Patent Grant
7604635
This invention relates generally to the field of medical devices, systems and methods for use upon a body during surgery. More particularly, the invention relates to electrosurgical devices, systems and methods for use upon tissues of a human body during surgery, particularly open surgery and minimally invasive surgery such as laparoscopic surgery.
The application of heat to tissue, typically from a flame heated metal object, has been used for centuries to cauterize bleeding wounds. In cauterization, the essential mechanism behind tissue treatment involves raising the temperature of the bleeding tissue by conductive heat transfer from the heated metal object. In order to arrest bleeding from the tissue's severed blood vessels, the tissue is heated adequately to shrink certain tissue proteins, such as collagen, thus closing the blood vessels and ultimately leading to blood vessel thrombosis.
Apart from shrinkage, the application of compressive force from a heated metal object to a blood vessel may also result in collagen welding, such as for the permanent joining together of opposite walls of a blood vessel, thus providing another mechanism of hemostasis in addition to simple shrinkage of collagen.
With the aid of electricity, cauterization spurred the development of electrocautery devices to treat bleeding. While electrocautery devices still involve the use of a heated metal object, the electrocautery device is heated via electrical energy converted to heat in the metal object as opposed to heating the metal with a direct flame.
More recently, coagulation may be accomplished by radio frequency (“RF”) electrosurgical devices where electrical energy is converted to heat in the tissue rather than in the device. Heating of the tissue is often performed by means of resistance heating. In other words, increasing the temperature of the tissue as a result of electric current flow through the tissue which is resisted by the tissue. Electrical energy is converted into thermal energy (i.e. heat) via accelerated movement of ions as a function of the tissue's electrical resistance and current flow.
Hemostasis of the above sort is not without its drawbacks. Current dry tip RF electrosurgical devices can cause the temperature of tissue being treated to rise significantly higher than 100° C., thus exceeding the boiling temperature of inter-cellular water and resulting in tissue desiccation, tissue sticking to the electrodes, tissue perforation, char formation and smoke generation. Peak tissue temperatures at a targeted tissue treatment site can be as high as 320° C. as a result of RF treatment, and such high temperatures can be transmitted to adjacent untargeted tissue via conduction. Undesirable results of such transmission to untargeted adjacent tissue include unintended thermal damage to the untargeted tissue.
According to U.S. Pat. No. 6,086,586 to Hooven entitled “Bipolar Tissue Grasping Apparatus and Tissue Welding Method”, currently-available bipolar grasping instruments for electro-coagulation of tissue, or “tissue welding,” generally use only two electrodes of opposite polarity, one of which is located on each of the opposite jaws of the grasper. As illustrated in Hooven's
The Hooven patent goes on to recite that “[t]hermal damage to adjacent structures can occur due to this spread of thermal energy outside the jaws of the instrument. Because of the spread of thermal energy outside the jaws of the instrument, it is difficult to coagulate long sections of tissue, such as bowel, lung, or larger blood vessels, without significant lateral thermal spread. Over-coagulation frequently occurs, resulting in tissue sticking to the jaws of the instrument. When the jaws of the instrument are opened, if the tissue sticking is severe, the tissue can be pulled apart, thus adversely affecting hemostasis.”
As part of the summary of the invention, the Hooven patent recites “a bipolar electrosurgical instrument having a pair of relatively moveable jaws, each of which includes a tissue contacting surface. The tissue contacting surfaces of the jaws are in face-to-face relation with one another, and adjacent each of the tissue contacting surfaces are first and second spaced-apart electrodes that are adapted for connection to the opposite terminals of a bipolar RF generator so as to generate a current flow therebetween.” Furthermore, the Hooven patent recites that, “[b]ecause each jaw is a bipolar electrode, multiple local current pathways, high current densities, and lower impediences are achieved. Indeed, the maximum current density is between the two insulated jaw surfaces, while a relatively lower current density exists at the electrode surfaces.”
However, the invention of the Hooven patent encounters certain difficulties. Due to tissue irregularities, the surface of the tissue to be treated may be uneven or undulated with peaks and valleys. Consequently, the area of electrical coupling of the tissue to the electrode surfaces can be limited to the isolated peaks in the tissue surface. In this situation, upon the application of RF power to tissue, the electrical coupling of only the tissue peaks to the electrode surfaces may result in corresponding increase in current density through the electrically coupled peaks which has the ability to desiccate and char the tissue at these isolated locations. Hooven does not address or provide for this situation.
Another difficulty encountered with the Hooven invention is that it does not address or provide for a decreasing electrical coupling between the tissue and electrode surfaces upon tissue shrinkage and/or desiccation during treatment. As tissue shrinks and/or desiccates during treatment, the tissue surfaces may loose contact with the electrode surfaces which, similar to above, decreases the area of electrical coupling therebetween and correspondingly increases the current density and associated heat at the locations which remain electrically coupled. This difficulty is further exacerbated if the tissue is undulated as described above.
Another difficulty encountered with the Hooven invention is that it does not address or provide for dissipating heat from the insulating members. Hooven does not address or provide how heat which may be conducted into the insulating members from the tissue between the two insulated surfaces is subsequently removed from the insulating members.
In light of the above, it is an object of the invention to provide devices, systems and methods which overcome the limitations of the art.
The present invention provides devices, systems and methods that inhibit, and more preferably minimize or prevent, tissue necrosis outside a targeted tissue treatment site during a medical procedure. The invention is particularly useful during surgical procedures upon tissues of a human body, where it is desirable to coagulate and shrink tissue, to occlude lumens of blood vessels (e.g. arteries, veins), airways (e.g. bronchi, bronchioles), bile ducts and lymphatic ducts.
According to the present invention, electrosurgical devices, systems and methods are provided in which the electrical current paths, associated electrical resistance heating and ensuing thermal conduction heating are substantially limited to tissue within the jaws of the device, so as to inhibit, and preferably prevent, tissue damage outside the jaws due to thermal effects. More preferably, the electrical current paths, as well as current density, are concentrated within the confines and borders of two electrically insulated surfaces of the jaws and, even more preferably, within the medial portions of the electrically insulated surfaces.
According to the present invention, electrosurgical devices, systems and methods are provided in which the maximum current density and heating of tissue (by both electrical resistance heating and thermal conduction heating) occurs apart or removed from the electrodes and preferably between the two electrically insulated surfaces. More preferably, the electrodes are configured such that the portion of the electrode surfaces closest to the two electrically insulated surfaces is remotely located and separated from the electrically insulated surfaces.
According to the present invention, electrosurgical devices, systems and methods are provided in which the electrical coupling between tissue and the electrodes is enhanced, so as to inhibit tissue damage outside the electrically insulated surfaces, particularly to tissue nearest the electrodes. Tissue damage can be manifest in many ways, depending on the tissue temperature encountered, ranging from coagulation necrosis at temperatures from 50 to 100° C., to sticking at temperatures above 120° C., to charring, arcing and smoke formation at temperatures exceeding 200° C.
According to the present invention, preferably the enhanced electrical coupling is provided by an electrically conductive fluid which couples between the tissue surface and the electrodes and increases the uniformity of the electrical coupling therebetween. In addition to inhibiting tissue damage as outlined above, this enhancement is particularly useful to counter poor electrical coupling associated with prior art dry devices, uneven and undulated tissue, shrinkage of treated tissue, desiccation of treated tissue and motion of the jaws while grasping tissue.
According to the present invention, electrosurgical devices, systems and methods are provided in which a portion of the electrical current, upon exiting from between the two electrically insulated surfaces, flows at least partially through the electrically conductive fluid, rather than through the tissue outside the electrically insulated surfaces, before reaching the counter electrode. According to the present invention, this will inhibit tissue damage outside the electrically insulated surfaces given the decrease in electrical current through the tissue and associated decrease in power in the tissue will correspondingly reduce the amount of resistance and conduction heating of the tissue.
According to the present invention, electrosurgical devices, systems and methods are provided and configured to provide a diversion and preferably divert at least a portion of the electrical current, upon exiting from between the two electrically insulated surfaces, at least partially through the conductive fluid before reaching the counter electrode. Preferably at least a portion of the electrically conductive fluid coupling the electrodes and the tissue outside the electrically insulated surfaces electrical couples tissue adjacent the electrically insulated surfaces. Also, preferably, at least a portion of the electrically conductive fluid coupling the electrodes and the tissue adjacent the electrically insulated surfaces electrical couples the tissue and the electrodes at the shortest distance there between.
Preferably the electrosurgical devices, systems and methods are configured such that the electrical current exiting from between the two electrically insulated surfaces will be more apt to be concentrated and flow at least partially through the electrically conductive fluid, rather than through the tissue outside the electrically insulated surfaces, to the counter electrode.
Preferably the electrically conductive fluid is provided in a configuration to present an electrical resistance to the electrical current exiting from between the two electrically insulated surfaces which is less than the electrical resistance encountered in tissue outside the electrically insulated surfaces. Preferably the electrically conductive fluid has an electrical resistivity less than the electrical resistivity of the tissue through which electrical current would flow in the absence of the electrically conductive fluid prior to treatment with the device.
According to the present invention, the source electrode side relative to the tissue grasping surfaces is configured similar to the counter electrode side. As electrical current flows from the source electrode and enters between the tissue grasping surfaces it will also seek a path to the counter electrode comprising the least electrical resistance. Consequently, in addition to the above, the device is also configured to provide a diversion for and preferably divert at least a portion of the electrical current, upon leaving the source electrode, at least partially through the conductive fluid before entering between the grasping surfaces.
Preferably the electrically conductive fluid is provided to tissue by means of the electrosurgical device. Also preferably, the electrically conductive fluid comprises a saline solution. Furthermore, in certain embodiments, the saline solution may comprise physiologic saline or hypertonic saline.
