COMBINATION ELECTROSURGICAL AND MECHANICAL RESECTION DEVICE

A combination medical device for removing and treating tissue in a patient is disclosed. The device includes a reusable handle and a blade selectively connectable to the handle. The blade includes an outer sleeve having a lumen with an inner shaft disposed therein. The inner shaft may be coupled to a motor drive unit disposed within the handle and may rotate so as to mechanically cut tissue as the inner shaft rotates. The outer sleeve includes at least one electrode for electrosurgically treating tissue. The reusable handle includes at least one control switch for controlling a parameter associated with the rotation of the inner shaft. The blade also may include a switch assembly in electrical communication with the at least one electrode, the switch assembly including attachment means for selective attachment of the switch assembly to the reusable handle.

FIELD OF THE INVENTION

This disclosure is related to a surgical apparatus and associated methods in general for resecting and electrosurgically treating tissue. This disclosure is related more particularly to a system for use in arthroscopic surgery, including a powered hand-held instrument coupled to a mechanical resection blade integral with a plurality of electrodes for ablating, cutting or coagulating tissue.

BACKGROUND

Surgical tools designed for mechanical cutting of tissue have been used for a number of years. These types of tools typically include a powered handpiece and a rotating cutting blade, which is secured in the distal end of the handpiece. The blade may have an inner drive member including a hub drivingly engaged with an output shaft associated with a motor of the handpiece, and a drive shaft fixed to the hub, which defines a cutting implement, or head at a distal end thereof. An outer cannulated housing element is disposed about the drive shaft of the inner drive member and defines a cutting window thereon which cooperates with the moving cutting head to manipulate targeted patient tissue positioned adjacent the window.

Electrosurgical tools have also been available for many years, employing electrical energy to treat targeted patient tissue in various ways. For example, electrocauterization is utilized to seal off and close blood vessels during surgery to prevent blood loss. In addition, ablation may be utilized to vaporize or remove tissue using electrical energy. Electrosurgical probes are typically designed to perform both of these functions, depending upon the level of power supplied thereto. Further, monopolar and bipolar electrosurgical tools are conventional wherein monopolar tools direct electric current from an active electrode defined on the tool through the patient's body to a return electrode, the return electrode typically defined by a grounding pad attached to the patient. Bipolar tools, on the other hand, include both an active and return electrode, wherein the current is directed between the active electrode and the return electrode through the contacted tissue. More recent developments in electrosurgery employ a treatment device using Coblation® technology, developed by the assignee of the present invention. Coblation® technology involves the application of a high frequency voltage difference between one or more active electrode(s) and one or more return electrode(s) to develop high electric field intensities in the vicinity of the target tissue. The high electric field intensities may be generated by applying a high frequency voltage that is sufficient to vaporize an electrically conductive fluid over at least a portion of the active electrode(s) in the region between the tip of the active electrode(s) and the target tissue. Upon sufficient energy being supplied to the vaporized conductive fluid, tissue may be volumetrically removed by molecular dissociation. A more detailed description of this phenomenon can be found in commonly assigned U.S. Pat. Nos. 5,697,882; 6,355,032; 6,149,120 and 6,296,136 the complete disclosure of which is incorporated herein by reference. More recently the assignee of the present invention has developed a further method of controlling the plasma field by regulating the volume flow rate of aspiration adjacent the active electrode, according to desired tissue effects and also in response to sensed parameters. This may improve control of the energy within the plasma and allow for more targeted tissue effect for a specific tissue type or procedure for example. A more detailed description of this phenomenon can be found in at least commonly assigned U.S. Pat. Nos. 8,192,424, 9,333,024 and 9,713,489 the complete disclosure of which is incorporated herein by reference.

In arthroscopic or endoscopic surgery both mechanical resection tools and electrosurgical tools are frequently interchanged within a single cannula, speaking to a need to combine both options in a single device. This may reduce surgery time and complication associated with blood loss. Combination devices generally tend to come with compromises. Firstly, the added functionality may require an increase in tip diameter or tip geometry, requiring larger and undesirable cannula sizes in the world of endoscopy and arthroscopy. A larger cannula size may also prevent access to required tissues. Alternatively, mechanical cutting surfaces may be recessed or reduced in size to allow space for the added functionality, but at a cost of potential reduced resection rates. Additionally the option to molecularly dissociate tissue as described above requires specific plasma resistant materials to be used, with added complexity when integrating in a mechanical resection device.

NOTATION AND NOMENCLATURE

Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, companies that design and manufacture electrosurgical systems may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function.

“Ablation” shall mean removal of tissue based on tissue interaction with a plasma.

“Mode of ablation” shall refer to one or more characteristics of an ablation. Lack of ablation (i.e., a lack of plasma) shall not be considered an “ablation mode.” A mode which performs only coagulation shall not be considered an “ablation mode.”

