Cryosurgical catheter

[0001] This application claims priority from U.S. Provisional Patent Application No. 60/349,077, filed on Jan. 16, 2002, entitled SURGICAL DEVICE WITH FIN STRUCTURE, and is a CIP of U.S. patent application Ser. No. 10/050,452, filed on Jan. 16, 2002, now issued U.S. Pat. No. 6,669,689, entitled CRYOSURGICAL CATHETER, which is a continuation of U.S. patent application Ser. No. 09/845,535, filed Apr. 30, 2001, now issued U.S. Pat. No. 6,629,972, entitled CRYOSURGICAL CATHETER, which is a continuation of U.S. patent application Ser. No. 09/201,071, filed Nov. 30, 1998, now issued U.S. Pat. No. 6,235,019 B1, entitled CRYOSURGICAL CATHETER, which is a continuation-in-part of U.S. patent application Ser. No. 08/893,825, filed Jul. 11, 1997, now issued U.S. Pat. No. 5,899,899, entitled CRYOSURGICAL LINEAR ABLATION STRUCTURE, which is a continuation-in-part of U.S. patent application Ser. No. 08/807,382, filed Feb. 27, 1997, now issued U.S. Pat. No. 5,899,898, and entitled CRYOSURGICAL LINEAR ABLATION, the entirety of which is incorporated herein by reference.

[0002] n/a

[0003] The invention relates to catheters, and more particularly to cryosurgical catheters used for tissue ablation.

[0004] Many medical procedures are performed using minimally invasive surgical techniques, wherein one or more slender implements are inserted through one or more small incisions into a patient's body. With respect to ablation, the surgical implement can include a rigid or flexible structure having an ablation device at or near its distal end that is placed adjacent to the tissue to be ablated. Radio frequency energy, microwave energy, ultrasound energy, laser energy, extreme heat, and extreme cold can be provided by the ablation device to kill the tissue.

[0005] With respect to cardiac procedures, a cardiac arrhythmia can be treated through selective ablation of cardiac tissue to eliminate the source of the arrhythmia. A popular minimally invasive procedure, radio frequency (RF) catheter ablation, includes a preliminary step of conventional electrocardiographic mapping followed by the creation of one or more ablated regions (lesions) in the cardiac tissue using RF energy. Multiple lesions are frequently required because the effectiveness of each of the proposed lesion sites cannot be predetermined due to limitations of conventional electrocardiographic mapping. Often, five lesions, and sometimes as many as twenty lesions may be required before a successful result is attained. Usually only one of the lesions is actually effective; the other lesions result in unnecessarily destroyed cardiac tissue.

[0006] Deficiencies of radio frequency ablation devices and techniques have been overcome by using cold to do zero degree or ice mapping prior to creating lesions, as taught in U.S. Pat. Nos. 5,423,807; and 5,281,213; and 5,281,215. However, even though combined cryogenic mapping and ablation devices permit greater certainty and less tissue damage than RF devices and techniques, both the cryogenic and the RF devices are configured for spot or roughly circular tissue ablation.

[0007] Spot tissue ablation is acceptable for certain procedures. However, other procedures can be more therapeutically effective if multiple spot lesions along a predetermined line, or a single elongate or linear lesion is created in a single ablative step. Radio frequency ablation devices are known to be able to create linear lesions by dragging the ablation tip along a line while it is active. However, no cryogenic devices are known that are optimized for, or which are even minimally capable of, creating an elongate lesion. The deficiency in creating elongate lesions is applicable for flexible, rigid, and semi-rigid catheter and surgical probe type systems. In the former, the method of access is through the blood vessel system and in the latter through a surgical incision in the patient's chest wall.

[0008] Additionally, as noted above, the surgical implement can include a rigid or flexible structure having an ablation device at or near its distal end. The rigid or flexible structure can be an elongate, highly-flexible shaft with a steerable distal end for negotiating a path through the body of a patient, as well as a rigid shaft for use in more invasive procedures where a more local opening or direct access to a treatment site is available or created.

[0009] While rigid structures or probes may be useful in some applications, they have certain limitations as well. For example, without a shape especially adapted for reaching a particular location in the body of a patient, the rigid nature of the probe limits the area of tissue that can be reached and treated. Even where a relatively large incision is provided, tissue areas that are not at least somewhat directly accessible cannot be reached.

[0010] Although a rigid probe can be provided with a predetermined shape, one must select a probe that has the most appropriate shape for positioning the working portion of the probe in contact with the treatment site in view of the particular anatomical pathway to be followed in the patient. It will be appreciated that a large inventory of rigid probes may be required to accommodate the various treatment sites and patient anatomies. Further, for a patient having a relatively uncommon anatomic configuration and/or a difficult to reach treatment site, all rigid probes of an existing set may have less than optimal shapes for positioning. This may impair the prospects of successfully carrying out the treatment procedure, especially when the treatment is one such as an ablation treatment that relies on good tissue contact and operates locally upon the contacted tissue. For an ablation probe which must bear against tissue at the remote region to ablate a lesion, the contour followed by the probe in reaching the target site will in general further restrict the direction and magnitude of the movement and forces which may be applied or exerted on the working portion of the device to effect tissue contact and treatment.

[0011] It would, therefore, be desirable to provide a probe that, while having sufficient rigidity to facilitate positioning of the probe to a selected location within the body of a patient, is also better adapted to reach or treat the particular targeted anatomy of the patient.

[0012] It would also be desirable to provide a probe having a working portion with sufficient controlled flexibility to conform to curved or irregular tissue surfaces, yet be resistant to kinking, folding or pinching, in addition to having sufficient strength to safely contain high-pressure working fluids.

[0013] The present invention provides a cryosurgical system including a housing having a front portion and a rear portion. The front portion and rear portion are connectable to support a fluid supply. A control unit attached to the front portion, and has a regulator assembly connecting the fluid supply to the control unit. A catheter or probe is connected to the control unit, being in fluid communication with the fluid supply. The catheter or probe includes a handle, a shaft, and a thermally-transmissive region, where the handle, the shaft, and the thermally-transmissive region define a fluid pathway which is in fluid communication with the fluid supply.