According to the present invention, electrosurgical devices, systems and methods are provided in which removal of heat from and cooling of the tissue outside the electrically insulated surfaces is enhanced, so as to inhibit tissue damage outside the electrically insulated surfaces. Preferably, the enhanced cooling is provided by a fluid, particularly the electrically conductive fluid. More particularly, in the event a portion of the electrical current exiting from between the two electrically insulated surfaces flows through tissue outside the electrically insulated surfaces, thus heating the tissue outside the electrically insulated surfaces by resistance and conduction heating, the conductive fluid function as a heat sink to absorb and remove heat from the tissue and cool the tissue. Furthermore, it is an object of the present invention that the conductive fluid lubricates the tissue/electrode interface and the tissue/electrically insulated surface interface as to inhibit sticking thereto.
According to the present invention, electrosurgical devices, systems and methods are provided which are configured to remove heat from and cool the jaws, particularly the electrically insulated surfaces of the jaws, and more particularly the medial portion of the insulated surfaces. In some embodiments, the electrically insulated surfaces of the jaws comprise or are supported by a material with a high thermal conductivity. In other embodiments, heat is removed from the jaws by the electrically conductive fluid.
According to the present invention, electrosurgical devices, systems and methods are provided for medical procedures, which preferably utilize radio frequency (“RF”) power and electrically conductive fluid during the treatment of tissue. Preferably, the temperature of the tissue, particularly outside a targeted tissue treatment site (e.g. outside the electrically insulated surfaces of the jaws), may be altered and at least partially controlled (e.g. maintained within a targeted temperature range or at a targeted tissue temperature) by adjusting parameters (e.g. the fluid flow rate of the electrically conductive fluid) that affect the temperature of the tissue.
According to the present invention, using a fluid in the above manner inhibits, and preferably minimizes or prevents tissue damage (e.g. necrosis), and such undesirable effects as tissue sticking to electrodes, smoke generation, char formation and desiccation, to tissue outside a targeted tissue treatment site.
According to the present invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. The first jaw includes a first tissue grasping surface and the second jaw includes a second tissue grasping surface. The tissue grasping surface of each jaw has a length defined by proximal and distal ends, a width defined by edges and further comprises an electrically insulative surface. The device further comprises first and second electrodes being connectable to different terminals of a radio frequency generator to generate electrical current flow therebetween, with the first electrode having a first electrode surface and the second electrode having a second electrode surface. One of the first and second electrode surfaces is located on one or the other of the jaws separated from one edge of the tissue grasping surface and the other of the electrode surfaces is located on one or the other of the jaws separated from the other edge of the tissue grasping surface. The device also includes at least one fluid passage being connectable to a fluid source.
According to the present invention, a device is provided with a tip portion configured to provide radio frequency power from a radio frequency generator with a fluid from a fluid source to tissue, with the fluid provided to the tissue at a tissue surface and the radio frequency power provided to the tissue below the tissue surface.
According to another aspect of the present invention, a device is provided with a tip portion configured to provide radio frequency power to tissue at least partially through a fluid coupling located on a surface of the tissue, with the fluid coupling comprising an electrically conductive fluid provided from a fluid source and the electrically conductive fluid provided from the tip portion with the radio frequency power.
According to another aspect of the invention, a device is provided that is configured to receive radio frequency power from a radio frequency generator at a power level and an electrically conductive fluid from a fluid source at a fluid flow rate, and deliver the electrically conductive fluid to tissue at a tissue surface and the radio frequency power to the tissue below the tissue surface.
According to yet another aspect to the invention, a device is provided that is configured to receive radio frequency power from a radio frequency generator at a power level and an electrically conductive fluid from a fluid source at a fluid flow rate, and deliver the electrically conductive fluid to tissue at a tissue surface and the radio frequency power to the tissue below the tissue surface at least partially through a fluid coupling comprising the electrically conductive fluid.
In certain embodiments, the tip portion further comprises at least one fluid outlet in fluid communication with a fluid passage configured to provide a fluid from a fluid source to tissue. Preferably, the at least one fluid outlet in fluid communication with the fluid passage further comprises a first fluid outlet and a second fluid outlet with the first fluid outlet being located on the same jaw as a first electrode and the second fluid outlet being located on the same jaw as a second electrode. Preferably, the first fluid outlet and the second fluid outlet are configured to receive the fluid from the fluid source and provide the fluid to tissue located outside of tissue grasping surfaces.
In one embodiment, a first fluid outlet and a second fluid outlet are configured to receive a fluid from a fluid source and provide the fluid to tissue located outside of and adjacent tissue grasping surfaces.
In another embodiment, a first fluid outlet and a second fluid outlet are configured to receive a fluid from a fluid source and provide the fluid to tissue located outside of and separated from tissue grasping surfaces.
In another embodiment, a first fluid outlet is configured to provide a fluid to tissue located adjacent a first electrode surface, and a second fluid outlet is configured to provide a fluid to tissue located adjacent a second electrode surface.
In another embodiment, a first fluid outlet is configured to provide a fluid between a first electrode surface and tissue, and a second fluid outlet is configured to provide a fluid between a second electrode surface and tissue.
In another embodiment, a first fluid outlet is configured to provide a fluid between a first electrode surface and one edge of one or the other of two tissue grasping surfaces, and a second fluid outlet is configured to provide a fluid between a second electrode surface and the other edge of one or the other of the tissue grasping surfaces.
In another embodiment, a first fluid outlet is configured to provide a fluid to the first electrode surface, and a second fluid outlet is configured to provide a fluid to a second electrode surface.
In another embodiment, a first fluid outlet is configured to provide a fluid to a first portion of one or the other of two jaws outside a tissue grasping surface, and a second fluid outlet is configured to provide a fluid to a second portion of one or the other of the jaws outside a tissue grasping surface.
In one embodiment, each of two first and second electrode surfaces is separated from a tissue grasping surface of a jaw to which it is located by a gap. In another embodiment, at least a portion of each gap separating each of the first and second electrode surfaces from the tissue grasping surface of the jaw to which it is located is configured to receive a fluid from a fluid source. In another embodiment, the fluid received by each of the gaps is configured to provide a fluid coupling which provides cooling and removing heat from tissue located outside the tissue grasping surfaces. In yet another embodiment, the fluid comprises an electrically conductive fluid, and the fluid received by each of the gaps is configured to provide a fluid coupling which enhances the electrical connection of the first and second electrode surfaces and tissue located outside the tissue grasping surfaces. Furthermore, in yet another embodiment, at least a portion of the electrical current flow between the first and second electrode surfaces may be caused to flow at least partially through at least one fluid coupling as opposed to tissue located outside the tissue grasping surfaces, whereby the amount of current flow through tissue located outside the tissue grasping surfaces may be correspondingly reduced. In one embodiment, the tissue grasping surface of each jaw has a length, and each gap further comprises an elongated gap separating each of the first and second electrode surfaces from the tissue grasping surface of the jaw to which it is located along the length of the tissue grasping surface. In another embodiment, at least a portion of each elongated gap separating each of the first and second electrode surfaces from the tissue grasping surface of the jaw to which it is located is configured to receive a fluid from the fluid source and provide a fluid flow channel for the fluid along the length of the tissue grasping surface.
In yet another embodiment, at least one jaw comprises at least one stand-off configured to keep tissue from physically contacting at least one of a first electrode surface and a second electrode surface. In various embodiments, the stand-off preferably comprises a coil wrapped around at least a portion of one of the first and second electrode surface, a material porous to a fluid provided from a fluid source there through with the material overlying at least a portion of one of the first and second electrode surface, or a foam material overlying at least a portion of one of the first and second electrode surface. In other embodiments, the stand-off comprises a polymer or ceramic material.
In other embodiments, at least one jaw comprises at least one obstruction configured to inhibit a fluid shunt from forming between the first electrode and the second electrode. In various embodiments, the obstruction comprises a tissue grasping surface of a jaw, a distal end portion of a jaw, a proximal end portion of a jaw or a backside portion of a jaw, such as a protrusion or recess which provides a drip edge.
In other embodiments, a tissue treatment indicator is provided which provides an output related to a level of treatment of tissue. In certain embodiments, the tissue treatment indicator comprises a bulb or a thermochromic device wired in parallel with an electrode.
According to another aspect of the invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. Each jaw includes a left-side portion, a right-side portion and a tissue grasping surface with the tissue grasping surface of each jaw further comprising an electrically insulative surface. The device further comprises first and second electrodes being connectable to different terminals of a radio frequency generator to generate electrical current flow therebetween with the first electrode having a first electrode surface and the second electrode having a second electrode surface. One of the first and second electrodes is located on one or the other of the jaws on the left-side portion of the jaw and the other of the electrodes is located on one or the other of the jaws on the right-side portion of the jaw. Each of the first and second electrode surfaces is separated from the tissue grasping surface of the jaw on which it is located. The device also includes at least one fluid passage being connectable to a fluid source.
According to another aspect of the invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. Each jaw includes a tissue grasping surface with the tissue grasping surface of each jaw further comprising an electrically insulative surface. A portion of each tissue grasping surface is located on each side of a center plane. The center plane is orientated longitudinal and to the tissue grasping surface. The device further comprises first and second electrodes being connectable to different terminals of a radio frequency generator to generate electrical current flow therebetween with the first electrode having a first electrode surface and the second electrode having a second electrode surface. One of the first and second electrodes is located on one or the other of the jaws on one side of the center plane and the other of the electrodes is located on one or the other of the jaws on the other side of the center plane. Each of the first and second electrode surfaces is separated from the tissue grasping surface of the jaw to which it is located. The device also includes at least one fluid passage being connectable to a fluid source.
