WO2015168391A1

WO2015168391A1 - Injection catheter and catheter console platform

Info

Publication number: WO2015168391A1
Application number: PCT/US2015/028491
Authority: WO
Inventors: Eduardo Marban; Eugenio CINGOLANI
Original assignee: Cedars-Sinai Medical Center
Priority date: 2014-05-02
Filing date: 2015-04-30
Publication date: 2015-11-05

Abstract

A catheter and monitoring apparatus for the catheter are described. In one embodiment, the catheter comprises a catheter body, a tip section, and injection needle, a tip electrode, a ring electrode and at least one recording electrode that is positioned on the injection needle. The catheter may be coupled to a monitoring apparatus configured to map an organ in real time using data from the multiple electrodes, as well as from a second catheter used for reference.

Description

INJECTION CATHETER AND CATHETER CONSOLE PLATFORM

FIELD

[0001] Embodiments of the claimed invention relate to medical devices, and in particular, to an injection catheter for intra-cardiac delivery of therapeutic or diagnostic agents and a monitoring apparatus for the injection catheter.

BACKGROUND

[0002] In patients with ischemic heart disease, assessment of the left ventricular global and regional contractile functions is a primary element of diagnosis and treatment. Therefore, caregivers typically evaluate a patient by first determining whether a patient has defective myocardial tissue, and then by localizing any defects. Accordingly, caregivers utilize numerous technologies including echocardiography, angiocardiography, radionuclide angiocardiography, CT, and magnetic resonance imagining to diagnose and quantify these areas of failing tissue.

[0003] Additionally, caregivers use a catheter based electromagnetic mapping system to generate a 3-dimensional electromechanical map of a patient's heart or left ventricle. A caregiver can determine the location of myocardial defects by evaluation of these maps as well. This allows the spatial quantification of the effects of infarcts on the regional LV mechanics, electrical activation, and electromechanical coupling. These mapping catheters may also include an injection ability, in order to inject cell products, gene therapy or drug products. An example of a conventional injection catheter tip is configured as shown in FIG. 1. As shown in FIG. 1 , an existing injection catheter tip 100 for delivery of therapeutic or diagnostic agents to the heart has a retractable needle 1 10, tip electrode 130 and ring electrode 140.

Mapping Procedure

[0004] The injection catheters may be utilized to create a voltage activation map of the heart, or a specific region of the heart. For example, prior to an injection, the catheter may be utilized to map the electrical activity of the heart using the tip electrode 130 and the ring electrodes 140. For instance, the catheter may be introduced into the right femoral artery, and advanced across the aortic valve in the left ventricle. Then, the catheter may be positioned and contact three initial mapping points, the apex, inflow tract, and the outflow tract, for example, in order to generate a three dimensional image of the electrical activity of the heart. Then, additional mapping points may be contacted and recorded (e.g. 26, 36 or other numbers of mapping points).

[0005] At each mapping sight, the local unipolar and bipolar electrograms (e.g. filtered at 0.5 to 400 Hz and 30 to 400 Hz) may be recorded from a tip electrode (e.g. 2 mm) and a ring electrode (1 mm). The tip electrode and ring electrode may be closely spaced, for example, 2mm apart. Then, the infarcted zone can be identified as the region with abnormally low voltage surrounded by a steep voltage gradient.

[0006] An electromagnetic mapping sensor on the tip of the catheter can then be used to sense the location on a coordinate system of each mapping point, and the sensed electrograms (e.g. electrocardiograms) can be overlaid on that coordinate system. In some embodiments, the mapping sensor will be a magnetic field sensor that senses the position of the catheter in the magnetic field. For instance, a magnetic field generator may be placed near the patient. Then a magnetic field detector that detects the strength and direction of the generated magnetic field(s) (e.g., magnetic fields generated in three orthogonal directions). For instance, a magnetic field sensor may be placed as a reference on a patient and an additional magnetic field sensor may be placed on the tip of the catheter to determine its position relative to the reference sensor. Then, a coordinate system may be constructed to determine the position of the tip of the catheter.

[0007] At each location the catheter is moved to, the point on the heart or a coordinate system can be recorded, along with the detected electrocardiogram at that point. This way, a three dimensional map of the heart structure may be created with the electrocardiogram recorded at each point.

