WO1999018870A1 - Catheter a ballonnet destine a provoquer un trauma thermique dans un foramen ovale permeable et procede d'utilisation dudit catheter - Google Patents

Catheter a ballonnet destine a provoquer un trauma thermique dans un foramen ovale permeable et procede d'utilisation dudit catheter Download PDF

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Publication number
WO1999018870A1
WO1999018870A1 PCT/US1998/021440 US9821440W WO9918870A1 WO 1999018870 A1 WO1999018870 A1 WO 1999018870A1 US 9821440 W US9821440 W US 9821440W WO 9918870 A1 WO9918870 A1 WO 9918870A1
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WO
WIPO (PCT)
Prior art keywords
catheter
balloon
foramen ovale
distal end
radio frequency
Prior art date
Application number
PCT/US1998/021440
Other languages
English (en)
Inventor
Bruce D. Stambaugh
Hien V. Nguyen
Tony R. Brown
Original Assignee
Hearten Medical, Inc.
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 Hearten Medical, Inc. filed Critical Hearten Medical, Inc.
Priority to AU10775/99A priority Critical patent/AU1077599A/en
Publication of WO1999018870A1 publication Critical patent/WO1999018870A1/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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • 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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • 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
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • 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
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition

Definitions

  • the present invention is related generally to medical/surgical devices that can be placed within the body of a patient to perform a procedure. More specifically, the present invention is a minimally invasive device useful in closing a patent foramen ovale.
  • the fetal circulation is vastly different than the normal adult circulation.
  • the blood circulating in a fetus is oxygenated by the placenta, not the developing lungs. Therefore, the fetal circulation directs only a small percentage of the circulating blood to the fetal lungs.
  • Most of the circulating blood is shunted away form from the lungs to the peripheral tissues through specialized vessels and foramens that are open ("patent") during fetal life. In most people these specialized structures quickly close after birth, unfortunately, sometimes they fail to close and create hemodynamic problems that can be fatal if left untreated.
  • the fetal circulation is illustrated in Fig. 1.
  • the umbilical arteries branch off of the iliac arteries and deliver unoxygenated (blue) blood to the placenta.
  • the fetal blood travels through the capillary bed in the placenta and transfers carbon dioxide to the maternal blood and takes oxygen and other nutrients from the maternal blood.
  • the umbilical vein returns oxygenated (red) blood to the fetus.
  • Most of the oxygenated blood from the umbilical vein bypasses the developing liver and travels through a specialized vessel called the ductus venosus to the inferior vena cava and then into the right atrium.
  • a good portion of the oxygenated blood from the inferior vena cava is directed across the right atrium and into the left atrium through a specialized curtain like opening in the heart called the foramen ovale.
  • the blood from the left atrium then enters the left ventricle and then into the aorta where it travels to the head and other body tissues delivering the needed oxygen and nutrients.
  • Another specialized vessel, called the ductus arteriosus is a vessel that connects the high pressure pulmonary artery to the lower pressure aorta. Therefore, most of the blood in the pulmonary artery flows into the lower pressure aorta through this specialized vessel.
  • the circulatory system goes through profound changes.
  • the lungs fill with air and the resistance to blood flow into the lungs drastically decreases.
  • the corresponding pressure in the right atrium, right ventricle, and pulmonary arteries also decrease.
  • the decrease in pressure in the right atrium causes the curtain like opening of the foramen ovale to close, driving more blood into the right ventricle and then to the lungs for oxygenation. Over time, the foramen ovale is replaced with a membrane called the fossa ovalis.
  • the decrease in pressure in the pulmonary arteries reduced the pulmonary arterial pressure to the same as or slightly less than the pressure in the aorta, which stops or reverses the flow through the ductus arteriosus.
  • a patent ductus venosus after birth is very rare and almost always fatal.
  • a patent ductus arteriosus occurs in about 1 out of every 5000 births.
  • the patent ductus arteriosus once diagnosed is either medically treated or surgically ligated to close the ductus.
  • the foramen ovale does not seal shut, instead it remains patent.
  • the curtain like opening usually remains shut.
  • the pressure in the right atrium increases, such as upon heavy lifting or while performing a Val Salva type maneuver, the curtain like fold of tissue opens and the blood flows from the right atrium to the left ventricle.
  • clots or plaque can pass through the venous circulation and into the arterial circulation and then into the brain or other tissues to cause a thromboembolic event like a stroke.
  • the clots may pass to the arterial side when there is an increase in the pressure in the right atrium. Then the clots travel through the left side of the heart, to the aorta, and then to the brain via the carotid arteries where they cause a stroke and the associated neurological deficits.
  • the present invention provides a device and method for closing a patent foramen ovale.
  • the present invention comprises a catheter sheath with proximal and distal ends.
  • a balloon catheter is deployably retained within the catheter sheath.
  • the fluid in the balloon is can be heated using radio frequency ("RF") energy via two electrodes contained within the balloon's lumen.
  • RF radio frequency
  • the treating healthcare professional then applies RF energy to the fluid in the balloon to heat the balloon to a temperature that causes thermal trauma to the lining of the foramen ovale.
