Patent ID: 12193722

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed device, delivery system, and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

The present invention will be described in relation to illuminated energy hand-pieces used for example, during electrosurgery for cutting or coagulation of tissue. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used with other instruments, and methods.

FIG.1Aillustrates a standard illuminated energy hand-piece10which includes a handle12, an energy tip or electrode20, an unmounted illumination element16, a cable14and an external power source40. The external power source40may be used to provide energy such as RF energy to the electrode20. Generally standard illumination energy devices have encapsulated power sources such as batteries in the handle or an external power source with a separate plug or connection. Because the illumination element is attached to a distal portion of the handle12, light emitted from the illumination element16may not always have the desired intensity, directionality or uniformity or other desired optical properties when directed onto the surgical field. This may further be seen when different lengths of electrodes20are used with the handle12which would change the relative distance from the light source to the target, such as a surgical target. Since the intensity of light is inversely proportional to the square of the distance to the target, keeping the source as close to the target is desirable. Lenses may be used in conjunction with the illumination element16, but these do not always provide the desired quality of light, especially since larger profile lenses are needed but these larger sizes are not always practical for a surgical application where space is very limited.

FIGS.1B-1Dillustrate exemplary illuminated electrosurgical instruments.FIG.1Billustrates an electrosurgical pencil having an RF electrode and an LED illumination element.FIG.1Chighlights the tip of the device inFIG.1B. Because the LED is attached to the pencil, if a long electrosurgical tip is used, the LED may be too far away from the surgical field to adequately illuminate the tissue in the surgical field.FIG.1Dillustrates another electrosurgical pencil having an illumination source disposed in the pencil of the instrument, thereby resulting in a large profile of the device which can obstruct access to the surgical field.

Some of the challenges mentioned above may be overcome with the exemplary embodiments of illuminated electrosurgical instrument described below.

FIG.2Aillustrates an exemplary embodiment of an electrosurgical pencil. The distal tip includes an electrode214for delivering energy, typically RF energy to the tissue for coagulation or cutting. Control buttons206on the pencil204(also referred to as the handle) allow the surgeon or operator to control the mode of operation from cutting or coagulation. A plastic sheath201or sleeve having a textured surface, here several annular rings, provide a finger grip for the operator to easily grasp the electrode and remove it from the pencil204.

FIG.2Billustrates an exemplary embodiment of an illuminated energy hand-piece having a handle204with an optical waveguide202coupled to a distal portion of the handle204, and an electrode (also referred to as an energy tip)214extending distally from the waveguide202. A cable208is coupled to the proximal portion of the handle and this operatively couples the energy hand-piece to an external power supply210. The power supply201may provide RF energy to the electrode214, and may also provide power to illumination elements (not shown) which deliver light to the waveguide202. Optionally, the power source201may also include an external light source (e.g. a xenon lamp) which can deliver light via a fiber optic cable included in cable208to introduce light into waveguide. The optional light source may be integral with the power source or it may be a separate component. Control buttons206allow a user to turn the power on and off for delivery to the electrode214. Often two buttons206are used, one for supplying RF current to the electrode that is optimal for cutting tissue, and the other button supplies RF current to the electrode that is optimized for coagulating. These controls may also automatically provide light to the waveguide which then illuminates the surgical field when current is delivered from the electrode to tissue. In some embodiments, a separate illumination control button may be disposed on the handle to active the light independently of the electrode power.

The electrode214may be fixedly attached to the waveguide202or the handle204, or it may be detachably connected thereto which allows a user to replace electrode tips depending on the procedure being performed.

The optical waveguide202may be fixedly attached to the handle204or it may be adjustably attached thereto, such as with a movable connection212to allow the length L of the optical waveguide to be adjusted based on the length of the electrode. Any mechanism known in the art may be used to allow adjustment of the movable optical waveguide, such as a collet, a threaded connection, a pin and detent mechanism, a spring loaded mechanism, a ratchet and pawl mechanism, etc. LEDs in the handle or coupled to a distal portion of the handle, or coupled to the proximal end of the waveguide may supply light to the optical waveguide. Thus in this or any embodiment, the LED may move with the waveguide, and the waveguide may move independently of the electrode. Any number of configurations of this device are possible, as described below. The energy tip may therefore be fixedly connected to the waveguide and the tip may move together with the waveguide as it is slid or otherwise moved inward or outward, or the tip may be detachably connected to the waveguide and the tip may also move with the waveguide as it is moved inward or outward. In still other embodiments, the tip may be coupled to the handle, and the tip may remain stationary as the waveguide is moved, or the tip may be moved independently of the waveguide.

The optical waveguide in any embodiment may be a hollow tubular waveguide having a central channel extending through the tube, and with the electrode extending partially or all the way through the central channel or the optical waveguide may be a solid rod with no space between the electrode and conductor wire and the inner surface of the optical waveguide. In either embodiment, the optical waveguide may be fixed or adjustable. When the optical waveguide is fixed, it has a specific tube length that is attached to the handle.

