US20020065465A1 - System for recording use of structures deployed in association with heart tissue - Google Patents
System for recording use of structures deployed in association with heart tissue Download PDFInfo
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- US20020065465A1 US20020065465A1 US10/016,322 US1632201A US2002065465A1 US 20020065465 A1 US20020065465 A1 US 20020065465A1 US 1632201 A US1632201 A US 1632201A US 2002065465 A1 US2002065465 A1 US 2002065465A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6858—Catheters with a distal basket, e.g. expandable basket
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
- A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
- A61B5/283—Invasive
- A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
- A61B5/7435—Displaying user selection data, e.g. icons in a graphical user interface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/04—Arrangements of multiple sensors of the same type
- A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
Abstract
A system records use of a structure deployed in operative association with heart tissue in a patient. An image controller generates an image of the structure while in use in the patient. An input receives data including information identifying the patient. An output processes the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation.
Description
- The invention generally relates to systems and methods for guiding or locating diagnostic or therapeutic elements in interior regions of the body.
- Physicians make use of catheters today in medical procedures to gain access into interior regions of the body for diagnostic and therapeutic purposes. It is important for the physician to be able to reliably and precisely position in proximity to desired tissue locations. For example, the need for precise control over the catheter is especially critical during procedures that ablate myocardial tissue from within the heart. These procedures, called ablation therapy, are used to treat cardiac rhythm disturbances.
- One aspect of the invention provides a system to record use of a structure deployed in operative association with heart tissue in a patient. An image controller generates an image of the structure while in use in the patient. An input receives data including information identifying the patient. An output processes the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation.
- In a preferred embodiment, the data that forms part of the data base record include other relevant information. For example, the data includes information identifying the procedure, or diagnostic information, or therapeutic information, or time stamped information, or processing information documenting the storage, retrieval, or manipulation of the data, or information identifying a person other than the patient (such as the attending physician). In a preferred embodiment, the output password-protects the data base record.
- In a preferred embodiment, the image controller includes functions to alter orientation, or shape, or view aspects of the image before or after processing by the output. In a preferred embodiment, the image controller also includes functions to mark or otherwise annotate one or more regions of the image in response to operator input before or after processing by the output.
- In a preferred embodiment, the image controller generates a proximity-indicating output showing the proximity of a roving element, deployed in the patient, to the structure.
- Another aspect of the invention provides a system for diagnosing or treating cardiac conditions of multiple patients. The system includes a network of local work stations, each one adapted to be coupled to an electrode structure, which, in use, is deployed in operative association with heart tissue of a patient. Each local work station includes an image controller to generate an image of the structure at least partially while the operative element performs a procedure in an interior body region. An input receives data including information identifying the patient, and an output processes the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation. The system further includes a central terminal coupled to the output of each work station. The central terminal receives the patient-specific data base records for all work stations for storage in a central patient data base.
- Other features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended claims.
- FIG. 1 is schematic view of a system for sensing the position of an operative element within a three-dimensional basket structure, in which an electrode on the operative element transmits an electrical field, which is sensed by one or more electrodes on the basket structure;
- FIG. 2A is a side view of the three-dimensional basket structure carried by a catheter tube, which-forms a part of the system shown in FIG. 1;
- FIG. 2B is a side view of the operative element carried by a catheter tube, which forms a part of the system shown in FIG. 1;
- FIG. 3 is a schematic view of the processing element which forms a part of the system shown in FIG. 1;
- FIG. 4 is a graph exemplifying how normalized voltage sensed by an electrode carried by the three-dimensional basket structure changes in relation to the proximity of the electrode to the operative element, which is a relationship that the system shown in FIG. 1 uses to generate a proximity-indicating output;
- FIG. 5 is a hard-wired display device displaying a polar view of a three-dimensional basket structure, which visually displays the presence or absence of a proximity-indicated output at each electrode carried by the three-dimensional basket structure;
- FIG. 6 is a schematic view of an embodiment of a graphical user interface used by the system to visually display the presence or absence of a proximity-indicated output at each electrode carried by the three-dimensional basket structure;
- FIG. 7 is a representative view of the split viewing screen of the graphical user interface shown in FIG. 6, showing the idealized model of the three-dimensional basket structure generated by the interface at different idealized orientations;
- FIG. 8 is a schematic view an idealized model of a three-dimensional basket structure generated by the interface, showing the interpolation of multiple proximity-indicated outputs;
- FIG. 9 is a schematic view of the system shown in FIG. 1 as part of a modular system used to diagnose and treat cardiac conditions;
- FIGS. 10A and 10B are representative views of the split viewing screen of the graphical user interface shown in FIG. 9, showing the use of markers and comments in association with the idealized model of the three-dimensional basket structure that the interface generates;
- FIG. 11 is a representative view of the viewing screen of the graphical user interface shown in FIG. 9, showing the pop up Patient Data Menu used to establish and maintain a patient-specific data base;
- FIG. 12 is a schematic view of a system for sensing the position of an operative element with respect to an elongated electrode array;
- FIG. 13 is a diagrammatic view of the operative element and elongated electrode array shown in FIG. 12 deployed for diagnostic or therapeutic purposes in the annulus region of a human heart;
- FIG. 14 is a schematic view of an embodiment of a Graphical user interface used by the system shown in FIG. 12 to visually display the presence or absence of a proximity-indicated out-put at each electrode carried by the elongated electrode array;
- FIG. 15 is a schematic view of a system for sensing the position of an operative element with respect to a multiple electrode loop structure;
- FIG. 16 is a side view of an exemplary multiple electrode loop structure suitable for use with the system shown in FIG. 15, with the loop structure withdrawn within an associated sheath for deployment into a body region;
- FIG. 17 is a perspective view of the multiple electrode loop structure shown in FIG. 16, with the loop structure deployed for use beyond the associated sheath;
- FIG. 18 is a diagrammatic view of the operative element and multiple electrode loop structure shown in FIG. 15 deployed for diagnostic or therapeutic purposes in the annulus region of a human heart;
- FIG. 19 is a schematic view of an embodiment of a graphical user interface used by the system shown in FIG. 15 to visually display the presence or absence of a proximity-indicated out-put at each electrode carried by the loop structure;
- FIG. 20 is schematic view of a system for sensing the position of an operative element within a three-dimensional basket structure, in which one or more electrodes on the basket structure transmit an electrical field, which is sensed by an electrode on the operative element;
- FIG. 21 is a schematic view of the processing element which forms a part of the system shown in FIG. 20;
- FIG. 22 is schematic view of an operative element oriented with a spline of the basket structure, as shown in FIG. 20, in which the electrical field is sensed by multiple electrodes on the operative element, which is shown in a not-parallel orientation with respect to the spline;
- FIG. 23 is schematic view of the operative element oriented with the spline, like that shown in FIG. 22, except that the operative element is shown in more-parallel orientation with respect to the spline;
- FIG. 24 is a schematic view an idealized model of the spline shown in FIG. 23 generated by the interface, showing the interpolation of multiple proximity-indicated outputs;
- FIG. 25 is an end perspective view of a dual electrode array structure having both an inner array of sensing electrodes and an outer array of sensing electrodes to locate a roving operative element both near a tissue wall and within the middle of an interior body region spaced from the tissue wall;
- FIG. 26 is an alternative embodiment of a dual electrode array structure having inner and outer arrays of sensing electrodes;
- FIG. 27 is schematic view of a system for sensing the position of an operative element within a dual electrode array structure of the type shown in FIGS. 25 and 26;
- FIG. 28 is a schematic view of an embodiment of a graphical user interface used by the system shown in FIG. 27 to visually display the presence or absence of a proximity-indicated out-put at each electrode carried by the dual electrode array structure;
- FIG. 29 is schematic view of a system for sensing the position of an operative element within a three-dimensional basket structure, in which one electrode on the operative element transmits an electrical field, which is sensed by an other electrode on the operative element and by one or more electrodes on the basket structure; and
- FIG. 30 is a schematic view of the processing element which forms a part of the system shown in FIG. 29.
