EP1218056A1 - Techniques et appareil permettant de deployer des electrodes cardiaques pour un traitement electrique - Google Patents

Techniques et appareil permettant de deployer des electrodes cardiaques pour un traitement electrique

Info

Publication number
EP1218056A1
EP1218056A1 EP00968445A EP00968445A EP1218056A1 EP 1218056 A1 EP1218056 A1 EP 1218056A1 EP 00968445 A EP00968445 A EP 00968445A EP 00968445 A EP00968445 A EP 00968445A EP 1218056 A1 EP1218056 A1 EP 1218056A1
Authority
EP
European Patent Office
Prior art keywords
heart
electrode
electrode structure
defibriuation
energy
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Withdrawn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
EP00968445A
Other languages
German (de)
English (en)
Inventor
Robert F. Buckman
Gregory T. Yocum
Jay A. Lenker
Robert A. Lawson
Rodney A. Brenneman
Stephen C. Masson
Keegan Harper
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.)
TheraCardia Inc
Original Assignee
TheraCardia 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 TheraCardia Inc filed Critical TheraCardia Inc
Publication of EP1218056A1 publication Critical patent/EP1218056A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Definitions

  • the present invention relates generally to medical devices and methods. More particularly, the present invention relates to devices and methods for performing minimally invasive direct cardiac defibriUation, pacing, monitoring, and massage. Sudden cardiac arrest is a leading cause of death in most industrial societies. While in many cases it is possible to re-establish cardiac function, irreversible damage to vital organs, particularly the brain and the heart itself, will usually occur prior to restoration of normal cardiac activity.
  • CCM cardiopulmonarv resuscitation
  • ECG electrocardiogram
  • Those patients found to be suffering from a heart arrhythmia should also be treated with direct current defibriUation to effect electrical cardioversion to a more stable heart rhythm.
  • Direct current defibriUation is performed using electrical countershock by placing defibrillating pads on the patient's chest.
  • a countershock typically in the range from 200 to 300 joules. If the initial countershock is unsuccessful, a second shock in the same energy range is given. If the arrhythmia persists, a third countershock at a higher energy level, typically about 360 joules, is used.
  • the availability of direct current defibriUation has enabled the saving of thousands of lives each year. It is effective in treating patients for whom no alternative therapies would be available. Despite such success, the need to use such high energy levels can itself cause injury to the patient. Many patients who have been successively revived using defibriUation suffer damage to the electrical pathways in the heart and require pacemakers and/or internal cardiac defibrillators for the rest of their lives.
  • 3,496,932 describes a sharpened stylet for introducing a cardiac massage device to a space between the sternum and the heart.
  • Cardiac assist devices employing inflatable cuffs and other mechanisms are described in U.S. Patent Nos. 5,256,132; 5,169,381; 4,731,076; 4,690,134; 4,536,893; 4,192,293; 4,048,990; 3,613,672; 3,455,298; and 2,826,193.
  • Dissectors employing inflatable components are desc ⁇ bed in U.S. Patent Nos.
  • the present invention provides improved methods, apparatus, and kits, for defibrillating a patient suffering from cardiac arrhythmia, such as ventricular fibrillation, ventricular tachycardia, ventricular bradycardia, electromechanical dissociation, and in some cases, even patients initially presenting in asystole.
  • cardiac arrhythmia such as ventricular fibrillation, ventricular tachycardia, ventricular bradycardia, electromechanical dissociation, and in some cases, even patients initially presenting in asystole.
  • the present invention is particularly useful for patients in sudden cardiac arrest and even more particularly useful for patients in sudden cardiac arrest who are simultaneously undergoing minimally invasive direct cardiac massage.
  • the prior art recognizes the desirability of combining direct cardiac massage with defibriUation, pacing, cardioversion, and/or monitoring
  • the devices described for performance of such combined therapies are far from optimized, at best, the prior art teaches that relatively simple electrode structures can be provided on a direct cardiac massage device or that electrodes which are not optimized for performing direct cardiac massage may be utilized for defibriUation.
  • the present invention provides a number of specific improvements for both the methods and apparatus used for the minimally invasive defibriUation, monitoring, and pacing, of patients in sudden cardiac arrest.
  • the present invention still further provides apparatus and kits which are optimized for performing such methods, particularly where the devices may also be used for direct cardiac compression.
  • methods according to the present invention comprise defibrillating a patient's heart.
