 PCT/BR2009/000376 BR2009000376W WO2010054456A9 WO 2010054456 A9 WO2010054456 A9 WO 2010054456A9 BR 2009000376 W BR2009000376 W BR 2009000376W WO 2010054456 A9 WO2010054456 A9 WO 2010054456A9
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
sensors
temperature
centralizer
apical
Prior art date
Application number
PCT/BR2009/000376
Other languages
French (fr)
Other versions
WO2010054456A1 (en
Inventor
Wagner Paula Ferreira
Original Assignee
Wagner Paula Ferreira
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
Priority claimed from BRMU8802573 external-priority patent/BRMU8802573U2/en
Priority claimed from BRMU8900187 external-priority patent/BRMU8900187U2/en
Application filed by Wagner Paula Ferreira filed Critical Wagner Paula Ferreira
Publication of WO2010054456A1 publication Critical patent/WO2010054456A1/en
Publication of WO2010054456A9 publication Critical patent/WO2010054456A9/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00084Temperature
    • A61B2017/00101Temperature using an array of thermosensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value

Definitions

  • This patent of Utility Model request deals with a new "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE", notably of a catheter to be used in the endovascular treatment of venous diseases that can be treated with therapeutic laser, whose distinction is to have sensors of temperature located strategically in the device centralizer of the optic fiber that extrapolates the end of the product, which combined with sound and/or light warning and specific software alerts the professional when specific temperature previously stipulated is reached, becoming the procedure simpler, safer, more precise and uniform, reproducible by any vascular surgeon, independent of his experience and practice.
  • the venous insufficiency responsible for varicose veins has as cause, among others, the lesion of the saphena veins, which provokes a reflux in the venous system, leading to the formation of varicose veins.
  • the older treatment is the removal of the saphena veins by a phleboextractor introduced in the veins through incisions; thus the vein is removed from its layer. This method brings some complications, as the lesion of structures nearby the hurt vein, as well as possibilities of infections among others.
  • the laser technique very used in this field, presents great efficacy and success in the treatment of big and little varicose veins, in both superficial and deep levels.
  • this technology it is possible to make an intervention minimally invasive and outpatient, liberating the patient for his usual activities almost immediately.
  • the laser technique occurs with the introduction of an optic fiber in the vein to be treated through a simple puncture.
  • the optic fiber is taken to the point where the reflux will be interrupted, being connected to a device emitter of laser.
  • the fiber is retreated concomitant to the bombing with laser.
  • the hemoglobin of blood absorbs the photons of laser, elevating the temperature and provoking the formation of bubbles that will take to a lesion of the layers of vein properly said, taking to its collapse with posterior absorption by organism, correcting then the venous reflux.
  • the state of technique anticipates the document WO 2004/004546 A2 that deals with an apparatus minimally invasive for endovascular treatment that uses laser and optic fiber capable of heating the vein to be treated.
  • the catheter comprehends an optic fiber and its end comprehends a series of fillets sectioned longitudinally that, once activated by extreme maniple, make said catheter to enlarge with the purpose of expand and contact the vein to be treated with help of the hot coming from laser.
  • the device above mentioned doesn't propitiate homogeneity in the thermal damage in the vein wall and the control of the time of shooting is made empirically by manual palpation on the skin, which can provoke some inconvenient, as:
  • the level of energy dispensed can exceed and take to the rupture of the vein with lesion of the nearby structures (nerves, fat, nodes, skin, etc.), producing undesirable burns;
  • the inventor created the "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE" in subject, that attaches sensors of temperature in the expandable end that extrapolates the catheter conductor of the optic fiber that, when reach the vein wall, monitor the temperature in real time, promoting thermal homogeneity. Like this, as soon as the temperature limit of the wall is reached, it is issued a sound and/or warning, signalizing to the surgeon the exact moment of retreating the fiber to a new point of treatment.
  • the innovation works together with specific software capable of calibrating the ideal temperature for that procedure consistent with several parameters involved, making possible also the recording of the thermal curve to further analysis. There is the option of having a connection for external digital thermometer for registration of temperatures.
  • the centralizer of the innovated catheter remains inlaid in the external tube of the product, being operated by maniple when of it reaches specific point of the vein to be treated.
  • the innovated catheter is produced in flexible material and resistant to "Kinging" and with columnar resistance and response efficient to touch in order to make possible the navigability of the venous system.
  • the catheter has lumen for passage of guidewire that is used as tread for the positioning, before of passing the optic fiber.
  • the catheter is built with radiopaque and echogenic markers for visualization with X rays and ultra-sound.
  • the catheter has maniple with lock for the device measurer and sealant to avoid leaking of blood.
  • the innovated catheter becomes the endoluminal treatment of varicose veins with laser more precise, simpler and safer, avoiding, for instance, that the vein is perforated by excess of heat, avoiding thermal damages to the tissues adjacent to the vein, or undertreated, demanding new intervention.
  • the innovation is explained with reference to the attached drawings, in which they are represented of an illustrative and not limitative way:
  • Fig. 1 Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature;
  • Fig. 2 View in perspective of the catheter for endoluminal laser with centralizer and apical sensors of temperature
  • Fig. 3 Frontal detail of the tip of the catheter for endoluminal laser with centralizer and apical sensors of temperature;
  • Fig. 4 Lateral detail of the tip of the catheter for endoluminal laser with centralizer and apical sensors of temperature
  • Fig. 5 Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature, in a constructive variation with four sensors
  • Fig. 6 Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature, in a constructive variation with two sensors.
  • the "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE object of this patent of utility model request, consists essentially of a catheter (1) with tube (2) coated by a cover (3), through which an optic fiber (4) passes over, linked to the laser device (not represented), whose distinction is the retractable tip (5) to the interior of said tube (2), of maniple (6), having thermal sensors (7) that, in contact with the vein wall to be treated, allow the monitoring of temperature that, when reaches the predetermined limit, activates the sound and/or light warning, alerting the professional about the exact moment of retracting the fiber (4) to a new point of treatment.
  • the catheter (1) is designed to conduct the optical fiber (4) until the exact point of vein to be treated through central tube (2) or internal lumen, which is coated by cover (3) in adequate material to slide through the vein properly said, in whose end it is projected a retractable tip (5) toward to the cover (3) composed by longitudinal sections (8) that, activated by maniple (6) open out toward to the vein, keeping the optical fiber (4) centralized related to the catheter (1).
  • each one of the sections (8) it is placed thermal sensors (7) that, when open, reach the vein wall, promoting a continuous measurement and in real time of temperature in that point, concomitant to the shooting of laser.
  • the catheter (1) When it reaches the required temperature, it is issued a sound and/or light warning, that alerts the professional that immediately retreats the fiber (4) toward to a new point to be treated.
  • the catheter (1) presents a connection (9) for external digital thermometer for registration of temperatures, as well as software capable of regulating the thermal levels and storing such temperatures for further evaluation.
  • the catheter (1) has four sections (8) and four thermal sensors (7) indexed.
  • the catheter (1) has two sections (8) and two thermal sensors (7) indexed.