In an alternative embodiment the sleeve may be integrated with micro LED dye, therefore the electrosurgical electrode tip can provide power to the sleeve to generate light. Thus, when the tip is inserted into the pencil and current is activated, current also flows to the LED.

FIGS.3A-3Bshow that any embodiment of the optical waveguide202may include optical structures such as lenslets302on the distal end of the tube, or the lenslets may be disposed on an inner surface, an outer surface, or any distal portion304of the tube. The lenslets help to extract and shape the light emitted from the waveguide. The proximal end of the waveguide may include LEDs306which provide light to the waveguide202. The LEDs may be coupled to the waveguide in any number of ways, including butt coupling to other coupling mechanisms, such as where the proximal end of the optical waveguide has a parabolic shape to capture the broad divergence of light emitted from a LED light source. In this embodiment, the ratio of the size of the waveguide diameter to the input size diameter of the parabola is preferably a minimum ratio of 2:1 as shown inFIG.3Bhaving LED light source324emitting light326into waveguide320. The proximal portion of the waveguide has a parabolically shaped322input with an input diameter330as shown inFIG.3B. The body of the waveguide is preferably cylindrically shaped and has a plurality of facets along the outer circumference to provide multiple surfaces against which the light may bounce, thereby allowing the light to mix better along the waveguide. The body of the waveguide has an output diameter328through which the light passes and then is extracted. In preferred embodiments, the ratio of the output diameter328to the input diameter330is at least 2:1. Alternative embodiments have LEDs positioned more distally located along the extended shaft, where the shaft may be composed of the waveguide, the LED section and a metal tube that provides heat sinking proximal to the LED source. The metal tube heat sink is described in more detail below. Additionally, the tube for heat sinking may be fabricated from any other material that dissipates heat.

In some embodiments, the optical waveguide may slidably or otherwise extend away from or toward the handle.FIGS.4A-4Billustrate this feature. InFIG.4Athe optical waveguide is collapsed into the handle, and inFIG.4Bthe optical waveguide is extended outward away from the handle. The optical waveguide may be a fixed length, but may collapse into the handle so that the length of the exposed portion of the optical waveguide decreases, or the optical waveguide may extend away from the handle so that the length of the exposed portion of the optical waveguide increases. Various mechanisms for allowing the telescoping of the optical waveguide have been disclosed previously or are otherwise known in the art. Allowing the optical waveguide to be adjusted allows the user to bring the light closer to the work surface such as a surgical target, or the light may be moved away from the work surface. This may be advantageous when a surgeon uses various length energy tips with the handle so when a long tip is used, a longer optical waveguide is desired to ensure that the light is delivered close to the target tissue, and similarly, when a short tip is used, a shorter optical waveguide is preferred so that the tip of the waveguide is not too close to the work surface. Thus, a variable length optical waveguide allows a user to adjust length as required and to position the light output relative to the electrode tip.

FIG.15illustrates an exemplary embodiment of a locking mechanism that may be used with any of the embodiments of movable waveguides or movable energy tips disclosed herein. A handle1502includes one or more control buttons, here three buttons1504,1506,1508which may be actuated by the user to turn the energy on or off in various modes. For example one button may be used to turn on and off RF cutting energy to the energy tip. The second button may be used to turn on or turn off coagulating RF energy to the energy tip. The third button may be used to turn on and off illumination from the energy tip without delivering energy to the energy tip. The third button may not be a button, and may instead be a switch such as a pressure sensor or other switch such as a foot switch, or slide. Depending on how the illumination element is coupled to the handle, the illumination element (e.g. a LED) may move relative to the buttons, or it may be fixed. A waveguide1510is disposed in the handle1502and it may extend outward or inward relative to the handle. The locking mechanism is preferably a “twist-lock” collet style mechanism that clamps circumferentially around an extendable shaft such as a waveguide or energy tip to securely hold it in place at any extended length and rotation. The locking mechanism consists of two pieces, a nose piece1514and a collet base piece1512. When in the un-locked position the shaft or waveguide1510can freely rotate, extend, or retract through the inner diameter of the collet. When twisted a predetermined amount, here preferably 90 degrees, in a clockwise motion, the shaft is securely held in place and resists axial movement and rotation.

The collet base piece has a hollow inner diameter with a split tapered end and is designed for a round shaft to be fully inserted through the inner diameter. On the outer diameter of the base piece are two small protrusions (not seen inFIG.15) that mate with two internal helix grooves on the inner diameter of the nose piece. These protrusions constrain the nose piece from coming free of the base piece and allow the nose piece to rotate a maximum of 90 degrees around the base. As the nose piece is rotated the helix grooves track along on the collet base protrusions and advance the nose piece in a downward direction. The nose piece and base piece have interfering tapers so as the nose piece is tightened against the base piece an inward radial force is created, thus making a secure clamping action around the extendable shaft. This locking mechanism may be used in any of the embodiments describe herein.