- The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
- FIG. 1 shows one embodiment of a
position sensing system 10, which locates the position of anoperative element 12 within a space (designated S). Thesystem 10 is well adapted for use inside body lumens, chambers or cavities for either diagnostic or therapeutic purposes. For this reason, thesystem 10 will be described in the context of its use within a living body. Thesystem 10 particularly lends itself to catheter-based procedures, where access to the interior body region is obtained, for example, through the vascular system or alimentary canal, without complex, invasive surgical procedures. - For example, the
system 10 can be used during the diagnosis and treatment of arrhythmia conditions within the heart, such as ventricular tachycardia or atrial fibrillation. Thesystem 10 also can be used during the diagnosis or treatment of intravascular ailments, in association, for example, with angioplasty or atherectomy techniques. Thesystem 10 also can be used during the diagnosis or treatment of ailments in the gastrointestinal tract, the prostrate, brain, gall bladder, uterus, and other regions of the body. - A. The Operative Element
- For deployment into an interior body space S, the
operative element 12 is carried at the distal end of a catheter tube 44 (as FIG. 2B also shows). Nevertheless, thesystem 10 an also be used in association with systems and methods that are not necessarily catheter-based, e.g., laser delivery devices, atherectomy devices, transmyocardial revascularization (TMR), or percutaneous myocardial revascularization (PMR). - The
operative element 12 an take different forms and can be used for either therapeutic purposes, or diagnostic purposes, or both. Theoperative element 12 an comprise, for example, a device for imaging body tissue, such as an ultrasound transducer or an array of ultrasound transducers, or an optic fiber element. Alternatively, theoperative element 12 an comprise a device to deliver a drug or therapeutic material to body tissue. Still alternatively, theoperative element 12 an comprise a device, e.g., an electrode, for sensing a physiological characteristic in tissue, such as electrical activity in heart tissue, or for transmitting energy to stimulate or ablate tissue. - B. Three-Dimensional Locating Probe
- The
system 10 includes a locating probe 14 (see FIG. 2A also), which, like theoperative element 12 is carried at the distal end of acatheter tube 45 for introduction into the body space S. In the embodiment illustrated in FIG. 1, the locatingprobe 14 comprises a composite, three-dimensional basket structure. As will be described later, the structure of the locatingprobe 14 can take other forms. - As best shown in FIG. 2A, the
structure 14 includes eight spaced apart splineelements 20 assembled together by adistal hub 16 and aproximal base 18. Eachspline 20, in turn, carries eightelectrodes 22, for a total of sixty-four 44electrodes 22 positioned about the space S. Of course, a greater or lesser number ofspline elements 20 and/orelectrodes 22 can be present. - Each
spline element 20 preferably comprises a flexible body made from resilient, inert wire or plastic. Elastic memory material such as nickel titanium (commercially available as NITINOL™ material) can be used. Resilient injection molded plastic or stainless steel can also be used. Eachspline element 20 is preferably preformed with a convex bias, creating a normally open three-dimensional basket structure. - As FIG. 2A shows, an
outer sheath 24 can be advanced by sliding forward along thecatheter tube 45 to compress and collapses thestructure 14 for introduction into the body region. Rearward movement retracts theslidable sheath 24 away from thestructure 14, which springs open and assumes its three-dimensional shape. - In FIGS. 1 and 2A, the geometry of
spline elements 20 is shown to be both radially and axially symmetric. Asymmetric structures, either radially or axially or both, can also be used. Examples of asymmetric arrays of spline structures are shown in copending U.S. application Ser. No. 08/742,569, filed Oct. 28, 1996 and entitled “Asymmetric Multiple Electrode Support Structures,” which is incorporated herein by reference. - FIG. 1 identifies the
electrodes 22 by the set designation (A,B), where A=1 to p and B=1 to e, where p is the total number ofsplines 20 and e is the number ofelectrodes 22 on each spline 20 (in the illustrated embodiment, p=8 and e=8). - It should be appreciated that the locating
probe 14 need not be a composite basket structure, but instead exist as separate probes located about the space S. However, thecomposite basket structure 14 is well suited for use within the heart and can perform other functions in addition to navigation, such as pacing and mapping, as will be described in greater detail later. - C. Generation of Proximity-Indicating Output
- (i) Transmission of Electrical
- Field by Roving Electrode
- As FIG. 1 shows, a
central processing unit 28 conditions anoscillator 26 to generate an electrical alternating current (AC) waveform at a predetermined amplitude and frequency. Thecentral processing unit 28 couples theoscillator 26 to a transmittingelectrode 30 carried by the rovingoperative element 12 Theelectrode 30 may be a component added to theoperative element 12 or it may comprise a component already on theoperative element 12 but used for an additional purpose. - An
indifferent electrode 32, carried as a patch on the exterior of the patient, comprises the voltage return, which is, in turn, coupled to an electrical reference. In the illustrated embodiment, the electrical reference is isolated orpatient ground 34, although other references can be used. Alternatively, another electrode carried by theoperative element 12 an serve as the voltage return. As another alternative, an electrode (A,B) on thestructure 14 can also serve as the voltage return. A voltage field is established, which varies in detected amplitude at each basket electrode (A,B) according to its distance from theelectrode 30 carried by theoperative element 12 For use within a living body space, the selected current amplitude of the oscillator output can vary between 0.1 mAmp to about 5 mAmp. The frequency selected can also vary from about 5 kHz to about 100 kHz. Currents substantially above about 5 mAmp and frequencies substantially below 5 KHz should be avoided when heart tissue is nearby, as they pose the danger of inducing fibrillation. The maximum current that can be used while avoiding fibrillation is a function of the frequency, as expressed in the following equation: - I=ƒ×10
- where I is current in μAmp, and f is frequency in kHz.
- The shape of the waveform can also vary. In the illustrated and preferred embodiment, the waveform is sinusoidal. However, square wave shapes or pulses can also be used, although harmonics may be encountered if capacitive coupling is present. Furthermore, the waveform need not be continuous. The
oscillator 26 may generate pulsed waveforms. - The
system 10 includes adata acquisition element 36 coupled to thecentral processing unit 28 and to a switch orsuitable multiplexer element 38. The switch element 38individually conditions each electrode (A,B) on thestructure 14 to sense a local voltage amplitude VS(A,B). Thedata acquisition element 36 includes an amplitude detector 37 (see FIG. 3), which acquires VS(A,B) for eachelectrode 22 in association with the electrode's (A,B) position coordinates. - The
switch element 38 also conditions theelectrode 30 on the operative element 12 o sense a local voltage amplitude VO(A,B) at the same time VS(A,B) is sensed by each basket electrode (A,B). Thedata acquisition element 36 includes a second amplitude detector 39 (see FIG. 3), which acquires a VO(A,B) in association with each VS(A,B). -
- As FIG. 3 also shows, the
processing element 40 further includes acomparator 46. Thecomparator 46 receives asinput 43 the normalized detected voltage value VN(A,B) generated by thecomponent 42. Thecomparator 46 also receives as input 41 a set line voltage, which constitutes a predetermined nominal voltage threshold value VTHRESH. Thecomparator 46 compares the magnitude of VN(A,B) (input line 43) to the magnitude of VTHRESH (input line 41). - The predetermined nominal voltage threshold value VTHRESH establishes a nominal separation distance between the
electrode 30 on theoperative element 12 nd a given basket electrode (A,B). The threshold voltage value VTHRESH serves to differentiate between a “close condition” between theelectrode 30 on theoperative element 12 nd a given basket electrode (A,B)(i.e., equal to or less than the nominal distance) and a “far condition” between theelectrode 30 on theoperative element 12 and a given basket electrode (A,B)(i.e., greater than the nominal distance). - If VN(A,B) is greater than or equal to VTHRESH, the
comparator 46 generates a proximity-indicatingoutput 47, also designed P(A,B), for the basket electrode (A,B). The proximity-indicated output P(A,B) for a given electrode (A,B) notifies the physician that the requisite “close condition” exists between theelectrode 30 on theoperative element 12 and the particular basket electrode (A,B). - When VN(A<B) is less than VTNRESH , the
comparator 46 generates no output for the particular electrode (A,B). The absence of a proximity-indicating output P(A,B) for a particular electrode (A,B) notifies the physician that the requisite “far condition” exists between theelectrode 30 on theoperative element 12 nd the particular basket electrode (A,B). - The magnitude selected for the threshold value VTHRESH sets the spacial criteria for “close condition” and “far condition,” given the physical characteristics of the
electrode 30 on theoperative element 12 nd the physical characteristics of the electrode (A,B) on thestructure 14. The physical characteristics include the diameter and shape of the electrode, as well as the electrical conductivity of the material from which the electrode is made and the electrical properties of the conductive medium exiting between theelectrode 30 and the structure 14 (for example, a blood pool or myocardial tissue mass) - The relationship between distance and expected normalized voltage detected value VN(A,B) for a given
electrode 30 on theoperative element 12 nd a given electrode (A,B) on thestructure 14 can be determined empirically, e.g., by in vitro or in vivo testing or by finite element analysis. FIG. 4 shows a representative data plot, showing the relationship between expected normalized voltage detected values VN(A,B) for a given electrode type on theoperative element 12 nd a given electrode type on thestructure 14. The plot in FIG. 4 shows that VN(A,B) (which is not expressed in units of volts, as it represents a normalized value derived by dividing two voltages) increases as the distance (in mm) between theelectrode 30 and a basket electrode (A,B) decreases. For example, in FIG. 4, at a distance of 4 mm, the expected normalized voltage detected value VN(A,B) is about 0.5 units, whereas, at a distance of about 1 mm, the expected normalized voltage detected value VN(A,B) is about 0.8 units. - By selecting an expected normalized voltage detected value VN(A,B) as the threshold VTHRESH, the operator is able to define the nominal distance between a given
