EP1434621A2 - Methodes et dispositifs de traitement d'une fibrillation auriculaire - Google Patents

Methodes et dispositifs de traitement d'une fibrillation auriculaire

Info

Publication number
EP1434621A2
EP1434621A2 EP02800429A EP02800429A EP1434621A2 EP 1434621 A2 EP1434621 A2 EP 1434621A2 EP 02800429 A EP02800429 A EP 02800429A EP 02800429 A EP02800429 A EP 02800429A EP 1434621 A2 EP1434621 A2 EP 1434621A2
Authority
EP
European Patent Office
Prior art keywords
scaffold
heart
platform
platform scaffold
creating
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Withdrawn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
EP02800429A
Other languages
German (de)
English (en)
Inventor
John A. Macoviak
David A. Rahdert
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.)
AM Discovery Inc
Original Assignee
AM Discovery 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 AM Discovery Inc filed Critical AM Discovery Inc
Publication of EP1434621A2 publication Critical patent/EP1434621A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • 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
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320052—Guides for cutting instruments
    • 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
    • A61B2018/00392—Transmyocardial revascularisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus

Definitions

  • This invention relates to methods and devices to improve the function of the heart. More particularly, the invention relates to methods and devices to treat atrial fibrillation.
  • Heart rhythm is normally established at a single point called the sinoatrial node, or SA node, located in the right atrium of the heart, near the opening of the superior vena cava.
  • SA node generates electrical impulses which spread throughout the heart and result in a rhythmic contraction of the heart, termed a sinus rhythm.
  • the SA node functions as a pacemaker for the heart.
  • a pacemaker other than the SA node is referred to as an ectopic pacemaker. Electrical signals from an ectopic pacemaker can disrupt a rhythmically contracting heart, resulting in an arrhythmia, characterized by a chaotic, disorganized heart rhythm. Fibrillation of the atria results in loss of atrial contraction and rapid impulses being sent to the ventricles causing high and irregular heart rates.
  • Atrial fibrillation is clinically related to several conditions, including anxiety, increased risk of stroke, reduced exercise tolerance, cardiomyopathy, congestive heart failure and decreased survival. Patients who experience AF are, generally, acutely aware of the symptoms. Current curative AF therapies are based upon a procedure that has become known as the
  • the Cox Maze procedure is an open-heart, surgical procedure that requires the patient to be placed on cardiopulmonary bypass equipment. The procedure requires six hours and the patient to be under general anesthesia. In this procedure, access to the heart is gained by way of a median sternotomy, which is a surgical split of the breast bone.
  • the left atrium is surgically incised along predetermined lines known to be effective in blocking the transmission of electrical signals from an ectopic pacemaker that triggers AF.
  • the incision lines create blocks that prevent conduction of unwanted electrical signals throughout the heart and permit a normal pattern of depolarization of the atria and ventricles beginning in the SA node and traveling to the AV or atrioventricular node.
  • the devices of the present invention form a platform, or scaffold for the precise delivery of various forms of energy for treatment of atrial fibrilation. Additionally, the devices of the present invention form a scaffold for the precise delivery of fluids to surrounding tissues. The use of additional energy sources can improve the delivery of various fluids into the surrounding tissue.
  • Figure 1 shows an embodiment of the invention in relation to its position within the heart, and within a patient's body.
  • Figure 2 shows an enlarged view of the device of Figure 1, with the loops surrounding the outlet of the pulmonary veins 210.
  • Figure 3 shows the reverse side of the device of Figures 1 and 2.
  • the reverse side's loop section 320 is shown having a multitude of holes, or micro-ports 330, that lie adjacent to the atrial walls.
  • Figure 4 shows an embodiment of the invention 400, in fluid communication with a catheter 410.
  • Figure 5 show an embodiment of the device shown in Figure 4.