[0014] The shaft can be semi-rigid, having a rigidity such that the shaft retains one shape until being influenced to a further shape by the application of moderate pressure on the shaft. The malleability stiffness of the shaft can vary depending upon the desired application. The stiffness of the shaft is generally such that a surgeon can bend the shaft by hand to a desired contour with the application of moderate pressure. The thermally-transmissive region can be flexible, being passively or selectively deformable and can assume a linear, curved, circular or irregular shape as required to conform to a tissue surface to be treated.

[0015] An adjustable insulation sleeve can be placed about the shaft and the thermally-transmissive region. The adjustable insulation sleeve can be used to increase or decrease the exposed portion of the thermally-transmissive region, allowing for accurate lesion placement. Additionally, the adjustable insulation sleeve protects adjacent tissue from being damaged.

[0062] FIG. 1 is a schematic illustration of a cryosurgical system in accordance with the invention. The system includes a supply of cryogenic or cooling fluid 10 in communication with the proximal end 12 of a flexible catheter 14. A fluid controller 16 is interposed or in-line between the cryogenic fluid supply 10 and the catheter 14 for regulating the flow of cryogenic fluid into the catheter in response to a controller command. Controller commands can include programmed instructions, sensor signals, and manual user input. For example, the fluid controller 16 can be programmed or configured to increase and decrease the pressure of the fluid by predetermined pressure increments over predetermined time intervals. In another exemplary embodiment, the fluid controller 16 can be responsive to input from a foot pedal 18 to permit flow of the cryogenic fluid into the catheter 14. One or more temperature sensors 20 in electrical communication with the controller 16 can be provided to regulate or terminate the flow of cryogenic fluid into the catheter 14 when a predetermined temperature at a selected point or points on or within the catheter is/are obtained. For example a temperature sensor can be placed at a point proximate the distal end 22 of the catheter and other temperature sensors 20 can be placed at spaced intervals between the distal end of the catheter and another point that is between the distal end and the proximal end.

[0063] The cryogenic fluid can be in a liquid or a gas state. An extremely low temperature can be achieved within the catheter, and more particularly on the surface of the catheter by cooling the fluid to a predetermined temperature prior to its introduction into the catheter, by allowing a liquid state cryogenic fluid to boil or vaporize, or by allowing a gas state cryogenic fluid to expand. Exemplary liquids include chlorodifluoromethane, polydimethylsiloxane, ethyl alcohol, HFC's such as AZ-20 (a 50—50 mixture of difluoromethane & pentafluoroethane sold by Allied Signal), and CFC's such as DuPont's FREON. Exemplary gasses include nitrous oxide, argon, and carbon dioxide.

[0064] The catheter 14 includes a flexible member 24 having a thermally-transmissive region 26 and a fluid path through the flexible member to the thermally-transmissive region. A fluid path is also provided from the thermally-transmissive region to a point external to the catheter, such as the proximal end 12. Although described in greater detail below, exemplary fluid paths can be one or more channels defined by the flexible member 24, and/or by one or more additional flexible members that are internal to the first flexible member 24. Also, even though many materials and structures can be thermally conductive or thermally transmissive if chilled to a very low temperature and/or cold soaked, as used herein, a “thermally-transmissive region” is intended to broadly encompass any structure or region of the catheter 14 that readily conducts heat. In the foregoing, reference will be made to a surgical device but all points and discussion will apply as well to flexible, semi-rigid, or rigid catheters and probes type devices, as well as devices using combination thereof.

[0065] For example, a metal structure exposed (directly or indirectly) to the cryogenic fluid path is considered a thermally-transmissive region 26 even if an adjacent polymeric or latex catheter portion also permits heat transfer, but to a much lesser extent than the metal. Thus, the thermally-transmissive region 26 can be viewed as a relative term to compare the heat transfer characteristics of different catheter regions or structures.

[0066] Furthermore, while the thermally-transmissive region 26 can include a single, continuous, and uninterrupted surface or structure, it can also include multiple, discrete, thermally-transmissive structures that collectively define a thermally-transmissive region that is elongate or linear. Depending on the ability of the cryogenic system, or portions thereof, to handle given thermal loads, the ablation of an elongate tissue path can be performed in a single or multiple cycle process without having to relocate the catheter one or more times or drag it across tissue. Additional details of the thermally-transmissive region 26 and the thermal transfer process are described in greater detail below.

[0067] In exemplary embodiments of the invention, the thermally-transmissive region 26 of the catheter 14 is deformable. An exemplary deformation is from a linear configuration to an arcuate configuration and is accomplished using mechanical and/or electrical devices known to those skilled in the art. For example, a wall portion of the flexible member 24 can include a metal braid to make the catheter torqueable for overall catheter steering and placement. Additionally, a cord, wire or cable can be incorporated with, or inserted into, the catheter for deformation of the thermally transmissive region 26.

[0068] The cryogenic system of FIG. 1 is better understood with reference to its use in an operative procedure as shown in FIG. 2. Following the determination of a proposed lesion site within a heart chamber 28, for example, the catheter 14 is directed through a blood vessel 30 to a region within the heart, such as an atrial or ventricular chamber, where the lesion will be made. The thermally-transmissive region 26 is placed proximate to the tissue to be ablated. The thermally-transmissive region of the catheter may be deformed to conform to the curvature of the tissue before, during, or after placement against the tissue. The controller 16 allows or causes cryogenic fluid to flow from the cryogenic fluid supply 10 to the fluid path in the catheter 14 and thence to the thermally-transmissive region 26 to ablate the desired area or to cold map along the same tissue area. In one embodiment (e.g., FIG. 12) a first conduit is concentric within a second conduit and cooling fluid travels to a thermally-transmissive region proximate a closed distal end of the catheter through a first conduit (fluid path) and is exhausted from the catheter through the second conduit (fluid path).

[0069] Having described the function of the cryogenic catheter 14 and its use in a system context, several exemplary embodiments of the thermally-transmissive region 26 of the catheter are now described in greater detail. FIGS. 3, 4, 5, 12-16 and 18 illustrate embodiments of the catheter, or portions thereof, having two or more thermally-transmissive segments in a spaced-apart relationship. Each of the illustrated catheters includes a closed tip 32 that can include a thermally-transmissive material.