Tissue Penetration Detection

[0008] Additionally, the needle electrode can be used to monitor that depth of penetration of the injection needle. For instance, the needle electrode lead may be placed at a somewhat proximal position on the needle. Accordingly, once the needle is injected into tissue and the needle electrode becomes inserted inside the heart tissue, the difference in impedance between the needle electrode lead and the tip electrode will be relatively high and change rapidly as the electrode lead is becoming buried in the tissue. Accordingly, the caregiver will have knowledge that the needle has been fully injected at that point. In some embodiments, the outside of the needle may be coated with a non-conductive layer (e.g. Teflon) except for the needle electrode leads so that the difference in impedance is easier to detect once the electrode lead is buried in the heart tissue.

[0009] U.S. Patent No. 8,079,982 describes another conventional injection catheter for infusing therapeutic or diagnostic agents into the heart. A tip electrode is mounted at the distal end of the tip section of the injection catheter. One or more ring electrodes are mounted on the distal end of the housing of the injection catheter. A retractable injection needle is provided through a passage in the tip electrode. In use, the injection needle can function as a mapping electrode or as an ablation electrode. An electromagnetic location sensor is contained within the distal end of the tip section of the injection catheter. By combining the electromagnetic mapping sensor, the needle electrode, the tip electrode and the ring electrode, a physician can simultaneously map the contours of the heart chamber, the electrical activity of the heart, and the extent and displacement of the catheter.

[0010] U.S. Patent No. 8,260,399 discusses conventional interventional cardiology procedures, such as those that deliver therapeutic agents like stem cells, genetic materials and growth factors into the myocardial tissue. Procedures such as balloon angioplasty typically involve the use of a balloon catheter to dilate the occluded artery and X-ray fluoroscopy to assist the attending cardiology to guide the catheter. However, according to U.S. Patent No. 8,260,399, X-ray fluoroscopy does not distinguish healthy from infarcted myocardial tissue, nor does it provide an anatomical image of the heart. The ability to distinguish infarcted tissue from healthy tissue in U.S. Patent No. 8,260,399 is of utmost importance to a cardiologist who is attempting to precisely deliver therapeutic agents during conventional cardiology procedures. Thus, U.S. Patent No. 8,260,399 proposes a catheter that can be actively tracked in an MRI environment.

SUMMARY OF THE INVENTION

[0011] However, conventional injection catheters face several problems which must be overcome to obtain desirable results. For example, because injection catheters typically have a limited number of electrodes, it is difficult to accurately map the heart chamber. Further, existing catheter console platforms have only a single input for a single catheter with no input for an additional reference catheter. This leads to inaccuracies when injecting the therapeutic or diagnostic agents into the heart tissue. [0012] Thus, embodiments of the claimed invention seek to improve existing injection catheters and their associated system platforms. In one embodiment, a catheter for injection of a therapeutic or diagnostic agent into an organ is provided. The catheter comprises a catheter body having a proximal end and a distal end, a tip section positioned at the distal end of the catheter body, an injection needle extending through the catheter body and tip section, a tip electrode and ring electrode positioned on the tip section, and at least one recording electrode positioned on the injection needle.

[0013] According to another embodiment, a catheter assembly is provided comprising a first catheter as described above and a monitoring apparatus comprising a processor in communication with the catheter that is configured to receive and process data indicative of a location of the injection needle. The catheter assembly may further comprise a second catheter configured to provide reference location data to the first catheter. In addition, the catheter assembly may comprise a display configured to display data indicative of the location of at least one of the first catheter and the second catheter.

[0014] A method for injecting a therapeutic or diagnostic agent into an organ is also provided. According to the method, at least the tip section of the catheter as described above is introduced into the organ. A distal end of the injection needle is extended into the organ. Penetration of the injection needle into the organ is determined using at least one of the ring electrode, the tip electrode and the at least one recording electrode. The therapeutic or diagnostic agent is injected into the organ through the injection needle. Data indicative of a location of the injection needle can be output from at least one of the ring electrode, the tip electrode and the at least one recording electrode to a catheter monitoring apparatus, such as the catheter monitoring apparatus described herein.