  • Figure 6 is a frontal view of the device of Figures 4 and 5, with an additional positioning element.
  • Figure 7 is a longitudinal cross section of one embodiment of a tubule 720, having several micro-ports 730.
  • Figure 8 shows a radial cross section of the tubule shown in Figure 7.
  • Figures 9 and 10 show alternative tubule 910 designs, wherein the micro-ports are filled with porous plugs 920.
  • Figure 11 shows a catheter being introduced from the inferior vena cava 1110, into the right atrium 1140, through a septum 1120 between the right and left atrium, and into the left atrium 1150.
  • Figure 12 illustrates an embodiment of the invention 1200 that may be used to deliver energy to designated tissue.
  • FIG. 13 shows an embodiment of the invention, and the use of an energy source 1310 to deliver energy to devices of the present invention.
  • Figure 14 shows an embodiment of the invention 1400 having a positioning structure 1410 to standardize scaffold orientation within a treated heart chamber.
  • Figure 15 shows a scaffold in the form of a wire coil that, when deployed, closely conforms to the interior of a patient's heart chamber, such as the patient's left atrium in the example shown.
  • FIG 16 shows another embodiment for the scaffold 1600 of present invention.
  • the scaffold is in the form of a wire cage that, when deployed, closely conforms to the interior of a patient's heart chamber, such as the patient's left atrium.
  • Figure 17 shows another embodiment for the scaffold 1700 of present invention.
  • Figure 18 illustrates an alternative embodiment 1800 of the invention, positioned within the right atrium.
  • FIGS 19 through 22 show various embodiments of the invention having dual chamber structures.
  • Figures 23-25 show schematic views of a patient with a catheter 2340 being advanced from the inferior vena cava 2330, into the right atrium, and across the septum into the left atrium.
  • a second catheter 2320 is being advanced through the esophagus 2320.
  • Figure 2 shows an enlarged view of the device of Figure 1, with the loops surrounding the outlet of the pulmonary veins 210.
  • the device may be used as a temporary platform, or scaffold, from which therapeutic fluids or energy can be deployed. Alternatively, the device may be left in place as a permanent implant.
  • the device 200 may have a gap of incomplete contact between the device and target tissue, the device is still effective, as described below, especially when used conjunction with tissue disrupting energies (electroporation or sonoporation), energies that promote fluid flow (electrophoresis or sonophoresis), and energies that promote scaffold vibrations.
  • tissue disrupting energies electroporation or sonoporation
  • energies that promote fluid flow electroporation or sonophoresis
  • energies that promote scaffold vibrations Many types of energies can be delivered to the scaffold either directly, or indirectly. Indirect application (using non-contact means) of energies can be applied trans-esophageally, trans- bronchially, trans-tracheally, trans-thoracically, across the sternum, etc.
  • Figure 3 shows the reverse side of the device of Figures 1 and 2.
  • the reverse side's loop section 320 is shown having a multitude of holes, or micro-ports 330, that lie adjacent to the atrial walls.
  • the micro-ports can be laser cut along the mural facing surface of the device.
  • the micro-ports direct fluids within the device to be released into adjacent tissues. Fluids within the device may include alcohol, potassium iodide, therapeutic drugs, etc.
  • the devices of the present invention may not have any micro-ports, and instead be used as a heat exchanger.
  • a heat removing fluid could be circulated within the device, thus giving rise to a temporary conduction block in the adjacent tissue.
  • the device 300 can be used a diagnostic tool, for determining the origin of ectopic pacemakers, for example.
  • the heat removal aspect of the device could result in permanent conduction block, tissue shrinkage (to tighten the skin, for promoting valve function, or close off an atrial appendage), etc.
  • the device's annular base 310 is positioned to surround the mitral annulus.
  • the loop section 320 is supported by upright members 315.
  • the loop section 320 is in fluid communication with the catheter via the inlet port 340.
  • this device may be used to prevent AF, but in a manner that differs from the Cox Maze procedure.
  • a specific pattern is cut into the heart to create a proper pathway for the signal generated from the SA node to travel throughout the heart.