  • An electrode structure having an active electrode surface area of at least 10 cm 2 , preferably at least 20 cm 2 , and most preferably in the range from 25 cm 2 to 80 cm 2 is percutaneously introduced to a region over the heart.
  • the electrode structure is contacted against the heart, and defibriUation energy applied to the heart through the electrode structure. Utilization of an electrode structure having the above minimum areas is advantageous since it reduces the current density entering the heart through any localized region.
  • the defibriUation energy can be applied in a bipolar fashion, e.g., using electrically isolated regions on the electrode structure where said regions are attached to opposite poles of the direct current defibriUation source.
  • one or more active electrodes could be formed on the region of the device which contacts the heart, while a counter electrode could be formed on a portion which contacts other than the heart, e.g., a counter electrode could be positioned to contact an inside surface of the rib cage or other segment of the inner thoracic cavity wall.
  • a counter electrode could be positioned to contact an inside surface of the rib cage or other segment of the inner thoracic cavity wall.
  • the defibriUation energy will be applied to the patient in a monopolar fashion, where the electrode structure contacted against the heart, is attached to one pole of the defibriUation power supply controller and a counter electrode is attached to the other pole of the power supply controller.
  • the counter electrode will usually be placed on the patient's skin, typically on the patient's back or left side so that the direct current countershock can be applied to the heart along an anterior-posterior axis.
  • the electrode structure can be divided into two or more electrically isolated regions which can be separately energized.
  • the regions can be separately but simultaneously energized from opposite poles of the power supply controller, providing bipolar defibriUation as mentioned above.
  • the isolated regions of the electrode structure can be energized with a common polarity but in a pre-determined time sequence selected to optimize the defibriUation.
  • the geometry and time sequence will be selected to mimic the normal electrical current flow responsible for heart contraction in the patient. In such instances, the heart will usually be contacted with at least two isolated regions, and frequently as many as four or more isolated electrode regions.
  • the sequential firing of the regions will typically occur within a very short total elapse time, typically less than 500 msec, usually less than 100 msec, with individual defibriUation energy bursts occurring within 50 msec, usually 10 msec or less.
  • a preferred determined time sequence and firing pattern will be selected to match the normal firing pattern of the heart, i.e., with isolated electrode structures engaging and stimulating the right atrium, right ventricle, left atrium, and left ventricle in that order.
  • preferred electrode structures will have isolated regions which are capable of contacting each of these regions of the heart with minimal or no cross-over to the adjacent regions.
  • the electrode structure will have an axis which is intended to be aligned with the heart in a pre-determined manner.
  • the axis will be intended to be aligned with the apex-to-base axis of the heart, for example, over the primary conductive bundle of the heart.
  • the methods of the present invention may further comprise aligning the electrode structure p ⁇ or to applying defibriUation energy.
  • alignment may be achieved by providing suitable markings on a handle of the apparatus which carries the electrode structure so that a user can visually align the handle to achieve the proper alignment of the electrode structure.
  • various automatic means can be provided for aligning the electrode structure.
  • the electrode structure will include at least two electrode regions with a space therebetween.
  • the space between the electrode structures may be positioned over the primary conductive bundle of the heart so that defibriUation energy being delivered by the electrode structure will not pass directly into the conductive bundle, thus lessening the risk of damaging the conductive bundle.
  • the two regions can be placed generally over the atrial and ventricular regions of the heart, respectively.
  • defibriUation By applying the electrode structure directly to the surface of the heart, usually directly over the pericardium, the total amount of energy needed for defibriUation is greatly reduced when compared to external defibriUation.
  • defibriUation according to the present invention will require a total amount of energy in the range from two joules, to 200 joules, usually from 20 joules to 80 joules for biphasic defibriUation.
  • Monophasic defibriUation will usually require more energy, typically about twice the values set forth above.
  • the energy per unit area is further reduced, greatly reducing the risk of damage to the heart and its electrical conduction system.
  • methods for defibrillating the heart comprise compressing the heart and selectively applying defibriUation energy to the heart while compressed.
  • the heart is compressed to a pre-defined maximum level of compression, and the defibriUation energy is applied to the heart only while the heart is compressed at some level close to the maximum level of compression, typically at least 50% of the maximum level of compression, preferably at least 75% of the maximum level of compression, and still more preferably at least 90% of the maximum level of compression.