“Active electrode” shall mean an electrode of disclosed embodiments which produces an electrically-induced tissue-altering effect when brought into contact with, or close proximity to, a tissue targeted for treatment.

“Return electrode” shall mean an electrode of a disclosed embodiment which serves to provide a current flow path for electrical charges with respect to an active electrode, and/or an electrode of a disclosed embodiment which does not itself produce an electrically-induced tissue-altering effect on tissue targeted for treatment.

“Controlling flow of fluid” shall mean controlling a volume flow rate. Control of applied pressure to maintain a set point pressure (e.g., suction pressure) independent of volume flow rate of liquid caused by the applied pressure shall not be considered “controlling flow of fluid.” However, varying applied pressure to maintain a set point volume flow rate of liquid shall be considered “controlling flow of fluid”.

Where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.

SUMMARY

Generally this disclosure describes a system including a combination device that both mechanically resects tissue and electrosurgically treats tissue. Various embodiments are therefore directed to a variety of systems and methods for removing tissue, using mechanical cutting, electrosurgical ablation and aspiration. The specification now turns to an example system.

Various embodiments are directed to a combination medical device for removing and treating tissue in a patient, including a handle portion and a blade portion. The handle portion includes a motor that is selectively able to be coupled to a control box for controlling the motor. The blade portion includes an outer sleeve with a lumen extending therethrough and an inner shaft along the lumen. The outer sleeve is fixed to the handle portion so as be a stationary sleeve. The outer sleeve has a window at the distal end, the window having a cutting edge. The inner shaft may also have a cutting edge at its distal end and is coupled to the motor, operable to cause the inner shaft to move and in cooperation with the outer sleeve window cutting edge mechanically cut tissue. The inner shaft may rotate for example. The outer sleeve comprises an electrically conductive material that is at least partially exposed defining an exposed electrically conductive portion at the distal end of outer sleeve. The outer sleeve also includes a lateral opening through the thickness of the outer sleeve wall, the lateral opening circumferentially spaced from the window. A dielectric spacer is coupled to the lateral opening, and extends through the lateral opening. The dielectric spacer may define a portion of the outer sleeve inner lumen. The spacer may have an inner surface that defines a portion of the outer sleeve lumen. The dielectric spacer may be configured to replace a portion of the outer sleeve and provide increased rigidity to the outer sleeve when compared to an outer sleeve with no latera oping. The dielectric spacer is configured to nest an active electrode and electrically isolates the active electrode from the outer sleeve. This allows the exposed electrically conductive portion to be electrically coupled to an RF generator and operate as a return electrode.

In some embodiments, the dielectric spacer may be ceramic, or a plasma-hardy dielectric material that is minimally degraded by adjacent plasma. The lateral opening may have a peripheral edge with a plurality of retention elements, such as axially spaced teeth elements that mesh with corresponding axially spaced retention elements on the dielectric spacer. The spacer may also have a circumferential overhang portion that partially wraps around/over an outer surface of the outer sleeve. The inner shaft may have a lumen that forms part of a fluid aspiration element, so as to remove tissue drawn through the window while mechanically resecting tissue and also so as to remove fluid and plasma by-products drawn through the active electrode while the device electrosurgically treats tissue. The active electrode may have an aspiration opening therethrough for delivering fluid and tissue debris into the inner shaft lumen.

Another embodiment device for removing and treating tissue in a patient may include an outer sleeve and a rotatable inner shaft disposed therein. The outer sleeve and inner shaft each have edge surfaces that mechanically cut tissue when the inner shaft rotates relative to the outer sleeve. The outer sleeve includes both an active electrode portion and a return electrode portion, electrically isolated from each other by a ceramic spacer. The ceramic spacer is spaced away from the outer sleeve edge surface and therefore does not form a portion of the mechanical cutting edge. The spacer extends through an opening in the outer sleeve from an outer circumferential surface of the outer sleeve towards an inner lumen surface of the outer sleeve.

This outer sleeve opening may having a peripheral edge with a plurality of retention elements, that mesh with complementary retention elements on the ceramic spacer so as to improve fixation of the ceramic to the metal outer sleeve. The plurality of retention elements may include a series of axially spaced teeth. The ceramic spacer may also include a circumferential overhang portion that partially wraps around an outer surface of the outer sleeve. This may improve fixation of the ceramic to the sleeve and also increase a distance between the active and return electrodes for improved electrosurgical tissue effect. The outer sleeve edge surface may form a portion of the return electrode. The inner shaft may also have a lumen that forms part of a fluid aspiration element, and therefore may remove tissue drawn through a window in the outer sleeve while the device mechanically resects tissue and also may remove fluid and plasma by-products drawn through the active electrode while the device electrosurgically treats tissue.