According to another aspect of the invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. Each jaw includes a tissue grasping surface with the tissue grasping surface of each jaw further comprising an electrically insulative surface. A portion of each tissue grasping surface is located on two opposing sides of a cutting mechanism, the cutting mechanism comprising a blade. The device further comprises first and second electrodes being connectable to different terminals of a radio frequency generator to generate electrical current flow therebetween with the first electrode having a first electrode surface and the second electrode having a second electrode surface. One of the first and second electrodes is located on one or the other of the jaws on one side of the cutting mechanism and the other of the electrodes is located on one or the other of the jaws on the other side of the cutting mechanism. Each the first and second electrode surfaces is separated from the tissue grasping surface of the jaw to which it is located. The device also includes at least one fluid passage being connectable to a fluid source.
According to another aspect of the invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. Each jaw includes a tissue grasping surface with the tissue grasping surface of each jaw further comprising an electrically insulative surface. The device further comprises at least two spaced-apart electrode surfaces separated from the tissue grasping surface of each jaw, with the two electrode surfaces on the first jaw in direct opposed relation with the two electrode surfaces on the second jaw, the opposing electrode surfaces being of like polarity and the electrode surfaces of each jaw being connectable to a power source for providing electrical current flow therebetween. The device also includes at least one fluid passage being connectable to a fluid source.
According to another aspect of the invention, a method of treating tissue is provided comprising providing tissue; providing electrical current; providing a fluid; providing a first tissue grasping surface and a second tissue grasping surface; grasping a first portion of tissue with the first portion of tissue located between the tissue grasping surfaces; providing the fluid to a second portion of tissue with the second portion of tissue located outside the tissue grasping surfaces; providing the electric current to the tissue; and directing the electric current in the first portion of tissue to flow across the tissue grasping surfaces. In certain embodiments, the method further comprises the step of cooling the second portion of tissue with the fluid and/or cooling the first portion of tissue with the fluid. Furthermore, in certain embodiments, the step of providing a fluid further comprises providing an electrically conductive fluid, and the method includes the additional step of reducing the electrical current in the second portion of tissue with the fluid.
According to another aspect of the invention, a method of treating tissue is provided comprising providing tissue; providing electrical current; providing a fluid; providing a first tissue grasping surface and a second tissue grasping surface; grasping a first portion of tissue, the first portion of tissue located between the tissue grasping surfaces; providing the fluid to a second portion of tissue, the second portion of tissue located outside the tissue grasping surfaces; providing the electric current to the tissue; and directing the electric current in the first portion of tissue to flow substantially parallel to the tissue grasping surfaces. In certain embodiments, the method further comprises the step of cooling the second portion of tissue with the fluid and/or cooling the first portion of tissue with the fluid. Furthermore, in certain embodiments, the step of providing a fluid further comprises providing an electrically conductive fluid, and the method includes the additional step of reducing the electrical current in the second portion of tissue with the fluid.
According to another aspect of the present invention, a tissue grasping device is provided comprising a tip portion including a first jaw and a second jaw with at least one of the jaws being movable toward the other jaw. Each jaw includes a tissue grasping surface with the tissue grasping surface of each jaw further comprising an electrically insulative surface. The device further comprises at least two electrodes separated by the tissue grasping surfaces and located between the two electrodes with the two electrodes being connectable to different terminals of a radio frequency generator to generate electrical current flow therebetween. The device also includes at least one fluid passage being connectable to a fluid source.
Throughout the present description, like reference numerals and letters indicate corresponding structure throughout the several views, and such corresponding structure need not be separately discussed. Furthermore, any particular feature(s) of a particular exemplary embodiment may be equally applied to any other exemplary embodiment(s) of this specification as suitable. In other words, features between the various exemplary embodiments described herein are interchangeable as suitable, and not exclusive. Also, from the specification, it should be clear that any use of the terms “distal” and “proximal” are made in reference to the user of the device, and not the patient.
An exemplary electrosurgical device according to the present invention will now be described in detail. The electrosurgical device may be used with the system of the invention to be described herein. However, it should be understood that the description of the combination is for purposes of illustrating the system of the invention only. Consequently, it should be understood that the electrosurgical device of the present invention can be used alone, or in conjunction with, the system of the invention. Conversely, it should be equally understood that the system of the present invention can be used with a wide variety of devices.
An exemplary electrosurgical device of the present invention, which may be used in conjunction with one or more aspects of the system of the present invention, is shown at reference character 10 in
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Before continuing with the description of jaws 16a, 16b, it should be understood that, as used herein, the longitudinal dimension is relative to the length of the jaws 16a, 16b and is directed proximally and distally, the lateral dimension is relative to the width of the jaws 16a, 16b and is directed laterally (outward) or medially (inward), and the vertical dimension is relative to the height of the jaws 16a, 16b and is directed by opening and closing relative to one another.
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Grasping surfaces 62a, 62b further comprise electrically insulative surfaces which are preferably provided by support members 58a, 58b and base portions 60a, 60b comprising electrically insulating materials. In this manner, support members 58a, 58b and base portions 60a, 60b may be electrically insulated relative to electrodes 64a, 66a, 64b, 66b discussed in greater detail below.
In some embodiments, the electrically insulating material may comprise an electrically insulating polymer, either thermoplastic or thermoset, reinforced or unreinforced, filled or unfilled. Exemplary polymer materials include, but are not limited to, polyacetal (POM), polyamide (PA), polyamideimide (PAI), polyetheretherketone (PEEK), polyetherimide (PEI), polyethersulfone (PES), polyimide (PI), polyphenylenesulfide (PPS), polyphthalamide (PPA), polysulfone (PSO), polytetrafluoroethylene (PTFE) and syndiotactic polystyrene (SPS). More preferably, the electrically insulating polymer comprises either a liquid crystal polymer and, more particularly, an aromatic liquid crystal polyester which is reinforced with glass fiber, such as Vectra® A130 from Ticona, or Ultem® 10% glass filled polyetherimide from the General Electric Company. Exemplary reinforcement materials for polymers include, but are not limited to, glass fibers and boron fibers. Exemplary filler materials for polymers include mica, calcium carbonate and boron nitride. Reinforcement materials for the polymer material may be preferable for increased strength while filler materials may be preferable for increased heat resistance and/or thermal conductivity. Still other electrically insulating materials for support members 58a, 58b and base portions 60a, 60b may comprise electrically insulating ceramics such as boron nitride.
In order that heat may be transferred away from surfaces 62a, 62b during use of device 10, preferably the material for support members 58a, 58b and base portions 60a, 60b has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 0.01 watt/cm° K. More preferably, the material for support members 58a, 58b and base portions 60a, 60b has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 0.16 watt/cm° K. Even more preferably, the material for support members 58a, 58b and base portions 60a, 60b has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 0.35 watt/cm° K.
In addition to grasping surfaces 62a, 62b comprising electrically insulating surfaces, preferably grasping surfaces 62a, 62b are substantially flat and provide for tissue removal there from. Furthermore, preferably grasping surfaces 62a, 62b also comprise hydrophobic surfaces to reduce the presence of fluid (e.g. conductive fluid 128 from fluid source 130; blood and other bodily fluids) on and between the grasping surfaces 62a, 62b, particularly those portions which are unoccupied by tissue during treatment.
However, so that grasping surfaces 62a, 62b don't become so smooth that tissue therebetween may slide out, preferably the surfaces 62a, 62b are not highly polished smooth surfaces. In other words, preferably surfaces 62a, 62b have a surface roughness or asperity of surface in the range between and including about 20 microns to 500 microns where 10 microns is indicative of a polished surface. More preferably, 62a, 62b surfaces have a surface roughness in the range between and including about 25 microns to 250 microns. Furthermore, in various embodiments, surfaces 62a, 62b may comprise textured surfaces (a surface which is not smooth, but rather includes a raised pattern on it), such as a stipple textured surfaces. Also, in various embodiments, surfaces 62a, 62b may include serrations 67 (as shown in
In certain applications, it may be necessary to further increase the thermal conductivity of support members 58a, 58b and base portions 60a, 60b to better function as heat sinks to remove heat transferred to surfaces 62a, 62b from tissue there between. In alternative embodiments as shown in
Preferably the material for support members 58a, 58b and base portions 60a, 60b underlying the coating 68 has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 0.1 watt/cm° K. More preferably, the material for support members 58a, 58b and base portions 60a, 60b underlying the coating 68 has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 1 watt/cm° K. Even more preferably, the material for support members 58a, 58b and base portions 60a, 60b underlying the coating 68 has a thermal conductivity ktc at 300° K (Kelvin) equal or greater than about 2 watt/cm° K.
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Preferably electrodes 64a, 64b comprise electrical source electrodes while electrodes 66a, 66b comprise counter electrodes. As shown in
Given the above configuration, electrodes 64a, 66a, 64b, 66b are configured such that electrical current flowing in the tissue between grasping surfaces 62a, 62b will flow across (substantially parallel to) the grasping surfaces 62a, 62b. With electrodes 64a, 66a, 64b, 66b in such a configuration, four possible electrical paths are created between: (1) electrodes 64a and 66a; (2) electrodes 64a and 66b; (3) electrodes 64b and 66b; and (4) electrodes 64b and 66a.
