APPARATUS AND METHODS FOR ABLATING TURBINATES
Cross Reference to Related Applications
This application is a continuation-in-part of the following co-pending applications Application Serial No 08/265,459, "Thin Layer Ablation Apparatus", filed June 24, 1994, in the name of Stuart D Edwards, Each of these applications is hereby incorporated by reference as if fully set forth herein
BACKGROUND OF THE INVENTION
Field of the Invention This invention relates to apparatus and methods for ablating turbinates
Description of Related Art
In certain known medical conditions, the nasal structures (such as turbinates) can become enlarged, causing air space through the nasal passages to become restricted In these cases it would be desirable to reduce the size of the turbinates and thus alleviate the constriction of the nasal passages
Known methods of reducing the size of the turbinates include surgery and pharmaceutical treatment However, while these known methods achieve the goal of reducing the size of turbinates, they are subject to several drawbacks Surgery has the drawback that it is complex, difficult, expensive, and sometimes subjects the patient to risk which is disproportionate to the adverse medical condition Pharmaceuticals have the drawback that they are sometimes not completely efficacious or efficient, and that they sometimes have adverse side effects It sometimes happens that a patient is not a good candidate for surgery and is unable to achieve relief from pharmaceutical treatment Another known method for reducing the size of body structures is ablation Known methods of ablation include use of chemical or laser ablation, or the use of mechanical devices such as rotatable blades, and using radiated RF energy While known methods of chemical, laser, mechanical, or radiated RF energy ablation could achieve the goal of reducing the size of the patient's turbinates, these known methods have the drawback that they are difficult to
control and could therefore cause indiscriminate ablation of turbinates Indiscriminate ablation of turbinates can cause loss of the proper function of that body structure Since known methods of ablation have been unable to avoid substantial unnecessary loss of proper function of the patient's turbinates, these known methods have heretofore been inapplicable to turbinates Accordingly, it would be advantageous to provide improved apparatus and methods for ablation of turbinates
SUMMARY OF THR INVENTION The invention provides apparatus and a method for ablating at least a portion of a turbinate A catheter having a porous membrane coupled to a source of an exudable substance is disposed proximate to the turbinate, whereby the exudable substance is emitted from the catheter and contacts the turbinate In a preferred embodiment, an electrode is disposed proximate to the turbinate, whereby the exudable substance aids the electrode in delivering ablating energy to the turbinate The exudable substance is preferably a dielectric substance, such as saline, which aids in delivery of energy, and may include substances with other bioactive, chemoactive, or radioactive effects
The energy delivered to the turbinate is preferably RF energy which ablates the turbinate by heat and cell destruction The catheter is preferably coupled to an energy source which provides energy delivered to the turbinate
The catheter preferably includes at least one sensor, such as a temperature sensor, and a communication link coupling the sensor to apparatus which controls the energy source, whereby feedback from the sensor is used to control operation of the energy source The catheter may include a lumen which delivers the exudable substance to the porous membrane The porous membrane may be microporous, or may include holes which allow the exudable substance to flow out from the catheter
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows a cut-away cross section of a patient's nose, showing a nasal cavity and a set of turbinates.
Figure 2 shows apparatus for ablating turbinates.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Figure 1 shows a cut-away cross section of a patient's nose, showing a nasal cavity and a set of turbinates.
In a preferred embodiment, the patient is a mature adult human being. In alternative embodiments, the patient may be a child, a neonate, a fetus in utero. In further alternative embodiments, the patient may be an animal subject to veterinary medicine.
A patient's nose 100 comprises at least one nasal cavity 101; the nasal cavity 101 comprises a set of turbinates 102, including a middle nasal concha (turbinate) 103 and an inferior nasal concha (turbinate) 104. The inferior nasal concha (turbinate) 104 comprises an anterior portion
105 and a posterior portion 106.
Ablating the inferior nasal concha (turbinate) 104, and preferably ablating the anterior portion 105, does not substantially degrade the function of the inferior nasal concha 104. Ablating the inferior nasal concha (turbinate) 104, and preferably the anterior portion 105, can therefore be performed to achieve the goals of ablating the turbinates 102 without substantial suffering of disadvantages of ablating the turbinates 102.
Accordingly, a method embodying the present invention is to ablate the turbinates 102, but to limit that ablation to the inferior nasal concha 104, and preferably to limit that ablation to the anterior portion 105 thereof.
In a preferred embodiment, the anterior portion 105 is defined as being no larger than about one-third the volume of the inferior nasal concha 104. Thus, in a method embodying the present invention, when the anterior portion 105 is ablated, no more than about one-third of the inferior nasal concha 104 is ablated.
Apparatus for Ablating Turbinates
Figure 2 shows apparatus for ablating turbinates. A catheter assembly 200 comprises a catheter tip 201 and a catheter tube 202. The catheter tip 201 comprises an structure having a distal end 203, a proximal end 204, a center 205 having a lumen 206, and a surface 207. In a preferred embodiment, the catheter tip 201 has a straight elongated shape. In alternative embodiments, the catheter tip 201 may have another shape, such as a curved shape, or a shape adapted to fit into or to avoid a body structure, such as a curved shape disposed to fit inside a blood vessel or an eyelid. In a preferred embodiment, the catheter tip 201 is manufactured with a predetermined (straight) shape. In alternative embodiments, the catheter tip 201 may be bendable or otherwise malleable to adopt a selected shape, may be dynamically adaptable to shapes selected by an operator, or may be actively adaptive to take on new shapes as it encounters obstructions or other body structures. The center 205 of the catheter tip 201 is coupled to the catheter tube 202 at the proximal end 204 of the catheter tip 201, so that substances can flow from the catheter tube 202 into the lumen 206
In a preferred embodiment, the substance flowed from the catheter tube 202 into the lumen 206 comprises saline, the saline comprising distilled water with a NaCl content of less than about 10% by weight. In alternative embodiments, the flowed substance may comprise saline with another amount of salt or another salt, may comprise a solution of other substances in other water or other solvents, or may comprise a substance with bioactive, chemoactive, or radioactive effects, such as an ablative acidic or alkaline substance, an antibiotic, a compound used for chemotherapy, or a fluorescent or radioactive dye or marker, or some combination of these substances with each other or with some other substance.
