Patent Abstract:
Malleable surgical ablation instruments are disclosed for creating lesions in tissue, including cardiac tissue for treatment of arrhythmias and other diseases. The hand held instruments are especially useful in open chest or port access cardiac surgery for rapid and efficient creation of curvilinear lesions to serve as conduction blocks. The malleable instruments disclosed are well adapted for use in or around the intricate structures of the heart. In one example, the distal end of the instrument can have a malleable shape or be in the shape of an open loop so as to allow the loop to be placed around at least one a pulmonary vein or artery. Such instruments can incorporate various ablative elements such as ablative radiation, RF heating, cryogenic cooling, ultrasound, microwave, ablative fluid injection and the like.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 09/924,393, filed on Aug. 7, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/616,777, filed on Jul. 14, 2000, now U.S. Pat. No. 6,558,375. This application is also a continuation-in-part of U.S. patent application Ser. No. 09/382,615, filed on Aug. 25, 1999. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates to surgical ablation instruments for ablation of tissue for the treatment of diseases and, in particular, to surgical instruments employing penetrating energy. Methods of ablating tissue using penetrating energy are also disclosed. The instruments can be used, for example, in the treatment of cardiac conditions such as cardiac arrhythmias.  
           [0003]    Cardiac arrhythmias, e.g., fibrillation, are irregularities in the normal beating pattern of the heart and can originate in either the atria or the ventricles. For example, atrial fibrillation is a form of arrhythmia characterized by rapid randomized contractions of the atrial myocardium, causing an irregular, often rapid ventricular rate. The regular pumping function of the atria is replaced by a disorganized, ineffective quivering as a result of chaotic conduction of electrical signals through the upper chambers of the heart. Atrial fibrillation is often associated with other forms of cardiovascular disease, including congestive heart failure, rheumatic heart disease, coronary artery disease, left ventricular hypertrophy, cardiomyopathy or hypertension.  
           [0004]    Various surgical techniques have been proposed for the treatment of arrhythmia. Although these procedures were originally performed with a scalpel, these techniques may also use ablation (also referred to as coagulation) wherein the tissue is treated, generally with heat or cold, to cause tissue necrosis (i.e., cell destruction). The destroyed muscle cells are replaced with scar tissue which cannot conduct normal electrical activity within the heart.  
           [0005]    For example, the pulmonary vein has been identified as one of the origins of errant electrical signals responsible for triggering atrial fibrillation. In one known approach, circumferential ablation of tissue within the pulmonary veins or at the ostia of such veins has been practiced to treat atrial fibrillation. Similarly, ablation of the region surrounding the pulmonary veins as a group has also been proposed. By ablating the heart tissue (typically in the form of linear or curved lesions) at selected locations, electrical conductivity from one segment to another can be blocked and the resulting segments become too small to sustain the fibrillatory process on their own. Ablation procedures are often performed during coronary artery bypass and mitral valve replacement operations because of a heightened risk of arrhythmias in such patients and the opportunity that such surgery presents for direct access to the heart.  
           [0006]    Several types of ablation devices have recently been proposed for creating lesions to treat cardiac arrhythmias, including devices which employ electrical current (e.g., radio-frequency “RF”) heating or cryogenic cooling. Such ablation devices have been proposed to create elongated lesions that extend through a sufficient thickness of the myocardium to block electrical conduction.  
           [0007]    These devices, however, are not without their drawbacks. When cardiac surgery is performed “on pump,” the amount of time necessary to form a lesion becomes a critical factor. Because these devices rely upon resistive and conductive heating (or cooling), they must be placed in direct contact with the heart and such contact must be maintained for a considerable period of time to form a lesion that extends through the entire thickness of the heart muscle. The total length of time to form the necessary lesions can be excessive. This is particularly problematic for procedures that are performed upon a “beating heart” patient. In such cases, the heart itself continues to beat and, hence, is filled with blood, thus providing a heat sink (or reservoir) that works against conductive and/or resistive ablation devices. As “beating heart” procedures become more commonplace (in order to avoid the problems associated with arresting a patient&#39;s heart and placing the patient on a pump), the need for better ablation devices will continue to grow.  
