ES2328036T3 - MULTIFUNCTIONAL MEDICAL CATHETER. - Google Patents

Abstract

A medical catheter, comprising: a flexible elongate body (105; 412) having a proximal end (110) and a distal end (120); a plurality of separate electrodes (132-136; 424), operatively attached to the flexible body near the distal end, in which at least some of the plurality of electrodes are adapted to graphically represent a tissue, and characterized by: a plurality of detectors (140-146; 428) of tissue orientation, spaced along an outer surface of the flexible body, in which at least some of the tissue orientation detectors are disposed between at least some of the electrodes.

Description

Multifunctional medical catheter

Background of the invention

The invention relates generally to the field of medical catheters, and in particular, medical catheters multifunctional adapted to graphically orient and / or provide treatment regarding a variety of medical conditions

Doctors currently use catheters in medical procedures that are best performed by achieving a access to the interior regions of the body. For example in electrophysiological therapy, ablation is used to treat heart rhythm disturbances Such therapy can be used, for example, to treat atrial fibrillation by the formation of lesions in cardiac tissue, in positions desired to interrupt electrical paths undesirable

During these procedures, the doctor graphically represents, first, the electrical activity of the  heart of the patient, to help determine the position of any abnormality The doctor can direct a catheter to through a vein or main artery to the inner region of the Heart to be treated. An ablation element, ported in the distal end of the catheter is positioned near the tissue that has if removed by cutting. For such treatments, the ablation power supply must be controlled so very close in order to avoid the incidence of tissue damage and clot formation. In addition, ablation catheters must be accurately positioned adjacent to, and preferably in contact with, the tissue to be treated, to ensure that the lesions are located appropriately.

Doctors and professionals who perform diagnosis and therapeutic procedures, such as electrophysiological therapy, typically require an imaging system that helps them position the ablation catheter. Minitransesophageal echocardiography (mini-TEE) probes are available; however, these probes must be swallowed or inserted through the patient's throat. Such probes are poorly tolerated by patients, unless they are completely anesthetized. In addition, these probes can be quite large (i.e., 20 French in diameter), use complex transducer configurations, and may have difficulties in detecting contact with the tissue by the ablation elements. In addition, mapping, imaging and treatment often require multiple instruments or catheters, leading to complex procedures.
as well as the introduction or re-introduction of multiple catheters in the patient. Improvements are desired.

EP 0 499 941 A2 (prior art closer), describes a catheter catheter with a tubular member flexible elongation comprising separate electrodes, and markers radio-opaque provided in a cylindrical member flexible expandable. The markers are embedded between bands of stainless steel underlying plastic layers, which are also sausages

Brief summary of the invention

The invention relates to a medical catheter of according to claim 1. The present invention provides Multifunctional catheters and medical systems. In some embodiments, the catheters include guided ablation catheters by ultrasound. Catheters and systems of this invention, they will be particularly useful for positioning Accuracy of ablation catheters prior to ablation of cardiac tissue, such as that required for treatment of atrial fibrillation In addition, the functionality of any of the embodiments allow a single catheter to be used for mapping of tissue, tissue orientation, imaging of the tissue, and / or tissue treatment, including ablation. Some of the systems of the present invention use transducers at the distal end of the catheter to help the operator to determine whether or not the ablation elements are in contact with the tissue to be removed by cutting. The non-ablation catheters also fall within the scope of the present invention, providing such catheters the functions of tissue mapping, tissue orientation, and / or formation of tissue images.

In a particular embodiment, a medical catheter of the present invention includes a flexible elongated body that It has a proximal end and a distal end. A plurality of separate electrodes are operatively attached to the body flexible, near the distal end. At least some of the Electrodes are adapted to graphically represent a tissue. The catheter includes a plurality of orientation detectors of the tissue, arranged between at least some of the electrodes. From this way, the medical catheter is trained for both functions of tissue mapping and tissue orientation. In some embodiments, at least one of the electrodes is adapted to remove a desired portion of the tissue, the catheter being qualified for tissue ablation or for others treatments

In some aspects, at least one of the electrodes are adapted for mapping as well as for ablation. In some aspects, electrodes adapted for ablation have at least one tissue orientation detector adjacent to the same. That way, the detector (s) support (n) for the location of the ablation electrode with prior to ablation. For example, detectors can operate so that they determine tissue contact, to detect a distance to the tissue, to detect a three-dimensional position in relation to tissue, and the like. In some ways, at least one of the electrodes includes a tip electrode, coupled to the tip of the distal end.

Tissue orientation detectors can have a diversity of configurations within the scope of the present invention For example, in one embodiment, the detectors Tissue orientation include a plurality of transducers. In a particular embodiment, at least some of the transducers They include ultrasound transducers. Alternatively, or additionally, at least some of the transducers are electrical, magnetic, or tracking transducers electromagnetic.