  • Applying the defibriUation energy while the heart is compressed has a number of advantages. First, the hydraulic load on the heart is reduced since the blood has been substantially expelled from the ventricles. Thus, the load on heart muscle for the next heart beat is lessened. Second, the electrode impedance is significantly reduced so the required current is lessened. The level of compression will typically be measured in terms of the degree to which the ventricular chambers have been emptied.
  • the heart will be compressed using an electrode structure contacted against a surface of the heart, typically the pericardium, where the electrode structure can be used to apply the defibriUation energy at the appropriate point of compression.
  • compression is in the anterior-posterior direction, and the electrode structure is preferably percutaneously introduced, as described elsewhere in this application and in the patents and copending applications which have been incorporated herein by reference.
  • the electrode structure is introduced intercostally in a low-profile configtiration and subsequently expanded over the heart in order to deploy the electrode structure in a desired manner.
  • the heart function will be assessed before and/or after applying defibriUation.
  • Assessment before applying defibriUation can determine whether it is necessary to apply such defibriUation energy.
  • Assessment after applying defibriUation energy will reveal whether electrical function of the heart has been improved or whether further defibriUation energy is necessary.
  • Assessment is typically performed using conventional ECG techniques where the electrode structure used for defibriUation may also be used for monitoring.
  • methods for defibrillating a patient' s heart comprise contacting a surface of the heart with a plurality of isolated electrode regions and delivering defibriUation energy to the heart by selectively energizing said isolated electrode regions in a pre-determined sequential pattern.
  • cardiac electrode deployment devices comprise a support and an electrode structure attached to the support.
  • the electrode structure will have an active surface area of at least 20 cm " , with preferred surface areas set forth above.
  • the electrode structure is configured to engage against an outer surface of the heart, such as the pericardium, in order to provide electrical contact with the heart.
  • the support may be any assembly, structure, system, or other mechanical framework which is suitable for positioning and manipulating the heart-engaging member so that it can engage and compress the heart.
  • the support could be a simple handle or shaft having the heart-engaging member attached at a distal end thereof. Once the heart-engaging member is deployed, cardiac defibriUation and optionally massage can be performed by energizing the electrode structure and by simple manual pumping or reciprocation of the handle or shaft.
  • the support comprises a shaft together with a sheath which is coaxially received over the shaft. The shaft and sheath may be manipulated relative to each other to deploy and retract the heart-engaging member, as described in more detail hereinbelow.
  • supports which comprise powered drivers, such as electric, pneumatic, or other motors.
  • drivers can be provided as part of the support, where the driver may be disposed externally, internally, or both externally and internally relative to the patient when the heart-engaging member is deployed over the pericardium.
  • the electrode structure on the deployment device will be collapsible, i.e., it will be capable of being shifted between a low profile configuration suitable for intercostal introduction to a region over the patient's heart to an open configuration where the entire active support area of the electrode can be engaged against the heart.
  • the electrode structure is mounted on a plurality of struts which are reciprocatably attached to the support. The struts are retractable to a radially contracted configuration and advancable along arcuate, diverging paths to define a surface which non-traumatically engages the pericardium to compress the heart when advanced against the pericardium.
  • the struts will typically be composed of a resilient material, more typically be composed of a shape memory alloy, such as nickel titanium alloy, and will usually be formed to deploy radially outwardly and advance along the desired arcuate, diverging paths as they are advanced from a constraining member, usually a tubular sheath.
  • the struts may be advanced and retracted relative to the sheath using any suitable mechanical system, typically a shaft which reciprocates together with the struts through a lumen of the sheath.
  • the struts with a temperature-responsive memory so that the shape of the struts will change in response to a transition from room temperature to body temperature and/or in response to an induced temperature change after they have been deployed, e.g., by electrically heating or cooling the struts and/or infusing a heated or cooled medium into the space surrounding the struts.
  • the active surface area of the electrode structure comprises a plurality of electrically isolated regions where the support includes separate electrical conduction paths connected to each electrically isolated region.
  • the conduction paths allow the regions to be separately connected to an external power supply controller.
  • Exemplary isolated region geometries include spaced-apart semi-circles, concentric rings, spaced-apart concentric rings, pie-shaped sections, concentric pie-shaped ring sections, rectilinear arrays, and the like.
  • two, three, or more, of the isolated electrode segments can be chosen to perform ECG monitoring of the patient at any time the electrode structure is in contact with the heart and defibriUation energy is not being applied using the structure.