The creation of certain of these electrical paths is denoted by electrical field lines 74 in
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As indicated above, preferably grasping surfaces 62a, 62b also comprise hydrophobic surfaces to reduce the presence of fluid on and between grasping surfaces 62a, 62b, particularly portions which are unoccupied by tissue. Reducing the presence of fluid on unoccupied portions of surfaces 62a, 62b is desirable to inhibit, and more preferably minimize or prevent, the formation of a conductive fluid shunt. In other words, if conductive fluid forms a bridge across the width of surfaces 62a, 62b, and the bridge connects an electrode pair configured to create an electrical path (i.e. 64a and 66a; 64a and 66b; 64b and 66b; 64b and 66a), an electrical path through the conductive fluid bridge is created parallel to the electrical path through tissue. Consequently, a portion of the electrical energy intended to be provided to tissue is diverted through the conductive fluid bridge and bypasses the tissue. This loss of energy can increase the time required to treat tissue.
Other than surfaces 62a, 62b comprising hydrophobic surfaces, in order to reduce the presence of fluid on and between the unoccupied portions of grasping surfaces 62a, 62b of device 10, preferably the contact angle θ of fluid droplets, particularly of fluid 128, on grasping surfaces 62a, 62b is about 30 degrees or greater after the droplet has stabilized from initial placement thereon. More preferably, the contact angle θ of fluid droplets, particularly of fluid 128, on grasping surfaces 62a, 62b is about 45 degrees or greater. More preferably, the contact angle θ of fluid droplets, particularly of fluid 128, on grasping surfaces 62a, 62b is about 60 degrees or greater. Even more preferably, the contact angle θ of fluid droplets, particularly of fluid 128, on grasping surfaces 62a, 62b is about 75 degrees or greater. Most preferably, the contact angle θ of fluid droplets, particularly of fluid 128, on grasping surfaces 62a, 62b is about 90 degrees or greater.
Contact angle, θ, is a quantitative measure of the wetting of a solid by a liquid. It is defined geometrically as the angle formed by a liquid at the three phase boundary where a liquid, gas and solid intersect. In terms of the thermodynamics of the materials involved, contact angle θ involves the interfacial free energies between the three phases given by the equation γLV cos θ=γSV−γSL where γLV, γSV and γSL refer to the interfacial energies of the liquid/vapor, solid/vapor and solid/liquid interfaces, respectively. If the contact angle θ is less than 90 degrees the liquid is said to wet the solid. If the contact angle is greater than 90 degrees the liquid is non-wetting. A zero contact angle θ represents complete wetting.
For clarification, while it is known that the contact angle θ may be defined by the preceding equation, in reality contact angle θ is determined by a various models to an approximation. According to publication entitled “Surface Energy Calculations” (dated Sep. 13, 2001) from First Ten Angstroms (465 Dinwiddie Street, Portsmouth, Virginia. 23704), there are five models which are widely used to approximate contact angle θ and a number of others which have small followings. The five predominate models and their synonyms are: (1) Zisman critical wetting tension; (2) Girifalco, Good, Fowkes, Young combining rule; (3) Owens, Wendt geometric mean; (4) Wu harmonic mean; and (5) Lewis acid/base theory. Also according to the First Ten Angstroms publication, for well-known, well characterized surfaces, there can be a 25% difference in the answers provided for the contact angle θ by the models. Any one of the five predominate models above which calculates a contact angle θ recited by a particular embodiment of the invention should be considered as fulfilling the requirements of the embodiment, even if the remaining four models calculate a contact angle θ which does not fulfill the recitation of the embodiment.
As best shown in
As shown in
It should be understood that the structure providing electrodes 64a, 66a, 64b, 66b need not wholly comprise an electrically conductive material. In other words, for example, only the tissue interacting/treating surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b need be electrically conductive. Thus, for example, the exemplary tubular structure for electrodes 64a, 66a, 64b, 66b may comprise an electrically conductive coating, such as metal, overlying an electrically insulative material, such as a polymer or ceramic.
As best shown by
In contrast to the contact angle θ of fluid droplets on device grasping surfaces 62a, 62b most preferably being about 90 degrees or greater, preferably the contact angle θ of fluid droplets, particularly fluid 128, on surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b is about 90 degrees or less after the droplet has stabilized from initial placement thereon. More preferably, the contact angle θ of fluid droplets, particularly fluid 128, on surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b is about 75 degrees or less. More preferably, the contact angle θ of fluid droplets, particularly fluid 128, on surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b is about 60 degrees or less. Even more preferably, the contact angle θ of fluid droplets, particularly fluid 128, on surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b is about 45 degrees or less. Most preferably, the contact angle θ of fluid droplets, particularly fluid 128, on surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b is about 30 degrees or less.
Preferably fluid 128 (shown in
As shown in
As best shown in
As best shown in
As shown in
In addition to central flow passages 84a, 86a, 84b, 86b, as best shown in
Also as shown, side flow passages 92a, 94a, 92b, 94b preferably each have a cross-sectional dimension, more specifically diameter, and corresponding cross-sectional area, less than the portion of central flow passage 84a, 86a, 84b, 86b from which fluid 128 is provided. Also as shown, the side flow passages 92a, 94a, 92b, 94b extend through the cylindrical portion of the electrodes 64a, 66a, 64b, 66b and are preferably formed substantially at a right angle (e.g. within about 10 degrees of a right angle) to the central flow passages 84a, 86a, 84b, 86b both longitudinally and circumferentially. Also as shown, the side flow passages 92a, 94a, 92b, 94b are preferably formed substantially at a right angle to the tissue interacting/treating cylindrical surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b.
Preferably, side flow passages 92a, 94a, 92b, 94b extend from central flow passages 84a, 86a, 84b, 86b to side flow passage fluid exit openings 96a, 98a, 96b, 98b located on surfaces 76a, 78a, 76b, 78b. More preferably, side flow passages 92a, 94a, 92b, 94b and associated side flow passage fluid exit openings 96a, 98a, 96b, 98b are defined and spaced both longitudinally and circumferentially around the surfaces 76a, 78a, 76b, 78b, along the length of the jaws 16a, 16b from the proximal end portions 70a, 70b to the distal end portions 72a, 72b of grasping surfaces 62a, 62b of the jaws 16a, 16b.
As shown in
Preferably, side flow passages 92a, 94a, 92b, 94b have a cross-sectional dimension (e.g. diameter) in the range between and including about 0.1 mm to 1 mm and more preferably have a diameter in the range between and including about 0.15 mm to 0.2 mm. As for central flow passages 84a, 86a, 84b, 86b, preferably central fluid flow passages 84a, 86a, 84b, 86b have a cross-sectional dimension (e.g. diameter) in the range between and including about 0.2 mm to 2 mm and more preferably have a diameter in the range between and including about 0.5 mm to 1 mm.
As shown in
However, wall portions 80a, 82a, 80b, 82b need not completely occlude and define the distal ends of central flow passages 84a, 86a, 84b, 86b. In other words, rather than extending only partially through electrodes 64a, 66a, 64b, 66b, central flow passages 84a, 86a, 84b, 86b may extend completely through electrodes 64a, 66a, 64b, 66b and have a distal end opening. However, in such an instance, a wall portions 80a, 82a, 80b, 82b should substantially occlude and inhibit fluid 128 from exiting from the central flow passage distal end exit opening. With regards to this specification, occlusion of a central flow passage distal end exit opening and the corresponding inhibiting of flow from exiting from the central flow passage distal end exit opening should be considered substantial when the occlusion and corresponding inhibiting of flow results in increased flow from the side flow passage fluid exit openings 96a, 98a, 96b, 98b of side flow passages 92a, 94a, 92b, 94b. In other words, wall portions 80a, 82a, 80b, 82b merely need to function as fluid flow diverters and redirect a portion of the fluid 128 coming in contact therewith from flowing parallel with the longitudinal axis of the central fluid flow passages 84a, 86a, 84b, 86b to flowing radially from the longitudinal axis through side flow passages 92a, 94a, 92b, 94b.
As shown, wall portions 80a, 82a, 80b, 82b are preferably integral, and more preferably unitary, with the remainder of electrodes 64a, 66a, 64b, 66b. Where electrodes 64a, 66a, 64b, 66b are provided by hypodermic tubing, closure or occlusion of the central flow passages 84a, 86a, 84b, 86b may be accomplished by welding or crimping (as best shown in
Jaws 16a, 16b preferably comprise at least one connector portion for attaching electrodes 64a, 66a, 64b, 66b thereto. As shown in
Preferably, receptacles 102a, 104a, 102b, 104b are formed unitarily with support members 58a, 58b as single pieces and provide a housing comprising cylindrical blind holes for containing distal end cylindrical portions 106a, 108a, 106b, 108b of electrodes 64a, 66a, 64b, 66b. The distal end cylindrical portions 106a, 108a, 106b, 108b of the electrodes 64a, 66a, 64b, 66b located in the receptacles 102a, 104a, 102b, 104b preferably form an interference fit within the receptacles 102a, 104a, 102b, 104b to inhibit removal therefrom.
Preferably jaws 16a, 16b also comprise a second connector portion for attaching electrodes 64a, 66a, 64b, 66b thereto. As shown in
Preferably, receptacles 110a, 112a, 110b, 112b are also formed unitarily with support members 58a, 58b as single pieces and provide a housing comprising cylindrical through holes for containing proximal end cylindrical portions 116a, 118a, 116b, 118b of electrodes 64a, 66a, 64b, 66b. The proximal end cylindrical portions 116a, 118a, 116b, 118b of the electrodes 64a, 66a, 64b, 66b located in the receptacles 110a, 112a, 110b, 112b preferably form an interference fit within the receptacles 110a, 112a, 110b, 112b to inhibit removal therefrom.