  • the balloon catheter is then deflated and then repositioned into the distal end of the catheter sheath and then removed from the patient.
  • the traumatized area created along the inner surfaces of the patent foramen ovale heals over time and turns into a scar obliterating the foramen ovale.
  • Fig. 1 is a schematic diagram of the fetal circulation of a mammal
  • Fig. 2 is a schematic diagram of a catheter of the present invention traveling up the inferior vena cava of a patient into the right atrium and through the foramen ovale;
  • Fig. 3 is a schematic plan view of a balloon foramen ovale catheter of the present invention.
  • Fig. 4 is an axial cross-sectional view of the distal end of the catheter of Fig.
  • Fig. 5 is a perpendicular cross-sectional view of the catheter of Fig. 3 taken along the plane indicated in Fig. 4 by line 5-5;
  • Fig. 6 is an axial cross-sectional view of the proximal end of the present invention.
  • the present invention provides a novel least invasive device and method for closing a patent foramen ovale in a mammal.
  • the device is specifically designed to be used in catheterization laboratories in hospitals for treating humans as well as veterinary hospitals for treating animals.
  • the term "patient” shall refer to human patients as well as animal patients.
  • the device is introduced into the blood stream using well known catheterization procedures. The device is initially introduced within a catheter sheath 11 with a distal end 14.
  • the device then extends distally from the catheter sheath to span the patent foramen ovale.
  • the device has an inflatable balloon 26 with RF electrodes within the lumen of the balloon.
  • the balloon is inflated while in the foramen ovale and RF energy is applied to thermally traumatize the interior tissue of the foramen ovale.
  • the balloon is deflated and the device is retracted into the catheter sheath.
  • the device is then removed from the patient. Once the interior of the foramen ovale has been traumatized, the body's healing mechanism begins. Because the pressure within the left atrium is greater than the pressure in the right atrium, the curtains of tissue that comprises the patent foramen ovale are directly opposed to each other.
  • the body's healing mechanism then replaces the traumatized tissue with scar tissue and the scar tissue forms across the curtain of tissue permanently sealing the foramen ovale. Over time, the foramen ovale becomes completely obliterated and turns into the normal fossa ovalis.
  • Fig. 3 the foramen ovale catheter of the present invention is further illustrated.
  • the patent foramen catheter has to be advanced through the skin of the patient into a blood vessel, preferably a standard femoral vein catheterization is used that is well known in the art, however other vessel access to the atriums can be used.
  • a standard introducer is used to gain access from the skin of the patient to the lumen of the vessel.
  • These introducers are commercially available from many different manufacturers, Cordis Corporation of Miami Florida being one, Cook of Bloomington Indiana being another.
  • the introducer can be of many different sizes, in the preferred embodiment the introducer varies from a 6 French to a 15 French introducer. Presently it is preferred to use a 7 or 8 French introducer.
  • a sheath catheter 11 is then advanced through the catheter port of the introducer.
  • the outer diameter of the sheath catheter can vary from about 5 French to about 15 French.
  • the inner diameter is such that a 4 French to about a 14 French foramen ovale catheter can be placed within its lumen.
  • the sheath catheter is a single lumen catheter made by extruding standard catheter materials using standard extrusion techniques. Currently it is preferred to extrude polyether-block-amide, nylon, polyurethane, polyimide, or a polyolefin copolyester. However, any other extrudable catheter material well known in the art can be used to manufacture the catheter. The smaller the catheter, the stronger the extruding material should be.
  • the catheter can be reenforced by using braided meshing, a technique already well known in the catheter arts.
  • the catheter has a proximal end 12 and a distal end 14.
  • a port access 13 which allows the balloon catheter to be introduced through the sheath catheter.
  • the sheath catheter's length is such that it can easily be used from a femoral site to reach an atrium of the heart, about 80 to 140 cm, with about 120 . cm being preferred.
  • the distal end of the sheath catheter can have a radio- opaque marker 24 such as a metallic ring placed around the distal end or incorporated into the distal end such that the distal end is visible under imaging techniques such as fluoroscopy.
  • the catheter has a proximal end 18 provided with a standard "Y" fitting 19 and a distal end 24.
  • the Y fitting comprises a standard port 21 for the placement of a guide wire 23.
  • the guide wire can be any standard guide wire in the industry.
  • the guide wire is made out of a coil and has a blunt distal end 32 to prevent damage to vessels when the catheter is advanced.
  • the angled stem 20 of the Y fitting is provided with a lure lock type fitting 22 which is used to inject fluid to inflate the balloon.
  • a syringe is connected to the port to control the inflation and deflation of the balloon.
  • the fluid used is preferably a physiological fluid that conduct RF energy such as saline.
  • a standard cable 30 with optional connectors is also provided at the proximal end of the balloon catheter. The cable is connected to a supply 31 of RF energy.
  • a standard grounding electrode (not illustrated) is also connected to the RF supply and the skin of the patient.
  • the foramen ovale catheter is actually comprised of two catheters, the outer catheter 16 which is placed within the catheter sheath, and an inner catheter 25 which has a lumen 40 for the guide wire 23.
  • the inner catheter is longer than the outer catheter, the length corresponding to the length of the balloon (about 1 to 2 cm) plus an additional amount for the movement of the free floating ring 27 that is bonded to the wires 31 that cover the balloon.
