Source: http://www.google.es/patents/US9211405
Timestamp: 2017-12-17 21:49:07
Document Index: 705602048

Matched Legal Cases: ['art.\n2', 'art.\n61', 'art.\n62', 'art.\n63', 'art.\n64', '§119', '§119', '§119', 'art 1', 'art 1', 'art 1']

Patente US9211405 - Electrode catheter for ablation purposes and related method thereof - Google Patentes
An electrode catheter for use with an endocardial ablation catheter, wherein the electrode catheter receives the transmitted energy for ablating a portion of the heart. The electrode catheter comprises a proximal portion, a distal portion, and a longitudinal structure there between; and an electrode...http://www.google.es/patents/US9211405?utm_source=gb-gplus-sharePatente US9211405 - Electrode catheter for ablation purposes and related method thereof
Número de publicación US9211405 B2
Número de solicitud US 12/532,233
Número de PCT PCT/US2008/057626
Fecha de publicación 15 Dic 2015
Fecha de prioridad 22 Mar 2007
También publicado como US20100211064, US20160331445, WO2008118737A1
Número de publicación 12532233, 532233, PCT/2008/57626, PCT/US/2008/057626, PCT/US/2008/57626, PCT/US/8/057626, PCT/US/8/57626, PCT/US2008/057626, PCT/US2008/57626, PCT/US2008057626, PCT/US200857626, PCT/US8/057626, PCT/US8/57626, PCT/US8057626, PCT/US857626, US 9211405 B2, US 9211405B2, US-B2-9211405, US9211405 B2, US9211405B2
Inventores Srijoy Mahapatra, George T. Gillies
Cesionario original University Of Virginia Patent Foundation
Citas de patentes (252), Otras citas (32), Citada por (1), Clasificaciones (21), Eventos legales (3)
Electrode catheter for ablation purposes and related method thereof
US 9211405 B2
An electrode catheter for use with an endocardial ablation catheter, wherein the electrode catheter receives the transmitted energy for ablating a portion of the heart. The electrode catheter comprises a proximal portion, a distal portion, and a longitudinal structure there between; and an electrode in communication with said electrode catheter, wherein said electrode receives the transmitted energy from the endocardial ablation catheter, or alternatively an epicardial ablation catheter.
an endocardial ablation catheter electrically connected to the energy source and configured to be disposed in a heart and to transmit energy received from the energy source for ablating a portion of the heart;
an electrode catheter configured to be disposed in the middle mediastinum of the thorax of a subject and configured for use with the endocardial ablation catheter, said electrode catheter comprising:
a proximal portion, a distal portion, and a longitudinal structure there between;
at least one distal fluid aperture adapted for passage of a fluid; and
an electrode in communication with said electrode catheter,
wherein said electrode is configured to receive the transmitted energy from the endocardial ablation catheter, and
wherein said electrode catheter is configured to be placed outside of the heart, and to receive the transmitted energy from the endocardial ablation catheter via said electrode while the endocardial ablation catheter is disposed inside of the heart.
2. The device of claim 1, wherein the electrode catheter is configured to be disposed in the pericardial space.
3. The device of claim 1, wherein the electrode catheter is configured to be disposed in outside the pericardium.
4. The device of claim 1, wherein the electrode catheter is configured to be disposed inside the pericardium.
5. The device of claim 1, wherein said at least one distal fluid aperture is in communication with a fluid lumen extending longitudinally through said longitudinal structure toward said proximal end.
6. The device of claim 5, wherein said distal fluid aperture is configured to emit a fluid.
7. The device of claim 5, wherein said distal fluid aperture is configured to extract a fluid.
8. The device of claim 5, wherein said distal fluid aperture is configured to emit and extract a fluid.
at least one proximal fluid aperture at said proximal portion, wherein said at least one proximal fluid aperture is in communication with said fluid lumen, and wherein said at least one proximal fluid aperture is adapted for passage of fluid.
10. The device of claim 9, wherein said proximal fluid aperture is configured to emit a fluid.
11. The device of claim 9, wherein said proximal fluid aperture is configured to extract a fluid.
12. The device of claim 9, wherein said proximal fluid aperture is configured to emit and extract a fluid.
13. The device of claim 9, further comprising a fluid control means configured for controlling passage of the fluid.
14. The device of claim 13, wherein said control means comprises a control handle in communication with said electrode catheter.
15. The device of claim 13, wherein said control means is in communication with an external fluid source.
16. The device of claim 9, wherein the device is configured such that the fluid may be used to cool said electrode.
17. The device of claim 9, wherein the device is configured such that the fluid may be used to distend proximate anatomical structures.
18. The device of claim 1, further comprising a stabilization means configured for stabilizing said electrode catheter.
19. The device of claim 18, wherein said stabilization means comprises at least one deployable member.
20. The device of claim 18, wherein said stabilization means comprises one or more protrusions for engaging proximal anatomical structures.
21. The device of claim 18, wherein said stabilization means comprises a non-conducting material.
22. The device of claim 18, further comprising a control means configured for controlling or adjusting said stabilization means.
23. The device of claim 22, wherein said control means comprises a control handle in communication with said electrode catheter.
24. The device of claim 1, further comprising a steering means configured for positioning said electrode catheter.
25. The device of claim 24, further comprising a second steering means configured for steering said electrode catheter.
26. The device of claim 24, wherein said steering means is configured to orient said electrode catheter about one center of curvature.
27. The device of claim 24, wherein said steering means is configured to adjust a curvature of said electrode catheter about two or more preconfigured centers of curvature.
28. The device of claim 24, wherein said steering means comprises at least one of the following: guide wire, pull string, positional adjustment device, tensioning line, or digitating distal tip.
29. The device of claim 24, further comprising a control means configured for controlling said steering means.
30. The device of claim 29, wherein said control means comprises a control handle in communication with said electrode catheter.
31. The device of claim 1, further comprising an electrical lead in communication with said electrode configured for supplying energy to said electrode.
32. The device of claim 31, further comprising a control handle in communication with said electrode catheter, wherein said control handle is controllably connected to said electrical lead.
33. The device of claim 1, wherein said electrode is made of a conducting material.
34. The device of claim 33, wherein said conducting material comprises at least one of the following: platinum, gold, silver, iridium or any other type of conducting material, alloy or metal.
35. The device of claim 1, wherein said electrode is contoured for the receiving of said transmitted energy.
36. The device of claim 1, wherein said electrode is contoured to be compatible with proximate anatomical structures.
37. The device of claim 1 wherein said electrode is semi-cylindrical in shape.
38. The device of claim 1, wherein said electrode is disposed on said distal portion of said electrode catheter.
39. The device of claim 1, wherein said electrode has a longitudinal length of between about 20 mm and about 50 mm.
40. The device of claim 1, wherein said electrode catheter has a total length of less than about 200 cm.
41. The device of claim 1, wherein said electrode catheter has a total length of less than about 100 cm.
42. The device of claim 1, wherein said electrode catheter has a total length of less than about 50 cm.
43. The device of claim 1, wherein said electrode catheter has a total length of less than about 25 cm.
44. The device of claim 1, wherein said electrode catheter has a total length of less than about 20 cm.
45. The device of claim 1, wherein said electrode catheter is configured to be used simultaneously in conjunction with the endocardial ablation catheter for the purpose of achieving localized burning of heart tissues.
46. The device of claim 45, wherein said device is configured to provide a roughly triangular shaped pattern of current density.
47. The device of claim 1, which when used in conjunction with the endocardial ablation catheter, is configured to provide a roughly triangular shaped pattern of current density.
48. The device of claim 1, wherein the device is configured to be navigated through a puncture of the thorax.
49. The device of claim 48, wherein the device is configured to puncture the sub-xiphoid.
50. The device of claim 48, further comprising a pressure probe needle configured to be used in navigating said electrode catheter.
51. The device of claim 50, wherein said pressure probe needle comprises an access needle.
52. The device of claim 50, wherein said pressure probe needle comprises a sensor configured for sensing pressure in the thorax.
