US20070129725A1 - Tissue heating device and rf heating method with tissue attachment feature - Google Patents
Tissue heating device and rf heating method with tissue attachment feature Download PDFInfo
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- US20070129725A1 US20070129725A1 US11/671,723 US67172307A US2007129725A1 US 20070129725 A1 US20070129725 A1 US 20070129725A1 US 67172307 A US67172307 A US 67172307A US 2007129725 A1 US2007129725 A1 US 2007129725A1
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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
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- 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
- A61B2018/00601—Cutting
-
- 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
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
- A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
- A61B2218/007—Aspiration
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Plasma & Fusion (AREA)
- Medical Informatics (AREA)
- Otolaryngology (AREA)
- Physics & Mathematics (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
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Abstract
A tissue heating instrument includes a device with a window at its distal end for admitting tissue against or into a compartment within the device. A cylindrical cartridge in the compartment includes a heating surface that supports an electrically conductive heating element, e.g. a band or wire. The tissue adjacent to the heating element can be heated to a selected temperature by generating an electrical current through the heating element. The device is maneuverable to position its distal end near the tissue to be treated. The device also incorporates a vacuum feature that urges tissue into the compartment prior to heating and assists in holding the tissue during the heating process. The device incorporates a dilatation balloon or other feature to urge the device against the tissue, so that at least part of the tissue may come in contact with, or enter the compartment through the window. Then, the cartridge is manipulated from the device's proximal end to move the heating element across the window, heating the adjacent tissue. According to alternative embodiments, the cartridge is either rotated or moved axially relative to the device and, in either event may be capable of closing the device window when the heating is complete. An additional feature of the device includes fluid (therapeutic or other) infusion before, during or after heating the targeted tissue.
Description
- This application is a continuation of Ser. No. 10/906,164 filed on Feb. 4, 2005, now U.S. Pat. No. 7,172,590, which is a continuation of Ser. No. 10/404,720 filed on Apr. 1, 2003, now U.S. Pat. No. 6,872,204, which is a Division of Ser. No. 09/804,009 filed Mar. 12, 2001 and issued on Apr. 1, 2003 as U.S. Pat. No. 6,540,761; Division of Ser. No. 09/256,020, filed Feb. 23, 1999, U.S. Pat. No. 6,214,024; Division of Ser. No. 08/899,490 filed on Jul. 19, 1997, U.S. Pat. No. 5,876,369, and a Division of application Ser. No. 08/376,226 filed on Jan. 23, 1995, U.S. Pat. No. 5,665,062.
- The present invention relates to devices for removing obstructions from body lumens, and more particularly to catheters for removing atherosclerotic plaque and thrombotic occlusions from blood vessels.
- Atherectomy catheters are known for their utility in removing atherosclerotic plaque and thrombotic occlusions from arteries. While intended mainly for use in the coronary arteries, such catheters may as well be used in peripheral vessels. Beyond coronary uses, such catheters can have neurological applications, e.g. removal of lesions in carotid arteries, gynecological use in recanalizing fallopian tubes, and a potential urological application for removal of benign prostate hyperplasia.
- Atherectomy catheters have a variety of designs. According to one design, the catheter has a rounded or bullet shaped tip with an abrasive surface. At the treatment site, the tip is rotated at high speed and burrows through the occlusion. The resulting debris, typically in particulate form, is not captured by the device. Rather, it is allowed to flow to the capillary bed where it is absorbed. The device is most effective in abrading hardened (calcified) occlusions, with the intent being to produce particulate debris no larger than about 7 microns in diameter. When encountering softer occlusions, however, the device presents the risk of an occlusion breaking off during the atherectomy procedure, causing an acute and potentially life-threatening reclosure of the artery. The abrasive tip may inadvertently remove endothelium cells during catheter insertion, use or removal, thereby creating sites for potential lesions.
- A second type of catheter employs a cartridge housed within the catheter, near the catheter distal tip. When the distal tip region is placed near the occlusion, plaque enters the cartridge through an opening or “cutting window”. A cup-shaped blade then is rotated or oscillated at high speed, and advanced to cut and capture plaque that entered the cartridge. U.S. Pat. No. 5,312,425 (Evans); U.S. Pat. No. 5,087,265 (Summers); and U.S. Pat. No. 5,085,662 (Willard) disclose versions of atherectomy catheters with a movable blade or cartridge within a tissue collection volume near the catheter distal tip.
