Abstract:
An ultrasonic finger probe including: a body having an ultrasonic transducer disposed therein, the ultrasonic transducer being operatively connected to an ultrasonic generator; and a securing device for securing the body to one or more fingers of an operator.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The present invention relates generally to ultrasonic medical instrumentation, and more particularly, to an ultrasonic probe for attachment to one or more fingers of a person.  
           [0003]    2. Prior Art  
           [0004]    Ultrasonic instruments are well known in the medical arts. Such instrumentation may be used to make lesions in tissue, but are also used to cut and coagulate tissue and blood, respectively. Typically, ultrasonic instrumentation have an ultrasonic transducer at a working end of the instrument, which is typically separated from a handle or other manipulation means by an elongated shaft.  
           [0005]    In certain medical procedures, such as a MAZE procedure, lesions are made on the heart in a specific pattern. Often, the lesions are to be made on tissue that is hard to reach with conventional instrumentation or where visibility is poor. Thus, there is a need in the medical arts for a device and methods for easily manipulating the ultrasonic transducer, for accessing hard to reach areas, and which increase the visibility of surgical sites.  
         SUMMARY OF THE INVENTION  
         [0006]    Therefore it is an object of the present invention to provide ultrasonic devices and methods that overcome the disadvantages of conventional ultrasonic instrumentation and methods known in the art.  
           [0007]    Accordingly, an ultrasonic finger probe is provided. The ultrasonic finger probe comprises: a body having an ultrasonic transducer disposed therein, the ultrasonic transducer being operatively connected to an ultrasonic generator; and securing means for securing the body to one or more fingers of an operator.  
           [0008]    The ultrasonic generator can be remote from the ultrasonic transducer and operatively connected thereto by wiring. The body can have a surface configured for creating lesions in tissue. Furthermore, the body of the ultrasonic transducer can be an elongated bar and can have a length sufficient to span the joints of the one or more fingers to which it is secured.  
           [0009]    The securing means can comprise one or more elastic loops fastened to the body and configured for securing one of the one or more fingers to the body, the one or more elastic loops being fabricated from an elastic material. The elastic material can be selected from a group consisting of an elastomer, a fabric, and a composite elastic/fabric. The one or more elastic loops can comprise two elastic loops and the one or more fingers can comprise one finger.  
           [0010]    The securing means can also comprise one or more loops, each of the loops having two free ends, one of the free ends having a hook material and the other of the free ends having a loop material, the free ends being wrapped around the one or more fingers and the hook material being secured to the loop material. The one or more loops can comprise two loops and the one or more fingers can comprise one finger.  
           [0011]    Also provided is a method for applying ultrasound energy to tissue. The method comprising: providing an ultrasonic finger probe having a body with an ultrasonic transducer disposed therein, the body having a surface for applying ultrasonic energy to tissue; securing the ultrasonic finger probe to one or more fingers of an operator; applying the surface of the ultrasonic finger probe to the tissue; and generating ultrasonic energy and supplying the same to the ultrasonic transducer.  
           [0012]    The applying can comprise applying the ultrasonic finger probe on a surface of the heart. The generating can comprise generating ultrasonic energy and supplying the same to the ultrasonic transducer in an amount sufficient to create lesions at least on the surface of the heart.  
           [0013]    The method can further comprise repeating the applying and generating steps to create a plurality of lesions by manipulating the ultrasonic finger probe with the at least one finger secured thereto. The manipulating can comprise joining the plurality of lesions to form a single long lesion.  
           [0014]    The method can further comprise stabilizing the heart with fingers of a same hand other than the one or more fingers secured to the ultrasonic finger probe.  
           [0015]    Still yet provided is an ultrasonic finger probe. The ultrasonic finger probe comprising: an ultrasonic transducer operatively connected to an ultrasonic generator; and securing means for securing the ultrasonic transducer to one or more fingers of an operator. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where:  
         [0017]    [0017]FIG. 1 illustrates an isometric view of an ultrasonic finger probe according to an embodiment of the present invention.  
