US20060271036A1 - Radio frequency ablation cooling shield - Google Patents
Radio frequency ablation cooling shield Download PDFInfo
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- US20060271036A1 US20060271036A1 US11/462,961 US46296106A US2006271036A1 US 20060271036 A1 US20060271036 A1 US 20060271036A1 US 46296106 A US46296106 A US 46296106A US 2006271036 A1 US2006271036 A1 US 2006271036A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1477—Needle-like probes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00017—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids with gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
- A61B2090/0409—Specification of type of protection measures
- A61B2090/0436—Shielding
- A61B2090/0445—Shielding by absorption
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
- A61B2090/0481—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery against EM radiation, e.g. microwave
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Abstract
A medical assembly and method are provided to effectively treat abnormal tissue, such as, a tumor. The target tissue is thermally ablated using a suitable source, such as RF or laser energy. A cooling shield is placed in contact with non-target tissue adjacent the target tissue, and actively cooled to conduct thermal energy away from the non-target tissue. In one method, the cooling shield can be placed between two organs, in which case, one of the two organs can comprise the target tissue, and the other of the two organs can comprise the non-target tissue. In this case, the cooling shield may comprise an actively cooled inflatable balloon, which can be disposed between the two organs when deflated, and then inflated. The inflatable balloon can be actively cooled by pumping a cooling medium through it. In another method, the cooling shield can be embedded within the non-target tissue. In this case, the cooling shield can comprise one or more needles. If a plurality of needles is used, they can be embedded into the non-target tissue in a series, e.g., a rectilinear or curvilinear arrangement. The needle(s) can be actively cooled by pumping a cooling medium through them.
Description
- The field of the invention generally relates to the structure and use of ablation to treat tissue abnormalities in a patient, and more particularly, to the use of radio frequency (RF) electrosurgical probes for the treatment of such tissue.
- The delivery of radio frequency (RF) energy to target regions within tissue is known for a variety of purposes of particular interest to the present inventions. In one particular application, RF energy may be delivered to diseased regions (e.g., tumors) in tissue for the purpose of tissue necrosis. RF ablation of tumors is currently performed within one of two core technologies.
- The first technology uses a single needle electrode, which when attached to a RF generator, emits RF energy from the exposed, uninsulated portion of the electrode. This energy translates into ion agitation, which is converted into heat and induces cellular death via coagulation necrosis. The second technology utilizes multiple needle electrodes, which have been designed for the treatment and necrosis of tumors in the liver and other solid tissues. PCT Publication WO 96/29946 and U.S. Pat. No. 6,379,353 disclose such probes.
- Whichever technique is used for treatment, the target site, e.g., the tumor, is often dangerously close to vital organs or tissue (e.g., colon, prostate, gall bladder, or diaphragm). In many cases, to prevent or reduce the risk of thermally injuring the vital organs or tissue, the physician will opt to discontinue the procedure, or prematurely stop the procedure, resulting in a high likelihood of re-occurrence.
- Thus, there is a need for an improved system and method for protecting vital organs or tissue from thermal damage that may otherwise result during ablation of adjacent tissue.
- In accordance with a first aspect of the present inventions, a medical assembly for cooling tissue is provided. The medical assembly comprises an elongate member and an inflatable cooling balloon mounted to the elongate member. The cooling balloon has an interior region and opposing planar surfaces when inflated. The planar surfaces can be of any shape, e.g., rectangular or oval. The planar surfaces can be curved or straight. The cooling balloon can be compliant, semi-compliant, or non-compliant. In the preferred embodiment, the balloon is configured to be placed between two distinct tissue layers, e.g., two organs. Depending upon the method of delivery, the elongate member can be rigid to facilitate, e.g., an open surgical or percutaneous introduction, or flexible to facilitate, e.g., a laparoscopic introduction. In one embodiment, the elongate member comprises a guide wire lumen, so that the cooling balloon can be guided between the two layers of tissue.
- The medical assembly further comprises cooling and return lumens that extend through the elongate member in fluid communication with the interior region of the cooling balloon. In the preferred embodiment, the cooling and return lumens are annular, but can have other configurations. The medical assembly may comprise a cooling pump assembly configured for pumping cooling medium (such as liquid or gas) through the cooling lumen into the interior region of the cooling balloon, and for pumping heated cooling medium from the interior region of the cooling balloon through the return lumen.
- Although the present inventions should not be so limited in its broadest aspects, the inflated balloon can be placed between ablation targeted tissue and non-target tissue in order to thermally protect the non-target tissue during ablative treatment of the target tissue.
- In accordance with a second aspect of the present inventions, another medical assembly for cooling tissue is provided. The medical assembly comprises an elongated member and an array of actively cooled needles extending from the distal end of the elongate member. The elongate member can be rigid or flexible. The needle array is arranged in a series. By way of non-limiting example, the array of needles can be arranged in a rectilinear or a curvilinear pattern, and can be staggered, fan-shaped, or rake-shaped.
- In the preferred embodiment, the needles are configured to be cooled by a liquid medium, such as liquid or gas. In this case, the medical assembly may comprise a cooling pump assembly configured for pumping cooling medium through the needles, and for pumping heated cooling medium from the needles. In one embodiment, the medical assembly comprises a cannula, wherein the elongate member is slidably disposed within the cannula, such that the array of needles can be selectively deployed from the cannula and retracted within the cannula. The cannula can be configured to be introduced percutaneously or laparoscopically into the body of a patient.
- Although the present inventions should not be so limited in its broadest aspects, the needle array can be embedded within the tissue along a border between tissue targeted to be ablated and non-target tissue in order to thermally protect the non-target tissue during ablative treatment of the target tissue.
- In accordance with a third aspect of the present inventions, a method of performing an ablation procedure is provided.: The method comprises thermally ablating target tissue, e.g., a tumor, of a patient. The ablation can be performed using any suitable source of energy, such as, e.g., RF or laser energy. The method further comprises placing a cooling shield in contact with non-target tissue adjacent the target tissue, and actively cooling the cooling shield to conduct thermal energy away from the non-target tissue. If the non-target tissue is within the body of the patient, the cooling shield can be variously introduced therein using a suitable technique, such as, e.g., percutaneously, laparoscopically, or via a surgical opening
- By way of non-limiting example, the cooling shield can be placed between two organs, in which case, one of the two organs can comprise the target tissue, and the other of the two organs can comprise the non-target tissue. In this case, the cooling shield may comprise an actively cooled inflatable balloon, which can be disposed between the two organs when deflated, and then inflated. The inflatable balloon can be guided between the two organs using a guide wire. The inflatable balloon can be actively cooled by pumping a cooling medium through it.