[0015] Still other aspects, features and advantages of the present invention are readily apparent from the following detailed description, simply by illustrating a number of exemplary embodiments and implementations, including the best mode contemplated for carrying out the present invention. The present invention also is capable of other and different embodiments, and its several details can be modified in various respects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention will be understood more fully from the detailed description given below and from the accompanying drawings of various embodiments of the invention, which, however, should not be taken to limit the invention to the specific embodiments, but are for explanation and understanding only.

[0017] FIG. 1 illustrates a conventional injection catheter.

[0018] FIG. 2 illustrates an improved injection catheter in accordance with an embodiment of the claimed invention.

[0019] FIG. 3 illustrates an improved injection catheter in accordance with another embodiment of the claimed invention.

[0020] FIG. 4 illustrates a catheter based mapping system in accordance with an embodiment of the claimed invention.

[0021] FIG. 5 is diagrammatic representation of a machine, such as a monitoring apparatus, having a set of instructions for causing the machine to perform any of the one or more methods described herein.

[0022] FIG. 6 is a flow chart outlining a method that may be implemented in accordance with an embodiment of the claimed invention.

DETAILED DESCRIPTION

[0023] An improved injection catheter and catheter console platform are described. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the exemplary embodiments. It is apparent to one skilled in the art, however, that the present invention can be practiced without these specific details or with an equivalent arrangement.

[0024] Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Szycher's Dictionary of Medical Devices CRC Press, 1995, may provide useful guidance to many of the terms and phrases used herein. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials specifically described.

[0025] In some embodiments, properties such as dimensions, shapes, relative positions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified by the term "about."

[0026] Various examples of the invention will now be described. The following description provides specific details for a thorough understanding and enabling description of these examples. One skilled in the relevant art will understand, however, that the invention may be practiced without many of these details. Likewise, one skilled in the relevant art will also understand that the invention can include many other obvious features not described in detail herein. Additionally, some well-known structures or functions may not be shown or described in detail below, so as to avoid unnecessarily obscuring the relevant description.

[0027] The terminology used below is to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific examples of the invention. Indeed, certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0028] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination. [0029] Similarly while operations may be depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0030] FIG. 2 illustrates an improved injection catheter tip 200 according to an embodiment of the invention. As shown in FIG. 2, catheter tip 200 has a retractable needle 210 comprising a recording electrode 220. In some embodiments, the recording electrode 220 will be constructed or manufactured in the form of a ring or other metal structure attached on the outside of a portion of the needle 210. In other embodiments, the recording electrode 220 will be integrated into at least a portion of the needle 210. The recording electrode 220 may also be used to detect an impedance difference between the recording electrode 220 and the tip 200 or ring electrodes 240, or may be utilized to take an electrocardiogram. The addition of recording electrode 220 to the needle 210 of catheter tip 200 allows the recording of intra- myocardial signals in the delivery site in a way that is more accurate and precise than existing catheters. Rather than recording the electrical signal from the surface, the electrocardiogram can be detected from inside the tissue, which may provide a more accurate reading at each detected location.

[0031] FIG. 3 illustrates an improved injection catheter tip 300 according to another embodiment of the invention. As shown in FIG. 3, catheter tip 300 has a retractable needle 310 comprising a plurality of recording electrodes 320a-c. In addition, catheter tip 300 has a tip electrode 330 and a ring electrode 340. Recording electrodes 320a-c are provided at different spacing sites to record the intra-myocardial signal at different locations, allowing a physician to more accurately assess the depth of the needle in the myocardium. This enhances safety and delivery accuracy, and reduces the chance of perforation. For example, the spacing may include electrode 320 that is most distal on the needle 210, which can detect when the needle 210 has first penetrated the heart tissue. Then, a second recording electrode 320 may determine the optimum depth for injection. Thereafter, a third recording electrode 320 may then be used to determine if the needle 210 has penetrated too far into the myocardium, and risking perforation. In other embodiments, the various other numbers of recording electrodes 320 may be utilized, including two, four, six, five, and others. In some embodiments, the recording electrodes 320 may be spaced 1 mm apart, or 2 mm, 3mm, 5 mm, or other suitable distances.