In any of the embodiments, the electrode tip may be disposed inside the hollow tube and as described above, the hollow tube may move independently of the electrode tip. Therefore an optical waveguide can slide relative to the length of the electrode tip which gives a surgeon flexibility to position the light at desired positions relative to the electrode tip. This also allows the surgeon to adjust the spot size of light emitted from the optical waveguide. Moving the optical waveguide distally moves the tip of the waveguide closer to the work surface therefore decreases the spot size, while retracting the optical waveguide proximally moves the tip of the waveguide away from the work surface, thereby increasing the spot size.

Any of the embodiments of optical waveguide may have a cylindrically shaped optical waveguide, or other shapes may also be employed such as square, rectangular, elliptical, ovoid, triangular, etc. In one example, flat facets can be used to provide better mixing of light in the waveguide. Odd number of facets is preferred. The number of facets is determined by the ratio of the sizes mentioned earlier. The more facets used, will push the outer waveguide shape closer to a circle, thus increasing the overall cross section size. Less facets will reduce the overall size of the waveguide. Some embodiments have a tapered optical waveguide such that the proximal portion of the optical waveguide has a larger size than the distal portion. In still other embodiments, the central channel of the hollow tube optical waveguide may be used to evacuate smoke from the surgical field. Thus, a vacuum is applied to a proximal portion of the optical waveguide to draw the smoke out of the surgical field and up into the central channel.

In other embodiments, the optical waveguide may be a solid rod such that there is no air space or gap between the electrode tip or conductor wire and the inner surface of the optical waveguide. As in previous embodiments, the solid optical waveguide may be fixedly coupled to the handle, or it may be adjustably attached to the handle so that its length may be adjusted to a desired position. The optical waveguide may have a central lumen through which a conducting element, such as a conductor wire or conductor rod is coupled to the electrode, or a proximal portion of the electrode tip may pass through the waveguide to occupy all of the space in the central lumen resulting in a solid waveguide. In some embodiments, this may be accomplished by over molding the waveguide onto the conducting element. The electrode tip may be coupled with the conducting element, or it may be integral with the conducting element. When the electrode tip is integral with the conductor element, the electrode tip is generally not exchangeable with other electrode tips. When the electrode tip is releasably coupled with the conductor element, it may be exchanged with other electrode tips. Preferred embodiments include a non-replaceable electrode tip which can be combined with the adjustable optical waveguide (e.g. slidable or otherwise moving waveguide) feature thereby allowing a user to adjust the light closer to, or away from the work surface for optimal lighting performance. Solid waveguides also provide additional benefits over hollow tube waveguides since they contain more material in the optical waveguide relative to a hollow tube waveguide which allows conduction of a greater amount of light. Additionally, a solid waveguide is structurally stronger than a hollow waveguide. Therefore, a stronger solid waveguide that can carry more light with a smaller profile is possible and preferred to a hollow tube which carries less light and may be weaker and have a larger profile relative to the solid waveguide. The conductor element passing through the solid waveguide also may provide strength to the waveguide.

In some embodiments, the conductor element which passes through the waveguide, either a solid waveguide or a tubular waveguide, provides energy from a power source (e.g. RF power supply) to the electrode. In other embodiments, such as inFIG.5A, the conductor element may be a wire502that is wrapped helically or otherwise around an outside surface of the optical waveguide202and coupled to the electrode tip214. InFIG.5B, the conductor element may be a wire502that runs along an outer surface of the waveguide.FIG.5Cshows an alternative embodiment of a cross-section taken along the line C-C inFIG.5Bwhere an optional concave cutout region504may be formed into the waveguide to accommodate the conductor element502to keep overall profile minimal. In a variation of the embodiment inFIG.5C, the conductor element may be shaped to complement the concave region of the waveguide so that when the conductor element and the waveguide are fit together, they form a cylinder having a circular cross-section. In still other embodiments, a conducting metal tube (not illustrated) may be disposed around the waveguide similar to electrical cladding disposed over the waveguide. Here the energy tip is coupled to the outer conducting metal tube.FIG.5Dillustrates still another embodiment of a conductor element502coupled with an optical waveguide202. In this embodiment the conductor element502is coupled to an outer surface of the waveguide and the conductor element runs axially therealong. The resulting cross-section forms a figure eight-like shape with a large profile waveguide and a smaller profile conductor element.

In any of the embodiments of the waveguide, a coating or cladding may be applied thereto in order to provide desired optical properties to the waveguide, thereby enhancing the efficiency of the waveguide. The coating or cladding may be applied to an outside surface of the waveguide, to the central channel of the waveguide, or to an outer surface of the conducting element in order to optically isolate the conductor element from the waveguide as well as to provide electrical or other insulation as required. The layer of cladding also provides a physical barrier to prevent damage to the waveguide from scratching, abrasion or other damage caused by adjacent surgical instruments. Optionally, any embodiment described herein may use air gaps disposed adjacent the waveguide to enhance optical transmission of light through the waveguide by minimizing light loss, as well as by using standoffs to maintain an air gap between the waveguide and adjacent components.