- By way of further non-limiting example, the cooling shield can be embedded within the non-target tissue. In this case, the cooling shield can comprise one or more needles. If a plurality of needles is used, they can be embedded into the non-target tissue in a series, e.g., a rectilinear or curvilinear arrangement. The needle(s) can be actively cooled by pumping a cooling medium through them.
- The drawings illustrate the design and utility of preferred embodiments of the present invention, in which similar elements are referred to by common reference numerals. In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the present inventions briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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FIG. 1 is a plan view of a tissue treatment system constructed in accordance with one preferred embodiment of the present inventions; -
FIG. 2 is a side view of an ablation probe assembly used in the tissue treatment system ofFIG. 1 , wherein a needle electrode array is particularly shown retracted; -
FIG. 3 is a side view of an ablation probe assembly used in the tissue treatment system ofFIG. 1 , wherein the needle electrode array is particularly shown deployed; -
FIG. 4 is a perspective view of a cooling probe used in the tissue treatment system ofFIG. 1 ; -
FIG. 5 is a partially cut-away cross-sectional view of the cooling probe ofFIG. 4 ; -
FIG. 6 is a cross-sectional view of the cooling probe ofFIG. 5 taken along the line 6-6; -
FIGS. 7A-7G illustrate cross-sectional views of one preferred method of using the tissue treatment system ofFIG. 1 to treat target tissue, wherein the cooling probe ofFIG. 4 is used to thermally protect adjacent tissue; -
FIG. 8 is a side view of a cooling probe that can be used in the tissue treatment system ofFIG. 1 , particularly showing a needle array in a rectilinear configuration; -
FIG. 9 is a side view of a cooling probe that can be used in the tissue treatment system ofFIG. 1 , particularly showing a needle array in a curvilinear configuration; -
FIG. 10 is a side view of a cooling probe that can be used in the tissue treatment system ofFIG. 1 , particularly showing a needle array in a staggered configuration; -
FIG. 11 is a side view of a cooling probe that can be used in the tissue treatment system ofFIG. 1 , particularly showing a needle array in a rake-shaped configuration; -
FIGS. 12A-12B illustrate cross-sectional views of another preferred method of using the tissue treatment system ofFIG. 1 to treat target tissue, wherein the cooling probe ofFIG. 8 is used to thermally protect adjacent tissue; -
FIG. 13 is a side view of another cooling probe that can be used in the tissue treatment system ofFIG. 1 , particularly showing the needle array retracted; -
FIG. 14 is a side view of the cooling probe ofFIG. 13 that can be used in the tissue treatment system ofFIG. 1 , particularly showing the needle array deployed into a fan-shaped configuration; -
FIG. 15 is a partially cutaway view of an inner probe used in the cooling probe ofFIG. 13 ; -
FIGS. 16A-16B illustrate cross-sectional views of still another preferred method of using the tissue treatment system ofFIG. 1 to treat target tissue, wherein the cooling probe ofFIG. 13 is used to thermally protect adjacent tissue; -
FIG. 17 is a side view of another cooling probe that can be used in the tissue treatment system ofFIG. 1 ; and -
FIGS. 18A-18B illustrate cross-sectional views of yet another preferred method of using the tissue treatment system ofFIG. 1 to treat target tissue, wherein the cooling probe ofFIG. 17 is used to thermally protect adjacent tissue. -
FIG. 1 illustrates atissue treatment system 100 constructed in accordance with a preferred embodiment of the present inventions. Thetissue treatment system 100 comprises atissue ablation subsystem 102, which generally includes anablation probe assembly 106 configured for introduction into the body of a patient for ablative treatment of target tissue (e.g., a tumor), and a radio frequency (RF)generator 108 configured for supplying RF energy to theablation probe assembly 106 in a controlled manner. Thetissue treatment system 100 further comprises atissue cooling subsystem 104, which generally includes acooling probe 110 with an associatedactive cooling shield 112 configured for being effectively placed in contact with non-target tissue (e.g., a vital organ adjacent the tumor), and anactive cooling unit 114 configured for actively removing thermal energy away from thecooling shield 112, and thus, the non-target tissue, during the ablation procedure. - Referring specifically to
FIGS. 2 and 3 , theablation probe assembly 106 generally comprises anelongate cannula 116 and an inner probe 118 slidably disposed within thecannula 116. As will be described in further detail below, thecannula 116 serve to deliver the active portion of the inner probe 118 to the target tissue. Thecannula 116 has aproximal end 120, adistal end 122, and a central lumen 124 (shown in phantom) extending between the proximal anddistal ends cannula 116 may be rigid, semi-rigid, or flexible depending upon the designed means for introducing thecannula 116 to the target tissue. Thecannula 116 is composed of a suitable material, such as plastic, metal, or the like, and has a suitable length, typically in the range from 5 cm to 30 cm, preferably from 10 cm to 20 cm. If composed of an electrically conductive material, thecannula 108 is preferably covered with an insulative material. Thecannula 116 has an outside diameter consistent with its intended use, typically being from 1 mm to 5 mm, usually from 1.3 mm to 4 mm. Thecannula 116 has an inner diameter in the range from 0.7 mm to 4 mm, preferably from 1 mm to 3.5 mm. - The inner probe 118 comprises a