         [0018]    [0018]FIG. 2 illustrates the ultrasonic finger probe of FIG. 1 being applied to a surface of the heart and having fingers other then the one(s) secured to the body of the ultrasonic finger probe used to support the heart.  
         [0019]    [0019]FIG. 3 a  illustrates a sectional view of a first variation of a securing means as taken along line  3 - 3  of FIG. 1.  
         [0020]    [0020]FIG. 3 b  illustrates a sectional view of a second variation of a securing means as taken along line  3 - 3  of FIG. 1.  
         [0021]    [0021]FIGS. 4 a  and  4   b  are schematic diagrams of the atria portion of the heart illustrating a pattern of transmural lesions to create a predetermined conduction path in the atrium formed thereon by the ultrasonic finger probe of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0022]    Although this invention is applicable to numerous and various types of ultrasonic transducers and instrumentation, it has been found particularly useful in the environment of creating lesions, particularly for a MAZE procedure. Therefore, without limiting the applicability of the invention to ultrasonic devices configured for making lesions or the use thereof in MAZE procedures, the invention will be described in such environment. Those skilled in the art will appreciate that the ultrasonic devices of the present invention are also useful in other ways known in the art, such as cutting and coagulation of tissue and blood, respectively, and even imaging of tissue and other anatomy.  
         [0023]    Referring now to FIGS. 1, 3 a,  and  3   b,  an ultrasonic finger probe is provided, the finger probe being referred to generally by reference numeral  100 . The ultrasonic finger probe  100  has a body  102  which has an ultrasonic transducer  104  disposed therein or thereon (collectively referred to as disposed therein). The ultrasonic transducer  104  is operatively connected to an ultrasonic generator  106 . The ultrasonic generator  106  can be integral with the finger probe  100  such as being housed in the body  102  or remotely connected to the ultrasonic transducer  104  by means of wiring  106   a  or the like. Where the finger probe  100  is used for imaging, the wiring  106   a  may also return signals to a processor and/or display for display or processing of the ultrasonic imaging corresponding to the signal. The finger probe  100  further has securing means for securing the body  102  to one or more fingers  108  of an operator. Although the finger probe  100  is preferably secured to a single finger  108 , those skilled in the art will appreciate that the finger probe  100  can be secured to more than one finger.  
         [0024]    The body  102  can have a surface  102   a  particularly configured for the intended purpose of the finger probe  100 , such as for creating lesions in tissue. Thus, the body  102  can be an elongated bar as shown in FIG. 1 with a length sufficient to span the joints  110  of the one or more fingers  108  to which it is secured. The elongated bar  102  and/or the surface  102   a  can be linear, curved or have linear and curved portions along the length of the body  102 . Those skilled in the art will appreciate that different procedures will call for different shaped surfaces  102   a  to improve the efficacy of the procedure. The body  102  can be fabricated from any materials known in the art for use with ultrasonic transducers, such as thermoplastics or metals.  
         [0025]    The securing means can comprise one or more elastic loops  112  as shown in FIG. 3 a.  Preferably, two such loops  112  are utilized. Each of the elastic loops  112  are fastened to the body  102  and configured for securing the one or more fingers  108  to the body  102 . However, the one or more elastic loops  112  do not have to be fastened to the body  102  and could merely be disposed around both the one or more fingers  108  and the body  102 . If the finger probe  100  is secured to more than one finger  108 , one or more elastic loops  112  can secure each finger  108  to the body  102  or all of the fingers  108  that are secured to the body  102  can share common elastic loops  112 . The elastic loops  112  can be fabricated from any resilient material, such as an elastic material. The elastic material can be an elastomer, a fabric, or a composite elastic/fabric. The elastic loops  112  are preferably sized smaller than a typically sized finger and stretch to accommodate the one or more fingers  108  therein. The finger probe  100  can be alternatively connected to one or more fingers of a surgical glove. In yet another alternative, the finger probe  100  can be secured to the one or more fingers  108  by attachment to a glove which itself is secured around the wrist, arm, or hand.  