53. The device of claim 48, further comprising an access needle, said access needle adapted to be inserted into the thorax.
54. The device of claim 53, further comprising a guidewire, wherein said guidewire is adapted to be inserted into said access needle.
55. A method using an endocardial ablation catheter, which transmits energy for ablating a portion of a heart, and an electrode catheter including an electrode and at least one aperture, said method comprising:
disposing the endocardial ablation catheter in the heart;
disposing the electrode in the middle mediastinum of the thorax of a subject;
at least one of providing a fluid or extracting a fluid via the aperture of the electrode catheter; and
receiving the transmitted energy with the electrode from the endocardial ablation catheter.
56. The method of claim 55, wherein navigation of the electrode is carried out through a sub-xiphoid puncture.
57. The method of claim 55, wherein the electrode is disposed in the pericardial space.
58. The method of claim 55, wherein the electrode is disposed outside the pericardium.
59. The method of claim 55, wherein the electrode is disposed inside the pericardium.
60. The method of claim 55, wherein the electrode is disposed in a first ventricle of the heart.
61. The method of claim 60, wherein the endocardial ablation catheter is positioned in a second ventricle of the heart.
62. The method of claim 61, wherein said first ventricle is the right ventricle of the heart and said second ventricle is the left ventricle of the heart.
63. The method of claim 61, wherein said first ventricle is the left ventricle of the heart and said second ventricle is the right ventricle of the heart.
64. The method of claim 55, wherein the electrode is made from a conducting material.
65. The method of claim 55, wherein the electrode is contoured for said receiving of the transmitted energy.
66. The method of claim 55, wherein the electrode is contoured to be compatible with proximate anatomical structures.
67. The method of claim 55, wherein the electrode is between 20 mm and 50 mm.
68. The method of claim 55, further comprising disposing the electrode on the electrode catheter.
69. The method of claim 68, wherein said disposing comprises the catheter being inserted into the middle mediastinum of the thorax by inserting the catheter into an access needle.
70. The method of claim 69, further comprising providing a guidewire, wherein the guidewire is adapted to be inserted into the access needle.
71. The method of claim 68, wherein the electrode is disposed on a distal portion of the catheter.
72. The method of claim 68, wherein the catheter further comprises a means for the passage of fluid through the catheter.
73. The method of claim 72, further comprising using the fluid to cool the electrode.
74. The method of claim 72, further comprising using the fluid to distend proximal anatomical structures.
75. The method of claim 68, further comprising using a stabilization means of the catheter for holding the electrode in a position facing the endocardial ablation catheter.
76. The method of claim 55, wherein electrode catheter further comprises at least one steering means for positioning the electrode, the method further comprising adjusting a curvature of the electrode catheter about two or more preconfigured centers of curvature via the at least one steering means.
The present invention is a national stage filing of International Application. No.
PCT/US2008/057626, filed on Mar. 20. 2008, which claims priority under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 60/919,351 filed Mar. 22, 2007, entitled “Epicardial-Cathode Catheter for Ablation Purposes and Related Method Thereof;” the disclosures of which are hereby incorporated by reference herein in their entirety.
This application is related to PCT International Application No. Ser. No. PCT/US2008/056643, filed Mar. 12, 2008, entitled, “Access Needle Pressure Sensor Device and Method of Use,” (and its corresponding U.S. National Stage application Ser. No. 12/530,830, filed Sep. 11. 2009) which claims benefit of priority under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 60/918,782, filed Mar. 19, 2007, entitled “Manometrically Monitored Introducer Needle and Method of Use;” the disclosures of which are hereby incorporated by reference herein in their entirety.
This application is related to PCT International Application No. Ser. No. PCT/US2008/056816, filed Mar. 13, 2008, entitled, “Epicardial Ablation Catheter and Method of Use,” (and its corresponding U.S. National Stage application Ser. No. 12/530,938, filed Sep. 11, 2009) which claims benefit of priority under 35 U.S.C. §119(e) from U.S. Provisional Application Ser. No. 60/906,689, filed Mar. 13, 2007, entitled “Epicardial Ablation Catheter and Access Sheath and Method of Use;” the disclosures of which are hereby incorporated by reference herein in their entirety.
The present invention relates generally to the field of medical devices to be used for cardiological procedures. More specifically, the invention is in the subfield of catheterization devices and other tools to be used for cardiac ablation and in electrophysiological procedures.
Cardiac arrhythmias are a widespread medical condition facing physicians today. Their most frequent cause is an abnormal routing of electricity though the cardiac tissue. While several surgical approaches have been developed for the purpose of treating or preventing different types of cardiac arrhythmias, ablation is now widely used as the preferred treatment. Typically, a physician places an endocardial catheter with an electrode at its tip inside the heart at a location where cells are giving off abnormal electrical signals. The electrode is activated according to various known modes of operation such that the adjacent targeted tissue is ablated and rendered non-conductive, halting the spread of improper cardiac signals.
The arrhythmia substrate is often deep in the wall of the heart, or transmural. Thus, the clinician performing the ablation wants the input energy and resulting heat to propagate entirely through the endocardium to the epicardium, thus thoroughly lesioning the substrate in question. However, critical structures lie directly outside the epicardium, and the fundamental conflict is one of depositing energy deep within the heart tissue on the one hand, but not damaging tissues, organs and structures beyond the heart wall, on the other. As an example, on average the esophagus in only 2 mm from the atrial epicardium yet the atrial is 3 mm thick. Therefore, ablationists essentially want to burn deep enough, but not too deep.
Although simple ablations are performed with relatively few complications, some of the more complex ablations that have been developed recently use more energy over longer periods of time. For example, whereas the standard ablation for atrioventricular nodal reentry requires only 60 seconds of burning, a standard ablation for atrial fibrillation (AF) may require 4000 seconds of burning. Furthermore, whereas traditional ablations are often done on the inner walls of the heart, the more complex ablations are often performed on the heart's free wall, which is even closer to the lungs, phrenic nerve, and esophagus. Recent case reports have shown complications and even death from burns that damage these structures after an AF ablation.
Modern radiofrequency ablation catheter procedures operate by delivering current between a small (2-8 mm) anode located in the tip of a standard ablation catheter coupled to a large surface area conductive cathode provided on the patient's back. Current flowing between the anode and the cathode is at its highest density at the tissue location directly adjacent to the treatment electrode. Thus, a planar sheet of the current flow can be modeled as a triangle with its apex at the ablation tip (anode) and its base on the patient's back (cathode). Though most of the burning is close to the apex of the triangle, the esophagus, lungs, and phrenic nerve are within the current density triangle. The current does not drop off sufficiently between the epicardium and the adjacent structures due to the inherent proximity.
There is therefore a need in the art for an effective electrode catheter that could be electrically coupled to an endocardial or other type of ablation catheter to provide better and safer modes of treatment. Particular needs remain for such a device with appropriate length, diameter, stabilization, steering capacity, and irrigation to allow effective energy transfers transmurally through the endocardial wall.
To overcome these limitations, we have conceived the subject device and method of use, as described in the Summary of the Invention and Detailed Description of the Drawings below.
Because ablation lesions must be created such that electrical conductivity is halted in the localized region, it is desirable to have a cathode as close to the anode as possible. The use of two standard endocardial catheters to carry out a procedure wherein one of them served as an epicardial cathode would cause several limiting considerations that would arise from such a practice. Most generally, an endocardial catheter is simply not designed for the mechanics of epicardial use. In particular, special issues regarding device length, diameter, stabilization, and steering capabilities have to be taken into account. Furthermore, the use of two standard endocardial catheters would mean that the anode and cathode would have the same size. Generally, the cathode should present a larger surface area towards the endocardial anode so that there is more current density near the anode. Lastly, the standard endocardial catheter is not able to provide a flow of irrigation fluid that could be used to cool the electrode or to separate the epicardial surface from critical neighboring anatomical structures.
The following U.S. patent documents discuss epicardial electrodes in the context of pacing: U.S. Pat. Nos. 7,085,606; 6,266,567; 5,509,924; 5,300,110; 4,971,070; 4,817,634; and 4,607,644; as well as U.S. Statutory Invention Registration H356, all of which are incorporated by reference herein in their entirety. No references disclose epicardial electrodes in the context of ablation or eletrophysiological procedures.