  • the device shown differs in that it does not create a signal pathway, but rather isolates unwanted signals from propagating. The procedure is intended for use by an interventional electro- cardiologist, or other skilled professional.
  • Figure 4 shows an embodiment of the invention 400, in fluid communication with a catheter 410.
  • the catheter 410 may be introduced into the femoral vein, and advanced through the vena cava into the right atrium.
  • the catheter may be 12 to 14 French in diameter and approximately 150 centimeters long, depending on the dimensions of the patient's anatomy.
  • An exemplary catheter 410 is shown to have a guide wire port 420, a thru lumen port 430, and an ablation agent vent 440. Not shown is an ablation agent inlet port.
  • Preferred ablation agents are alcohol, or potassium iodide.
  • the catheter may be introduced into the patient under fluoroscopic guidance and advanced through the venous return to the right atrium of the heart. Using standard cardiology procedures, a trans-septal puncture will be performed and the catheter 410 may be advanced through the trans-septal puncture into the left atrium. Guide wires may be advanced into the atrial appendage, the mitral valve annulus and one of the pulmonary veins.
  • the device is preferably designed from a biocompatible, super-elastic material that will expand aggressively under the effects of body heat, or with the aid of an inflatable balloon. Under continued fluoroscopic guidance with the adjunctive capability for verification by intravascular ultrasound, the cardiologist will ensure that the device has expanded completely, and is positioned correctly and in close contact with surrounding heart wall.
  • Conduction block lines preferably fully transect the myocardium of the atrium (about 3 to 5 millimeters in thickness). Once the conduction block has been completed, the device may be removed from the patient.
  • the proximal end 520 of the device is positioned adjacent the trans-septal entry point.
  • the opposition member 540 is positioned along the anterior wall, opposite the pulmonary veins. The opposition member functions to transmit mural pressure from the atrium through the device to the tubules.
  • the superior tubule, 530 is positioned adjacent the apex of the left atrium.
  • the inferior tubule, 560 is positioned adjacent the base of the posterior wall.
  • the tubules, 530 and 560 have a multitude of micro-ports 500. The micro-ports allow a fluid to be released from inside the tubules and into the atrial walls.
  • Figure 6 is a frontal view of the device of Figures 4 and 5.
  • An additional aspect of the device includes an orienting structure, so that the device takes advantage of anatomical features to achieve proper orientation within a heart chamber.
  • Figure 6 shows a circular structure 600 projecting from the distal end of the device. This circular projection may be positioned within an atrial appendage to aid with orientation of the device. This may be designed in the shaped of a pigtail, or corkscrew projecting from the distal end of the device.
  • Figure 7 is a longitudinal cross section of one embodiment of a tubule 720, having several micro-ports 730. The tubule 720 is encased within a sleeve 710.
  • a preferred sleeve 710 is a polymeric sleeve made from sintered gel.
  • the sleeve 710 functions as a diffusion barrier so that when fluid is released from the tubule 720, it is slowed down and allowed to diffuse into the adjacent atrial wall, rather than be released like a jet into the surrounding atrial wall.
  • the sleeve 710 also promotes an equal distribution of fluid throughout the tubule 720.
  • Figure 8 shows a radial cross section of the tubule shown in Figure 7.
  • Nitinol is a material that may be used for the tubule 720.
  • Figures 9 and 10 show alternative tubule 910 designs, wherein the micro-ports are filled with porous plugs 920.
  • a preferred porous plug 920 is comprised of sintered gel beads formed into a porous plug.
  • Figure 11 shows a catheter being introduced from the inferior vena cava 1110, into the right atrium 1140, through a septum 1120 between the right and left atrium, and into the left atrium 1150.
  • This figure illustrates a pump 1130 positioned within a catheter 1180.
  • the pump 1130 may be a piezoelectric pump used to drive fluid out through the micro-ports of the tubules.
  • Figure 12 illustrates an embodiment of the invention 1200 that may be used to deliver energy to designated tissue.