[0070] Referring specifically to the embodiment depicted in FIG. 3, multiple thermally-transmissive elements 34 are integral with a distal portion of a catheter. Each of the thermally-transmissive elements 34 includes a first side or face 36 (shown in FIGS. 12 and 13) exposed to a cryogenic fluid path and cryogenic fluid (shown by arrows) and a second side or face 38 exposed to points exterior to the catheter. As shown in FIG. 13, the first side 36 and/or second side 38 of any or all of the thermally-transmissive elements 34 can be substantially flush with, recessed below, or protruding from the inner surface 40 and outer surface 42 of a portion of the catheter. The thermally-transmissive elements 34 are separated by flexible portions of material 44 than can range from slightly less thermally-transmissive than the adjacent thermally-transmissive elements to substantially less thermally-transmissive than the adjacent elements. In the illustrated embodiment of FIG. 3, the thermally-transmissive elements 34 are annular, cylindrical elements which are made of gold-plated copper or bronze. Thermocouples 35 can be associated with one or more of the elements 34 and the tip 32. The thermally-transmissive elements 34 can be completely exposed, embedded, or a combination thereof along the full 360 degrees of the catheter's circumference. In certain applications the thermally-transmissive elements traverse or define less than 360 degrees of the catheter's circumference as shown in FIGS. 14-16 and as described below. The longitudinal width of each thermally-transmissive element 34, the spacing between elements, the material thickness, and the material composition are matched with a selected cryogenic fluid, one or more cryogenic fluid delivery locations within the catheter and fluid delivery pressure to produce overlapping cold regions which produce a linear lesion.

[0071] The embodiment illustrated in FIG. 4 is substantially identical to the embodiment of FIG. 3, however, at least one of the thermally-transmissive elements 34 includes a first open end 46 that defines a first plane and a second open end 48 that defines a second plane, wherein the first and second planes intersect to give the annular elements a wedge-like appearance. Such a configuration permits adjacent thermally-transmissive elements 34 to be positioned very closely together, but it can limit the possibilities for deforming the thermally-transmissive region 26, which, in this embodiment, is flexible in the direction indicated by the arrow.

[0072] With respect to the embodiments shown in both FIGS. 3 and 4, the thermally-transmissive elements 34 are substantially rigid and are separated and/or joined by a flexible material 44. However, in other embodiments the thermally-transmissive elements 34 are flexible and are interdigitated with either rigid or flexible segments. FIG. 5, for example, illustrates an embodiment of the cryogenic catheter having three thermally-transmissive elements 34 that are flexible. The flexibility is provided by a folded or bellows-like structure 50. In addition to being shapable, a metal bellows can have enough stiffness to retain a selected shape after a deforming or bending step.

[0073] Instead of, or in addition to, flexible, thermally-transmissive elements 34 and/or flexible material 44 between elements, the distal tip 32 (or a portion thereof) can be deformable. For example, FIG. 6 illustrates a tip 32 having thermally-transmissive, flexible, bellows 50.

[0074] Referring now to FIGS. 7-10, a different approach is shown for providing multiple thermally-transmissive segments in a spaced-apart relationship. FIG. 7 illustrates a catheter embodiment having an elongate, thermally-transmissive region 26 that includes a helical coil 52 at least partially embedded in the flexible member 24. As shown in FIG. 8, at least a first portion 54 of the helical coil 52 is exposed to a fluid path within the flexible member 24 and a second portion 56 of the helical coil is exposed to the exterior of the flexible member. As described above with respect to FIG. 13, the first portion 54 of the coil can be substantially flush with, recessed below, or protruding from an inner surface 58 of the flexible member 24. Similarly, the second portion 56 of the coil 52 can be substantially flush with, recessed below, or protruding from an outer surface 60 of the flexible member 24.

[0075] In the embodiment of FIG. 8, the second portion 56 of the coil 52 is exposed along only a portion of the outer circumference of the flexible member 24 to define a longitudinally-elongate, thermally-transmissive region 26. This configuration can be provided by eccentrically mating the helical coil 52 to the catheter so that the longitudinal axis of the coil and the longitudinal axis of the catheter are substantially parallel. The eccentric positioning of the coil 52 provides excellent cooling performance because the surface area available for thermal exchange between the first portion 54 of coil and the cryogenic fluid is greater than the surface area available for thermal exchange between the second portion 56 of the coil and adjacent tissue where cooling power is delivered by each exposed coil portion to provide a linear lesion.

[0076] Referring now to FIG. 9, an alternative embodiment is shown wherein a first portion 62 of the coil 52 is exposed around the entire circumference of the flexible member 24, and a second portion 64 is exposed to a fluid path around the inner surface of the flexible member 24. This is achieved by having the longitudinal axis of the helical coil 52 co-axial with the longitudinal axis of the catheter.

[0077] In the embodiments illustrated in FIGS. 7-9, the coil 52 is solid. However, in other embodiments the coil can be an elongate, hollow, gas expansion chamber. For example, FIG. 10 illustrates a portion of a helical coil 52 that includes a passage that defines at least a portion of a fluid path through a flexible member of the catheter. The coil 52 defines a first fluid path diameter at a fluid entry point 66 and a second fluid path diameter that is greater than the first fluid path diameter at a gas expansion or boiling location 68. Gas escaping from a fluid exit point 70 can be exhausted through an open central region of the coil and/or another passage through the flexible member 24.

[0078] FIG. 11 illustrates an embodiment of the catheter wherein a continuous, elongate, thermally-transmissive strip 72 is longitudinally integrated with a flexible member 24. The strip can include a bellows-like structure. As described above with respect to other embodiments, a first portion of the strip can be substantially flush with, recessed below, or protrude from the outer surface of the flexible member. Similarly, a second portion of the strip can be substantially flush with, recessed below, or protrude from an inner surface of the flexible member.

[0079] Referring now to FIG. 12, an embodiment of the catheter is illustrated having a second or inner flexible member 74 within a lumen of first or outer flexible member 24, wherein the second flexible member defines a fluid path to the thermally-transmissive region 26. The inner member 74 can include a single opening 76 at or near the tip 32. Cryogenic fluid is expelled from the opening 76 and returns to the proximal end of the catheter along a fluid path defined by the outer wall of the inner member 74 and the inner wall of the outer member 24. This fluid path configuration is also partially illustrated in FIGS. 8, 9, and 13. Alternatively, as also shown in FIG. 12, the inner member 74 can be provided with multiple openings 78 proximate to and/or aligned with the inner face of one or more thermally-transmissive elements 34 to achieve more uniform cooling across the entire elongate, thermally-transmissive region 26.

