Patent Grant
8439907
Medical technology has made various attempts to treat internal pathologies such as uterine fibroid tumors, cervical neoplasia and HPV lesions, prostate hyperplasia or cancer, liver cancer, malignant bone and soft tissue sarcoma, and other tissue pathologies. In some instances, rigid needle systems have been devised for purposes of mechanically penetrating tissue and delivering treatment to the tissue. Such systems, however, are difficult to use, particularly when tortuous paths must be followed to reach the target tissue and when the tissue to be treated is resistant to entry of such needles. What is needed is a delivery system for a flexible catheter that can penetrate and destroy tissue masses or tumors of variable size and hardness.
Described herein are various embodiments of an integrated multi-purpose catheter configured for insertion into tissue of a patient for treatment of the tissue. In at least one embodiment, the catheter comprises a radio frequency (RF) electrode and an insulating sleeve. The RF electrode has an elongated body configured to conduct electrical RF energy to a conductive tip at a distal end of the elongated body. The insulating sleeve surrounds the elongated body to suppress inadvertent shunting of RF energy from the elongated body when the catheter is being inserted into the patient's tissue.
In a first mode of operation for insertion of the catheter into the tissue of a patient, the conductive tip of the RF electrode is exposed outside the insulating sleeve. The RF electrode is configured to deliver, via the conductive tip, RF energy capable of producing sparks that erode the tissue of the patient and create a tunnel through which the catheter can advance into the tissue of the patient.
In a second mode of operation for treatment of the tissue in the patient, the insulating sleeve is retractable to expose a portion of the RF electrode between the conductive tip and the insulating sleeve. The RF electrode thereafter conducts non-sparking RF energy to the tissue in the patient. The non-sparking RF energy is able to heat the tissue surrounding the RF electrode to necrotize the tissue.
The insulating sleeve may be adjustably retracted to expose a desired portion of the RF electrode in accordance with a desired volume of tissue to be necrotized. Generally speaking, exposing a larger portion of the RF electrode will produce a greater volume of tissue destruction, while exposing a smaller portion of the RF electrode will produce a smaller volume of tissue destruction.
In combination with, or separate from, the features described above, the catheter may further comprise a visualization apparatus that is operable to visualize the tissue surrounding the RF electrode. For example, in one embodiment, ultrasound imaging may be used. Visualization of the surrounding tissue can be used to determine the amount of the RF electrode to expose when retracting the insulating sleeve. Alternatively, or in addition, the visualization apparatus may be used to observe treatment-induced changes, such as bubbles, in the heated tissue to track the progression of treatment of the tissue.
In combination with, or separate from, the features described above, the catheter may further comprise a lumen configured to deliver a biocompatible electrically-resistant fluid that fills a volume around the RF electrode within the insulating sleeve when the catheter is in the first mode of operation.
Likewise, in combination with, or separate from, the features described above, the catheter may further comprise a lumen configured to deliver a biocompatible electrically-conductive fluid that perfuses the tissue surrounding the exposed portion of the RF electrode. The electrically-conductive fluid, such as a hypertonic saline or other electrolyte, increases the electrical conductivity of the tissue and enhances the volume of the tissue that is necrotized when RF heating energy is applied in the second mode of operation. Alternatively, or in addition, the biocompatible fluid may comprise a thermally-activated chemical adjuvant configured to aid in necrotizing the tissue with reduced thermal dosage. The lumen may also be a multi-purpose lumen configured to selectively deliver both a biocompatible electrically-resistant fluid, as referenced above, in the first mode of operation, and a biocompatible electrically-conductive fluid, as referenced above, in the second mode of operation.
In addition, the catheter may further include a second lumen that is configured to conduct fluid away from the tissue of the patient. In cooperation with the second lumen, a conveyance mechanism such as a pump, syringe, auger, etc., may be used to help draw the fluid (including, possibly, debris) away from the tissue.
In combination with, or separate from, the features described above, the catheter may further comprise a lumen configured to deliver a debriding agent that degrades the necrotized tissue.