[0032] With the additional electrodes provided on the catheters of FIGS. 2 and 3, the respective catheters can be guided to an injection site with fluoroscopy guidance and intracardiac electrophysiological recordings alone. Thus, in some embodiments and for some procedures, magnetic navigation and its associated components are unnecessary, resulting in a smaller catheter size.

[0033] It is understood that catheter tips 200 and 300 of FIGS. 2 and 3, respectively, form tip sections of full catheters (not shown). One such catheter comprises a catheter body having a proximal end and a distal end, a catheter tip 200 or 300 positioned at the distal end of the catheter body and a needle 210 or 310 extending through the catheter body and the catheter tip 200 or 300.

Methods

[0034] FIG. 6 illustrates a method of implementing the systems and devices disclosure herein. Caregivers may perform the following methods for mapping a heart structure and/or injection of therapeutic or diagnostic agents using the systems and devices disclosed herein. For example, at least the tip section (such as catheter tips 200 or 300) of a catheter is navigated to the heart 700 through, for example, the femoral artery. Then, the catheter may be navigated to the left ventricle of the heart. In some embodiments, an electrogram reading may then be recorded 720 with some combination of the electrodes on the catheter. In some embodiments, this may be performed by first penetrating a needle in the heart tissue. In some embodiments, electrogram readings may be taken with different combinations of electrodes including with and without a recording electrode to provide a surface based electrogram and an electrogram that includes readings from within the heart tissue. In some embodiments, an electrogram reading may be taken for three or four recording electrodes to determine the most effective location and depth for injection of therapeutic compounds.

[0035] The electrogram reading may then be associated with location data 730 recorded by the catheter and associated systems and stored in a memory. Then, the catheter may be navigated to a new position on the heart structure 700. At this location, a new electrogram reading may be taken 720 and again associated with location data 730 and stored in memory. Finally, this process may be repeated for the desired number of data points 740 that is required. Then, once the points are mapped and the data is associated, an activation map may be output 750 that may be viewed on a display, or sent over a network to a remote location.

[0036] Then, in some embodiments, a therapeutic or diagnostic agent is injected into the myocardium at the desired location. In some embodiments, this will be after the cardiac mapping so the optimal location (e.g. the location of damaged heart tissue) can be determined. In other embodiments, the injection will be made when the electrogram indicates the optimal or sufficiently optimal position has been reached. In order to perform the injection, once the distal end of the catheter is navigated to the correct position, the injection needle will be extended into the myocardial tissue. In order to determine the appropriate depth of injection, various of the catheter's electrode impedances will be monitored to determine when the impedance of the correct recording electrode increases substantially with respect to the ring and/or tip electrode. Once the appropriate depth is reached, therapeutic or diagnostic agent is then injected into the organ through the injection needle.

[0037] Embodiments of the invention further provide for an improved catheter console platform that can be used with the catheters of FIGS. 1-3. The catheter console platform allows a second catheter to be connected for reference to be able to obtain more accurate activation maps. Existing catheter console platforms, such as the NOGA™ system console platform, allow only one catheter to be connected, and no additional reference catheter (such as a coronary sinus catheter) can be connected. In accordance with these improvements, the console platform of embodiments of the invention also display different intra-myocardial signals obtained by the multiple electrodes to provide the operator with direct visualization of the signals.

[0038] FIG. 4 illustrates a catheter assembly and mapping system in accordance with an embodiment of the invention. The catheter assembly and mapping system comprises a first catheter 400, an optional second catheter 450, and a monitoring apparatus 460. The first catheter 400 comprises a catheter body having a proximal end and a distal end and a tip section positioned at the distal end of the catheter body (such as catheter tips 200 or 300 of FIGS. 2 or 3, respectively). The tip section comprises an injection needle extending through the catheter body and the tip section, at least one recording electrode positioned on the injection needle, and a tip electrode and ring electrode.

[0039] The monitoring apparatus 460 comprises a processor in communication with the first catheter 400 and the optional second catheter 450. Although shown as wired, it is contemplated that the connection between the first catheter 400, the second catheter 450 and the monitoring apparatus 460 can be wireless. The processor is configured to receive and process data indicative of a location of the injection needle from the first catheter 400 and the second catheter 450. Specifically, the processor receives data from at least one of the tip electrode, the ring electrode and the at least one recording electrode.