In certain situations tissue laterally outside grasping surfaces 62a, 62b may be compressed by a portion of the jaws 16a, 16b, particularly electrodes 64a, 66a, 64b, 66b. In order to concentrate a great majority of the electrical power converted to heat in the tissue located in the medial portion of grasping surfaces 62a, 62b (equal to about the middle one-third of the width) preferably the tissue outside grasping surfaces 62a, 62b will be compressed to a lesser extent (e.g. percentage) than the tissue between grasping surfaces 62a, 62b. Consequently, as shown in
Continuing with
As shown in
In the presence of tissue 156 as shown in
Given that air gaps 119 are elongated in that they extend longitudinally along the length of surfaces 62a, 62b and electrodes 64a, 66a, 64b, 66b, the air gaps 119 also provide an open fluid flow channel or trough for fluid 128 from fluid source 130 to flow along the length of surfaces 62a, 62b and electrode surfaces 76a, 78a, 76b, 78b.
As shown in
As shown in
Similarly to distal end portions 100a, 100b, proximal end portions 114a, 114b of jaws 16a, 16b also provide an obstruction (e.g. the structure forming receptacles 110a, 112a, 110b, 112b) for inhibiting fluid 128 from flowing around the proximal end 54 of the jaws 16a, 16b and forming a conductive fluid bridge which may form a shunt between certain electrode pairs having different polarities (e.g. 64a, 66a and 64b, 66b).
As shown in
Continuing with
As indicated above, device 10 may be used as part of a system.
In a preferred embodiment, the output fluid line 132 and the input fluid line 44 are flexible and are made from a polymer material, such as polyvinylchloride (PVC) or polyolefin (e.g. polypropylene, polyethylene). In another embodiment, the output fluid line 132 and the input fluid line 44 are preferably connected via a male and female mechanical fastener configuration 133, preferably comprising a Luer-Lok® connection from Becton, Dickinson and Company.
Preferably, fluid 128 comprises a saline solution and, more preferably sterile, physiologic saline. It should be understood that where description herein references the use of saline as the fluid 128, other electrically conductive fluids, as well as non-conductive fluids, can be used in accordance with the invention.
For example, in addition to the conductive fluid comprising physiologic saline (also known as “normal” saline, isotonic saline or 0.9 weight-volume percentage sodium chloride (NaCl) solution), the conductive fluid may comprise hypertonic saline solution, hypotonic saline solution, Ringers solution (a physiologic solution of distilled water containing specified amounts of sodium chloride, calcium chloride, and potassium chloride), lactated Ringer's solution (a crystalloid electrolyte sterile solution of distilled water containing specified amounts of calcium chloride, potassium chloride, sodium chloride, and sodium lactate), Locke-Ringer's solution (a buffered isotonic solution of distilled water containing specified amounts of sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate, magnesium chloride, and dextrose), or any other electrolyte solution. In other words, a solution that conducts electricity via an electrolyte, a substance (salt, acid or base) that dissociates into electrically charged ions when dissolved in a solvent, such as water, resulting solution comprising an ionic conductor.
In certain embodiments as discussed herein, hypertonic saline, saturated with NaCl to a concentration of about 15% (weight-volume percentage), may be preferred to physiologic saline to reduce the electrical resistivity of the saline from about 50 ohm-cm at 0.9% to about 5 ohm-cm at 15%. This ten-fold reduction in electrical resistivity of the conductive fluid will enhance the reduction in heating (both resistance heating and conduction heating) of tissue and the conductive fluid itself as shown herein.
While a conductive fluid is preferred, as will become more apparent with further reading of this specification, the fluid 128 may also comprise an electrically non-conductive fluid. The use of a non-conductive fluid is less preferred to that of a conductive fluid as the non-conductive fluid does not conduct electricity. However, the use of a non-conductive fluid still provides certain advantages over the use of a dry electrode including, for example, thermal cooling and reduced occurrence of tissue sticking to the electrodes of the device 10. Therefore, it is also within the scope of the invention to include the use of a non-conducting fluid, such as, for example, deionized water or 1.5% glycine.
Returning to
As shown, the system may be configured to first direct the RF power from the generator 136 via a cable 138 to a power measurement device 140 that measures the actual RF power provided from the generator 136. In one exemplary embodiment, preferably the power measurement device 140 does not turn the RF power off or on, or alter the RF power in any way. Rather, a power switch 142 connected to the generator 136 is preferably provided by the generator manufacturer and is used to turn the generator 136 on and off.
The power switch 142 can comprise any switch to turn the power on and off, and is commonly provided in the form of a footswitch or other easily operated switch, such as a switch 142a mounted on the electrosurgical device 10. The power switch 142 or 142a may also function as a manually activated device for increasing or decreasing the rate of energy provided from the surgical device 10. Alternatively, internal circuitry and other components of the generator 136 may be used for automatically increasing or decreasing the rate of energy provided to the surgical device 10.
As shown in
Power P is preferably measured before it reaches the electrosurgical device 10. For the situation where capacitive and inductive effects are negligibly small, from Ohm's law, power P, or the rate of energy delivery (e.g. joules/sec), may be expressed by the product of current times voltage (i.e. I×V), the current squared times resistance (i.e. I2×R), or the voltage squared divided by the resistance (i.e. V2/R); where the current I may be measured in amperes, the voltage V may be measured in volts, the electrical resistance R may be measured in ohms, and the power P may be measured in watts/joules/sec). Given that power P is a function of current I, voltage V, and resistance (impedance) R as indicated above, it should be understood, that a change in power P is reflective of a change in at least one of the input variables. Thus, one may alternatively measure changes in such input variables themselves, rather than power P directly, with such changes in the input variables mathematically corresponding to a changes in power P as indicated above. Furthermore, it should be understood that the terms “impedance” and “resistance” as used herein are used interchangeably given the capacitive and inductive effects are considered negligible.
Heating of the tissue is preferably performed by means of electrical resistance heating. In other words, increasing the temperature of the tissue as a result of electric current flow through the tissue, with the associated electrical energy being converted into thermal energy (i.e. heat) via accelerated movement of ions as a function of the tissue's electrical resistance. Resistance heating provides direct, instantaneous heating inside tissue due to the current flow through the tissue.
Heating of the tissue is also accomplished by thermal conduction heating. With conduction, tissue is heated by thermal energy flowing through tissue to adjacent tissue by virtue of gradients in temperature. The source of the conduction heating is ultimately from the resistance heating.
Once a steady-state condition has been achieved, and all temperatures everywhere in the vicinity of the electrodes and grasped tissue are not changing with time, it is a reasonable approximation to assume that all heat delivered to tissue by RF power is ultimately carried away by the convective cooling of the flowing fluid 128. Thus, the flow of the fluid 128 not only physically surrounds the grasped tissue, but it also can be seen as a cooling blanket around the targeted tissue treatment site and also limits the maximum temperature of the fluid 128 heated by tissue by forcing the heated fluid to drip off the electrodes and jaws of the device as the fluid 128 is replenished.
In one exemplary embodiment, the system may comprise a flow rate controller 144. Preferably, the flow rate controller 144 is configured to actively link and mathematically relate the power P and the flow rate Q of fluid 128 to one another. Preferably, the controller 144 receives an input related to the level of RF power being provided from the generator 136 (e.g. from power measurement device 140), and adjusts the flow rate Q of the fluid 128 to device 10, thereby adjusting the temperature (preferably within a predetermined range) of tissue, particularly outside the targeted tissue treatment site (i.e. outside surfaces 62a, 62b).
In one embodiment, the flow rate controller 144 may receive an input signal 146 (e.g. from the power measurement device 140) and calculate an appropriate mathematically predetermined fluid flow rate Q to achieve a predetermined tissue and/or fluid temperature. The flow rate controller may include a selection switch 148 that can be set to provide a safety factor (e.g. 10%, 20%, 30%) beyond the mathematically predetermined fluid flow rate Q. An output signal 150 from the flow rate controller 144 may then be sent to the pump 134 which is correlated to the predetermined flow rate Q of fluid 128, and thereby provide an appropriate fluid flow rate Q which corresponds to the power P being provided by the generator 136.
In another exemplary embodiment, elements of the system are physically included together in one electronic enclosure. One such embodiment is shown by enclosure within the outline box 152 of
In various embodiments, the flow rate controller 144 of
In yet another embodiment, the flow rate controller 144 can include additional features, such as a delay mechanism, such as a timer, to automatically keep the flow of fluid 128 on for several seconds after the RF power is turned off to provide a post-coagulation cooling of the tissue or “quench,” which can increase the strength of the tissue seal. Also, in another embodiment, the flow rate controller 144 can include a delay mechanism, such as a timer, to automatically turn on the flow of fluid 128 several seconds before the RF power is turned on to inhibit the possibility of undesirable effects as sticking, desiccation, smoke production and char formation.
In still another embodiment, the flow rate controller 144 can be used to turn the flow on and off in response to an electrical switch, such as 142a, located in the handle 22. This would automatically turn the flow on when the jaws were clamped on tissue, and turn the flow off when the jaws were unclamped from tissue. As the lever 24 is moved toward the grip 26 of the handle 22, a normally-closed single pole, single-throw electrical switch (e.g. switch 142a) could be activated, completing a circuit, either through the power measurement device 140 or an additional pair of wires that would exit the handle 22 of device 10 and continue directly to the controller 144. Such a switch would function in a manner similar to that of the generator footswitch to turn the RF power on and off.
Instead of using an electrical switch as described above, a separate on-off flow switch 143 could be located in the handle 22 such that it would be normally closed when the device jaws were open, and little or no fluid 128 could flow from, for example a fluid source such as a passive gravity-fed saline delivery system. As lever 24 is moved into a latched or use position, clamping the jaws on tissue in a use position, a simple mechanism (push-rod, cam, lever) would open the flow switch 143 and allow fluid 128 to flow. This would be one of the simplest forms of flow control, and would be useful to minimize wasteful dripping of fluid 128 when the device 10 is not being used, as well as to minimize the amount of fluid 128 that would have to be suctioned out of the patient at a later time.
