Apparatus for safe performance of transseptal technique and placement and positioning of an ablation catheter

Abstract

A steerable catheter system to perform a transseptal puncture procedure comprises a steerable catheter shaft with at least one inner lumen, and an inner element slidably positioned within a shaft lumen, wherein the distal tip of the shaft can be deflected, counter-deflected, rotated, and counter-rotated and wherein the inner element can be deployed or retracted. In one embodiment, a single steerable catheter is capable of performing an intended procedure and a transseptal procedure all in one, wherein the catheter comprises an outer steerable catheter and an inner element which can be deployed to perform a transseptal puncture, and wherein, once the inner element crosses the inter-atrial septum, the catheter itself can slide forward without advancement of the inner element.

1 . A steerable catheter system to perform a transseptal puncture procedure, comprising:
 a steerable catheter shaft having a proximal portion, a distal portion, and at least one inner lumen; and   an inner element slidably positioned within a shaft lumen,   wherein the distal tip of the shaft can he deflected, counter-deflected, rotated, and counter-rotated and wherein the inner element can be deployed or retracted.   
     
     
         2 . The catheter system of  claim 1 , which has a control handle integral with the proximal portion. 
     
     
         3 . The catheter system of  claim 1 , wherein deployment or retraction of the inner element is controlled via a knob, button, lever, or switch on the catheter handle. 
     
     
         4 . The catheter system of  claim 1 , wherein deployment or retraction of the inner element is controlled without a switch. 
     
     
         5 . The catheter system of  claim 1  in which the inner element which is designed to safely engage and traverse the inter-atrial septum. 
     
     
         6 . The catheter system of  claim 1  in which the inner element has sensors to determine the appropriate location of the tip of the inner element. 
     
     
         7 . The catheter system of  claim 6  in which the inner element employs feedback from said sensors to guide the positioning of the inner element and the delivery of the ablation catheter. 
     
     
         8 . The catheter system of  claim 6 , wherein the sensors are magnetic sensors to facilitate magnetic navigation of the distal portion of the catheter. 
     
     
         9 . The catheter system of  claim 1  in which said inner element is capable of recording and/or displaying essential information to assure appropriate placement. 
     
     
         10 . The catheter system of  claim 1  in which said inner element would be radio-opaque and trackable on fluoroscopy. 
     
     
         11 . The catheter system of  claim 1 , wherein said inner element is a needle comprising a tapered end, a guide wire, a stylet, or a probe with an energy modality capable of generating a hole in the septum. 
     
     
         12 . The catheter system of  claim 1 , wherein said inner element is conical and/or cylindrical. 
     
     
         13 . The catheter system of  claim 1 , wherein said inner element contains electrodes for recording contact with heart tissue. 
     
     
         14 . The catheter system of  claim 1  comprising a steerable catheter with a shaft and handle and an inner element which when deployed creates a target and protective shield larger than the tip of the catheter and which is intended to guide another device on the other side of the heart across the inter-atrial septum. 
     
     
         15 . The catheter system of  claim 14 , wherein the catheter contains one or more electrodes to electrically locate structures via a myriad of imaging means (electrically, fluoroscopically, nonfluoroscopically, and/or via intracardiac echocardiography). 
     
     
         16 . The catheter system of  claim 14 , which, once the distal tip of the catheter is positioned adjacent the inter-atrial septum, is capable of deploying the inner element and of deploying a large protective shield and target is deployed. 
     
     
         17 . The catheter system of  claim 16 , wherein as on one side of the heart a transseptal procedural system is delivered towards the target and shield, the intent is to mate the two and at the same time protect the inner element (including a transseptal needle/stylet) from going beyond the shield and puncturing the wall of the left atrium. 
     
     
         18 . A single steerable catheter intended to perform an intended procedure and a transseptal procedure all in one, wherein the catheter comprises an outer steerable catheter with a control handle and an inner element which can be deployed to perform a transseptal puncture, and wherein, once the inner element crosses the atrial septum, the catheter itself can slide forward without advancement of the inner element. 
     
     
         19 . The catheter of  claim 18 , wherein control on the handle can deploy an inner element to cross the atrial septum and then allow advancement over the inner element via said catheter. 
     
     
         20 . A system which comprises a steerable catheter specifically designed to deploy a barrier or shield to provide a target for a transseptal needle, guide wire, stylet, or other puncture element crossing from one side of the heart to the other side and to protect cardiac tissue from damage. 
     
