Cardiac Stimulation System and Method

Abstract

A cardiac stimulation assembly includes an energy source coupled to an energy emitter that extends form a delivery member into a region of tissue in the heart. An array of the emitters are adapted to extend from a delivery assembly and into unique locations along the region of tissue, such as by use of extendable, pre-shaped needles. A volume of conductive agent is delivered into the region and enhances stimulation of the region with the energy emitter. The agent may be an injectable preparation of living cells that express production of connexin, e.g. connexin 43, and may be genetically modified to over-express such production. The agent may include a non-living material, such as conductive polymer or metal or combination thereof. The combination of energy emitters and conductive agent enhances stimulation of the region. Delivering the stimulation assembly and conductive agent into the interventricular septum allows for improved biventricular septal pacing.

1 . A cardiac stimulation system, comprising:
 a cardiac stimulation assembly that is adapted to deliver electrical energy into a region of tissue within a heart of a patient so as to stimulate the region; and   a volume of conductive agent that is adapted to be delivered into the region and to enhance stimulation of the region with the electrical energy delivered by the cardiac stimulation assembly, wherein the conductive agent is other than a protein.   
   
   
       2 . The system of  claim 1 , wherein the cardiac stimulation assembly comprises:
 a delivery member with a proximal and portion and a distal end portion that is adapted to be positioned at a location within a heart of a patient; and   an array of extendable electrode assemblies cooperating with the delivery member and that each includes a stimulation electrode that is adjustable to extend from the delivery member at the location and into a unique location relative to the other extendable electrode assemblies within the region of tissue.   
   
   
       3 . The system of  claim 2 , wherein each of the array of extendable electrode assemblies comprises an extendable needle that is adjustable to extend from the distal end portion of the delivery assembly and into cardiac tissue so as to position the respective stimulation electrode at the unique location. 
   
   
       4 . The system of  claim 3 , wherein the stimulation electrode of each extendable electrode assembly is integrated with the needle. 
   
   
       5 . The system of  claim 3 , wherein the stimulation electrode of each extendable electrode assembly is adjustable to extend from the respective needle to the unique respective location. 
   
   
       6 .- 89 . (canceled) 
   
   
       90 . A cardiac stimulation system, comprising:
 a cardiac stimulation device with an elongate body with a proximal end portion, a distal end portion, and a cardiac stimulation electrode along the distal end portion;   a volume of cells that are adapted to express connexin 43;   wherein the cardiac stimulation device and volume of cells are adapted to cooperate so as to stimulate a region of tissue within a heart of a patient.   
   
   
       91 . The system of  claim 90 , wherein the cardiac stimulation electrode is adjustable to extend from the distal end portion and into a region of tissue within the heart when the distal end portion is at the location. 
   
   
       92 . The system of  claim 91 , wherein the cardiac stimulation device further comprises:
 an array of said cardiac stimulation electrodes that are each adjustable to extend from the elongate body and into a unique location relative to the other cardiac stimulation electrodes within the region of tissue when the distal end portion is positioned at a location within the heart associated with the region.   
   
   
       93 . The system of  claim 90 , wherein the volume of cells are genetically modified to over-express production of connexin 43. 
   
   
       94 . A cardiac stimulation assembly, comprising:
 an elongate body having a proximal end portion, a distal end portion that is adapted to be positioned at least in part at a location within a heart of a patient, and a lumen extending at least in part along the distal end portion;   an electrical energy delivery assembly with an electrical energy emitter that is coupled to the elongate body and is adjustable to extend from the distal end portion and into a region of tissue within the heart when the distal end portion is at the location, and also with an electrical energy lead that is adapted to couple to the electrical energy emitter and also to a source of electrical energy along the proximal end portion when the electrical energy emitter is in the second position; and   a volume of conductive agent coupled to the lumen and that is adapted to be delivered at least in part through the lumen into the region of tissue when the distal end portion is at the location and the electrical energy emitter is in the second position.   
   
   
       95 . The assembly of  claim 94 , wherein the energy emitter comprises a cardiac stimulation electrode. 
   