Also in another embodiment, the flow rate controller 144 can include a low level flow standby mechanism, such as a valve, which continues the flow of fluid 128 at a standby flow level (which prevents the flow rate from going to zero when the RF power is turned off) below the surgical flow level ordinarily encountered during use of device 10.
The pump 134 can be any suitable pump used in surgical procedures to provide saline or other fluid 128 at a desired flow rate Q. Preferably, the pump 134 comprises a peristaltic pump. With a rotary peristaltic pump, typically fluid 128 is conveyed within the confines of fluid line 132 by waves of contraction placed externally on the line which are produced mechanically, typically by rotating rollers which squeeze flexible tubing against a support intermittently. Alternatively, with a linear peristaltic pump, typically a fluid 128 is conveyed within the confines of a flexible tube by waves of contraction placed externally on the tube which are produced mechanically, typically by a series of compression fingers or pads which squeeze the flexible tubing against a support sequentially. Peristaltic pumps are generally preferred for use as the electro-mechanical force mechanism (e.g. rollers driven by electric motor) does not make contact the fluid 128, thus reducing the likelihood of inadvertent contamination.
Alternatively, pump 134 can be a “syringe pump”, with a built-in fluid supply. With such a pump, typically a filled syringe is located on an electromechanical force mechanism (e.g. ram driven by electric motor) which acts on the plunger of the syringe to force delivery of the fluid 128 contained therein. Alternatively, the syringe pump may comprise a double-acting syringe pump with two syringes such that they can draw saline from a reservoir (e.g. of fluid source 130), either simultaneously or intermittently. With a double acting syringe pump, the pumping mechanism is generally capable of both infusion and withdrawal. Typically, while fluid 128 is being expelled from one syringe, the other syringe is receiving fluid 128 therein from a separate reservoir. In this manner, the delivery of fluid 128 remains continuous and uninterrupted as the syringes function in series. Alternatively, it should be understood that a multiple syringe pump with two syringes, or any number of syringes, may be used in accordance with the invention.
In various embodiments, fluid 128, such as conductive fluid, can also be provided from an intravenous (IV) bag full of saline (e.g. of fluid source 130) that flows under the force of gravity. In such a manner, the fluid 128 may flow directly to device 10, or first to the pump 134 located there between. In other embodiments, fluid 128 from a fluid source 130, such as an IV bag, can be provided through a flow rate controller 144 which directly acts on controlling the flow of fluid 128, rather than indirectly by means of pump 134. Such a flow rate controller 144 may provide a predetermined flow rate Q by adjusting the cross sectional area of a flow orifice (e.g. lumen of fluid line such as 44 or 132) while also sensing the flow rate Q with a sensor such as an optical drop counter. Furthermore, fluid 128 from a fluid source 130, such as an IV bag, an be provided through automatically or manually adjusting flow rate controller 144, such as a roller clamp (which also adjusts the cross sectional area of a flow orifice such as lumen of fluid line 44 or 132) and is adjusted manually by, for example, the user of device 10 in response to their visual observation that the fluid rate Q needs adjustment.
Similar pumps can be used in connection with the invention, and the illustrated embodiments are exemplary only. The precise configuration of the pump 134 is not critical to the invention. For example, pump 134 may include other types of infusion and withdrawal pumps. Furthermore, pump 134 may comprise pumps which may be categorized as piston pumps, rotary vane pumps (e.g. axial impeller, centrifugal impeller), cartridge pumps and diaphragm pumps. In some embodiments, the pump 134 can be substituted with any type of flow controller, such as a manual roller clamp used in conjunction with an IV bag, or combined with the flow controller to allow the user to control the flow rate of conductive fluid to the device. Alternatively, a valve configuration can be substituted for pump 134.
In various embodiments, other configurations of the system can be used with device 10, and the illustrated embodiments are exemplary only. For example, the fluid source 130, pump 134, generator 136, power measurement device 140 or flow rate controller 144, or any other components of the system not expressly recited above, may comprise a portion of the device 10. For example, in one exemplary embodiment the fluid source 130 may comprise a compartment of the device 10 which contains fluid 128, as indicated at reference character 130a. In another exemplary embodiment, the compartment may be detachably connected to device 10, such as a canister which may be attached via threaded engagement with the device 10. In yet another exemplary embodiment, the compartment may be configured to hold a pre-filled cartridge of fluid 128, rather than the fluid directly.
Also for example, with regards to alternatives for the generator 136, an energy source, such as a direct current (DC) battery used in conjunction with inverter circuitry and a transformer to produce alternating current at a particular frequency, may comprise a portion of device 10, as indicated at reference character 136a. In one embodiment the battery element of the energy source may comprise a rechargeable battery. In yet another exemplary embodiment, the battery element may be detachably connected to device 10, such as for recharging.
Turning to
As shown in
Fluid 128 expelled from the side flow passage flow exit openings 96a, 98a, 96b, 98b couples tissue 156 and electrodes 64a, 66a, 64b, 66b. As shown in
Continuing with
As shown in
Turning fluid couplings 162, as shown in
Turning to fluid couplings 164, unlike fluid couplings 160 and 162, fluid couplings 164 are not configured to cool tissue 156. Rather, fluid couplings 164 are configured to remove heat and cool support members 58a, 58b and base portions 60a, 60b of jaws 16a, 16b. As shown in
Surfaces 166a, 166b of tissue 156 are often uneven or undulated with microscopic peaks and valleys. Without fluid 128, the area of electrical coupling of tissue 156 to the surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b can be limited to the isolated peaks in the tissue surfaces 166a, 166b. In this situation, upon the application of RF energy to tissue 156, the electrical coupling area of surfaces 166a, 166b, by virtue of being limited to the tissue peaks, results in corresponding increase in current density through the peaks which has the ability to desiccate and char the tissue 156. Conversely, fluid 128 enters and occupies the previously unoccupied valleys and gaps 167 (as shown in
Furthermore, the intimacy of electrical coupling between surfaces 166a, 166b of tissue 156 and the surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b often decreases as the tissue shrinks away from surfaces 76a, 78a, 76b, 78b and/or desiccates during tissue treatment. Conversely, fluid 128 provides a mechanism to offset losses in electrical coupling due to tissue shrinkage and/or desiccation by entering and occupying any gaps 167 (as shown in
Once the jaws 16a, 16b are closed to a use position, RF power is then provided to the tissue 156. RF power is provided at the tissue surface 166a, 166b and below the tissue surface 166a, 166b into the tissue 156 directly from electrodes 64a, 66a, 64b, 66b, as well as through the fluid couplings 160 and 162 to a targeted tissue treatment site, here between grasping surfaces 62a, 62b, thereby heating the tissue 156 to coagulate, shrink, weld or otherwise treat the tissue 156.
If desired, after treating the tissue 156 between the jaws 16a, 16b, the jaws 16a, 16b can be held clamped together and cutting mechanism 32 can be actuated to cut the tissue 156. As shown in
In order to reduce tissue treatment time, lateral thermal spread and ensuing necrosis of tissue 156 laterally outside grasping surfaces 62a, 62b, particularly tissue 156 laterally adjacent grasping surfaces 62a, 62b, adjacent the electrodes 64a, 66a, 64b, 66b and there in between, it is desirable to concentrate the energy to the tissue 156 between grasping surfaces 62a, 62b of device 10 as shown below as part of the present invention. Before continuing, however, it should be noted that the examples below should only be considered to an order of magnitude approximation for explanatory purposes.
Electrical resistance Re to the passage of RF current can be described by equation (1) below:
Re=ρeL/A (1)
In determining the electrical resistance of tissue Ret located between surfaces 62a, 62b of device 10, the length of tissue L is represented by the width across surfaces 62a, 62b of jaws 16a, 16b. The area A of the tissue is represented by a longitudinal dimension of surfaces 62a, 62b and the thickness of tissue between surfaces 62a, 62b. In other words, with reference to
Ret (between grasping surfaces)=ρetb/ac (2)
By way of example, where the tissue 156 located between surfaces 62a, 62b of device 10 has a dimension a of 0.025 cm, a dimension b of 0.3 cm, a dimension c of 3 cm and an electrical resistivity of the tissue ρet of 200 ohm-cm before treatment, the electrical resistance of the tissue Ret between surfaces 62a, 62b of device 10 is about 800 ohms. Conversely, for tissue 156 adjacent electrodes 64a, 66a, 64b, 66b, equation (1) is expressed as:
Ret (adjacent the electrodes)=ρeta/bc (3)
Note that the area A of tissue 156 is now measured by the product of (b)(c). For tissue 156 adjacent electrodes 64a, 66a, 64b, 66b, dimension b comprises the portion of the circumference of the electrodes 64a, 66a, 64b, 66b electrically coupled to tissue 156. Thus, as shown in
In the case of four electrodes with the electrical potential and positioning such as electrodes 64a, 64b and 66a, 66b, the electrical resistance of the tissue Ret adjacent electrodes 64a, 64b and 66a, 66b could be considered in parallel. However, in order to assume a worse case scenario, as well as simply the system, the existence of only two electrodes (e.g. 64a, 66b) will be assumed in continuing with the calculations herein.
