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WO2017023382A1 - Système et procédé de mise en place d'électrode dans le sac péricardique d'un patient - Google Patents

Système et procédé de mise en place d'électrode dans le sac péricardique d'un patient Download PDF

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Publication number
WO2017023382A1
WO2017023382A1 PCT/US2016/030902 US2016030902W WO2017023382A1 WO 2017023382 A1 WO2017023382 A1 WO 2017023382A1 US 2016030902 W US2016030902 W US 2016030902W WO 2017023382 A1 WO2017023382 A1 WO 2017023382A1
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WO
WIPO (PCT)
Prior art keywords
placement catheter
prong
electrode
catheter
myocardium
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Ceased
Application number
PCT/US2016/030902
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English (en)
Inventor
Guy P. Curtis
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Individual
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Individual
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Filing date
Publication date
Priority claimed from US14/815,711 external-priority patent/US20160310724A1/en
Application filed by Individual filed Critical Individual
Publication of WO2017023382A1 publication Critical patent/WO2017023382A1/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61N1/059—Anchoring means

Definitions

  • the present invention pertains to systems and methods for improving heart muscle function. More particularly, the present invention pertains to systems and methods which stimulate sympathetic nerves to secrete norepinephrine during the absolute refractory period of a heart muscle cycle, to thereby improve heart muscle contraction.
  • the present invention is particularly, but not exclusively, useful as a system or method wherein nerve stimulation in the absolute refractory period is triggered by a local electrical depolarization of the heart muscle.
  • a normal heart muscle cycle i.e. a heartbeat
  • a heartbeat is repetitive and is characterized by several well-known and distinctly identifiable mechanical and electrical characteristics.
  • the heart muscle In its mechanical cycle, the heart muscle alternately functions to pump blood into the vasculature of a patient by its contractions (systole), and to receive blood from the vasculature by its relaxation (diastole).
  • the heart muscle cycle is the result of an electrical cycle that is superposed on the mechanical cycle. Of immediate interest here, however, is the absolute refractory period.
  • the heart muscle is not able to respond to an electrical stimulation.
  • Sympathetic nerves on the epicardial surface of the heart can be electrically stimulated during the absolute refractory period to thereby secrete norepinephrine.
  • the import here is that the secreted norepinephrine can then subsequently assist in controlling and improving a heart muscle contraction. It is, of course, essential to stimulate the sympathetic nerve during the heart's absolute refractory period so that the electrical and mechanical cycles of the heart are not disturbed.
  • Identifying the appropriate time for electrically stimulating a sympathetic nerve must necessarily be established relative to the heart muscle cycle.
  • the timing for nerve stimulation has been determined by the operation of a pacing device.
  • U.S. Patent No. 8,463,376, which issued to Curtis for an invention entitled “System and Method for Transvascular Activation of Cardiac Nerves with Automatic Restart,” discloses and claims the electrically paced stimulation of a heart muscle.
  • the present invention now recognizes that the heart muscle itself creates natural signals (i.e. electrical events) which can be used to trigger a subsequent electrical stimulation of a sympathetic nerve. Importantly, this subsequent nerve stimulation can be timed to occur in the absolute refractory period of the heart muscle cycle.
  • an electrode To be effective, an electrode must be stabilized when it is used for the purpose of stimulating a sympathetic nerve to assist with a contraction of the patient's heart muscle. As disclosed elsewhere here, the required stabilization is provided for this purpose when the electrode is positioned in an epicardial vein, adjacent a sympathetic nerve, on the heart's epicardial surface. Other approaches for a proper electrode placement, however, are also anatomically possible. Of specific interest here is the potential space that exists between the myocardium and the pericardial sac.
  • an object of the present invention to provide a system and method for electrically stimulating a sympathetic nerve of a patient in response to a naturally occurring electrical event of the heart muscle.