           [0008]    Moreover, devices that rely upon resistive or conductive heat transfer can be prone to serious post-operative complications. In order to quickly perform an ablation with such “contact” devices, a significant amount of energy must be applied directly to the target tissue site. In order to achieve transmural penetration, the surface that is contacted will experience a greater degree of heating (or freezing). For example, in RF heating of the heart wall, a transmural lesion requires that the tissue temperature be raised to about 50° C. throughout the thickness of the wall. To achieve this, the contact surface will typically be raised to at least 80° C. Charring of the surface of the heart tissue can lead to the creation of blood clots on the surface which can lead to post-operative complications, including stroke. Even if structural damage is avoided, the extent of the lesion (i.e., the width of the ablated zone) on the surface that has been contacted will typically be greater than necessary.  
           [0009]    Ablation devices that do not require direct contact have also been proposed, including acoustic and radiant energy. Acoustic energy (e.g., ultrasound) is poorly transmitted into tissue (unless a coupling fluid is interposed). Laser energy has also been proposed but only in the context of devices that focus light into spots or other patterns. When the light energy is delivered in the form of a focused spot, the process is inherently time consuming because of the need to expose numerous spots to form a continuous linear or curved lesion.  
           [0010]    In addition, existing instruments for cardiac ablation also suffer from a variety of design limitations. The shape of the heart muscle adds to the difficulty in accessing cardiac structures, such as the pulmonary veins on the anterior surface of the heart.  
           [0011]    Accordingly, there exists a need for better surgical ablation instruments that can form lesions with minimal overheating and/or damage to collateral tissue. Moreover, instruments that are capable of creating lesions uniformly, rapidly and efficiently would satisfy a significant need in the art.  
         SUMMARY OF THE INVENTION  
         [0012]    Surgical ablation instruments are disclosed for creating lesions in tissue, especially cardiac tissue for treatment of arrhythmias and the like. The hand held instruments are especially useful in open chest or port access cardiac surgery for rapid and efficient creation of curvilinear lesions to serve as conduction blocks. The instruments can be applied to form either endocardial or epicardial ablations, and are designed to create lesions in the atrial tissue in order to electrically decouple tissue segments on opposite sides of the lesion.  
           [0013]    In one aspect of the invention, surgical ablation instruments are disclosed that are well adapted for use in or around the intricate structures of the heart. In one embodiment, the distal end of the instrument can have a malleable shape so as to conform to the surgical space in which the instrument is used. The instruments can include at least one malleable strip element disposed within the distal end of the instrument body or housing so that the distal end can be conformed into a desired shape. In addition, the instruments can also include a clasp to form a closed loop after encircling a target site, such as the pulmonary veins. Such instruments can be used not only with penetrating energy devices but also with other ablation means, such as RF heating, cryogenic cooling, ultrasound, microwave, ablative fluid injection and the like.  
           [0014]    In another aspect of the invention, hand-held and percutaneous instruments are disclosed that can achieve rapid and effective photoablation through the use of penetrating radiation, especially distributed radiant energy. It has been discovered that penetrating energy, e.g., microwave or diffused infrared radiation, can create lesions in less time and with less risk of the adverse types of tissue destruction commonly associated with prior art approaches. Unlike instruments that rely on thermal conduction or resistive heating, controlled penetrating radiant energy can be used to simultaneously deposit energy throughout the full thickness of a target tissue, such as a heart wall, even when the heart is filled with blood. Distributed radiant energy can also produce better defined and more uniform lesions.  
           [0015]    It has also been discovered that infrared radiation is particularly useful in forming photoablative lesions. In one preferred embodiment, the instruments emit radiation at a wavelength in a range from about 800 nm to about 1000 nm, and preferably emit at a wavelength in a range of about 915 nm to about 980 nm. Radiation at a wavelength of 915 nm or 980 nm is commonly preferred in some applications because of the optimal absorption of infrared radiation by cardiac tissue at these wavelengths. In the case of ablative radiation that is directed towards the epicardial surface, light at a wavelength about 915 nm can be particularly preferably.  