reciprocating shaft 126 having aproximal end 128 and adistal end 130, and anarray 132 of tissue penetratingneedle electrodes 134 extending from thedistal end 130 of theshaft 126. Like thecannula 116, theshaft 126 is composed of a suitable material, such as plastic, metal or the like. It can be appreciated that longitudinal translation of theshaft 126 relative to thecannula 116 in adistal direction 136 deploys theelectrode array 132 from thedistal end 122 of the cannula 116 (FIG. 3 ), and longitudinal translation of theshaft 126 relative to thecannula 116 in aproximal direction 138 retracts theelectrode array 132 into thedistal end 122 of the cannula 116 (FIG. 2 ). - Each of the
individual needle electrodes 134 is in the form of a small diameter metal element, which can penetrate into tissue as it is advanced from a target site within the target region. When retracted within the cannula 116 (FIG. 2 ), theelectrode array 132 is placed in a radially collapsed configuration, and theindividual needle electrodes 134 are constrained and held in generally axially aligned positions within thecannula 116 to facilitate its introduction to the tissue target site. Theablation probe assembly 106 optionally includes a core member (not shown) mounted to the distal tip of theshaft 126 and disposed within the center of theelectrode array 132. In this manner, substantially equal circumferential spacing between theneedle electrodes 134 is maintained when retracted within thecentral lumen 124 of thecannula 116. - When deployed from the cannula 116 (
FIG. 3 ), theelectrode array 132 is placed in a three-dimensional configuration that usually defines a generally ellipsoidal or spherical volume having a periphery with a maximum radius in the range from 0.5 cm to 3 cm. Theneedle electrodes 134 are resilient and pre-shaped to assume a desired configuration when advanced into tissue. In the illustrated embodiment, theneedle electrodes 134 diverge radially outwardly from thecannula 116 in a uniform pattern, i.e., with the spacing betweenadjacent needle electrodes 134 diverging in a substantially uniform and/or symmetric pattern. In the illustrated embodiment, theneedle electrodes 134 also evert proximally, so that they face partially or fully in theproximal direction 138 when fully deployed. In exemplary embodiments, pairs ofadjacent needle electrodes 134 can be spaced from each other in similar or identical, repeated patterns that can be symmetrically positioned about anr axis of theshaft 126. It will be appreciated that a wide variety of particular patterns can be provided to uniformly cover the region to be treated. It should be noted that a total of sixneedle electrodes 134 are illustrated inFIG. 3 .Additional needle electrodes 134 can be added in the spaces between the illustratedelectrodes 134, with the maximum number ofneedle electrodes 134 determined by the electrode width and total circumferential distance available (i.e., theneedle electrodes 134 could be tightly packed). - Each
individual electrode 134 is preferably composed of a single wire that is formed from resilient conductive metals having a suitable shape memory, such as stainless steel, nickel—titanium alloys, nickel—chromium alloys, spring steel alloys, and the like. The wires may have circular or non-circular cross-sections, but preferably have rectilinear cross-sections. In this manner, theneedle electrodes 134 are generally stiffer in the transverse direction and more flexible in the radial direction. By increasing transverse stiffness, proper circumferential alignment of theneedle electrodes 134 within thecannula 116 is enhanced. Exemplary needle electrodes will have a width (in the circumferential direction) in the range from 0.2 mm to 0.6 mm, preferably from 0.35 mm to 0.40 mm, and a thickness (in the radial direction) in the range from 0.05 mm to 0.3 mm, preferably from 0.1 mm to 0.2 mm. - The distal ends of the
needle electrodes 134 may be honed or sharpened to facilitate their ability to penetrate tissue. The distal ends of theseneedle electrodes 134 may be hardened using conventional heat treatment or other metallurgical processes. They may be partially covered with insulation, although they will be at least partially free from insulation over their distal portions. The proximal ends of theneedle electrodes 134 may be directly coupled to the connector assembly (described below), or alternatively, may be indirectly coupled thereto via other intermediate conductors, e.g., RF wires. Optionally, theshaft 126 and any component between theshaft 126 and theneedle electrodes 134, are composed of an electrically conductive material, such as stainless steel, and may therefore conveniently serve as intermediate electrical conductors. - In the illustrated embodiment, the RF current is delivered to the
electrode array 132 in a monopolar fashion, which means that current will pass from theelectrode array 132, which is configured to concentrate the energy flux in order to have an injurious effect on the surrounding tissue, and a dispersive electrode (not shown), which is located remotely from theelectrode array 132 and has a sufficiently large area (typically 130 cm2 for an adult), so that the current density is low and non-injurious to surrounding tissue. As previously described, however, inadvertent damage to surrounding tissue cannot always be avoided. In the illustrated embodiment, the dispersive electrode may be attached externally to the is patient, e.g., using a contact pad placed on the patient's flank. In a monopolar arrangement, theneedle electrodes 134 are bundled together with their proximal portions having only a single layer of insulation over thecannula 116. - Alternatively, the RF current is delivered to the
electrode array 132 in a bipolar fashion, which means that current will pass between “positive” and “negative”electrodes 134 within the array. In a bipolar arrangement, the positive andnegative needle electrodes 134 will be insulated from each other in any regions where they would or could be in contact with each other during the power delivery phase. - Further details regarding needle electrode array-type probe arrangements are disclosed in U.S. Pat. No. 6,379,353, entitled “Apparatus and Method for Treating Tissue with Multiple Electrodes,” which is hereby expressly incorporated herein by reference.