One aspect of the present invention provides an electrode catheter disposed in the middle mediastinum of the thorax of a subject for use in ablation procedures with an endocardial ablation catheter. The electrode catheter may comprise a proximal portion, a distal portion, and a longitudinal structure there between. In accordance with the invention, the electrode catheter may further include an electrode adapted for receiving energy from the endocardial ablation catheter.
Another aspect of the present invention provides an electrode catheter disposed in the intra-cardiac space of a subject for use in ablation procedures with an epicardial ablation catheter. The electrode catheter may comprise a proximal portion, a distal portion, and a longitudinal structure there between. In accordance with the invention, the electrode catheter may further include an electrode adapted for receiving energy from the epicardial ablation catheter.
Yet another aspect of the present invention relates to a method of ablating a portion of the heart by disposing an electrode in the middle mediastinum of the thorax of a subject and receiving transmitted energy from an endocardial ablation catheter.
Further yet, another aspect of the present invention relates to a method of ablating a portion of the heart by disposing an electrode in the intra-cardiac space of a subject and receiving transmitted energy from an epicardial ablation catheter.
It should be appreciated that the present invention cardiac catheter may be place or disposed in, adjacent or proximal to any space, structure, blood vessel, vasculature or organ.
An aspect of an embodiment of the present invention comprises a method for use with an endocardial ablation catheter, which transmits energy for ablating a portion of a heart. The method may comprise: disposing an electrode in the middle mediastinum of the thorax of a subject; and receiving the transmitted energy from the endocardial ablation catheter. The middle mediastinum may include, for example, an area outside the pericardium, an area inside the pericardium, or the pericardium space itself.
An aspect of an embodiment of the present invention comprises a method for use with an epicardial ablation catheter, which transmits energy for ablating a portion of a heart. The method may comprise: disposing an electrode in the intra-cardiac space of a subject; and receiving the transmitted energy from the epicardial ablation catheter.
Advantageously, upon activation of the electrode catheter and endocardial or other type of ablation catheter, energy from the ablation catheter is transmitted through the heart wall and is received by the electrode catheter. In this way, a triangular-shaped current density pattern is formed between the endocardial or other type of ablation catheter and the electrode of the electrode catheter. Tissue within this current flow is ablated, while proximal organs are left undamaged by the ablation energy. In older methods a large electrode is placed on or in contact with the patient's back, allowing ablation energy to reach not only the heart-wall tissue, but to travel through other proximal vital organs.
FIG. 1 schematically illustrates the overall configuration of the electrode catheter device in position relative to the heart of a patient or subject.
FIGS. 2(A)-(C) schematically illustrate the steering means employed to position the electrode catheter for use in ablation procedures in un-tensioned, partial steering, and full steering modes, respectively.
FIGS. 3(A)-(C) schematically illustrate the configuration of the distal portion of the electrode catheter in the pre-deployment and alternative deployment modes, respectively.
FIG. 4 schematically illustrates the pericardium and heart alone (FIG. 4(A)) and the pericardium and distension thereof following an influx of fluid from the distal aperture of the electrode catheter (FIG. 4(B)).
FIG. 5(A) schematically illustrates the relative positions of the endocardial ablation catheter and the electrode catheter during an ablation procedure, wherein the electrode catheter has been navigated into position outside the epicardium and pericardium. FIG. 5(B) schematically illustrates the relative positions of the endocardial ablation catheter and the electrode catheter during an ablation procedure, wherein electrode catheter has been navigated into position inside the pericardium, but outside the epicardium.
FIG. 6 schematically illustrates a cross-sectional view of the components inside the lumen of the electrode catheter.
FIG. 7 schematically illustrates a diagram representing the standard existing approach to endocardial ablation therapy, wherein an electrode is placed on or in the exterior proximity of a patient's back.
FIG. 1 is a schematic illustration of an overview of an exemplary embodiment of the electrode catheter 6 and its major components relative to the heart 1 of a patient being treated for a cardiac arrhythmia. The electrode catheter 6 in accordance with the present invention may comprise a proximal portion 40, a distal portion 45, and a longitudinal structure there between. It should be appreciated that the distal portion may be considered at the end tip of the catheter; or a portion or segment at or in the vicinity of the end tip of the catheter or a portion or segment leading up to (or partially up to but not all the way up to) the end tip of the catheter as desired or required. It should also be appreciated that the proximal end may be considered the tip of the beginning of the catheter; or a portion or segment at or in the vicinity of the beginning of the tip of the catheter or a portion or segment leading up to (or partially up to but not all the way up to) the beginning of the catheter, as desired or required. The distal portion 45, proximal portion 40, and longitudinal structure 45 there between may be integrally formed from a biocompatible material having requisite strength and flexibility for deployment within a patient. The electrode catheter 6 further comprises an electrode 3, which is commonly referred to in the art as a cathode. The electrode 3 is in communication with the distal portion of the catheter. The electrode 3 may be constructed of platinum, gold, sliver, iridium, or any other conducting material, alloy or other metal known in the art and is contoured for receiving energy from the endocardial ablation catheter. The electrode 3 is contoured to be compatible with proximate anatomical structures and may be semi-cylindrical in shape with a longitudinal length of between about 20 mm and about 50 mm along the catheter.
The proximal portion 40 of the catheter 6 may be implemented as desired or required along any point or segment, for example, as illustrated by the bracket in FIG. 1. It should be appreciated that the proximal portion may include, for example: a point at the proximal tip of the cathode; a portion or segment at or in the vicinity of the proximal tip of the cathode; or a portion or segment leading up to (or partially up to but not all the way up to) the proximal tip of the cathode. The length and location may vary as desired or required in order to practice the invention according to medical procedures and anatomical considerations. In summary, the proximal end may be translated in the proximal or distal direction on a case by case basis.
The electrode catheter 6 may further comprises a distal fluid aperture, 2, located at the distal portion 45, a proximal fluid aperture 7 located at the proximal portion 40, and a fluid lumen 22, 23 (as shown in FIG. 6) extending longitudinally through the catheter connecting the apertures. Both the distal fluid aperture 2 and proximal fluid aperture 7 are adapted for the emitting and extracting of fluid or other medium. The fluid or other medium may be used to distend adjacent tissue and to cool the electrode during ablation procedures. The proximal fluid aperture lis connected to an external fluid source (not shown).
The catheter 6 further comprises a distal steering means 4 and a proximal steering means 5 which have the steering characteristics taught by Mahapatra et al. in PCT International Application No. Serial No. PCT/US2008/056816, filed Mar. 13, 2008, entitled, “Epicardial Ablation Catheter and Method of Use,” hereby incorporated by reference herein in its entirety. The steering means may be guide wires, tensioning lines, pull strings, digitating distal tips, magnetic guidance means, wires, rods, chains, bands, chords, ropes, string tubes, filaments, threads, fibers, stands, other extended elements, or any other method known in the art. At the proximal end of the catheter may be a control handle 8, which may have integral to it the distal steering control means 9, the proximal steering control means 10, and the control means for the stabilization means 14. The handle is preferably sized to be grasped, held and operated by a user. It should be appreciated that other control and operating interface members, devices or means may be utilized for the handle. Attached to the proximal end of the control handle is the handle proximal port 11, which has a second fluid aperture 13, and from which the electrical lead 12 for the electrode 3 extends, in order to make electrical connections. Wire(s) (shown in FIG. 6, for example) may extend through the proximal portion to the distal portion 45 of the catheter.
For instance, referring to FIGS. 4(A)-(C) PCT International Application No. Serial No. PCT/US2008/056816, there is provided the mechanism of action for obtaining bi-directional steering of the distal tip or portion that may be implemented for the present invention via tensioning or steering means whereby the tip or end is straight, towards the left, and towards the right, respectively.