Turning to dimension a, as shown in
The total electrical resistance ReTotal encountered in an electrical circuit for resistors in series can be approximated by adding the electrical resistance of each resistor in the circuit. Thus, for the example above, the total electrical resistance ReTotal may be approximated as 866 ohms. Continuing with the above, assuming a power P of 35 watts and a total electrical resistance ReTotal is 866 ohms, from Ohm's Law the current I is about 0.2 amps. In turn, also from Ohm's Law. the amount of the power P converted to heat in the tissue 156 located between surfaces 62a, 62b of device 10 is about 32 watts while the power P converted into heat in the tissue 156 adjacent electrodes 64a, 66b is about 3 watts. Stated another way, about 90% of the power is converted to heat in the resistance of the tissue 156 located between surfaces 62a, 62b of device 10.
Once the current I flowing through tissue 156 is known, the current density in tissue 156 may also be calculated. Current density is a vector quantity whose magnitude is the ratio of the magnitude of current I flowing through a substance to the cross-sectional area A perpendicular to the current direction of flow and whose direction points in the direction of the current flow.
Current density is commonly expressed in amperes per square centimeter (i.e. amps/cm2).
In light of the above definition, the current density in tissue 156 between surfaces 62a, 62b of device 10 when using an area A of 0.075 cm2 (i.e. dimension a of 0.025 cm and dimension c of 3 cm) as above is about 2.7 amps/cm2. Conversely, the current density in tissue 156 adjacent electrodes 64a, 66b when using an area A of 0.3 cm as above is about 0.6 amps/cm2. Thus, the current density in tissue 156 between surfaces 62a, 62b of device 10 is on a magnitude of 4 times greater than the current density in tissue 156 adjacent electrodes 64a, 66a, 64b, 66b for the preceding example.
In certain instances, use of device 10 may result in a load impedance outside the working range of a general-purpose generator 136. For example, the schematic graph of
As shown in
As shown by the exemplary calculations above, the high impedance cut-off where power P begins to decrease as shown by high impedance ramp 170 may be exceeded with use of device 10 and quite possibly be completely outside the working range of generator 136. Consequently, as shown in
As already described herein, an exemplary electrical resistivity of the tissue ρet is about 200 ohm-cm. Also as already described herein, for saline the electrical resistivity of the fluid ρef is about 50 ohm-cm for physiologic saline and about 5 ohm-cm for hypertonic saline. Thus, the electrical resistivity of the tissue ρet for the present example is about four times to forty times greater than the electrical resistivity of the fluid ρef. Consequently, assuming all else equal, electrical current I will flow more predominately through the conductive fluid 24 rather than through tissue 32. The position of fluid couplings 160 is configured for this and exploits it.
As electrical current flows in the tissue 156 between surfaces 62a, 62b and exits from between surfaces 62a, 62b, it will seek a path to the counter electrode comprising the least electrical resistance Re. As already discussed herein, among other things, electrical resistance Re is a function of electrical resistivity ρe and length L of the resistor. In the case of physiologic saline, the electrical resistivity of the conductive fluid ρef making up fluid couplings 160 is one-fourth the electrical resistivity of the tissue ρet. Furthermore, as shown in
Consequently, electrosurgical device 10 and the system is configured to provide a diversion for (and preferably divert at least a portion of) electrical current, upon exiting from between grasping surfaces 62a, 62b, to flow at least partially through conductive fluid 128 before reaching the counter electrode. In other words, couplings 160 and 162 provide a diversion there through for at least a portion of the electrical current flowing in tissue 156 outside grasping surfaces 62a, 62b, whereby the amount of electrical energy available to be converted into heat in tissue 156 outside grasping surfaces 62a, 62b may be correspondingly reduced.
Similar to the counter electrode side of the electrical path, as electrical current flows from the source electrodes and enters between surfaces 62a, 62b it will also seek a path to the counter electrode comprising the least electrical resistance Re. Consequently, in addition to the above, device 10 and the system are also configured to provide a diversion for (and preferably divert at least a portion of) at least a portion of the electrical current, upon leaving the source electrode, at least partially through conductive fluid 128 before entering between grasping surfaces 62a, 62b.
In light of the above, it may be desirable to increase the size (i.e. volume and area) of the fluid coupling between tissue 156 and the electrodes 64a, 66a, 64b, 66b. More specifically, preferably the jaws 16a, 16b are configured such that tissue 156 is inhibited from direct contact with the electrodes 64a, 66a, 64b, 66b. Referring to
As shown, stand-off 174 preferably comprises a coil, preferably comprising electrically insulated surfaces, superimposed (overlying) and wrapped around the electrode surfaces 76a, 78a, 76b, 78b, thus providing a helical flow channel 177 between bordering windings of the coil. As a result, fluid couplings 160 and 162 merge in a new fluid coupling shown at 176. Fluid coupling 176, by virtue of its increased size, provides an even greater diversion than fluid coupling 160 for at least a portion of the electrical current flowing in tissue 156 outside grasping surfaces 62a, 62b and, consequently, further reduces the amount of electrical energy available to be converted into heat in tissue 156 outside grasping surfaces 62a, 62b.
Preferably the electrically insulative surfaces of the coil are provided by the coil being formed of an electrically insulative material, such as a polymer. For assembly, preferably each electrode 64a, 66a, 64b, 66b is passed through the center longitudinal aperture of a coil, with the coil wrapped around and extending along the length of the surfaces 76a, 78a, 76b, 78b of electrodes 64a, 66a, 64b, 66b between the distal and proximal connector portions of jaws 16a, 16b which connect the electrodes 64a, 66a, 64b, 66b to the jaws 16a, 16b.
In yet another embodiment, the stand-off may comprise a material pervious to the passage of fluid 128 therethrough. As shown in
Similar to stand-off 174, preferably stand-off 175 comprises a electrically insulative material, such as a polymer or ceramic, superimposed over the electrode surfaces 76a, 78a, 76b, 78b. With an electrically insulative porous structure, RF energy is provided to tissue 156 through the electrically conductive fluid 128 contained within the plurality of interconnected tortuous pathways rather than the porous material itself. A porous polymer structure may be provided by a cellular solid comprising interconnected voids which define the tortuous and interconnected passages. For example, the porous polymer structure may comprise a polymer foam at least partially comprising an open cellular structure. Furthermore, in certain embodiments, the stand-off 175 may comprise a compressible, resilient structure, such as provided by a flexible or semi-rigid polymer foam. In this manner, the stand-off 175 can deform around tissue 156 to provide better electrical and fluid coupling therewith.
In certain embodiments, the electrodes 64a, 66a, 64b, 66b may also comprise a material pervious to the passage of fluid 128 therethrough, such as a porous metal. The discrete, linear side flow passages 92a, 94a, 92b, 94b may be either supplemented with or replaced by a plurality of tortuous, interconnected pathways formed in the porous material which, among other things, provide porous electrode surfaces 76a, 78a, 76b, 78b which more evenly distribute fluid flow and provide fluid 128 to tissue 156.
Preferably the porous materials provide for the wicking (i.e. drawing in of fluid by capillary action or capillarity) of the fluid 128 into the pores of the porous material. In order to promote wicking of the fluid 128 into the pores of the porous material, preferably the porous material, and in particular the surface of the tortuous pathways, is hydrophilic. The porous material may be hydrophilic with or without post treating (e.g. plasma surface treatment such as hypercleaning, etching or micro-roughening, plasma surface modification of the molecular structure, surface chemical activation or crosslinking), or made hydrophilic by a coating provided thereto, such as a surfactant.
As described herein, in order that heat may be transferred away from surfaces 62a, 62b during use of device 10, preferably the material for support members 58a, 58b (particularly the medial portion of support members 58a, 58b adjacent surfaces 62a, 62b) and base portions 60a, 60b have a high thermal conductivity. As shown above, given that the vast amount of the power provided to tissue 156 is converted to heat in the tissue 156 between surfaces 62a, 62b of device 10, it may be necessary to configure support members 58a, 58b and bases 60a, 60b such that surfaces 62a, 62b do not overheat. However, support members 58a, 58b and bases 60a, 60b should be also configured such that surfaces 62a, 62b do not overcool. Preferably, during a typical use of device 10, surfaces 62a, 62b should remain in the temperature range between and including about 75° C. to 120° C. More preferably, during use of device 10, surfaces 62a, 62b should remain in the temperature range between and including about 75° C. to 100° C. Stated another way, surfaces 62a, 62b should be hot enough to shrink collagen in the range between and including about 1 second to 10 seconds after RF activation.
As shown in
Based on a simple, one-dimensional, steady-state, lumped parameter model of the heat transfer and a predetermined peak tissue temperature, the flow rate Q of fluid 128 corresponding to the peak tissue temperature can be determined. The RF electrical power P that is converted into heat can be defined as:
P=ρmcρQ1ΔT (4)
where P=the RF electrical power that is converted into heat. The term [ρmcρQ1ΔT] in equation (4) is heat used to warm up the flow of fluid 128 to peak temperature (without boiling the fluid), where:
ΔT=Temperature rise of the fluid. The difference in temperature between the peak fluid temperature and the initial (input) fluid temperature. The inlet fluid temperature is typically at ambient temperature or about 20° C. for a hospital operating room.
Assuming that the peak fluid temperature is the same as the peak tissue temperature at steady state, the flow rate for a predetermined peak fluid temperature (provided the temperature is at or below boiling of the fluid) can be determined by solving equation (4) for Q1:
Q1=[P]/ρmcρΔT (5)
This equation defines the lines shown in
Outside of surfaces 62a, 62b it is desirable to provide a tissue temperature which inhibits tissue necrosis. The onset of tissue necrosis will generally occur at about 60° C. with an exposure time of about 0.02 seconds. As temperature decreases, the time for tissue necrosis increases. For a tissue temperature of about 45° C., exposure time increases to about 15 minutes. Thus, an exemplary targeted steady state temperature is about 50° C.