electrode 30 on theoperative element 12 nd a given electrode (A,B) on thestructure 14 at which the proximity-indicating output P(A,B) is first generated. - The threshold value VTHRESH is the
voltage line input 46 to thecomparator 46. The value of VTHRESH can be set at a desired fixed voltage value representing a nominal threshold distance. In the illustrated and preferred embodiment, theprocessing element 40 includes aninput 50 by which the physician can designate a value for the nominal distance. For example, the physician can designate the nominal distance within a range of distances of 1 mm to 5 mm. Theprocessing element 40 includes a look-up table 52 or its equivalent, which expresses the empirically determined relationship between voltage and distance (which FIG. 4 exemplifies). Using the table, theprocessing element 40 converts the distance value entered byinput 50 to a corresponding normalized voltage value, which constitutes VTHRESH. Theprocessing element 40 also includes avoltage regulator 54, which sets thevoltage line input 46 to the normalized voltage value (VTHRESH), to thereby achieve the spacial sensitivity established by the physician for the proximity-indicating output P(A,B). - The operative components controlled by the
central processing unit 28, as previously discussed, can incorporate the particular electrical configuration shown in FIGS. 1 and 3, or another analog or digital configuration, to carry out the signal sampling and processing functions as described. - (ii) Transmission of Electrical Field by One or More Stationary Electrodes
- As FIG. 20 shows, the
central processing unit 28 can couple the oscillator 26 (through the switch or suitable multiplexer element 38) to one ormore electrodes 22 carried by thestructure 14. Theindifferent electrode 32 remains the voltage return, being coupled to an electrical reference, which, in the illustrated embodiment, is isolated orpatient ground 34. As before stated, alternatively, another electrode carried by theoperative element 12 an serve as the voltage return, or anelectrode 22 on thestructure 14 can also serve as the voltage return. - The transmission of electrical energy from one or more of the
electrodes 22 on thestructure 14 to theindifferent electrode 32 establishes a voltage field, like that earlier described in connection with FIGS. 1 and 3. The voltage field will vary in detected amplitude at theroving electrode 30 according to its distance from the transmitting basket electrode (A,B). - In this configuration (see FIG. 21, as well) the
switch element 38 individually conditions a selected one or group of electrodes (A,B) on thestructure 14 to transmit electrical energy. Theswitch element 38 also conditions each selected transmitting electrode (A,B) on thestructure 14 to sense a local voltage amplitude VS(A,B). Thedata acquisition element 36 includes the amplitude detector 37 (see FIG. 21), which acquires VS(A,B) for each transmittingelectrode 22 in association with the electrode's (A,B) position coordinates. - The
switch element 36 also conditions theelectrode 30 on theoperative element 12 to sense a local voltage amplitude VO(A,B) at the same time VS(A,B) is sensed by each transmitting basket electrode (A,B). Thedata acquisition element 36 includes the second amplitude detector 39 (see FIG. 21), which acquires a VO(A,B) in association with each VS(A,B). -
-
- As FIG. 21 shows, the
processing element 40 includes thecomparator 46. Thecomparator 46 receives asinput 43 the normalized detected voltage value VN(A,B) generated by thecomponent 42. Thecomparator 46 also receives as input 41 a set line voltage, which constitutes the predetermined nominal voltage threshold value VTHRESH, as previously described. Thecomparator 46 compares the magnitude of VN(A,B) (input line 43) to the magnitude of VTHRESH (input line 41). Also as previously described, if VN(A,B) is greater than or equal to VTHRESH, thecomparator 46 generates a proximity-indicating output 47 (also designed P(A,B)) for the basket electrode (A,B). Conversely, when VN(A<B) is less than VTHRESH thecomparator 46 generates no output for the particular electrode (A,B). - As FIG. 22 shows, the
roving element 12 an carry several sensing electrodes (three are shown for purposes of illustration, designated 30(1), 30(2), and 30(1)). The use of several sensing electrodes 30(1), 30(2), and 30(3) in the embodiment shown in FIGS. 20 and 22 allows the physician to assess, not only proximity information, but also information pertaining to the orientation of theroving element 12 itself. - More particularly, the
switch element 38 individually conditions all electrodes (A,B) along anentire spline 20 of thestructure 14 to transmit electrical energy and to sense a local voltage amplitude VS(A,B) at each transmitting electrode (A,B) along thespline 20. Theswitch element 38 also conditions each electrode 30(1), 30(2), and 30(3) on the operative element 12 o sense a local voltage amplitude VO(A,B) at the same time VS(A,B) is sensed by each transmitting basket electrode (A,B). The normalized detected voltage value VN(A,B) is generated for each combination of transmitting basket electrode (A,B) and non-transmitting, sense-only electrode 30(1), 30(2), and 30(3) and compared the magnitude of the threshold voltage VTHRESH (input line 41). - The resulting generation of one or more proximity-indication outputs provides orientation information. For example, in FIG. 22, the axis of the
roving element 12 is oriented in a not-parallel relationship with axis of thespline 20. The roving electrode 30(1) lays in a close condition to only two of the spline electrodes 22(2) and 22(3). The resulting two proximity-indicating outputs P(22(2)) and P(22(3)) for the electrode 30(1), and the absence of proximity-indicating outputs for the other roving electrodes 30(2) and 30(3), denotes that the axis of the roving element 12 s oriented generally not-parallel or “head-on” with respect to the axis of thespline 20. - In FIG. 23, the axis of the
roving element 12 is oriented in a more-parallel relationship with thespline 20. In this orientation, the roving electrode 30(1) lays in a close condition to the spline electrode 22(4); the roving electrode 30(2) lays in a close condition to two spline electrodes 22(3) and 22(4); and the roving electrode 30(3) lays in a close condition to two spline electrodes 22(2) and 22(3). Multiple proximity-indicating outputs result: one output P(22(4)) for roving electrode 30(1); two outputs P(22(4)) and P(22(3)) for roving electrode 30(2); and two outputs P(22(2)) and P(22(3)) for roving electrode 30(3). The pattern of proximity-indicating outputs for all roving electrodes 30(1), 30(2), and 30(3) denotes that the roving element 12 s oriented generally parallel or “side-by-side” with respect to the axis of thespline 20. - Transmitting an electrical field from all electrodes along a spline, sequentially about each spline of a three-
dimensional basket structure 14, generates a pattern of proximity-indicating outputs. The pattern locates the position and orientation of theoperative element 12 within the three-dimensional space thebasket structure 14 defines. - More particularly, as FIGS. 22 and 23 demonstrate, for a given electrode30(1), 30(2), or 30(3) selected on the
roving element 12 the number proximity-indicating outputs varies according to proximity of the selected electrode to one or more the electrodes 22(1), 22(2), 22(3), and 22(4) on thespline 20. The number of proximity-indicating outputs for a given electrode 30(1), or 30(2), or 30(3) will increase in proportion to the number of basket electrodes 22(1) to 22(4) in proximity to it. As FIGS. 22 and 23 also demonstrate, the total number of position-indicating outputs combined for all the electrodes 30(1) to 30(3) varies according to the orientation of the axis of the roving electrode to the axis of thespline 20. As the axis of theroving electrode 12 becomes more parallel to the axis of thespline 20, the total number of proximity-indicated outputs for all the electrodes 30(1) to 30(3) will increase. - As will be described in greater detail later, the pattern of multiple, simultaneous proximity-indicating outputs can be interpolated for display purposes.
- (iii) Transmission of Electrical Field by An Other Roving Electrode
- As FIG. 29 shows, the roving
operative element 12 an carry, in addition to asingle sensing electrode 30 or multiple sensing electrodes 30(1), 30(2), and 30(3), anenergy transmitting electrode 260. In the illustrated embodiment, theelectrode 260 comprises a ring of electrically conductive material, spaced proximally of the single ormultiple sensing electrodes 30. Of course, theelectrode 260 can take other forms, as will be discussed later in connection with other electrode structures. - In this embodiment, the
central processing unit 28 couples theoscillator 26 to theroving electrode 260. Theindifferent electrode 32 remains the voltage return, being coupled to an electrical reference, which, in the illustrated embodiment, is isolated orpatient ground 34. As before stated, alternatively, another electrode carried by theoperative element 12 an serve as the voltage return, or anelectrode 22 on thestructure 14 can also serve as the voltage return. - The transmission of electrical energy from the
electrode 260 to theindifferent electrode 32 establishes a voltage field, like that earlier described in connection with FIGS. 1 and 3, and FIGS. 20 and 21. The voltage field will vary in detected amplitude at theroving electrode 30 according to its distance from a given electrode (A,B) on thestructure 14. - In this embodiment, neither the
roving electrode 30 nor any of the electrodes (A,B) on thestructure 14 transmits the electrical field. Instead (see FIG. 30 ) theswitch element 38 individually conditions a selected one or group of electrodes (A,B) on thestructure 14 to sense a local voltage amplitude VS(A,B). Thedata acquisition element 36 includes the amplitude detector 37 (see FIG. 30 ), which acquires VS(A,B) for eachelectrode 22 in association with the electrode's (A,B) position coordinates. - The
switch element 36 also conditions the sensing electrode orelectrodes 30 on the operative element 12 o sense a local voltage amplitude VO(A,B) at the same time VS(A,B) is sensed by each transmitting basket electrode (A,B). Thedata acquisition element 36 includes the second amplitude detector 39 (see FIG. 30 ), which acquires a VO(A,B) in association with each VS(A,B). -
- As FIG. 30 shows, the
processing element 40 includes thecomparator 46. Thecomparator 46 receives asinput 43 the normalized detected voltage value VN(A,B) generated by thecomponent 42. Thecomparator 46 also receives as input 41 a set line voltage, which constitutes the predetermined nominal voltage threshold value VTHRESH, as previously described. Thecomparator 46 compares the magnitude of VN(A,B) (input line 43) to the magnitude of VTHRESH (input line 41). Also as previously described, if VN(A,B) is greater than or equal to VTHRESH, thecomparator 46 generates a proximity-indicating output 47 (also designed P(A,B)) for the basket electrode (A,B). Conversely, when VN(A<B) is less than VTHRESH, thecomparator 46 generates no output for the particular electrode (A,B). - D. Displaying the Proximity-Indicating Output