  • the electrode structures are also suitable for performing defibriUation in a variety of ways. Most simply, all isolated regions could be energized simultaneously at a common plurality or in a bipolar fashion in order to perform a monopolar defibriUation treatment with the advantage that the surface electrode area is maximized. Alternatively, selected isolated regions could be energized in a monopolar or bipolar fashion with regions over the electrically conductive bundle being un-energized.
  • the isolated electrode regions could be energized in a progressive, sequential matter in order to perform optimized monopolar and bipolar defibriUation.
  • the use of isolated regions on the electrode allows sensitive regions on the heart to be protected. In particular, by spacing apart two or more electrode regions on opposite sides of the conductive bundle, damage to the conductive bundle from electrical discharge is minimized.
  • the present invention still further provides systems employing a cardiac deployment device as described above in combination with a power supply controller which may include the circuitry and programming necessary for performing defibriUation, ECG monitoring, pacing, cardioversion, and the like.
  • the systems may further comprise a counter electrode for performing monopolar treatments.
  • the present invention will also comprise kits including a cardiac electrode deployment device in combination with instructions for use setting forth any of the methods described above.
  • FIG. 1 is schematic illustration of a cardiac electrode deployment device constructed in accordance with the principles of the present invention.
  • Figs. 2A-2H illustrate alternative electrode structure configurations for the device of Fig. 1.
  • Fig. 2AA illustrates an exemplary electrically conductive fabric comprising conductive and non-conductive threads.
  • Fig. 3 is a perspective view of an exemplary cardiac electrode deployment device of the present invention.
  • Fig. 4 is a detailed view of the distal end of the device of Fig. 3 shown with the electrode deployment structure in its open or expanded configuration.
  • Figs. 5 and 6 illustrate an alternative, hinged-strut structure in a retracted and deployed configuration, respectively.
  • Figs. 7A-7C illustrate use of the device of Figs. 3 and 4 in the simultaneous cardiac compression and cardiac defibriUation methods of the present invention.
  • Fig. 7D illustrates use of a device having an integral counter electrode configured to engage an interior surface of the patient's rib cage.
  • Fig. 8 is a chart illustrating an exemplary treatment protocol according to the methods of the present invention.
  • Fig. 9 illustrates an exemplary kit constructed in accordance with the principles of the present invention.
  • the methods, apparatus, and kits, of the present invention rely on contacting an electrode structure directly against a patient's heart to deliver defibriUation energy to the heart.
  • the electrode structures may comprise a wide variety of specific designs, but will typically include an electrically conductive surface which is configured to directly engage the pericardium or other heart surface.
  • the electrically conductive surface will usually, but not necessarily, be compliant (elastic or non-elastic) so that it can conform to the heart tissue when the electrode structure is engaged against the heart.
  • the electrically conductive surface may be formed entirely from a conductive metal or electrically conductive fibers, e.g., be woven from metal filaments, or may be formed from an electrically insulating backing which is coated with an electrically conductive surface material, typically by plating, sputtering, plasma deposition, or the like.
  • the electrically insulating backing may be formed from a mesh, fabric, polymeric film, or the like.
  • the electrically conductive surface will have an area within the ranges set forth above and may have any one of a wide variety of particular geometries, as discussed in more detail below in connection with Figs. 2A-2H.
  • the electrode structures be compliant or otherwise conformable to the heart surface
  • the present invention will find its greatest use in minimally invasive procedures where the electrode structure is introduced to a region over the heart via a percutaneous access route.
  • a preferred percutaneous access route is intercostal, typically through the fourth or fifth infracostal space and directly over the heart.
  • the electrode structure may be introduced in a generally anterior-posterior direction so that direct compression of the heart could be achieved by engaging electrode structure against the heart. More specifically, the electrode structure will usually engage the pericardium covering the heart.
  • the following description will refer to engaging the heart. In come cases it might be possible to engage the epicardium directly, but such an approach will be less preferred.
  • the electrode structure could be introduced via a subxiphoid approach, i.e., from a point below the sternum to a region above the heart.
  • the handle of the device When the anterior-posterior approach is employed, the handle of the device will preferably be introduced through an intercostal space in the patient's left rib cage (over the heart), with the handle of the device inclined in the mid-sagittal plane, typically at an angle in the range from 20° to 45° toward the patient's right side, so that the device compresses the heart toward the patient's spine.
  • the handle Preferably, the handle will have little or no inclination in the cranial-caudal plane.
  • the electrode structure will be collapsible, i.e., be shiftable between a low profile configuration where it can easily be introduced in either the intercostal or subxiphoid approach and thereafter deployed at the target region to expand the surface area of the electrode to its desired size.