           [0016]    In yet another aspect of the invention, surgical ablation instruments are disclosed having a housing with at least one lumen therein and having a distal portion that is at least partially transmissive to photoablative radiation. The instruments further include a light delivery element within the lumen of the housing that is adapted to receive radiation from a source and deliver radiant energy through a transmissive region of the housing to a target tissue site. The radiant energy is delivered without the need for contact between the light emitting element and the target tissue because the instruments of the present invention do not rely upon conductive or resistive heating.  
           [0017]    The light delivering element can be a light transmitting optical fiber adapted to receive ablative radiation from a radiation source and a light emitting tip at a distal end of the fiber for emitting diffuse or defocused radiation. The light delivering element can be slidably disposed within the inner lumen of the housing and the instrument can further include a translatory mechanism for disposing the tip of the light delivering element at one or more of a plurality of locations with the housing. Optionally, a lubricating fluid can be disposable between the light delivery element and the housing. This fluid can be a physiologically compatible fluid, such as saline, and the fluid can also be used for cooling the light emitting element or for irrigation via one or more exit ports in the housing.  
           [0018]    The light emitting tip can include a hollow tube having a proximal end joined to the light transmitting optical fiber, a closed distal end, and an inner space defining a chamber therebetween. The light scattering medium disposed within the chamber can be a polymeric or liquid material having light scattering particles, such as alumina, silica, or titania compounds or mixtures thereof, incorporated therein. The distal end of the tube can include a reflective end and, optionally, the scattering medium and the reflective end can interact to provide a substantially uniform axial distribution of radiation over the length of the housing.  
           [0019]    Alternatively, the light emitting tip can include at least one reflector for directing the radiation through the transmissive region of the housing toward a target site and, optionally, can further include a plurality of reflectors and/or at least one defocusing lens for distributing the radiation in an elongated pattern.  
           [0020]    The light emitting tip can further include at least one longitudinal reflector or similar optical element such that the radiation distributed by the tip is confined to a desired angular distribution.  
           [0021]    The hand held instruments can include a handle incorporated into the housing. An inner lumen can extend through the handle to received the light delivering element. The distal end of the instrument can be resiliently deformable or malleable to allow the shape of the ablation element to be adjusted based on the intended use.  
           [0022]    In one embodiment, a hand held cardiac ablation instrument is provided having a housing with a curved shape and at least one lumen therein. A light delivering element is disposable within the lumen of the housing for delivering ablative radiation to form a curved lesion at a target tissue site adjacent to the housing.  
           [0023]    In another aspect of the invention, the light delivering element can be slidably disposed within the inner lumen of the housing, and can include a light transmitting optical fiber adapted to receive ablative radiation from a radiation source and a light diffusing tip at a distal end of the fiber for emitting radiation. The instrument can optionally include a handle joined to the housing and having an inner lumen though which the light delivering element can pass from the radiation source to the housing.  
           [0024]    In another aspect of the present invention, the light diffusing tip can include a tube having a proximal end mated to the light transmitting optical fiber, a closed distal end, and an inner chamber defined therebetween. A light scattering medium is disposed within the inner chamber of the tube. The distal end of the tube can include a reflective end surface, such as a mirror or gold coated surface. The tube can also include a curved, longitudinally-extending reflector that directs the radiant energy towards the target ablation site. The reflective surfaces and the light scattering medium interact to provide a substantially uniform axial distribution of radiation of the length of the housing.  
           [0025]    In other aspects of the present invention, a hand held cardiac ablation instrument is provided having a slidably disposed light transmitting optical fiber, a housing in the shape of an open loop and having a first end adapted to receive the slidably disposed light transmitting optical fiber, and at least one diffuser chamber coupled to the fiber and disposed within the housing. The diffuser chamber can include a light scattering medium disposed within the housing and coupled to the slidably disposed light transmitting optical fiber.  