A further embodiment disclosed herein includes a system for mechanically resecting tissue and electrosurgically treating tissue. The system includes a motor drive unit and a blade that may be detachable to the motor drive unit. The motor drive unit and blade may each form a portion of a fluid aspiration conduit that is in fluid communication with each other. The system also includes a motor drive unit controller in communication with the motor drive unit, a fluid aspiration controller to control a flow rate through the motor drive unit and blade fluid aspiration conduits and an RF generator in electrical communication with an active and return electrode of the blade. The blade has an outer sleeve with an inner sleeve concentrically disposed therein, the inner sleeve coupled to the motor drive unit so as to the drive the inner sleeve and move it, relative to a stationary outer sleeve to mechanically cut tissue. The outer sleeve has an exposed electrically conductive portion coupled to the RF generator, sized so as to act as the return electrode. The outer sleeve also includes a ceramic spacer that extends through a lateral opening in the outer sleeve and replaces a portion of the outer sleeve, the ceramic spacer coupled to and electrically isolating an active electrode from the outer sleeve.

The fluid aspiration controller may be communicably coupled to the motor drive unit controller and also the RF generator so as to control a flow rate at a first flow rate when the motor drive unit controller is in operation and a second flow rate, different to the first flow rate when the RF generator is in operation. This second flow rate may be a variable flow rate, adjusted in response to a sensed parameter associated with an electrode circuit impedance of the blade.

A further embodiment disclosed herein may include a combination medical device for removing and treating tissue in a patient with a reusable handle portion and a blade portion selectively connectable to the handle portion. The blade portion includes an outer sleeve having a lumen with an inner shaft disposed therein, the inner sleeve coupled to a motor drive unit disposed within the handle portion. The inner sleeve is coupled to rotate and mechanically cut tissue. The outer sleeve may include at least one electrode for electrosurgically treating tissue. The reusable handle portion includes at least one control switch in electrical communication with the motor drive unit for controlling a parameter associated with the rotation of the inner shaft. The blade portion may also include a switch assembly in electrical communication with the at least one electrode, the switch assembly extending from a proximal end of the blade portion. The switch assembly may be selectively coupled to the reusable handle using attachment means. The switch assembly may include or be formed of a flexible substrate having first and second opposing sides, with attachment means on a first side and at least one button on the second side of the flexible substrate, and an electrically conductive element operably connected to the button for selectively coupling the at least one electrode with an output of an electrosurgical generator. The switch assembly attachment means may include an adhesive, or a clip, or a sleeve, or a wrap. The button may be a series of buttons or controls and may be operable to electrically couple two electrical contacts such that upon closure of the button the electrosurgical generator delivers energy to the at least one electrode. The button may be a series of buttons or controls and may be operable to electrically couple two electrical contacts such that upon closure of the button a fluid control apparatus adjusts the flow of fluid along the blade portion lumen and also controls the delivery of energy to the at least one electrode. The switch assembly may include two buttons, for selecting between two tissue treatment modes, each tissue treatment mode including a combination of energy delivery and fluid flow rate of fluid along the lumen of the blade portion.

A further embodiment disclosed herein may include a system for mechanically resecting tissue and electrosurgically treating tissue. The system may include a motor drive unit and a blade selectively coupled thereto, the motor drive unit and blade each having a fluid aspiration conduit in fluid communication with each other. The system may also include a motor drive unit controller communicably coupled to the motor drive unit and a fluid aspiration controller configured to control a flow rate through the motor drive unit and blade fluid aspiration conduits. The system may also include an RF generator in electrical communication with an active and return electrode of the blade. The blade may include an outer sleeve with an inner sleeve concentrically disposed therein, the inner sleeve coupled to the motor drive unit and configured to move relative to the outer sleeve to mechanically cut tissue. The inner sleeve may rotate relative to the outer sleeve. The outer sleeve may have a return electrode and active electrode on an outer surface of the outer sleeve at the distal end of the blade. The blade may also include a switch assembly in electrical communication with the return and active electrode, the switch assembly extending from a proximal end of the blade and including attachment means for selective attachment of the switch assembly to an external surface of the motor drive unit. The switch assembly may be formed of a flexible substrate having first and second opposing sides, a button on the second side of the flexible substrate, and an electrically conductive element operably connected to said button and at least partially disposed within the substrate. The electrically conductive element may be a series of wires for selectively coupling the active and return electrode with an output of the electrosurgical generator. The blade may include a cable for electrically coupling the blade with the RF generator, and the button may be operatively coupled to the cable. The switch assembly attachment means may be either an adhesive on a portion of the switch assembly, a clip, a sleeve or a wrap. The button is operable to electrically couple two electrical contacts such that upon closure the RF generator delivers energy to the active and return electrode. The switch assembly may include two buttons, for selecting between two tissue treatment modes. The button is operable to electrically couple two electrical contacts such that upon closure an RF generator delivers energy to the active and return electrodes and also adjusts a flow rate through the motor drive unit and blade fluid aspiration conduits.