- In the illustrated and preferred embodiment, the
system 10 includes anoutput display device 56 coupled to theprocessing element 40. Thedevice 56 presents the presence or absence of proximity-indicating outputs P(A,B) for each basket electrode (A,B) in a visual or graphic format useful to the physician for remotely locating and guiding theoperative element 12 relative to thestructure 14. - (i) Hard-Wired Polar Grid
- In one embodiment (see FIG. 5), the
output display device 56 comprises a hard-wiredgrid 58 of individual light emitting diodes 60 (LED's) arranged to depict a polar map of all the electrodes (A,B) carried by thebasket structure 14. The LED's 60 are normally maintained in an designated “OFF” state by theprocessing element 40. The LED's 60 can be unlit in the “OFF” state. - When a proximity-indicating output P(A,B) is generated for a given basket electrode (A,B), the
processing element 40 switches to an “ON” state theLED 60 that marks the location of the given electrode (A,B) on the hard-wiredgrid 58. TheLED 60, when switched “ON,” displays a color, e.g., green, to visually signal to the physician the proximity of theoperative element 12 to the given basket electrode (A,B). - It is possible for more than one
LED 60 on the hard-wiredgrid 58 to be switched “ON” at the same time, depending upon the orientation of theoperative element 12 to the basket electrodes (A,B) and the spacial sensitivity established for thecomparator 46. - (ii) Graphical Display
- In a preferred embodiment (see FIG. 6), the
output display device 56 comprises a Graphical User Interface (GUI) 62. TheGUI 62 is implemented by agraphical control program 82 resident in an external microprocessor based computer control, such as alaptop computer 64 having akeyboard 66, adisplay screen 68, andmouse 70. Thelaptop computer 64 is coupled to the processing element 40 (and thus also to the central processing unit 28) via acommunication port 72, such as RS 232 or an Ethernet™ connection. - The processing element40 (or alternatively, the central processing unit 28) conditions the GUI
graphical control program 82 to generate on thedisplay screen 68 an idealizedgraphical image 74, which models the geometry of theparticular basket structure 14 deployed in the body region. By reference to thismodel image 74, the physician is able to visualize the location of each basket electrode (A,B) andspline 20. - In the illustrated and preferred embodiment (see FIGS. 6 and 7), the
GUI control program 82 provides a split screen image having aleft panel 76 and aright panel 78. Theimage 74 of thebasket structure 14 appears in the left andright panels nodes 80. - The
panels image 74 from different idealized orientations. Acontrol program 82 generates an Operational Screen Toolbar 150 (see FIG. 7), which provides the physician with a variety of options to customize theidealized image 74 in eachpanel left panel 76 can show theimage 74 from a selected oblique angle, such as a right or left anterior angle or a right or left posterior oblique angle, while theright panel 78 can show theimage 74 from a selected orthogonal side angle. - In the illustrated embodiment (see FIG. 7), the
Toolbar 150 includes an array ofView buttons 156. TheView Buttons 156 allow the physician to choose among typical orientations for theimage 74 in theleft panel 76, such asLeft 45° or 30° (designated respectively LAO45 LAO30 in FIG. 7), Right 45° or 30° (designated respectively RAO45 RAO30 in FIG. 7), or Anterior/Posterior (designated A/P in FIG. 7). Theimage 74 in theright panel 78 is consistent with the orientation selected for the image in the left panel, however, another array ofView buttons 158 allows the physician to select among typical views for the right panel image, such as Superior, Inferior, Left, and Right. - Thus, by pointing and clicking the
mouse 70, or by making command entries using thekeyboard 66, the physician is able to set up the desired views in the left andright panels Save View button 152 in theToolbar 150, the physician is able to save the image in an associated patient data base 12 (see FIG. 9), the details of which will be described later. - A fluoroscope or other imaging device may be used in association with the
GUI 62 to visualize the actual orientation of thebasket structure 14 and operative element 12 n the body region. TheGUI 62 provides a simplified and idealized representation that supplements the fluoroscopic or other independent image. - In the illustrated embodiment, the physician can compare the fluoroscopic or other independent image and manipulate the
GUI image 74 to more closely match the view of the fluoroscopic display. To accomplish this (see FIG. 7), theToolbar 150 includes a set of on-screen X, Y, andZ buttons 92, which can be clicked to cause at least one of themodel images 74 to incrementally rotate about idealized X, Y, Z coordinate axes. - In a preferred embodiment, the
control program 82 can be controlled by themouse 70 to change the shape of theidealized image 74 to more closely match the shape of thestructure 14 as seen in a fluoroscopic or other independent view. The shape of theimage 74 can be formed by dragging themouse 70, for example, to appear in a range of configurations from spherical to a more elongated ellipsoid (when the structure is a three-dimensional basket structure, as shown in FIG. 1) or to appear in a range of curve radii for an elongated, curvilinear structure (as will be described later). The shape characteristic formed by the physician is saved along with other image information when thesave button 152 is clicked. - When saving any image manipulated by use of the
Toolbar 150, e.g., to match the particular fluoroscopic or other independent view, thecontrol program 82 allows the physician to uniquely associate the view with one of thepreset view buttons Toolbar 150, the physician can switch views of thegraphic image 74 electronically, without manipulating the fluoroscopic display. - The
GUI control program 82 initialized thenodes 80 on themodel image 74 at a designated color or shade. The initialized color or shade for a givennode 80 constitutes a visual signal to the physician, that the operative element 12 s at a “far condition” relative to the associated electrode (A,B). - A proximity-indicating output P(A,B) generated by the
processing element 40 for a given electrode (A,B) is transmitted to thecontrol program 82. Thecontrol program 82 switches “ON” the node 80(*) marking the location of the given electrode (A,B) in theimage 74, by changing the designated color or shade. Thenode 80, when switched “ON,” displays a different color or shade, e.g., green, to visually signal the physician that the operative element 12 s in a “Close Condition” relative to the corresponding basket electrode (A,B). - In the illustrated and preferred embodiment (see FIG. 7), the physician is able to point and click the
mouse 70 on aSensitivity Adjustment button 154 on the Toolbar 150 (or enter commands by the keyboard 66) to open a pop-upSensitivity Adjustment Window 84. TheWindow 84 allows the physician to access theinput 50 at any point during the procedure, to alter the spacial sensitivity for the proximity-indicating output P(A,B). - In the illustrated embodiment, the
Window 84 includes aslide icon 86, which can be dragged by the mouse 70 (or moved by a corresponding keyboard command) between a “Coarse” setting and a “Fine” setting. The “Coarse” setting selects a low-relative value forinput 50, in response to which thecentral processing element 40 sets a VTHRESH corresponding to a large-relative nominal distance (for example, at 5 mm). The “Fine” setting selects a high-relative value forinput 50, in response to which theprocessing element 40 sets a VTHRESH corresponding to a small-relative nominal distance (for example, at 1 mm). TheWindow 84 can also displays in alpha/numeric format the current selected nominal distance. The physician is thereby able, in real time during the procedure, to adjust the sensitivity at which the proximity-indicating output P(A,B) is generated, to obtain the desired resolution for the displayedmodel image 74. - It is possible for more than one
node 80 to be switched “ON” at the same time, depending upon the orientation of the operative element 12 o the basket electrodes (A,B) and the spacial sensitivity established. In the illustrated and preferred embodiment (see FIG. 6), thegraphical control program 82, includes an interpolatingfunction 88. - As illustrated in FIG. 8, if two
nodes 80 are ordered to be switched “ON” simultaneously (for example, nodes 80(10) and 80(11) in FIG. 8), the interpolatingfunction 88 switches “ON” a phantom node 80(10,11) midway between the twoelectrode nodes 80. - As also illustrated in FIG. 8, if more than two
nodes 80 are ordered to be switched “ON” simultaneously (for example, nodes 80(2), 80(5), and 80(6) in FIG. 8), the interpolatingfunction 88 switches “ON” a phantom node 80(2, 5, 6) at the geometric center of the three ormore electrode nodes 80. - FIG. 24 shows an image of several nodes80(1) to 80(4), corresponding to the arrangement of electrodes 22(1) to 22(4) along a
single spline 20 shown in FIG. 23. In the FIG. 23 embodiment (as previously described), the electrodes 22(1) to 22(4) serve as the transmitting electrodes, and they are energized simultaneously. As shown in FIG. 23 (and as previously described), theroving element 12 carries multiple sensing electrodes 30(1), 30(2), and 30(3). The generation of multiple, simultaneous proximity-indicating outputs (as previously described) orders node 80(4) to be switched “ON” due to its close condition to both roving electrode 30(1) and 30(2); node 80(3) to be switched “ON” due to its close condition to both roving electrodes 30(2) and 30(3); and node 80(2) switched “ON” due to its close condition to roving electrode 30(3). The interpolatingfunction 88 switches “ON” phantom nodes (3,4) and (2,3), mid-way between the nodes (2) and (3) and midway between the nodes (3) and (4). As FIG. 24 shows, switched “ON” node (4) and the switched “ON” phantom nodes (3,4) and (2,3) collectively create a pattern that matches both the actual position and general orientation of the roving electrodes 30(1) to 30(3) relative to the electrodes 22(1) to 22(4), as shown in FIG. 23. - The display of the proximity-indicating outputs P(A,B) continuously tracks movement of the
roving electrode 30 and electrodes 30(1), 30(2) and 30(3) relative to the electrodes (A,B) on thestructure 14. - E. Electrically Identifying Structures
- The
system 10 an be used in association with a family ofbasket structures 14.Basket structures 14 within the family are characterized by different physical properties, such as the size of thestructure 14; the shape of thestructure 14; the radial symmetry or asymmetry of thestructure 14; the axial symmetry or asymmetry of thestructure 14; the number ofspline elements 20; the total number ofelectrodes 22 carried by thestructure 14; the number ofelectrodes 22 carried perspline element 20; the distance betweenelectrodes 22 on eachspline element 20; the distribution or density pattern ofelectrodes 22 on thestructure 14; or combinations thereof. - As FIG. 6 shows, the