The present invention further provides Examples of medical catheter systems in accordance with the present invention. In one embodiment, the system includes a medical catheter. as detailed in this description, with a controller coupled to the plurality of electrodes and detectors of tissue orientation In one aspect, the controller is adapted to control a tissue mapping function carried out by the  plurality of electrodes. In a particular aspect, the function of tissue mapping includes a tissue mapping function without Contact. In one aspect, the controller is also adapted to determine a pattern of tissue ablation based on a result of the tissue mapping function.

In another aspect, the system controller of medical catheter is adapted to receive a plurality of signals from the tissue orientation detectors, and determine a elongated body orientation in relation to tissue.

In some embodiments, the catheter system doctor also includes a scanning system, and / or a RF generator electrically coupled to the plurality of electrodes The scanning system is adapted to produce a digitized image of the tissue. These images can be based, in part, on the data received by the electrodes and / or by the detectors. The RF generator can facilitate the use of one or more electrodes to remove the tissue, or Similary.

It is possible to precisely position a medical catheter with respect to a tissue. This is done by flexible elongated body insertion in a patient, mapping a electrical profile of the tissue with the use of at least some of the electrodes, and positioning the elongated body so that it is next to the fabric with the use of the detectors of tissue orientation The positioning is based, at least on part, in the electrical profile of the tissue.

At least one of the electrodes is activated to remove a desired region of tissue if the controller determines that at least one of the tissue orientation detectors is in contact with the desired region. At least one of the electrodes is active to remove a desired region of tissue if the controller determines that one of the tissue orientation detectors, positioned adjacent to the electrode, is in contact with the region desired, if the tissue orientation detector located directly proximal to the electrode, is in contact with the tissue, and / or if the tissue orientation detectors closest to the electrode in both proximal and distal directions, are in contact With the tissue. In this way, tissue contact can be determined prior to ablation.

A desired region of tissue that is going to be treated, can be identified based on the electrical profile of the tissue. As discussed here, the mapping may include a mapping without contact to obtain, or help obtain, the electrical profile.

In another precise positioning procedure of a catheter inside a patient, the catheter is inserted in the patient Next, a patient's tissue is mapped, using at least some of the plurality of electrodes separated, to produce a tissue profile. Tissue profile it can include, for example, a map or other representation of a plurality of electrical paths of the tissue. One is identified tissue region to be treated with the use, at least in part, of the tissue profile. The elongated body is positioned using the transducers so that at least one of the electrodes are close to the tissue region. Positioning of the elongated body includes a location positioning three-dimensional The electrode (s) can (n) also be operated (s) to remove the tissue region where it is desired to provide the treatment to the patient.

The diagnosis and treatment of heart rhythm disturbances, includes the insertion of a catheter in a patient and mapping a patient's tissue, using at least some of the plurality of electrodes separated to produce a tissue profile. A profile that will be treated is identified using the tissue profile, positioning the elongated body with the use of detectors tissue orientation so that at least one of the detectors is close to the tissue that is going to be treated, and treating the tissue with the use of the catheter. Treatment may include the tissue ablation using at least one electrode. Ablation can be produced by using RF ablation, by ultrasonic ablation, or similar. An example description of acoustic ablation using transducer elements, is found described in U.S. Pat. no. 5,630,837. The experts in the matter will appreciate that other elements of ablation within the framework of the present invention.

Other features and advantages of the invention will be highlighted from the description that follows, in the that the preferred embodiment has been defined in detail together with The accompanying drawings.

Brief description of the drawings

Figure 1 represents a global view of a tissue ablation system according to an embodiment of the present invention;

Figure 2 represents the distal end of a elongated flexible body as part of a catheter system according to an embodiment of the present invention;

Figure 3 represents a side view, in cross section, of the flexible elongated body shown in the Figure 2;

Figure 4A represents an extreme view, in cross section, of the flexible body shown in Figure 3, taken along line 4A-4A;

Figure 4B represents a global view of a cylindrical transducer element as part of a catheter apparatus according to an embodiment of the present invention;

Figures 5A and 5B represent embodiments alternatives of a medical catheter apparatus according to the present invention;

Figure 6 represents a schematic of a multiplexer for use with medical catheters of the present invention;

Figures 7A-7B represent exciting and reflected signals sent to, and received by, a transducer element of the present invention;

Figure 8 represents an embodiment of a medical catheter apparatus of the present invention, in contact with the tissue;

Figure 9 is an overall view of a catheter doctor according to an alternative embodiment of the present invention;

Figure 10 is a simplified global view of a medical catheter system according to an embodiment of the present invention;

Figure 11 is a flow chart simplified a procedure to treat a tissue with steps of the invention, and

Figures 12A and 12B represent a view global simplified and a cross-sectional side view of an alternative embodiment of a catheter in accordance with the present invention.