In combination with, or separate from, the features described above, the catheter may further comprise a sleeve electrode disposed on the insulating sleeve. In the second mode of operation, the insulating sleeve is retractable to expose a portion of the RF electrode between the conductive tip and the sleeve electrode. The RF electrode is configured to conduct electrical RF energy to or from the sleeve electrode through the surrounding tissue in the patient. If desired, the sleeve electrode may be switchable to a non-conducting state in which the sleeve electrode is electrically isolated from RF energy conducted by the RF electrode. By switching the sleeve electrode into a non-conducting state, the catheter may operate in a monopolar mode of delivering RF energy.
Further, if desired, a plurality of sleeve electrodes may be disposed on the insulating sleeve. In such an embodiment, when the catheter is in the second mode of operation, each of the sleeve electrodes may be configured to separately and selectively switch between a conducting state and a non-conducting state. In the conducting state, a sleeve electrode is configured to conduct the RF energy to or from the RF electrode. In a non-conducting state, the sleeve electrode is electrically isolated from the flow of RF energy.
In combination with, or separate from, the features described above, the catheter may further comprise one or more temperature sensors that are configured to sense the temperature of the surrounding tissue to guide the delivery of the RF energy when the catheter is in the second mode of operation.
The present application also describes a method for inserting a catheter as described above into tissue of a patient for treatment. The method, in at least one embodiment, includes positioning the insulating sleeve to expose the conductive tip of the RF electrode; delivering first RF energy to the conductive tip in a first mode of operation for insertion of the catheter into the tissue of the patient, wherein the first RF energy produces sparks that erode the tissue of the patient and creates a tunnel through which the catheter advances into the tissue of the patient; and while in a second mode of operation for treatment of the tissue of the patient, retracting the insulating sleeve to expose a portion of the RF electrode between the conductive tip and the insulating sleeve, and conducting second RF energy from the RF electrode to the tissue in the patient, wherein the second RF energy heats the tissue surrounding the RF electrode for necrotization of the tissue without producing sparks.
As described above, the insulating sleeve may be adjustably retracted to expose a desired portion of the RF electrode in accordance with a desired volume of the tissue to be heated for necrotization. The tissue surrounding the RF electrode may be visualized to determine the amount that the insulating sleeve should be retracted. The method may also comprise visualizing the tissue surrounding the RF electrode to track the progression of treatment by observing treatment-induced changes in the heated tissue.
Furthermore, as described above, a biocompatible electrically-resistant fluid, a biocompatible electrically-conductive fluid, a thermally-activated chemical adjuvant and/or a debriding agent may be delivered to the catheter and/or to the tissue of the patient.
In combination with, or separate from, the method elements described above, the method may additionally comprise withdrawing the catheter from the tissue that was treated in the second mode of operation and repeating a delivery of RF energy via the conductive tip. In this instance, the RF energy is used to precipitate shrinkage of the patient's tissue and/or produce an area of coagulation that seals the tunnel in the treated tissue. In one aspect, this seal may act to prevent the flow of fluids, such as a chemical adjuvant or debriding agent, out of the tunnel. If desired, the catheter may thereafter be reinserted into a different location in the patient's tissue and the treatment repeated, which may be advantageous when treating large fibroids or tumors.
A catheter as described herein may also be combined with a rigid guide for directing the catheter into the tissue of a patient. The guide has a hollow core that is sized to receive the catheter and allow the catheter to extend therethrough. Visualization apparatus is used to obtain an image of the tissue of the patient, wherein, in the first mode of operation, the catheter is extendable from a distal end of the guide into the tissue of the patient. Using RF sparking energy, the catheter creates a tunnel in the tissue of the patient in a direction determined by the position of the guide. Thereafter the catheter uses RF heating energy to treat a volume of tissue surrounding the catheter.
In accordance with another embodiment, an RF electrode and an insulating sleeve are used to create a tunnel or lumen into a tissue site to be treated. At least one of the RF electrode or the insulating sleeve is retracted from the tissue site and a second treatment apparatus is used to treat the tissue. If the insulating sleeve is fully retracted, the shaft of the RF electrode can be used as a guide wire to guide the second treatment apparatus to the treatment site. If the RF electrode is fully retracted, the remaining insulating sleeve can be used as a guide catheter to guide the second treatment apparatus to the treatment site. Examples of secondary treatment apparatus include a linear array of ultrasound transducers, an array of cylindrical ultrasound transducers, a spherical ultrasound transducer, a liquid delivery/removal catheter, a microwave catheter and an RF loop.