[0080] Referring now to FIGS. 14-16, sectional views of catheter embodiments are illustrated to show alternative configurations for thermally-transmissive elements. The previously described thermally-transmissive elements 34 are arcuate and form complete and continuous 360 degree structures that traverse the complete circumference of the catheter, notwithstanding being flush with, depressed below, or raised above the outermost surface of the flexible member 24. However, the arcuate elements 34′, 34″, and 34′″ illustrated in FIGS. 14-16, respectively, traverse less than 360 degrees of the circumference of the first flexible member and do not form complete loops. For example, in FIG. 14, element 34′ defines an approximately 270 degree arc. In FIG. 15 the thermally-transmissive element 34″ defines an approximately 180 degree arc; and in FIG. 16, the thermally-transmissive element 34′″ defines an approximately 90 degree arc. A catheter can include combinations of element types, such as a complete ring or loop element, a 270 degree element and a 180 degree element as desired to define a thermally transmissive region. In addition to the having applicability with respect to rigid thermally-transmissive elements, the bellows-like elements can also be less than 360 degrees.

[0081] The less than 360 degree arcuate elements provide unique functional benefits with respect to thermal transfer and flexibility of the thermally-transmissive region. For example, because the portion of the catheter between the opposing ends of element 34′, 34″, 34′″ does not include a rigid structure, but rather only the resilient material of flexible member 24, the thermally-transmissive region of the catheter can be more tightly curved (gap between ends inward and element facing outward) than it could with complete 360 degree structures, especially if the elements are relatively long longitudinally.

[0082] The inner member 74 can be adapted to direct cooling fluid at only the thermally transmissive element(s) and the shape and/or the number of openings for cooling fluid can be configured differently depending on the length of the arc defined by the thermally-transmissive element(s). For example, FIG. 14 illustrates an embodiment of the inner member having three openings opposing the thermally transmissive element 34′; FIG. 15 illustrates two openings for a smaller arc; and FIG. 16 discloses a single opening for an even smaller arc.

[0083] Another advantage to providing one or more thermally-transmissive elements that have a less than 360 degree configuration is that limiting the span of the elements to a desired lesion width, or somewhat greater than a desired lesion width, reduces the thermal load on the system and/or permits colder temperatures to be achieved than with respect to a complete 360 degree structure. Unnecessary and perhaps undesirable cooling does not occur at any other location along the catheter except at an elongate region of predetermined width. A similar effect can also be achieved by providing a non-circular 360 degree element or by eccentrically mounting a circular 360 degree element with respect to the flexible member, wherein a portion of the 360 degree element is embedded within the wall of the flexible member or otherwise insulated from the cryogenic fluid path in a manner similar to that shown in FIG. 8.

[0084] Referring now to FIG. 17, a portion of the inner face of an outer flexible member showing in an exemplary embodiment, thermal transfer pins 80 protruding from the inner face of a thermally-transmissive element 34. The pins permit thermal transfer through the flexible member 24. As with the other features of the invention, the pins are equally suitable for complete 360 degree element structures or less than 360 degree structures. Although only pins are shown on any geometric or surface means to increase heat transfer including but not limited to pins, irregularities, channels or surface modifications may be used.

[0085] Referring now to FIG. 18, yet another embodiment of the catheter is shown wherein rigid metal rings 34a-c are interdigitated with flexible segments 44a-c to define a first flexible member and a thermally-transmissive region approximately one inch in length. A second flexible member is concentric within the first flexible member and has an outlet for cryogenic fluid at its distal end. Thermocouples 82a-c can be associated with one or more of the rings 34a-c.

[0086] It has been described above how the thermal loading of a cooling system can be reduced by providing thermally-transmissive elements that span less than 360 degrees. However, the thermal loading can also be reduced by sequentially cooling the thermally-transmissive region. One way to sequentially cool is to modulate the pressure of the cooling fluid along the fluid path through the flexible member. This modulation can be performed by the fluid controller which can be programmed to increase and decrease the pressure of the fluid by predetermined pressure increments over predetermined time intervals. When the cryogenic fluid is a liquid that provides cooling by changing phase from liquid to gas, the change of pressure alters the physical location along the fluid path where the phase change takes place and concomitantly changes the point of coldest temperature along the thermally-transmissive region. Thus, varying the pressure of the fluid can provide a moving ice-formation “front” along the catheter, enabling the creation of a linear lesion.

[0087] Therefore, a method of forming an elongate tissue lesion can include the following steps using any of the above described catheters having an elongate, thermally-transmissive region. In a first step a cryogenic fluid is introduced into the flexible member at a first predetermined pressure. Next, the pressure of the cryogenic fluid is incrementally increased within the flexible member until a second predetermined pressure is achieved. Similarly, the pressure of the cryogenic fluid within the flexible member can be decreased incrementally from the second predetermined pressure to the first predetermined pressure, wherein the steps of incrementally increasing and decreasing the pressure define a thermal cycle. Typically, from one to eight thermal cycles are required to achieve a desired therapeutic effect. In an exemplary method, about ten increments of about five seconds in duration are selected and pressure is increased by about 20 to 40 pounds per square inch in each increment. Thus, using this method an elongate lesion can be created in less than 20 minutes.

[0088] FIG. 19 is a table that illustrates sequential cooling in a catheter as described above having a thermally-transmissive region that includes a tip and three elements or rings. The table illustrates three tests conducted in a still bath at 37° C., using AZ-20 as the cryogenic fluid. Associated with each pressure increment are measured temperatures at the tip, first ring, second ring, and third ring. The shaded region illustrates the sequential movement of a target temperature range (upper −40's to low −50's) in response to a change in pressure. Although values are only provided for three rings, a similar effect and pattern is obtained with more than three rings or elements.

[0089] Turning now to FIG. 20, a thermally-transmissive portion of another embodiment of a medical device or structure such as a catheter is illustrated in a sectional view. The structure can include an inner passage or lumen as described above with respect to other embodiments, but which is not shown in this illustration for purposes of clarity. Thus, the illustrated portion is the outer passage or lumen that defines an elongate ablation region. Thermally-transmissive elements 84, such as gold plated copper, are joined to adjacent elements by resilient connecting elements 86, such as a stainless steel springs welded to the ends of the elements 84. A resilient bio-compatible material 88 covers the connecting elements 86 and the interstices between adjacent thermally-transmissive elements. In an exemplary embodiment, the material 88 is vulcanized silicone. It should be noted in the illustration that the surface of the elements 84 is contiguous and co-planar with the material 88 to provide a smooth outer surface.