           [0026]    The present invention also provides methods for ablating cardiac tissue. One method of ablating cardiac tissue, comprises positioning a distal end of a photoablation instrument in proximity to a target region of cardiac tissue, the instrument having a hollow housing and a light delivering element coupled to a source of photoablative radiation and disposed within the distal end, the distal end being transmissive to a selected wavelength of ablative radiation and curved to permit the distribution of radiation by the light emitting element in an elongated arcuate pattern; activating the light emitting element to transmit radiant energy through the housing to expose the target region and induce an curvilinear lesion; and, optionally, repeating the steps of positioning and exposing until a composite lesion of a desired shape is formed.  
           [0027]    In another method, a device is provided having a light delivering element coupled to a source of photoablative radiation and configured in a curved shape to emit an arcuate pattern of radiation. The device is positioned in proximity to a target region of cardiac tissue, and applied to induce a curvilinear lesion. The device is then moved to a second position and reapplied to induce a second curvilinear lesion. The steps of positioning and reapplying can be repeated until the lesions are joined together to create a composite lesion (e.g., a closed loop encircling one or more cardiac structures).  
           [0028]    In another embodiment, methods of ablating cardiac tissue are provided. A device is provided having a housing in the shape of a hollow ring or partial ring having at least one lumen therein and at least one open end, and a light delivering element slidably disposed within the lumen of the housing for delivering ablative radiation to form a circular lesion at a target region adjacent the housing. The methods include the steps of positioning the device in proximity to the target region of cardiac tissue, applying the device to the target region to induce a curvilinear lesion, advancing the light delivering element to a second position, reapplying the device to the target region to induce a second curvilinear lesion, and repeating the steps of advancing and applying until the lesions are joined together to create a composite circumferential lesion. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]    The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which like reference numerals designate like parts throughout the figures, and wherein:  
         [0030]    [0030]FIG. 1 is a schematic, perspective view of a hand held surgical ablation instrument in accordance with this invention;  
         [0031]    [0031]FIG. 1A is a partially cross-sectional view of the hand held surgical ablation instrument of FIG. 1;  
         [0032]    [0032]FIG. 2 is a schematic, perspective view of another embodiment of a hand held surgical ablation instrument in accordance with this invention;  
         [0033]    [0033]FIG. 2A is a partially cross-sectional view of the hand held surgical ablation instrument of FIG. 2;  
         [0034]    [0034]FIG. 3 is a schematic, side perspective view of a tip portion of an ablation instrument in accordance with this invention illustrating a light delivery element;  
         [0035]    [0035]FIG. 3A is a schematic, side perspective view of a tip portion of another ablation instrument in accordance with this invention;  
         [0036]    [0036]FIG. 4 is a schematic, cross sectional view of the light delivery element of FIG. 3;  
         [0037]    [0037]FIG. 4A is a schematic, cross sectional view of another embodiment of a light delivery element;  
         [0038]    [0038]FIG. 4B is a schematic, cross sectional view of another embodiment of a light delivery element surrounded by a malleable housing;  
         [0039]    [0039]FIG. 5 is a schematic, cross sectional top view of a surgical ablation element of according to the invention, illustrating the different ablating positions of the light delivering element;  
         [0040]    [0040]FIG. 6 is a schematic, perspective view of a human heart and an instrument according to the invention, showing one technique for creating epicardial lesions;  
         [0041]    [0041]FIG. 7 is a schematic, perspective view of a human heart and an instrument according to the invention, showing one technique for creating endocardial lesions; and  
         [0042]    [0042]FIG. 8 is a schematic, perspective view of a human heart and an instrument according to the invention, showing another technique for creating endocardial lesions. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0043]    The present invention provides a hand held cardiac ablation instrument that is useful, for example, for treating patients with atrial arrhythmia. As shown in FIG. 1, the hand held ablation instrument  10  generally includes a handle  12  having a proximal end  14  and a distal end  16 , an ablation element  20  mated to or extending distally from the distal end  16  of the handle  12 , and an energy source  50 . The energy source  50  can be a source, for example, of electromagnetic radiation, e.g., coherent light, which can be efficiently and uniformly distributed to the target site while avoiding harm or damage to surrounding tissue. In one use, the instrument can be employed to perform cardiac ablations and can be applied either endocardially or epicardially, and is effective to uniformly irradiate a target ablation site.  