- An example of an atherectomy catheter that depends on vaporization of plaque is found in U.S. Pat. No. 5,087,256 (Taylor). A dome-shaped head on the tip can be heated to temperatures in the range of 300 400 degrees C., for disintegrating plaque. U.S. Pat. No. 5,098,431 (Rydell) discloses a catheter in which an RF discharge between two spaced apart annular electrodes, electrosurgically cuts tissue to remove a blockage.
- Conventional atherectomy catheters are limited principally to an axial cutting direction and subject to smooth cell muscle migration (restonosis) after treatment. Patients treated with conventional atherectomy devices have restonosis rates of 30 40 percent within the six months following treatment.
- Therefore, it is an object of the present invention to provide an atherectomy catheter with a cutting edge that achieves a finer, more accurate cutting of unwanted tissue, to reduce the risk of acute blockage due to the breaking off of an occlusion.
- Another object is to provide a tissue cutting element for an atherectomy catheter that is effective in severing calcified and soft occlusions.
- A further object is to provide a flexible atherectomy catheter that incorporates means for capturing tissue being severed, to ensure against the escape of such tissue into the blood stream.
- Yet another object is to provide an atherectomy catheter with enhanced versatility, due to the incorporation of longitudinal and transverse (arcuate) tissue cutting motions.
- Further, it is an object of the present invention to provide an atherectomy catheter and procedure tending to seal the region of the cut, thus tending to reduce the incidence of restonosis.
- To achieve these and other objects, there is provided a device for removing atheromas from a body lumen. The device includes an elongate catheter having a proximal end and a distal end. The catheter has a wall that defines a compartment within the catheter near its distal end, and a window is formed through the catheter wall to allow entry into the compartment. The catheter incorporates an electrically conductive tissue cutting element. A means is provided for generating an electrical current in the cutting element to heat the cutting element and adjacent tissue at least to a selected temperature above normal body temperature (i.e. 37° C.). A carrier is mounted movably relative to the catheter, for supporting the cutting element proximate the window and for a controlled movement of the cutting element along and adjacent the window. The catheter is flexible and maneuverable to locate its distal tip within a body lumen and to place the window against a tissue wall segment of the body lumen to acquire tissue within the compartment. The cutting element, when heated and when undergoing the controlled movement, severs the acquired tissue.
- There are several suitable approaches for generating the current necessary for cutting. At present, the most preferred approach involves a biocompatible cutting element (e.g. of platinum) subjected to RF energy in combination with an indifferent plate electrode on the patient's back. Application of the RF energy causes ohmic heating of tissue near the cutting element as current passes through the tissue.
- As an alternative, RF energy can be applied to heat an electrically resistive cutting element formed of nickel or a nickel chromium alloy. In this approach, the cutting element is heated to a temperature sufficient to sever a lesion that comes into contact with the element. As a third and presently least preferred alternative, DC power is applied to heat an electrically resistive cutting element, again of nickel or a nickel chromium alloy. For biocompatability, an insulative jacket or coating is applied to the nickel or nickel chromium cutting element.
- The preferred cutting element is a flat band, having a thickness of about 0.015 inches and a substantially greater width. The band achieves a highly accurate and fine cut of the tissue, considerably reducing the pulling and tearing of tissue as compared to the conventional oscillating or rotating blades. Unwanted tissue is severed more cleanly, reducing patient risk. Further, it is believed that the elevated temperatures of the band and adjacent tissue have a sealing or cauterizing effect along the region of the cut. This is believed to result in a substantial reduction in restonosis in the treated artery.
- As an alternative to a flat band, the cutting element can be a fine wire having a diameter of about 0.030 inches or less to provide the cutting edge.
- The carrier preferably includes a cartridge contained within the compartment. The cartridge can have an axialy extended cartridge wall, a cartridge opening and a cutting edge along the cartridge opening for supporting the cutting element. A control means is coupled to the cartridge proximal end, and operable to selectively position and move the cartridge within the compartment, to provide the controlled movement of the cutting element. Preferably the cartridge wall is longer axially than the window, so that the cartridge can be positioned to substantially close the window and thus capture severed tissue. With tissue secured in this manner, there is no need for a suction device or other means to withdraw tissue proximally through the catheter immediately after it is cut. With no need to pay attention to a vacuum or suction means, the physician is able to direct more attention to the atherectomy procedure at hand.
