Steerable epicardial pacing catheter system placed via the subxiphoid process

Abstract

The epicardial pacing system and related method includes an epicardial catheter configured to be disposed in the middle mediastinum of the thorax of a subject for use in electrical pacing of the heart at one or more locations on the epicardial surface. The epicardial pacing catheter may include at least one electrode whereby the electrode is insulated on at least one side to allow pacing of the heart without damage to adjacent anatomical structures.

1 . An epicardial pacing system, said system comprising:
 an epicardial catheter configured to be disposed in the middle mediastinum of the thorax of a subject for use in electrical pacing of the heart at one or more locations on the epicardial surface, said epicardial pacing catheter comprising:
 a proximal portion, distal portion, and a longitudinal structure there between; and 
 at least one electrode in communication with the distal portion, wherein the at least one electrode is insulated on at least one side to allow pacing of the heart without damage to adjacent anatomical structures. 
   
     
     
         2 . The system of  claim 1 , wherein said disposing comprises a minimally invasive procedure. 
     
     
         3 . The system of  claim 1 , wherein said disposing comprises a non-surgical procedure. 
     
     
         4 . The system of  claim 1 , wherein said disposing comprises an interventional procedure. 
     
     
         5 . The system of  claim 1 , wherein the middle mediastinum includes the pericardial space. 
     
     
         6 . The system of  claim 1 , wherein said epicardial pacing catheter is a lead. 
     
     
         7 . The system of  claim 1 , further comprising at least one electrical wire in communication with said at least one electrodes, said electrical wire extending longitudinally through said longitudinal structure toward the proximal end, wherein said at least one electrical wire is adapted for transmitting and receiving electrical energy. 
     
     
         8 . The system of  claim 7 , further comprising a control means in communication with the proximal portion, wherein said control means is controllably connected to said at least one electrical wire. 
     
     
         9 . The system of  claim 8 , wherein said control means is removable. 
     
     
         10 . The system of  claim 9 , wherein said control means is a control handle. 
     
     
         11 . The system of  claim 1 , wherein said at least one electrode comprises a conducting material. 
     
     
         12 . The system of  claim 11 , wherein said conducting material comprises at least one of the following: copper, platinum, gold, silver, iridium and/or alloys thereof. 
     
     
         13 . The system of  claim 1 , said catheter further comprising an insulating material, said insulating material in communication with said at least one electrode and a portion of said catheter located opposite the heart. 
     
     
         14 . The system of  claim 13 , wherein said insulating material is non-conductive. 
     
     
         15 . The system of  claim 13 , wherein said insulating material mitigates the transmission of electrical energy away from the heart. 
     
     
         16 . The system of  claim 1 , said catheter further comprising a distal tip, wherein said distal tip comprises a non-conducting material. 
     
     
         17 . The system of  claim 1 , wherein said at least one electrode is semi-cylindrical or arc-like in shape. 
     
     
         18 . The system of  claim 1 , wherein the surface of said at least one electrode is roughened, profiled, or otherwise prepared so as to maximize surface area. 
     
     
         19 . The system of  claim 1 , wherein said at least one electrode comprises at least one electrode pair. 
     
     
         20 . The system of  claim 19 , wherein said at least one electrode pair comprises an anode and cathode. 
     
     
         21 . The system of  claim 1 , wherein said at least one electrode is deployable. 
     
     
         22 . The system of  claim 1 , wherein the cross section of said longitudinal structure comprises an oval, circle, ellipse, or semi-circular shape. 
     
     
         23 . The system of  claim 1 , wherein at least a portion of said longitudinal structure comprises a biocompatible material. 
     
     
         24 . The system of  claim 1 , wherein at least a portion of said longitudinal structure comprises a lubricious material having a low coefficient of friction. 
     
     
         25 . The system of  claim 1 , wherein at least a portion of said longitudinal structure comprises at least one of the following: silicone, polyurethane, or Teflon, any combination thereof, or similarly lubricious material. 
     
     
         26 . The system of  claim 1 , wherein at least a portion of said longitudinal structure is impregnated with sirilimus. 
     
     
         27 . The system of  claim 1 , wherein at least a portion of said longitudinal structure comprises a drug eluting surface. 
     
     
         28 . The system of  claim 1 , wherein said longitudinal structure is between about 15 and about 100 centimeters in length. 
     