Detailed description of the invention

Figure 1 represents a catheter apparatus 2 doctor as part of a catheter system 4 according to a embodiment of the present invention. The apparatus 2 comprises a elongated flexible body 12, which has a distal end 10 and a proximal end 14. The proximal end 14 includes a handle 16 which It contains an addressing mechanism 18. The mechanism 18 of addressing includes a routing lever 22 that operates a cam wheel (not shown) to maneuver the end 10 flexible distal, as shown by the arrows on the Figure 1. System 4 includes a connector 20 that connects to a controller 23 for the operation of an apparatus 2 as described in more detail in what follows. The controller 23 is susceptible of providing an electrical input to the apparatus 2, as need, to graphically, form images, orient and / or cut a patient's tissue by cut. The experts in the matter will appreciate that the addressing mechanism 18 can vary from that shown in Figure 1, within the scope of The present invention. Examples of addressing mechanisms are They are described in International Application no. PCT / US94 / 11748.

The medical catheter apparatus 2 represented in Figure 1 may be particularly useful in the treatment of atrial fibrillation by positioning the distal end 10 in the inside of a desired region of the heart. To enter the right atrium, the doctor can direct the elongated body 12 to through a conventional vascular introducer, through the vein femoral. To enter the left atrium, the doctor can direct elongated body 12 through a vascular regressor introducer conventional, through the aortic and mitral valves. For him treatment of atrial fibrillation, it is believed that the formation of lesions in heart muscle tissue. The catheters of the present invention can be used, in some embodiments, to remove heart tissue containing abnormal electrical paths, such as arrhythmogenic foci. Other details of the apparatus 2 have been shown in Figures 2 and 3.

Figures 2 and 3 represent a body 12 elongate having a plurality of ablation elements 24 separated, each separated by a space 26 of the adjacent ablation elements 24. Interspaced between ablation elements 24, there are a plurality of elements 28 transducers In one embodiment, ablation elements 24 and the transducer elements 28, are operatively subject to the body 12 alternatively. The apparatus 2 includes, with preference, between two (2) and about fourteen (14) elements of ablation, and between about three (3) and about fifteen (15) transducer elements More preferably, the apparatus 2 has at least one transducer element 28 more than elements 24 of ablation. In another embodiment, a sensor 30 of temperature at or near the distal end 10, and is provided a temperature sensor 32 proximal, in position proximal to the 24 ablation elements. Temperature sensors 30 and 32 preferably comprise thermocouples. The sensors 30 and 32 of temperature may also comprise thermistors and the like within the framework of the present invention. Sensors temperature, or thermocouples 30 and 32, operate in order to detect the temperature in the ablation region. A plurality of insulators 40 have been provided between the 28 transducer elements and the 24 ablation elements. The insulators 40 may comprise polyimide, polyesters, teflon or similar, to isolate the elements 28 transducers of ablation elements 24.

In one embodiment, the elements 28 transducers comprise cylindrical transducer elements according to It is best shown in Figures 4A-4B. The Transducer elements 28 include an external face 46 and a face 48 internal. The internal faces 48 of the transducer elements 28 are positioned such that a longitudinal axis 38 of the body 12 passes through a hole 44 through each element 28 transducer That way, the transducer elements 28 are configured so that they expose the faces 46 external to the fabric and to the surrounding fluid inside the patient. In this way, the transducer elements 28 can operate to form images within a plane of three hundred and sixty degrees (360º) which is perpendicular in general to the longitudinal axis 38 without the need for rotate body 12 or transducers 28. Experts in the matter will appreciate that other forms of transducers can be used within the framework of the present invention. For example, the transducer elements 28 may comprise transducer elements rectangular or elliptical, operatively attached to end 10 distal

The transducer elements 28 may comprise ultrasound transducers. In this embodiment, elements 28 transducers can comprise materials piezo-compounds, piezo-ceramics (such as PZT), piezo-plastics, and the like. Alternatively, as detailed better in the following, the transducer elements 28 may be adapted to transduce between a magnetic field and a tension. They can also be used Other types of transducers within the framework of this invention, including, without limitation, electrical, magnetic, electromagnetic, permanent magnet, wireless, optical, and Similar.

In the embodiment shown in Figure 3, the transducers 28 comprise elements 28 transducers of ultrasound Each of the transducers 28 may include a pairing layer 42, or multiple pairing layers 42, operatively attached to the outer face 46 of each element 28 transducer The pairing layers 42 operate to improve the performance of the transducer element 28. The elements 28 transducers can also operate without pairing layers 42 within the framework of the present invention.

The transducer elements 28 have a outer diameter 29. The outer diameter 29 may be smaller than the external diameter 31 of the elongated body 12 flexible or, so alternative, approximately equal to diameter 31. Preferably, the diameter 31 of the body 12 is less than eight (8) French, for allow the introduction of apparatus 2 into the tortuous vasculature of the patient.

The space 26 separates ablation elements 24 adjacent. The space 26 preferably has between approximately 1.5 mm and approximately 3.0 mm wide. He space 26, however, can be larger or larger in size small, and does not need to be of uniform size between every two adjacent ablation elements 24. Similarly, each space 26 does not need to contain a transducer element 28, and the space 26 may contain more than one transducer element 28 within the frame of the present invention. However, preferably, at least some spaces 26 contain elements 28 transducers, and in some embodiments, each space 26 between elements 24 of Ablation contains at least one transducer element 28.