- Conversely, a vacuum means (or alternatively a plunger device and a diaphragm valve) may be provided if desired for removing severed tissue from the compartment, to allow cutting and removal of tissue at several locations during a single procedure.
- There are several alternatives for supporting the cutting element. For example, the cutting edge can be the leading or distal edge of the cartridge, preferably but not necessarily annular. In this event, the cartridge is moved distally to provide the necessary controlled movement of the cutting element. Alternatively, the cutting edge can be an axial edge of the cartridge opening, in which event the cartridge is rotated about a longitudinal axis to move the cutting element in an arcuate path.
- A preferred control means includes an elongate drive member, e.g. a rod, coil or tube, attached to the proximal end of the cartridge and extending proximally to a proximal end of the catheter. The member can be rotated, pushed or pulled at the catheter proximal end, to impart like motion to the cartridge.
- Another aspect of the invention is a process for removing tissue from a body lumen, according to the following steps:
- a. providing, near a distal end of an elongate catheter, a compartment and a window to the compartment through a catheter wall, and an electrically conductive tissue cutting element mounted to the catheter for a controlled movement of the cutting element adjacent and along the window;
- b. inserting the catheter into a body lumen, and guiding the catheter to position the window against a tissue wall segment of the body lumen, thus to cause tissue to enter the compartment via the window and occupy the compartment;
- c. generating an electrical current in the cutting element to heat the cutting element and adjacent tissue at least to a selected temperature above normal body temperature, while causing the cutting element to undergo the controlled movement, thereby to sever the tissue occupying the compartment.
- After the tissue is severed, the compartment can be closed to prevent egress of the severed tissue. The controlled movement of the cutting element can be one of two alternatives: substantially linear and axial with respect to the catheter, or arcuate about an axis running longitudinally of the catheter.
- Thus in accordance with the present invention, there is provided an atherectomy device and procedure suitable for treating soft occlusions and calcified occlusions alike, with clean and accurate cutting that reduces the risk of tissue tearing and escaping into the blood vessel under treatment. The catheter is versatile, due to its flexibility for traversing tortuous vessels and for the ability to cut in either an arcuate or axial path. The application of heat is concentrated along the region of the cut, i.e. the cutting element and adjacent tissue, reducing the required cutting force, increasing cutting accuracy and tending to cauterize or seal the region of the cut, thus tending to substantially prevent restonosis.
- For a further understanding of the above features and advantages, reference is made to the following detailed description and to the drawings, in which:
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FIG. 1 is an elevation of an atherectomy device constructed in accordance with the present invention; -
FIG. 2 is a sectional view taken along the line 2-2 inFIG. 1 ; -
FIGS. 3 and 4 are sectional views taken along the lines 3-3 inFIGS. 1 and 4 -4 inFIG. 2 ; -
FIG. 5 is a perspective view of a tissue retaining cartridge employed in the device; -
FIG. 6 is a schematic view illustrating circuitry for providing an electrical current through a mounted heating element on the cartridge; - FIGS. 7 9 are diagrammatic views illustrating use of the device;
-
FIG. 10 is an elevational view of the distal end region of an alternative atherectomy device constructed according to the invention; -
FIG. 11 is a sectional view taken along the line 11-11 inFIG. 10 ; -
FIG. 12 is a perspective view of a tissue retaining cartridge used in the device ofFIG. 10 ; -
FIGS. 13 and 14 diagrammatically illustrate use of the device ofFIG. 9 ; -
FIG. 15 is a three-dimensional illustration of an alternative embodiment cartridge; and -
FIG. 16 is a schematic view of an alternative circuit for heating the cutting element. - Turning now to the drawings, there is shown in
FIG. 1 anatherectomy device 16 for removing unwanted tissue from body lumens, more particularly blood vessels. The device includes a control housing or handle 18, and an elongate andpliable catheter 20 connected at its proximal end to the handle. -