Moreover, for instance and referring to FIGS. 4(A)-(C) PCT International Application No. Serial No. PCT/US2008/056816, there is provided FIGS. 7(A)-(B) are schematic illustrations of the details of an exemplary mechanism of action for directional steering of the medial segment of the device that may be implemented for the present invention.
It should be appreciated that the medium to flow through ablation catheter device or system may be at least one of the following: agent, substance, material, saline solutions, thrombolytic agents, clot lysis agents, chemotherapies, cell slurries, gene therapy vectors, growth factors, contrast agents, angiogenesis factors, radionuclide slurries, anti-infection agents, anti-tumor compounds, receptor-bound agents and/or other types of drugs, therapeutic agent and/or diagnostic agent, or any combination thereof.
Further, it should be appreciated that the present invention ablation system may be inserted into a subject via an interventional procedure or a surgical procedure, as well as a combination thereof.
FIGS. 2(A)-(B) provide a schematic illustration of some details of an exemplary embodiment of the electrode catheter steering means in un-tensioned, partial steering, and full steering modes, respectively. The steering means are preferably of a type known in the art, including, but not limited to, guide wires, tensioning lines, pull strings, digitating distal tips, guidance means, propulsion means, or tensioning means that may be applied to the various sheaths, catheters and guidewires, or any related components disclosed herein. Steering adjustments are made along the centers of curvature, referenced as A and B, at the proximal steering means 5, and the distal 4 steering means, respectively. Specifically, FIG. 2(A) shows the electrode catheter 6 in the undeflected state. FIG. 2(B) shows the electrode catheter 6 in the partially deflected state. FIG. 2(C) shows the electrode catheter 6 in the fully deflected state as would be the case when it has been navigated into the pericardial space of a subject's heart, or other space or structure. The steering means are used to direct the electrode catheter through or navigate it within a patient's body.
It should be appreciated that the various sheaths, catheters and guidewires, or any related components disclosed herein, may have a circular or oval shaped cross-section or various combinations thereof. Further, it should be appreciated that various sheaths, catheters and guidewires, or any related components disclosed herein may have any variety of cross sections as desired or required for the medical procedure or anatomy.
FIGS. 3(A)-(C) schematically illustrate exemplary embodiments of construction of the distal portion 45 of the electrode catheter 6. FIG. 3(A) shows a view in profile of the catheter 6 in the undeployed stage having a distal fluid aperture 2, the electrode 3, one of the two slots 15, from which a stabilization means (see FIGS. 3(B)-(C), for example) can issue or deploy, and a second fluid aperture 30. A fluid lumen and second fluid lumen (as shown in FIG. 6) may extend from the control handle 8 through the proximal portion 40 of the catheter 6 and terminate in a distal fluid aperture 2, and second distal fluid aperture 30, respectively. The fluid aperture 2 and second fluid aperture 40 are adapted for allowing the emitting and extracting of fluid or other medium as desired or required.
FIG. 3(B) schematically illustrates an example embodiment of the distal portion 45 configuration of the catheter 6 in the deployed stage for the case where the stabilization means comprises a pair of tabs 16 that have been extended from the slots 15. The stabilization means may be made of a number of non-conducting materials known in the art in order to allow the rotational orientation of the catheter to remain fixed in place relative to the surface of the heart. The stabilization tabs 16 can engage proximal anatomical structures in order to keep the electrode facing the energy source. If the catheter 6 were allowed to rotate so that the electrode faced away from the energy source, the adjacent anatomical structures could suffer burns from energy during ablation.
FIG. 3(C) schematically illustrates another example embodiment of the catheter 6 in the deployed stage in which the stabilization means is now a pair of wires 17 extending from the slots 15. In the case of either the tabs 16 or the wires 17, the control means 14 on the control handle 8 is used to regulate the degree of extension of said stabilization means via a pull-wire arrangement or some other suitable tensioning, positional adjustment or digitation means know in the art. The tabs 16 and wires 17 are just two examples of stabilization means. There are many other embodiments of stabilization means known in the art.
FIGS. 4(A) and 4(B) schematically illustrates the heart 1 and pericardium 18 of a patient. The pericardium is in close proximity to the epicardium 32. FIG. 4(B) shows an embodiment wherein the catheter 6 has had its distal portion 45 positioned in the pericardial space, cavity or sack 34, or the area between the pericardium 18 and epicardium 32. A fluid can be pumped through the distal fluid aperture 2 or second distal fluid aperture 30 (as shown in FIG. 3) in order to create a distention 19 of the pericardium. As a result, any anatomical structures, such as the esophagus and lungs that might have been as close as about 2 mm from the epicardium will now be substantially farther from it. The danger of suffering burns during ablation is, therefore, reduced or eliminated. Danger to the esophagus from ablation is described in detail by H. Aupperle et al. in their article “Ablation of Atrial Fibrillation and Esophageal Injury: Effects of Energy Source and Ablation Technique, “Journal of Thoracic and Cardiovascular Surgery, Vol. 130, pp. 1549-1554, (2005), of which is hereby incorporated by reference herein. The fluid not only distends the pericardium, but also serves to cool the electrode, 3, during the ablation process.
FIG. 5(A) schematically illustrates an exemplary embodiment wherein an endocardial ablation catheter 20 is in place inside the heart 1 just inside the endocardium 33, as illustrated by D. Schwartzman et al. in FIG. 3 of their article, “Catheter Ablation of Ventricular Tachycardia Associated with Remote Myocardial Infarction: Utility of the Atrial Transseptal Approach,” Journal of Interventional Cardiac Electrophysiology, Vol. 1, pp. 67-71, (1997), of which is hereby incorporated by reference herein in its entirety. The electrode catheter 6 has been navigated into position outside and in close proximity to the epicardium 32 and pericardium 18, or as desired or required. The electrode catheter 6 is oriented such that the electrode 3 faces the heart. The distal portion of the electrode catheter 45 is held in place by the stabilization means of the invention, and the ablation process is started. The electrode 3 of the electrode catheter 6 receives the current from the endocardial ablation catheter 20. In one embodiment, the ablation energy is in the form of RF waves. The characteristic triangular-shaped current density pattern 21 is then observed between the tip of the endocardial ablation catheter 20 and the electrode 3 as the majority of current density remains between the two catheters. In this way, the anatomical structures located outside the triangular-shaped current density pattern 21 are protected from burns.
FIG. 5(B) schematically illustrates another exemplary embodiment similar to FIG. 5(A), but wherein the electrode catheter 6 is positioned between the epicardium 32 and pericardium 18 in the pericardial space, cavity or sack 34.
For instance, but not limited thereto, the electrode catheter may be disposed in the middle mediastinum, any area outside the pericardium, or any area inside the pericardium.
Although not illustrated, an embodiment of the present invention provides an endocardial electrode catheter disposed in the intra-cardiac space of a subject for use in ablation procedures with an epicardial ablation catheter. In accordance with the invention, the electrode catheter further includes an electrode adapted for receiving energy from the epicardial ablation catheter. For example, but not limited thereto, the intra-cardiac space includes the left ventricle and/or right ventricle, as well as any interior region or region in proximity to the interior of the heart.
Although not illustrated, an embodiment of the present invention provides an electrode catheter disposed in the intra-cardiac space of a subject for use in ablation procedures with an endocardial ablation catheter. In accordance with the invention, the electrode catheter further includes an electrode adapted for receiving energy from the endocardial ablation catheter. For example, but not limited thereto, the endocardial cathode catheter may be disposed in the intra-cardiac space and the endocardial ablation catheter may be in a second intra-cardiac space. The intra-cardiac spaces may be various ventricles or chambers of the heart, or any desirable or required regions of the heart.
