BACKGROUND OF THE INVENTION1. Field of the Invention[0001]
The present invention relates to a cryoablation catheter, and more particularly to a cryoablation catheter for creating long lesions.[0002]
2. Description of the Prior Art[0003]
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 may 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, laser energy, extreme heat, and extreme cold may be provided by the ablation device to destroy the tissue.[0004]
With respect to cardiac procedures, cardiac arrhythmia may 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 mapping followed by the creation of one or more ablated regions (lesions) in the cardiac tissue using RF energy. Multiple lesions are frequently required. Often, five lesions, and sometimes as many as twenty lesions may be required before a successful result is attained. Sometimes only one of the lesions is actually effective.[0005]
Deficiencies of radio frequency ablation devices and techniques have been to some extent overcome by cryogenic mapping and ablation. Such cryogenic mapping techniques are in U.S. Pat. Nos. 5,423,807; 5,281,213 and 5,281,215. However, even though combined cryogenic mapping and ablation devices often times permit greater certainty and less tissue damage than RF devices and techniques, both cryogenic and RF ablation devices are usually configured for spot or circular tissue ablation.[0006]
Spot tissue ablation is acceptable for certain procedures. However, other procedures may be more therapeutically effective if multiple spot lesions are made 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 the ablation electrode is energized. U.S. patent application Ser. No. 09/518,044 entitled, “Cryoablation Catheter For Long Lesion Ablations,” assigned to the same assignee as the present invention disclosing the concept of “dragging” the ablation tip, or the cooling tip, of a cryoablation catheter along a line in order to create a long lesion. In order to accomplish this function, the cryogenic cooling nozzle is moved longitudinally along the inside of a cooling chamber to thereby cause the outer surface of the cooling chamber to be cooled along a linear path which in turn creates a linear lesion along the path.[0007]
SUMMARY OF THE INVENTIONIn accordance with one aspect of the present invention there is provided a cryoablation catheter system for creating linear lesions which includes an outer tubular member capable of insertion into the vessels of the body, a ceiling cap disposed at the distal end of the outer tubular member for forming a cooling chamber at the distal end of the tubular member, an inner tubular member slidably disposed within the outer tubular member. The proximal end of the inner tubular member is adapted to receive a fluid, such as nitrous oxide. A fluid expansion nozzle, such as a Joule-Thompson nozzle, is disposed on the distal end of the inner tubular member. The catheter system also includes a nozzle control system which is comprised of an inner ring member formed of a magnetic material which is mounted on the proximal end of the inner tubular member, and an outer ring member formed of magnetic material which is slidably mounted on the outer tubular member. Because of the magnetic attraction between these two magnetic members, when the outer ring member is moved along the outer tubular member it “pulls” or draws the inner magnetic ring member along with the outer magnetic ring member to thereby cause the inner tubular member to be moved longitudinally which in turn causes the fluid expansion nozzle to be moved longitudinally within the cooling chamber.[0008]
In accordance with another aspect of the present invention, the inner tubular member is disposed coaxially within the outer tubular member so as to define a passageway between the inner tubular member and the outer tubular member, and a cylindrical support member is disposed between the inner tubular member and the outer tubular member for supporting the inner tubular member for movement within the cooling chamber. The cylindrical support member includes at least one passageway which extends through the support member to permit fluid, such as, nitrous oxide, to be returned through the passageway for removal from the catheter system. In accordance with still another aspect of the present invention, the inner magnetic ring member is disposed coaxially within the outer tubular member and extends in the passageway between the inner tubular member and the outer tubular member, and includes at least one passageway which extends through the inner magnetic ring member to permit fluid to be returned through the passageway for removal from the catheter. In accordance with still another aspect of the present invention, the fluid expansion nozzle takes the form of a Joule-Thompson nozzle which is disposed on the distal end of the inner tubular member.[0009]
With the nozzle control system of the present invention, it is possible to provide a cryoablation catheter system for creating linear lesions by moving the fluid expansion nozzle in a longitudinal direction along the interior of the cooling chamber while maintaining an entirely sealed catheter system. In other words, by use of magnetic attraction which exists from an external ring magnet and an internal ring magnet it is possible to “pull” the fluid expansion nozzle along a longitudinal path within the sealed cooling chamber while maintaining a hermetically sealed catheter system.[0010]
These and other objects of the present invention will become more apparent when considered in view of the following description of a preferred embodiment of the present invention.[0011]
BRIEF DESCRIPTION OF THE DRAWINGSFurther properties, advantages and measures according to the present invention will be explained in greater detail in the description of a preferred embodiment, with reference to the attached figures in which:[0012]
FIG. 1 is a schematic view of a system for cryoablation with a catheter according to the present invention placed within a human heart;[0013]
FIG. 2 illustrates in detail the distal tip of the cryoablation catheter according to the present invention placed within a human heart;[0014]
FIG. 3 illustrates in detail the proximal end of the cryoablation catheter, the control handle and the coolant system including the cooling nozzle control system in more detail; and[0015]
FIG. 3A illustrates in more detail a cross sectional view of the cooling nozzle control system.[0016]
DESCRIPTION OF THE PREFERRED EMBODIMENTIn FIG. 1 a cryoablation catheter system[0017]1 according to the present invention has been illustrated with acatheter2. Thecatheter2 comprises anouter body3, aninner body6, a handle4 and adeflection knob5. Thedeflection knob5 is connected with theinner body6 and the handle4 with theouter body3, whereby thedeflection knob5 is movable in the axial direction of thecatheter2 in relation to the handle4 in such a way that the distal tip of theinner body6, where theinner body6 opens out into the lumen of theouter body3, is movable in an axial direction with respect to the distal tip of thecatheter2.