Catheter 20 is formed of a biocompatible polymer such as Pebax (brand name) polyether block amides, Pellethane (brand name) polyurethane or polyimide, and can have an outside diameter in the range of 3 Fr. (1 mm) to 8 Fr. (2.7 mm) or larger.Catheter 20 includes several lumens that run axially fromhandle 18 to adistal end region 22. Aguidewire 24, contained within one of the lumens, extends proximally beyondhandle 18 and distally beyond a tapereddistal tip 26 of the catheter. Further lumens are provided in the catheter, for delivery of contrast fluid or treatment fluid to the distal end region, and for balloon inflation. While not shown, a braided or other filament structure can be embedded into the catheter body to enhance torque transmission, if desired. - A
window 28 is formed through awall 30 of the catheter along the distal end region.Window 28 is elongate in the axial direction and extends along about forty percent of the circumference ofcatheter wall 30. A cartridge or cuttingsleeve 32 is contained withincatheter 20. The cartridge is shown adjacent and alongwindow 28, but is movable axially relative to the catheter. This enables a proximal retraction of the cartridge fromwindow 28, to open the window whereby the catheter can acquire tissue. Anelongate drive rod 34, contained within a lumen ofcatheter 20, is coupled to the proximal end ofcartridge 32 and extends proximally through the catheter and intohandle 18. - Drive
rod 34 is formed of an electrically insulative material, e.g. a PTFE coated wire coil or spiral wrapped polyimide. The drive rod has a high degree of bending elasticity to permit its movement (with the remainder of catheter 20) along serpentine passages toward an intended treatment site. At the same time,drive rod 34 is sufficiently rigid in the axial direction to permit controlling the cartridge axial position by manipulating the drive rod at its proximal end. Driverod 34 is constructed of an electrically insulated material. A pair ofconductors Conductors housing 18. - A
dilatation balloon 40 is formed to extend axially alongdistal end region 22, axially aligned withwindow 28 but also spaced apart angularly 180 degrees, i.e. on the opposite side of the catheter from the window.Balloon 40 is inflated using a fluid supplied to the balloon under pressure via a lumen ofcatheter 20. - A
fluid port 42 admits contrast or treatment fluids in the region just proximally ofwindow 28, while such fluids can be administered distally of the window via the guidewire lumen. -
Control housing 18 includes three branches for coupling two sources of fluid (not shown): abranch 44 for balloon inflation, and twobranches 46 and 48 for delivery of contrast fluids or treatment fluids such as heparin. At the proximal end of the control housing is aconnector 50 with two electrically independent paths coupled toconductors connector 50 to apower supply 54.Power supply 54 preferably is an RF source, but can be a DC source as well. Also mounted at the housing proximal end are a fitting 56 and acontrol knob 58.Knob 58, coupled to the proximal end ofdrive rod 34, is movable axially relative to fitting 56, to control the axial position ofcartridge 32. - A display 60 (e.g. LED) indicates the temperature of a cutting element mounted to the cartridge. A
temperature control 62 adjusts the current through the cutting element, thus to set the cutting element temperature. -
FIG. 2 shows several lumens running through the catheter, including aguidewire lumen 64 that also can be used to administer contrast and treatment fluids. Acontrol lumen 66 accommodatesdrive rod 34. Further lumens include aballoon inflation lumen 68 and anupper infusion lumen 70 for providing fluids tofluid port 42. - As seen in
FIGS. 3 and 4 ,control lumen 66 along the distal end region forms acompartment 72 to accommodatecartridge 32. The compartment extends distally beyond window 28 a slight distance, and extends proximally of the window a sufficient amount to allow cartridge retraction, i.e. placing the complete cartridge proximally of the window. -
Cartridge 32 is cylindrical, having anaxial wall 74 and a disk-shapedproximal wall 76. As seen inFIG. 5 ,cartridge 32 is open at its distal end to provide acircular cutting edge 78. A tissue cut element, more particularly a fine,flat band 80, is mounted to the cutting edge to form an arc.Band 80 need not circumscribe the cutting edge, but should extend a sufficient amount to spanwindow 28.Band 80 has a thickness of about 0.015 inches, and is formed of nickel or a nickel chromium alloy coated for biocompatability. Alternatively (in an indifferent electrode approach discussed below) the band can be formed of platinum or another electrically conductive and body compatible material. The band is heated when subject to an electrical current. As an alternative to the band, the cutting element can be a wire with a diameter of at most 0.030 inches. - The