  • Another object of the present invention is to electrically stimulate a sympathetic nerve of a patient using a single pulse, or multiple pulses, during the absolute refractory period of a heart muscle cycle to assist with a contraction of the patient's heart muscle.
  • Yet another object of the present invention is to stabilize an electrode in a position adjacent a sympathetic nerve to prevent electrode movements that could otherwise cause pericarditis or irritations due to possible tissue damage.
  • Still another object of the present invention is to provide a system and method for electrically stimulating a sympathetic nerve of a patient which is easy to use, is simple to manufacture and is commercially cost effective.
  • a system and method are provided to improve the heart contractions of a patient during a heart function cycle (heartbeat).
  • a deployment catheter is used to position an electrode and a sensor in an epicardial vein that is located on the epicardial surface of the heart. A proper positioning of the electrode and the sensor requires they be located adjacent a sympathetic nerve.
  • the present invention detects a local electrical event (depolarization) of the heart muscle. Based on the occurrence of this local electrical event at a time to, a stimulation interval, At, is established.
  • At begins at the time to, and it ends at a time during the absolute refractory period of the heart function cycle.
  • the sympathetic nerve which is located on the epicardial surface of the heart, is stimulated. With this stimulation the sympathetic nerve will secrete norepinephrine to improve a subsequent contraction of the heart.
  • a device of the present invention includes a sensor for detecting the local electrical event of the heart, at the time to.
  • a local electrical event is selected and used that occurs during a heart contraction, during diastole, in the patient's natural heart muscle cycle.
  • the device also includes a timer that is activated at the time to and is used for measuring the predetermined stimulation interval At.
  • the device includes a stimulator that is connected with an electrode for stimulating the sympathetic nerve with at least one electrical pulse at the time .
  • the electrical pulse(s) for stimulating the sympathetic nerve has(have) a predetermined intensity that is essentially less than about three times the intensity required for activating a contraction of the heart muscle.
  • the system of the present invention may also include a pacing device which, along with the sensor, can be selectively connected by a switch with the stimulator.
  • the pacing device when selected, is used to electronically establish to.
  • the switch can be used to selectively alternate between a connection of the stimulator with the sensor, or with the pacing device, the overall purpose and functionality of the system remains unchanged.
  • Additional components for the device of the present invention include a voltage source that will generate the electrical pulse at the time ti. These components also include a computer for coordinating an operation of the stimulator with respective operations of the sensor, the pacing device, the switch, and the timer.
  • a method for electrically stimulating a sympathetic nerve of a patient to improve heart function requires first positioning an electrode/sensor in an epicardial vein, on the epicardial surface of the heart, adjacent the sympathetic nerve. The electrode/sensor is then used to detect a local electrical event. Specifically, the local electrical event that is to be detected by the sensor needs to occur near the electrode and will result from the patient's natural heart muscle cycle.
  • a computer can then be used to establish a predetermined stimulation interval At that will extend from the start time to, to a time ti.
  • a predetermined stimulation interval At that will extend from the start time to, to a time ti.
  • the computer can then activate the stimulator at the time ti.
  • the purpose here is to electrically stimulate the sympathetic nerve with at least one electrical pulse, to thereby improve a subsequent contraction of the patient's heart muscle.
  • a device and method are provided for accessing the sympathetic nerve to be stimulated by using a different approach.
  • the present invention also envisions approaching the sympathetic nerve through the potential space between the myocardium and the pericardial sac surrounding the heart muscle.
  • an elongated placement catheter which has an electrode mounted at its distal end.
  • the placement catheter is dimensioned for insertion into the potential space between the myocardium and the pericardial sac.
  • the electrode on the placement catheter is advanced through the potential space to a position adjacent the sympathetic nerve.
  • an engagement mechanism which is located on the placement catheter is activated to insert an anchor into the myocardium, to thereby stabilize and maintain the location of the electrode relative to the sympathetic nerve.