FIGS.6A-6Dillustrate an exemplary embodiment of an optical waveguide illuminated by LEDs. InFIG.6Athe LED board layout606includes an array of LEDs with dye elements602formed into a square pattern. Any number or combination of dye elements may be used in order to provide the desired light. A conductor element604passes through the center of the board layout606.FIG.6Billustrates an alternative board layout606having an array of two LEDs with dye elements602instead of the four LEDs illustrated inFIG.6A. Any pattern and number of LEDs may be used.FIG.6Cillustrates the board layout606with the conductor element604passing through the board.FIG.6Dillustrates the board layout606coupled to the proximal portion of the optical waveguide608with a power cable612coupled to the board. The conductor element604extends axially through the waveguide with a distal portion610exposed so that it may be formed into an electrode tip or coupled with an electrode tip. Preferably the electrode tip is flat, and the conductor element may be round or flat in order to keep profile minimized. The optical waveguide608may be any of the embodiments of optical waveguides described in this specification. It may be a round cylinder or it may have a hexagonal, octagonal, or other polygonal shaped cross-section for facilitating mixing of the light passing through the waveguide as discussed previously. The polygonal shaped cross-sections preferably have flat planar facets around the outer circumference of the waveguide. The flat surfaces enable better mixing of light from the LEDs so that the image of the actual dye is not projected onto a target. The electrode tip is coupled directly to the LED board. The proximal end of the waveguide may be parabola shaped or have other custom shapes in or to provide better capture and mixing of light from the LEDs or other light source. This embodiment therefore preferably does not have a hole drilled through the waveguide to accommodate the conducting element. The conducting element fills the entire space in the waveguide and the two are integral with one another and the conducting element and the LED light source are integrated onto a single circuit board.

FIG.6Eillustrates an optional variation of the previous embodiment with the major difference being that only a single LED is used. The board652includes a recessed region654which is sized and shaped to receive a portion of the conductor668which is connected to the electrode tip658. A single LED656is disposed on the board, and it is centered on the board so as to be coaxial with the central axis of the electrode658, and also optionally with the waveguide. The electrode658may have any of the features of any of the electrodes described herein including coatings or other insulation layers, especially those described with reference toFIGS.16A-16C. The electrode658includes a generally flat and planar section with proximal and distal tapered ends660. The distal portion of the electrode forms an electrode tip662for delivering energy to tissue. The proximal portion forms an elongate arm664having an angled section666which couples the electrode to the conductor668, thereby disposing the conductor off-center from the central axis of the electrode.

FIG.7illustrates an exemplary embodiment of an optical waveguide702with electrode tip714. The electrode tip714is a flat planar shape and is coupled to a conductor element712which extends through the waveguide702. A layer of cladding710is disposed over the conductor element in order to isolate it from the waveguide702. Additionally, a layer of cladding704is disposed over the outer surface of the waveguide702to isolate it from blood or contaminants. The waveguide in this embodiment is a polygonal shape (e.g. hexagonal, octagonal, etc.) having flat planar facets on the outer surface. A LED706is coupled to the proximal end of the waveguide, and the proximal end of the waveguide is parabolically shaped708in order to receive a maximum amount of light from the LED. Other coupling means can be used to optically couple the LED to the waveguide, such as by using lenses, hollow reflectors, gradient lenses, etc. Also, coatings may be applied to the waveguide to enhance coupling efficiency. The illumination element706may be an LED or LED array, including any of the LED embodiments disclosed herein.

FIG.8illustrates the proximal portion of the waveguide702inFIG.7. The conductor element712extends all the way through the waveguide and exits the proximal-most end of the waveguide and is coupled with the illumination element706. The conductor element may be electrically bonded to the illumination element706or it may be disposed in a hole that extends through the illumination element706. The illumination element in this embodiment is an array of LED elements714which generally takes the same form as described inFIGS.6A-6D. Additionally, the proximal portion of the waveguide is parabolically shaped in order to capture a maximum amount of light from the LEDs. Cladding710is seen disposed over the conductor element712to isolate the conductor element from the waveguide and this helps prevent light loss from contact between the two components. Also, as disclosed previously, air gaps may be used to help minimize light loss.

Any of the embodiments of illuminated electrode tips may also include a smoke evacuation feature.FIG.9illustrates an exemplary embodiment of an illuminated electrode tip with smoke evacuation lumens (also referred to as channels). The optical waveguide702includes cladding704disposed over the outer surface of the waveguide. The conductor element712extends through the waveguide and a layer of cladding710is disposed over the conductor element. Electrode tip714is coupled with conductor element712. The electrode may be bent relative to the conductor element or the optical waveguide. Optional lenslets902are provided on the distal face of the optical waveguide in order to shape the light exiting the waveguide to provide a desired illumination pattern on the target, here a surgical target. Smoke evacuation channels904may extend axially all the way through the waveguide to the proximal end thereof where the evacuation channels are coupled to a vacuum so that suction may be applied to the channels to draw out smoke created during electrosurgery. In other embodiments where the optical waveguide is a hollow tube, the central channel of the hollow tube may be used for smoke evacuation.