An aspect of an embodiment of the present invention ablation system may be implemented with an access needle (introducer needle), conduit or the like. The access needle or conduit is adapted to be inserted into the epicardial region or other body part or body space so as to provide an access or guideway for the present invention ablation catheter, sheath, guidewire, etc. An example of an access system is disclosed in PCT International Application No. Serial No. PCT/US2008/056643, filed Mar. 12, 2008, entitled, “Access Needle Pressure Sensor Device and Method of Use,” of which is hereby incorporated by reference herein in its entirety. See for example, but not limited thereto, FIGS. 2 and 5 of the PCT International Application No. Serial No. PCT/US2008/056643. The access needle sensor device or the like serves as a guideway for introducing other devices into the pericardium, for instance sheath catheters that might subsequently be employed for procedures in the pericardium and the epicardium of the heart, or other applicable regions, space or anatomy. Other devices that the access device may accommodate with the practice of this invention include, but not limited thereto, the following: ablation catheters, guidewires, pacing leads, pacing catheters, pacemakers, visualization and recording devices, drugs, and drug delivery devices, lumens, steering devices or systems, drug or cell delivery catheters, fiber endoscopes, suctioning devices, irrigation devices, electrode catheters, needles, optical fiber sensors, sources of illumination, vital signs sensors, and the like Theses devices may be deployed for procedures in an integral body part or space.
Although not shown, as mentioned above, the insertion of the electrode catheter into the epicardial region may be aided by the use of an access needle and subsequent passage of a guidewire. The access needle may first be inserted into the epicardium, with the guidewire then put in place. The electrode catheter may then be coaxially slid over the guidewire to access the epicardial region.
Although not shown and involving another approach, the insertion of a sheath into the epicardial region may be aided by the use of an access needle and subsequent passage of a guidewire. The access needle may first be inserted into the epicardium, with the guidewire then put in place. The sheath may then be coaxially slid over the guidewire to access the epicardial region. After positioning the sheath in the desired position, the catheter may then be inserted through the sheath to reach the epicardium.
For example, with present invention, an epicardial access needle-stick is may be implemented in the subxiphoid area of the chest and the catheter device must then only be advanced a short distance to get to the heart. However, it may immediately be steered through an acute angle to avoid the heart itself. Because of this, aspects of the present invention devices and those used in conventional techniques can be contrasted. For instance, conventional endocardial catheters may typically be 100 cm in length or longer since they must go from the leg to the heart, while an embodiment of the present invention electrode catheter could be, for example, about 30 cm or less since it may only need to go from the chest to the heart. It should be appreciated that the length may be greater than 30 cm as well. Similarly, catheters in excess of the required 30 cm could be an awkward physical obstacle that would interfere with the procedure and, if inadvertently bumped or moved, could injure the patient. Similarly the conventional long catheters used in cathode and ablation devices, while not dangerous as such, are nevertheless awkward. Another reason that present invention shorter catheters may be preferred in epicardial procedures is that it is easier to effect rotation of the distal end of a catheter through rotation of the proximal end if the length of the catheter is shorter. Therefore, a shorter sheath and catheter would be less awkward, easier to use, and safer.
It should be appreciated that various embodiments of the present invention electrode catheter may have a total length of less than about 200 cm, less than about 100, less than about 50 cm, less than about 25 cm, or less than about 20 cm, or may be shorter even yet if desired or required. It should be appreciated that the total length may be longer than any of the ranges provided above.
Although not shown, in another exemplary embodiment the electrode catheter 6 may be placed endocardially in order to receive transmitted energy from an epicardial ablation catheter or another endocardial ablation catheter.
FIG. 6 schematically illustrates a cross sectional view of an exemplary embodiment of the electrode catheter located on the proximal portion. The fluid lumen 22 and second fluid lumen 23 occupy internal cross-sectional area of the electrode catheter 6. The fluid lumen 22 may extend from the proximal fluid aperture 7 (for example, as shown in FIG. 1) to the distal fluid aperture 2 (as shown in FIG. 3). The second fluid lumen 23 may extend from the second proximal fluid aperture 13 (as shown in FIG. 1) to the second distal fluid aperture 30 (as shown in FIG. 3). The steering pull-wire or tensioning means 24 for controlling the steering means and second steering means are also shown. The steering tensioning means 24 extend from the control handle 8 (for example, as shown in FIG. 1) through the body catheter 6 and terminate at or near a point of curvature (for example, as referenced as A and B of FIG. 2). In this particular embodiment, there are two distal steering means (bi-directional control) and one proximal steering means (uni-directional control). Many other configurations of the steering tensioning means for adjustable positioning and digitation can be implemented. The stabilization pull-wire or tensioning means 25 for the deployment of the stabilization means are also shown. The stabilization tensioning means 25 extend from the control handle 8 (for example, as shown in FIG. 1) through the body of the catheter 6 and terminate at or near the stabilization means 25 at the distal portion 45 of the electrode catheter 6. Lastly, the electrical lead wire(s) 26 for the electrode is shown. The lead wire 26 may extend from the control handle 8 through the body of the catheter 6 and terminates at the electrode 3 at the distal portion 45 of the electrode catheter 6.
FIG. 7 schematically illustrates an approach to endocardial ablation therapy, in contrast to the method of the subject invention. The figure may follow most of the details of FIG. 1 from J.C. Lin, “Catheter Microwave Ablation Therapy for Cardiac Arrhythmias,” Bioelectromagnetics, Vol. 20, pp. 120-132, (1999), incorporated by reference herein in its entirety. In an approach, an endocardial catheter, 2, is placed in the heart of a patient as is known in the art. A radiofrequency generator 27 is used to produce a high frequency or radio frequency AC signal that is passed to the tip of the endocardial ablation catheter 20 when the system switch 28 is closed by the operator. A return path for the RF energy is provided by the dispersive electrode 29 (as shown with dashed lines) that is mounted on the back of the patient in proximity to the heart. This approach stands in contrast to that of the subject invention, as illustrated in detail in FIGS. 1-6, and discussed throughout.
One skilled in the art can see that many other embodiments of means and methods for using the electrode catheter in the ablation of cardiac tissues according to the technique of the invention, and other details of construction and use thereof, constitute non-inventive variations of the novel and insightful conceptual means, system and technique which underlie the present invention.
In a specific example embodiment, the overall length of the electrode catheter from the distal end to the proximal end is approximately 30 cm: 5 cm from the distal tip of the catheter to the distal steering point, 15 cm from the distal steering point to the proximal steering point, and 10 cm from the proximal steering point to the control handle or proximal fluid aperture. The electrode catheter is nominally 8 french in about 2.7 mm. The catheter further comprises a platinum cathode at the distal tip having a semi-cylindrical geometry (an arc of 180 degrees), a circumference of 5.7 mm (consistent with the 8 Fr size), and an axial length of 25 mm. Additionally, the catheter comprises two distal fluid apertures of different sizes, wherein the larger of the two apertures is used for suction of fluid and the smaller is used for emission of fluid, preventing tamponade. Further, the catheter is steerable at two points along its axial length. Finally, the catheter is able to deploy two side flaps or extensions that, when open, work to rotationally stabilize the catheter so that it can not flip over, thus providing confidence that only the desired side of the device would be facing the heart during heating or usage.
U.S. PATENT AND APPLICATION DOCUMENTS
7,147,633 December 2006 Chee et al 606/41
7,146,225 December 2006 Guenst et al 607/119
7.090,637 August 2006 Danitz et al 600/141
7,041,099 May 2006 Thomas et al 606/41
6,974,454 December 2005 Hooven 606/41
6,960,205 November 2005 Jahns et al 606/41
6,916,318 July 2005 Francischelli et al 606/41
6,849,075 February 2005 Bertolero et al 606/41
6,827,715 December 2004 Francischelli et al 606/34
6,827,714 December 2004 Swanson 606/32
6,752,805 June 2004 Maguire et al 606/41
6,723,092 April 2004 Brown et al 606/41
6,689,128 February 2004 Sliwa et al 606/41
6,558,382 May 2003 Jahns et al 606/41
6,231,518 May 2001 Grabek et al 600/508
6,206,004 May 2001 Schmidt et al 604/500
6,156,009 December 2000 Grabek 604/117;
U.S. Pat. Application Publication 2002/0045895 A1 to Sliwa et al.,
EP 1181896 February 2002
WO 01/05306 January 2002
WO 01/80757 November 2001
WO 01/68173 September 2001
WO 01/58373 August 2001
WO 01/80724 April 2001
WO 99/18869 April 1999
Au 70522/96 October 1996
DE 43 13 903 September 1994
WO 93/20886 October 1993
EP 0 450 608 October 1991
CA 2236958 July 1973
A. d'Avila et al., “Transthoracic Epicardial Catheter Ablation of Ventricular Tachycardia,” Heart Rhythmn, Vol. 3, pp. 1110-1111, (2006).