  • the catheter is formed with a hollow lumen that is surrounded by an outer wall.
  • the engagement mechanism includes a threaded shaft having an end that is fixedly attached to the wall. As attached, the shaft extends diametrically across the lumen inside the placement catheter between its attachment point and an aperture that is formed into the wall of the catheter opposite the attachment point.
  • a bar which is formed with a serrated surface. Specifically, the bar is mounted in the lumen of the placement catheter for axial movement in the catheter's lumen.
  • the actuator is a hollow, cylindrically shaped body that is formed with an internal cylindrical surface and it has an external cylindrical surface that is parallel to the internal surface.
  • the internal surface is formed for a threaded engagement with the threaded shaft and the external surface is serrated for engagement with the serrated surface of the bar.
  • a corkscrew is used as the anchor.
  • the corkscrew is affixed to the actuator for extension of the corkscrew through the aperture in the wall of the placement catheter.
  • the actuator is rotated for advancement along the threaded shaft. This then extends the corkscrew from the placement catheter and into engagement with the myocardium to thereby stabilize the electrode against the myocardium.
  • the anchor is a prong.
  • the engagement mechanism is formed with a compartment inside the placement catheter. The prong is then mounted in the compartment for movement between a first configuration wherein the prong is withdrawn into the compartment, and a second configuration wherein the prong extends from the compartment. More specifically, to move the prong into the second configuration it is effectively rotated on the placement catheter to extend from the catheter and into the myocardium to stabilize the electrode against the myocardium.
  • the compartment is formed with an opening and it has an arcuate surface that extends from the opening to an abutment that is formed inside the compartment.
  • the prong is formed with a locking pin.
  • the engagement mechanism includes a push rod that is engaged with the prong by a pivot pin to permit a rotation of the prong on the pivot pin.
  • both embodiments will include an orientation mark that is located at the distal end of the placement catheter. The purpose here is to observe the mark for verifying a proper positon and orientation of the placement catheter prior to stabilizing the electrode. Functionally, the orientation mark should be observable only within an arc of less than 180°. This function can be performed by any method well known in the pertinent art, such as by using systems which incorporate a technology such as OCT, MRI , or fluoroscopy.
  • a method for employing the devices disclosed above will include the steps of advancing the electrode on the placement catheter through the potential space between the myocardium and the pericardial sac around the heart muscle. Next, a user of the present invention needs to orient the electrode at a location adjacent the sympathetic nerve of the patient that is to be stimulated. Once the electrode has been oriented at a proper location, the engagement mechanism on the placement catheter is activated to insert the anchor into the myocardium to stabilize and maintain the location of the electrode relative to the sympathetic nerve.
  • an operation of the present invention requires consecutively repeating the stimulation interval At for each heart function cycle.
  • the stimulation interval At that determines when a sympathetic nerve is to be stimulated is in an approximate range of 100-120 msec.
  • the electrical pulse(s) for stimulating the sympathetic nerve has(have) a predetermined intensity that is less than about three times the intensity required for activating a contraction of the heart muscle.
  • Fig. 1 is a depiction of a system in accordance with the present invention shown together with the intended environment of its operation;
  • Fig. 2 is a functional layout of the components employed in a system of the present invention
  • Fig. 3 is a time-line depiction of a heart muscle cycle with an operation of the present invention superposed thereon in its relation to the absolute refractory period;
  • Fig. 4 is a logic flow chart for the functional tasks that are required during an operation of the computer-controlled system of the present invention
  • Fig. 5 is a perspective view of the distal end of a placement catheter of the present invention.
  • Fig. 6A is a cross-section view of an anchor (i.e. a corkscrew) for the preferred embodiment of the present invention as seen along the line 6/8-6/8 in Fig. 5, prior to a deployment of the anchor from the placement catheter;
  • an anchor i.e. a corkscrew