FIG.10illustrates another exemplary embodiment of an illuminated energy tip and hand-piece1002which demonstrates many of the individual features previously described above combined into one embodiment. The illuminated energy tip and hand-piece1002includes a handle1004, an optical waveguide1006, conductor element1012and energy tip1010. The optical waveguide1006is preferably coaxially disposed in the handle1004and coaxial to the tip1010and may be either fixed to the handle or slidably adjustable as described above so that the exposed length of the waveguide1006may be increased or decreased as required. The waveguide1006preferably has a plurality of flat planar facets which form the polygonal outer surface of the waveguide, and this shape as discussed previously helps light mixing in the waveguide. Optional tube1015is disposed over the waveguide and is made from a heat conductive material and acts as a heat sink to conduct heat away from the device. Additionally, optional lenslets1008are disposed on the distal end of the optical waveguide to shape and direct the light so that the beam of light illuminates the surgical target properly. An optical cladding such as a polymer like fluorinated ethylene propylene (FEP), or a heat shrink may be disposed over the waveguide to isolate it from direct contact with the handle, thereby minimizing light leakage and protecting it from damage caused by contact with adjacent surgical instruments. A conductor element1012extends preferably coaxially through the optical waveguide and into the handle1004and provides energy to the tip1010. The energy tip1010, here a flat planar blade is coupled to the conductor element. A thin neck region may be used to couple the energy tip with the conductor element so that the energy tip may be bent into a desired shape during use. An optical cladding and/or insulation layer1014may be disposed over the conductor element to isolate it from the optical waveguide. The layer of cladding or insulation1014helps to prevent light leakage from the optical waveguide and also may help prevent energy from leaking from the conductor element.

FIG.11illustrates a cross-section of the device1002inFIG.10and highlights the relationship of some of the elements of the device. For example, energy tip1010is coupled with conductor element1012which extends through the waveguide1006. An outer FEP (fluorinated ethylene propylene) cladding1112is disposed over the waveguide1006and an inner layer of FEP cladding1114is disposed over the conductor element1012. The waveguide and conductor element extend preferably coaxially through the handle1004. An outer heat sink1106maybe coupled to an inside surface of the handle to help dissipate heat from the waveguide. This heat sink may be a metal cylinder extending axially along the longitudinal axis of the handle or it may be made from other heat conductive materials than can act as a heat sink. A small wire channel1104may extend through the proximal end of the waveguide in order to allow the conductor element or a wire coupled to the conductor element to pass through the proximal end of the waveguide which in this embodiment is preferably a parabolically shaped proximal end similar to those previously described. A metal core LED printed circuit board (PCB)1110and this may have the LEDs as described elsewhere in this specification. An inner heat sink such as a metal tube1108may be butt coupled or otherwise coupled to the proximal end of the waveguide to further help dissipate heat from the waveguide, and an elongate portion1102of the PCB may extend axially away from the LED PCB to the proximal end of the handle where it may be coupled with a fitting or connector to allow it to be operatively coupled with an external power source, or other service. In this embodiment, the waveguide has a length that is longer than the length of the inner heat sink. In alternative embodiments, instead of, or in addition to the inner heat sink butt coupled with a proximal end of the waveguide, a heat sink tube maybe disposed over the waveguide to partially or fully enclose the waveguide and dissipate heat. The assembly may therefore have a metal tube heat sink, the waveguide and any of the LED embodiments, along with any of the energy tips and handle embodiments.

FIG.12illustrates an exemplary embodiment of an illuminated hand-piece with an energy tip that is substantially the same as the embodiment inFIG.11with the major difference being that the waveguide1202is considerably shorter than the inner heat sink1204. The inner heat sink1204is coupled to the proximal end of the waveguide1202. In any of the embodiments, the inner heat sink tube1204,1108may also be conductive to provide energy to the LED PCB or the energy tip.

FIGS.13A-13Billustrate exemplary embodiments of an illumination element coupled to an energy tip or conductor element. The illumination element is preferably a waveguide such as those described herein, but may be any illumination element including those disclosed herein. The energy tip similarly may be any energy tip disclosed herein. The energy tip1308is coupled to a conductor element1306which is coupled to a handle1302. The waveguide may be a rigid or malleable waveguide1304which is coupled to the conductor1306inFIG.13A, while inFIG.13Bthe waveguide1304may be rigid or malleable and is coupled to the energy tip1308. This provides lighting that is close to the energy tip. In any embodiment, the energy tip may be fixedly coupled to the conductor element or to the handle, or the energy tip may be releasably coupled to the conductor element or the handle. The energy tip, conductor element, waveguide, or handle may be any of the embodiments disclosed herein. The waveguide may be formed from any of the waveguide materials disclosed herein.