Abstract

Catheter for endoluminal laser with centralizer and apical sensors of temperature notably of a catheter (1) with tube (2) coated by cover (3), through which passes over an optic fiber (4) linked to laser device (not represented), whose distinction is the retractable tip (5) to the interior of said tub (2), of maniple (6), having thermal sensors (7) that, in contact with the vein wall to be treated, allow the monitoring of temperature that, when reaches the predetermined limit, activates a sound and/or light warning, alerting the professional about the exact moment of retracting the fiber (4) to a new point of treatment.

Description

"CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL
SENSORS OF TEMPERATURE"
This patent of Utility Model request deals with a new "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE", notably of a catheter to be used in the endovascular treatment of venous diseases that can be treated with therapeutic laser, whose distinction is to have sensors of temperature located strategically in the device centralizer of the optic fiber that extrapolates the end of the product, which combined with sound and/or light warning and specific software alerts the professional when specific temperature previously stipulated is reached, becoming the procedure simpler, safer, more precise and uniform, reproducible by any vascular surgeon, independent of his experience and practice.
The venous insufficiency responsible for varicose veins has as cause, among others, the lesion of the saphena veins, which provokes a reflux in the venous system, leading to the formation of varicose veins. The older treatment is the removal of the saphena veins by a phleboextractor introduced in the veins through incisions; thus the vein is removed from its layer. This method brings some complications, as the lesion of structures nearby the hurt vein, as well as possibilities of infections among others.
By the other side, the laser technique, very used in this field, presents great efficacy and success in the treatment of big and little varicose veins, in both superficial and deep levels. With this technology, it is possible to make an intervention minimally invasive and outpatient, liberating the patient for his usual activities almost immediately.
Basically, the laser technique occurs with the introduction of an optic fiber in the vein to be treated through a simple puncture. Thus, the optic fiber is taken to the point where the reflux will be interrupted, being connected to a device emitter of laser. Then, the fiber is retreated concomitant to the bombing with laser. The hemoglobin of blood absorbs the photons of laser, elevating the temperature and provoking the formation of bubbles that will take to a lesion of the layers of vein properly said, taking to its collapse with posterior absorption by organism, correcting then the venous reflux. The state of technique anticipates the document WO 2004/004546 A2 that deals with an apparatus minimally invasive for endovascular treatment that uses laser and optic fiber capable of heating the vein to be treated. The catheter comprehends an optic fiber and its end comprehends a series of fillets sectioned longitudinally that, once activated by extreme maniple, make said catheter to enlarge with the purpose of expand and contact the vein to be treated with help of the hot coming from laser.
However, the device above mentioned doesn't propitiate homogeneity in the thermal damage in the vein wall and the control of the time of shooting is made empirically by manual palpation on the skin, which can provoke some inconvenient, as:
• The level of energy dispensed in a specific segment is insufficient for an adequate lesion of the vein wall, re-channeling after and demanding new intervention;
• The level of energy dispensed can exceed and take to the rupture of the vein with lesion of the nearby structures (nerves, fat, nodes, skin, etc.), producing undesirable burns;
• The energy dispensed is not uniformly distributed by segment of the vein, taking to points in that the vein can be treated with small energy or with excess of energy, producing thermal damage in peripheral structures. Briefly, all the inconvenient and limitations above become the procedure totally dependent of the surgeon experience, patient biotype, caliber of the vein, etc., not being possible get a standardization of results between the treated patients.