     
         29 . The system of  claim 1 , wherein said longitudinal structure is between about 2 and about 6 millimeters in diameter. 
     
     
         30 . The system of  claim 1 , further comprising at least one distal fluid aperture located at the distal tip of said distal portion, said at least one distal fluid aperture in communication with a fluid lumen extending longitudinally through said longitudinal structure toward said proximal portion, wherein said at least one distal fluid aperture is adapted for passage of fluid. 
     
     
         31 . The system of  claim 30 , wherein said passage comprises emitting fluid. 
     
     
         32 . The system of  claim 30 , wherein said passage comprises extracting fluid. 
     
     
         33 . The system of  claim 30 , wherein said passage comprises emitting and extracting fluid. 
     
     
         34 . The system of  claim 30 , wherein said passage comprises emitting a drug or agent. 
     
     
         35 . The system of  claim 30 , further comprising at least one proximal fluid aperture at said proximal portion, wherein the at least one proximal fluid aperture is in communication with said fluid lumen, and wherein the at least one proximal fluid aperture is adapted for passage of fluid. 
     
     
         36 . The system of  claim 35 , wherein said passage comprises emitting fluid. 
     
     
         37 . The system of  claim 35 , wherein said passage comprises extracting fluid. 
     
     
         38 . The system of  claim 35 , wherein said passage comprises emitting and extracting fluid. 
     
     
         39 . The system of  claim 35 , wherein said passage comprises emitting a drug or agent. 
     
     
         40 . The system of  claim 35 , further comprising a fluid control means for controlling said fluid passage. 
     
     
         41 . The system of  claim 40 , wherein said control means comprises a control handle in communication with said epicardial pacing catheter. 
     
     
         42 . The system of  claim 40 , wherein said control means is in communication with an external fluid source. 
     
     
         43 . The system of  claim 40 , wherein said control means is in communication with an external drug or agent source. 
     
     
         44 . The system of  claim 1 , wherein said catheter further comprising a stabilization means for stabilizing said epicardial pacing catheter. 
     
     
         45 . The system of  claim 44 , wherein said stabilization means comprises at least one deployable member. 
     
     
         46 . The system of  claim 45 , wherein said deployable member comprises a screw, hook, or tab. 
     
     
         47 . The system of  claim 45 , wherein said deployable member is in communication with said at least one electrode. 
     
     
         48 . The system of  claim 45 , wherein said deployable member comprises a conductive material. 
     
     
         49 . The system of  claim 48 , wherein said conducting material comprises at least one of the following: copper, platinum, gold, silver, or iridium, and/or alloys thereof. 
     
     
         50 . The system of  claim 45 , further comprising a stabilizer actuator, wherein said stabilizer actuator deploys said at least one deployable member. 
     
     
         51 . The system of  claim 50 , wherein said stabilizer actuator comprises:
 at least one longitudinal member in communication with at least one of the following: gear, hinge, joint, rack and pinion, pulley, linear actuator, or linear-rotational actuator, or any combination thereof.   
     
     
         52 . The system of  claim 51 , wherein said at least one longitudinal member comprises at least one of the following: push-rod, pull-rod, wire, string, pole, thread, filament, cord, strand or rope. 
     
     
         53 . The system of  claim 50 , wherein said stabilizer actuator comprises a micro electrical mechanical system (MEMS). 
     
     
         54 . The system of  claim 44 , further comprising a control means for controlling said stabilization. 
     
     
         55 . The system of  claim 54 , wherein said control means comprises a control handle. 
     
     
         56 . The system of  claim 45 , wherein said at least one deployable member comprises a catheter-side surface and anatomical-side surface. 
     
     
         57 . The system of  claim 56 , wherein said catheter-side surface comprises a rough surface and said anatomical-side surface comprises a lubricious surface. 
     
     
         58 . The system of  claim 56 , wherein said at least one deployable member is adapted to engage proximate anatomical structures. 
     
     
         59 . The system of  claim 56 , wherein said catheter-side and anatomical-side surfaces comprise non-conductive materials. 
     
     
         60 . The system of  claim 56 , wherein said catheter-side surface comprises a material having a larger coefficient of friction than said anatomical-side surface. 
     
     
         61 . The system of  claim 56 , wherein said at least one deployable member in a deployed state prevents or impedes said distal portion from slipping or moving. 
     
     
         62 . The system of  claim 56 , wherein said distal portion can be moved around within the middle mediastinum when said stabilization means is in a non-deployed state. 
     