- The
ablation probe assembly 106 further comprises ahandle assembly 140, which includes aconnector sleeve 142 mounted to theproximal end 120 of thecannula 116 and aconnector member 144 slidably engaged with thesleeve 142 and mounted to theproximal end 128 of theshaft 126. Theconnector member 144 also comprises an electrical connector 146 (in phantom) in which the proximal ends of the needle electrodes 134 (or alternatively, the intermediate conductors) extending through theshaft 126 of the inner probe 118 are coupled. Thehandle assembly 140 can be composed of any suitable rigid material, such as, e.g., metal, plastic, or the like. - The
ablation probe assembly 106 may optionally have active cooling functionality, in which case, a heat sink (not shown) can be mounted within thedistal end 130 of theshaft 126 in thermal communication with theelectrode array 132, and cooling and return lumens (not shown) can extend through the shaft in fluid communication with the heat sink to draw thermal energy away back to the proximal end of theshaft 126. A pump assembly (not shown) can be provided to convey a cooling medium through the cooling lumen to the heat sink, and to pump the heated cooling medium away from the heat sink and back through the return lumen. Further details regarding active cooling of theelectrode array 132 are disclosed in copending U.S. application Ser. No. 10/______, (Bingham & McCutchen Docket No. 24728-7011). - Referring back to
FIG. 1 , theRF generator 108 is electrically connected to theelectrical connector 146 of thehandle assembly 140, which as previously described, is directly or indirectly electrically coupled to theelectrode array 132. TheRF generator 108 is a conventional RF power supply that operates at a frequency in the range of 200 KHz to 1.25 MHz, with a conventional sinusoidal or non-sinusoidal wave form. Such power supplies are available from many commercial suppliers, such as Valleylab, Aspen, and Bovie. Most general purpose electrosurgical power supplies, however, operate at higher voltages and powers than would normally be necessary or suitable for vessel occlusion. - Thus, such power supplies would usually be operated at the lower ends of their voltage and power capabilities. More suitable power supplies will be capable of supplying an ablation current at a relatively low voltage, typically below 150V (peak-to-peak), usually being from 50V to 100V. The power will usually be from 20 W to 200 W, usually having a sine wave form, although other wave forms would also be acceptable. Power supplies capable of operating within these ranges are available from commercial vendors, such as Radio Therapeutics of Mountain View, Calif., which markets these power supplies under the trademarks RF2000™ (100 W) and RF3000™ (200 W).
- Referring now to
FIG. 4 , thecooling probe 110 comprises anelongate catheter shaft 150 having aproximal end 152 and adistal end 154. Thecatheter shaft 150 is composed of a flexible biocompatible material, such as, e.g., polyurethane or polyethylene, and has a suitable diameter, e.g., 7 F. In this embodiment, thecooling shield 112 is an inflatable balloon that is mounted to thedistal end 154 of thecatheter shaft 150. In the illustrated embodiment, theballoon 112 is bonded to thecatheter shaft 150 by a suitable adhesive, for example, epoxy adhesives, urethane adhesives, cyanoacrylates, and other adhesives suitable for bonding nylon or the like, as well as by hot melt bonding, ultrasonic welding, heat fusion or the like. Alternatively, the balloon may be integrally molded with thecatheter shaft 150 or may be attached to thecatheter shaft 150 by mechanical means such as swage locks, crimp fittings, threads, and the like. - As illustrated in
FIG. 4 , theballoon 112 exhibits a substantially thin profile, when expanded, so that it can be effectively located between adjacent planes of tissue, such as, e.g., two organs. That is, theballoon 112 has a pair of opposingplanar surfaces balloon 112 can easily fit between and conform to the adjacent planes of tissue. Theplanar surfaces balloon 112 have a rectangular shape, but can have other shapes (e.g., oval, oblong, triangular, trapezoidal, etc.) depending upon the specific tissue planes between which theballoon 112 is intended to be located. It is noted that, in the illustrated embodiment, theplanar surfaces balloon 112 will conform to the curved surface of an organ. Theballoon 112 can be of any dimension that allows it to be effectively placed between the desired planes of tissue, so that the non-target tissue is protected. - The
balloon 112 can be composed of a suitable compliant, semi-compliant, or non-compliant, such as, e.g., polyethylene, nylon, polyamide, polyether block amides (PEBAX), polyethylene terephthalate (PET), silicone, POC, polypropylene, polyether block PBT, and the like. In addition, theballoon 112 may be formed of multiple layers of these materials and/or be coextruded. Further, theballoon 112 may comprise fiber reinforcements. Preferably, theballoon 112 exhibits some non-compliancy so that it can inflate between the adjacent planes of tissue. If non-compliant, theballoon 112 can be manually folded or collapsed onto thedistal end 154 of thecatheter shaft 150 and held in place using suitable securing means (not shown) to maintain a low profile when introduced into the body of the patient. The securing means can then be released when theballoon 112 is to be inflated. If theballoon 112 exhibits enough compliancy, theballoon 112 will naturally have a low profile when deflated, possibly obviating the need to manually fold or collapse theballoon 112. Depending upon its size, however, theballoon 112, whether compliant or not, may need to be folded and secured to ensure that it exhibits a low profile when not inflated. - Referring now to
FIGS. 5 and 6 , thecatheter shaft 150 comprises an outertubular element 160, an innertubular element 162 that resides within, and extends distally from, the outertubular element 160, and a centraltubular element 164 that resides within, and extends distally from, the innertubular element 162. Thecooling probe 110 comprises a coolant flow conduit that is in fluid communication with aninterior region 166 of theballoon 112. The coolant flow conduit serves to cool the external surface of theballoon 112, and thus the tissue in contact with theballoon 112, by thermally drawing heat away from theballoon 112. In particular, the coolant flow conduit comprises acooling lumen 168 that is configured for conveying a suitable cooling medium (such as, e.g., a liquid or gas) into theinterior region 166 of theballoon 112, and areturn lumen 170 that is configured for conveying the heated cooling medium from theinterior region 166 of theballoon 112. Preferably, the cooling medium is composed of saline that is cooled to just above the cryotemperature that would cause unintended necrosis of tissue. It should be noted that for the purposes of this specification, however, a cooled medium is any medium that has a temperature suitable for drawing heat away from the tissue. For example, a cooled medium at room temperature or lower.may be suited for cooling tissue during ablation under certain circumstances. - In the illustrated embodiment, the