The[0018]deflection knob5 is connected via aheat exchanger25, aconnecting tube27 through acontrol unit24 and a valve8 with a gas cylinder7, containing N2O. By way of an alternative, or as an addition, also other substances than N2O may be used. Preferably, a fluid is used of which the cooling effect only occurs on expansion when it is ejected via theinner body6 close to the distal end of thecatheter2 into the lumen of theouter body3. This fluid will expand, as a result of which the cooling effect will be achieved. N2O meets this requirement with satisfactory results.
As illustrated in FIG. 1 the valve[0019]8 constitutes the control means with which the flow of N2O through theinner body6, and the pressure inside thisinner body6 is regulated. The pressure depends on the intended effect of the cryoablation at the distal tip of thecatheter2. In an embodiment of the present invention not illustrated here, thecatheter2 has been provided near to the distal end with measuring equipment, such as a thermocouple, which also forms part of the control means, in which case the valve8 is activated on the basis of the measuring results obtained at the thermocouple. In that case the measurement of the temperature is set to a target value established in advance, in order to effect the required degree of cryoablation.
The tip at the distal end of the[0020]catheter2 may also be provided with other measurement equipment to determine the position of thenozzle12 for instance. Examples of such measuring equipment are marking rings which are recognizable when using imaging techniques like MRI or when using x-ray radiation. Equipment to determine whether the surrounding tissue also needs to be ablated may be included here as well.
In the situation illustrated in FIG. 1, the distal end of the[0021]catheter2 has been introduced into a chamber of theheart10 and advanced to a position wheretissue14 is located which is suitable for ablation. It could however also concern here applications in a vein or at any other location. The only thing which is important, is that in the body cavity there is tissue, like thetissue14 illustrated here, which qualifies for ablation.
FIG. 2 is a detailed and partly cross-sectional view of the distal end of the[0022]catheter2 in a position for use. Theinner body6 opens out into theinternal lumen16 of theouter body3 close to the distal end of the catheter. Through the inner body6 a flow of N2O coolant is supplied, which is ejected via anozzle12, which preferably takes the form of a Joule-Thompson nozzle, so that acold zone13 is created. In the immediate proximity of thiscold zone13, at thenozzle12 of theinner body6, the coldness created on the outside of theouter body3 is such thatice15 is formed and thetissue14 is ablated.
As has been described in connection with FIG. 1, the[0023]deflection knob5, which is connected with theinner body6, is movable in relation to the handle4, which is connected with theouter body3. In this manner thenozzle12 at the distal end of theinner body6 is moved in relation to theouter body3. In the situation illustrated here, theouter body3 on the other hand has in the meantime become stuck in theice15, and is consequently no longer movable. Theinner body6 and, in particular in the proximity of thenozzle12 hereof, a sliding block11 has been arranged around theinner body6 close to thenozzle12, which functions as a distancing body. The dimensions of the sliding block11 correspond to those of theinternal lumen16 of theouter body3, so that it can move freely up and down in theouter body3 in the direction indicated by arrow “A,” in which changes can be made in the position of the nozzle2012. The sliding block11 also includes passageways11awhich extend through the sliding block. The sliding block11 is provided with the passageways11ato allow the coolant fluid to flow back from the cooling chamber.
All components of the catheter illustrated here have preferably been made of materials which do not shrink together due to expansion or contraction of the materials.[0024]
In the embodiment illustrated here, the[0025]outer body3 has been closed off by means of aclosure17.