  • the device is shown connected to an energy component 1210 that may be a generator, defibrillator, pacemaker, or radio frequency device, that has been positioned underneath the skin (subclavian pocket) and that makes its way into the superior vena cava via the subclavian vein.
  • the device structure 1220 shown within the superior vena cava may function as a transformer, capacitor, or electrode.
  • Figure 13 shows an embodiment of the invention, and the use of an energy source 1310 to deliver energy to devices of the present invention.
  • the in-line member 1320 could be a transformer, capacitor, or electrode, depending on the need.
  • Figure 14 shows an embodiment of the invention 1400 having a positioning structure 1410 to standardize scaffold orientation within a treated heart chamber.
  • the positioning structure 1410 is shown being introduced to a pulmonary vein.
  • Figures 15 through 18 illustrate various embodiments of the invention.
  • Figure 15 shows a scaffold in the form of a wire coil that, when deployed, closely conforms to the interior of a patient's heart chamber, such as the patient's left atrium in the example shown.
  • the deployed scaffold has an approximately cylindrical configuration.
  • the wire coil of the scaffold may be constructed of a malleable or elastic biocompatible metal, such as stainless steel or a super-elastic or shape memory nickel/titanium alloy, for example.
  • the scaffold is sufficiently flexible such that it does not interfere with the normal contraction of the heart.
  • the wire coil may have a coating for improved biocompatibility, thermal and/or electrical insulation, etc.
  • FIG 16 shows another embodiment for the scaffold 1600 of present invention.
  • the scaffold is in the form of a wire cage that, when deployed, closely conforms to the interior of a patient's heart chamber, such as the patient's left atrium.
  • the deployed scaffold may have a dome-shaped or tapered cylindrical configuration, with an upper loop and a lower loop joined by longitudinal struts.
  • FIG 17 shows another embodiment for the scaffold 1700 of present invention.
  • the scaffold is in the form of a hoop-and-strut wire cage that, when deployed, closely conforms to the interior of a patient's heart chamber, such as the patient's left atrium.
  • the deployed scaffold may have a dome-shaped or tapered cylindrical configuration, with an upper hoop, a middle hoop and a lower hoop joined by longitudinal struts.
  • Figures 19 through 22 show various embodiments of the invention having dual chamber structures.
  • Figures 23-25 show schematic views of a patient with a catheter 2340 being advanced from the inferior vena cava 2330, into the right atrium, and across the septum into the left atrium.
  • a second catheter 2320 is being advanced through the esophagus 2320, and its close proximity to the left atrium makes it a suitable pathway for delivering a non-contact energy source, such as ultrasound (preferably low frequency ultrasound, below 1 MHz), radio frequency, or an inductive coupling mechanism.
  • Alternative non-contact energy source include microwaves. These energy sources can be applied to various devices to encourage the flow of ions in a prefe ⁇ ed direction, encourage fluid absorption, or cause ablation to occur.

Abstract

Les dispositifs de l'invention forment une plate-forme, ou un échafaudage, pour l'administration précise de diverses formes d'énergie destinées au traitement d'une fibrillation auriculaire. Les dispositifs de l'invention forment en outre un échafaudage pour l'administration précise de fluides à des tissus environnants. L'utilisation de sources d'énergie supplémentaires peut améliorer l'administration de divers fluides dans le tissu environnant.
EP02800429A 2001-10-01 2002-10-01 Methodes et dispositifs de traitement d'une fibrillation auriculaire Withdrawn EP1434621A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US326590P 2001-10-01
PCT/US2002/031374 WO2003028802A2 (fr) 2001-10-01 2002-10-01 Methodes et dispositifs de traitement d'une fibrillation auriculaire

Publications (1)

Publication Number Publication Date
EP1434621A2 true EP1434621A2 (fr) 2004-07-07

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Application Number Title Priority Date Filing Date
EP02800429A Withdrawn EP1434621A2 (fr) 2001-10-01 2002-10-01 Methodes et dispositifs de traitement d'une fibrillation auriculaire

Country Status (2)

Country Link
EP (1) EP1434621A2 (fr)
WO (1) WO2003028802A2 (fr)

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