     
         21 . The system of  claim 20  which also comprises a steerable catheter with a shaft and optionally a handle and an inner element which when deployed creates a target and protective shield larger than the tip of the catheter and which is intended to guide another device on the other side of the heart across the inter-atrial septum. 
     
     
         22 . The system of  claim 21 , wherein the catheter contains one or more electrodes to electrically locate structures via an imaging modality. 
     
     
         23 . The system of  claim 22 , wherein the image modality is electrically, fluoroscopically, non-fluoroscopically, 3-D mapping, intracardiac echocardiography, or a combination of two or more thereof. 
     
     
         24 . The system of  claim 21 , which, once the distal tip of the catheter is positioned adjacent the inter-atrial septum, is capable of deploying the inner element and of deploying a large protective shield and target. 
     
     
         25 . The system of  claim 21 , wherein as on one side of the heart a transseptal procedural system is delivered towards the target and shield, the intent is to mate the target and shield and at the same time protect the inner element from going beyond the shield and puncturing the wall of the left atrium. 
     
     
         26 . The system of  claim 25 , wherein the inner element is a transseptal needle, guide wire, or stylet. 
     
     
         27 . A cardiac transseptal system comprising:
 a first catheter for deploying a transseptal element and crossing the inter-atrial septum and having a distal end, and   a second catheter for providing protection and covering the element and having a distal end,   wherein each catheter has one or more coils at its distal end and the magnetic fields of the distal ends of the two catheters are configured to draw both catheters together at or near the inter-atrial septum.   
     
     
         28 . The system of  claim 27  wherein one catheter is an ablation catheter and the other catheter is an introducer sheath. 
     
     
         29 . The system of  claim 27 , wherein the catheters are configured such that one catheter can slide into the other and the larger catheter can cross the septum and provide access through its inner lumen to the other side of the heart. 
     
     
         30 . A method to safely perform transseptal puncture which comprises crossing an apparatus from the left-atrium across the inter-atrial septum into the right atrium. 
     
     
         31 . A method for safely transversing an inter-atrial septum, which comprises:
 advancing a distal end of a catheter having a lumen into the left atrium of a patient so that the distal end contacts the inter-atrial septum;   advancing a distal end of a guide wire through the distal end of the catheter across the inter-atrial septum into the patient's right atrium;   advancing the distal end of the guide wire distally to a point where a sheath having a distal end can he engaged; and   advancing the sheath over the guide wire so that the distal end of the sheath enters the left atrium.   
     
     
         32 . The method of  claim 31 , wherein magnetic navigation is used to position the distal end of the catheter in the left atrium. 
     
     
         33 . The method of  claim 31 , wherein the catheter is advanced across the inter-atrial septum and the sheath is advanced over the catheter. 
     
     
         34 . The method of  claim 31 , wherein the guide wire and/or catheter are withdrawn. 
     
     
         35 . The method of  claim 31 , wherein the sheath is a long, right-sided transseptal sheath. 
     
     
         36 . The method of  claim 31 , wherein a guide wire, needle, stylet, or RF or other modality punctures the inter-atrial septum. 
     
     
         37 . A method for safely transversing an inter-atrial septum, which comprises:
 advancing a distal end of a first catheter having magnetic coils and having a lumen into the left atrium of a patient so that the distal end contacts the inter-atrial septum;   advancing a distal end of second catheter having magnetic coils and a lumen into the right atrium of a patient so that the distal end of the catheter contacts the inter-atrial septum;   advancing a guide wire through the distal end of the first catheter across the inter-atrial septum into the lumen of the second catheter;   advancing the distal end of the guide wire distally to a point where a sheath or dilator having a distal end can be engaged; and   advancing the sheath or dilator over the guide wire so that the distal end of the sheath or dilator enters the left atrium,   
     
     
         38 . The method of  claim 37 , wherein magnetic navigation is used to position the distal ends of the catheters. 
     
     
         39 . The method of  claim 37 , wherein the first catheter is advanced across the inter-atrial septum and the sheath or dilator is advanced over the catheter. 
     
     
         40 . The method of  claim 37 , wherein the guide wire and/or first catheter are withdrawn. 
     
     
         41 . The method of  claim 37 , wherein the sheath is a long, right-sided transseptal sheath. 
     
     
         42 . The method of  claim 37 , wherein a guide wire, needle, stylet, or RF modality punctures the inter-atrial septum. 
     
     
         43 . A steerable catheter system to perform a transseptal puncture, mapping, and ablation procedure, comprising:
 a steerable catheter shaft having a proximal portion, a distal portion, and at least one inner lumen;   a control handle integral with the proximal portion; and   an inner element slidably positioned within a shaft lumen,   wherein the distal tip of the shaft can be deflected, counter-deflected, rotated, and/or counter-rotated and wherein the inner element can be deployed or retracted.   
     