polymer forming cartridge 32 can be blended with barium sulphate, bismuth trioxide or another suitable radiopaque material to facilitate fluoroscopic observation of the cartridge position before and during tissue removal. Radiopaque markers also may be placed along the cartridge cutting edge and on corresponding (distal and proximal, or intermediate) edges of the window. Along with aiding accurate positioning, these markers are useful in confirming when the cartridge is closed after cutting. -
Conductors element 80. As indicated in broken lines,conductors axial wall 74 which, like the drive rod, is electrically insulative. Athermocouple 82 can be mounted to the cartridge near cuttingedge 78 and preferably bonded to cuttingelement 80, to monitor the cutting element temperature.Conductors 84, embedded in the cartridge and the drive rod, permit the cutting element temperature to be monitored fromcontrol housing 18. Alternatively, thermistors can be used to sense temperature. Further, for a resistive cutting element (i.e. nickel or nickel chromium) a characteristic dependence of resistance upon temperature can be used to monitor the cutting element temperature. - Tissue is cut by advancing
cartridge 32 distally from the retracted position, with cuttingelement 80 and adjacent tissue maintained at at least a predetermined temperature above body temperature. A circuit for heating the cutting element and tissue is schematically illustrated inFIG. 6 . Acontroller 86 adjusts power fromsupply 54 as required, for generating current through cuttingelement 80 in an amount selected to heat the cutting element to the predetermined temperature.Thermocouple 82 senses the temperature and provides the corresponding temperature reading atdisplay 60. If the display indicates a need to increase or reduce the temperature,controller 86 is adjusted to alter the current accordingly. A broken line at 88 indicates that if desired, the output ofthermocouple 82 can be employed to automatically adjust the cutting element current. - The use of
device 16 to remove unwanted tissue is shown in FIGS. 7 9, wherecatheter 20 has been either steered or moved overguide wire 24 to a treatment position near alesion 90 in a coronary artery.Catheter 20 is manipulated fromhousing 18 to axially and angularly align the catheter andlesion 90, so thatwindow 28 faces the lesion (FIG. 7 ). At this point, dilatation fluid is supplied to expandballoon 40 against anarterial wall 92 opposite the lesion (e.g. as in aforementioned U.S. Pat. No. 5,085,662). Balloon dilatation drives the catheter distal end upward as viewed in FIGS. 7 9, forcing the catheter against the arterial wall aboutlesion 90 and causing at least a portion of the lesion to entercompartment 72 throughwindow 28. - With tissue thus acquired,
cartridge 32 is advanced distally from the retracted position, while cuttingelement 80 is maintained at the selected temperature, from 50-600° C. and more preferably 50-400° C. This heating of the wire and adjacent tissue considerably enhances the cutting of tissue. Moreover, the heating has a cauterizing effect at the region of the cut and thus tends to seal the wound almost immediately after cutting, to significantly reduce smooth cell muscle migration or restonosis after treatment. The minute filament results in a precise, well defined cutting path that minimizes stretching and tearing of tissue. Accordingly, cutting element is effective in severing soft tissue as well as calcified or hardened tissue. This minimizes the risk of tissue fragmenting into particles or pieces that escape into the bloodstream. -
Cartridge 32 is advanced until cuttingedge 78 is distally of window 28 (FIG. 9 ), to completely acquire severed tissue within the cartridge. During or following the cut, a treatment fluid may be administered throughlumens - In addition to the cauterizing/sealing effect, a salient feature of the invention is the continuity of
axial wall 74, which closeswindow 28 when the cartridge is completely advanced. This insures that severed tissue remains captured withincompartment 72 as the catheter is withdrawn, thus to eliminate the risk that severed tissue will enter the bloodstream. -
FIG. 10 illustrates, in axial (longitudinal) section, the distal end region of analternative device 96. This device differs fromdevice 16 in several respects concerning primarily the catheter distal end, but also as to the manner of controlling the cartridge. Acatheter 98 ofdevice 96 hasflexible band 100 along its distal end in lieu of a dilatation balloon. Band 100 can be flexed radially away from the catheter and, upon contacting an artery, drives the catheter toward the opposite end of the artery. An example of such band and its control is found in U.S. Pat. No. 5,087,265 (Summers). - A single,
central lumen 102 accommodates the guidewire and is enlarged to provide acompartment 104. The compartment accommodates acartridge 106 having an axially extendedwall 108, aproximal end wall 110 and adistal end wall 112. Adrive tube 114, connected to the proximal end wall, is manipulated at the housing to selectively positioncartridge 106. - Drive