[0090] FIG. 21 illustrates a single thermally-transmissive element 84 having reduced diameter ends 90 and 92. The wider central portion 94 provides an expansion chamber for gas (shown by arrows) exiting an apertured inner passage 96. FIG. 22 shows additional detail of the end 90 of the element 84. The end 90 is textured, such as by providing serrations 98, to provide a good adhesion surface for the material 88.

[0091] Referring now to FIG. 23, a thermally-transmissive portion of yet another embodiment of a flexible cryogenic structure is illustrated in a sectional view. In this embodiment an inner, apertured structure 100 has a flat wire 102 wrapped around it in a spiral manner. Thermally-transmissive segments 104 are disposed upon the wire 102 in a spaced-apart relationship, and a flexible, bio-compatible material 106 fills the interstices between segments 104. A thermocouple 108 can be associated with each segment 104. A wire 109 connects the thermocouple 108 to instrumentation near the proximal end of the structure. The exterior surface of the structure is smooth, and the structure can include 3 to 12 segments 104. In an exemplary embodiment the inner structure 100 is made of PTFE, the material 106 is 33 D PEBAX, and the wire 102 is stainless steel or Nitinol. An apertured inner passage (similar to that shown in FIG. 21) is placed within the structure.

[0092] FIG. 24 illustrates still another embodiment of a cryogenic cooling structure that includes a surface or wall 110 including a polymer or elastomer that is thin enough to permit thermal transfer. For example, polyamide, PET, or PTFE having a thickness of a typical angioplasty balloon or less (below 0.006 inches) provides acceptable thermal transfer. However, the thinness of the wall 110 allows it to readily collapse or otherwise deform under vacuum or near vacuum conditions applied to evacuate fluid/gas from the structure. Accordingly, the structure is provided with one or more supporting elements 112 such as a spring. The cooling structure is illustrated in association with a catheter 114 having a closed distal tip 116 and mono or bipolar ECG rings 118, 120, 122. The thermally-transmissive region is approximately 30 mm in length and is effective for thermal transfer over its entire circumference. However, as illustrated in FIG. 11, the thermally-transmissive region can be confined to specific region(s) of the device's circumference.

[0093] Referring now to FIG. 25, an embodiment of the catheter is illustrated having three flexible members or injection tubes 210, 211 and 212 disposed within a first or outer flexible member 200. In an exemplary embodiment, the inner flexible members 210, 211 and 212 are arranged in a staggered configuration within the outer flexible member 200. As used herein, term “staggered” may be used to designate both a linearly/axially staggered configuration or alternatively, a rotationally staggered configuration. The flexible members 210, 211 and 212 thus define multiple staggered fluid paths within the outer member 200. In such a configuration, the injection tubes 210, 211 and 212 allow for greater aggregate cooling power as well as the creation of a variety of different cooling/freeze zones 201, 203 and 205 along the length of the outer flexible member 200. In an exemplary embodiment, thermocouples 204 disposed along the outer surface of the outer flexible member 200 may be integrated with an internal feedback loop to provide independent and variable regulation of these freeze zones.

[0094] In an exemplary embodiment, the first inner member 210 includes at least one opening 214 positioned proximate an electrode ring member 207. Cryogenic fluid is expelled from the opening 214 and returns to the proximal end of the catheter along a fluid path defined by the inner wall 218 of the outer member 200, as shown in FIG. 26. Similarly, the second inner member 211 includes at least one opening 215 positioned proximate a second electrode ring member 208. Cryogenic fluid is also expelled from the opening 215 and returns to the proximal end of the catheter along the fluid path defined by the inner wall 218 of the outer member 200. Similarly, the third inner member 212 includes at least one opening 216 positioned proximate a third electrode ring member 209. Alternatively, the catheter can be provided with only two inner members, or four or more inner members, not shown, disposed within the outer member. The inner members would have one or more openings proximate to and/or aligned with the inner face of one or more transmissive elements, as described earlier herein, to achieve different regions of freeze zones across the entire elongate member. Alternatively, all the staggered inner members may be simultaneously provided with cryogenic fluid to create a linear lesion for selected applications. The flow of cooling fluid along the fluid paths through the flexible members can also be alternated in any number of patterns among the multiple inner members to provide a desired cooling pattern such as a discontinuous or a continuous lesion across the entire catheter.

[0095] In an exemplary embodiment, a catheter with a plurality of thermally conductive electrode rings would have an underlying injection tube or tubes controlling the release of cryogenic fluid to each electrode. Such a catheter could be placed in the coronary sinus or endocardially along the atrioventricular junction. Once positioned, an electrogram of interest is located using a specific electrode ring on the catheter. Coldmapping may be performed on the selected location to confirm the correctness of the location. Once, confirmed, the area is cryoablated using the same electrode ring. The same embodiments and others described herein are equally suited to other organs besides the heart and/or any body portion that would benefit from the application of thermal energy.

[0096] Referring now to FIG. 27, an embodiment of the catheter is illustrated having an outer member 220 with a fixed injection tube 230 disposed within a slidable sheath or overtube 240 therein. The injection tube and overtube are shown spaced apart for illustrative purposes only. Preferably, the injection tube is sized so that an outer surface of the injection tube engages an inner surface of the overtube while still allowing one member to slide or rotate relative to the other.

[0097] The fixed injection tube 230 has multiple openings 232, 234 formed thereon and the slidable overtube also has multiple openings or ports 242, 244 formed thereon. In one configuration shown in FIG. 27, opening 232 on the injection tube 230 coincides or is aligned with opening 242 on the slidable overtube 240. Thus, any fluid exiting the injection tube 230 from opening 232 is able to escape through opening 242.

[0098] As the slidable overtube 240 is slid or moved in a first direction as shown by arrow 236 along longitudinal axis 222, opening 232 is covered or blocked by the surface of overtube 240 as now shown in FIG. 28. In a second configuration shown in FIG. 29, opening 234 of injection tube 230 is aligned with opening 244 of overtube 240. In the same configuration, as shown in FIG. 30, opening 242 is not aligned with any opening formed on the surface of injection tube 230. Although only shown in two positions or configurations, the slidable overtube is positionable in any number of positions relative to the fixed injection tube. The overtube may also be used to partially cover the openings on the injection tube to provide for a limited or controlled flow of cryogenic fluid.