     
         63 . The system of  claim 56 , wherein said anatomical-side surface comprises at least one of the following: silicone, polyurethane, or Teflon, combination thereof, or similarly lubricious material. 
     
     
         64 . The system of  claim 56 , wherein said catheter-side surface comprises a textured surface to increase friction. 
     
     
         65 . The system of  claim 56 , wherein said at least one deployable member comprises a radio-opaque material. 
     
     
         66 . The system of  claim 44 , wherein said stabilization means comprises one or more protrusions for engaging proximal anatomical structures. 
     
     
         67 . The system of  claim 66 , wherein at least one of said one or more protrusions is non-deployable. 
     
     
         68 . The system of  claim 66 , wherein said one or more protrusions comprise a non-conducting material. 
     
     
         69 . The system of  claim 68 , wherein said non-conducting material comprises at least one of the following: silicone, polyurethane, or Teflon, combination thereof, or similarly lubricious material. 
     
     
         70 . The system of  claim 68 , wherein the non-conducting material comprises a radio-opaque material. 
     
     
         71 . The system of  claim 1 , further comprising a steering means for positioning the epicardial pacing catheter. 
     
     
         72 . The system of  claim 71 , further comprising a second steering means for steering said epicardial pacing catheter. 
     
     
         73 . The system of  claim 71 , further comprising a third and fourth steering means for steering said epicardial pacing catheter. 
     
     
         74 . The system of  claim 71 , wherein said steering means allows orientation of said epicardial pacing catheter about one point of curvature. 
     
     
         75 . The system of  claim 71 , wherein said steering means allows orientation of said epicardial pacing lead about two or more points of curvature. 
     
     
         76 . The system of  claim 75 , wherein the most proximal point of curvature is located about 15 cm from the proximal end. 
     
     
         77 . The system of  claim 75 , wherein the most distal point of curvature is located between about 1 and about 20 cm from the distal end. 
     
     
         78 . The system of  claim 75 , wherein the most distal point of curvature is a bidirectional center of curvature. 
     
     
         79 . The system of  claim 75 , wherein the most distal point of curvature is greater than tri-directional. 
     
     
         80 . The system of  claim 71 , wherein said steering means comprises at least one of the following: guide wire, pull string, digitating member or tensioning line. 
     
     
         81 . The system of  claim 71 , wherein said steering means comprises a non-conductive material. 
     
     
         82 . The system of  claim 71 , wherein said steering means comprises a material of high-tensile strength. 
     
     
         83 . The system of  claim 71 , further comprising a control means for controlling said steering means. 
     
     
         84 . The system of  claim 83 , wherein said control means comprises a removable handle in communication with the proximal portion. 
     
     
         85 . The system of  claim 1 , wherein said epicardial pacing catheter is adapted to be in communication with a power supply. 
     
     
         86 . The system of  claim 85 , wherein said epicardial pacing catheter is adapted to be in communication with a processor. 
     
     
         87 . The system of  claim 86 , wherein said epicardial pacing catheter is adapted to be in communication with said power supply and said processor by hardwire, wireless, or a combination thereof. 
     
     
         88 . The system of  claim 87 , wherein said wireless comprises BlueTooth, Infrared, other optical, photo-optical, or radio-based type of telemetry or communication. 
     
     
         89 . The system of  claim 85 , further comprising an interface member in communication with said power supply and processor. 
     
     
         90 . The system of  claim 89 , wherein said interface member is used by a patient, a physician, a technician, or a clinician. 
     
     
         91 . The system of  claim 90 , wherein said interface member may be in remote or local communication with a control means. 
     
     
         92 . The system of  claim 91 , wherein said control means comprises an external control handle. 
     
     
         93 . The system of  claim 1 , wherein navigation of said epicardial pacing catheter is carried out through a puncture of the thorax. 
     
     
         94 . The system of  claim 93 , wherein said puncture comprises a sub-xiphoid puncture. 
     
     
         95 . The system of  claim 93 , wherein a pressure probe needle is used in navigating the epicardial pacing catheter. 
     
     
         96 . The system of  claim 95 , wherein said pressure probe needle comprises an access needle. 
     
     
         97 . The system of  claim 95 , wherein said pressure probe needle comprises a sensor for sensing pressure in the thorax. 
     