The elongated body 12 preferably includes a Lumen 39 of work through which longitudinal axis 38 passes. As best shown in Figure 4A, the pairing layer 42 extends around the exit surface of element 28 transducer The pairing layer 42 has been fastened operatively to the transducer element 28, using epoxy or Similary. The transducer element 28 may be operatively subject to elongated body 12 in a variety of ways, including epoxy. The use of lumen 39 has been best shown in Figures 5A and 5B, which represent two embodiments Apparatus alternatives 2 of the present invention.

Figure 5A represents the catheter apparatus doctor shown in Figure 3 without pairing layers 42. As can be seen in Figure 5A, a plurality of cables 50 they are operatively linked to thermocouples 30 and 32, to transducer elements 28, and ablation elements 24. For one embodiment having electrodes for ablation elements 24, Each electrode has a single 50 cable. Each of the thermocouples 30 and 32 has a pair of cables 50. The elements 28 transducers they have a cable 50 in electrical communication with the face 46 external In addition, a land 52 extends from the inner face 48 of transducer 28. As shown in Figure 5A, it can be use a common ground for all 28 transducer elements within a particular device. An advantage of using a land 52 is that fewer cables or wires are passed 50 from the distal end 10, through lumen 39, to the controller 23.

The embodiment shown in Figure 5B represents the use of a multiplexer 54 operatively linked to the distal end 10 of elongated body 12 flexible. The multiplexer 54 is preferably arranged proximal to the elements 24 ablation and 28 transducer elements. The multiplexer 54 allows the clamping of the cables 50 from the elements 28 transducers up to multiplexer 54 without extending these cables 50 to the controller 23. Such a configuration can reduce the number of threads that need to be extended through the lumen 39 to controller 23.

The operation of multiplexer 54 is described. better in conjunction with Figure 6. Figure 6 represents 28 transducer elements, each of which has a ground 52 and a cable 50. The cables 50 are operatively connected to the multiplexer 54, preferably on the distal side of the multiplexer 54. Multiplexer 54 has a ground 62 and a line 60 of transmission to provide power to the multiplexer circuit 54. The transmission and reception lines 56 provide a means to transmit electrical signals to multiplexer 54. The multiplexer 54 then directs electrical signals up to the appropriate transducer (s) 28. The 56 transmit / receive wires carry excitation signals of transducer 28 as a differential pulse in serial format, from controller 23 to multiplexer 54. In the multiplexer 54, each excitation signal is routed to an appropriate one of the 28 transducer elements, in order to execute a sequence of excitation used by controller 23. Similarly, the return inputs or echoes, received by the element (s) 28 transducer (s), are transferred to the multiplexer 54, and return to controller 23 along lines 56 of transmission / reception.

Minimizing the number of cables required to carry the excitation signals from the controller 23 to each of the transducer elements 28, the elongated body diameter 12, and more specifically the size of the lumen 39, can be reduced. Alternatively or additionally, the number of elements 28 transducers can be increased in the distal end 10 without requiring cables to extend through lumen 39 to controller 23.

The multiplexer 54 may also include a line 58 clock extending from controller 23 to the multiplexer 54. Clock line 58 helps multiplexer 54 to determine which transducer element 28 will receive a signal from excitement. Alternatively, as shown in Figure 6, a clock line 58 operates by counting the number of excitation signals transmitted through transmission / reception lines 56, and increasing a counter in multiplexer 54, to coordinate the transfer of excitation signals to transducer 28 appropriate. In one embodiment, multiplexer 54 also includes a data line (not shown in Figure 6), which extends from controller 23 to multiplexer 54. This line of data allows controller 23 to control the operation of the multiplexer 54.

Returning now to Figures 7 and 8, it is going to describe the operation of the medical catheter apparatus 2 and the system 4 according to an embodiment of the present invention. The medical catheter apparatus 2 operates by having elements 28 transducers that detect the proximity of a tissue 70 with with respect to the distal end 10 of the elongated body 12. He controller 23 calculates the time delay between the excitation of the transducer element 28 and the reception of a reflected signal 66 from the surrounding tissue 70, to determine the distance between transducer element 28 and tissue 70, as best described in what follows.