system 10 includesidentification codes 94 to identifyindividual basket structures 14 within the family of basket structures. Eachidentification code 94 uniquely identifies aparticular basket structure 14 in terms of its physical property or properties. - As FIG. 6 shows, the
code 94 is carried by a codedcomponent 96,which is attached in association with eachbasket structure 14. In the illustrated embodiment, the codedcomponent 96 is located within ahandle 98 attached at the proximal end of thecatheter tube 45 that carries thebasket structure 14. However, thecomponent 96 could be located elsewhere on thecatheter tube 45 orstructure 14. Thecode 94 can also be manually inputted by the physician using thekeyboard 66. - The coded
component 96 can be variously constructed. It can, for example, take the form of an integrated circuit, which expresses in digital form thecode 94 for input in ROM chips, EPROM chips, RAM chips, resistors, capacitors, programmed logic devices (PLD's), or diodes. Examples of catheter identification techniques of this type are shown in Jackson et al. U.S. Pat. 5,38 3,874, which is incorporated herein by reference. - Alternatively, the coded
component 96 can comprise separate electrical elements, each one of which expresses an individual characteristic. For example, thecomponent 96 can comprise several resistors having different resistance values. The different independent resistance values express the digits of thecode 94. - The coded
component 96 is electrically coupled to anexternal interpreter 100 when thebasket structure 14 is plugged into thecentral processing unit 28 for use. Theinterpreter 100 inputs thecode 94 and electronically compares theinput code 94 to, for example, a preestablished master table 102 of codes contained in memory. The master table 102 lists, for eachcode 94, the physical characteristics of thestructure 14. Theinterpreter 100 generates aidentification output 104 based upon the table 102. Thegraphical control program 82 retains a library of idealized graphical images that reflect the different geometries identified by theoutput 104. Based upon theidentification output 104 received from thecentral processing unit 28, thecontrol program 82 generates the particular idealizedgraphical image 74 that corresponds to the geometry of theparticular basket structure 14 in use. - F. Use With Cardiac Diagnosis and Treatment Systems
- In a preferred embodiment (see FIG. 9), the
system 10 forms a part of amodular system 106, which is used to diagnose and treat abnormal cardiac conditions. FIG. 9 shows a representative embodiment of themodular system 106 of which thesystem 106 forms a part. Additional details of themodular system 106 not material to the invention can be found in copending U.S. patent application Ser. No. 08/813,62 4, entitled “Interface Unit for Use with Multiple Electrode Catheters,” filed Mar. 7, 1997. - In FIG. 9, the
basket structure 14 andoperative element 12 are shown deployed and ready for use within a selected region inside a human heart H. FIG. 9 generally shows thebasket structure 14 andoperative element 12 deployed in the right ventricle RV of the heart H. Of course, thebasket structure 14 andelement 12 an be deployed in other regions of the heart, too. It should also be noted that the heart shown in the FIG. 9 is not anatomically accurate. FIG. 1 shows the heart in diagrammatic form to demonstrate the features of the invention. - In FIG. 9, the
basket structure 14 andelement 12 have each been separately introduced into the selected heart region through a vein or artery (typically the femoral vein or artery) through suitable percutaneous access. Alternatively, thebasket structure 14 andoperative element 12 an be assembled in an integrated structure for simultaneous introduction and deployment in the heart region. - Further details of the deployment and structures of the
basket structure 14 andelement 12 are set forth in pending U.S. patent application Ser. No. 08/033,641, filed Mar. 16, 1993, entitled “Systems and Methods Using Guide Sheaths for Introducing, Deploying, and Stabilizing Cardiac Mapping and Ablation Probes.” - The electrodes (A,B) carried by the
basket structure 14 are electrically coupled to asignal processing system 108. The electrodes (A,B) sense electrical activity in heart tissue. The sensed activity is processed by theprocessing system 108 to assist the physician in identifying the site or sites within the heart appropriate for ablation. This process, called mapping, can be accomplished in various way, according to the choice of the physician. - For example, the physician can condition the
processing system 108 to take multiple, sequential measurements of the transmission of electrical current by heart tissue to obtain tissue resistivity measurements. The processing of tissue resistivity signals to identify appropriate ablation sites is disclosed in co-pending U.S. patent application Ser. No. 08/197,236, filed Jan. 28, 1994, and entitled “Systems and Methods for Matching Electrical Characteristics and Propagation Velocities in Cardiac Tissue to Locate Potential Ablation Sites.” - Alternatively, or in conjunction with tissue resistivity measurements, the physician can condition the
processing system 108 to acquire and process electrograms in a conventional fashion. - The
processing system 108 processes the electrogram information to map the conduction of electrical impulses in the myocardium. - The
identification code 94 previously described can also identify a functional property of the electrodes (A,B) on thebasket structure 14 in terms of a diagnostic capability, such as mapping, or derivation of an electrical characteristic, or pacing. Theprocessing system 108 can includefunctional algorithms 109, which set operating parameters based upon thecode 94. For example, thecode 94 can provide input to tissue mapping algorithms to enable early activation detection, or fractionation mapping, or pace mapping, or entrainment pacing. Thecode 94 can also provide input to electrical characteristic derivation algorithms, or provide interpolation for evaluating electrograms between electrodes, or extrapolate sensed electrical activities to locate potential ablation sites. - The
electrode 30 on theoperative element 12 also serves as an ablation electrode. Of course, other configurations employing multiple ablation electrodes are possible, as described in pending U.S. patent application Ser. No. 08/28 7,310, filed Aug. 8, 1994, entitled “Systems and Methods for Ablating Heart Tissue Using Multiple Electrode Elements.” - A
catheter tube 44 which carries theoperative element 12 includes asteering mechanism 110 contained within aproximal handle 112 see FIG. 2B also). As FIG. 2B shows, thesteering mechanism 110 electively bends or flexes thecatheter tube 44 to bring theoperative element 12nd ablation electrode 30 into conforming, intimate contact against the endocardial tissue. Details of the steering mechanism are shown in U.S. Pat. No. 5,254,088, which is incorporated herein by reference. - The
ablation electrode 30 is electrically coupled to agenerator 114 of ablation energy. The type of energy used for ablation can vary. Typically, thegenerator 114 supplies electromagnetic radio frequency energy, which theelectrode 30 emits into tissue. - The
operative element 12 an also carry acode 120, in the same manner as thecode 94 is carried by thebasket structure 14. Thecode 120 identifies the physical characteristics of theelement 12, such as its diagnostic function or its therapeutic functions. Thecode 120, can also identify the physical characteristics of theablation electrode 30, such as its size and the presence or absence of temperature sensing capabilities. Based upon thecode 120, thecentral processing unit 28 can condition the ablation energy supply functions of thegenerator 114, such as by setting maximum or minimum power, and enabling specialized ablation control algorithms, e.g., by tissue temperature sensing. - The physician places the
ablation electrode 30 in contact with heart tissue at the site identified by thebasket structure 14 for ablation. Theablation electrode 30 emits ablating energy to heat and thermally destroy the contacted tissue. - The
system 10 is electrically coupled to thebasket structure 14 and theoperative element 12 as already described. Thesystem 10 collects and processes information to generate proximity-indicating outputs P(A,B) regarding the proximity of theablation electrode 30 relative to the electrodes (A,B) on thestructure 14. The display of the proximity-indicating outputs P(A,B) as previously described, wither on thehardware grid 58 or theGUI 62, continuously tracks movement of theablation electrode 30 relative to the electrodes (A,B) on thestructure 14. The display of the proximity-indicating outputs P(A,B) thereby aids the physician in guiding theablation electrode 30 into contact with tissue at the site identified for ablation. - G. Patient Data Base
- In a preferred embodiment (see FIGS. 9, 10A, and10B), the
graphical control program 82 includes aMARKERS function 116. TheMARKER function 116 enables the physician to alter and enhance the displayedmodel image 74 of thebasket structure 14. - The MARKERS function116 enables the operator to annotate the image by adding an identifier or marker to selected locations of the
image 74. As FIG. 10A shows, the MARKERS function 116 is activated by clicking theADD MARKER button 118 hat appears on thescreen 68 after the general “MARKERS”button 120 is clicked on theToolbar 150. Pressing the right mouse button on an electrode (A,B) causes amarker 122 to appear on the screen. With the right mouse button depressed, the physician can “drag” themarker 122 to the desired location. When the right mouse button is released, themarker 122 is “dropped” into the desired marker location. - The MARKERS function116 also enables the physician to add custom annotations in the form of notes or comments to each
marker 122. As FIG. 10A shows, aCOMMENT window 124 appears as soon as themarker 122 is “dropped” at the selected site. A time stamp is preferably automatically included in thecomment window 124. The operator can enter the desired comment into thecomment window 124 using the computer keyboard. - As FIG. 10B best shows,
markers 122 andcomments 124, can be placed near electrodes on either the foreground or background of theimage 74, e.g., to mark selected locations that are significant or of interest, such as mapping sites, ablation sites, etc. The physician is thereby better able to remain coordinated and oriented with the displayed image and, therefore, better able to interpret data recovered by thebasket structure 14. - By clicking a pop up SAVE button126 (or alternatively, clicking the
Save View button 152 on the Toolbar 150) at desired times, the entire graphical display, includingmodel image 74,markers 122, and associatedcomment windows 124 can be saved as a data file record for storage, retrieval, or manipulation. The physician is thereby able to create during a given diagnostic or therapeutic procedure a patient-specific data base 128, stored in on board memory, which records the diagnostic or therapeutic events of the procedure. Further details about thepatient data base 128 will be described later. - In the illustrated embodiment (see FIG. 9), a