  • electrodes which are formed from or on a film, mesh, fabric, or other foldable material, electrode structures may be folded or otherwise collapsed prior to introduction and deployment.
  • the electrode structures will be capable of being collapsed to a profile having a width (or diameter when circular) no greater than 20 mm, preferably no greater than 15 mm.
  • the electrode structures will be used to deliver defibriUation energy directly to the heart.
  • the defibriUation energy may take any of the forms which are conventionally used or which have been suggested for use in external or internal defibriUation.
  • Such waveforms are generally classified as either monophasic or biphasic. In monophasic waveforms, the current travels in only one direction, i.e., from a positive defibrillator electrode to a negative defibrillator electrode. Thus, monophasic waveforms have only one phase and no change in polarity.
  • biphasic waveforms In biphasic waveforms, the current travels in one direction stops, and then is reversed to travel the opposite direction, biphasic waveforms thus have two phases with polarity changing with the phase change.
  • Current defibriUation waveforms may be further classified as either truncated exponential or damped sine.
  • the present invention will preferably use a biphasic, truncated exponential waveform.
  • variable energy could be used, i.e., starting at a low energy level and being raised to a higher energy level.
  • automatic sensing of impedance could be provided, allowing for automatic adjustment of energy output.
  • the defibriUation energy will be applied at levels in the ranges defined above.
  • the electrode structures may be utilized for pacing.
  • Pacing requires at least one isolated electrode region on the heart to deliver an electrical current pulse to induce heart contraction, with a series of such pulses along with and through electrode structures elsewhere on the body delivered at the rate of heart compression.
  • the amplitude of such pacing pulses will be significantly smaller than those utilized for defibriUation, typically being in the range from 5 mA to 200 mA, usually in the range from 10 mA to 100 mA.
  • the pacing pulse may take the form of any conventional cardiac pacing pulse waveform, e.g., square wave, sine wave, BTE, or other suitable waveform including truncated exponential and combination waveforms.
  • the negative pulse of the biphasic waveform is typically shorter than the positive pulse and has a sharp end point that does not tail off to zero.
  • switching or sensing apparatus can be applied to coordinate the delivery of a pacing shock with the heart compression.
  • a motion or other limit switch could be provided to deliver the pacing shock at a pre- determined, repeatable point in the compression cycle which is being induced by direct cardiac massage, usually at the beginning of a compression cycle.
  • the electrode structures may also be utilized and configured to permit ECG monitoring.
  • the same transmission lines which connect the isolated region(s) of the electrode structure can be connected to conventional ECG monito ⁇ ng circuitry within the power supply controller or other control box.
  • at least two electrode regions, and preferably three or more electrode regions can be used for ECG monitoring.
  • additional ECG electrodes could be placed externally on the patient's skin.
  • the treating professional can estimate the duration of ventricular fibrillation, in order to determine how the defibriUation shock may best be administered. If it appears that the patient has been in fibrillation for greater than a pre-determined period of time, such as five minutes, the professional may determine that pharmacological or other mechanical therapies are necessary.
  • the ECG could also be used to determine the appropriate timing for pacing the heart.
  • the ECG could further be used to confirm and/or adjust the position of the electrode structure on the heart based on expected waveforms, etc.
  • Cardiac electrode deployment device 12 is part of a system 10 which further includes power supply controller 14 and optionally a counter electrode 16.
  • Power supply controller 14 contains the circuitry necessary for producing the defibriUation energy, pacing energy, ECG monitoring, and optionally cardioversion energy which can be delivered or sensed by the electrode structure 18 which is shown in its deployed configuration in broken line.
  • Electrode structure 18 is preferably shiftable between a low profile configuration (where it is drawn rearwardly) into delivery cannula 20 and the deployed configuration shown in broken line. Most simply, the electrode structure can be formed from a plurality of resilient struts having an active electrode surface 22 at their forward ends.
  • the struts may be collapsed inwardly by drawing shaft 24 rearwardly relative to the cannula 20, thus drawing the electrode structure 18 into the cannula.
  • the electrically conductive surface 22 will be connected to the power supply controller 14 through a connecting cable 26. Usually, at least one connector will be provided for each electrically isolated region within the active electrode area 22, as described in more detail below.
  • the active electrode surface 22 may have a wide variety of configurations.
  • the electrode surface will have a generally circular periphery, although other peripheral geometries, such as ovoid, rectangular, triangular, irregular, and the like, could also be utilized.