As shown by Figures 7A and 7B, an excitation signal 64 is transmitted from the controller 23 to the transducer elements 28, or to the multiplexer 54 for its transmission to the 28 transducer elements. Signal 64 of excitation is converted by transducer 28 into a signal of ultrasound that spreads out, towards the fluid and the surrounding tissues inside the patient. The elements 28 transducers detect reflected signals 66, and transfer electrical representations of these signals to the controller 23 for processing

Controller 23 uses the time delay between the excitation 64 and the reception of the signal 66 reflected for Calculate the approximate distance to the reflective object. He controller 23 is able to differentiate between reflections blood vessels of low amplitude and reflections 66 major tissue amplitude, as shown in Figure 7. Controller 23 it also differentiates a randomized return dispersion versus a more stable tissue dispersion. The distance from each transducer 28 to tissue 70, can be calculated by knowing the speed of sound and measuring the response of time at larger tissue reflections. If the signal consists totally in waveforms of greater amplitude, a intimate contact While transducers 28 have inherently a blind zone / a period of time in which signals cannot be measured, the distance from the blind zone The result is quite small. For example, for a transducer of 30 MHz, the distance is approximately 0.15 mm. Hence the 66 signal reflected, measured almost immediately after excitation 64 occurs, it results in the distance from transducer 28 to tissue 70 is less than the blind distance of approximately 0.15 mm.

The medical catheter system 4, therefore, it can be operated by inserting the device 2 into the patient, and positioning the distal end 10 of the apparatus 2 near a Desired position of the patient's anatomy. The elements 28 transducers are energized with the excitation signal 64, and the 66 reflected signals are received and processed by the controller 23. Controller 23 determines whether elements 28 transducers are or are not in contact with tissue 70. If at least a transducer element 28 is in contact with the tissue, can ablation occur using an adjacent ablation element 24. Preferably, as shown in Figure 8, it can be desirable to have more than one transducer element 28 in contact with the fabric 70.

The controller 23 can be operated according to a diversity of ways to determine the number and positioning of elements 28 transducers that may be in contact with the fabric 70. For example, as shown in Figure 8, the Elements 28A, 28B and 28C transducers could indicate that they are in contact with tissue 70. This may allow the doctor removes tissue 70 using electrode 24A and the 24B electrode The transducer element 28D may not indicate tissue contact 70. Therefore, it is inconclusive that the ablation element 24C is in contact with tissue 70. Hence that, the doctor may choose not to perform the removal with the 24C ablation element.

In one embodiment, controller 23 may use a green and red light system to indicate when they are the transducer elements 28 in contact with the tissue 70. In a particular embodiment, for example, controller 23 has a red light and one green light for each element 28A-28D transducer depicted in Figure 8. The green light could be illuminated by controller 23 when transducer element 28 corresponding be in contact with tissue 70. Red light could be illuminated for those 28 transducer elements that They are not in contact with the tissue.

Alternatively, a single one could be used green and red light for device 2, so the green light is illuminated by controller 23 only when all 28 transducer elements are in contact with the tissue. Still another embodiment includes several elements 28 transducers corresponding to a single set of green / red light. By For example, elements 28A and 28B may have a green light than the controller 23 illuminates it when both elements 28A and 28B are in tissue contact The red light corresponding to the elements 28A and 28B would be illuminated if one or both elements 28A and 28B Transducers are not in contact with tissue 70. Experts in the matter they will appreciate that there are numerous forms within the framework of the present invention for the controller 23 to indicate when contact with tissue 70 has been achieved by the 28 transducer elements, including audible tones and Similar.

The ablation elements 24 are used preferably for mono-polar ablation, although the bi-polar ablation is also contemplated within of the framework of the present invention. The ablation elements 24 They comprise electrodes, preferably. This way, you can RF ablation occurs using ablation elements 24. Alternatively, the ablation elements 24 may comprise ultrasonic ablation transducers. In this way, the 28 transducer elements are operated in pulse mode to determine its distance from the fabric 70. After contact with the tissue, ablation transducers 24 could be used to remove tissue 70. The use of transducers for ablation acoustics is further described in U.S. Pat. no. 5,630,837.

Alternatively, the transducer elements 28 they can be used both for imaging and for tissue removal 70. Elements 28 transducers could be operated first in pulse mode, to determine if the transducer elements 28 are in contact with tissue 70. The transducer elements 28 could receive then a continuous or continuous wave electrical signal of rectangular pulses, having a frequency of approximately 10-15 MHz, and the 28 transducer elements can remove tissue 70 using ultrasonic ablation.

Returning now to Figures 9 and 10, it is going to describe an alternative embodiment of a medical catheter 100, and of a medical catheter system 200 according to the present invention. The medical catheter 100 includes an elongated body 105 that It has a proximal end 110 and a distal end 120. The extreme 110 proximal is coupled to an addressing device 210 as shown in Figure 10. The device 210 of addressing may, although not necessarily, be similar to that has been described in conjunction with Figure 1. The length of the Catheter 100 may vary within the scope of the present invention. In one embodiment, the length of catheter 100 is sufficient to allow its insertion into the femoral vein of the leg of a patient, and go through the patient's vasculature until reach the heart muscle or other region to be treated. The distal end 120, as best shown in Figure 9, includes a plurality of elements coupled to, or disposed of another mode in it, for tissue mapping, detection of tissue orientation, tissue imaging, tissue treatment, and the like. In the embodiment shown in the Figure 9, the distal end 120 includes a tip electrode 130, disposed at or near the distal tip of catheter 100. In a embodiment, the tip electrode 130 provides an example of electrode for ablation treatment as described previously.