In yet another embodiment, both the RF electrode and insulating sleeve can be fully retracted from the body leaving a tunnel or lumen that leads to the tissue site to be treated. A second treatment apparatus is routed through the tunnel to the tissue site.
It should be understood that the foregoing summary introduces only a selection of concepts in simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter.
The foregoing aspects and many of the attendant advantages of this invention will become more readily appreciated as they become better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
As will be appreciated from the description herein, various implementations of a catheter can be used to penetrate tissue of a patient for treating various internal pathologies of the patient. Minimally-invasive surgery may thus be conducted in various parts of a patient's body.
In particular, the implementations described herein facilitate the insertion of a catheter through a cavity or tunnel that is created in the patient's tissue to reach intended target tissue for treatment. These implementations of a catheter can be applied to any part of the patient's body. As may be appropriate, the catheter may initially be inserted percutaneously, or alternatively the catheter may be transported through existing body orifices and cavities. Endoscopes, laparoscopes, transport catheters or probes can be employed to position the catheter near the tissue to be treated. For example, for treatment of a uterine fibroid, an implementation of a catheter as described herein may be transported transvaginally to a position in the vaginal or uterine cavity, after which the catheter is directed toward the tissue to be treated. For purposes of illustration, the implementations herein are shown and discussed in the context of using radio frequency (RF) energy for treatment of tissue in the patient, though other energy delivery systems, modalities, and therapies may be used to accomplish the desired treatment.
Surrounding the elongated body 16 is a hollow core insulating sleeve 20. The elongated body 16 extends axially through the interior of the insulating sleeve 20. The insulating sleeve 20 is configured to prevent electrical RF energy conducted by the elongated body 16 from being inadvertently transmitted by the elongated body 16 to the tissue of the patient surrounding the elongated body 16 when the catheter 12 is being inserted into the tissue of the patient. The dimensions of the insulating sleeve 20 may vary according to the particular implementation of the catheter 12, particularly in relation to the elongated body 16 of the RF electrode 14. For convenience of illustration,
As further depicted in
In an embodiment as depicted in
The catheter 12 is configured to operate in different modes of operation. In a preferred embodiment as described herein, the catheter 12 is configured to operate in a first mode and second mode of operation. Prior to discussing the different modes of operation of the catheter 12, it is helpful to first observe other features that may be included in the catheter system 10 as shown in
As indicated in
During either the first or second mode of operation of the catheter 12, a return channel may be used to convey fluid away from the tissue of the patient. For that purpose, the embodiment shown in
The conveyance mechanism 62 is an optional feature, as are the fluid sources illustrated in
It should be recognized that
The catheter 12 is configured to use an electrical discharge from the tip 18 for ablating tissue of the patient to create a cavity or tunnel in the tissue through which the catheter 12 can advance into the tissue of the patient. By using an electrical discharge at a radio frequency, hazards from electric shock are minimized since radio frequency is above the neuromuscular threshold for reacting to such electrical discharge. Furthermore, by delivering RF energy at a magnitude that produces electric sparks, one is able to hemostatically ablate and penetrate hard or soft tissue at the tip 18 of the electrode 14. Provided that the tissue of the patient is electrically conductive and contains volatile elements such as water, the RF sparking energy causes a rapid and explosive expansion of water vapor bubbles, for example, when the RF sparks enter the tissue and cause heating at a microscopic level. Small pockets of steam in the intracellular or interstitial fluids cause rupture of the cells, thus permitting the electrode 14 to advance with greater ease into the tissue of the patient.
Proceeding to
The sparking discharge illustrated in
In this mode of operation, the insulating sleeve 20 is positioned adjacent the ceramic insulator 19 to insulate the elongated body 16 of the RF electrode 14 from the tissue of the patient. This minimizes any unintended leakage or shunting of RF energy from the elongated body 16 to the adjacent tissue of the patient. The RF sparking energy is thus concentrated at the tip 18 of the electrode 14.