tube 114 is used to rotatecartridge 106 about a longitudinal axis, rather than to move the cartridge axially. Consequently, while it requires less axial stiffness thandrive rod 34,drive tube 114 must be resistant to torsional bending to apply the necessary torque to rotatecartridge 106. Also because of the lack of axial movement,compartment 104 need not extend proximally beyondwindow 116 to accommodate the cartridge length. As seen inFIGS. 11 and 12 ,cartridge wall 108 is open along a portion of its circumference, to provide anarcuate cartridge opening 118 defined byend walls axial edges Axial edge 120 provides the cutting edge, and supports alinear cutting element 124. Cuttingelement 124 is flat and thin (e.g. 0.015 inches thick), with a rectangular profile, to provide a lower profile cutting edge as compared to a wire. -
FIGS. 13 and 14 illustrate the use ofcatheter 98 to remove alesion 126 from anartery 128. The catheter is positioned to axially alignwindow 116 withlesion 126, and further to angularly align the window and lesion. A control knob (not shown but similar to knob 58) is turned rather than pushed or pulled, to angularly aligncartridge 106 such thatopening 118 coincides with window 116 (FIG. 13 ). At this point,band 100 is flexed to urge the catheter upwardly against the arterial wall whereby a portion oflesion 126 enterscompartment 104. - At this point, the knob is turned to rotate
cartridge 106 clockwise as viewed inFIG. 13 while cuttingelement 124 is heated, thus to progressively cut the lesion. Cartridge rotation continues until cuttingedge 120 is carried beyond the clockwise edge ofwindow 116, which closes the window and captures acquired tissue. Then,catheter 98 is proximally withdrawn to remove captured tissue, or a plunger is used to remove tissue from the cartridge. -
FIG. 15 illustrates analternative embodiment cartridge 130 having an axial wall that is open at the distal end and along part of its circumference to define twocutting edges arcuate segment 138 mounted to cuttingedge 132, and alinear segment 140 alongaxial cutting edge 134. Accordingly,cartridge 130 can be used to effect axial cutting and arcuate cutting.Cartridge wall 142 is continuous over at least sixty percent of its circumference to enable axial and angular positioning that closes the associated catheter window, to insure capture of severed tissue.Drive member 144 can be a tube, rod or coil and has sufficient axial and torsional rigidity to impart axial and rotational movement to the cartridge. -
FIG. 16 illustrates an alternative circuit for heating anarcuate cutting element 146. Aconductor 148 connects the cutting element with anRF power supply 150. Asecond conductor 152 couples the power supply and anindifferent electrode 154. The indifferent electrode preferably is an electrode plate, typically applied to the back of the patient. The power supply provides an RF signal to the cutting element viaconductor 148. The signal returns to the power supply viaconductor 152. Between cuttingelement 146 andindifferent electrode 154, current flows through body tissue. Consequently, ohmic heating of tissue is the primary factor in raising the temperature of tissue adjacent the cutting element to the predetermined or desired level. Cuttingelement 146 preferably is platinum, for high biocompatability and electrical conductivity. Accordingly cutting element heating from the current, while present to a degree, is slight compared to the ohmic heating effect. Acontroller 156 governspower supply 150 to provide the appropriate current in cuttingelement 146. While not shown inFIG. 16 , a thermocouple or other sensing element can be mounted at the cutting element, to sense the temperature of the cutting element and adjacent tissue, and provide feedback tocontroller 156. As noted above, this approach (highly conductive cutting element and indifferent electrode) is presently the most preferred. - While the disclosure has focused on the treatment of coronary arteries, it is to be appreciated that devices in accordance with the present invention can be used to treat peripheral arteries and other vessels. These principles further can be applied in constructing and utilizing devices in neurology for removal of lesions in the carotid arteries, in gynecology for recanalization of Fallopian tubes, and in urology for removal of benign prostrate hyperplasia. The heating of the cutting element and adjacent tissue provides a fine, accurate cut to sever tissue at minimal risk of forming fragments, and provides a sealing action believed to reduce the incidence of restonosis. The cartridge can be either rotated or moved axially of the catheter, for greater versatility in severing unwanted tissue. After the cut, the cartridge completely closes the tissue-admitting window of the catheter, to insure complete capture of severed tissue.