         [0044]    The handle  12  of the cardiac ablation instrument  10  is effective for manually placing the ablation element  20  proximate to a target tissue site. While the handle  12  can have a variety of shapes and sizes, preferably the handle is generally elongate with at least one inner lumen extending therethrough. The proximal end  14  of the handle  12  is adapted for coupling with a source of phototherapeutic radiation, i.e. a laser energy source  50 , and the distal end of the handle  16  is mated to or formed integrally with the ablation element  20 . In a preferred embodiment, the handle  12  is positioned substantially coaxially with the center of the ablation element  20 . The handle  14  can optionally include an on-off switch  18  for activating the laser energy source  50 .  
         [0045]    One circumferential ablation element  20  is shown in more detail in FIG. 1A, and includes an outer housing  22  having an inner lumen extending therethrough, and a light delivering element  32  disposed within the inner lumen of the outer housing  22 . The outer housing  22  can be flexible, and is preferably malleable to allow the shape of the outer housing  22  to be adapted based on the intended use. As shown in FIG. 2, the outer housing  22  can be in the shape of a hollow ring (or partial ring) forming an opening loop having leading and trailing ends  24 ,  26 . The open loop-shape allows the circumferential ablation element  20  to be positioned around one or more pulmonary veins. While an open loop shape is illustrated, the outer housing  22  can also be formed or positioned to create linear or other shaped lesions.  
         [0046]    The housing can be made from a variety of materials including polymeric, electrically nonconductive material, like polyethylene or polyurethane, which can withstand tissue coagulation temperatures without melting. Preferably, the housing is made of Teflon® tubes and/or coatings. The use of Teflon® improves the procedures by avoiding the problem of fusion or contact-adhesion between the ablation element  12  and the cardiac tissue during usage. While the use of Teflon® avoids the problem of fusion or contact-adhesion, the hand held cardiac ablation instrument  10  does not require direct contact with the tissue to effect a therapeutic or prophylactic treatment.  
         [0047]    The outer housing  22  can optionally include a connecting element for forming a closed-loop circumferential ablation element  20 . By non-limiting example, FIG. 1A illustrates a connecting element  30  extending from the leading, distal end  24  of the outer housing  22 . The connecting element  30  has a substantially U-shape and is adapted for mating with the trailing end  26  of the outer housing  22  or the distal end  16  of the handle  12 . The connecting element  30  can optionally be adapted to allow the size of the circumferential ablation element  20  to be adjusted once positioned around the pulmonary veins. For example, the connecting element  30  can be positioned around the trailing end  26  of the outer housing  22  after the circumferential ablation element  20  is looped around the pulmonary veins, and the handle  12  can then be pulled to cause the ablation element  20  to tighten around the pulmonary veins. While FIG. 1A illustrates a U-shaped connecting element, a person having ordinary skill in the art will appreciate that a variety of different connecting elements or clasps  30  can be used such as, for example, a hook, a cord, a snap, or other similar connecting device.  
         [0048]    The light delivering element  32  which is disposed within the outer housing  22  includes a light transmitting optical fiber  34  and a light diffusing tip  36 . The light transmitting optical fiber  34  is effective for delivering radiant energy from the laser energy source  50  to the light diffusing tip  36 , wherein the laser energy is diffused throughout the tip  36  and delivered to the target ablation site. The light delivering element  32  can be slidably disposed within the outer housing to allow the light diffusing tip  36  to be positioned with respect to the target ablation site. A lever  52  or similar mechanism can be provided for slidably moving the light delivering element  32  with respect to the handle  12 . As shown in FIG. 1A, the lever  52  can be mated to the light delivering element  32  and can protrude from a distally extending slot  54  formed in the handle  12 . Markings can also be provided on the handle for determining the distance moved and the length of the lesion formed. A person having ordinary skill in the art will readily appreciate that a variety of different mechanisms can be employed to slidably move the light delivering element  32  with respect to the handle  12 .  