   
       96 . The assembly of  claim 95 , wherein the energy delivery assembly further comprises:
 an array of said cardiac stimulation electrodes that are each adjustable to extend from the elongate body and into a unique location relative to the other cardiac stimulation electrodes within the region of tissue when the distal end portion is positioned at the location.   
   
   
       97 . The assembly of  claim 94 , wherein the volume of conductive agent comprises living cells. 
   
   
       98 . The assembly of  claim 97 , wherein the living cells are adapted to express connexin at a gap junction with cardiac cells in the region. 
   
   
       99 . The assembly of  claim 98 , wherein the living cells are adapted to express production of connexin 43 at the gap junction. 
   
   
       100 . The assembly of  claim 99 , wherein the cells are genetically modified to over-express production of connexin 43. 
   
   
       101 . A cardiac stimulation assembly, comprising:
 an elongate body having a proximal end portion, a distal end portion that is adapted to be positioned at least in part at a location within a heart of a patient;   an electrical energy delivery assembly having a plurality of electrical energy emitters, each electrical energy emitter being coupled to the elongate body and adjustable to extend from the distal end portion and into a unique respective position relative to the other electrical energy emitters within a region of tissue within the heart when the distal end portion is at the location, and each electrical energy emitter being adapted to couple to a source of electrical energy when the respective electrical energy emitter is in the second position within the region of tissue; and   an anchor that is adapted to anchor the distal end portion at the location within the heart.   
   
   
       102 . A cardiac stimulation assembly, comprising:
 an elongate body having a proximal end portion, a distal end portion that is adapted to be positioned at least in part at a location within a heart of a patient, and a delivery lumen extending at least in part along the distal end portion;   an electrical energy delivery assembly having a plurality of energy emitters, each electrical energy emitter being coupled to the elongate body and adjustable to extend from the distal end portion and into a unique respective position relative to the other electrical energy emitters within a region of tissue within the heart when the distal end portion is at the location, and each electrical energy emitter being adapted to couple to a source of electrical energy via the proximal end portion when the respective electrical energy emitter is in the second position; and   a cardiac stimulation electrical energy source that is adapted to couple to each of the electrical energy emitters and to energize each electrical energy emitter so as to emit energy into the region of tissue;   wherein the electrical energy emitters at each unique respective position within the region of tissue are adapted to stimulate the region of tissue.   
   
   
       103 . A cardiac stimulation device, comprising:
 an elongate body with a proximal end portion, a distal end portion, and a passageway located at least in part along the distal end portion;   a needle having a shank with a distal tip and an inner lumen;   an electrical energy emitter that is adapted to be coupled to an electrical energy source;   wherein the distal end portion of the elongate body is adapted to be positioned at a location within a heart of a patient;   wherein the needle is adapted to be coupled to the passageway and is adjustable between a first position located at least in part within the passageway and a second position that extends at least in part from the passageway and into a region of tissue within the heart when the distal end portion is at the location; and   wherein the electrical energy emitter is coupled to the inner lumen of the needle and is adjustable to extend from the needle into the region of tissue.   
   
   
       104 . A bi-ventricular cardiac stimulation system, comprising:
 an array of stimulation electrodes that are each adapted to be positioned at unique locations relative to the other stimulation electrodes within an intra-ventricular septum of a heart of a patient and such that the array of positioned electrodes is adapted to form a pattern that defines a region of tissue within the septum; and   wherein the pattern and region defined thereby is adapted to stimulate at least one-third of the septum.   
   