Thinking of these inconvenient, the inventor created the "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE" in subject, that attaches sensors of temperature in the expandable end that extrapolates the catheter conductor of the optic fiber that, when reach the vein wall, monitor the temperature in real time, promoting thermal homogeneity. Like this, as soon as the temperature limit of the wall is reached, it is issued a sound and/or warning, signalizing to the surgeon the exact moment of retreating the fiber to a new point of treatment. The innovation works together with specific software capable of calibrating the ideal temperature for that procedure consistent with several parameters involved, making possible also the recording of the thermal curve to further analysis. There is the option of having a connection for external digital thermometer for registration of temperatures. The centralizer of the innovated catheter remains inlaid in the external tube of the product, being operated by maniple when of it reaches specific point of the vein to be treated.
The innovated catheter is produced in flexible material and resistant to "Kinging" and with columnar resistance and response efficient to touch in order to make possible the navigability of the venous system. On the other hand, the catheter has lumen for passage of guidewire that is used as tread for the positioning, before of passing the optic fiber. The catheter is built with radiopaque and echogenic markers for visualization with X rays and ultra-sound. Finally, the catheter has maniple with lock for the device measurer and sealant to avoid leaking of blood.
Therefore, the innovated catheter becomes the endoluminal treatment of varicose veins with laser more precise, simpler and safer, avoiding, for instance, that the vein is perforated by excess of heat, avoiding thermal damages to the tissues adjacent to the vein, or undertreated, demanding new intervention. To follow, the innovation is explained with reference to the attached drawings, in which they are represented of an illustrative and not limitative way:
Fig. 1 : Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature;
Fig. 2: View in perspective of the catheter for endoluminal laser with centralizer and apical sensors of temperature;
Fig. 3 : Frontal detail of the tip of the catheter for endoluminal laser with centralizer and apical sensors of temperature;
Fig. 4: Lateral detail of the tip of the catheter for endoluminal laser with centralizer and apical sensors of temperature; Fig. 5: Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature, in a constructive variation with four sensors;
Fig. 6: Lateral view of the catheter for endoluminal laser with centralizer and apical sensors of temperature, in a constructive variation with two sensors.
The "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE", object of this patent of utility model request, consists essentially of a catheter (1) with tube (2) coated by a cover (3), through which an optic fiber (4) passes over, linked to the laser device (not represented), whose distinction is the retractable tip (5) to the interior of said tube (2), of maniple (6), having thermal sensors (7) that, in contact with the vein wall to be treated, allow the monitoring of temperature that, when reaches the predetermined limit, activates the sound and/or light warning, alerting the professional about the exact moment of retracting the fiber (4) to a new point of treatment. The catheter (1) is designed to conduct the optical fiber (4) until the exact point of vein to be treated through central tube (2) or internal lumen, which is coated by cover (3) in adequate material to slide through the vein properly said, in whose end it is projected a retractable tip (5) toward to the cover (3) composed by longitudinal sections (8) that, activated by maniple (6) open out toward to the vein, keeping the optical fiber (4) centralized related to the catheter (1). In each one of the sections (8), it is placed thermal sensors (7) that, when open, reach the vein wall, promoting a continuous measurement and in real time of temperature in that point, concomitant to the shooting of laser. When it reaches the required temperature, it is issued a sound and/or light warning, that alerts the professional that immediately retreats the fiber (4) toward to a new point to be treated. Besides, the catheter (1) presents a connection (9) for external digital thermometer for registration of temperatures, as well as software capable of regulating the thermal levels and storing such temperatures for further evaluation.
In a first constructive variation, keeping the same inventive concept here claimed, the catheter (1) has four sections (8) and four thermal sensors (7) indexed.
In a second constructive variation, keeping the same inventive concept here claimed, the catheter (1) has two sections (8) and two thermal sensors (7) indexed.