         [0049]    Another embodiment of the surgical ablation instrument  10 A is shown in FIG. 2, where a rotatable lever  82  can be used to control the positioning of a light delivery element in the distal tip of the instrument. The lever  82  turns a translatory mechanism  80 , as shown in more detail in FIG. 2A. In this embodiment, a portion  84  of the handle is separated from the rest of the housing  88  such that it can rotate, and preferably is sealed by O-rings  90  and  91 , or the like. The rotatable segment  84  has internal screw threads  92 . Within this segment of the handle, the light delivering fiber  32  is joined to a jacket  93  that has an external screw thread  94 . The threads  94  of jacket  93  mate with the threads  92  of rotatable segment  84 . The lever  82  is affixed to rotatable segment  84  (e.g., by set screw  86 ) such that rotation of knob  82  causes longitudinal movement of the fiber  32  relative to the housing  88 .  
         [0050]    The inner lumen of the outer housing  22  in FIGS. 1 and 2 can optionally contain a lubricating and/or irrigating fluid to assist the light delivering element  32  as it is slidably movable within the outer housing  22 . The fluid can also cool the light delivering element  32  during delivery of ablative energy. Fluid can be introduced using techniques known in the art, but is preferably introduced through a port and lumen formed in the handle. The distal end  24  of the outer housing  22  can include a fluid outflow port  28  for allowing fluid to flow therethrough.  
         [0051]    As shown in FIG. 3, the fluid travels between the light delivering element  32  toward the leading, distal end  26  of the outer housing  22  and exits the fluid outflow port  28 . Since the port  28  is positioned on the distal end  26  of the outer housing  22 , the fluid does not interfere with the ablation procedure. Suitable cooling and/or lubricating fluids include, for example, water and silicone. While FIG. 3 illustrates the fluid outflow port  28  disposed on the distal end  24  of the outer housing  22 , a person having ordinary skill in the art will readily appreciate that the fluid outflow port  28  can be disposed anywhere along the length of the outer housing  22 .  
         [0052]    In FIG. 3A another embodiment of a light delivery element according to the invention is shown. As illustrated, fiber  34  terminates in a series of partially reflective elements  35 A- 35 G. (It should be appreciated that the number of reflective elements can vary depending on the application and the choice of six is merely for illustration.) The transmissivity of the various segments can be controlled such that, for example, segment  35 A is less reflective than segment  35 B, which in turn is less reflective than  35 C, etc., in order to achieve uniform diffusion of the light. The reflective elements of FIG. 3A can also be replaced, or augmented, by a series of light scattering elements having similar progressive properties. FIG. 3A also illustrates another arrangement of exit ports  28  in housing  22  for fluid, whereby the fluid can be used to irrigate the target site.  
         [0053]    With reference again to FIG. 3, the light transmitting optical fiber  34  generally includes an optically transmissive core surrounded by a cladding and a buffer coating (not shown). The optical fiber  34  should be flexible to allow the fiber  34  to be slidably moved with respect to the handle  12 . In use, the light transmitting optical fiber  34  conducts light energy in the form of ultraviolet light, infrared radiation, or coherent light, e.g., laser light. The fiber  34  can be formed from glass, quartz, polymeric materials, or other similar materials which conduct light energy.  
         [0054]    The light diffusing tip  36  extends distally from the optical fiber  34  and is formed from a transmissive tube  38  having a light scattering medium  40  disposed therein. For additional details on construction of light diffusing elements, see, for example, U.S. Pat. No. 5,908,415, issued on Jun. 1, 1999.  
         [0055]    The scattering medium  40  disposed within the light diffusing tip  36  can be formed from a variety of materials, and preferably includes light scattering particles. The refractive index of the scattering medium  40  is preferably greater than the refractive index of the housing  22 . In use, light propagating through the optical fiber  34  is transmitted through the light diffusing tip  36  into the scattering medium  40 . The light is scattered in a cylindrical pattern along the length of the light diffusing tip  36  and, each time the light encounters a scattering particle, it is deflected. At some point, the net deflection exceeds the critical angle for internal reflection at the interface between the housing  22 . and the scattering medium  40 , and the light exits the housing  22  to ablate the tissue.  