  • Fig. 6B is a cross-section view of the anchor for the preferred embodiment of the present invention as shown in Fig. 6A, after a deployment of the anchor from the placement catheter;
  • Fig. 7 is a plan cross-section view of an anchor (i.e. a prong) as seen along the line 7-7 in Fig. 5;
  • an anchor i.e. a prong
  • Fig. 8A is a cross-section view of the anchor (i.e. a prong) for the alternate embodiment of the present invention as seen along the line 6/8-6/8 in Fig. 5, prior to a deployment of the anchor from the placement catheter; and Fig. 8B is a cross-section view of the anchor for the alternate embodiment of the present invention as shown in Fig. 8A, after a deployment of the anchor from the placement catheter.
  • the anchor i.e. a prong
  • a system for electrically stimulating a sympathetic nerve of a patient to improve heart function is shown and is generally designated 10.
  • the system 10 includes a deployment catheter 12 which has a sensor 14 and an electrode 16 that are mounted in combination at the distal end of the deployment catheter 12.
  • the system 10 also includes various electronic components which are disclosed below with reference to Fig. 2. As disclosed below, these electronic components are mounted in the console 18 and interact with each other to provide operational control over the system 10.
  • the console 18 may be either extracorporeal or implantable.
  • the console 18 may be part of a pacemaker or a defibrillator.
  • a heart muscle 20 is shown as the surgical target for the present invention.
  • a view of the diaphragmatic surface of the heart muscle 20 shows its coronary sinus 22 and several connecting veins.
  • the posterior vein 24 of the left ventricle, and the middle cardiac vein 26 are shown.
  • sympathetic nerve(s) 28 in the nervous system of which the nerve bundles 28a, 28b and 28c are only exemplary.
  • the nerves 28 are located on the epicardial surface of the left ventricle, and they are adjacent to either the coronary sinus 22 or one of the veins connected with the coronary sinus 22 (e.g. veins 24 or 26).
  • a computer 30 is provided for the system 10, and that the computer 30 is electronically connected with a switch 32, a timer 34, a stimulator 36 and a voltage source 38.
  • a pacing device 40 can also be electronically incorporated with the aforementioned components.
  • the switch 32, the timer 34, the stimulator 36, and the voltage source 38, as well as the pacing device 40 can all be mounted on the extracorporeal console 18.
  • the sensor 14 and the electrode 16 are incorporated into the deployment catheter 12.
  • Fig. 2 For a disclosure of their interaction with each other, the components mentioned above are shown in Fig. 2 in their relationship with the heart muscle 20. Specifically, the sensor 14 and the electrode 16 are operationally shown in direct contact with the heart muscle 20. Depending on whether the operation of system 10 is to rely on a paced event, which can be alternatively provided using the pacing device 40, the switch 32 is used to alternatively connect the sensor 14 or the pacing device 40 with the timer 34. Further, under the control of the computer 30, the stimulator 36 is energized by the voltage source 38 for a timed activation of the electrode 16. In turn, the electrode 16 will stimulate a sympathetic nerve 28 on the heart muscle 20. As envisioned for the present invention, each pulse that is used to stimulate the sympathetic nerve 28 will have an intensity that is less than about three times the intensity required for activating a contraction of the heart muscle 20.
  • a normal heart function cycle i.e. a heartbeat
  • Fig. 3 The depiction of a normal heart function cycle (i.e. a heartbeat) is shown in Fig. 3 and is generally designated 42.
  • the heart function cycle 42 is depicted by an isoelectric line 44.
  • the absolute refractory period 46 of the heart function cycle 42 is shown in its overall relationship with the heart function cycle 42.
  • the absolute refractory period 46 is a period of time in which the heart muscle 20 is not able to respond to an electrical stimulation.
  • the present invention requires there be a stimulation of a sympathetic nerve 28 during the absolute refractory period 46.
  • the system 10 of the present invention establishes a stimulation interval 48 that will begin with an electrical event 50 at a time to and will end at a time ti in the absolute refractory period 46 when a sympathetic nerve 28 is stimulated.
  • an exemplary electrical event 50 is shown on the isoelectric line 44 to occur at a time to.
  • the exact time for selection of an occurrence for the electrical event 50 is somewhat arbitrary. Preferably, however, it will be before and relatively near the beginning of the absolute refractory period 46.
  • a pacing device 40 can be employed to set the start time to.