FIG.13Cshows the use of an optional coating on the electrode ofFIGS.13A-13Bor any of the electrodes described herein. The electrode1904is at least partially disposed in the waveguide1902which is then movably coupled to an electrosurgical pencil or other handle. A portion of the electrode1906may be coated with glass and/or may be polished in order to help reflect light emitted from the waveguide1902. The light is preferably reflected toward the tip and toward target work area and this can help minimize glare emitted toward a surgeon or other operator. The coated portion1906may be selectively disposed on only a portion of the electrode, or it may be disposed on the entire portion of the electrode. The coating may also be on a distal portion1908adjacent the portions of the electrode where energy is delivered to target tissue.

In any of the embodiments, the LED may be disposed in a number of positions other than just at the proximal end of the waveguide. For example, the LED may be positioned between the proximal end and the distal end of the waveguide, or the LED may be positioned at the distal end. Additionally, the LED may be positioned in any number of orientations relative to the waveguide.

FIGS.14A-14Cillustrate alternative embodiments with varying LED positions.FIG.14Aillustrates an energy tip1406coupled to a conductor element1404which extends through waveguide1402. A conductor element such as a wire1408is coupled to electrical connection1412(as best illustrated inFIG.14B) on the LED board1410and supplies energy to energy tip1406such as RF energy. A single LED1414or an array of LEDs may be disposed on the LED board1410. In this embodiment, the LED board is disposed against a proximal portion of the handle and waveguide1402. A parabolic shaped1416proximal portion of the waveguide receives light from the LED.FIG.14Billustrates an end view of the LED board. The LED board is preferably transverse to the longitudinal axis of the waveguide. A single LED may be coaxial with the electrode tip and the board may lie in a plane that is generally orthogonal or otherwise transverse to the axis of the waveguide. The board may help dissipate heat into the heat sink that may be surround the waveguide or that is butt coupled to the board. Optionally, in any embodiment the waveguide may be coaxial with the electrode.

FIG.14Cillustrates an alternative embodiment where the LED board1410is oriented generally parallel to the longitudinal axis of the waveguide1402and is disposed adjacent a proximal end of the waveguide. An angled parabolic section1420of the waveguide receives the light from the LED and transmits it distally toward the energy tip1406. In this embodiment, a conductor element such as a wire1422is coupled to the conductor element1404for providing energy to the energy tip1406. Also, a conductor element1424provides power to the LED board. Other positions for the LED along the waveguide are contemplated and these embodiments are not intended to be limiting.

FIG.16Ashows an exploded view of another exemplary embodiment of an illuminated energy tip1602which may be coupled to a handpiece such as an electrosurgical pencil (not illustrated). One advantage of this embodiment is that the light and the electrode may be rotated together, thereby ensuring uniform lighting of the target tissue. The illuminated energy tip1602includes an anodized aluminum shaft1600, FEP cladding1604, an LED board1606, waveguide halves1608, and an electrode blade1612. The waveguide may be molded as a single unit as described elsewhere in this specification, and therefore does not necessarily have two halves coupled together.

The electrode blade1612preferably includes a distal portion which is used to deliver energy (preferably RF energy) to tissue in order to cut or coagulate the tissue. This distal section1616is preferably insulated with a layer of material, here preferably a glass coating. The glass coating is advantageous since it has desirable optical properties and is distal to the waveguide1608and therefore helps to ensure that light emitted therefrom is properly reflected from the waveguide toward the surgical target area and minimizes glare back toward the surgeon or other operator. The tip is preferably insulated by a Teflon (polytetrafluorinated ethylene, PTFE) coating. This coating will scatter and absorb light. Having a reflective surface on the tip will aid the efficiency of the device by reflecting the light from the waveguide off the surface of the tip towards the target and therefore reduce unnecessary scatting. The tip can also have various shapes to aid in dispersion of light. The tip may have a curvature or taper. For example,FIG.19Aillustrates a top view of an electrode1904.FIG.19Bshows a cross-section of the electrode1904taken along the line B-B and shows upper and lower flat planar surfaces whileFIGS.19C and19Dshow optional convex upper and lower surfaces. The distal portion may be thin enough to allow an operator to bend the tip in order to conform to the anatomy being treated. A middle section1614of the electrode blade1612is preferably also insulated, here preferably with FEP (fluorinated ethylene propylene) in order to prevent energy from leaking out of the electrode along the middle section, and also the FEP provides an index of refraction lower than the index of refraction of the waveguide1608thereby helping to prevent or minimize light leakage from the waveguide due to contact between the waveguide and electrode blade. A low index of refraction coating or air gaps may also be used in conjunction with or instead of FEP to provide similar results. A proximal portion of the electrode includes a thin elongate section which serves as a conductor element and allows the electrode to be coupled to wires in the handle (not shown) which are operably connected to the power supply, preferably an RF generator. The proximal portion of the electrode may be straight and linear, or it may have an angled section so that a proximal portion of the thin elongate section is off-center, allowing it to pass through the LED board1606off center. Optionally, the proximal portion of the electrode may also be straight and pass through the center of the LED board.