[0040] In one embodiment, the monitoring apparatus 460 comprises a display 465, as described further herein. The display 465 is configured to display the data indicative of the location of the injection needle in the form of a map of the organ to be injected. For example, the display can display data from at least one of the tip electrode, the ring electrode and the at least one recording electrode, as well as reference data from the second catheter 450. This data can be used, for example, to map the organ to be injected. By using data from multiple electrodes on the first catheter 400, as well as data from the second catheter 450 as reference, the first catheter 400 can be guided to an injection site with fluoroscopy guidance and intra-cardiac electrophysiological recordings alone. Thus, magnetic navigation and its associated components are unnecessary.

[0041] In some embodiments, the platform may process data from multiple catheters, including a catheter taking a reading at a reference point such as the coronary sinus. This will allow more accurate readings to be processed taking this data into account. For instance in some embodiments, each of the readings from the tip, ring, and needle electrode will be first subtracted from the reading taken at the coronary sinus or vice versa.

[0042] FIG. 5 shows a diagrammatic representation of a machine in the exemplary form of computer system 600 within which a set of instructions, for causing the machine to perform any one or more of the methodologies or functions discussed herein, may be executed.

[0043] According to some embodiments, computer system 600 comprises processor 650 (e.g., a central processing unit (CPU), a graphics processing unit (GPU) or both), main memory 660 (e.g., read only memory (ROM), flash memory, dynamic random access memory (DRAM) such as synchronous DRAM (SDRAM) or Rambus DRAM (RDRAM), etc.) and/or static memory 670 (e.g., flash memory, static random access memory (SRAM), etc.), which communicate with each other via bus 695.

[0044] According to some embodiments, computer system 600 may further comprise video display unit 610 (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)). According to some embodiments, computer system 600 also may comprise alphanumeric input device 615 (e.g., a keyboard), cursor control device 1320 (e.g., a mouse), disk drive unit 630, signal generation device 640 (e.g., a speaker), and/or network interface device 680.

[0045] Disk drive unit 630 includes computer-readable medium 634 on which is stored one or more sets of instructions (e.g., software 638) embodying any one or more of the methodologies or functions described herein. Software 638 may also reside, completely or at least partially, within main memory 660 and/or within processor 650 during execution thereof by computer system 600, main memory 660 and processor 650 also constituting computer-readable media. In other embodiments, software 638 may reside partially or completely on a remote server. Software 638 may further be transmitted or received over network 690 via network interface device 680.

[0046] It should initially be understood that the disclosure herein may be implemented with any type of hardware and/or software, and may be a pre-programmed general purpose computing device. For example, the system may be implemented using a server, a personal computer, a portable computer, a thin client, or any suitable device or devices. The disclosure and/or components thereof may be a single device at a single location, or multiple devices at a single, or multiple, locations that are connected together using any appropriate communication protocols over any communication medium such as electric cable, fiber optic cable, or in a wireless manner.

[0047] It should also be noted that the disclosure is illustrated and discussed herein as having a plurality of modules which perform particular functions. It should be understood that these modules are merely schematically illustrated based on their function for clarity purposes only, and do not necessary represent specific hardware or software. In this regard, these modules may be hardware and/or software implemented to substantially perform the particular functions discussed. Moreover, the modules may be combined together within the disclosure, or divided into additional modules based on the particular function desired. Thus, the disclosure should not be construed to limit the present invention, but merely be understood to illustrate one example implementation thereof.

[0048] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some implementations, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.

[0049] Implementations of the subject matter described in this specification can be implemented in a computing system that includes a back-end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front-end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network ("LAN") and a wide area network ("WAN"), an internetwork (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).