control line 130 couples thegenerator 114 to thegraphic control software 82. Transmission of ablation energy by thegenerator 114 generates an output signal in thecontrol line 130. The output signal commands thecontrol program 82 to automatically save the entire graphical display as it exists at the instant ablation occurs. The physician is thereby able to record each ablation event in the context of a graphical image for inclusion in thedata base 128 specific to the patient. - The output signal commands identification of the location of the ablation electrode, generates a time stamped
marker 122, and generate an ablation-indicating annotation, e.g., acomment window 124 ormarker 122, identifying the position of the electrode at the instant ablation occurs. - To establish and maintain records in the
patient data base 128, thegraphical control program 82 includes a PATIENT DATA function 132. As FIG. 11 shows, at the time that thecontrol program 82 generates the Operational Screen Toolbar 150 (previously described), thecontrol program 82 also opens aPatient Data Window 134. ThePatient Data Window 134 allows the physician to enter data about the particular patient and thereby make patient specific subsequent information recorded and saved in thedata base 128. - To create a patient-specific record in the
data base 128, the physician enters in thePatient field 136 of theWindow 134 the name of the patient and clicks theNew Study button 138. Thecontrol program 82 enters a default file name in aStudy Name field 140, with associatedtime marker 142. The physician can enter in theText field 144 additional information or comments regarding the patient, such as the patient's ID number, age, etc, which the physician wants to save as part of the patient record. The physician can also enter diagnostic information, e.g., heart tissue pacing data; or therapeutic information, e.g., heart tissue ablation data; or identify the attending physician or staff personnel. The physician can also select in theDevice field 146 the type ofstructure 14 that will be deployed in the patient. The physician can then click theopen Study button 148 to begin the new study. - When beginning a new study, the
control program 82 gives the physician the option of starting the new study with new image views in the left andright panels 76 and 78 (by clicking theReset button 160 on theToolbar 150, as shown in FIG. 7). TheToolbar 150, previously described, allows the physician to customize the left andright panel images 74 for the new study, in the manner previously described in connection with FIG. 7. - Alternatively, the
control program 82 gives the physician the option of using the same image views set in an immediately preceding study. This option allows the physician to quickly switch among different diagnostic or therapeutic protocols (each constituting a “study”) on the same patient using thesame structure 14 in the same heart chamber. - During a given study, the physician can implement the MARKERS function116 to set up
markers 122 and commentwindows 124 in association with the selected image views, as FIGS. 10A and 10B show. In thecomment windows 124, the physician can include further information identifying the procedure, diagnostic information, therapeutic information, or otherwise annotate the image. By clicking theSAVE view button 126 on theToolbar 150 at desired times, the entire graphical display, includingmodel image 74,markers 122, and associatedcomment windows 124 are saved as a data file uniquely associated for the particular study and particular patient for storage, retrieval, or manipulation. Thecontrol program 82 gives the physician the option of protecting the data by use of a password, to restrict access to all or some of the data base records. - As FIG. 9 shows, an output device, such as a
printer 164 or graphics display terminal 166, allows patient record information to be recalled or down loaded for off-line analysis or compilation. The patient record will contain the entire graphical image 74 (including shape characteristics or orientations added by the physician),markers 122, and associatedcomment windows 124 in existence at the time the record was saved. As FIG. 11 shows, thepatient study Window 134 can withtime markers 142 provide information documenting the storage, retrieval, or manipulation of the data base record, such as the date on which data in the record is entered or updated, or the date on which data was retrieved or otherwise manipulated. - As FIG. 9 also shows, a
communications port 168 allows patient record information to be transmitted to a centraldata storage station 170. A network of local orremote systems 106, 106(A), 106(B), and 106(C), each having all or some of the features described formodule 106, can be linked to the centraldata storage station 170, by an Internet-type network, or by an intranet-type network. The network ofwork station modules 106, 106(A), 106(B), and 106(C), all linked to the centraldata storage station 170, allows patient-specific data base records for many patients at one or more treatment facilities to be maintained at a single location for storage, retrieval, or manipulation. - To exit the
control program 82, the physician clicks the Patient/Quit button 162 on the Toolbar 150 (see FIG. 7). - II. Proximity Sensing Using Other Structures
- A. Elongated Structures
- FIG. 12 shows another embodiment of a
position sensing system 168, which locates the position of anoperative element 170 along a locating probe 172. In FIG. 12 the locating probe 172 takes the form of anelongated electrode array 174. - The
operative element 170 is constructed in the same way as theelement 12 previously described and shown in FIG. 2B. As FIG. 13 shows, theelement 170 is carried at the distal end of acatheter tube 176. However, like theelement 12, theelement 170 need not be necessarily catheter-based. - As earlier described, the
operative element 170 can be used for either therapeutic purposes, or diagnostic purposes, or both. In the illustrated embodiment, theoperative element 170 includes anelectrode 178, which can be conditioned to sense a physiological characteristic in myocardial tissue. Theelectrode 178 can also be conditioned to transmit electrical energy to stimulate (i.e., pace) myocardial tissue, as well as transmit radio frequency energy to ablate myocardial tissue. - As shown in FIG. 12 the elongated array of
electrodes 174 are also carried at the distal end of acatheter tube 180 in the same way that thestructure 14 is carried by acatheter tube 45 in FIG. 2A. In the illustrated embodiment, theelectrodes 174 take the form ofconventional rings 175 of electrically conductive material (e.g., copper alloy, platinum, or stainless steel), arranged in a spaced apart, segmented relationship about asleeve 182 of electrically insulating material. Alternatively, theelectrodes 174 can be coated upon thesleeve 182 using conventional coating techniques or an ion beam assisted deposition (IBAD) process, or comprise spaced apart lengths of wound, spiral coils made of electrically conducting material. - In the illustrated embodiment, the distal regions of both
catheter tubes - FIG. 13 shows the
operative element 170 and array ofelectrodes 174 deployed in theannulus region 184 of a human heart H. FIG. 13 shows the deployment diagrammatically and not with anatomic precision. - The
annulus region 184 lays at the intersection of theatrial structure 186 and theventricular structure 186 of the heart. Theannulus region 184 is a site where the electrophysiological source of many arrhythmias can be mapped and successfully eliminated by ablation. - In FIG. 13, the
operative element 170 and itselectrode 178 are shown deployed inside anatrium 194 near theannulus region 184. The physician is able to selectively move theelement 170 along theendocardial surface 196 inside the atrium at or near theannulus region 184. - As shown in FIG. 13, the elongated array of
electrodes 174 is deployed outside theatrium 194, within an adjacent region of the greatcardiac vein 190. The greatcardiac vein 190 is a fixed anatomic structure, which extends close to theepicardium 192 along theannulus region 184. The greatcardiac vein 190 thereby serves as an anatomic marker to aid the physician in situating the locating array ofelectrodes 174 in theannulus region 184. - As FIG. 12 shows, and functioning in the same manner as previously described with reference to FIG. 1, the
central processing unit 28 conditions theoscillator 26 to transmit an electrical AC waveform through theelectrode 178 carried by theoperative element 170. Theindifferent electrode 32 comprises the voltage return, coupled to an electrical reference, which, in the illustrated embodiment, is isolated orpatient ground 34. The voltage field that is created varies in detected amplitude at eachelectrode ring 175 according to its distance from theelectrode 178 carried by theoperative element 170. A proximity-indicating output 198 (designated P(A)) is generated in the manner previously described for a given electrode ring 175 (where A equals 1to the number of electrode rings 175 on the array 174), when the prescribed “close condition” between the givenring electrode 175 and theelectrode 178 exists. - Since the position and orientation of the great
cardiac vein 190 is known, agraphic display 204 can generate an idealized graphical image 200 (see FIG. 14) for theelectrode array 174, in whichnodes 202 mark thering electrodes 175. Thedisplay 204 thereby graphically depicts for the physician an idealized graphical image of the portion of theannulus region 184 where theelectrode array 174 is deployed. - Using the
ring electrodes 174, the physician can pace and sense electrical events in myocardial tissue along theannulus region 184. In tandem, the physician can also pace and sense using theelectrode 178 on theoperative element 170. Pacing and sensing both inside and outside theatrium 194 permit the detection of differences between electrophysiological activities near the epicardial surface (detected by the ring electrodes 175) and near the endocardial surface (detected by the electrode 178). This differential detection technique provides advanced diagnostic capabilities. - Generation of the proximity-indicated output198 (as previously described with reference to the basket structure 14) switches “ON” the
node 202 when the prescribed “close condition” to theroving electrode 178 exits. Thedisplay 204 thereby tracks the movement of theroving electrode 178 along theannulus region 184 as mapping and diagnostic functions proceed. - Once mapping identifies a candidate ablation site, the
display 204 aids the physician in moving theelectrode 178 to the site for the purpose of transmitting ablation energy. - B. Loop Structures
- FIG. 15 shows still another embodiment of a
position sensing system 268 to locate the position of the same or equivalentoperative element 170 and associatedelectrode 178 shown and described in connection with the FIG. 13 embodiment. In this embodiment, the locating probe comprises a multipleelectrode loop structure 274. - The