Waveguide halves1608maybe snap fit, adhesively bonded, ultrasonically welded together or otherwise joined together, sandwiching the electrode in between the two waveguide halves. The waveguide halves form a cylindrical shape around the electrode, thereby illuminating around the electrode. The distal portion of the waveguide may include a lens, a plurality of lenslets or other optical features which help shape the light emitted therefrom. In this embodiment, the optical waveguide has an outer surface that is multi-faceted forming a polygon which approximates a cylinder. This extraction surface of the waveguide may be flat or curved or even angled or tapered to provide better light directionality, for example with respect to divergence of the light. Having a plurality of facets allows better mixing of light as it passes through the waveguide. Standoffs1610in a channel in each half of waveguide prevent direct contact between the waveguide and the electrode, thereby minimizing contact and subsequent light loss. The channel in each half of the waveguide preferably matches the shape of the electrode which lies therein.

LED board1606includes one or more LEDs for providing light which passes through the waveguide. The LED board may be any of the LED or other light sources described in this specification. The LED may also be parabolically shaped to help focus and deliver the light to the waveguide. In some embodiments, the conductor portion of the electrode may pass through the center of the LED board, or the conductor may pass off center through the LED board.

A layer of FEP cladding is disposed over the waveguide and may be heat shrunk down on the two halves, thereby securing the two together. Optionally in conjunction with the FEP cladding or as an alternative to the FEP cladding, other optical coatings may be used in this or any of the embodiments disclosed herein in order to provide a low index of refraction material adjacent the waveguide to prevent or minimize light loss. Also, an air gap may be disposed against the waveguide to help minimize or prevent light loss since the air gap would provide a lower index of refraction adjacent the waveguide. An outer-most aluminum tube1600or other heat conductive material, is then disposed over the FEP cladding and helps keep the components together and also serves as a heat sink to remove heat buildup. This tube is coupled to the LED core to dissipate the heat. The entire assembly may then be coupled to a handpiece and it may telescope in or out of the handpiece. A locking mechanism (not shown) such as a collet or quarter turn lock may be used to lock the electrode in position once it has been telescoped into a desired position.

FIG.16Bis an end view of the illuminated energy tip1602, andFIG.16Cis a cross-section taken along the line B-B inFIG.16B.FIG.16Chighlights the FEP coated section1620, as well as the section of electrode1622coupled with standoffs1610to minimize direct contact between the electrode and the waveguide.

In any of the embodiments described herein, the waveguide may also be a lens or have a lens portion for controlling light delivered from the waveguide. Therefore, the waveguide with or without a lens, or a separate lens may be mounted on or otherwise coupled to the LED light source or illumination element being used. Optionally, and embodiment may therefore include an optical element such as a lens mounted in front of the illumination element such as an LED to direct and shape the light onto the surgical field.

In any of the embodiments described herein, light may be provided to the waveguide by any number of techniques. An illumination element may be disposed in the handle or adjacent a portion of the waveguide. The illumination element may be a single LED or multiple LEDs. The LED or multiple LEDs may provide white light, or any desired color. For example, when multiple LEDs are used, the LEDs may provide different colors such as red, green, or blue (RGB) and therefore the multiple LEDs may be adjusted to provide a desired color of light that is input into the waveguide. Thus, the waveguide becomes more important since it will mix the different colors of light as the light is transmitted along the length of the waveguide, mixing the different colors of light so that a uniform color light is delivered to the target. Multiple colors may be used to provide varying shades of white colored light, or any other desired color which helps the surgeon or operator visualize and distinguish various objects such as tissue in the surgical field. Filters or coatings may be applied to any of the waveguides to filter specific frequencies of energy out.

Alternatively or in combination, the illumination element may be a fiber optic or fiber bundle in any of the embodiments described herein. For example, a fiber optic may input light to the waveguide from an external source such as a xenon lamp. Light from the external source may be transmitted through the fiber optic or fiber optic bundle through a cable, through the handle, and to the proximal end of the waveguide. The fiber optic or fiber optic bundle may be butted up against the waveguide to provide light to the waveguide and subsequently to a surgical field through the waveguide. A lens or other optical element may be used at the distal end of the fiber optic or fiber bundle to input light to the waveguide with desired optical properties. The light source, for example an external lamp box, may be provided outside the surgical field. Alternatively or in combination, the light source may be a light source in the cable connection. Alternatively or in combination, the light source may be provided in a housing coupled to the cable or to any part of the device.

In any of the embodiments, the waveguide may be made out of a material which has desired optical and mechanical properties. Exemplary materials include acrylic, polycarbonate, cyclo olefin polymer or cylco olefin copolymer. Additionally malleable silicones may be used to form the waveguide so that they may be shaped (plastically deformed) into a desired configuration. Moldable Silicone can also be coupled directly to the energy tip to provide a waveguide coupled to the tip and that flexes with the tip when the tip is bent or otherwise flexed. Manufacturers such as Dow Corning and Nusil produce moldable silicones which may be used to form the waveguide.