cooling lumen 168 is an annular lumen that is formed between the inner and centraltubular elements return lumen 170 is an annular lumen that is formed between the outer and innertubular elements tubular elements return lumen 170, and the annular lumen formed between the outer and innertubular elements cooling lumen 168. It should be noted that the cooling and returnlumens catheter shaft 150 in a side-by-side relationship. In any event, the cooling and returnlumens interior region 166 of theballoon 112 to provide a more efficient flow of the medium through theinterior region 166 of the balloon 112 (as shown by the arrows), i.e., the medium will flow through the entire length of theballoon 112. - Referring back to
FIG. 4 , thecooling probe 110 further comprises ahandle 172 mounted to theproximal end 152 of thecatheter shaft 150. Thehandle 172 is configured to mate with theactive cooling unit 114, which as will be discussed below, takes the form of a pump assembly. To this end, thehandle 172 comprises aninlet fluid port 174, which is in fluid communication with thecooling lumen 168, and anoutlet fluid port 176, which is in fluid communication with thereturn lumen 170. Thehandle assembly 140 can be composed of any suitable rigid material, such as, e.g., metal, plastic, or the like. - In the illustrated embodiment, the
cooling probe 110 is configured to be laparoscopically introduced into the pertinent body cavity of the patient and guided between the tissue planes with a guide wire. To this end, thecooling probe 110 comprises a guide wire lumen 178 (shown inFIG. 5 ), which is formed by the central lumen of the centraltubular element 164. So that thecooling probe 110 can be tracked over the guide wire, thecatheter shaft 150 is preferably composed of a flexible biocompatible material. Alternatively, a semi-rigid sheath can be used to guide thecooling probe 110. Even more alternatively, thecooling probe 110 may be configured to be percutaneously inserted into the pertinent body cavity (e.g., using a direct chest puncture), in which case, a rigid shaft can be used in place of theflexible catheter shaft 150. The rigid shaft can also be reciprocatably disposed within acannula 116 in a manner similar to that described above with respect to theablation probe assembly 106. The rigid shaft can even be used to facilitate manual placement of theballoon 112 in an open surgical setting with or without the cannula. - Referring back to
FIG. 1 , thepump assembly 114 comprises apower head 180 and asyringe 182 that is front-loaded on thepower head 180 and is of a suitable size, e.g., 200 ml. Thepower head 180 and thesyringe 182 are conventional and can be of the type described in U.S. Pat. No. 5,279,569 and supplied by Liebel-Flarsheim Company of Cincinnati, Ohio. Thepump assembly 114 further comprises asource reservoir 184 for supplying the cooling medium to thesyringe 182, and adischarge reservoir 186 for collecting the heated medium from coolingprobe 110. Thepump assembly 114 further comprises atube set 188 removably secured to anoutlet 190 of thesyringe 182. Specifically, adual check valve 192 is provided with first andsecond legs first leg 194 serves as a liquid inlet connected bytubing 197 to thesource reservoir 184. Thesecond leg 196 is an outlet leg and is connected bytubing 198 to theinlet fluid port 174 on theconnector 170 of thecooling probe 110. Thedischarge reservoir 186 is connected to theoutlet fluid port 176 on theconnector 170 of thecooling probe 110 viatubing 199. - Thus, it can be appreciated that the
pump assembly 114 can be operated to periodically fill thesyringe 182 with the cooling medium from thesource reservoir 184, and convey the cooling medium from thesyringe 182, through thetubing 198, and into theinlet fluid port 174 on thehandle 172. Heated medium is conveyed from theoutlet fluid port 176 on thehandle 172, through thetubing 198, and into thecollection reservoir 186. Thepump assembly 114, along with theRF generator 108, can include control circuitry to automate or semi-automate the cooled ablation process. - Having described the structure of the
tissue ablation system 100, its operation in treating targeted tissue will now be described. The treatment region may be located anywhere in the body where hyperthermic exposure may be beneficial. Most commonly, the treatment region will comprise a solid tumor within an organ of the body, such as the liver, kidney, pancreas, breast, prostrate (not accessed via the urethra), and the like. The volume to be treated will depend on the size of the tumor or other lesion, typically having a total volume from 1 cm3 to 150 cm3, and often from 2 cm3 to 35 cm3. The peripheral dimensions of the treatment region may be regular, e.g., spherical or ellipsoidal, but will more usually be irregular. The treatment region may be identified using conventional imaging techniques capable of elucidating a target tissue, e.g., tumor tissue, such as ultrasonic scanning, magnetic resonance imaging (MRI), computer-assisted tomography (CAT), fluoroscopy, nuclear scanning (using radiolabeled tumor-specific probes), and the like. Preferred is the use of high resolution ultrasound of the tumor or other lesion being treated, either intraoperatively or externally. A contrast agent, such as an echogenic fluid, can be used as the cooled medium, so that theballoon 112 of thecooling probe 110 can be visualized using. - Referring now to
FIGS. 7A-7G , the operation of thetissue treatment system 100 is described in treating a treatment region TR within a tissue T located beneath the skin or an organ surface S of a patient. The tissue T, and an adjacent organ O, prior to treatment is shown inFIG. 7A . Theablation probe assembly 106 is introduced within the treatment region TR, so that thedistal end 122 of thecannula 116 is located at the target site TS, as illustrated inFIG. 7B . This can be accomplished using any one of a variety of techniques. In some cases, thecannula 116 and inner probe 118 may be introduced to the target site TS percutaneously directly through the patient's skin or through an open surgical incision. In this case, thecannula 116 may have a sharpened tip, e.g., in the form of a needle, to facilitate introduction to the treatment region TR. In such cases, it is desirable that thecannula 116 or needle be sufficiently rigid, i.e., have a sufficient column strength, so that it can be accurately advanced through tissue. In other cases, thecannula 116 may be introduced using an internal stylet that is subsequently exchanged for theshaft 150 andelectrode array 132. In this latter case, thecannula 116 can be relatively flexible, since the initial column strength will be provided by the stylet. More alternatively, a component or element may be provided for introducing thecannula 116 to the treatment region TR. For example, a conventional sheath and sharpened obturator (stylet) assembly can be used to initially access the tissue T. The assembly can be positioned under ultrasonic or other conventional imaging, with the obturator/stylet then removed to leave an access lumen through the sheath. Thecannula 116 and inner probe 118 can then be introduced through the sheath lumen, so that thedistal end 122 of thecannula 116 advances from the sheath into the target site TS. - A