loop structure 274 can be constructed in various ways. In the illustrated embodiment (see FIGS. 16 and 17), thestructure 274 is formed from acore spline leg 246 covered with an electricallyinsulating sleeve 248.Multiple electrode elements 228 are secured on thesleeve 248. - In the illustrated embodiment, the
electrodes 228 take the form of conventional rings 275 of electrically conductive material (e.g., copper alloy, platinum, or stainless steel), arranged in a spaced apart, segmented relationship about thesleeve 248. As previously described in connection with theelectrode array 174, theelectrodes 174 can, in an alternative construction, be coated upon thesleeve 248, or comprise spaced apart lengths of wound, spiral coils made of electrically conducting material. - As demonstrated in FIG. 17, the
ring electrodes 228 can be arranged in a prearranged pattern. In FIG. 17, the pattern comprises paired groups of eightelectrodes 228, separated by enlarged spacer rings 229. The pattern assists the physician to orient thestructure 274 when viewing it fluoroscopically. - The number of
electrodes 228 can vary. Typically, between 10 and 24electrodes 228 are used. - The
structure 274 is carried at the distal end of acatheter tube 212. Asheath 302 is also carried by thecatheter tube 212 As FIGS. 16 and 17 show, thedistal section 304 of thesheath 302 is joined to thedistal end 308 of thestructure 274 by a short length ofwire 306, e.g., by adhesive or thermal bonding. - The
catheter tube 212 slidable within thesheath 302 to deploy thestructure 274. Pushing the catheter tube 212 n the forward direction through the sheath 302 (as shown byarrow 310 in FIG. 17), moves thestructure 274 outward from the end of thesheath 302. Thewire 306 forms a flexible joint 344, pulling thedistal end 308 of thestructure 274 toward thesheath 302. Thestructure 274 thereby is bent into a loop, as FIG. 17 shows. The physician can alter the diameter of theloop structure 274 from large to small, by incrementally moving the catheter tube 312 in the forward direction (arrow 310 in FIG. 17) and rearward direction (arrow 316 in FIG. 17) through thesheath 302. Moving thestructure 274 fully in the rearward direction (arrow 316) returns thestructure 274 into a low profile, generally straightened configuration within the sheath 302 (as FIG. 16 shows), well suited for introduction into the intended body region. - FIG. 18 shows the
operative element 170 andstructure 274 deployed in theannulus region 180 of a human heart H. Like FIG. 13, FIG. 18 shows the deployment diagrammatically and is not intended to be anatomically accurate. - In FIG. 18, the
loop structure 274 is deployed within anatrium 194 of the heart H. Due to its geometry, theloop structure 274 tends to seek the largest diameter in theatrium 194 and occupy it. The region of largest diameter in an atrium is typically located above and close to theannulus region 184. Theloop structure 274 thereby serves to reliably situate itself close to theannulus region 184. - In FIG. 18 the
operative element 170 and itselectrode 178 are deployed in the space S immediately below (i.e., toward the ventricle 188) of theloop structure 274, which is nearer to theannulus region 184 than theloop structure 274. The physician is able to selectively move theelement 170 along the endocardial surface within this space S near theannulus region 184. - As FIG. 15 shows, and functioning in the same manner as previously described, the
central processing unit 28 conditions theoscillator 26 to transmit an electrical AC waveform through theelectrode 178 carried by theoperative element 170. Theindifferent electrode 32 comprises the voltage return, coupled to an electrical reference, which, in the illustrated embodiment, is isolated orpatient ground 34. The voltage field that is established varies in detected amplitude at eachelectrode ring 228 on theloop structure 274 according to its distance from theelectrode 178 carried by theoperative element 170. A proximity-indicating output 198 (designated P(A)) is generated for a given electrode ring 228 (where A equals 1 to the number of electrode rings 228 on the loop structure 274), when the prescribed “close condition” between the givenring electrode 228 and theelectrode 178 exists. - As previously described in the context of other structures, a
graphic display 250 can generate an idealized graphical image 252 (see FIG. 19) for theloop electrode array 274, in whichnodes 254 mark thering electrodes 228. A fluoroscope used in association with thedisplay 250 allows the physician to visualize the actual radius of curvature and orientation of theloop 274 in the atrium. The physician compares the fluoroscopic image and uses the Toolbar 150 (previously described) to manipulate thegraphic image 252 to more closely match the view of the fluoroscopic display. The physician can then use theToolbar 150 to switch views of thegraphic image 252 electronically, without manipulating the fluoroscopic display, as previously described. - Using the
ring electrodes 228 on theloop structure 274, the physician can pace and sense electrical events in myocardial tissue along theannulus region 184. - Generation of the proximity-indicated
output 198 switches “ON” the node 254(*) when the prescribed “close condition” to theroving electrode 178 exits. Thedisplay 250 thereby tracks the movement of theroving electrode 178 along theannulus region 184 as mapping and diagnostic functions proceed. - Once mapping identifies a candidate ablation site, the
display 250 aids the physician in moving theelectrode 178 to the site for the purpose of transmitting ablation energy. - C. Dual Electrode Arrays
- FIG. 27 shows another embodiment of a
position sensing system 400, which locates the position of the same or equivalentoperative element 170 and associatedelectrode 178 shown and described in connection with the preceding embodiments (FIGS. 12 and 15). In this embodiment (see also FIG. 25), the locating probe comprises a three-dimensional structure 402 carrying dual outer and inner arrays ofelectrodes - As best shown in FIG. 25, the
outer electrode array 404 comprises an outer structure formed by spaced apart splineselements 408 constrained between a base 418 and ahub 416, in the same manner as thebasket structure 14 shown in FIG. 1.Spline elements 408 are carried at the distal end of acatheter tube 412 in the same way that thestructure 14 is carried by acatheter tube 45 in FIG. 2A. In FIG. 25, fourspline elements 408 are shown for the purpose of illustration. - As in the
basket structure 14, eachspline element 408 carries a number ofelectrodes 410. In FIG. 25, eachspline element 408 carries eightelectrodes 410, for a total of thirty-twoelectrodes 410, in theouter electrode array 404. Of course, theouter electrode array 404 can comprise a greater or lesser number ofspline elements 408 and/orelectrodes 410 Thehub 416 can also serve as an electrode on theouter array 404. - The
inner electrode array 406 shown in FIG. 25 comprises aninner structure 414, formed of electrically insulating material, which is supported by and within theouter electrode array 404. As shown in FIG. 25, theinner structure 414 is retained by acenter support wire 420 between thehub 416 andbase 418. - In FIG. 25, the
inner structure 414 is shown to be a cylindrical tube. However, theinner structure 414 can take other shapes and be constructed differently. - For example, as shown in FIG. 26, the
inner structure 414 can comprise anexpandable balloon 422. The proximal end of theballoon 422 extends through the base 418 into the interior of theouter electrode array 404. Asupport wire 424 extends from the distal end of theballoon 422 and is attached to thehub 416. Alumen 423 in the associatedcatheter tube 412 carries an inflation fluid into theballoon 422, to expand it at time of use. In FIG. 26, when inflated, theballoon 422 has a preformed elliptical shape. - Regardless of its shape or construction, the
inner structure 414 carries an array ofelectrodes 426, position in a spaced-apart pattern on thestructure 414. Theelectrodes 426 can comprise metallic strips of electrically conductive material (e.g., copper alloy, platinum, or stainless steel), attached in the spaced apart pattern on theinner structure 414. Alternatively, theelectrodes 426 can be coated on theinner structure 414, using conventional coating techniques or an ion beam assisted deposition (IBAD) process. Preferably, theelectrodes 410 on theouter structure 404 and theelectrodes 426 on theinner structure 406 are made of substantially equivalent materials. - The number of
electrodes 426 carried by theinner structure 414 can vary. Preferably, the number ofelectrodes 426 on theinner structure 414 should at least equal the number of electrodes 410 n theouter structure 404. - As FIG. 27 shows, the
central processing unit 28 conditions theoscillator 26 to transmit an electrical AC waveform through theelectrode 178 carried by theoperative element 170. Theindifferent electrode 32 comprises the voltage return, coupled to an electrical reference, which, in the illustrated embodiment, is isolated orpatient ground 34. The voltage field that is established varies in detected amplitude at eachelectrode electrode 178 carried by theoperative element 170. Theswitch 38 serves to couple thedata acquisition element 36 to selectedelectrodes 410 on theouter array 404 or selectedelectrodes 426 on theinner array 406, or both. - A proximity-indicating output198 (designated P(A)) is generated in the manner previously described for a given
electrode electrode electrode 178 exists. - The
electrodes 410 onouter electrode array 404 provide information for localizing the rovingoperative element 170 when it resides close to the tissue walls of the interior body region, e.g., near the endocardial wall, when thestructure 402 is deployed in a heart chamber. Theelectrodes 426 on theinner electrode array 406 provide information for localizing the rovingoperative element 170 when it resides close to the central region of the interior body region, e.g., inside a heart chamber away from the endocardial wall. Voltage amplitude sensing can be accomplished in sequence by groups ofelectrodes 410 on theouter array 404, groups ofelectrodes 426 on theinner array 406, or by groups of electrodes distributed on both the inner andouter arrays - As FIG. 28 shows, a
graphic display 428 can generate an idealizedgraphical image 430 for the dualelectrode array structure 402, in whichnodes 432 mark theelectrodes - Using the
electrodes 410 on theouter array 404, the physician can pace and sense electrical events in myocardial tissue. Generation of the proximity-indicated output 198 (as previously described with reference to the basket structure 14) switches “ON” the node 434 when the prescribed “close condition” to theroving electrode 178 exits. Coupled to the dualarray sensing structure 402, thedisplay 428 tracks the movement of theroving electrode 178 both near to and far from tissue as diagnostic and therapeutic functions proceed. - Once mapping identifies a candidate ablation site, the
display 428 aids the physician in moving theelectrode 178 to the site for the purpose of transmitting ablation energy. - The