  • the outer and inner catheters can be made by extruding standard catheter materials using standard extrusion techniques, just like the sheath catheter.
  • the outer catheter typically has an outer diameter of about 6 French to about 14 French, with 8 French being presently preferred.
  • the inner catheter is sized to fit within the outer catheter leaving adequate room for the fluid space 36.
  • the inner catheter has an outer diameter of about 3 French to about 12 French with 6 French being presently preferred.
  • the balloon 26 is bonded to the distal end 17 of the outer catheter with an appropriate adhesive 39 such as heat curable polyurethane and the like.
  • the balloon is also bonded near the distal end 24 of the inner catheter using an adhesive 37. This creates the fluid cavity 38 of the balloon.
  • the balloon can be made of any standard medical grade balloon material that can resist being damaged at relatively high temperatures. Currently it is preferred that the balloon is somewhat non-compliant and can resist deforming at high temperatures and thus a balloon manufactured from poly-ethylene-terephthalte ("PET") or nylon is presently preferred.
  • PET poly-ethylene-terephthalte
  • the balloon can vary in length from about 5 mm to about 25 mm with 10 mm being presently preferred.
  • the balloon's diameter can also vary from about 3 mm to about 20 mm, with a diameter of 5 mm being presently preferred.
  • proximal electrode 42 is bonded near the proximal end of the balloon, and the distal electrode 41 is bonded near the distal end of the balloon.
  • Lead wires 46 and 47 are provided for the electrodes between the inner and outer catheters. The lead wires span from the cable at the proximal end to the electrodes at the distal end. Means for measuring the temperature within the balloon is optionally provided.
  • a thermocouple 43 is provided using standard copper and constantan wires 48. The thermocouple is ideally bonded to the inner catheter at the midpoint of the balloon.
  • the RF energy is typical RF energy ranging from about 100 kHz to about 1000 kHz, with about 460 kHz being presently preferred.
  • the watts of power can vary from about 0.1 watt to about 100 watts, with a range of about 3 watts to 25 watts being presently preferred.
  • Many different RF generators can be used to supply the RF energy.
  • an RF generator manufactured by Stellartech Research Corporation of Mountain View, CA is preferred.
  • the RF generator can deliver a maximum wattage of RF energy, with that maximum wattage chosen by the user of the generator.
  • the RF generator then can measure the temperature at a thermocouple inside the needle to then regulate the wattage to maintain a set temperature.
  • a preferred Y type fitting 19 is illustrated.
  • the proximal end of the outer catheter 16 is bonded in the distal end 53 of the Y fitting with bonding material 52.
  • the proximal end of the inner catheter extends proximally past the fluid port 20 and is bonded in the middle of the Y fitting with bonding material 51.
  • the lumen 58 of the fluid port is in direct communication with the fluid space 36 between the inner and outer catheters.
  • the guide wire port 57 at the most proximal end of the Y fitting is slightly tapered.
  • the taper then increases to a conical section 54 until the inner diameter 55 is about identical to the inner diameter of the inner catheter.
  • the tapering makes it easy to place the guide wire through the lumen 40 of the inner catheter.
  • the cable 30 is connected to the Y fitting opposite the Y arm 20.
  • the lead wires and thermocouple wires traverse through the Y fitting and into the space between the inner and outer catheters.
  • the present invention provides for a method of training a person to perform the procedure of traumatizing a patent foramen ovale using the disclosed embodiments.
  • the method of training includes the steps of demonstrating the device, supervising the person being trained, and the labeling instructions included with the device on when and how to use the device.
  • the embodiments of the present invention are all used similarly. Fist the shape and size of the foramen ovale is determined using standard imaging techniques such as magnetic resonance imaging, trans-esophageal echocardiography, and the like.
  • an appropriate sized balloon can be used to fill the inside of the patent foramen ovale. Then, access is gained to a blood vessel.
  • the femoral vein is catheterized using any one of may commercially available introducing catheters that are well known in the art. Once the introducing catheter is in place, a single lumen catheter that is long enough to reach the foramen ovale and is large enough to allow the particular embodiment of the present invention to pass through the lumen is placed through the introducing catheter.
  • An example of this type of catheter is the 8 French Mullins Introducer Set manufactured by Cook of Bloomington IN.
  • these catheters are provided with a fairly stiff guide wire to allow for probing the right atrium for the foramen ovale.
  • the single lumen catheter is advanced to the right atrium and then through the foramen ovale to the left atrium.
  • the guide wire is removed and the foramen ovale catheter is advanced in the single lumen catheter to the left atrium.
  • the single lumen catheter is then removed from the left atrium and the foramen ovale.
  • the balloon catheter is then placed within the foramen ovale by slowly withdrawing the catheter back from the left atrium towards the right atrium.
  • the balloon is then positioned within the foramen ovale.
  • the balloon is inflated and RF energy is applied to raise the temperature within the balloon to the desired temperature, with 85 degrees centigrade being presently preferred.
  • the temperature is applied for a sufficient time to cause thermal damage to the interior of the foramen ovale, currently for 30 seconds.
  • the balloon is then deflated and the foramen ovale catheter is withdrawn into the single lumen catheter and then removed from the patient. All the catheters are then removed and the puncture site is sealed using standard techniques.