Claims (20)
- 69. A device for heating tissue comprising:an elongate catheter having a proximal end and a distal end, a catheter wall defining a compartment within the catheter, a window through the catheter wall open to the compartment, and at least one lumen passing between a first opening in the proximal end and a second opening in the compartment, the first opening being connected to a vacuum source;a cartridge at least partially disposed within the compartment, the cartridge having a surface with a heating element disposed along the cartridge, and an energy source operatively coupled to the heating element, the cartridge being operable to urge tissue into the compartment when the first opening is connected to the vacuum source; anda controller coupled to the cartridge and operable to selectively position and move the cartridge relative to the catheter and thereby provide a controlled movement of the heating surface along the window.
- 70. The device of
claim 69 wherein the second opening is either distal to the window in the catheter wall or proximal to the window in the catheter wall. - 71. The device of
claim 69 wherein the second opening is positioned to be open to the compartment. - 72. The device of
claim 69 wherein a drive tube couples the controller to the cartridge. - 73. The device of
claim 72 wherein the drive tube includes a lumen having an opening in the compartment and the lumen is configured to be connected to the vacuum source. - 74. The device of
claim 72 wherein the drive tube is positioned in the lumen. - 75. The device of
claim 69 wherein the catheter is maneuverable to locate the window against a tissue wall segment and the heating element is configured to heat tissue when vacuum is applied to the window. - 76. The device of
claim 75 wherein the application of vacuum from the vacuum source to the window when the window is located against the tissue wall segment causes the application of vacuum to at least the tissue wall segment. - 77. The device of
claim 69 further comprising a second lumen passing between a first opening in the proximal end and a second opening in the distal end. - 78. The device of
claim 77 further comprising a fluid source connected to the first opening of the second lumen. - 79. The device of
claim 78 wherein the fluid source comprises one or both of a therapeutic agent and a contrast agent. - 80. The device of
claim 69 wherein the heating element is configured to heat tissue adjacent to the heating element. - 81. The device of
claim 69 further including a temperature sensing means for detecting the temperature of the heating element. - 82. The device of
claim 69 wherein the cartridge is moveable axially relative to the catheter to provide the controlled movement of the heating element. - 83. The device of
claim 69 wherein the cartridge is rotatable relative to the catheter to provide the controlled movement of the heating element. - 84. A tissue heating system comprising:a tissue heating device comprising:an elongate catheter having a proximal end and a distal end, a catheter wall defining a compartment within the catheter, a window through the catheter wall open to the compartment, a first lumen passing between a first opening in the proximal end and a first opening in the compartment, and a second lumen passing between a second opening in the proximal end and a second opening in the compartment,a cartridge at least partially disposed within the compartment, the cartridge having a heating surface with a heating element disposed along the cartridge, and an energy source operatively coupled to the heating element, anda controller coupled to the cartridge and operable to selectively position and move the cartridge relative to the catheter and thereby provide a controlled movement of the heating element along the window, wherein the catheter is maneuverable to locate the window against a tissue wall segment;a vacuum source connectable to the first lumen; anda fluid source connectable to the second lumen, wherein the cartridge is operable to urge tissue into the compartment when the first lumen is connected to the vacuum source.
- 85. The tissue heating system of
claim 84 wherein the heating element is configured to heat tissue adjacent the heating element. - 86. A method of heating tissue, the method comprising:providing a tissue heating device comprising:an elongate catheter having a proximal end and a distal end, a catheter wall defining a compartment within the catheter, a window through the catheter wall open to the compartment, and a first lumen passing between a first opening in the proximal end and a first opening in the compartment,a cartridge at least partially disposed within the compartment, the cartridge having a heating surface with a heating element disposed along the cartridge surface, and an energy source operatively coupled to the heating element, anda controller coupled to the cartridge and operable to selectively position and move the cartridge relative to the catheter and thereby provide a controlled movement of the heating surface along the window, a drive tube coupling the controller to the cartridge, the drive tube including a second lumen having an opening in the compartment and being configured to be connected to a vacuum source, wherein the catheter is maneuverable to locate the window against a tissue wall segment;connecting a vacuum source to one of the first lumen and the second lumen;applying a vacuum to the tissue heating device, wherein the cartridge is operable to urge tissue into the compartment when one of the first lumen and the second lumen is connected to the vacuum source;connecting a fluid source to the other of the first lumen and the second lumen; andapplying a fluid to the tissue heating device to supply the fluid to the tissue.