DETAILED DESCRIPTION

The disclosure may generally include a system that combines mechanical resection with electrosurgical tissue treatments in a single device, electrosurgical tissue treatment including but not limited to tissue ablation, cutting and coagulation. Combining these two modalities may reduce the need for multiple instruments during surgery, such as endoscopic or arthroscopic surgery. The mechanical blade edge surfaces of both the stationary member and rotating member preferably comprise a metal. The active and return electrodes are preferably both disposed on a stationary outer sleeve portion of the blade, for reliable and simpler electrical communication between the electrodes and energy source. The electrodes are also integrated with or form a portion of the outer sleeve portion so as to minimally alter the outer diameter of the blade.

An overview of the surgical system100is best seen inFIG. 1, and includes a combination device110having a motor drive unit (“MDU”)112mechanically coupled to a blade114. Combination device110may be configured and operate similar to commercially available metal shavers or burrs with high speed rotating inner shafts disposed within a stationary outer sleeve. Combination device110also includes a RF bipolar power cord116electrically and mechanically coupled to blade114for supplying RF power to blade114. Surgical system100further includes a control box120for supplying power to MDU112through a power cord130, and an RF generator140for supplying RF power to blade114through RF power cord116.

Furthermore, device110includes an aspiration tube210extending along the MDU112which may couple to an aspiration control mechanism220. Aspiration control mechanism220may control a fluid flow through tube210, and may be suction pump or plurality of suction pumps (not shown), a peristaltic pump having a rotor or other devices to provide and control aspiration of tissue and fluid. As a further example, the aspiration control mechanism may include a pinch valve having a plurality of positions that pinch or release the aspiration tube or the control mechanism may include a means of altering a fluid conduit size (orifice) associated with the aspiration tube. Aspiration control220may be in communication (141) with a controller of the RF power supply140, and may also be in communication121with the control box120discussed in more detail later. Control box120, generator140and aspiration control220are represented as separate enclosures; however these may be combined into a single enclosure in some embodiments. In alternative embodiments, the control box120and generator140may each have their own dedicated aspiration control system, and associated tubing and fluid flow control means. In alternative embodiments, aspiration may be at least partially controlled by a control valve disposed on the MDU112that may selectively allow stronger aspiration and reduce it during use. In this embodiment, the aspiration control220may supply a constant aspiration flow rate and manually be alterated by the user, by depressing the valve for example to alter the aspiration rate.

Blade114includes a lumen that extends through blade114and communicates with aspiration tube210for aspiration at distal portion230, such that fluid and debris may be aspirated through a window in distal portion230, flowing along lumen and through tube210. Blade114includes a distal portion230that is inserted into a patient's body to cut tissue mechanically and to electrosurgically treat tissue. Blade114includes a proximal portion240configured to selectively connect and detach blade114to MDU112, and configured to mechanically engage portions of blade114to a motor within the MDU112.

Control box120may be , for example, the Dyonics® Power Shaver system or the Dyonics® EP-18 Shaver System supplied by Smith & Nephew, Inc. of Andover, Mass. Generator140may be a commercially available generator such as, for example, a COBLATION WEREWOLF system supplied by Smith and Nephew, Inc of Andover, Mass. The blade114is sized to accommodate the desired application. For example, for use in a shoulder the blade is sized differently from one for use in a prostate. Applications include, for example, use in a shoulder, a knee, and other joints, as well as use in natural orifices such as, for example, a uterus, a urethra, a nasal cavity, and a mouth.

Referring toFIG. 2, RF power cord116may terminate at a free end with a connector320. Connector320may have at least two prongs322and324designed to connect to either a generator140or a foot switch. Each prong connects to one of two separate conductors within RF power cord116to provide both a supply path and a return path for blade114. Additional prongs (not shown) may provide further information to the RF generator/controller140such as the type of device and/or desired or candidate settings such as fluid flow settings or power settings. Alternatively connector may include a series of pins configured to connect to a connector of an RF Controller140, such as the system described in the commonly assigned U.S. Pat. No. 9,333,024 the complete disclosure of which is incorporated herein by reference.

MDU112includes a drive shaft (not shown) that is configured to selectively couple with a proximal end of blade114, and may include coupling means similar to those disclosed in commonly assigned U.S. Pat. No. 7,150,747 the complete disclosure of which is incorporated herein by reference.

Aspiration controller220may be in communication with both the MDU control box120and RF generator140, represented inFIG. 1, such that during times that the MDU is in operation, aspiration rates may be controlled at a fluid flow rate regulated by the control box120. This may further be dynamically altered in response to sensed parameters associated with the MDU or sensed temperature in a patient's joint. Furthermore, during times that the RF Generator140is in operation, aspiration may be controlled at a fluid flow rate commanded by the RF generator140. The fluid flow rate may further dynamically altered in response to sensed parameters such as electrode circuit impedance as described in commonly assigned U.S. Pat. Nos. 8,192,424 and 9,333,024 the complete disclosure of which is incorporated herein by reference.