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  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • 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)
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  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif et un procédé qui s'utilisent pour fermer un foramen ovale perméable. Le dispositif comprend une gaine de cathéter (11) munie d'une extrémité proximale et d'une extrémité distale. Un cathéter à ballonnet (16) est retenu et déployé à l'intérieur de la gaine de cathéter. Le liquide contenu dans le ballonnet peut être chauffé par énergie radiofréquence (RF) via deux électrodes (41, 42) situées à l'intérieur de la lumière du ballonnet. Le cathéter est placé à travers un foramen ovale perméable et avancé de telle sorte que le ballonnet est déployé hors de l'extrémité distale de la gaine de cathéter. Cette dernière est ensuite retirée du foramen ovale à l'intérieur duquel on gonfle le ballonnet. Une énergie RF est ensuite exercée sur le fluide dans le ballonnet pour chauffer cette dernière à une température suffisante pour provoquer un trauma thermique dans le revêtement du foramen ovale. Le cathéter à ballonnet est ensuite dégonflé, replacé à l'intérieur de l'extrémité distale de la gaine de cathéter puis retiré du patient.
PCT/US1998/021440 1997-10-10 1998-10-09 Catheter a ballonnet destine a provoquer un trauma thermique dans un foramen ovale permeable et procede d'utilisation dudit catheter WO1999018870A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU10775/99A AU1077599A (en) 1997-10-10 1998-10-09 A balloon catheter for causing thermal trauma to a patent foramen ovale and method of using the balloon catheter