         [0026]    The securing means can alternatively comprise one or more loops  114 , as shown in FIG. 3 b.  Each of the loops  114  has two free ends  116 ,  118 . One of the free ends ( 118  in FIG. 3 b ) has a hook material  120  and the other of the free ends ( 116  in FIG. 3 b ) has a loop material  122 . The hook and loop materials  120 ,  122  are typically referred to by the trade name Velcro®. At least one of the free ends  116 ,  118  are wrapped around the one or more fingers  108  and the hook material  120  is secured to the loop material  122 .  
         [0027]    The body  102  and/or ultrasonic transducer  104  can be configured in any way known in the art for creating lesions, cutting tissue, and/or imaging of tissue, such as that disclosed in co-pending U.S. application Ser. No. 10/______, (attorney Docket No. 16334), entitled System For Creating Linear Lesions for the Treatment of Atrial Fibrillation, the entire contents of which is incorporated herein by its reference. For example, the ultrasonic transducer can have an ultrasonic crystal  123  housed in a cavity  124  in the body  102  and convexly curved as shown in FIGS. 3 a  and  3   b  such that the resulting ultrasonic energy is focused along a straight or curved line along the length of the ultrasonic crystal  123  to create a lesion. The cavity  124  can be covered with an acoustic window  126  fabricated from a suitable material. The ultrasonic crystal  123  may also have an impedance matching coating (not shown) on the side of the ultrasonic crystal  123  that faces the acoustic window  126 . The ultrasonic transducer  104  can further provide for circulation of a cooling medium, such as a fluid, through the cavity  124  and/or through one or more conduits  128  provided in the body  102 . A cooling medium, for example, water or saline, may be re-circulated through the conduits  128  or through other openings (not shown) in the body  102 . The ultrasonic crystal  123  can also be positioned in the cavity  124  such that an air gap exists between a back surface  123   a  of the ultrasonic crystal and a front surface  124   a  of the cavity  124 . The configuration of the ultrasonic transducer  104  is given by way of example only and not to limit the spirit or scope of the present invention. Those skilled in the art will appreciate that the ultrasonic transducer  104  can be configured in any manner known in the art for producing ultrasonic energy for its intended purpose, whether it be creating lesions in tissue, cutting tissue, or imaging of anatomy proximate the finger probe  100 .  
         [0028]    A method for applying ultrasound energy to tissue using the finger probe  100  will now be described with reference to FIGS. 2, 4 a  and  4   b.  The method is particularly useful for applying ultrasonic energy to tissue, and more particularly in creating lesions on a surface of the tissue, such as on a surface of the heart. Ideally, the lesions are transmural and created in the heart wall. Firstly, the ultrasonic finger probe  100  is secured to one or more fingers  108  of an operator. As discussed above, the finger probe  100  is preferably secured to a single finger  108 , such as the index (pointer) finger  108  and has a length sufficient to span the joints  110  of the finger(s) to which it is secured. Those skilled in the art will appreciate that the finger probe can also be shorter than a length sufficient to span the joints  110  of the finger(s) to which it is attached. In fact, the finger probe can be very small and attached only to a tip of one or more fingers and used to “write” lesions on the heart (i.e., create a continuous lesion line) instead of making linear lesion segments.  
         [0029]    The surface  102   a  of the ultrasonic finger probe  100  is then applied to the tissue and while applied, ultrasonic energy is generated and supplied to the ultrasonic transducer to create lesions. The application of the surface  102   a  on the tissue can comprise applying the ultrasonic finger probe  100  on a surface of the heart  130 . The generation of ultrasonic energy can comprise generating ultrasonic energy and supplying the same to the ultrasonic transducer  104  in an amount sufficient to create lesions at least on the surface of the heart  130  and ideally transmurally in the heart wall. As will be discussed below in an Example, the method can further comprise repeating the applying and generating steps to create a plurality of lesions by manipulating the ultrasonic finger probe  100  with the at least one finger  108  secured thereto. The manipulating can also comprise joining the plurality of lesions to form a single long lesion. As shown in FIG. 2, the heart, or other tissue structure being worked on can be stabilized with fingers  109  of a same hand other than the one or more fingers  108  secured to the ultrasonic finger probe  100 . For example, where the finger probe  100  is secured to only the index (pointer) finger  108 , the thumb, pinky, ring, and middle fingers  109  can be used to stabilize, hold, and otherwise manipulate the heart  130  (collectively referred to herein as stabilizing).  