S. Mahapatra et al., “Incidence and Predictors of Cardiac Perforation after permanent Pacemaker Placement,” Heart Rhythm, Vol. 2, pp. 907-911, (2005).
D. L. Packer et al., “Multimodality 3-D Ultrasound and Computed Tomographic Image Fusion: A Novel Basis for Catheter Navigation and Electroanatomic Mapping,” Circulation, Vol. 112, p. U684, (2005).
W. P. Beukema et al., “Radiofrequency Ablation of Atrial Fibrillation in Patients Undergoing Concommitant Cardiac Surgery. First Experience,” PACE, Vol. 20 (Part II), p. 1100, (April 1997).
L. S. Klein et al., “Radiofrequency Ablation of Cardiac Arrhythmias,”Scientific American Science & Medicine, pp. 48-57, (May/June 1994).
US3794026 3 Ago 1972 26 Feb 1974 H Jacobs Ventilating apparatus embodying selective volume or pressure operation and catheter means for use therewith
US4349023 9 Oct 1980 14 Sep 1982 Abbott Laboratories Epidural needle catheter and adapter
US4607644 1 Abr 1985 26 Ago 1986 Cordis Corporation Self-suturing porous epicardial electrode assembly
US4935008 20 Jul 1988 19 Jun 1990 Lewis Jr Ronald L Double lumen introducing needle
US5158097 8 Jun 1990 27 Oct 1992 Allegheny-Singer Research Institute Paraneural stimulating lead
US5213570 14 Dic 1990 25 May 1993 Mallinckrodt Medical, Inc. System and method for oxygenation of the pericardium
US5465711 13 Ago 1993 14 Nov 1995 Origin Medsystems, Inc. Surgical procedures using endoscopic inflatable retraction devices
US5484423 15 Abr 1994 16 Ene 1996 Te Me Na Logistics Needle, for example epidural needle
US5669882 23 Abr 1996 23 Sep 1997 Pyles; Stephen Curved epidural needle system
US5779699 * 29 Mar 1996 14 Jul 1998 Medtronic, Inc. Slip resistant field focusing ablation catheter electrode
US5792217 28 Jun 1996 11 Ago 1998 Medtronic, Inc. Temporary bipolar heart wire
US5812978 9 Dic 1996 22 Sep 1998 Tracer Round Associaties, Ltd. Wheelchair voice control apparatus
US5885217 20 Ene 1995 23 Mar 1999 Tyco Group S.A.R.L. Catheter introducer
US6120476 1 Dic 1997 19 Sep 2000 Cordis Webster, Inc. Irrigated tip catheter
US6148825 13 Feb 1998 21 Nov 2000 Anderson; Bernard Bradley Method of using a dedicated internal shunt and stent for the inferior vena cava
US6200315 18 Dic 1997 13 Mar 2001 Medtronic, Inc. Left atrium ablation catheter
US6206874 * 6 Abr 1999 27 Mar 2001 Siemens-Elema Ab Apparatus and method for locating electrically active sites with an animal
US6270484 17 Feb 1999 7 Ago 2001 Inbae Yoon Safety penetrating instrument with expandible portion and method of penetrating anatomical cavity
US6273877 20 Jul 2000 14 Ago 2001 Becton, Dickinson And Company Epidural needle with secondary bevel
US6278975 19 Ago 1999 21 Ago 2001 Johns Hopkins University Voice command and control medical care system
US6325776 10 Ago 1999 4 Dic 2001 Bernard Bradley Anderson Internal by-pass shunt apparatus for the inferior vena cava
US6416505 * 5 May 1998 9 Jul 2002 Scimed Life Systems, Inc. Surgical method and apparatus for positioning a diagnostic or therapeutic element within the body and pressure application probe for use with same
US6500130 21 Dic 2000 31 Dic 2002 Scimed Life Systems, Inc. Steerable guidewire
US6551289 27 Sep 1999 22 Abr 2003 Dr. Japan Co., Ltd. Outer needle of anesthetic needle assembly for epidural
US6592552 19 Sep 1997 15 Jul 2003 Cecil C. Schmidt Direct pericardial access device and method
US6616676 10 Abr 2001 9 Sep 2003 Scimed Life Systems, Inc. Devices and methods for removing occlusions in vessels
US6783510 8 Jul 1999 31 Ago 2004 C.R. Bard, Inc. Steerable catheter
US6827714 * 7 Mar 2001 7 Dic 2004 Scimed Life Systems, Inc. Internal indifferent electrode device for use with lesion creation apparatus and method of forming lesions using the same
US6869414 22 Mar 2002 22 Mar 2005 Cardiac Pacemakers, Inc. Pre-shaped catheter with proximal articulation and pre-formed distal end
US6918890 29 Ene 2003 19 Jul 2005 Cecil C. Schmidt Direct pericardial access device and method
US6928313 27 Ene 2003 9 Ago 2005 Cardiac Pacemakers, Inc. System and method for accessing the coronary sinus to facilitate insertion of pacing leads
US6936040 29 Oct 2001 30 Ago 2005 Medtronic, Inc. Method and apparatus for endovenous pacing lead
US6968223 1 Feb 2002 22 Nov 2005 Ge Medical Systems Global Technology Company, Llc System and method for wireless voice control of an interventional or diagnostic medical device
US6973352 5 Dic 2002 6 Dic 2005 Pacesetter, Inc. Steerable cardiac pacing and sensing catheter and guidewire for implanting leads
US7037296 2 Abr 2004 2 May 2006 Advanced Medical Optics, Inc. Curved multi-purpose phacoemulsification needle
US7059878 23 Feb 2005 13 Jun 2006 Remington Medical, Inc. Epicardial pacer extension cable system
US7089063 16 May 2001 8 Ago 2006 Atrionix, Inc. Deflectable tip catheter with guidewire tracking mechanism
US7104986 * 12 May 2003 12 Sep 2006 Arthrocare Corporation Intervertebral disc replacement method
US7146225 30 Oct 2002 5 Dic 2006 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
US7147633 14 Mar 2002 12 Dic 2006 Boston Scientific Scimed, Inc. Method and apparatus for treatment of atrial fibrillation
US7207988 26 Jun 2003 24 Abr 2007 Medtronic Inc. Method and apparatus for providing intra-pericardial access
US7232422 30 Ago 2004 19 Jun 2007 C.R. Bard, Inc Steerable catheter
US7247139 23 Dic 2003 24 Jul 2007 Ge Medical Systems Global Technology Company, Llc Method and apparatus for natural voice control of an ultrasound machine
US7259906 13 Ene 2004 21 Ago 2007 Cheetah Omni, Llc System and method for voice control of medical devices
US7286992 11 Jun 2003 23 Oct 2007 Leica Microsystems (Schweiz) Ag Voice control system for surgical microscopes
US7468029 4 Jun 2002 23 Dic 2008 Robertson Jr Abel L Progressive biventricular diastolic support device
US8048072 * 6 Jul 2007 1 Nov 2011 Les Hospitaux Universitaires de Geneva Medical device for tissue ablation
US8271095 * 30 Dic 2005 18 Sep 2012 Biosense Webster, Inc. System and method for monitoring esophagus proximity
US20010025178 25 May 2001 27 Sep 2001 Mulier Peter M.J. Method and apparatus for creating a bi-polar virtual electrode used for the ablation of tissue
US20010039410 26 Ene 2001 8 Nov 2001 Verrier Richard L. Kit for transvenously accessing the pericardial space via the right atrium
US20020045895 5 Dic 2001 18 Abr 2002 Epicor, Inc. Methods and devices for ablation
US20020055714 19 Dic 2001 9 May 2002 Rothschild Richard B. Method and apparatus for the non-surgical placement of a subcutaneously tunnelled catheter through the skin into a central vein
US20020072737 17 Abr 2001 13 Jun 2002 Medtronic, Inc. System and method for placing a medical electrical lead
US20020077600 19 Dic 2000 20 Jun 2002 Laksen Sirimanne Percutaneous catheter assembly
US20020082523 21 Dic 2000 27 Jun 2002 Bryan Kinsella Steerable guidewire
US20020161361 13 Dic 2000 31 Oct 2002 Sherman Marshall L. RF ablation system and method having automatic temperature control
US20030065318 28 Sep 2001 3 Abr 2003 Rajesh Pendekanti Method and tool for epicardial ablation around pulmonary vein
US20030114796 29 Ene 2003 19 Jun 2003 Schmidt Cecil C. Direct pericardial access device and method
US20030181855 22 Mar 2002 25 Sep 2003 Simpson John A. Pre-shaped catheter with proximal articulation and pre-formed distal end
US20040024413 31 Jul 2002 5 Feb 2004 Lentz David J. Wire reinforced articulation segment