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6295497P 1997-10-10 1997-10-10
US60/062,954 1997-10-10

Publications (1)

Publication Number Publication Date
WO1999018870A1 true WO1999018870A1 (fr) 1999-04-22

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PCT/US1998/021440 WO1999018870A1 (fr) 1997-10-10 1998-10-09 Catheter a ballonnet destine a provoquer un trauma thermique dans un foramen ovale permeable et procede d'utilisation dudit catheter

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WO (1) WO1999018870A1 (fr)

Cited By (44)

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WO2004087235A2 (fr) 2003-03-27 2004-10-14 Cierra, Inc. Procedes et appareil pour le traitement de foramen ovale permeable
US6939348B2 (en) * 2003-03-27 2005-09-06 Cierra, Inc. Energy based devices and methods for treatment of patent foramen ovale
EP1605851A2 (fr) * 2003-03-27 2005-12-21 Cierra, Inc. Methodes et appareil pour le traitement d'un foramen ovale patent
EP1605849A2 (fr) * 2003-03-27 2005-12-21 Cierra, Inc. Dispositifs et procedes fondes sur l'application d'une energie pour le traitement du foramen ovale persistant
WO2007055783A1 (fr) * 2005-11-08 2007-05-18 Nmt Medical, Inc. Cathéter à électrode conformable et méthode d'utilisation
WO2008079639A1 (fr) * 2006-12-20 2008-07-03 Terumo Kabushiki Kaisha Procédés et appareil de fermeture d'une malformation tissulaire multicouche
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US9216014B2 (en) 2002-06-03 2015-12-22 W.L. Gore & Associates, Inc. Device with biological tissue scaffold for percutaneous closure of an intracardiac defect and methods thereof
US9241695B2 (en) 2002-03-25 2016-01-26 W.L. Gore & Associates, Inc. Patent foramen ovale (PFO) closure clips
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US9545247B2 (en) 2004-05-07 2017-01-17 W.L. Gore & Associates, Inc. Catching mechanisms for tubular septal occluder
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US9861346B2 (en) 2003-07-14 2018-01-09 W. L. Gore & Associates, Inc. Patent foramen ovale (PFO) closure device with linearly elongating petals
WO2020010144A1 (fr) * 2018-07-03 2020-01-09 Subramaniam Krishnan Systèmes et méthodes pour traiter le foramen ovale perméable
US10792025B2 (en) 2009-06-22 2020-10-06 W. L. Gore & Associates, Inc. Sealing device and delivery system
US10806437B2 (en) 2009-06-22 2020-10-20 W. L. Gore & Associates, Inc. Sealing device and delivery system
US10828019B2 (en) 2013-01-18 2020-11-10 W.L. Gore & Associates, Inc. Sealing device and delivery system
US11844913B2 (en) 2012-03-23 2023-12-19 Boston Scientific Medical Device Limited Transseptal puncture apparatus and method for using the same

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