       EXAMPLE  
       [0030]    Cardiac arrhythmias, particularly atrial fibrillation, are a pervasive problem in modern society. Although many individuals lead relatively normal lives despite persistent atrial fibrillation, the condition is associated with an increased risk of myocardial ischemia, especially during strenuous activity. Furthermore, persistent atrial fibrillation has been linked to congestive heart failure, stroke, and other thromboembolic events. Thus, atrial fibrillation is a major public health problem.  
         [0031]    Normal cardiac rhythm is maintained by a cluster of pacemaker cells, known as the sinoatrial (“SA”) node, located within the wall of the right atrium. The SA node undergoes repetitive cycles of membrane depolarization and repolarization, thereby generating a continuous stream of electrical impulses, called “action potentials.” These action potentials orchestrate the regular contraction and relaxation of the cardiac muscle cells throughout the heart. Action potentials spread rapidly from cell to cell through both the right and left atria via gap junctions between the cardiac muscle cells. Atrial arrhythmias result when electrical impulses originating from sites other than the SA node are conducted through the atrial cardiac tissue.  
         [0032]    In most cases, atrial fibrillation results from perpetually wandering reentrant wavelets, which exhibit no consistent localized region(s) of aberrant conduction. Alternatively, atrial fibrillation may be focal in nature, resulting from rapid and repetitive changes in membrane potential originating from isolated centers, or foci, within the atrial cardiac muscle tissue. These foci exhibit centrifugal patterns of electrical activation, and may act as either a trigger of paroxysmal atrial fibrillation or may even sustain the fibrillation. Recent studies have suggested that focal arrhythmias often originate from a tissue region along the pulmonary veins of the left atrium, and even more particularly in the superior pulmonary veins.  
         [0033]    Several surgical approaches have been developed for the treatment of atrial fibrillation. One particular example, known as the “MAZE” procedure, is disclosed by Cox, J. L. et al.,  The surgical treatment of atrial fibrillation. I. Summary,  Thoracic and Cardiovascular Surgery 101(3): 402-405 (1991) and also by Cox, J. L.,  The surgical treatment of atrial fibrillation. IV. Surgical Technique,  Thoracic and Cardiovascular Surgery 101(4): 584-592 (1991). In general, the MAZE procedure is designed to relieve atrial arrhythmia by restoring effective SA node control through a prescribed pattern of lesions about the cardiac tissue wall. Although early clinical studies on the MAZE procedure included surgical incisions in both the right and left atrial chambers, more recent reports suggest that the MAZE procedure may be effective when lesions are created and performed only in the left atrium (see for example Sueda et al., “Simple Left Atrial Procedure for Chronic Atrial Fibrillation Associated With Mitral Valve Disease” (1996)).  
         [0034]    The MAZE procedure involves forming lesions in the atrial tissue of the heart  108 . In this process, the lesions on the atrial tissue eliminates the atrial arrhythmia by blocking conduction of the aberrant action potentials. FIGS. 4 a  and  4   b  show a human heart  108  incorporating a series of strategically positioned transmural lesions  202  throughout the right atrium RA and the left atrium LA formed with the finger probe of the present invention. As shown in FIGS. 4 a  and  4   b,  these individual lesions  202  collectively form a pattern of transmurally ablated heart tissue to surgically treat medically refractory atrial fibrillation. The finger probe enables the surgical formation of the series of lesions illustrated in FIGS. 4 a  and  4   b.  The process for forming the lesions is more fully described in U.S. Pat. No. 6,161,543, the entire contents of which is incorporated herein by its reference. The lesion shape and pattern is shown by way of example only and not to limit the scope or spirit of the present invention.  
         [0035]    While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated, but should be constructed to cover all modifications that may fall within the scope of the appended claims.