     
         98 . The system of  claim 1 , further comprising an access needle, the access needle adapted to be inserted into the thorax. 
     
     
         99 . The system of  claim 98 , further comprising a guidewire, wherein the guidewire is adapted to be inserted into said access needle. 
     
     
         100 . The system of  claim 98 , wherein said guidewire and said access needle are navigated into the pericardial sack. 
     
     
         101 . The system of  claim 100 , wherein said epicardial pacing catheter is adapted to be inserted into or around said guidewire. 
     
     
         102 . The system of  claim 1 , wherein said epicardial pacing catheter is configured to be used with a sheath, said sheath comprising a distal portion, proximal portion, and a longitudinal structure there between, wherein said sheath is adapted for receiving said epicardial pacing catheter therein. 
     
     
         103 . A method for use with an epicardial pacing catheter, said method comprising:
 disposing said epicardial pacing catheter in the middle mediastinum of the thorax of a subject;   pacing the heart at one or more locations with electrical energy from an at least one electrode; and   at least partially insulating the electrical energy to allow pacing of the heart without damage to adjacent anatomical structures.   
     
     
         104 . The method of  claim 103 , wherein said disposing comprises a minimally invasive procedure. 
     
     
         105 . The method of  claim 103 , wherein said disposing comprises a non-surgical procedure. 
     
     
         106 . The device of  claim 103 , wherein said disposing comprises an interventional procedure. 
     
     
         107 . The method of  claim 103 , wherein said middle mediastinum includes the pericardial space. 
     
     
         108 . The method of  claim 103 , wherein said at least one electrode may be used to stabilize said epicardial pacing catheter. 
     
     
         109 . The method of  claim 103 , wherein said at least one electrode is deployed. 
     
     
         110 . The method of  claim 103 , further comprising irrigating said middle mediastinum. 
     
     
         111 . The method of  claim 110 , wherein said irrigating comprises emitting a fluid, drug, or agent. 
     
     
         112 . The method of  claim 110 , wherein said irrigating comprises extracting a fluid, drug, or agent. 
     
     
         113 . The method of  claim 110 , wherein said irrigating comprises both emitting and extracting a fluid, drug, or agent. 
     
     
         114 . The method of  claim 103 , further comprising stabilizing said epicardial pacing catheter. 
     
     
         115 . The method of  claim 114 , further comprising a at least one deployable member, wherein said deployable member is used for stabilizing. 
     
     
         116 . The method of  claim 115 , wherein said at least one deployable member comprises a screw, hook, or tab. 
     
     
         117 . The method of  claim 115 , wherein said at least one deployable member comprises a non-conductive material. 
     
     
         118 . The method of  claim 115 , wherein said at least one deployable member comprises a conductive material. 
     
     
         119 . The method of  claim 118 , wherein said at least one deployable member is in electrical communication with said at least one electrode. 
     
     
         120 . The method of  claim 103 , further comprising steering said epicardial pacing catheter. 
     
     
         121 . The method of  claim 120 , wherein said steering is about at least one point of curvature. 
     
     
         122 . The method of  claim 103 , further comprising supplying power to said epicardial pacing catheter. 
     
     
         123 . The method of  claim 103 , further comprising processing data received from said epicardial pacing catheter. 
     
     
         124 . The method of  claim 103 , further comprising controlling said at least one electrode. 
     
     
         125 . The method of  claim 124 , wherein said controlling comprises controllably connecting a control handle to said epicardial pacing catheter. 
     
     
         126 . The method of  claim 103 , wherein said disposing is carried out through a puncture of the thorax. 
     
     
         127 . The method of  claim 126 , wherein said puncture comprises a sub-xiphoid puncture. 
     
     
         128 . The method of  claim 126 , wherein said disposing is carried out through a pressure probe needle. 
     
     
         129 . The method of  128 , wherein said pressure probe needle comprises an access needle. 
     
     
         130 . The method of  128 , wherein said pressure probe needle comprises a sensor for sensing pressure in the thorax. 
     
     
         131 . The method of  claim 103 , further comprising inserting an access needle into the thorax of said subject. 
     
     
         132 . The method of  claim 131 , further comprising inserting a guidewire into said access needle. 
     
     
         133 . The method of  claim 132 , further comprising inserting a sheath over said guidewire. 
     
     
         134 . The method of  claim 133 , further comprising inserting said epicardial pacing catheter into said sheath.