Generally the blade114mechanically resects in a manner similar to other commercially available mechanical resections devices; in that blade114includes an outer sleeve310that is fixedly attached to the M DU112and is a stationary sleeve during use, and an inner sleeve410, concentric with the outer sleeve, coupled to the MDU112such that it may rotate at high speeds relative to the stationary outer sleeve310. Blade114can be attached to MDU112using various structures, for example, threaded connections and pressure-fit connections. Various embodiments of MDU112include motor drive units manufactured by Smith & Nephew, Inc., of Andover, Mass., such as, for example, part numbers 7205354, 7205355, and 7205971.

A variety of cutting surfaces can provide mechanical cutting. Such surfaces include, for example, blades that are curved, burred, straight, serrated, or miniature. Mechanical cutting is typically achieved with speeds in the thousands of cycles (for example, revolutions or reciprocations) per minute.

Now referring toFIGS. 3A-3Dshowing an embodiment of the blade distal tip340, outer sleeve310includes a longitudinal opening320defining an edge surface325around at least a portion of the perimeter of the opening320. Edge surface325is preferably sufficiently sharp to cut tissue when used in combination with the inner sleeve410. Inner sleeve410may have a similar opening420and edge surface425that is configured to cooperate with edge surface325to mechanically resect tissue as the inner sleeve rotates. Inner sleeve410and opening420may be in communication with aspiration tube210such that inner sleeve410defines an elongate fluid conduit along its lumen (not shown) so that tissue debris formed during mechanical resection may be removed through said conduit and opening420. Both inner and outer sleeves (410and310) including their cutting edge surfaces425and325may be formed from a metal such as stainless steel as the inventors have found this material offers good strength generally and a durable cutting edge. An alternative option for one of the sleeves may be Invar, a nickel-iron alloy that is readily brazed to. A metal cutting edge is preferable to reduce particulate formation during cutting, which can occur with more brittle materials.

Outer sleeve310is preferably a metallic or electrically conductive tube, configured to provide an electrical path from the electrical cord116to blade distal tip. Outer sleeve310may be at least partially coated or covered by a layer or sheath305to electrically insulate a portion of the outer sleeve310and limit an exposed portion of the outer sleeve to controlled areas. For example a proximal portion of the outer sleeve310, adjacent the MDU112may be exposed sufficient to electrically couple with cord116and thereby the RF generator140(not shown). A distal portion of the outer sleeve310may also be left exposed, so that the metallic cutting edge surface325is exposed for mechanical resection and also such that a surface area is exposed defining the return electrode350of the system100, for use during application of the RF energy.

Outer sleeve310further comprises an active electrode360, electrically coupled to the RF generator140via cables or wires (not shown) and electrically insulated from the outer sleeve310and thereby return electrode350via an electrically insulative spacer370. Since the active electrode360is intended to selectively ablate tissue and therefore form plasma, spacer370is preferably an electrically insulative material that is also resistant to degradation from plasma, or plasma-hardy. Materials may include a ceramic or glass material, such as alumina, zirconia and the like. The preferred embodiment may use a unique high strength and fracture-resistant ceramic such as zirconia. This ceramic is capable of being molded into detailed shapes similar to alumina, but it will not decompose under plasma like traditional zirconia. Silicon Nitride is a further option.

In addition, the active electrode360should preferably be a material that is resistant to degradation to plasma, such as a tungsten, titanium, platinum, molybdenum, aluminum, gold and copper. More specifically the active electrode may preferably be a different material from the inner and outer sleeve material. While stainless steel is preferred for the mechanical cutting edges, stainless steel tends to be less resistant to degradation by plasma and therefore is not the preferred material for an ablation electrode. In addition, tungsten for example is a more brittle metal than stainless steel and therefore would not be preferable as a cutting edge, as particulate may form during mechanical resection. Additionally the inventors have found that the portion of the distal end that forms plasma should be spaced away from the mechanical cutting edge, as whatever the material of choice for the mechanical cutting edge, the edge may be degraded by the plasma and mechanical cutting may be compromised. Asperities such as sharp edges have more tendancy to form plasma thereon, therefore a minimum distance between peripheral edges of the active electrode360and the cutting edge325should be at least 2 mm. The portion of the distal end that forms plasma should be spaced away from the mechanical cutting edge, such that plasma formation along the mechanical cutting edge is not preferential.