         [0056]    Preferred scattering medium  40  includes polymeric material, such as silicone, epoxy, or other suitable liquids. The light scattering particles can be formed from, for example, alumina, silica, or titania compounds, or mixtures thereof. Preferably, the light diffusing tip  36  is completely filled with the scattering medium  40  to avoid entrapment of air bubbles.  
         [0057]    As shown in more detail in FIG. 3, the light diffusing tip  36  can optionally include a reflective end  42  and/or a reflective coating  44  extending along a length of one side of the light diffusing tip  36  such that the coating is substantially diametrically opposed to the target ablation site. The reflective end  42  and the reflective coating  44  interact to provide a substantially uniform distribution of light throughout the light diffusing tip  36 . The reflective end  42  and the reflective coating  44  can be formed from, for example, a mirror or gold coated surface. While FIG. 3 illustrates the coating extending along one side of the length of the diffusing tip  36 , a person having ordinary skill in the art will appreciate that the light diffusing tip  36  can be coated at different locations relative to the target ablation site. For example, the reflective coating  44  can be applied over 50% of the entire diameter of the light diffusing tip  36  to concentrate the reflected light toward a particular target tissue site, thereby forming a lesion having a relatively narrow width.  
         [0058]    In one use, the hand held ablation instrument  10  is coupled to a source of phototherapeutic radiation  50  and can be positioned within a patient&#39;s body either endocardially or epicardially to ablate the tissue. The radiation source is activated to transmit light through the optical fiber  34  to the light diffusing tip  36 , wherein the light is scattered in a circular pattern along the length of the tip  36 . The tube  38  and the reflective end  42  interact to provide a substantially uniform distribution of light throughout the tip  36 . When a mirrored end cap  42  is employed, light propagating through the light diffusing tip  36  will be at least partially scattered before it reaches the mirror  42 . When the light reaches the mirror  42 , it is then reflected by the mirror  42  and returned through the tip  36 . During the second pass, the remaining radiation encounters the scattering medium  40  which provides further diffusion of the light.  
         [0059]    When a reflective coating or longitudinally disposed reflector  44  is used, as illustrated in FIG. 4, the light  58  emitted by the diffusing tip  36  will reflected toward the target ablation site  56  to ensure that a uniform lesion  48  is created. The reflective coating or element  44  is particularly effective to focus or direct the light  58  toward the target ablation site  56 , thereby preventing the light  58  from passing through the housing  22  around the entire circumference of the housing  22 .  
         [0060]    In another embodiment as illustrated in FIG. 4A, the light emitting element can further include a longitudinally extended lens element  45 , such that light scattered by the scattering medium  40  is not only reflected by reflector  44  but also confined to a narrow angle.  
         [0061]    In yet another embodiment of the invention, illustrated in FIG. 4B, the housing  22  that surrounds the light delivery element includes or surrounds a malleable element  47 , e.g., a soft metal bar or strip such that the clinician can form the distal end of the instrument into a desired shape prior to use. Although the malleable element  47  is shown embedded in the housing  22 , it should be clear that it can also be incorporated into the light delivery element (e.g., as part of the longitudinally extended reflector) or be distinct from both the housing and the light emitter.  
         [0062]    Although illustrated in the context of light delivering surgical instruments, the malleable structures disclosed herein are equally adaptable for use with other sources of ablative energy, such as such as RF heating, cryogenic cooling, ultrasound, microwave, ablative fluid injection and the like. RF Heating devices, for example, are described in U.S. Pat. No. 5,690,611 issued to Swartz et al. and herein incorporated by reference. Cryogenic devices are similarly described, for example, in U.S. Pat. No. 6,161,543 issued to Cox et al. and herein incorporated by reference.  