The catheter system illustrated in FIG. 3 includes a[0026]catheter2. The proximal end of thecatheter2 carries a handle4, with which the catheter has been received in thedeflection knob5. Apressure line23 extends from the proximal end of thecatheter2 to the distal end. Thepressure line23 supplies high pressure refrigerant to the distal end of the catheter.
FIGS. 3 and 3A also illustrate in more detail the[0027]nozzle positioning mechanism5awhich is comprised of anouter ring40 formed of a magnetic material which is slidably mounted on acylindrical piston42. The outer magnetic ring is hermetically sealed within apolymer layer44. Aninner ring46 extends around and is fixedly attached to theinner body6. Theinner ring46 is also formed of a magnetic material. In addition, the inner magnetic ring includesmultiple passageways47 which serve to permit the cooled fluid to be removed from thecatheter system2. As previously described, the coolingnozzle12 is mounted on the distal end of theinner body6. Accordingly, as the outermagnetic ring40 is moved along thecylindrical piston42, it causes the innermagnetic ring46 to be pulled along through magnetic attraction. As theinner ring46 is pulled along, it causes the inner body to be moved which in turn draws the coolingnozzle12 along a longitudinal path through the cooling chamber. Accordingly, the wall of the cooling chamber is cooled along the path of travel of the coolingnozzle12. This path of travel creates a linear lesion along the line of contact between the cooling chamber and adjacent tissue.
The expanded gaseous fluid flows, via the discharge channel formed by the[0028]internal lumen16 in the catheter body and through the passageways11aback to the proximal end of the catheter. The discharge channel of the catheter body is connected in a suitably sealed-off manner with theline32 in thedeflection knob5.
To achieve sufficient cooling effect in the tip of the[0029]catheter2, the refrigerant is pre-cooled in theheat exchanger25, before it is introduced into the catheter. The cooling means illustrated schematically in FIG. 3 comprises an insulatedcooling chamber26, through which a connectingpressure tube27 extends in a helical pattern. Thepressure line23 is connected with thisconnection tube27. The fluid under pressure is supplied to theconnection tube27 from a refrigerant source illustrated here as a gas cylinder7. The required quantity is regulated by means of theadjustable valve29.
Preceding the valve[0030]29 a line branches off from the refrigerant line which, via arestriction34, opens out into the coolingchamber26. The quantity of fluid supplied to the coolingchamber26 is regulated by the size and the dimensions of therestriction34 and thecontrol valve30. On passing therestriction34 the refrigerant expands in thechamber26 and removes heat from the surroundings, that is to say from the refrigerant flowing through the connectingtube27 which is cooled as a result. The expanded fluid is extracted from thechamber26 through theline31, so that a sufficient pressure difference is maintained across the restriction.
As shown in FIG. 3, a[0031]temperature sensor22 has been arranged at the proximal end of the pressure line, which is connected via a signal line21 with a temperature measuring device. In this way it is possible to check the temperature of the refrigerant supplied to the proximal end of thepressure line23. Thecontrol valve30 may be regulated on the basis of the temperature measured. In another embodiment, thecontrol valve30 may be regulated by a control means on the basis of the temperature measured with thesensor22.
A temperature sensor (not shown) may also be placed at the tip of the[0032]catheter2. By means of this temperature sensor the temperature at the tip of thecatheter2 may be monitored. The value measured by this sensor may be used to adjust theadjustable valve29. Alternatively, theadjustable valve29 may be regulated automatically in response to the temperature measured at the tip.
The catheter device according to the invention is for instance used to ablate surface tissue inside the heart, when treating certain cardiac arrhythmias.[0033]
Because of the relatively high heat resistance coefficient of the material of which the[0034]pressure line23 has been made, the pre-cooled fluid will at the most absorb only little heat from the surroundings. Inside theouter body3 of thecatheter2 thepressure line23 forming theinner body6 extends through the central lumen. The expanded gas which is being removed from the tip flows through this lumen. This expanded gas has initially a very low temperature and is only heated to limited degree in the tip. The gas flowing through thelumen16 forming the discharge channel consequently still has a low temperature, so that as a result none or only little heating of the refrigerant supplied under pressure will take place.
It should be noted that only a possible embodiment has been illustrated. Other embodiments are possible as well. The[0035]heat exchanger25 for instance may be integrated into thedeflection knob5. Thepressure line23 may in that case be surrounded along more or less its entire length by expanded fluid which is being discharged, so that the temperature of the pressure fluid may be controlled accurately. Alternatively, the nozzle configuration may be radially placed inside the distal end of the pressure tube, or in other possible configurations.
These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.[0036]