In order to maintain a smaller outer diameter of the distal tip340, spacer370may replace a portion of the outer sleeve310so as to extend through the wall thickness of outer sleeve310from the outer surface towards the inner lumen. Stated otherwise outer sleeve310comprises a second opening330, for receiving a spacer370therethrough. Opening330may be an enclosed opening, spaced away from the cutting edge325and distal-most tip of the outer sleeve310and may be at least partially diametrically opposite opening320. Opening330preferably axially overlaps opening420of inner sleeve. Spacer370is preferably formed from a high-strength ceramic which provides structural integrity to the outer sleeve310, and may add rigidity to the outer sleeve so as to provide a strength improvement compared to an all metal outer sleeve. Insulative spacer370is not used as a cutting surface, but instead serves to seal off the metal inner sleeve410and provide insulation from the plasma. Spacer370extends through the second opening330but preferably does not extend into or intrude into the outer sleeve lumen, as this may interfere with the inner sleeve410as it rotates. Best seen inFIG. 3Cspacer370may extend through second opening330up to the inner lumen wall312of outer sleeve310. Inner curved surface371of spacer370may be curved so as be substantially continuous with the curvature of inner lumen wall312. Compared to a spacer that may solely lie on an outer surface of the outer sleeve310, replacing a portion of the outer sleeve310with spacer370allows for a significantly smaller overall cross-section to be maintained (SeeFIG. 3C), while still maintaining spacing requirements between active and return electrodes to control the electrical path between the two electrodes. Thus with the spacer configuration as disclosed, minimal increase to outer cross section of device is achieved. For example, the inventors have found that if outer sleeve outer diameter (OD) is approximately 4.5 mm, similar to existing devices such as the Platinum Bonecutter, the maximum cross-section (CS) including spacer370and electrode360still fits through a 5 mm cannula.

Further detail of the spacer370and active electrode360are best seen inFIGS. 4A and 4B, showing exploded views of the top side and underside of distal portion340. Second opening330extends through to inner lumen of outer sleeve310and inner sleeve410may be seen therethrough inFIGS. 4A and 4B. Inner sleeve410may be preferably oriented such that inner sleeve opening420is in fluid communication with second opening330during operation of the RF generator140. Stated otherwise inner sleeve opening420may preferably be facing second opening330during operation of ablation mode. (Figures show inner sleeve opening420facing away from opening330).

In some modes this inner sleeve opening420may be rotated so as to only partially overlap second opening330or adjustably overlap second opening330, as a means of controlling the fluid flow rate through the active electrode360, spacer370and second opening330. This may further control the tissue effect and energy within any plasma formed at the active electrode360, as explained earlier. Alternatively, the inner sleeve opening420may be aligned with second opening330and the volume flow rate may be controlled using a flow control device such as a pump in communication with controller220.

Second opening330may include mechanical locking features335, such as a plurality of axially spaced teeth to better couple the spacer370with outer sleeve310. Complementary retention features375may be seen on spacer370inFIG. 4B, the teeth formation configured to improve stresses distribution between the two parts. Bond strength may also be improved due to the increased contact area. Spacer retention features375may be recessed within the spacer370surrounding by overhang380, seen in bothFIGS. 4B and 3C. This overhang380provides several advantages. Firstly it better distributes stress between the spacer370and outer sleeve310due to any side loading during use of the device. It also increases surface area contact between the spacer370and outer sleeve310adding area for adhesive coupling. In addition, this overhang380provides a preferred electrical insulation gap between the return electrode350and active electrode360, and thus improving plasma formation around the active electrode360. Gap is shown inFIGS. 3B and 3Cas spacing X and Y. Too small a distance between the two electrodes can disrupt the high voltage build up that form plasma, and electrical shorting may occur. Additionally the profile or peripheral edge381of the overhang follows the peripheral edge surface profile of the cutting window325to maintain visibility of the window325, and limit visibility being obscured by the ceramic spacer370.

Spacer370includes aspiration opening372through the thickness of spacer370so as to be in fluid communication with inner lumen of outer sleeve310. As discussed earlier, when inner sleeve opening420is oriented so as to at least partially face or be in fluid communication with aspiration opening372, aspiration of fluid and plasma and coagulation by-products may be removed from the tissue treatment site, allowing the same aspiration path to be used for both mechanical resection and RF tissue treatment. Typically, this would require the active electrode360to be offset farther from the return350to prevent plasma from forming inside the device. (The distance between the active and return on the inside of the device must preferably be greater than the distance between the active and return at the outer surface of the device). Since a portion of the inside of the outer sleeve310is now replaced with insulative spacer370(curved surface portion371) the distance from the active electrode360to return350(surface312) is now increased, thereby minimizing unintended plasma inside the device. Active electrode360also includes at least one aspiration opening362in fluid communication with aspiration opening372of the spacer370, to remove debris and plasma by-products through the active electrode surface during use. Active electrode360has a rounded outer surface and nests within a spacer cavity376, minimizing any additional size increase so the device may fit within a5mm cannula. The active electrode360is constrained and supported by the ceramic spacer370, by a slot373and bilateral overhangs374on lateral sides of cavity376. Electrode flange or tail363slides into slot373in the spacer370and lateral portions of the electrode360are partially covered by overhangs374. Overhangs374further increases distance between active electrode360and return electrode350. This type of mechanical interface is possible by using a metal-injection moulded electrode360, ideally composed of predominantly tungsten. Flange363is electrically conductive and forms a portion of the electrical path from active electrode360to RF generator. Flange363may be a moulded portion of the electrode360so that the flange363and electrode360are a single moulded piece. Alternatively, flange363may be an electrically conductive wire or cable, electrically coupled to the electrode360. Electrically conductive cable or flexible circuit (not shown) may be electrically coupled to the flange363or electrode360and extend along outer sleeve310to a proximal portion of blade114and electrical cord116. This electrically conductive cable is electrically isolated from outer sleeve310, as outer sleeve310preferably provides the electrically conductive path for the return electrode350to the cord116.