[0050] Implementations of the subject matter and the operations described in this specification can be implemented in digital electronic circuitry, or in computer software, firmware, or hardware, including the structures disclosed in this specification and their structural equivalents, or in combinations of one or more of them. Implementations of the subject matter described in this specification can be implemented as one or more computer programs, i.e., one or more modules of computer program instructions, encoded on computer storage medium for execution by, or to control the operation of, data processing apparatus. Alternatively or in addition, the program instructions can be encoded on an artificially-generated propagated signal, e.g., a machine-generated electrical, optical, or electromagnetic signal that is generated to encode information for transmission to suitable receiver apparatus for execution by a data processing apparatus. A computer storage medium can be, or be included in, a computer-readable storage device, a computer-readable storage substrate, a random or serial access memory array or device, or a combination of one or more of them. Moreover, while a computer storage medium is not a propagated signal, a computer storage medium can be a source or destination of computer program instructions encoded in an artificially-generated propagated signal. The computer storage medium can also be, or be included in, one or more separate physical components or media (e.g., multiple CDs, disks, or other storage devices).

[0051] The operations described in this specification can be implemented as operations performed by a "data processing apparatus" on data stored on one or more computer-readable storage devices or received from other sources.

[0052] The term "data processing apparatus" encompasses all kinds of apparatus, devices, and machines for processing data, including by way of example a programmable processor, a computer, a system on a chip, or multiple ones, or combinations, of the foregoing The apparatus can include special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit). The apparatus can also include, in addition to hardware, code that creates an execution environment for the computer program in question, e.g., code that constitutes processor firmware, a protocol stack, a database management system, an operating system, a cross-platform runtime environment, a virtual machine, or a combination of one or more of them. The apparatus and execution environment can realize various different computing model infrastructures, such as web services, distributed computing and grid computing infrastructures.

[0053] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub-programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.

[0054] The processes and logic flows described in this specification can be performed by one or more programmable processors executing one or more computer programs to perform actions by operating on input data and generating output. The processes and logic flows can also be performed by, and apparatus can also be implemented as, special purpose logic circuitry, e.g., an FPGA (field programmable gate array) or an ASIC (application-specific integrated circuit).

[0055] Processors suitable for the execution of a computer program include, by way of example, both general and special purpose microprocessors, and any one or more processors of any kind of digital computer. Generally, a processor will receive instructions and data from a read-only memory or a random access memory or both. The essential elements of a computer are a processor for performing actions in accordance with instructions and one or more memory devices for storing instructions and data. Generally, a computer will also include, or be operatively coupled to receive data from or transfer data to, or both, one or more mass storage devices for storing data, e.g., magnetic, magneto-optical disks, or optical disks. However, a computer need not have such devices. Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device (e.g., a universal serial bus (USB) flash drive), to name just a few. Devices suitable for storing computer program instructions and data include all forms of non-volatile memory, media and memory devices, including by way of example semiconductor memory devices, e.g., EPROM, EEPROM, and flash memory devices; magnetic disks, e.g., internal hard disks or removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry. CONCLUSIONS

[0056] The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described can be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as taught or suggested herein. A variety of alternatives are mentioned herein. It is to be understood that some embodiments specifically include one, another, or several features, while others specifically exclude one, another, or several features, while still others mitigate a particular feature by inclusion of one, another, or several advantageous features.

[0057] Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be employed in various combinations by one of ordinary skill in this art to perform methods in accordance with the principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments.

[0058] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof.

[0059] In some embodiments, the terms "a" and "an" and "the" and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0060] Certain embodiments of this application are described herein. Variations on those embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.

[0061] Particular implementations of the subject matter have been described. Other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results.

[0062] All patents, patent applications, publications of patent applications, and other material, such as articles, books, specifications, publications, documents, things, and/or the like, referenced herein are hereby incorporated herein by this reference in their entirety for all purposes, excepting any prosecution file history associated with same, any of same that is inconsistent with or in conflict with the present document, or any of same that may have a limiting affect as to the broadest scope of the claims now or later associated with the present document. By way of example, should there be any inconsistency or conflict between the description, definition, and/or the use of a term associated with any of the incorporated material and that associated with the present document, the description, definition, and/or the use of the term in the present document shall prevail.

[0063] In closing, it is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.

Claims

WHAT IS CLAIMED IS:

1. A catheter for injection of a therapeutic or diagnostic agent into an organ, the catheter comprising:

a catheter body having a proximal end and a distal end;

a tip section positioned at the distal end of the catheter body;

an injection needle extending through the catheter body and tip section;

a tip electrode and a ring electrode positioned on the tip section; and

at least one recording electrode positioned on the injection needle.