guide wire 175 is then laparoscopically introduced within the body of the patient and advanced to a location between the treatment region TR and the organ O, as illustrated inFIG. 7C . Thecooling probe 110 is then advanced over theguide wire 175 until theuninflated balloon 112 resides between the treatment region TR and the organ O, as illustrated inFIG. 7D . Alternatively, thecooling probe 110 can percutaneously or laparoscopically deliver theballoon 112 between the treatment region TR without the use of theguide wire 175 in the same manner that theablation probe assembly 106 is delivered to the treatment region TR. - After the
cannula 116 andcooling probe 110 are properly placed, theshaft 150 of the ablation.probe assembly 106 is distally advanced to deploy theelectrode array 132 radially outward from thedistal end 122 of thecannula 116 until theelectrode array 132 fully everts in order to circumscribe substantially the entire treatment region TR, as illustrated inFIG. 7E . - The
RF generator 108 is then connected to theelectrical connector 146 of theablation probe assembly 106, and thepump assembly 114 is connected tofluid ports cooling probe 110. Thepump assembly 114 is then operated to inflate and convey the cooling medium through theballoon 112, thereby providing a thermal barrier between the treatment region TR and the organ O, as illustrated inFIG. 7F . Specifically, thepower head 180 conveys the cooled medium from thesyringe 182 under positive pressure, through thetubing 198, and into theinlet fluid port 174 on thehandle 172. The cooled medium then travels through thecooling lumen 168 and into theinterior region 166 of theballoon 112. Thermal energy is transferred from the treatment region TR, to theballoon 112, and then to the cooled medium, thereby preventing the thermal energy from reaching the organ O at a cool temperature. The heated medium is then conveyed from the interior region of theballoon 112 back through thereturn lumen 170. From thereturn lumen 170, the heated medium travels through theoutlet fluid port 176 on thehandle 172, through thetubing 199, and into thedischarge reservoir 186. - The
RF generator 108 is then operated to ablate the treatment region TR. Specifically, a lesion L is formed within the treatment region TR, as illustrated inFIG. 7G . Because the actively cooledballoon 112 forms a thermal barrier between the treatment region TR and the organ O, the lesion L does not extend to the organ O. - Referring to
FIG. 8 , anothercooling probe 210 that can be used in thecooling subsystem 104 is illustrated. Thecooling probe 210 comprises ashaft 212 having a proximal end 214 and adistal end 216. Thecooling probe 210 further comprises ahandle 218 mounted to the proximal end 214 of theshaft 212, and a cross-member 220 mounted to thedistal end 216 of theshaft 212. The cross-member 220 can be integrally formed with theshaft 212 to form a unibody design, or can be suitably bonded, welded, or mechanically attached to theshaft 212. Like the previously describedhandle assembly 140, thehandle 218 comprises aninlet fluid port 222 and anoutlet fluid port 224. In this embodiment, thecooling shield 112 comprises anarray 226 of tissue penetrating coolingneedles 228 that is mounted to thecross-member 220. Theneedles 228 can be integrally formed with the cross-member to form a unibody design, or can be suitably bonded, welded, or mechanically attached to thecross-member 220. Theshaft 212, cross-member 220, and needles 228 are formed of a suitable rigid material, such as, e.g., stainless steel. The diameter and length of theneedles 228 are preferably within the range of 0.5 mm to 4.0 mm, and 5 cm to 25 cm, respectively. - As illustrated in
FIG. 8 , theneedles 228 are arranged in a series to maximize the cooling efficiency ofcooling probe 210, i.e., the span of theneedle array 226 is maximized, thereby allowing larger non-target tissue regions to be thermally protected. In the illustrated embodiment, theneedle array 226 is arranged in a rectilinear pattern. It should be noted, that depending upon the contour of the non-target tissue, theneedle array 226 can also be arranged in a curvilinear pattern, as illustrated inFIG. 9 . Theneedles 228 can also be staggered if additional thermal protection is required, as illustrated inFIG. 10 . Although, in the illustrated embodiment, theneedles 228 are shown parallel to each other, they can also be non-parallel, e.g., a rake-shape, as illustrated inFIG. 11 . - Referring back to
FIG. 8 , thecooling probe 210 further comprises a coolant flow conduit (shown in phantom) that serves to cool theneedles 228, and thus the tissue in contact with theballoon 112, by thermally drawing heat away. In particular, the coolant flow conduit comprises amain cooling lumen 230 that is in fluid communication with theinlet fluid port 222 of thehandle 218 and extends through theshaft 212, a common cooling lumen 234 that is in fluid communication with themain cooling lumen 230 and extends through the cross-member 220, and a plurality of branched coolinglumens 238 that is in fluid communication with the common cooling lumen 234 and extends through theneedles 228. The coolant flow conduit also comprises amain return lumen 232 that is in fluid communication with theoutlet fluid port 224 of thehandle 218 and extends through theshaft 212, acommon return lumen 236 that is in fluid communication with themain return lumen 232 and extends through the cross-member 220, and a plurality of branchedreturn lumens 240 that is in fluid communication with thecommon return lumen 236 and extends through theneedles 228. The distal ends of the branched coolinglumens 238 are in fluid communication with the respective distal ends of the branchedreturn lumens 240 to complete the cooling circuit. - Operation of the
cooling probe 210 is similar to that previously described with the exception that it is designed to be inserted into the tissue during an open surgical setting. Specifically, theelectrode array 132 of theablation probe assembly 106 is deployed within the target tissue TR, as illustrated inFIG. 7 . Theneedle array 226 of thecooling probe 210 is inserted within the tissue, so that theneedles 228 lie along a boundary B separating the treatment region TR from the non-treatment region NTR, as illustrated inFIG. 12A . - The
pump assembly 114 is then operated to convey the cooling medium through theneedles 228, thereby providing a thermal barrier between the treatment region TR and the non-treatment region NTR. Specifically, thepower head 180 conveys the cooled medium from thesyringe 182 under positive pressure, through thetubing 198, and into theinlet fluid port 222 on thehandle 218. The cooled medium then travels through themain cooling lumen 230, through the common cooling lumen 234, and into the branched coolinglumens 238 within theneedles 228. Thermal energy is transferred from the treatment region TR, to theneedles 228, and then to the cooled medium, thereby preventing the thermal energy from reaching the non-treatment region NTR and maintaining it at a cool temperature. The heated medium is then conveyed from the branchedreturn lumens 240, through thecommon return lumen 236, and through themain return lumen 232. From themain return lumen 232, the heated medium travels through theoutlet fluid port 224 on thehandle 218, through thetubing 199, and into thedischarge reservoir 186. - The