The surface 207 of the catheter tip 201 comprises a sheath 208. The sheath 208 has a generally cylindrical shape, thus surrounding the lumen 206,
and comprises a plurality of holes 209 disposed so that substances can flow from the lumen 206 out through the sheath 208 to outside the catheter tip 201
In a preferred embodiment, the sheath 208 comprises a relatively inert and relatively hard substance, such as metallic copper or metallic silver. In alternative embodiments, the sheath 208 may comprise other relatively inert and relatively hard substances, such as gold, stainless steel, titanium, various plastic compounds, or some combination of these substances with each other or with some other substance
In a preferred embodiment, the sheath 208 has a traverse diameter of about 6 french One french is about 0 015 inches, thus 6 french is about 0 090 inches In alternative embodiments, the sheath 208 may have another size, such as less than 2 french, between about 2 to about 6 french, or more than 6 french In a preferred embodiment, the sheath 208 has a thickness of about 0 001 inches, this embodiment is particularly preferred in the case when the sheath 208 is copper The surface 207 of the catheter tip 201 also comprises a porous membrane 210 surrounding the sheath 208, disposed so that when substances flow out from the lumen 206, they encounter the membrane 210 and are trapped therein. As the membrane 210 is porous, the substances flow out through the membrane 210 and into proximity with the turbinate (specifically, the anterior portion 105 of the inferior nasal concha 104)
In a preferred embodiment, the membrane 210 comprises a microporous and inflatable balloon As the substances flow into the membrane 210, pressure from the flow causes the balloon to inflate and to come into contact with the turbinate's anterior portion 105
In a first preferred embodiment, the catheter tip 201 comprises at least one ring electrode 21 1 disposed proximate to the membrane 210 There may be a plurality of ring electrodes 21 1, disposed for example parallel with a first ring electrode 211 shown in figure 2 with their axes aligned with a long axis of the
catheter tip 201. The ring electrode 211 is coupled to a conductor 212 for coupling to an RF energy source 213
In a second preferred embodiment, a surface (preferably an outside surface) of the membrane 210 is disposed with a plurality of electrodes An example of a suitable surface for disposition on the membrane is shown in Application Serial No 08/319,373, "Thin Layer Ablation Apparatus", filed
October 6, 1994, in the name of inventors James Baker, et al , and hereby incorporated by reference as if fully set forth herein The surface is coupled to a conductor 212 for coupling to an RF energy source 213
In alternative embodiments, the catheter tip 201 may comprise a combination of the first and second preferred embodiment disclosed hereinabove may be used, such as a surface coupled using a conductor to a ring electrode 21 1 , which is itself coupled to a conductoi 212 for coupling to an RF energy source 213
RF energy is supplied by an RF energy source 213 In a preferred embodiment, the RF energy source 213 comprises a power source (or a power regulator coupled to a standard power source such as a wall socket or battery), a signal generator (such as a generator for pulses, sine waves, square waves, or some combination of these wave forms with each other or with some other wave form), and a processor for controlling the signal generator In a preferred embodiment, the signal generator generates pulses of RF energy having an RF radiation frequency between about 300 megahertz and about 700 megahertz, such as preferably about 465 megahertz In alternative embodiments, the RF energy may have an RF radiation frequency in the microwave range or in another range of the electromagnetic spectrum The processor controls the signal generator to generate pulses to provide an effective amount of RF energy so as to deliver between about 5 and about 30 watts of RF energy to the turbinate's anterior portion 105, so as to raise a temperature of at least a part of the turbinate's anterior portion 105 to a temperature between about 40 degrees Celsius and about 120 degrees Celsius, preferably above about 90 degrees Celsius
In a preferred embodiment, the exudable substance, preferably saline, acts as an electrode or an electrolyte for delivering RF energy to the turbinate's anterior portion 105.
The catheter tip 201 comprises at least one temperature sensor 214, such as a thermocouple or thermistor. The temperature sensor 214 is coupled to a communication link 215 (such as a conductor), which is coupled to the processor. For example, in the case where the temperature sensor 214 comprises a thermocouple, the communication link 215 may comprise a D/A converter coupled to a register disposed for reading by the processor The processor reads an sensor value from the sensor and, responsive thereto, controls the signal generator so as to achieve delivery of an effective amount of RF energy to the turbinate's anterior portion 105 The processor thus uses the signal generator, catheter tip 201, ring electrode 21 1, and temperature sensor 214 as a feedback loop for controlled delivery of RF energy to the turbinate's anterior portion 105 For example, the processor may control the delivery of RF energy to achieve delivery of a selected amount of energy, to achieve a selected temperature, or to achieve a selected amount of ablation of the turbinate's anterior portion 105 In alternative embodiments, the catheter tip 201 may comprise other sensors, in addition to or instead of the temperature sensor 214, such as a chemical or biochemical sensor to detect ablation.