Catheter 100 includes a plurality of electrodes 132, 134 and 136 separated, coupled to end 120 distal In one embodiment, electrodes 132-136 They comprise ring electrodes. In a particular embodiment, the ring electrodes 134 and 136 operate as a pair of electrodes for a tissue mapping function. In addition, electrodes 130 and 132 They can operate as a pair of electrodes for a mapping function of the tissue. Catheter 100 further includes a plurality of 140, 142, 144 and 146 tissue orientation detectors, separated along the body 105 elongated. As shown in Figure 9, the tissue orientation detector 140 is in relation to proximity to tip electrode 130. Similarly, the detector 146 is arranged proximal to the remaining end elements 120 distal, and can be used to guide or detect 120 distal end position.

The distal end 120 further includes a plurality of insulators 150. Insulators 150 are adapted to isolate electrodes 130-136 from each other, and / or to isolate detectors 140-146 from each other, and / or to isolate detectors 140-146 from electrodes 130-136. In a particular embodiment, each electrode 130-136 has at least one detector 140-146 arranged adjacent to it, possibly with an insulator 150 interposed between them. For example, him tip electrode 130 has the detector 140 located proximal to the same. The electrode 132 has the detector 140 located distal to the same, and the detector 142 located proximal thereto. While electrodes 134 and 136 are separated from each other by means of a insulator 150 only, each electrode 134 and 136 has a detector 142 and 144 adjacent, respectively. In this way, the detectors 140-146 and electrodes 130-136 can be used according to a diversity of procedures, as described herein further. The experts in the matter they will appreciate that the orientation and order of the various detectors 140-146, electrodes 130-136 and 150 insulators, may vary within framework of the present invention.

In one embodiment, the detectors 140-146 tissue orientation include transducers 140-146 transducers can be adapted to transduce between a variety of parameters physicists For example, in one embodiment, at least some 140-146 transducers are adapted to transduce between ultrasonic energy and a voltage. This can occur, for example, when one or more detectors 140-146 comprise ultrasound transducers that are adapted to transmit a wave of energy from ultrasound when a voltage is applied across the opposite surfaces of detector 140-146. The wave Ultrasonic travels to a 170 fabric, and is reflected by the tissue 170. The reflected wave is received by the detector 140-146, and is converted into voltage by the detector 140-146. The voltage is transmitted up to controller 230, as shown in Figure 10. Of this way, detectors 140-146 transduce between ultrasonic energy and tension. Alternatively, the detectors 140-146 may be adapted to transduce between a tension and a magnetic field. For example, you can arrange a magnetic or electromagnetic field generator in the vicinity of the patient. In one embodiment, the catheter carries one or more transducers that detect the magnetic or electromagnetic field and They make it a tension. The voltage is fed to then to controller 230 for orientation purposes of detection. Alternatively, other types of transducers, including electrical transducers, magnets permanent, optical transducers, and the like.

The medical catheter 100 is adapted to perform one or more functions, and can be adapted to form tissue images, graph the tissue, help your self-orientation with respect to the tissue, try the tissue, and the like. For example, catheter 100 may be adapted to graphically represent a patient's tissue, such as heart tissue. This may occur from a number of forms within the scope of the present invention. For example, 140-146 tissue orientation detectors can be used by inserting catheter 100 into the vasculature of the patient and transferring the distal end 120 to a region desired of the patient. Catheter 100 can be used to continued together with one or more reference catheters for perform a three-dimensional localization process that helps graphically represent the general shape of the patient's tissue, such as the heart muscle. The details of a process three-dimensional location are best described in the U.S. Patent no. 6,490,474, entitled "System and Procedure for Positioning Electrodes Using Ultrasound. "

In an alternative embodiment, catheter 100 It is used to graphically represent the electrical activity of the fabric 170. For example, in one embodiment, catheter 100 is inserted into a desired region of the patient, and positioned itself in such so that one or more electrodes 130-136 are in contact with tissue 170. They can then be carried out tissue mapping procedures, to graphically represent the electrical activity of the heart muscle. Such mapping techniques by electrode are best described in U.S. Pat. no. 5,598,848, entitled "Systems and Procedures for Positioning of Multiple Electrode Structures in Contact Electrical with the Myocardium "; U.S. Patent No. 5,487,391, entitled "Systems and Procedures to Derive and Present the Speeds of Propagation of Electrical Events in the Heart "; and U.S. Patent no. 6,516-807, titled "System and Procedures for Positioning and Guiding Elements Operational within Internal Body Regions ".

While the references mentioned in the above discuss the use of a basket-type catheter to put electrodes in contact with the heart tissue to be mapped, the present invention can be adapted to ensure the tissue contact prior to mapping. For example, it they can use the techniques discussed in conjunction with the Figures 1-8, including the time delay of ultrasound signals transmitted by and received subsequently by detectors 140-146, to verify contact with tissue.