Additionally, in any of the embodiments described herein, sensors may be integrated into the waveguide or energy tip. These sensors include but are not limited to image sensors such as CMOS or CCD sensors. Sensors could also be thermal or fiber optic to collect spectroscopic information. Sensors may be disposed or otherwise integrated into the handle.

The tip may also include means for sensing to actively measure inductance of the tissue in the surgical field. Knowing the inductance of the tissue allows warning the user if the tip is about to cut through or otherwise damage critical structures. It is also contemplated integrating fiber sensing into the tip to measure temperature spread of the tissue as well as to perform spectroscopic analysis of the tissue. Still other embodiments may include an imaging element such as a camera that can be mounted on the pencil handle or integrated into the sleeve or other portions of the electrosurgical tip. Any of these features may be used or combined with the illuminated tip.FIG.16Dshows an exemplary embodiment of an energy tip1602with sensor1624integrated therein. The sensor1624may for example be an optical sensor, thermal sensor, inductance sensor, or spectroscopic sensor. Only one sensor is represented herein, however it will be understood that any number or combination of sensors may be integrated into one or more of the energy tip, waveguide, handle, or combinations thereof.

Still other embodiments may include handle that has venting features which allow air to circulate through the handle, thereby facilitating cooling of the handle and waveguide.

FIGS.17A-17Billustrate use of an optional battery or other power source that provides energy to the illumination element. This optional feature may be used in any of the embodiments described herein.

FIG.17Aillustrates an electrosurgical instrument having a pencil or handle1702with an electrode1704with or without illumination element coupled to the distal portion of the handle. An instrument cable1706is fixedly or releasably coupled to the proximal portion of the handle, and the opposite end of the cable1706includes a plug or adapter or connector1708with electrical connector prongs1710for coupling with the electrosurgical generator or any other external box (e.g. controller, light source, power source, etc.)

FIG.17Bhighlights features of the plug1708which includes a recessed region1714that is sized and shaped to receive a battery1712or other power source (e.g. capacitor) that can be used to provide power to the illumination element (e.g. a LED). Contacts on the battery1716engage corresponding contacts1718in the recessed region1714to complete the electrical circuit. The battery may be a disposable battery or a rechargeable battery. This feature allows a battery to be easily replaced during surgery without interrupting a surgeon who may be using the electrosurgical instrument. Also, this portion of the plug is typically outside of the sterile field thereby further facilitating its replacement. The end of the cable1706coupled to the plug1708may be fixedly or releasably attached to the plug. Thus, the plug may be easily swapped with a new plug having a fresh battery if needed, further facilitating the procedure.

FIGS.18A-18Eillustrate still another exemplary embodiment of an illuminated electrosurgical tip1802. One of skill in the art will appreciate that any of the features described in this embodiment may be used in conjunction with, or substituted for features in any of the other embodiments described herein.

FIG.18Aillustrates illuminated electrosurgical tip1802having an electrode tip1804coupled to a waveguide1808and having an illumination element1828on a circuit board1826adjacent a proximal end of the waveguide. The electrode tip1804has a distal rounded tip1806and may have an insulated and uninsulated area similar to that previously described in other embodiments to control delivery of energy to target tissue. The electrode tip1804flares outwardly1816(or tapers distally) into a flat planar section which then terminates and only an elongate arm1820extends proximally. The elongate arm1820is used as a conductor to deliver energy from an energy source to the electrode tip. The waveguide has a narrow vertically oriented slit1818which then transitions into an elongate channel1822for receiving the flat planar section and the elongate arm. A rounded protrusion1832(best seen inFIG.18B) extends from the elongate arm and is received in a correspondingly shaped recess in the waveguide and prevents axial movement of the electrode relative to the waveguide.

The waveguide is preferably a non-fiber optic optical waveguide formed as a single integral piece such as by injection molding. The distal portion of the waveguide includes a plurality of microstructures1812for controlling the light extracted therefrom and ensuring that the extracted light has desired optical properties (e.g. divergence, intensity, etc.). A rim1814is formed around the microstructures and serves as a surface against which the inner surface of metal tube may lie against. The metal tube has been previously described above and serves as a heat sink. The body of the waveguide is preferably multi-faceted with a series of outer planar surfaces forming a polygonal outer surface. This helps with light transmission through the waveguide as the multiple surfaces allow light to bounce off multiple surfaces, thereby providing more mixing of light.

The proximal end of the waveguide is preferably parabolically shaped in order to help guide light into the waveguide from the illumination element1828which is preferably an LED. The parabola is centered over the LED. Arm1820is offset from the central axis of the waveguide and is received in a slot1830in circuit board1826.

FIG.18Cillustrates an exploded view of the illuminated electrode tip1802, whileFIG.18Dshows an exploded side view of the illuminated electrode tip1802.

FIG.18Eillustrates a perspective of the electrode1804andFIG.18Fshows a perspective view of the waveguide1808.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.