Active electrode360may have a concave underside364. This is to increase distance between the active electrode360and inner sleeve410, and mitigate the inner sleeve410inadvertently acting as an electrical path shunt in some orientations and thereby effecting plasma formation. This may occur if the active electrode is not concave or is too close to the metallic inner sleeve410. As discussed earlier, in order for consistent plasma to be formed on the outer portion of the active electrode360, the spacing between the internal surfaces of the active and return electrodes should preferably be further than the distances X and Y on outer surface portions. While the outer sleeve310is coupled as the return electrode, there may be no electrically insulative means between the inner and outer sleeve (410and310respectively). Given that the inner sleeve may be in contact with the outer sleeve is some locations, the inner sleeve410is at times electrically coupled to the outer sleeve and thereby may form part of the return path. Therefore it is to be assumed that the inner sleeve410may be operable to form a portion of the electrically conductive path as it contacts the inner lumen of the outer sleeve310. It follows therefore that the inner sleeve410may bridge or shunt the electrical path between the active electrode inner surface364and return electrode350, when the inner sleeve is in certain orientations, such as the orientation shown inFIG. 4A. If inner sleeve410is rotated as shown inFIGS. 4A and 4B, the spacing between the inner surface364and an outer surface of the inner sleeve310should preferably by further than the distance X and/or Y as described inFIGS. 3B and 3C. A concave inner surface364is one means of achieving this minimum spacing. An alternative means includes a boss, described in later figures.

Active electrode has a distal tip368that may extend around the rounded distal tip of outer sleeve, to minimize device cross-section and also provide for an RF tissue effect at the distal-most tip of the device. Distal tip368may also be tapered to minimize the overall diameter at the tip for improved access to tight areas. The outer curved surface, together with the recessed position of the active electrode360within spacer370also minimizes tissue snagging with manipulating the device. In addition to reducing snagging, the blade distal end should include components that transition smoothly with each other, and preferably have a curved and smooth outer profile. This maintains the feel or tactile feedback of the device similar to devices that the surgeon is familiar with such as pure mechanical resection devices only. The tactile feedback is important to the feel of the device while mechanically resecting or generally manipulating tissue.

Aspiration through the active electrode360and spacer370may be controlled by a “Window Lock” feature of the shaver. The surgeon has the capability to set the opening420of the inner sleeve410to “closed”, thereby allowing flow exclusively through opening362through the active electrode360. This may be necessary to clear the field of bubbles created during the RF plasma ablation. Laser marks may be added to the inner and/or outer sleeve to show alignment when the opening420is closed. By sharing the aspiration channel with the mechanical resection handle, the surgeon can also customize ablation performance by controlling aspiration on the handle. Seen best inFIG. 3Daspiration openings362and372may be angled and slightly axially offset from each other. This may help direct flow or debris and by-products proximally.

FIG. 5Ashows an isometric view of an alternative embodiment for a blade distal portion. Similar to the previously described embodiment, blade distal portion includes an inner sleeve510, outer sleeve520, active electrode560and spacer570. Outer sleeve520and inner sleeve510may both have openings with sharp edges to mechanically cut tissue. Active electrode560may be electrically coupled to the RF generator140via cables or wires and electrically insulated from the outer sleeve520and thereby return electrode550via an electrically insulative spacer570. Similar material factors such as plasma hardiness and durable cutting surfaces as described for previously embodiments are considered for the spacer, outer sleeve and active electrode560.