  • FIG. 4 A logic flow chart for the tasks to be performed during an operation of the present invention is shown in Fig. 4 and is generally designated 52.
  • the inquiry block 54 questions whether the sensor 14 is being used. If so, task block 56 requires that the heart muscle function be monitored by the sensor 14.
  • inquiry block 58 asks whether an electrical event 50 has been detected. If not, the sensor 14 continues monitoring the heart function cycle 42.
  • task block 60 requires the establishment of a stimulation interval 48. As disclosed above, the stimulation interval At 48 extends from a time to when the electrical event 50 is detected, to a time ti when a pulse(s) is(are) to be fired by the stimulator 36 to stimulate a sympathetic nerve 28.
  • a pacing device 40 rather than the sensor 14, is used to trigger the stimulation interval 48.
  • inquiry block 54 together with task block 62 directs there be an engagement of the timer 34 with the pacing device 40.
  • the inquiry block 64 and task block 66, together, indicate that when the stimulation interval 48 has expired, the stimulator 36 is activated by the computer 30 to stimulate the sympathetic nerve 28.
  • the system 10 then proceeds to monitor the next heart function cycle 42.
  • a portion of a placement catheter for use in another aspect of the present invention is shown and is generally designated 100.
  • the placement catheter 100 defines a longitudinal axis 102 and has a distal end 104.
  • FIG. 1 also shows that an engagement mechanism 110 is provided for the present invention, and that the engagement mechanism 1 10 is positioned on the placement catheter 100 just proximal the distal end 104. Details of the engagement mechanism 110 are best appreciated with reference to Fig. 6A.
  • the engagement mechanism 110 includes a portion of the outer wall 1 12 of the placement catheter 100 which surrounds a lumen 1 14. As further indicated in Fig. 6A, the present invention envisions use of the placement catheter 100, and the engagement mechanism 110, in the potential space 1 16 which is located between the pericardial sac 1 18 and the myocardium 120 of a heart muscle 20.
  • the engagement mechanism 1 10 includes a threaded shaft 122 which is attached to the outer wall 112 of the placement catheter 1 10 at an attachment point 124. Specifically, with this attachment, the threaded shaft 122 is diametrically oriented in the lumen 1 14. Also included in the engagement mechanism 110 is a rod 126 which has a serrated surface 128. Further, engagement mechanism 110 includes an actuator 130 which has a serrated surface 132 that is engaged with the serrated surface 128 of the rod 126. Additionally, an anchor 134 (i.e. a corkscrew) is mounted on the actuator 130 and, as shown, is positioned over an aperture 136 which extends through the outer wall 1 12 of the placement catheter 100.
  • an anchor 134 i.e. a corkscrew
  • an operation of the engagement mechanism 1 10 merely requires pulling on the rod 126 in a proximal direction as indicated by arrow 138 in Fig. 6A.
  • the proximal movement of rod 126 will rotate the actuator 130.
  • This rotation of the actuator 130 will, in turn, cause the actuator 130 to advance along the threaded shaft 122 toward the aperture 136.
  • the anchor 134 (corkscrew) is also rotated as it extends from the placement catheter 100 through the aperture 136.
  • the anchor 134 will extend from the placement catheter 100 through a distance less than about V « of an inch as it engages with the myocardium 120 (see Fig. 6B) to stabilize and maintain the location of the electrode 106.
  • Fig. 7 shows an assembly of components that are to be incorporated into an engagement mechanism 140.
  • the engagement mechanism 140 includes and anchor 142 (i.e. prong) which is engaged with a push rod 144 by a pivot pin 146.
  • the anchor 142 is formed with a locking pin 148.
  • the placement catheter 100 is formed with a compartment 150 having an exit opening 152.
  • the compartment 150 has an arcuate surface 154 that extends from the opening 152 to an abutment 156.
  • the push rod 144 is advanced in a distal direction as indicated by the arrow 158 in Fig. 8A.
  • the anchor (prong) 142 is guided in rotation about the pivot pin 146 by the arcuate surface 154. This advancement continues until the locking pin 148 on the anchor (prong) 142 has entered the compartment 50. The locking pin 148 can then be brought into contact with the abutment 156 to hold the anchor (prong) 142 in an extended configuration as shown in Fig. 8B.
  • the anchor (prong) 140 will extend from the placement catheter 100 through a distance less than about /s of an inch as it engages with the myocardium 120 (see Fig. 8B) to stabilize and maintain the location of the electrode 106. While the particular System and Method for Electrode Placement in the Pericardial Sac of a Patient as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.