Claims

1) "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE" designed to conduct the optical fiber (4) until the exact point of vein to be treated through central tube (2) or internal lumen, which is coated by cover (3) in adequate material to slide through the vein, wherein, from end, it is projected a retractable tip (5) toward to the cover (3) composed by longitudinal sections (8) that, activated by maniple (6) open outside; in each one of the sections (8), it is placed thermal sensors (7); when it reaches the required temperature, it is issued a sound and/or light warning; the catheter (1) presents a connection (9) for external digital thermometer for registration of temperatures, as well as software capable of regulating the thermal levels and storing such temperatures for further evaluation.
2) "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE", according to claim 1, wherein the catheter (1) has four sections (8) and four thermal sensors (7) indexed.
3) "CATHETER FOR ENDOLUMINAL LASER WITH CENTRALIZER AND APICAL SENSORS OF TEMPERATURE", according to claim 1, wherein the catheter (1) has two sections (8) and two thermal sensors (7) indexed.
PCT/BR2009/000376 2008-11-14 2009-11-13 Catheter for endoluminal laser with centralizer and apical sensors of temperature WO2010054456A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
BRBR-MU-8802573-0 2008-11-14
BRMU8802573 BRMU8802573U2 (en) 2008-11-14 2008-11-14 endoluminal laser catheter with temperature sensors
BRMU8900187 BRMU8900187U2 (en) 2009-02-12 2009-02-12 endoluminal laser catheter with centralizer and apical temperature sensors
BRBR-MU-8900187-7 2009-02-12

Publications (2)

Publication Number Publication Date
WO2010054456A1 WO2010054456A1 (en) 2010-05-20
WO2010054456A9 true WO2010054456A9 (en) 2010-07-08

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BR2009/000376 WO2010054456A1 (en) 2008-11-14 2009-11-13 Catheter for endoluminal laser with centralizer and apical sensors of temperature

Country Status (1)

Country Link
WO (1) WO2010054456A1 (en)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3617019A1 (en) * 1986-05-21 1987-11-26 Siegfried Dr Wieshammer Catheter to dissolve atheromatous plaque - with distal deflector for laser beam to prevent vessel perforation
US7273478B2 (en) * 2002-07-10 2007-09-25 Angiodynamics, Inc. Endovascular treatment device having a fiber tip spacer

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WO2010054456A1 (en) 2010-05-20

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