- 87. The method of heating tissue of
claim 86 wherein the fluid comprises one or more of a treatment agent, a contrast agent, and a therapeutic agent - 88. The method of
claim 86 further comprising heating tissue adjacent the heating element.
Priority Applications (2)
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US12/768,587 US20100211057A1 (en) | 1995-01-23 | 2010-04-27 | Tissue heating device and rf heating method with tissue attachment feature |
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US08/376,226 US5665062A (en) | 1995-01-23 | 1995-01-23 | Atherectomy catheter and RF cutting method |
US08/899,490 US5876369A (en) | 1995-01-23 | 1997-07-19 | Tissue removing catheter and RF cutting method |
US09/256,020 US6214024B1 (en) | 1995-01-23 | 1999-02-23 | Tissue cutting catheter and RF cutting method |
US09/804,009 US6540761B2 (en) | 1995-01-23 | 2001-03-12 | Tissue cutting/tissue removing device with vacuum feature |
US10/404,720 US6872204B2 (en) | 1995-01-23 | 2003-04-01 | Tissue cutting catheter and RF cutting method |
US10/906,164 US7172590B1 (en) | 1995-01-23 | 2005-02-04 | Tissue heating device and RF heating method with tissue attachment feature |
US11/671,723 US20070129725A1 (en) | 1995-01-23 | 2007-02-06 | Tissue heating device and rf heating method with tissue attachment feature |
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US08/899,490 Expired - Fee Related US5876369A (en) | 1995-01-23 | 1997-07-19 | Tissue removing catheter and RF cutting method |
US09/256,020 Expired - Lifetime US6214024B1 (en) | 1995-01-23 | 1999-02-23 | Tissue cutting catheter and RF cutting method |
US09/804,009 Expired - Lifetime US6540761B2 (en) | 1995-01-23 | 2001-03-12 | Tissue cutting/tissue removing device with vacuum feature |
US10/404,720 Expired - Fee Related US6872204B2 (en) | 1995-01-23 | 2003-04-01 | Tissue cutting catheter and RF cutting method |
US10/906,164 Expired - Fee Related US7172590B1 (en) | 1995-01-23 | 2005-02-04 | Tissue heating device and RF heating method with tissue attachment feature |
US11/671,723 Abandoned US20070129725A1 (en) | 1995-01-23 | 2007-02-06 | Tissue heating device and rf heating method with tissue attachment feature |
US12/768,587 Abandoned US20100211057A1 (en) | 1995-01-23 | 2010-04-27 | Tissue heating device and rf heating method with tissue attachment feature |
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US08/376,226 Expired - Lifetime US5665062A (en) | 1995-01-23 | 1995-01-23 | Atherectomy catheter and RF cutting method |
US08/899,490 Expired - Fee Related US5876369A (en) | 1995-01-23 | 1997-07-19 | Tissue removing catheter and RF cutting method |
US09/256,020 Expired - Lifetime US6214024B1 (en) | 1995-01-23 | 1999-02-23 | Tissue cutting catheter and RF cutting method |
US09/804,009 Expired - Lifetime US6540761B2 (en) | 1995-01-23 | 2001-03-12 | Tissue cutting/tissue removing device with vacuum feature |
US10/404,720 Expired - Fee Related US6872204B2 (en) | 1995-01-23 | 2003-04-01 | Tissue cutting catheter and RF cutting method |
US10/906,164 Expired - Fee Related US7172590B1 (en) | 1995-01-23 | 2005-02-04 | Tissue heating device and RF heating method with tissue attachment feature |
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US12/768,587 Abandoned US20100211057A1 (en) | 1995-01-23 | 2010-04-27 | Tissue heating device and rf heating method with tissue attachment feature |
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Also Published As
Publication number | Publication date |
---|---|
US20100211057A1 (en) | 2010-08-19 |
US6214024B1 (en) | 2001-04-10 |
US6540761B2 (en) | 2003-04-01 |
WO1996022737A1 (en) | 1996-08-01 |
US20020013580A1 (en) | 2002-01-31 |
US5665062A (en) | 1997-09-09 |
US20040002706A1 (en) | 2004-01-01 |
US7172590B1 (en) | 2007-02-06 |
US5876369A (en) | 1999-03-02 |
US6872204B2 (en) | 2005-03-29 |
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