2. The catheter of claim 1 , wherein the at least one recording electrode comprises two recording electrodes.

3. The catheter of claim 1 , wherein the at least one recording electrode comprises three recording electrodes.

4. The catheter of claim 1, wherein the at least one recording electrode comprises four recording electrodes.

5. The catheter of claim 1, wherein the injection needle is reversibly retracted into the distal end of the catheter body.

6. The catheter of claim 1 , wherein the injection needle protrudes from the distal end of the catheter body.

7. The catheter of claim 1 , further comprising: a first electrode lead wire having a first end connected to the tip electrode and a second end connected to a monitoring apparatus;

a second electrode lead wire having a first end connected to the ring electrode and a second end connected to the monitoring apparatus; and at least one third electrode lead wire having a first end connected to the at least one recording electrode and a second end connected to the monitoring apparatus.

8. The catheter of claim 1, wherein the catheter body is flexible.

9. The catheter of claim 1, wherein the at least one recording electrode is electrically insulated from the injection needle.

10. The catheter of claim 1 , further comprising a needle control handle at the proximal end of the catheter body.

11. A method for injecting a therapeutic or diagnostic agent into an organ, the method comprising: navigating at least the tip section of the catheter according to claim 1 to a location of an organ;

extending a distal end of the injection needle into the organ;

determining a depth of penetration of the injection needle into the organ using at least one of the ring electrode, the tip electrode and the at least one recording electrode; and

injecting the therapeutic or diagnostic agent into the organ through the injection needle.

12. The method of claim 11 , further comprising:

outputting from at least one of the ring electrode, the tip electrode and the at least one recording electrode data indicative of a location of the injection needle.

13. The method of claim 12, wherein the data is output to a catheter monitoring apparatus.

14. The method of claim 11 , wherein the depth of penetration is determined using at least two recording electrodes.

15. A method for outputting an electrical activation map for an organ, the method comprising: navigating the catheter according to claim 1 so that the tip section is in close proximity to a first location of an organ;

recording a first electrocardiogram at the first location using the at least one recording electrode;

associating the first location with the first electrocardiogram and storing the associated data as a first associated data set;

navigating the catheter so that the tip section is in close proximity to a second location on the organ;

recording a second electrocardiogram at the second location using the at least one recording electrode;

associating the second location with the second electrocardiogram and storing the associated data as a second associated data set; and

outputting data representing an electrical activation map based on at least the first and second associated data sets.

16. The method of claim 15, wherein the recording of the first electrocardiogram is performed after inserting the needle into the myocardial tissue.

17. The method of claim 15, wherein the first electrocardiogram is recorded using at least two recording electrodes.

18. The method of claim 15, wherein the organ is the left ventricle.

19. A catheter assembly comprising: a first catheter comprising:

a catheter body having a proximal end and a distal end;

a tip section positioned at the distal end of the catheter body;

an injection needle extending through the catheter body and tip section;

a tip electrode and a ring electrode positioned on the tip section;

at least one recording electrode positioned on the injection needle; and a monitoring apparatus comprising a control system in communication with the first catheter configured to receive and process data indicative of a location of the injection needle.

20. The catheter assembly of claim 15, wherein the control system is coupled to the first catheter.

21. The catheter assembly of claim 15, wherein the control system is in wireless communication with the first catheter.

22. The catheter assembly of claim 15, wherein the monitoring apparatus further comprises a display configured to display the data indicative of the location of the injection needle.

23. The catheter assembly of claim 15, wherein the control system is in communication with at least one of the tip electrode, the ring electrode and the at least one recording electrode.

24. The catheter assembly of claim 15, further comprising a second catheter in communication with the control system.

25. The catheter assembly of claim 24, wherein the second catheter is configured to provide location data to the control system.

26. The catheter assembly of claim 24, wherein the control system is further configured to receive data indicative of a location of the second catheter.

27. The catheter assembly of claim 26, wherein the control system is further configured to use the data indicative of the location of the second catheter to determine the location of the injection needle.

28. The catheter assembly of claim 27, wherein the determining the location of the injection needle is based in part on using the second catheter's location data as a reference point to determine the location of the top of the first catheter.

29. The catheter assembly of claim 24, wherein the display is further configured to display the data indicative of a location of the second catheter.