Once the catheter 12 has tunneled through the tissue of the patient to the desired position in the tumor mass 72, the delivery of the RF sparking energy is terminated. The catheter 12 thereafter proceeds to a second mode of operation for treatment of the tumor mass 72 in the patient.
In the second mode of operation, the insulating sleeve 20 is retracted to expose a portion 24 of the RF electrode 14 between the conductive tip 18 and the insulating sleeve 20, as illustrated in
Persons having ordinary skill in electrode design will recognize that various materials, including memory metals, may be used to construct the RF electrode 14. One example of a surgical-grade material that is suitable for constructing the RF electrode is Nitinol. Nitinol is a superelastic memory alloy well known for its ability to bend around tight corners, yet retain its original form without fatigue or metallic yield.
In some cases, the conductive tip 18 and/or the body 16 of the RF electrode 14 may be coated with known materials or etched with known patterns to more easily observe the position of the RF electrode 14 in the patient via enhanced radiopacity or ultrasonic echogenicity, respectively. The tip 18 may be comprised of a thermally refractory metal alloy, such as platinum-iridium, for example, to reduce the erosion of the metal surface of the tip 18 when RF energy is delivered via the tip. At present, it is anticipated that the elongated body 16 of the RF electrode 14 may measure (in diameter) in the range of 0.004 to 0.060 inches in diameter. For example, an embodiment of the RF electrode 14 may be made of Nitinol having an outside diameter in the range of 0.010 inches in order to have adequate flexibility to turn corners, such as at a launch point as shown in
After sufficient RF energy has been delivered to the tissue 72 to achieve the desired heating and necrotization of the tissue, the delivery of the second RF energy may be terminated, after which the catheter 12 may be withdrawn from the tissue of the patient. Normal body processes that break down the necrotized tissue, including the action of microphages, will eventually cause the necrotic tissue 72 to be eliminated and/or absorbed.
During the first mode of operation of the catheter 12 as illustrated in
After the catheter 12 has tunneled to a desired position in the patient, as shown in
The first lumen 54 and the second lumen 56 depicted in
The embodiment in
To help increase the size of the thermal lesion in the patient's tissue 72 (e.g., as illustrated in
If desired, the catheter 12 may be configured to conduct fluid away from the tissue surrounding the RF electrode 14 through the second lumen 84, as illustrated in
As further depicted in
In the second mode of operation for treatment of tissue in the patient, as illustrated in
In both
As may be appreciated from the foregoing description, a multi-purpose lumen may be configured to deliver the electrically-resistive fluid 34 as well as the electrically-conductive fluid 36 to the catheter 12. The multi-purpose lumen may also be configured to conduct other types of fluid. For example, during or after the period in which the tissue of the patient is necrotized in the second mode of operation, the multi-purpose lumen may be configured to deliver a debriding agent from the source 40 shown in
In yet another embodiment, a thermally-activated chemical adjuvant may be delivered separately or in connection with delivery of the electrically-conductive fluid that perfuses the tissue surrounding the RF electrode in the second mode of operation. A thermally-activated chemical adjuvant is configured to aid in necrotizing the tissue with reduced thermal dosage. For example, heat-sensitive liposomes or other heat-sensitive blood-borne vehicles may thus be used to deliver therapeutic agents of various types, e.g., antitumor agents, cytotoxic drugs, debriding enzymes, and/or wound-healing stimulants, when hyperthermia-inducing energy is applied to the target tissue. One example of a commercially-available, heat-activated liposome is available under the name ThermoDox from Celsion Corporation of Columbia, Md. Heat-sensitive liposomes may also be configured to carry proteins that either digest the necrotized tissue or induce the body's own immune response. The liposomes are prepared to release the proteins when a threshold temperature in the tissue is reached. This threshold temperature may be lower than the temperature required for destruction of the tissue by heating alone.