  • the most simple electrode surface geometry is illustrated in Fig. 2A, where the surface 22a comp ⁇ ses a single, continuous electrode covering the entire circular area of the electrode structure.
  • the electrically conductive surface may be formed in any of the ways described above.
  • the electrode can be formed from a wide variety of conformable, electrically conductive materials or composites. Usually, the materials will be flexible but non-distensible, most usually being formed from non-distensible fabrics. In one instance, the fabrics can be metalized, for example by vapor deposition or plating (either electro or electroless) of a conductive metal surface over a fabric matrix. More usually, however, the conductive fabrics will be formed by weaving at least part of the fabric from a metal, preferably in both directions of the weave, but in some cases only in a single direction.
  • the metal filaments in the fabric may be disposed at each strand or fiber, optionally at every other strand or fiber, usually will be placed at least once every 100 strands or fibers, more usually at at least every tenth strand.
  • the other strands or fibers may be formed from electrically non-conductive materials, such as polyester.
  • the fabric 400 comprises warp 402 and woof 404 threads which are woven at right angles in a conventional pattern.
  • the warp threads 402 and the woof threads 404 will be electrically conductive, most preferably being a metal, such as gold, silver, stainless steel, or other electrically conductive medically acceptable metal.
  • the conductive and non-conductive threads will be arranged in an alternating pattern as illustrated. Such an alternating construction provides very uniform strength and electrical conductivity characteristics.
  • a first alternative electrode configuration 22b is shown in Fig. 2B, where a pair of semi-circular electrode regions 30 and 32 are spaced-apart on the exposed surface of the electrode structure.
  • the two isolated regions are electrically isolated from each other and connected independently through the shaft 24 by isolated electrical connectors. This way, the electrode regions 30 and 32 can be energized separately or commonly, depending on how the power supply controller 14 is arranged.
  • the isolated electrode configuration of Fig. 2B is particularly useful for applying to the surface of the heart so that the non-electrode region 34 can be placed over the conductive bundle of the heart. In this way, the conductive bundle can be protected from direct delivery of electrical current.
  • a second alternative configuration comprising a pair of concentric ring electrodes is shown in Fig. 2C.
  • the concentric ring electrodes could also be laterally spaced-apart, as shown in the electrode surface 22d shown in Fig. 2D.
  • the plurality of opposed C-shaped electrode surfaces 40, 42, 44, and 46 may be formed on the electrode support.
  • FIG. 2E An electrode surface 22e comprising four pie-shaped isolated electrode regions 50, 52, 54, and 56, is illustrated in Fig. 2E.
  • a similar electrode surface 22f comprising eight pie-shaped isolated electrode regions 62-74 is illustrated in Fig. 2F.
  • An additional electrode configuration 22g comprising four pie-shaped electrodes further divided into concentric rings, for a total of eight isolated electrode regions 80-94 is illustrated in Fig. 2g.
  • a rectilinear array of electrode regions 22h is illustrated in Fig. 2H.
  • electrode configurations can easily be fabricated using a variety of metal deposition techniques, where an electrically conductive metal, such as titanium, stainless steel, silver, gold, and copper, can be deposited, plated, or otherwise coated and patterned onto a suitable electrode substrate.
  • an electrically conductive metal such as titanium, stainless steel, silver, gold, and copper
  • the sleeve 102 includes a positioning flange 110 near its distal end, typically spaced proximally of the tip 112 of the device by an optimum distance, generally as set forth above.
  • a blunt cap 120 is positioned at the distal-most end of the device 100 and facilitates entry of the device into the chest cavity by blunt dissection, as described in more detail hereinafter.
  • a flared bell structure 130 is attached to the distal end of shaft 104 and assumes a trumpeted configuration when fully deployed, as shown in both of those figures.
  • the flared bell structure 130 comprises a plurality of outwardly curving struts 132 (the illustrated embodiment has a total of eight struts, but this number could vary).
  • the struts are preferably formed from a resilient metal, usually formed from a superelastic alloy, such as nitinol. The use of such resilient materials will not always provide the degree of rigidity desired for the forward surface 136 (Fig. 6) of the flared bell structure.
  • re- enforcing beams 138 may be provided. It has been found that the combination of the curved struts with straight beam supports provides a useful combination of stiffness over the proximal portion of the structure and greater flexibility at the tip portions.