         [0063]    Epicardial ablation is typically performed during a by-pass procedure, which involves opening the patient&#39;s chest cavity to access the heart. The heart can be arrested and placed on a by-pass machine, or the procedure can be performed on a beating heart. The hand held ablation instrument  10  is placed around one or more pulmonary veins, and is preferably placed around all four pulmonary veins. The connecting element  30  can then be attached to the distal end  16  of the handle  12  or the proximal, trailing end  24  of the outer housing  22  to close the open loop. The handle  12  can optionally be pulled to tighten the ablation element  20  around the pulmonary veins. The light delivering element  32  is then moved to a first position, as shown in FIG. 5, and the laser energy source  50  is activated to transmit light. The first lesion is preferably about 4 cm in length, as determined by the length of the light diffusing tip  36 . Since the distance around the pulmonary veins is about 10 cm, the light delivering element  32  is moved forward about 4 cm to a second position  60 , shown in phantom in FIG. 5, and the tissue is ablated to create a second lesion. The procedure is repeated two more times, positioning the light delivering element  32  in a third position  62  and a fourth position  64 . The four lesions together can form a lesion  48  around the pulmonary veins, for example.  
         [0064]    In another aspect of the invention, the instruments of the present invention are particularly useful in forming lesions around the pulmonary veins by directing radiation towards the epicardial surface of the heart and the loop configuration of distal end portion of the instruments facilitates such use. It has been known for some time that pulmonary veins can be the source of errant electrical signals and various clinicians have proposed forming conduction blocks by encircling one or more of the pulmonary veins with lesions. As shown in FIG. 6, the instrument  10  of the present invention is well suited for such ablation procedures. Because the pulmonary veins are located at the anterior of the heart muscle, they are difficult to access, even during open chest surgery. An open loop distal end is thus provided to encircle the pulmonary veins. The open loop can then be closed (or cinched tight) by a clasp, as shown. (The clasp can also take the form of suture and the distal end of the instrument can include one or more holes to receive such sutures as shown in FIG. 2.) The longitudinal reflector structures described above also facilitate such epicardial procedures by ensuring that the light from the light emitting element is directed towards the heart and not towards the lungs or other adjacent structures.  
         [0065]    Endocardial applications, on the other hand, are typically performed during a valve replacement procedure which involves opening the chest to expose the heart muscle. The valve is first removed, and then the hand held cardiac ablation instrument  10  according to the present invention is positioned inside the heart as shown in FIG. 7. In another approach the instrument  10  can be inserted through an access port as shown in FIG. 8. The ablation element  20  can be shaped to form the desired lesion, and then positioned at the atrial wall around the ostia of one or more of the pulmonary veins. Once shaped and positioned, the laser energy source  50  is activated to ablate a first portion of tissue. The light delivering element  32  can then be slidably moved, as described above with respect to the epicardial application, or alternatively, the entire device can be rotated to a second position to form a second lesion.  
         [0066]    The term “penetrating energy” as used herein is intended to encompass energy sources that do not rely primarily on conductive or convective heat transfer. Such sources include, but are not limited to, acoustic and electromagnetic radiation sources and, more specifically, include microwave, x-ray, gamma-ray, and radiant light sources.  
         [0067]    The term “curvilinear,” including derivatives thereof, is herein intended to mean a path or line which forms an outer border or perimeter that either partially or completely surrounds a region of tissue, or separate one region of tissue from another. Further, a “circumferential” path or element may include one or more of several shapes, and may be for example, circular, annular, oblong, ovular, elliptical, or toroidal. The term “clasp” is intended to encompass various types of fastening mechanisms including sutures and magnetic connectors as well as mechanical devices. The term “light” is intended to encompass radiant energy, whether or not visible, including ultraviolet, visible and infrared radiation.  
         [0068]    The term “lumen,” including derivatives thereof, is herein intended to mean any cavity or lumen within the body which is defined at least in part by a tissue wall. For example, cardiac chambers, the uterus, the regions of the gastrointestinal tract, the urinary tract, and the arterial or venous vessels are all considered illustrative examples of body spaces within the intended meaning.  
         [0069]    The term “catheter” as used herein is intended to encompass any hollow instrument capable of penetrating body tissue or interstitial cavities and providing a conduit for selectively injecting a solution or gas, including without limitation, venous and arterial conduits of various sizes and shapes, bronchioscopes, endoscopes, cystoscopes, culpascopes, colonscopes, trocars, laparoscopes and the like. Catheters of the present invention can be constructed with biocompatible materials known to those skilled in the art such as those listed supra, e.g., silastic, polyethylene, Teflon, polyurethanes, etc.

Technology Classification (CPC): 0