In some circumstances, to ensure the thermally-activated chemical adjuvant reaches the tissue to be treated, it may be appropriate to inject the chemical adjuvant into the patient's bloodstream which is circulated throughout the body. Alternatively, the thermally-activated chemical adjuvant may be injected directly into the targeted tissue. An implementation of a catheter 12 may include one or more needles that can be extended from the catheter during or after the RF tunneling is completed. The needles are preferably configured to deliver the thermally-activated chemical adjuvant to the tissue to be treated prior to delivery of the RF heating energy. Lower temperature treatment is advantageous in that it creates less thermally-fixed tissue which the body may not be able to reabsorb, and thus allows greater shrinkage of the treated tissue 72 post treatment.
The RF generator 32 may be a dual-purpose generator configured to switchably deliver to the RF electrode 14 said first RF energy that is capable of producing sparks to erode the tissue near the tip 18 of the RF electrode and said second RF energy that is capable of heating the tissue surrounding the RF electrode 14 without producing sparks.
The embodiment shown in
In still another embodiment, the catheter 12 may include a plurality of sleeve electrodes 104, 106 disposed on the insulating sleeve 20, as depicted in
In
In
In this manner, by switching the sleeve electrodes 104, 106 between a conducting state and a non-conducting state, a variable volume of tissue in the patient may be treated. In addition to controlling the volume of heated tissue, selective switching of the sleeve electrodes 104, 106 between the conducting and non-conducting states also provides control over the temperature of the heated tissue as the flow of electrical energy through the variable tissue volumes is controlled.
As can be appreciated from the foregoing discussion, the volume of tissue destruction in the tissue 72 being treated may be controlled via a number of factors which can be chosen by design. These factors include the shape and size of the RF electrode 14; the spacing of electrode elements such as the conductive tip 18, the exposed portion 24 of the RF electrode 14, and the sleeve electrodes 100 or 104, 106; the use of electrical conduction-enhancing fluids; the length of exposure of the tissue to RF heating energy; the magnitude of the RF heating energy; the suppression of convective flow through the tissue 72; the number of electrodes; the choice of monopolar or bipolar mode of energy delivery; and/or the choice of electrical waveform and duty cycle in delivering the RF energy to the tissue.
In the discussion above, the catheter 12 is shown directly tunneling through the patient's tissue 70 into the tumor mass 72. In further embodiments, the catheter 12 may be transported internal to the patient tissue by way of an additional transport mechanism, such as a probe with or without visualization apparatus. For example,
During initial delivery, as illustrated in
After placing the probe 120 in an approximate nearby position, the transducer array 122 on the probe 120 may be used to obtain a smaller but finer view of the tissue to be treated. With the finer imaging provided by the transducer array 122, the probe 120 can be properly positioned so that, when forward pressure is placed on the catheter 12, the catheter 12 will launch from the exit port of the probe 120 in the desired trajectory towards the tissue to be treated.
The exit port of the probe 120 may be placed within the transducer array 122, as depicted in
The embodiment shown in
Alternatively, in the embodiment shown in
In at least one embodiment, the catheter 12 is flexible yet stiff enough to stay on a straight course once launched out of the exit port and tunneling through the tissue of the patient. Alternatively, the catheter 12 is constructed with pull wires inside the insulating sleeve 20 that permit active steering of the tip 18 at the time of launch of the catheter 12, as well as later during the RF tunneling through the patient's tissue. Under the guidance of ultrasonic visualization, such active steering of the catheter tip 18 can be used to fine tune the trajectory of the catheter 12 as it approaches a tumor or lesion to be treated. This allows for midcourse corrections of the penetration of the catheter system if the original launch direction was incorrect.
As a further alternative to pull wires in the catheter 12, active steering of the tip 18 may be obtained by connecting a bi-metal strip to the tip 18. Where the metals forming the bi-metal strip have different thermal expansion coefficients, the curvature of the bi-metal strip may be controlled by controlling the temperature of the strip. Because the bi-metal strip is connected to the tip 18, the variable curvature of the strip may be used to actively steer the tip 18.