dual array structure 402 can be used in association with theelongated electrode structure 174 or theloop structure 274, previously described. Use of thedual array structure 402 can provide improved navigational accuracy, particularly in interior body regions, away from the tissue wall. - All the previously described features of the
GUI 62 can be employed in association with thegraphical images interpolation function 88 can be used to interpolate multiple proximity-indicatedoutput 198 in the manner shown in FIGS. 8 and 24.Identification codes 94 can be used in the manners shown in FIG. 9 to uniquely identify the particular geometries and physical characteristics of theelongated structure 174, theloop structure 274, themultiple array structure 402, or an other structure deployed. Thecodes 94 can be employed to create theidealized image Markers 122 and commentwindows 124 can be generated in theimage graphical image markers 122 and commentwindows 124, can be periodically saved during mapping, and again saved at the instant of ablation, and retained in the patient-specific data base 128, as previously described. - Use of the
elongated electrode structure 174, theloop structure 274, and thedual array structure 402 has been described, during which the electrical field is transmitted by theelectrode 178 on theoperative element 170 to theindifferent electrode 32, and the electrical field is sensed by electrodes carried on thestructure structure indifferent electrode 32, for sensing by theelectrode 178 on theoperative element 170. The operative element can also carrymultiple sensing electrodes 178 to provide orientation information as well as proximity information, as previously described in connection with FIGS. 22 and 23. - Furthermore, with respect to the
dual array structure 402, the electrical field can be transmitted to theindifferent electrode 32 by groups of electrodes on theouter array 404, or groups of electrodes on theinner array 406, or groups of electrodes distributed on both the outer andinner arrays operative element 170 can be used to sense the voltage amplitude. - The foregoing GUI and implementing control programs can be implemented using the MS WINDOWS™ application and the standard controls provided by the WINDOWS™ Development Kit, along with conventional graphics software disclosed in public literature.
- Various features of the invention are set forth in the following claims.
Claims (46)
1. A system to record use of a structure deployed in operative association with heart tissue in a patient comprising
an image controller to generate an image of the structure while in use in the patient,
an input to receive data including information identifying the patient, and
an output to process the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation.
2. A system comprising
a structure, which, in use, is deployed in operative association with heart tissue in a patient, the structure carrying an operative element,
a device coupled to the operative element to condition the operative element to perform a diagnostic or therapeutic procedure involving the heart tissue while deployed in the patient,
an image controller to generate an image of the structure at least partially while the operative element performs the procedure,
an input to receive data including information identifying the patient, and
an output to process the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation.
3. A system according to claim 2
wherein the electrode structure comprises an elongated body.
4. A system according to claim 2
wherein the electrode structure comprises a loop.
5. A system according to claim 2
wherein the structure comprises a three-dimensional basket.
6. A system according to claim 2
wherein the structure comprises an outer electrode element and an inner array of electrode element located within the outer electrode element.
7. A system according to claim 1 or 2
wherein the image controller is coupled to the input to display the data in association with the image.
8. A system according to claim 1 or 2
wherein the data further includes information identifying the procedure.
9. A system according to claim 1 or 2
wherein the data includes diagnostic information.
10. A system according to claim 9
wherein the diagnostic information includes heart tissue pacing data.
11. A system according to claim 1 or 2
wherein the data includes therapeutic information.
12. A system according to claim 11
wherein the therapeutic information includes heart tissue ablation data.
13. A system according to claim 1 or 2
wherein the data includes time stamped information.
14. A system according to claim 1 or 2
wherein the data includes processing information documenting the storage, retrieval, or manipulation of the data.
15. A system according to claim 14
wherein the processing information includes a date on which data was entered into the data base record.
16. A system according to claim 14
wherein the processing information includes a date on which data was retrieved from the data base record.
17. A system according to claim 1 or 2
wherein the data includes information identifying a person other than the patient.
18. A system according to claim 1 or 2
wherein the output password-protects the data base record.
19. A system according to claim 1 or 2
wherein the image controller includes an adjustment function to alter appearance of the image in response to operator input before or after processing by the output.
20. A system according to claim 19
wherein the adjustment function alters orientation of the image before or after processing by the output.
21. A system according to claim 19
wherein the adjustment function alters shape of the image before or after processing by the output.
22. A system according to claim 19
wherein the adjustment function alters view aspects of image before or after processing by the output.
23. A system according to claim 1 or 2
wherein the image controller includes a comment function to insert annotations in the image in response to operator input before or after processing by the output.
24. A system according to claim 1 or 2
wherein the image controller includes a marker function to mark one or more regions of the image in response to operator input before or after processing by the output.
25. A system according to claim 1 or 2
wherein the image generated by the image controller comprises an idealized graphical image.
26. A system according to claim 1 or 2
wherein the image controller generates a proximity-indicating output showing the proximity of a roving element, deployed in the patient, to the structure.
27. A system according to claim 24
wherein the output processes the proximity-indicating output with the image as part of the patient-specific, data base record.
28. A system according to claim 24
wherein the image controller includes an input for establishing a proximity threshold for the proximity-indicating output.
29. A system according to claim 28
wherein the output processes the proximity threshold with the image as part of the patient-specific, data base record.
30. A system according to claim 1 or 2
wherein the image controller is adapted to be coupled to a source of ablation energy to generate an ablation-indicating annotation when ablation energy is applied to the heart tissue of the patient.
31. A system according to claim 30
wherein the output processes the ablation-indicating annotation with the image as part of the patient-specific, data base record.
32. A system according to claim 30
wherein the image controller generates an ablation-proximity output on the image showing a location where ablation energy is applied.
33. A system according to claim 30
wherein the output processes the ablation-proximity output with the image as part of the patient-specific, data base record.
34. A system according to claim 1 or 2
and further including a central station coupled to the output.
35. A system according to claim 1 or 2
and further including a printer coupled to the output.
36. A system according to claim 1 or 2
and further including a display device coupled to the output.
37. A system according to claim 1 or 2
and further including a communications port coupled to the output.
38. A system according to claim 1 or 2
wherein the image controller generates a graphical user interface that includes the image.
39. A system for diagnosing or treating cardiac conditions of multiple patients comprising
a network of local work stations, each one adapted to be coupled to an electrode structure, which, in use, is deployed in operative. association with heart tissue of a patient, the device being operative to condition the electrode structure to perform a diagnostic or therapeutic procedure involving the heart tissue, each local work station including an image controller to generate an image of the structure at least partially while the operative element performs the procedure, an input to receive data including information identifying the patient, and an output to process the image in association with the data as a patient-specific, data base record for storage, retrieval, or manipulation, and
a central terminal coupled to the output of each work station to receive the patient-specific data base records for all work stations for storage in a central patient data base.
40. A system according to claim 39
and further including a printer coupled to the central terminal.
41. A system according to claim 39
and further including a display device coupled to the central terminal.
42. A system according to claim 39
and further including a communications port coupled to the central terminal.
43. A system according to claim 39
wherein the image controller of at least one of the work stations generates a graphical user interface that includes the image.
44. A system according to claim 39
and further including a local memory unit coupled to the output of at least one work station to store a patient-specific data base record generated by the at least one work station.
45. A system according to claim 39
wherein the output of at least one work station is coupled to the central terminal using an Internet-type network.
46. A system according to claim 39
wherein the output of at least one work station is coupled to the central terminal using an intranet-type network.
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US10/016,322 US20020065465A1 (en) | 1997-09-26 | 2001-10-30 | System for recording use of structures deployed in association with heart tissue |
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Also Published As
Publication number | Publication date |
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EP1017314A1 (en) | 2000-07-12 |
US20010009976A1 (en) | 2001-07-26 |
EP1017314B1 (en) | 2004-04-21 |
ATE264655T1 (en) | 2004-05-15 |
US6221013B1 (en) | 2001-04-24 |
CA2304607A1 (en) | 1999-04-08 |
US6490468B2 (en) | 2002-12-03 |
DE69823367T2 (en) | 2005-05-04 |
DE69823367D1 (en) | 2004-05-27 |
AU9491998A (en) | 1999-04-23 |
ES2217584T3 (en) | 2004-11-01 |
US20020143250A1 (en) | 2002-10-03 |
US6565511B2 (en) | 2003-05-20 |
CA2304607C (en) | 2008-01-29 |
US6086532A (en) | 2000-07-11 |
WO1999016350A1 (en) | 1999-04-08 |
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