  • the blunt cap 120 is mounted on a rod 140 (Fig. 6) having an electrical connector 142 at its proximal end.
  • a rod 140 Fig. 6
  • the forward tip of the sleeve will engage the rear of the end cap 120, as best seen in Fig. 18.
  • end cap 120 will be free to move axially. In use, the end cap will typically be withdrawn proximally into the interior of the structure 130.
  • the distal tips of the struts 130 are preferably connected by a fabric electrode structure 150 having an edge which is folded over and stitched to hold the cover in place.
  • the fabric cover may be a light mesh, composed of polyester or the like, and will help distribute forces quite evenly over the region of the pericardium which is contacted by the flared bell structure.
  • the fabric electrode structure 150 may have any of the configurations set forth above in Figs. 2A-2H.
  • the isolated region(s) on the electrode surface are electrically connected through a plurality of conductors (not shown) which terminate in the electrical connector 142.
  • the connector 142 will typically include an array of plug prongs or receptacles which permit inner connection of the connector with a cable, e.g., cable 26 as shown in Fig. 1.
  • the cable in turn, connects the device to a suitable power supply controller.
  • the electrode deployment device 100 can be introduced into a region over the heart and used for direct cardiac massage. Initially, a small incision I is made over the heart, preferably on the patient's left side between the forth and fifth ribs (R 4 and R 5 ). After the incision I is made, the device 100 is pushed through the incision with the blunt cap 120 bluntly dissecting tissue until the flange 110 engages the outer chest wall, as illustrated in Fig. 7B. At that point, the flared bell structure is still not deployed. The flared bell structure 130 is then deployed by advancing shaft 104 until a first marker 160 approaches the proximal end 162 of the sleeve 102.
  • the handle 106 may be manually grasped and the device shaft 104 pumped through the sleeve 102. This will cause the deployed flared bell structure 130 to engage the electrode surface against the heart.
  • the structure can then be advanced in a posterior direction to compress the heart, generally shown in broken line in Fig. 7C.
  • the handle will be inclined from 20° to 45° toward the patient's left in the mid-sagittal plane while being held generally vertically in the cranial-caudal plane. In this way, the electrode structure compresses the heart toward the patient's spine to maximize compression.
  • Defilation energy is then applied using a power supply 170 connected via a cable 172 to the electrode structure on the flared bell structure 130 and via a cable 174 to a counter electrode 180 which is usually disposed on the patient's back. Energy is applied according to the protocols described below.
  • the device 100 may be withdrawn by retracting the shaft 104 relative to sleeve 102 to draw the structure 130 back into the sleeve.
  • the structure 130 will be sufficiently retracted as soon as the second marker 162 becomes visible out of the proximal end of the sleeve.
  • the device may be proximally withdrawn through the incision and the incision closed in the conventional manner.
  • FIG. 8 A preferred protocol for utilizing the cardiac electrode deployment device to resuscitate a patient in cardiac arrest is shown in Fig. 8.
  • the heart may be compressed.
  • the electrically conductive surface of the bell structure 130 can be coated with an electrically conductive gel prior to introduction. The gel helps establish electrical contact and reduces the impedance between the electrically conductive surface and the heart. It will be necessary, however, when it is desired to retain electrically isolated regions, to make sure that the conductive gel does not short adjacent regions of the electrode structure.
  • the electrode structure on the device may be used to monitor the patient ECG.
  • the device can be used to perform compression until the situation is resolved, hopefully with the patient being resuscitated. If the observed ECG is not acceptable, the electrode structure can be used to apply defibriUation energy to the heart. Usually, defibriUation energy will be applied in a single step (although the step may be divided into a series of discreet, progressively more energetic applications of energy over a very short time period, as described above). After the single application of energy has been completed, heart function will again be assessed by ECG. If the initial defibriUation has been successful, the treatment can frequently be terminated or continued with compression alone, or compression plus pacing, until the patient is resuscitated.
  • the patient may again be defibrillated following direct cardiac massage. Third and subsequent defibriUation steps can further be provided until restoration of an acceptable ECG is achieved. If defibriUation continues to be unsuccessful, the patient can continue to be compressed until the situation is resolved, further surgical or other interventions are initiated, or there is no reason to continue cardiac compression.
  • the device 200 comprises a sleeve 202 and flared bell structure 230, as generally desc ⁇ bed above for the device 100.
  • the device 200 differs principally in that it includes an integral second electrode 240 which serves as a counter electrode in performing defibriUation according to the present invention.