RF generator 108 is then operated to ablate the treatment region TR. Specifically, a lesion L is formed within the treatment region TR, as illustrated inFIG. 12B . Because the actively cooledneedle array 226 forms a thermal barrier between the treatment region TR and the non-treatment region NTR, the lesion L does not extend to the non-treatment NTR, but instead exhibits a scalloped contour that extends along the barrier B. - Referring to
FIGS. 13 and 14 , acooling probe 310 that can be used in thecooling subsystem 104 is illustrated. Thecooling probe 310 is generally similar in structure to theablation probe assembly 106 in that it comprises anelongate cannula 312 and aninner probe 314 slidably disposed within thecannula 312. Thecannula 312 has aproximal end 316, adistal end 318, and a central lumen 320 (shown in phantom) extending between the proximal anddistal ends cannula 312 can have a dimension and composition similar to that described above with respect to thecannula 116 of theablation probe assembly 106. Theinner probe 314 comprises a reciprocating shaft 322 (shown best inFIG. 15 ) having aproximal end 324 and adistal end 326, acooling manifold 328 mounted to thedistal end 326 of theshaft 322, and anarray 330 of tissue penetrating coolingneedles 332 extending from themanifold 328. Like thecannula 312, theshaft 322 is composed of a suitable material, such as plastic, metal or the like. Like theshaft 322 of theablation probe assembly 106, it can be appreciated that longitudinal translation of theshaft 322 relative to thecannula 312 in thedistal direction 136 deploys the coolingneedle array 330 from thedistal end 318 of the cannula 312 (FIG. 14 ), and longitudinal translation of theshaft 322 relative to thecannula 312 in theproximal direction 138 retracts the coolingneedle array 330 into thedistal end 318 of the cannula 312 (FIG. 13 ). - The cooling needles 332 are of similar construction and composition as the previously described
needle electrodes 134. That is, each coolingneedle 332 is preferably composed of a single wire that is formed from resilient conductive metals having a suitable shape memory, such as stainless steel, nickel—titanium alloys, nickel—chromium alloys, spring steel alloys, and the like. The wires may have circular or non-circular cross-sections. The distal ends of the cooling needles 332 may be honed or sharpened to facilitate their ability to penetrate tissue. The distal ends of these coolingneedles 332 may be hardened using conventional heat treatment or other metallurgical processes. The diameter and length of theneedles 332 are preferably within the range of 0.5 mm to 4.0 mm, and 5 cm to 25 cm, respectively. - When deployed from the cannula 312 (
FIG. 14 ), theneedle array 330 is placed in a fan-shaped configuration. As with the previously describedneedle array 226, theneedles 332 are arranged in a series to maximize the cooling efficiency ofcooling probe 310. In the illustrated embodiment, theneedle array 330 is arranged in a rectilinear pattern, but can also be arranged in a curvilinear pattern or can be staggered. - The
cooling probe 310 further comprises ahandle assembly 334, which includes aconnector sleeve 336 mounted to theproximal end 316 of thecannula 312 and aconnector member 338 slidably engaged with thesleeve 310 and mounted to theproximal end 324 of theshaft 322. Theconnector member 338 of thehandle assembly 334 comprises aninlet fluid port 340 and anoutlet fluid port 342. Thehandle assembly 334 can be composed of any suitable rigid material, such as, e.g., metal, plastic, or the like. - Referring now to
FIG. 15 , thecooling probe 310 further comprises a coolant flow conduit (shown in phantom) that serves to cool theneedles 332, and thus the tissue in is contact with theneedle array 330, by thermally drawing heat away. In particular, the coolant flow conduit comprises amain cooling lumen 344 that is in fluid communication with theinlet fluid port 340 of thehandle assembly 334 and extends through theshaft 322, a network of coolinglumens 348 in fluid communication with themain cooling lumen 344 and extending through thecooling manifold 328, and a plurality of coolinglumens 352 that are in fluid communication with the network of coolinglumens 348 and extend through theneedles 332. The coolant flow conduit also comprises amain return lumen 346 that is in fluid communication with theoutlet fluid port 342 of thehandle assembly 334 and extends through theshaft 322, a network ofreturn lumens 348 in fluid communication with themain return lumen 346 and extending through thecooling manifold 328, and a plurality ofreturn lumens 354 that are in fluid communication with the network ofreturn lumens 348 and extend through theneedles 332. The distal ends of the coolinglumens 352 are in fluid communication with the respective distal ends of thereturn lumens 354 to complete the cooling circuit. - Operation of the
cooling probe 310 is similar to the operation of thecooling probe 210, with the exception that the array ofneedles 332 can be deployed during a percutaneous or laparoscopic procedure. Specifically, theelectrode array 132 of theablation probe assembly 106 is deployed within the target tissue TR, as illustrated inFIG. 7 . Theneedle array 330 of thecooling probe 312 is deployed from thedistal end 318 of thecannula 312 into the tissue, so that theneedles 332 lie along a boundary B separating the treatment region TR from the non-treatment region NTR, as illustrated inFIG. 16A . Thepump assembly 114 is then operated to convey the cooling medium through theneedles 332, thereby providing a thermal barrier between the treatment region TR and the non-treatment region NTR. Specifically, thepower head 180 conveys the cooled medium from thesyringe 182 under positive pressure, through thetubing 198, and into theinlet fluid port 340 on thehandle 334. The cooled medium then travels through themain cooling lumen 344, through the network of coolinglumens 348 within themanifold 328, and into the coolinglumens 352 within theneedles 332. Thermal energy is transferred from the treatment region TR, to theneedles 332, and then to the cooled medium, thereby preventing the thermal energy from reaching the non-treatment region NTR and maintaining it at a cool temperature. The heated medium is then conveyed from thereturn lumens 354, through the network ofreturn lumens 350 within themanifold 328, and into themain return lumen 346. From themain return lumen 346, the heated medium travels through theoutlet fluid port 342 on thehandle 334, through thetubing 199, and into thedischarge reservoir 186. - The