As previously described, in the first mode of operation of the catheter 12 shown in
The particular embodiment shown in
With other embodiments of the catheter 12, alternative apparatus for visualizing the tissue of the patient may be used. For example, insertion of the catheter 12 into tissue of a patient may be guided visually (e.g., hysteroscopically, laparoscopically, or by direct vision) or by fluoroscopy, computed tomography (CT), magnetic resonance imaging (MRI), etc. In yet another alternative embodiment, the catheter 12 and deflecting mechanism 124 may be piggybacked onto a commercially-available linear array catheter or probe to avoid unnecessary design and manufacturing cost of a custom-made probe 120. In circumstances where ultrasound imaging is used, it is also advantageous to provide a coupling gel or fluid that fills any space between the ultrasound transducer array and the tissue being imaged. Thus, the probe 120 may include one or more channels to convey such coupling gel or fluid to the interface between the ultrasound transducer 122 and the tissue 72 being imaged. Alternatively, the site of this interface may be immersed in coupling fluid or if the site of the interface is inside a body cavity, the cavity may be filled with coupling fluid, e.g., as described in co-owned U.S. patent application Ser. No. 11/831,048, filed Jul. 31, 2007, and incorporated by reference herein.
Once the catheter 12 has advanced through the tissue of the patient and is positioned within the tissue 72 to be treated, as shown in
Alternative modes of tracking the progress of treatment of the tissue 72 may rely on detection of tissue temperature. For example, a temperature sensor may be used to detect the temperature of the tissue being treated. The temperature sensor (or sensors) may be mounted on the catheter 12 itself or alternatively on a needle probe that can be extended from the catheter 12 into the surrounding tissue. Yet other alternatives for monitoring the progress of the treatment may rely on temperature sensing MRI scans, blood flow reports via doppler ultrasound, tissue echogenicity via B-mode ultrasound, tissue elasticity via elastography, or acoustic radiation force impulse imaging; RF impedance of the surrounding tissue; and/or monitoring of cavitation via passive or active acoustic detectors.
In addition, the visualization apparatus 122 may be operable to visualize the tissue surrounding the RF electrode 14 to assist in determining the desired portion 24 of the RF electrode to be exposed when conducting the second (treating) mode of operation of the catheter 12. Further depicted in
Visualization of the tissue being treated may further be used to help guide the therapy being provided to the patient. Different treatment regimens may be prescribed to adjust to different tissue characteristics observed by the visualization apparatus.
After subjecting the tissue 72 to treatment in the second mode of operation, the catheter 12 may be withdrawn from the treated tissue. Prior to fully withdrawing the catheter 12 from the treated tissue, it may be desirable to seal the tunnel in the tissue 72. One effect of this seal is to prevent the flow of fluids, such as a chemical adjuvant or debriding agent, out of the tunnel. In this circumstance, the catheter 12 may be operated to again deliver RF energy via the conductive tip 18. The RF energy is used to precipitate shrinkage of the patient's tissue and/or produce an area of coagulation at the exit of the tunnel, thus sealing the tunnel in the tissue. By depositing thermal energy at the exit of the tunnel, clotting factors in adjacent blood may plug the hole. Moreover, platelets tend to deposit themselves in a zone of damage such as thermal necrosis.
In yet another embodiment, after concluding treatment of the target tissue, the catheter 12 may apply a negative pressure to the tunnel in the tissue. The suction resulting from this negative pressure causes the tunnel to collapse and the tissue walls of the tunnel to pull together forming a seal. If desired, the exit of the tunnel could be “welded” shut by applying RF heating energy to the tissue at the exit, as described above. Again, this seal may prevent fluids deposited in the treated tissue from escaping out of the tunnel. The conveyance mechanism 62 shown in
While illustrative embodiments have been depicted and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention. For example, rather than using an ultrasound probe 120, the catheter 12 may initially be transported through the patient using an endoscope, laparoscope, or other transport mechanism to a position near the tissue to be treated. Such transport mechanisms are known in the art and can be guided in two or three dimensions to reach a desired position in the patient.
The catheter 12 could also be launched from a commercially-available needle guide, such as the type used for delivering a biopsy needle. The needle guide may be mechanically attached to or integrated with a probe having visualization apparatus that images the target tissue. These images may help point the needle guide in the proper direction toward the target tissue so that the catheter 12, when launched from the needle guide, is able to directly tunnel through the patient's tissue into the target tissue to be treated.