[0099] Depending on which opening of the injection tube is aligned with the openings formed on the overtube, cryogenic fluid is expelled from the opening and returns to the proximal end of the catheter along a fluid path defined by the inner wall 226 of the outer member 220. The non-aligned opening will not expel fluid since the opening will be blocked. Alternatively, the injection tube and overtube can be provided with three or more openings to achieve multiple cooling/freeze zones along the length of the catheter.

[0100] Referring now to FIG. 31, an embodiment of the catheter is illustrated having a slidable injection tube 260 disposed within a fixed sheath or overtube 270. As shown in FIG. 31, both the injection tube 260 and overtube 270 are disposed within a flexible outer member 250. The slidable injection tube 260 has multiple openings 262, 264 formed thereon which allows for the release of cryogenic fluid. The fixed overtube 270 also has multiple perforations or openings 272, 274 formed thereon which allows for the differential release of fluid as described in more detail below. The injection tube may be further provided with a thermistor 254 disposed proximate the distal end of the tube to provide thermistor feedback. In one embodiment, the openings can be controlled by miniaturized means such as micro or nanovalves.

[0101] In a first configuration shown in FIG. 31, opening 262 of the injection tube 260 coincides or is aligned with opening 274 of the fixed overtube 270. As the slidable injection tube 260 is slid or moved in a first direction as shown by arrow 266, opening 262 is then aligned with corresponding opening 272 on the overtube 270 in FIG. 32.

[0102] In this second configuration, as shown in FIGS. 32-34, openings 262, 264 of injection tube 260 are aligned with openings 272, 274 of overtube 270. Although only two configurations for the catheter are shown, the injection tube 260 is positionable in any number of locations relative to the fixed overtube 270.

[0103] In operation, cryogenic fluid is expelled from the openings and returns to the proximal end of the catheter along a fluid path defined by an inner wall 256 of the outer member 250. Alternatively, the injection tube 260 and overtube 270 can be provided with multiple openings proximate to and/or aligned with the inner face of one or more thermally-transmissive elements as described earlier herein to achieve more uniform cooling across the entire elongate, thermally-transmissive region.

[0104] Referring to FIG. 35, an embodiment of the catheter is illustrated having an outer member 280 with an injection tube 290 with multiple opposed openings 292-297 formed therein. Either the injection tube 290 or the overtube 300 may be slidable in a longitudinal plane to expose and/or cover one or more of the opposed openings on the injection tube 290. For example, as shown in FIG. 35, openings 294, 295 formed on the injection tube 290 are aligned with openings 302, 303 formed on the overtube 230. Furthermore, the injection tube may be positioned in a forwardmost position, not shown, to expose openings on the injection tube proximate the tip of the catheter. In this configuration, the injection tube would provide fluid to cool the area around the tip of the catheter.

[0105] In the embodiments described and shown above in FIGS. 32-35, electrode rings as shown in FIG. 25 may be provided along the outer surface of any of the outer members. The electrodes would serve both as electrical conductors and as a thermal transmitter at each location.

[0106] Referring to FIGS. 36 and 37, an embodiment of the catheter is illustrated have one or more rotatable members disposed within a flexible outer member 310. In this embodiment, the catheter includes an overtube member 312 and an injection tube member 314, one or both of which are rotatable with respect to one another. In an exemplary embodiment as shown in FIGS. 36 and 37, the injection tube 314 is rotatable relative to the fixed overtube 312. The injection tube 314 may be rotatable in either or both a clockwise and counterclockwise direction as indicated by arrows 320 and 322. As shown in FIG. 36, in a first configuration, opening 316 formed on the overtube 312 aligns with an opening 318 formed on the injection tube 314. As the injection tube 314 is rotated in a counterclockwise direction, the opening 318 on the injection tube 314 is placed out of alignment with the opening 316 formed on overtube 312, as shown in FIG. 37. Alternatively, the injection tube 314 may be fixed in the catheter while the overtube 312 is rotatable. In another embodiment, both the injection tube and overtube may both be rotatable. In yet a further embodiment, the injection tube and/or the overtube are rotatable and slidable within the outer member.

[0107] In the embodiments shown and described above, the slidable and rotatable inner and outer tubes may have openings so arranged as to allow the fluid releasing openings to be in a variety of open and closed configurations with a minimum of relational movement between the tubes. For example, as shown in FIG. 38, an outer member 330 has disposed therein one slidably disposed inner tube 336 which has openings 338 formed thereon in a constant sequence, and a matching slidably disposed outer tube 332 which has openings 334 formed thereon in a constant sequence of slightly different length or intervals. In this configuration, as shown in FIG. 39, small linear relational movements bring the openings on the outer tube 332 and the inner tube 336 into an overlapping configuration.

[0108] In addition, the openings as shown and described herein may be so shaped as to allow additional control of fluid release. For example, an outer hole could be tear-shaped and match up with an inner opening that is tear-shaped rotationally aligned 180 degrees oppositely not shown. As the two narrow ends begin to overlap with slidable motion, a tiny aperture is created. With further slidable motion in the same direction, larger areas of the two openings overlap and larger volumes of cryogenic fluid can be released.

[0109] Referring to FIG. 40, an exploded view of an exemplary system 340 is shown. The exemplary system 340 includes a catheter 342 connectable to a control unit 344. A fluid supply 350, for supplying fluid to the catheter 342, is connectable to the control unit 344 with a high-pressure hose 346 and regulator assembly 348. The fluid supply 350 can be, for example, a tank of pressurized argon gas. The fluid supply 350 can be secured within a housing 352, where the housing 352 includes a front portion 354 and a rear portion 356. Wheels 358 can be provided on the housing 352 to enhance portability of the system 340.