In an alternative embodiment, catheter 100 maps the electrical activity of tissue 170 using a technique Contactless mapping. Contactless mapping uses electrodes 130-136 to detect electrical activity in the inside the fabric 170 although there may be a space 160 between electrode (s) 130-136 and tissue 170. These far-field signals, received by the electrodes 130-136, are mapped on the tissue surface 170 using an algorithm that has in counts the relationship between the distal end 120 and the tissue 170, and the general orientation of catheter 100 with respect to tissue 170. In this way, the electrically active fabric 170 is mapped. Additional details on tissue mapping, including mapping without contact, can be found in U.S. Pat. no. 6,240,307, entitled "Endocardiac Mapping System".

The data received or generated by the detectors 140-146, and / or by electrodes 130-136, can optionally be transmitted to controller 230 via coupling of catheter 100 to the controller 230 using a cable 220 or other electrically conductive means. In one embodiment, controller 230 comprises a microprocessor. coupled to a computer readable storage medium, which have software or other programs adapted to carry perform a variety of procedures. The controller 230 can include an input device 250 for receiving a disk compact, a DVD or similar, containing reference data, algorithms or related processing software, or similar. In a particular embodiment, controller 230 further includes a light matrix 240 which is adapted to visually indicate the operator or doctor, when one or more detectors is found 140-146 in contact with tissue 170. As has been described above, the light matrix 240 may comprise a green / red light system, and / or may include some other indicator visual or audio In one embodiment, controller 230 includes a digitizer that is adapted to digitize the data received from catheter 100 and present an image of tissue 170 on a monitor 270. The controller 230 can be coupled to the monitor 270 using a 260 or similar cable. Alternatively, it can use wireless connections to couple the controller 230 with display 270 and / or to couple controller 230 with the catheter 100.

Turning now to Figure 11, an embodiment of a method 300 of precise positioning of the catheter 100 will be described. The method 300 includes inserting the catheter 100 into a patient (block 310). As described above, this can occur, for example, by insertion of catheter 100 through the patient's femoral vein. Catheter 100 is then used to graph the tissue (block 320). The tissue mapping 170 may include three-dimensional localization techniques, and / or the mapping of the electrical activity inside the tissue 170, both as described above. The method 300 further includes identifying a region of the tissue to be treated (block 330). This may occur, for example, by presenting an image of tissue 170 on a display 270, so that it is seen by a doctor or by another operator of the
200 system.

Procedure 300 also includes the elongated body positioning 105 (block 340). This can include the various procedures as described in the above, and may include the use of detectors 140-146 to orient the catheter 100 inside of the desired region of the patient. For example, the detectors 140-146 can be used to determine in general that the distal end 120 is in the appropriate region of the patient. In addition, the positioning of catheter 100 may include the use of one or more detectors 140-146 to determine that tissue 170 has been contacted. In other embodiment, electrodes 130-136 are used to facilitate the orientation of catheter 100. This may occur, for example, by receiving electrical signals from the heart, and the comparison of electrical signals with a previously generated map of electrical signals from the tissue 170, as received as a result of tissue mapping in the block 320. The comparison can help determine the orientation of catheter 100 relative to tissue 170.

Once catheter 100 has been positioned precisely, or in case contactless techniques are used once the cardiac map has been obtained, the doctor or the operator of system 200 can optionally treat fabric 170 (block 350). As discussed above, a treatment of that type includes ablation of tissue 170, or a portion of tissue 170, as may be desired to treat atrial fibrillation. The aspects of treatment of the procedure 300 may further include the supply of medications or other therapy to tissue 170 in time of ablation. Those skilled in the art will appreciate that while procedure 300 has been represented and described in mode that includes a series of processes, procedures identified in Figure 11 can occur in an order different from what has been shown. For example, the doctor may have already identified a region of the tissue to be treated. In this case, block 330 can be removed from procedure 300. In addition, the positioning of the elongated body in block 340 may occur prior to tissue mapping and / or after of tissue treatment.

An alternative embodiment of a medical catheter in accordance with the present invention will be described together with Figures 12A and 12B. As shown, the catheter includes an elongated body 412 having a working lumen 439 and a longitudinal axis 438. A plurality of separate electrodes 424 have been arranged in the body 412. Interspaced between the electrodes 424, there is a plurality of detectors 428 of tissue orientation. In one embodiment, the tissue orientation detectors 428 include transducer elements 428. For embodiments in which the orientation detectors 428 comprise transducers, and in particular ultrasound transducers, the detectors 428 may include one or more pairing layers 442 operatively attached to the outer face 446 of at least some of the detectors 428. The layers 442 pairing operate so as to improve the behavior of transducer 428. Detectors 428 can also operate without pairing layers 442 within the framework of the present invention. Furthermore, although they have been shown coupled to the elongated body 412 in an alternative manner, the arrangement of electrodes 424 and detectors 428 may vary within the scope of the present.
invention.