  • the electrode 240 is expansible from a low profile configuration to an expanded configuration so that it can engage the interior thoracic wall, e.g., an interior surface of the rib cage, when the device 200 is deployed.
  • the electrode 240 will usually be attached to the sleeve 202 so that the elecfrode 240 remains generally stationary against the interior thoracic wall as the flared bell structure 230 (carrying the primary electrode structure) is reciprocated to compress the heart.
  • DefibriUation current can be applied by any of the protocols described herein, and the current wall will generally follow the flux lines 250 shown in Fig. 7D. Cables 270 at 274 connect the power supply 280 to the primary and counter electrodes on the device 200.
  • a kit 300 comprises a cardiac electrode deployment tool, such as device 100 described in detail previously, in combination with instructions for use IFU setting forth any of the methods described above.
  • the device and instructions for use will be combined in a suitable package P that can be in the form of any conventional medical device packaging, such as a tray, tube, box, pouch, or the like.
  • the instructions for use will usually be provided on a separate package insert, but could also be printed directly on all or a portion of the packaging P. Additional components, such as a counter electrode, could also be provided as part of the kit.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif de déploiement (12) d'électrodes cardiaques comprenant une structure d'électrodes (18) destinées à distribuer une énergie de défibrillation au coeur, à surveiller un électrocardiogramme, à distribuer une énergie d'entraînement, et/ou à distribuer une énergie de cardioversion. Ce dispositif est également approprié pour effectuer un massage cardiaque direct.
EP00968445A 1999-09-27 2000-09-27 Techniques et appareil permettant de deployer des electrodes cardiaques pour un traitement electrique Withdrawn EP1218056A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US40605099A 1999-09-27 1999-09-27
US406050 1999-09-27
PCT/US2000/026595 WO2001023035A1 (fr) 1999-09-27 2000-09-27 Techniques et appareil permettant de deployer des electrodes cardiaques pour un traitement electrique

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EP1218056A1 true EP1218056A1 (fr) 2002-07-03

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AU (1) AU7835800A (fr)
WO (1) WO2001023035A1 (fr)

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US10668270B2 (en) 2013-05-06 2020-06-02 Medtronic, Inc. Substernal leadless electrical stimulation system
US10933230B2 (en) 2013-05-06 2021-03-02 Medtronic, Inc. Systems and methods for implanting a medical electrical lead
US9220913B2 (en) 2013-05-06 2015-12-29 Medtronics, Inc. Multi-mode implantable medical device
US20140330287A1 (en) 2013-05-06 2014-11-06 Medtronic, Inc. Devices and techniques for anchoring an implantable medical device
US10556117B2 (en) 2013-05-06 2020-02-11 Medtronic, Inc. Implantable cardioverter-defibrillator (ICD) system including substernal pacing lead
US10471267B2 (en) 2013-05-06 2019-11-12 Medtronic, Inc. Implantable cardioverter-defibrillator (ICD) system including substernal lead
US9717923B2 (en) 2013-05-06 2017-08-01 Medtronic, Inc. Implantable medical device system having implantable cardioverter-defibrillator (ICD) system and substernal leadless pacing device
US10434307B2 (en) 2013-10-15 2019-10-08 Medtronic, Inc. Methods and devices for subcutaneous lead implantation
US10792490B2 (en) 2013-11-12 2020-10-06 Medtronic, Inc. Open channel implant tools and implant techniques utilizing such tools
US10531893B2 (en) 2013-11-12 2020-01-14 Medtronic, Inc. Extravascular implant tools with open sheath and implant techniques utilizing such tools
US10842988B2 (en) 2014-06-02 2020-11-24 Medtronic, Inc. Over-the-wire delivery of a substernal lead
US9636512B2 (en) 2014-11-05 2017-05-02 Medtronic, Inc. Implantable cardioverter-defibrillator (ICD) system having multiple common polarity extravascular defibrillation electrodes
US11083491B2 (en) 2014-12-09 2021-08-10 Medtronic, Inc. Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools
US10729456B2 (en) 2014-12-18 2020-08-04 Medtronic, Inc. Systems and methods for deploying an implantable medical electrical lead
US10349978B2 (en) 2014-12-18 2019-07-16 Medtronic, Inc. Open channel implant tool with additional lumen and implant techniques utilizing such tools

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WO2001023035A1 (fr) 2001-04-05
WO2001023035A9 (fr) 2002-10-03
AU7835800A (en) 2001-04-30

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