[0110] As shown in FIGS. 40 and 41, the control unit 344 is secured to the front portion 354 of the housing 352, and includes a display screen 358 and integrated keypad controls 360. The display screen 358 displays information including freeze duration, thermally-transmissive region temperature, current operation mode, and user messages. The integrated keypad 360 includes a temperature selector 362 for setting the target temperature of the thermally-transmissive region of the catheter 342, the temperature can for example be set in degrees C. A time selector 364 is used to set the duration of treatment. The time selector 364 records the freeze time in minutes and seconds and automatically stops the freeze upon completion of the selected time. To start the freeze the start button 366 is depressed. A stop button 368 is included, which can be used to stop the freeze prior to the expiration of the selected time. The control unit 344 further includes a vent button 370 to vent excess pressurized gas. A user message indicator 372 will be illuminated when a user message is displayed on the screen 358.

[0111] As shown in FIG. 42, an embodiment of the catheter 342 includes a handle 376 with a shaft 378 extending therefrom, where the shaft 378 includes a thermally-transmissive region 380 distal to the handle 376. Tubing 382 and connector 384 are affixed to the handle 376 for connecting the catheter 342 to the control unit 344. The handle 376 facilitates handling and manipulation of the shaft 378 and thermally-transmissive region 380, and can include controls for regulating the shape and function of the shaft 378 and the thermally-transmissive region 380.

[0112] The shaft 378 can be semi-rigid, having a rigidity such that the shaft 378 retains one shape until being influenced to a further shape by the application of moderate pressure on the shaft 378. The malleability stiffness of the shaft 378 can vary depending upon the desired application. The stiffness of the shaft 378 is generally such that a surgeon can bend the shaft 378 by hand to a desired contour with the application of moderate pressure. However, it is understood that its stiffness may, as a whole or in particular regions, may be such that additional tools, e.g., pliers, are required or desirable for exerting enough force to change the shape of the shaft 378. In an exemplary embodiment, the shaft 378 can have a length from about 15 cm to 60 cm.

[0113] Alternatively, the shaft 378 can be flexible, being passively or selectively deformable and can assume a linear, curved, circular or irregular shape as required to conform to a tissue surface to be treated. The shape of the shaft 378 can be controlled using pull wires and shims.

[0114] The thermally-transmissive region 380 can be flexible, being passively or selectively deformable and can assume a linear, curved, circular or irregular shape as required to conform to a tissue surface to be treated. The shape of the thermally-transmissive region 380 can be controlled using pull wires and shims. In an exemplary embodiment, the thermally-transmissive region 380 is made of metal or another material that readily conducts heat. For example, the thermally-transmissive region 380 can be made from nickel, copper, silver, gold, aluminum, stainless steel, or other suitable conductive material.

[0115] Alternatively, the thermally-transmissive region 380 can be semi-rigid, having a rigidity such that the thermally-transmissive region 380 retains one shape until being influenced to a further shape by the application of moderate pressure on the thermally-transmissive region 380. The malleability stiffness of the thermally-transmissive region 380 can vary depending upon the desired application. The stiffness of the thermally-transmissive region 380 is generally such that a surgeon can bend the thermally-transmissive region 380 by hand to a desired contour with the application of moderate pressure. However, it is understood that its stiffness may, as a whole or in particular regions, may be such that additional tools, e.g., pliers, are required or desirable for exerting enough force to change the shape of the thermally-transmissive region 380.

[0116] As shown in FIG. 43, an adjustable insulation sleeve 386 can be placed about the shaft 378 and the thermally-transmissive region 380, where the adjustable insulation sleeve 386 is actuated with a slidable lever 388 on the handle 376. The adjustable insulation sleeve 386 can be used to increase or decrease the exposed portion of the thermally-transmissive region 380, allowing for accurate lesion placement. Additionally, the adjustable insulation sleeve 386 protects adjacent tissue from being damaged. For example, where the thermally-transmissive region 380 has a longitudinal length of about 100 mm, the adjustable insulation sleeve 386 can be used to vary the exposed portion of the thermally-transmissive region 380 from about 10 mm to about 100 mm.

[0117] In an alternative embodiment, as shown in FIG. 44, a flexible insulation sleeve 390 can be placed about the shaft 378 and the thermally-transmissive region 380, where the insulation sleeve 390 includes a slotted segment 392, which only partially circumferences the thermally-transmissive region 380. The slotted segment 392 forms a partial circumferential blanket or insulating pad, which prevents thermal action from affecting tissue on one side of the thermally-transmissive region 380, while leaving the other side, exposed for contact with tissue.

[0118] Alternatively, the insulation sleeve 390 can have rigidity such that the insulation sleeve 390 retains one shape until being influenced to a further shape by the application of moderate pressure on the insulation sleeve 390. The malleability stiffness of the insulation sleeve 390 can vary depending upon the desired application. The stiffness of the insulation sleeve 390 is generally such that a surgeon can bend the insulation sleeve 390 by hand to a desired contour with the application of moderate pressure. However, it is understood that its stiffness may, as a whole or in particular regions, may be such that additional tools, e.g., pliers, are required or desirable for exerting enough force to change the shape of the insulation sleeve 390. Additional details regarding the malleable shaft and insulation feature are disclosed in U.S. Pat. No. 6,270,476 which is incorporated herein by reference.

[0119] The handle 376, shaft 278, and thermally-transmissive region 380 are substantially hollow and define a lumen to accommodate one or more conduits, wires and/or tubes that can ultimately extend to the distal end of the probe. Generally, the conduits and/or wires extend proximally from the handle 376 through the tubing 382 for connection to the control unit 344 as described above with respect to FIG. 40. In one embodiment, an electrical conduit, a vacuum conduit and a refrigerant conduit extend within the lumen. The electrical conduit provides a passageway for electrical leads to one or more devices, such as at least one thermocouple disposed within the distal portion of the probe for providing temperature information.

[0120] Referring back to FIGS. 5 and 6, the thermally transmissive region has a folded or bellows-like structure or configuration 50, where a bellows-like structure includes alternating larger and smaller annular diameters in a repetitive pattern along the length of the thermally transmissive region. As also shown in FIG. 45, an expanded view of the bellow configuration 50, the bellows configuration 50 includes a plurality of hollow annular extensions 394 joined together at their inner ends 396 and spaced apart at their outer radial ends 398. The hollow annular extensions 394 are joined in such a manner to allow the hollow annular extensions 394 to bend or deflect with respect to adjacent hollow annular extensions 394.