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  • 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

La présente invention concerne un dispositif de stabilisation d'une électrode adjacente à un nerf sympathique d'un patient, ledit dispositif comprenant un cathéter de mise en place allongé présentant une électrode montée à son extrémité distale. Le cathéter de mise en place est dimensionné pour pouvoir avancer à travers l'espace potentiel entre le myocarde et le sac péricardique autour du muscle cardiaque du patient, de façon à positionner l'électrode de manière adjacente au nerf sympathique. Lorsqu'il est activé, un mécanisme de mise en prise sur le cathéter de mise en place insère un élément d'ancrage dans le myocarde pour stabiliser et maintenir l'emplacement de l'électrode par rapport au nerf sympathique.
PCT/US2016/030902 2015-07-31 2016-05-05 Système et procédé de mise en place d'électrode dans le sac péricardique d'un patient Ceased WO2017023382A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/815,711 2015-07-31
US14/815,711 US20160310724A1 (en) 2015-04-24 2015-07-31 System and method for electrode placement in the pericardial sac of a patient

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WO2017023382A1 true WO2017023382A1 (fr) 2017-02-09

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PCT/US2016/030902 Ceased WO2017023382A1 (fr) 2015-07-31 2016-05-05 Système et procédé de mise en place d'électrode dans le sac péricardique d'un patient

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6102887A (en) * 1998-08-11 2000-08-15 Biocardia, Inc. Catheter drug delivery system and method for use
US20050113901A1 (en) * 2003-10-24 2005-05-26 Cardiac Pacemakers, Inc. Myocardial lead attachment system
US20090299445A1 (en) * 2004-11-24 2009-12-03 Flea Street Translational, Llc Sensor-assisted catheter-based procedures
US20100331854A1 (en) * 2008-01-07 2010-12-30 Ilan Greenberg Device and method for performing treatment in a pericardial space
US20110082466A1 (en) * 2009-10-07 2011-04-07 Jean-Francois Ollivier Epicardial screw lead for stimulation / defibrillation implantable by a guide catheter inserted into a pericardial space
US20150196752A1 (en) * 2012-08-10 2015-07-16 Intermountain Invention Managment, Llc Epicardial lead placement apparatus, systems, and methods

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6102887A (en) * 1998-08-11 2000-08-15 Biocardia, Inc. Catheter drug delivery system and method for use
US20050113901A1 (en) * 2003-10-24 2005-05-26 Cardiac Pacemakers, Inc. Myocardial lead attachment system
US20090299445A1 (en) * 2004-11-24 2009-12-03 Flea Street Translational, Llc Sensor-assisted catheter-based procedures
US20100331854A1 (en) * 2008-01-07 2010-12-30 Ilan Greenberg Device and method for performing treatment in a pericardial space
US20110082466A1 (en) * 2009-10-07 2011-04-07 Jean-Francois Ollivier Epicardial screw lead for stimulation / defibrillation implantable by a guide catheter inserted into a pericardial space
US20150196752A1 (en) * 2012-08-10 2015-07-16 Intermountain Invention Managment, Llc Epicardial lead placement apparatus, systems, and methods

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