RF generator 108 is then operated to ablate the treatment region TR. Specifically, a lesion L is formed within the treatment region TR, as illustrated inFIG. 16B . Because the actively cooledneedle array 330 forms a thermal barrier between the treatment region TR and the non-treatment region NTR, the lesion L does not extend to the non-treatment NTR, but instead exhibits a scalloped contour that extends along the barrier B. - Referring to
FIG. 17 , asingle cooling needle 410 that can be used in thecooling subsystem 104 is illustrated. Theneedle 410 comprises ashaft 412, aproximal end 414, and adistal end 416, and is composed of a rigid thermally conductive material, such as, e.g., stainless steel. Theneedle 410 can have any cross-section as long as it is capable of penetrating tissue, but in the preferred embodiment its cross-section is circular, oval or flat. The diameter and length of theneedle 410 is preferably within the range of 0.5 mm to 4.0 mm, and 5 cm to 25 cm, respectively. Theneedle 410 comprises aninlet fluid port 418 and anoutlet fluid port 420 formed at itsproximal end 414 for connection to thepump assembly 114. Theneedle 410 further comprises a coolant flow conduit (shown in phantom) that serves to cool theshaft 412, and thus the tissue in contact with theshaft 412, by thermally drawing heat away. In particular, the coolant flow conduit comprises acooling lumen 422 that is in fluid communication with theinlet fluid port 418 and extends through theshaft 412, and a return lumen 424 that is in fluid communication with theoutlet fluid port 420 and extends through theshaft 412. The distal end of thecooling lumen 422 is in fluid communication with the distal end of the return lumen 424 to complete the cooling circuit. - Operation of the cooling
needle 410 is similar to the operation of thecooling probe 310, with the exception that the coolingneedle 410 is percutaneously introduced through the skin of the patient or through a surgical opening into the tissue. Specifically, theelectrode array 132 of theablation probe assembly 106 is deployed within the target tissue TR. The coolingneedle 410 is inserted, percutaneously or through a surgical opening, into the tissue T on the boundary B separating the treatment region TR from the non-treatment region NTR, as illustrated inFIG. 18A . Thepump assembly 114 is then operated to convey the cooling medium through theneedle 410, thereby providing a thermal barrier between the treatment region TR and the non-treatment region NTR. Specifically, thepower head 180 conveys the cooled medium from thesyringe 182 under positive pressure, throughtubing 198, and into theinlet fluid port 418. The cooled medium then travels through thecooling lumen 422 of theneedle 412. Thermal energy is transferred from the treatment region TR, to theshaft 412 of theneedle 410, and then to the cooled medium, thereby preventing the thermal energy from reaching the non-treatment region NTR and maintaining it at a cool temperature. The heated medium is then conveyed from the return lumen 424, through theoutlet fluid port 420, through thetubing 199, and into thedischarge reservoir 186. - The
RF generator 108 is then operated to ablate the treatment region TR. Specifically, a lesion L is formed within the treatment region TR, as illustrated inFIG. 18B . Because the actively cooledneedle 410 forms a thermal barrier between the treatment region TR and the non-treatment region NTR, the lesion L does not extend to the non-treatment NTR - In alternative methods,
multiple needles 410 can be inserted along the length of the boundary B to provide a broader thermal barrier, in which case a scalloped lesion L will be formed similar to those illustrated inFIGS. 12B and 16B . Thetubings pump assembly 114 can be branched in order to feed the medium to, and remove the heated medium from, themultiple needles 410. - Although particular embodiments of the present inventions have been shown and described, it will be understood that it is not intended to limit the present inventions to the preferred embodiments, and it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present inventions. Thus, the present inventions are intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the present inventions as defined by the claims.
Claims (15)
1.-13. (canceled)
14. A medical assembly for cooling tissue, comprising:
an elongate member having a proximal end and a distal end;
an array of actively cooled needles extending from the distal end of the elongate member, the needle array arranged in a serried.
15. The medical assembly of claim 14 , wherein the array of needles is arranged in a rectilinear pattern.
16. The medical assembly of claim 14 , wherein the array of needles is arranged in a curvilinear pattern.
17. The medical assembly of claim 14 , wherein the array of needles is staggered.
18. The medical assembly of claim 14 , wherein the array of needles is fan-shaped.
19. The medical assembly of claim 14 , wherein the array of needle is rake-shaped.
20. The medical assembly of claim 14 , wherein the needles are configured to be cooled by a liquid medium.
21. The medical assembly of claim 14 , further comprising a cooling pump assembly configured for pumping cooling medium through the needles, and for pumping heated cooling medium from the needles.
22. The medical assembly of claim 14 , wherein the elongate member is flexible.
23. The medical assembly of claim 14 , wherein the elongate member is rigid.
24. The medical assembly of claim 14 , further comprising a cannula, wherein the elongate member is slidably disposed within the cannula, such that the array of needles can be selectively deployed from the cannula and retracted within the cannula.
25. The medical assembly of claim 24 , wherein the cannula is configured to be introduced percutaneously into a body of a patient.
26. The medical assembly of claim 24 , wherein the cannula is configured to be introduced laparoscopically into a body of a patient.
27.-43. (canceled)
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US12/849,699 US8617158B2 (en) | 2003-04-30 | 2010-08-03 | Radio frequency ablation cooling shield |
US14/143,782 US9526561B2 (en) | 2003-04-30 | 2013-12-30 | Radio frequency ablation cooling shield |
US15/351,993 US10524855B2 (en) | 2003-04-30 | 2016-11-15 | Radio frequency ablation cooling shield |
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US15/351,993 Expired - Fee Related US10524855B2 (en) | 2003-04-30 | 2016-11-15 | Radio frequency ablation cooling shield |
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US15/351,993 Expired - Fee Related US10524855B2 (en) | 2003-04-30 | 2016-11-15 | Radio frequency ablation cooling shield |
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EP1620028A1 (en) | 2006-02-01 |
US20110022044A1 (en) | 2011-01-27 |
US10524855B2 (en) | 2020-01-07 |
US20170181791A1 (en) | 2017-06-29 |
US20040220562A1 (en) | 2004-11-04 |
US20140324042A1 (en) | 2014-10-30 |
US8617158B2 (en) | 2013-12-31 |
US7101387B2 (en) | 2006-09-05 |
WO2004098427A1 (en) | 2004-11-18 |
US9526561B2 (en) | 2016-12-27 |
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