[0121] The multiple hollow annular extensions 394 are integrated about the circumference of and longitudinally traverse the thermally-transmissive region 380. The hollow annular extensions 394 are integrated with the thermally-transmissive region 380 such that the interior 400 of the hollow annular extensions 394 are exposed to the fluid pathway and fluid (shown by arrows). The hollow annular extensions 394 and thermally-transmissive region 380 are substantially hollow and define an outer lumen 402 to accommodate one or more inner lumens, wires and/or tubes that can ultimately extend to the distal end of thermally-transmissive region 380. For example, the controller 344, as shown in FIG. 40, allows or causes cryogenic fluid to flow from the cryogenic fluid supply 350 to the fluid path in the catheter 342 and thence through the thermally-transmissive region 380 and the hollow annular extensions 394 to thermally treat, ablate the desired area or to cold map along the same tissue area.

[0122] The longitudinal length of the thermally-transmissive region 380 and the radial height and spacing of the hollow annular extensions 394 are configured such that the thermally-transmissive region 380 can be deflected about a radius without impeding the fluid pathways through the thermally-transmissive region 380. The hollow annular extensions 394 also result in an increase in the surface area of the thermally-transmissive region 380. The longitudinal length “L” of the thermally-transmissive region 380 can be about 10 mm to 100 mm, and have a diameter “d” of about 1 mm to 6 mm. The hollow annular extensions 394 are spaced apart along the thermally-transmissive region's longitudinal length at a distance “w,” such that the thermally-transmissive region 380 can be deflected about an arc without the thermally-transmissive region 380 or the hollow annular extensions 394 kinking.

[0123] In an exemplary embodiment, the outer radial ends 396 and the inner ends 390 have about a 0.5 mm radius and the depth of the spaces between the hollow annular extensions 394 is about 2 mm. The hollow annular extensions 394 have limited axial compression and have a kink radius of less than 15 mm.

[0124] The thermally-transmissive region 380 is illustrated having three flexible members or injection tubes 404, 406, and 408 disposed within the outer lumen 402. The inner flexible members 404, 406, and 408 are arranged in a staggered configuration within the outer lumen 402. As used herein, the term “staggered” may be used to designate both a linearly/axially staggered configuration or alternatively, a rotationally staggered configuration. The flexible members 404, 406, and 408 thus define multiple staggered fluid paths within the outer lumen 402. In such a configuration, the injection tubes 404, 406, and 408 allow for greater aggregate cooling power as well as the creation of a variety of different cooling/freeze zones along the length of the outer lumen 402. Additionally, as shown in FIGS. 27-37, alternative configurations may be utilized for defining a fluid path into and out of the thermally-transmissive region 380.

[0125] Referring to FIG. 46, the handle 376 can include a heat exchanger where a helically coiled fluid supply line 410 is disposed within the outer lumen 402. The helically coiled fluid supply line 410 is connected to the injection tubes 404, 406, and 408, supplying fluid to the thermally transmissive region 380. The expanded gas is exhausted through the outer lumen 402 over the helical gas supply line, pre-cooling and condensing the incoming fluid allowing the thermally transmissive region 380 to obtain lower temperatures. The helically coiled fluid supply line 410 is made of metal or another material that readily conducts heat. For example, the helically coiled fluid supply line 410 can be made from nickel, copper, silver, gold, aluminum, stainless steel, or other suitable conductive material.

[0126] In one embodiment, as shown in FIG. 47, the helically coiled fluid supply line 410 is made with finned tubing, with numerous fins 412 throughout its length. The expanded gas is exhausted through the outer lumen 402 over the helical gas supply line 410 and between the fins 412, pre-cooling and condensing the incoming fluid allowing the thermally transmissive region 380 to obtain lower temperatures.

[0127] In an illustrative application, the exemplary system 340 is used to treat cardiac arrhythmias. Types of cardiac arrhythmias can include atrial fibrillation (AF), atrial flutter (AFL), ventricular tachycardia (VT), and superventricular tachycardia (SVT). The patient will in general be examined, for example with known cardiac mapping, fluoroscopy endoscopic camera and soft tissue imaging techniques, or such techniques in conjunction with a mapping catheter having the structure of the present invention together with mapping electrodes, so as to determine accurate anatomic heart characteristics and signal pathways, and to identify and map the location of tissue to be treated. Based on the patient's anatomy and treatment site, the shaft 378 and/or the thermally-transmissive region 380 is shaped to achieve an optimal configuration for reaching and orienting the ablation segment in physical contact with the target tissue for ablating a spot, line, or contour.

[0128] To access the treatment site, an opening is formed for insertion of the catheter 342 into the patient's body. For example, to ablate a linear line on the wall of the atrium, a chest opening provides access to the heart. The catheter 342 may be inserted into the atrium via a local cut to form, for example, an elongated lesion on the atrial wall. Most preferably, however, the catheter 342 of the present invention is used to form epicardial ablation lines, for example to reach around to the posterior outer surface of the heart and form ablation lines in an occluded region. In an illustrative treatment, the thermally-transmissive region 380 is brought into contact with the desired ablation site and maintained at a temperature (as measured internally of the segment) ranging from about 37 degrees Celsius to about −200 degrees Celsius, while resting in contact with the tissue site for a period of several minutes, e.g., about five minutes. The temperature as measured inside the tip may be correlated with a somewhat higher tissue interface contact temperature by empirical calibration measurements if desired in order to implement various treatment control regimens. The exemplary system 340 can also be used for the Maze procedure, and in conjunction with coronary artery bypass surgery (CABG) and mitral valve procedures.

[0129] A variety of modifications and variations of the present invention are possible in light of the above teachings. Specifically, although many embodiments are illustrated being slender and flexible, other embodiments may be thick and rigid, and introduced into the body directly through incisions or through structures such as trocars. The opening and closing of the catheter openings may also be controlled by using nanotechnology and miniaturized valving. Furthermore, although some of the illustrated devices are particularly well suited for cardiac procedures, the same embodiments and others are equally suited to other organs and/or any body portion that would benefit from the application of thermal energy. For example, the illustrated devices may be used for treating arteries for restenosis or portions of the GI tract to stop bleeding or portions of the GU tract to treat spasm, inflammation, obstruction or malignancy. Thus, the devices as shown are not to be limited to catheters but should be viewed more broadly as cryogenic structures or portions thereof. It is therefore understood that, within the scope of the appended claims, the present invention may be practiced otherwise than as specifically described hereinabove. All references cited herein are expressly incorporated by reference in their entirety.

[0130] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the invention, which is limited only by the following claims.