The detectors 428 have an external diameter that may be less than an external diameter 431 of the flexible elongated body 412 or, alternatively, approximately equal to the diameter 431. Preferably, the diameter 431 of the body 412 is less than approximately eight (8) French, to allow the introduction of the medical catheter into the tortuous vasculature of the patient. A plurality of spaces 426 separate electrodes 424 and detectors 428 from each other and / or each other. Each space 426 does not have to contain a detector 428, and the spaces 426 may contain more than one detector within the framework of the present invention. A plurality of insulators 440 are disposed between at least some of the orientation detectors 428 and / or electrodes 424. The insulators 440 may comprise polyimide, polyesters, Teflon or the like, to isolate detectors 428 and / or electrodes 424
contiguous

In one embodiment, a sensor has been arranged 430 temperature at or near the distal end of the body 412, and a proximal temperature sensor 432 has been arranged in the proximity of electrodes 424. Sensors 430 and 432 of temperature may comprise thermocouples, thermistors or the like within the framework of the present invention. In one embodiment alternatively, the temperature sensor 432 is replaced by a tip electrode In this way, you can use the tip 412 elongated body distal for mapping procedures and / or ablation.

In one embodiment, electrodes 424 are adapted for a tissue mapping function. In one embodiment in particular, electrodes 424 are adapted for a single tissue mapping function, and can be sized in consequence. For example, electrodes 424 may comprise ring electrodes In such an embodiment, the electrodes 424 may have an external surface 436 at discovered, smaller than similar ablation electrodes. In a particular embodiment, electrodes 424 further include an internal surface 434, which facilitates electrical coupling with a controller when having a cable or cables (not shown) that extend through lumen 439. In this way, the catheter of Figures 12A and 12B is adapted for mapping functions of tissue and tissue orientation, and optionally, for tissue ablation. Tissue imaging may be also included.

The invention has now been described in detail. However, it will be appreciated that some changes can be made and modifications. For example, while Figures 2, 3, 5 and 8 represent elements 28 interspaced transducers among all ablation elements 24, transducers 28 may exist only between some of the ablation elements 24 and in some spaces 26. Therefore, the scope and content of This invention is not limited by the foregoing description. On the contrary, the scope and content are defined by the claims that follow.

Claims (16)

1. A medical catheter, comprising: a flexible elongated body (105; 412) having a proximal end (110) and a distal end (120); a plurality of electrodes (132-136; 424) separated, operatively subject to flexible body near the distal end, in which at least some of the plurality of electrodes are adapted to graphically represent a fabric, and characterized by: a plurality of detectors (140-146; 428) tissue orientation, spaced along an external surface of the flexible body, in which at least some of the tissue orientation detectors are arranged between at least some of the electrodes. 2. The medical catheter according to claim 1, in which at least one of the plurality of electrodes (132-136; 424) is adapted for the ablation of a desired portion of tissue. 3. The medical catheter according to claim 2, in which each of the electrodes adapted for ablation, has at least one detector (140-146; 428) of tissue orientation, adjacent to it. 4. The medical catheter according to claim 1, in which at least one of the plurality of electrodes (132-136; 424) is adapted both to represent graphically the tissue as for tissue ablation. 5. The medical catheter according to claim 1, wherein at least one of the plurality of electrodes comprises a tip electrode (130), coupled to the tip of the end distal 6. The medical catheter according to claim 1, in which the detectors (140-146; 428) of tissue orientation comprise a plurality of transducers 7. The medical catheter according to claim 6, in which at least some of the plurality of transducers comprise at least one electric ultrasonic transducer, magnetic or electromagnetic. 8. The medical catheter according to claim 1, in which the detectors (140-146; 428) of tissue orientation are adapted to detect a position three-dimensional in relation to tissue and / or to detect a tissue distance 9. The medical catheter system, which comprises a medical catheter as claimed in claim 1, and which includes a controller (200) coupled to the plurality of electrodes (132-136; 424) and coupled to the plurality of orientation detectors (140-146; 428) tissue. 10. The medical catheter system according to the claim 9, wherein at least one of the plurality of electrodes (132-136; 424) is adapted for the ablation of a desired portion of the tissue, and in which the controller (230) is adapted for tissue ablation. 11. The medical catheter system according to claim 9, wherein the graphical representation of the tissue it comprises a function of graphical representation of the tissue without Contact. 12. The medical catheter system according to claim 9, wherein the controller (230) is adapted to control a function of graphical representation of the tissue taken to out by the plurality of electrodes (132-136; 424). 13. The medical catheter system according to the claim 12, wherein the controller (230) is further adapted to determine a pattern of tissue ablation based on a result of the function of graphical representation of the tissue. 14. The medical catheter system according to claim 9, wherein the controller (230) is adapted to receive a plurality of signals from the detectors (140-146; 428) of tissue orientation, and for determine an orientation of the elongated body in relation to the tissue. 15. The medical catheter system according to claim 9, further comprising a coupled RF generator electrically to the plurality of electrodes. 16. The medical catheter system according to the claim 9, further comprising a scanning system,  the scanning system being adapted to produce a digitized image of the tissue.