For example, U.S. Pat. No. 4,742,829, incorporated herein by reference, describes an ultrasound probe and needle guide that could be adapted to launch a catheter 12 as described herein. In one embodiment illustrated in
The guide 136 has a hollow core that permits the catheter 12 to extend therethrough. As with previous embodiments described herein, the catheter 12 has a tip 18 that conducts RF energy and a retractable sleeve 20. The catheter 12 may further have a handle 26, as well as first and second tubes 52, 58 for conveying fluids as previously described. An electrical lead 144 connects the catheter 12 to a source of RF energy. For ease of illustration, a break 146 is depicted in
Once mounted, the guide 136 has an axis 148 aligned parallel to a central axis 150 of the probe body 132. The probe 130 is fitted with visualization apparatus 152, which may be, for example, an optical device or an ultrasound transducer assembly as described in U.S. Pat. No. 4,742,829, which has a forward-looking field of view in the direction that the guide 136 launches the catheter 12. Instead of launching a biopsy needle as described in U.S. Pat. No. 4,742,829, the guide 136 shown in
As an alternative to, or in addition to, the treatment of the tissue with lower power RF energy from the RF electrode, a second treatment apparatus can be used to treat the tissue. As shown in
The linear array of ultrasound transducers 150 may be secured to the elongated body 16 of the RF electrode that supports the conductive tip 18. Alternatively, the transducers 150 can be mounted on a separate catheter that fits in the space between the elongated body 16 and the surrounding insulating sleeve 20. Examples of a linear array of ultrasound transducers can be found in U.S. Published Patent App. No. US 2007/0239062 A1, which is herein incorporated by reference.
During use, the RF electrode creates a tunnel into the tissue 72 to be treated. The insulating sleeve 20 can then be retracted to expose the linear array of ultrasound transducers 150 that are then activated to treat the tissue.
In another embodiment illustrated in
The array of cylindrical transducers 154 is exposed by retracting the insulating sleeve 20 such that the tissue 72 can be treated.
In the embodiment shown in
The microwave catheter 170 is connected to a source of microwave energy that is selectively delivered in the tissue treatment area. In the example shown, the insulating sleeve 20 is shown as having been retracted to expose the antenna of the microwave catheter 170. However, it is also possible to apply microwave energy through the insulating sleeve 20 in order to treat the tissue 72.
In some embodiments it may be desirable to deliver the second treatment apparatus to the treatment area by fully retracting the RF electrode but leaving the insulating sleeve in the body. The insulating sleeve therefore can act as a guide catheter to guide the second treatment apparatus to the desired treatment area.
Once the RF electrode 14 is fully retracted from the insulating sleeve, other treatment apparatus can be routed through the insulating sleeve 20 and into the area of the tissue 72 to be treated. In the example shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
In the embodiment shown in
Yet another example of a second treatment apparatus that can be placed in the area of the tissue to be treated is an expandable RF loop (not shown) that is connected to a source of RF energy. Application of RF energy to the RF loop, expansion of the loop into the tissue and revolution of the loop about its axis can allow volumetric necrosis and/or dissection within the area of tissue 72. Such a treatment apparatus could be used with or without morcellation and evacuation of the necrosed tissue.
In some embodiments, it may be advantageous to place a guide wire into the insulating sleeve 20 after removal of the RF electrode 14 and prior to the insertion of the second treatment apparatus. The second treatment apparatus may be adapted to track over the guide wire to aid its placement in the treatment area.
In other embodiments, the shaft of the RF electrode itself can be used as a guide wire to guide a second treatment apparatus to a treatment area.
In some environments, the tunnel or lumen created in the tissue by the RF electrode 14 is sufficient to allow the second treatment apparatus to be routed through the tunnel and into the area of tissue 72 to be treated.
As previously noted, various embodiments have been depicted and described herein. While these embodiments achieve a variety of benefits, patent protection obtained herewith should not be limited to the precise forms shown, but should be determined from the claims that follow and equivalents thereto.
The present application is a continuation-in-part of U.S. patent application Ser. No. 11/936,748, filed Nov. 7, 2007 now U.S. Pat. No. 8,187,270, which is herein incorporated by reference in its entirety.
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| Number | Date | Country | |
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| Parent | 11938748 | Nov 2007 | US |
| Child | 12112967 | US |