US20040024435 26 Jun 2003 5 Feb 2004 Leckrone Michael E. Method and apparatus for providing intra-pericardial access
US20040064138 30 Sep 2003 1 Abr 2004 Grabek James R. Atrial appendage remodeling device and method
US20040087938 26 Jun 2003 6 May 2004 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US20040138527 17 Jul 2003 15 Jul 2004 Bonner Matthew D. Methods and apparatus for accessing and stabilizing an area of the heart
US20040147826 27 Ene 2003 29 Jul 2004 Cardiac Pacemakers, Inc. System and method for accessing the coronary sinus to facilitate insertion of pacing leads
US20040186507 24 Jul 2003 23 Sep 2004 Percardia, Inc. Stent delivery system and method of use
US20040215168 23 Ene 2004 28 Oct 2004 Beth Israel Deaconess Medical Center Kit for transvenously accessing the pericardial space via the right atrium
US20040267303 29 Jul 2004 30 Dic 2004 Guenst Gary W. Methods and tools for accessing an anatomic space
US20050027243 30 Ago 2004 3 Feb 2005 Gibson Charles A. Steerable catheter
US20050085769 30 Ene 2004 21 Abr 2005 Kerberos Proximal Solutions Fluid exchange system for controlled and localized irrigation and aspiration
US20050096522 5 Nov 2003 5 May 2005 Ge Medical Systems Global Technology Company, Llc Cardiac imaging system and method for quantification of desynchrony of ventricles for biventricular pacing
US20050154376 5 Nov 2004 14 Jul 2005 Riviere Cameron N. Robot for minimally invasive interventions
US20050251094 15 Jul 2005 10 Nov 2005 Cardiac Pacemakers, Inc. System and method for accessing the coronary sinus to facilitate insertion of pacing leads
US20050273006 26 Abr 2005 8 Dic 2005 Medtronic, Inc. Heart wall ablation/mapping catheter and method
US20050273144 16 Ago 2005 8 Dic 2005 Medcool, Inc. Method and device for reducing secondary brain injury
US20060025705 24 Mar 2005 2 Feb 2006 Whittaker David R Method for use of vascular guidewire
US20060025762 14 May 2005 2 Feb 2006 Mohan Ashik A Ablation probe with stabilizing member
US20060064056 17 Sep 2004 23 Mar 2006 James Coyle Guiding catheter assembly for embolic protection by proximal occlusion
US20060064058 17 Sep 2004 23 Mar 2006 James Coyle Guiding catheter with embolic protection by proximal occlusion
US20060074397 29 Sep 2005 6 Abr 2006 Jin Shimada Devices and methods for access through a tissue wall
US20060122591 30 Dic 2005 8 Jun 2006 Yaron Keidar Ultrasound ablation catheter and method for its use
US20060189840 18 Feb 2005 24 Ago 2006 Acorn Cardiovascular, Inc. Transmyocardial delivery of cardiac wall tension relief
US20060200002 26 Abr 2006 7 Sep 2006 Guenst Gary W Methods and tools for accessing an anatomic space
US20060247522 28 Abr 2005 2 Nov 2006 Boston Scientific Scimed, Inc. Magnetic navigation systems with dynamic mechanically manipulatable catheters
US20060247672 27 Abr 2005 2 Nov 2006 Vidlund Robert M Devices and methods for pericardial access
US20060259017 27 Abr 2005 16 Nov 2006 Cardiac Pacemakers, Inc. Adhesive elements and methods for accessing the pericardial space
US20070016068 8 May 2006 18 Ene 2007 Sorin Grunwald Ultrasound methods of positioning guided vascular access devices in the venous system
US20070016069 8 May 2006 18 Ene 2007 Sorin Grunwald Ultrasound sensor
US20070016070 8 May 2006 18 Ene 2007 Sorin Grunwald Endovascular access and guidance system utilizing divergent beam ultrasound
US20070016072 8 May 2006 18 Ene 2007 Sorin Grunwald Endovenous access and guidance system utilizing non-image based ultrasound
US20070032796 7 Jul 2006 8 Feb 2007 Chao Chin-Chen Patent foramen ovale closure device with steerable delivery system
US20070043397 25 Oct 2006 22 Feb 2007 Ocel Jon M Cardiac mapping instrument with shapeable electrode
US20070055142 14 Mar 2003 8 Mar 2007 Webler William E Method and apparatus for image guided position tracking during percutaneous procedures
US20070198041 12 Ago 2004 23 Ago 2007 Heinz Rupp Tissue Or Organ Manipulation Device
US20070270882 19 May 2006 22 Nov 2007 Acorn Cardiovascular, Inc. Pericardium management method for intra-pericardial surgical procedures
US20080051671 30 Oct 2007 28 Feb 2008 Boston Scientific Scimed, Inc. Intravascular filter monitoring
US20080097399 15 Jun 2007 24 Abr 2008 Ravish Sachar Catheter With Adjustable Stiffness
US20080183080 12 Oct 2007 31 Jul 2008 Innoscion, Llc Image guided catheter having deployable balloons and pericardial access procedure
US20080208184 27 Dic 2007 28 Ago 2008 Gareth Davies Cardiac electrosurgery
US20080262432 19 Abr 2007 23 Oct 2008 Medtronic Vascular, Inc. System and method for manipulating a guidewire through a catheter
US20080294174 12 May 2008 27 Nov 2008 Epitek, Inc. Methods and apparatus for pericardial access
US20090030469 10 Ago 2006 29 Ene 2009 Gideon Meiry Cardiac Resynchronization Therapy Systems and Methods
US20100069849 29 Jun 2007 18 Mar 2010 Kassab Ghassan S Percutaneous intravascular access to cardiac tissue
US20100094143 12 Mar 2008 15 Abr 2010 University Of Virginia Patent Foundation Access Needle Pressure Sensor Device and Method of Use
US20100114093 13 Mar 2008 6 May 2010 University Of Virginia Patent Foundation Epicardial Ablation Catheter and Method of Use
US20100211064 20 Mar 2008 19 Ago 2010 University Of Virginia Patent Foundation Electrode Catheter for Ablation Purposes and Related Method Thereof
US20100241185 7 Nov 2008 23 Sep 2010 University Of Virginia Patent Foundation Steerable epicardial pacing catheter system placed via the subxiphoid process
AU7052296A Título no disponible
CA2236958A1 6 May 1998 7 Nov 1998 Douglas Murphy-Chutorian Ultrasound device for axial ranging
EP0450608A1 4 Abr 1991 9 Oct 1991 Richard Wolf GmbH Medical forceps
EP1129681A1 23 Feb 2001 5 Sep 2001 Optikon 2000 S.p.a. Phacoemulsification tip
EP1181896A1 20 Ago 2001 27 Feb 2002 Biosense Webster, Inc. Ablation catheter with cooled linear electrode
EP2279773B1 19 May 2009 23 Ene 2013 Terumo Kabushiki Kaisha Catheter retaining tool
WO1993020878A1 8 Abr 1993 28 Oct 1993 Cardiorhythm Shapable handle for steerable electrode catheter
WO1993020886A1 12 Abr 1993 28 Oct 1993 Ep Technologies, Inc. Articulated systems for cardiac ablation
WO1995010319A1 14 Oct 1994 20 Abr 1995 Ep Technologies, Inc. Electrodes for creating lesions in body tissue
WO1995015115A1 1 Dic 1994 8 Jun 1995 Boaz Avitall Atrial mapping and ablation catheter system
WO1997033526A3 3 Feb 1997 13 Nov 1997 Medtronic Inc Method and apparatus for r-f ablation
WO1999018869A1 8 Oct 1998 22 Abr 1999 Camran Nezhat Methods and systems for organ resection
WO2001080724B1 27 Abr 2001 10 May 2002 Atricure Inc Transmural ablation device and method
WO2001080757A3 27 Abr 2001 21 Mar 2002 Medtronic Inc Vibration sensitive ablation device and method
WO2008112870A2 13 Mar 2008 18 Sep 2008 University Of Virginia Patent Foundation Epicardial ablation catheter and method of use
WO2008115745A3 12 Mar 2008 6 Nov 2008 Univ Virginia Access needle pressure sensor device and method of use
WO2008118737A1 20 Mar 2008 2 Oct 2008 University Of Virginia Patent Foundation Electrode catheter for ablation purposes and related method thereof
WO2009062061A1 7 Nov 2008 14 May 2009 University Of Virginia Patent Foundation Steerable epicardial pacing catheter system placed via the subxiphoid process
1 Arrow International Corporation, AN-05505 Epidural Needle, www.arrowintl.com/products/boms/AN05505.asp?cat=17&item=AN-05505&xsec= (accessed Feb. 13, 2007).