   
       105 . A cardiac stimulation system, comprising:
 a bi-ventricular cardiac stimulation electrical energy source;   a septal stimulation device with an elongate body having a proximal end portion and a distal end portion with an array of extendable cardiac stimulation electrodes;   wherein the distal end portion is adapted to be positioned at a location within a heart of a patient associated with a ventricular septum;   wherein each of the extendable cardiac stimulation electrodes is adjustable to extend from the distal end portion so as to be positioned at a unique respective location relative to the other extendable cardiac stimulation electrodes within a region of tissue within the ventricular septum;   wherein each of the extendable stimulation electrodes is adapted to be coupled to the bi-ventricular cardiac stimulation electrical energy source; and   whereby positioning the distal end portion of the elongate body at the location, positioning each of the extendable cardiac stimulation electrodes at each respectively unique location within the region of tissue, and coupling each extendable cardiac stimulation electrode to the bi-ventricular cardiac stimulation electrical energy source, the array of electrodes is adapted to substantially stimulate the region of tissue be energizing each electrode of the array with the electrical energy source to emit current from its respectively unique location within the region.   
   
   
       106 . A method for stimulating a region of a heart in a patient, comprising:
 providing a cardiac stimulation assembly;   providing a conductive agent delivery system;   delivering electrical energy to a location associated with the region of the heart to be stimulated with the cardiac stimulation system;   delivering a volume of conductive agent from the conductive agent delivery system to the region of the heart; and   wherein the volume of conductive agent enhances stimulation of the region of the heart with the electrical energy being delivered to the location.   
   
   
       107 . A method for providing bi-ventricular stimulation to a heart of a patient, comprising:
 providing an array of cardiac stimulation electrodes;   positioning a distal end portion of a delivery member against a portion of an intra-ventricular septum of the heart; and   extending the array of cardiac stimulation electrodes from the distal end portion of the delivery member and into the intra-ventricular septum such that each cardiac stimulation electrode is positioned at a unique location relative to the other cardiac stimulation electrodes within a region of tissue of the intra-ventricular septum.   
   
   
       108 . A method for manufacturing a bi-ventricular cardiac stimulation system for providing bi-ventricular stimulation to a heart of a patient, comprising:
 providing a bi-ventricular stimulation device having an elongate body with a proximal end portion, a distal end portion that is adapted to be positioned at a location within a ventricle, a stimulation electrode located at a position along the distal end portion so as to be electrically coupled to a region of tissue of a septum of the heart when the distal end portion is at the location, and a passageway extending at least along the distal end portion; and   loading a volume of cells within the passageway of the bi-ventricular stimulation device, wherein the cells are adapted to over-express connexin-43 or an analog, derivative, or biological equivalent thereof.   
   
   
       109 . A method for manufacturing a cardiac stimulation system for providing cardiac stimulation to a heart of a patient, comprising:
 providing a cardiac stimulation device having an elongate body with a proximal end portion, a distal end portion that is adapted to be positioned at a location within the heart, an array of extendable cardiac stimulation electrodes that are each adapted to be extended from the distal end portion at the location so as to be positioned at a unique location relative to the other extendable cardiac stimulation electrodes within a region of tissue within the heart, and a passageway extending at least along the distal end portion; and   loading a volume of cells within the passageway, wherein the cells are adapted to enhance electrical stimulation of the region of tissue from the array of extendable electrodes.   
   
   
       110 . A method for stimulating a region of a septum in a heart of a patient, comprising:
 delivering at least one cardiac stimulation electrode into at least one septal perforator vessel within an intra-ventricular septum of the heart;   delivering a volume of conductive agent to a region of tissue within the septum associated with the septal perforator vessel; and   after the volume of conductive agent is delivered into the region, electrically stimulating the region of tissue with the at least one cardiac stimulation electrode.   
   
   
       111 . A method for providing bi-ventricular stimulation to a heart in a patient, comprising:
 artificially electrically stimulating a region of tissue that comprises at least one-quarter of the septum.   
   
   
       112 . A method for stimulating a region of a heart in a patient, comprising:
 delivering a volume of cells into the region that are adapted to over-express connexin-43 or an analog, derivative, or biologic equivalent thereof; and   providing an electrical stimulus to the region.   
   
   
       113 . A method for stimulating a region of a heart in a patient, comprising:
 providing a cardiac electrical stimulation assembly that is adapted to deliver energy into a region of tissue within a heart of a patient so as to stimulate the region; and   delivering a volume of conductive agent that is adapted to be delivered into the region and to enhance stimulation of the region with the energy delivered by the cardiac stimulation assembly.