Worse case, assuming all the power to tissue (i.e. here 35 watts) has to be removed by fluid 128 after the jaws 16a, 16b and fluid 128 have reached a targeted steady state temperature of 50° C., the calculated flow rate Q is [35]/(1)(4.1)(50-20)=0.28 cc/sec or about 17 cc/min.
It should be understood that the flow rate Q above is merely exemplary. An exemplary range of flow rates for device 10 is from about 0.01 cc/min. to about 100 cc/min.
In light of the above, an exemplary control strategy which can be employed for the device 10 is to provide a flow rate Q of fluid 128 to inhibit necrosis of tissue 156 outside surfaces 62a, 62b which may be subject to necrosis by the portion of the total power P provided to tissue 156 outside surfaces 62a, 62b.
In order to determine when a predetermined temperature of the fluid 128 has been achieved (e.g., when the fluid reaches, for example, 50° C.), a thermochromic material (a material that changes color as it is heated or cooled), such as a thermochromic dye (e.g., leuco dye), may be added to the fluid. The dye can be formulated to provide a first predetermined color to the fluid at temperatures below a predetermined temperature, such as 50° C., then, upon heating above 50° C., the dye provides a second color, such as clear, thus turning the fluid clear (i.e. no color or reduction in color). This color change may be gradual, incremental, or instant. Thus, a change in the color of the fluid, from a first color to a second color (or lack thereof) provides a visual indication to the user of the electrosurgical device 5 as to when a predetermined fluid temperature has been achieved. Thermochromic dyes are available, for example, from Color Change Corporation, 1740 Cortland Court, Unit A, Addison, Ill. 60101.
In some embodiments, it can be desirable to control the temperature of the fluid 128 before it is released from the device 10. In one embodiment, a heat exchanger is provided for the outgoing fluid flow to either heat or chill fluid 128. The heat exchanger may be provided as part of device 10 or as part of another part of the system, such as within the enclosure 152. Cooling the fluid 128 to a predetermined temperature, typically below room temperature, further inhibits thermal damage to tissue outside surfaces 62a, 62b. More specifically, the use of chilled saline (i.e. below room temperature of about 20° C. and of any salt concentration) will inhibit tissue damage outside surfaces 62a, 62b due to heat conduction. Flowing fluid 128 will absorb the heat from higher temperature tissue, dilute it with the cooler fluid 128 and remove it from the device 10. Chilling and convective cooling should not significantly affect the amount of resistance heating except by slightly increasing the electrical resistivity for saline and chilled tissue. Chilling and convective cooling with the fluid 128 will simply reduce the peak temperatures that are created in the tissue outside surfaces 62a, 62b.
In other embodiments, as shown in
Preferably device 10 is provided with a means to inform the use of the device when tissue between surfaces 62a, 62b has been sufficiently coagulated. As known in the art, with the application of RF power through tissue its impedance changes. As shown by Bergdahl, the electrical impedance of tissue initially decreases (to an impedance value below its initial untreated impedance value) and then subsequently increases as the tissue desiccates and coagulates. (Bergdahl, J. Neurosurg., Vol. 75, July 1991, pages 148-151). Correspondingly, in a constant voltage situation and by virtue of Ohm's law, the electrical current through the tissue initially increases (as tissue impedance decreases) and then decreases (as tissue impedance increases). Thus, the electrical current in the tissue is inversely proportional to the impedance.
However, prior art electrosurgical devices such as device 10 do not indicate the tissue impedance, or provide any visual or audible feedback as to the state of the tissue being treated at the targeted tissue treatment site. In a small number of instances, ammeters have been known to be located on generators, but due to relative location, for example in a hospital operating room, are not easily usable. Often the generator is removed from the patient and electrosurgical device, and not viewable by the user of the electrosurgical device without looking away from the surgical procedure. Consequently, clinical judgment and operator training are required to minimize or prevent incomplete coagulation or charring and sticking from overheating. If an under treated vessel is transected or cut, it may bleed or worse leak, often after the surgical incision is closed.
An advancement of the art would be to provide direct information when coagulation or other tissue treatment is completed, preferably such that the surgeon or other user of the electrosurgical device would be informed of the completion of tissue treatment while still looking towards the surgical procedure/patient and viewing the indicator within the their vision, either direct or indirect (peripheral) vision. Such would be particularly useful for laparoscopic surgery, particularly if the information was provided to the user of the device while viewing the peritoneal cavity.
As shown in
As shown in
More specifically, as shown in
During use of device 10, the brightness and change in brightness of the indicator 184 during tissue coagulation can be used to indicate the level of coagulation and consequent coaptation of a vessel and tissue structure. More specifically, as the tissue impedance decreases initially, the indicator will increase in brightness (with increasing current) and thereafter decrease in brightness (with decreasing current) as the tissue impedance increases.
As shown in
Upon the application of device 10 to tissue, generally impedance will initially reside within the generator's working range between the low impedance cut-off 168 and high impedance cut-off 170. Before tissue is treated in any significant manner, the indicator 184 will provide a first brightness level which is representative of a first impedance level.
For a period thereafter, the tissue impedance decreases. From Ohm's law, the change in impedance (here decrease) over a constant power P output from generator 136 will result in a change in the current I (here increase) of the circuit. As the current increases, the brightness of the indicator 184 will correspondingly increase to a second brightness level which is representative of a second impedance level.
After reaching a minimum tissue impedance, the tissue impedance will change direction and begin to increase with tissue coagulation and desiccation. Here, the change in impedance (here increase) over a constant power P output from generator 136 will result in a change in the current I (here decrease) of the circuit. As the current decreases, the brightness of the indicator 184 will correspondingly decrease to a third brightness level which is representative of a third impedance level.
Thus from the above configuration, one would see current changes mirroring the tissue impedance changes. If the bulb (e.g. a tungsten filament type #47 or equivalent) were placed across a 1-foot segment of the power cable, the lamp brightness would provide visual indication of current. The lamp will glow brightly when device 10 is activated and the electrodes are in good contact with the tissue. Subsequently, there will be a marked decrease in brightness or dimming of the lighted bulb as coagulation advances and is completed.
The jaw configurations described above may be particularly useful for use through a 12 mm or greater diameter trocar cannula. In still other embodiments, the jaws may be configured to use through a 3 mm, 5 mm, 10 mm or greater diameter trocar cannula. As shown in
Thus far the device 10 has been described relative to use with an endoscopic grasper, and in particular endoscopic forceps. In still other embodiments, as shown in
For purposes of the appended claims, the term “tissue” includes, but is not limited to, organs (e.g. liver, lung, spleen, gallbladder), highly vascular tissues (e.g. liver, spleen), soft and hard tissues (e.g. adipose, areolar, bone, bronchus-associated lymphoid, cancellous, chondroid, chordal, chromaffin, cicatricial, connective, elastic, embryonic, endothelial, epithelial, erectile, fatty, fibrous, gelatiginous, glandular, granulation, homologous, indifferent, interstitial, lymphadenoid, lymphoid, mesenchymal, mucosa-associated lymphoid, mucous, muscular, myeloid, nerve, osseous, reticular, scar, sclerous, skeletal, splenic, subcutaneous) and tissue masses (e.g. tumors).
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.
All publications and patent documents cited in this application are incorporated by reference in their entirety for all purposes, to the extent they are consistent.
This application is a continuation of U.S. application Ser. No. 10/147,373, filed May 16, 2002, now U.S. Pat. No. 6,953,461. This application is also a continuation-in-part of U.S. application Ser. No. 09/947,658, filed Sep. 5, 2001, now U.S. Pat. No. 7,115,139, which is a continuation-in-part of U.S. application Ser. No. 09/797,049, filed Mar. 1, 2001, now U.S. Pat. No. 6,702,810, which claimed priority under 35 U.S.C. § 119(e) to U.S. provisional application Ser. No. 60/187,114, filed Mar. 6, 2000. This application is also a continuation-in-part of U.S. application Ser. No. 10/746,222, filed Dec. 22, 2003, now pending, which is a continuation of U.S. application Ser. No. 09/797,049, filed Mar. 1, 2001, now U.S. Pat. No. 6,702,810, which claimed priority under 35 U.S.C. § 119(e) to U.S. provisional application Ser. No. 60/187,114, filed Mar. 6, 2000. This application is also a continuation-in-part of U.S. application Ser. No. 10/773,503, filed Feb. 6, 2004, now pending, which is a continuation of U.S. patent application Ser. No. 09/802,288, filed Mar. 8, 2001, now U.S. Pat. No. 6,689,131. This application is also a continuation-in-part of U.S. application Ser. No. 10/354,643, filed Jan. 29, 2003, now pending, which is a continuation of U.S. patent application Ser. No. 09/668,403, filed Sep. 22, 2000, now U.S. Pat. No. 6,558,385. The entire disclosure of each of these patent applications is incorporated herein by reference to the extent it is consistent.
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| Number | Date | Country | |
|---|---|---|---|
| 20050010212 A1 | Jan 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
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| Number | Date | Country | |
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| Parent | 10147373 | May 2002 | US |
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| Child | 10746222 | US | |
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| Parent | 09802288 | Mar 2001 | US |
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| Parent | 10914650 | US | |
| Child | 10773503 | US | |
| Parent | 09668403 | Sep 2000 | US |
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| Number | Date | Country | |
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| Parent | 09947658 | Sep 2001 | US |
| Child | 10147373 | US | |
| Parent | 09797049 | Mar 2001 | US |
| Child | 09947658 | US | |
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| Child | 09947658 | US | |
| Parent | 10746222 | Dec 2003 | US |
| Child | 10914650 | US | |
| Parent | 10773503 | Feb 2004 | US |
| Child | 10914650 | US | |
| Parent | 10354643 | Jan 2003 | US |
| Child | 10914650 | US |