2 Beukema, "Radiofrequency Ablation of Atrial Fibrillation in Patients Undergoing Concommitant Cardiac Surgery. First Experience," PACE, 1997, p. 1100, vol. 20 (Part II).
3 D'Avila, "Transthoracic Epicardial Catheter Ablation of Ventricular Tachycardia," Heart Rhythmn, 2006, p. 1110-1111, vol. 3.
4 Derose, Jr., "Robotically Assisted Left Ventricular Epicardial Lead Implantation for Biventricular Pacing: the Posterior Approach," The Annals of Thoracic Surgery, 2004, p. 1472-1474, vol. 77.
5 DP25B-S Strain Gage Pagel Meter: User's Guide, OMEGA Engineering, Inc., 2002 (accessed Jul. 9, 2007), Stamford, CT. Online at http://www.omega.com/Manuals/manualpdf/M3598.pdf.
6 DP41B Universal Input Meter: User's Guide, OMEGA Engineering, Inc., 2005 (accessed Dec. 5, 2007), Stamford, CT. Online at http://www.omega.com/Manuals/manualpdf.M2544.pdf.
7 DPI 603 Portable Pressure Calibrator User Guide, OMEGA Engineering, Inc., 1996 (accessed Dec. 5, 2007), Stamford, CT. Online at http://www.omega.com/Manuals/manual.pdf/M2913.pdf.
8 Frölich, "Pioneers in Epidural Needle Design," Anesthesia & Analgesia, 2001, p. 215-220, vol. 93.
9 Hansky, "Lead Selection and Implantation Technique for Biventricular Pacing," European Heart Journal Supplements, 2004, p. D112-D116, vol. 6, Supplement D.
10 Klein, "Radiofrequency Ablation of Cardiac Arrhythmias," Scientific American Science & Medicine, 1994, p. 48-57.
11 Lin, "Catheter Microwave Ablation Therapy for Cardiac Arrhythmias," Bioelectromagnetics, 1999, p. 120-132, vol. 20.
12 Mahapatra, "Access Device and Manometric Monitoring System for Epicardial Electrophysiology: Improved Porototype and Use in Human Trials", Jan. 2008, Technical Report No. UVA/640419/MAE08/102.
13 Mahapatra, "Access Device and Manometric Monitoring System for Epicardial Electrophysiology: Improved Porototype and Use in Human Trials", Jul. 2007, Technical Report No. UVA/640419/MAE08/101.
14 Mahapatra, "Incidence and Predictors of Cardiac Perforation after permanent Pacemaker Placement," Heart Rhythm, 2005, p. 907-911, vol. 2, No. 9.
15 Mair, "Epicardial Lead Implantation Techniques for Biventricular Pacing via Left Lateral Mini-Thoracotomy, Video-Assisted Thoracoscopy, and Robotic Approach," The Heart Surgery Forum #2003-4883, 2003, p. 412-417, vol. 6 (5).
16 Moses, "Sirolimus-Eluting Stents Versus Standard Stents in Patients with Stenosis in a Native Coronary Artery", New England Journal of Medicine, 2003, p. 1315-1323, vol. 349, No. 14.
17 Packer, "Multimodality 3-D Ultrasound and Computed Tomographic Image Fusion: A Novel Basis for Catheter Navigation and Electroanatomic Mapping," 2005, Circulation, Clinical Science, Supplement II, vol. 112, No. 17, #2939.
18 PX26 Series Pressure Transducers: Instruction Sheet, OMEGA Engineering, Inc., 2004 (accessed Dec. 5, 2007), Stamford, CT. Online at http://www.omega.com/Manuals/manualpdf/M1608.pdf.
19 PX26 Series Pressure Transducers: Instruction Sheet, OMEGA Engineering, Inc., 2004 (accessed Jul. 9, 2007), Stamford, CT. Online at http//www.omega.com/Pressure/pdf/PX26.pdf.
20 Sarabanda, "Efficacy and Safety of Circumferential Pulmonary Vein Isolation Using a Novel Cryothermal Balloon Ablation System" Journal of the American College of Cardiology, 2005, p. 1902-1912, vol. 46, No. 10.
21 Sosa, "Epicardial Mapping and Ablation Techniques to Control Ventricular Tachycardia," Journal of Cardiovascular Electrophysiology, 2005, p. 449-452, vol. 16, No. 4.
22 Sosa, "Nonsurgical Transthoracic Epicardial Approach in Patients with Ventricular Tachycardia and Previous Cardiac Surgery," Journal of Interventional Cardiac Electrophysiology, 2004, p. 281-288, vol. 10.
23 Sosa, "Percutaneous Pericardial Access for Mapping and Ablation of Epicardial Ventricular Tachycardias," Circulation, Journal of the American Heart Association, 2007, p. e542-e544, vol. 115.
24 Stokes, U.S. Statutory Invention Registration H356, Nov. 3, 1987.
25 Thomas, "Analysis of Human Epidural Pressures," Regional Anesthesia, 1992, p. 212-215, vol. 17, No. 4.
26 Tomaske, "Do Daily Threshold Trend Fluctuations of Epicardial Leads Correlate with Pacing and Sensing Characteristics in Paediatric Patients," Europace, 2007, p. 662-668, vol. 9.
27 U.S. Appl. No. 12/530,938 , "Final Office Action", Nov. 21, 2013, 30 pages.
28 U.S. Appl. No. 12/530,938 , "Office Action", Feb. 26, 2013, pp. 32.
29 U.S. Appl. No. 12/530,938 , "Office Action", Jun. 25, 2012, 48.
30 U.S. Appl. No. 12/741,710 , "Final Office Action", Apr. 22, 2014, 24 pages.
31 U.S. Appl. No. 12/741,710 , "Non Final Office Action", Jul. 3, 2013, 14 pages.
32 U.S. Appl. No. 12/741,710 , "Office Action", Nov. 8, 2012, 54 pages.
Clasificación internacional A61B17/00, A61B18/00, A61B19/00, A61N1/06, A61B18/14
Clasificación cooperativa A61B2018/00279, A61B2018/00363, A61B2018/00035, A61B2017/00323, A61B18/1492, A61B2018/00357, A61B2018/00577, A61B2218/007, A61B2018/00916, A61N1/06, A61B2090/064, A61B2018/1497, A61B2218/002, A61B2018/00029, A61B2017/003, A61B2019/464
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