     
         44 . The catheter system of  claim 43 , wherein deployment or retraction of the inner element is controlled via a knob, button, lever, or switch on the catheter handle. 
     
     
         45 . The catheter system of  claim 43 , wherein deployment or retraction of the inner element is controlled without a switch. 
     
     
         46 . The catheter system of  claim 43  in which said catheter contains at least one distal electrode 
     
     
         47 . The catheter system of  claim 43  in which said catheter contains at least two recording electrodes 
     
     
         48 . The catheter system of  claim 47  in which said distal electrode permits the passage of an inner element for the purpose of crossing the inter-atrial septum. 
     
     
         49 . The catheter system of  claim 47  in which at least one of the electrodes could be used to perform a catheter ablation procedure. 
     
     
         50 . The catheter system of  claim 47  in which the distal electrode is enlarged and/or irrigated to perform radiofrequency catheter ablation. 
     
     
         51 . The catheter system of  claim 43  in which an inner element which is designed to safely engage and traverse the inter-atrial septum. 
     
     
         52 . The catheter system of  claim 43  in which the distal electrode has a central lumen for passage of the inner element. 
     
     
         53 . The catheter system of  claim 43  in which the inner element is designed for easy and safe passage across the inter-atrial septum. 
     
     
         54 . The catheter system of  claim 53  in which the inner element has sensors to determine the appropriate location of the tip of the inner element. 
     
     
         55 . The catheter system of  claim 53  in which the inner element employs feedback from said sensors to guide the positioning of the inner element and the delivery of the ablation catheter. 
     
     
         56 . The catheter system of  claim 43  in which said inner element could record and help display essential information to assure appropriate placement. 
     
     
         57 . The catheter system of  claim 43  in which said inner element would be radio-opaque and trackable on fluoroscopy. 
     
     
         58 . The catheter system of  claim 43 , wherein said inner element is a needle consisting of a tapered end. 
     
     
         59 . The catheter system of  claim 43 , wherein said inner element is conical or cylindrical. 
     
     
         60 . The catheter system of  claim 43 , wherein said inner element contains electrodes for recording contact with heart tissue. 
     
     
         61 . The system of  claim 43 , wherein a steerable catheter with inner deployable and retractable inner transseptal element is delivered via an arterial approach via the retrograde aortic approach (male component) and the tip is placed in the left atrium; wherein a right-sided, larger inner diameter female mating guide catheter is positioned from the venous approach and placed in the right atrium; wherein the two catheters are guided towards one another to identify the inter-atrial septum; wherein, once identified, the steerable left-sided catheter's transseptal member is deployed across the septum and within the right-sided guide catheter; wherein the steerable catheter is then advanced (without advancing the inner element) into the guide catheter and then the guide catheter is advanced across the septum into the left atrium; and wherein the left-sided catheter is then removed, and an ablation catheter is then placed into the right-sided guide catheter and delivered into the left atrium. 
     
     
         62 . A single steerable catheter intended to perform catheter ablation and the transseptal procedure all in one, wherein the ablation catheter comprises an outer steerable catheter with a controllable handle and an inner element which can be deployed to perform a transseptal puncture, and wherein, once the inner element crosses the atrial septum, the catheter itself can slide forward without advancement of the inner element. 
     
     
         63 . The catheter of  claim 62 , wherein control on the handle can deploy an inner element to cross the atrial septum and then allow advancement over the inner element via said catheter. 
     
     
         64 . An apparatus which comprises a steerable catheter specifically designed to deploy a barrier or shield to provide a target for a transseptal needle or element crossing from one side of the heart to the other and to protect cardiac tissue from damage. 
     
     
         65 . A cardiac transseptal system comprising:
 a catheter for deploying a transseptal element and crossing the inter-atrial septum; and   a catheter for providing protection and covering the element,   wherein each catheter has one or more coils at its distal end and the magnetic fields of the two catheters are configured to draw both catheters together at or near the inter-atrial septum.   
     
     
         66 . The system of  claim 65 , wherein one catheter is an ablation catheter and the other catheter is an introducer sheath. 
     
     
         67 . The system of  claim 65 , wherein the catheters are configured such that one catheter can slide into the other and the larger catheter can cross the septum and provide access through its inner lumen to the other side of the heart. 
     
     
         68 . A system and method to safely perform transseptal puncture in which an apparatus is designed and employed from the left-atrium across the atrial septum into the right atrium.