In order to maintain a smaller outer diameter of the distal portion, spacer570may replace a portion of the outer sleeve560so as to extend through the wall thickness of outer sleeve560from the outer surface towards or up to the inner lumen. Opening530may be an enclosed opening, spaced away from the cutting edge525and distal-most tip of the outer sleeve520. Spacer570is preferably formed from a high-strength ceramic which provides structural integrity to the outer sleeve520, and may add rigidity to the outer sleeve520so as to provide a strength improvement. Insulative spacer570is not preferably used as a cutting surface, but instead serves to seal off the metal inner sleeve510and provide insulation for the RF ablation plasma. Spacer570extends through the opening530but preferably does not extend into or intrude into the outer sleeve lumen, as this may interfere with the inner sleeve510as it rotates. Best seen inFIGS. 5B and 5Cshowing cross sections ofFIG. 5A, spacer570may extend through opening530towards but not beyond the inner lumen wall of outer sleeve520. Inner curved surface of spacer570may be curved so as be substantially continuous with the curvature of inner lumen wall512. By making this hybrid tip, with the spacer570replacing a portion of the outer sleeve520a significantly smaller overall cross-section is maintained (SeeFIGS. 5B and 5C). Thus with the spacer configuration as disclosed, minimal increase to outer cross section of device is necessary. For example, the inventors have found that if outer sleeve outer diameter (OD) is approximately 4.5 mm, similar to existing devices such as the Platinum Bonecutter, the maximum cross-section (CS) including spacer570and electrode560still fits through a 5 mm cannula.

Not shown inFIGS. 5A-5C, opening530and spacer570may include mechanical locking features similar to those described inFIGS. 4A and 4B. Spacer570may also include overhang580, seen in bothFIGS. 5B and 5Cto improve stress distribution between the spacer570and outer sleeve520due to any side loading during use of the device. Overhang580may also increase surface area contact between the spacer570and outer sleeve520adding area for adhesive coupling. In addition, this overhang580provides a preferred gap between the return electrode550and active electrode560, to form consistent plasma at the active electrode560; gaps similar to those shown inFIGS. 3B and 3Cas spacing X and Y.

Spacer570includes aspiration-opening572through the thickness of spacer570in fluid communication with inner lumen of outer sleeve520. In this embodiment, the aspiration opening572includes a boss573, to increase dielectric spacing between the active electrode560and effective return electrode. As explained previously it is preferable that the distance between the active and return on the inside of the device be greater than the distance between the active and return at the outer surface of the device. Since a portion of the inside of the outer sleeve520is now replaced with insulative spacer570and a bossed opening572,573, the distance from the active electrode560to return electrode550is now increased, thereby minimizing unintended plasma formation inside the device. Boss573extends through and nests within a complimentary opening565in the active electrode560, terminating to be slightly recessed from the top surface of active electrode560. This maintains an exposed edge surface around the active electrode opening565to focus the electrical field and form plasma at the edges of opening565. Aspiration opening565and boss573are sized to remove tissue debris and plasma by-products from the active electrode surface during use. Active electrode560has a rounded outer surface and nests a least partially within a spacer cavity576so as to keep the distal tip cross-section minimalized, and fit within a 5 mm cannula. Unlike the embodiment in previous figures, that disclosed a concaved underside of the active electrode, this embodiment of the active electrode560may be flush within the spacer cavity576as the boss572provides the supplemental electrical pathway spacing to preference the primary electrical pathway on the outer surface of the device. This may further reduce the distal tip cross section. This may also provide a better tactic feel as described earlier.

In addition to manual control, the device110may be connected directly to the WEREWOLF⋄COBLATION⋄System, owned by the common assignee of this application and incorporated herein by reference. This allows automated control of suction when COBLATION is active and may provide constant or controlled suction for the shaver device when COBLATION is not active. Shaver flow control can be controlled based on a variety of feedback such as pressure in the tubing, power draw the motor, torque transducer connected to the motor, and/or motor temperature. The flow control module can also be run in reverse to remove clogs.

This combination device110may also have a coagulation mode characterized generally as a lower voltage mode relative to ablation mode. The coagulation field of this device110is contained to the area around the active electrode360. This controlled area reduces unintended thermal tissue damage.

The electrical path for this device may use a flex circuit on the outside of the outer sleeve310for power delivery to the active electrode. This same flex circuit may incorporate the circuit to enable Ambient⋄technology, owned by the common assignee of this application and incorporated herein by reference. Ambient technology provides temperature information to the RF Controller and/or the control box120thereby sensing a value indicative of temperature of fluid inside the joint during both mechanical resection and RF tissue treatment. A sensor for sensing a value indicative of temperature may be coupled to any portion of the device distal tip340, and may for example by coupled to a portion of the spacer, axially spaced proximally from the active electrode.

An alternative embodiment of a blade distal portion600is shown inFIGS. 6A and 6Bwhich includes a dedicated suction channel650for operation while delivery RF energy to the blade distal portion600. Features such as the cutting windows or openings and return electrode may be similar to the previously disclosed embodiments. Suction channel650may be a portion of spacer670, which may extend proximally along device shaft. In this embodiment, a suction path separate from the mechanical resection aspiration path, extends along an outer portion of the device and connects with a separate suction tube (not shown) directly coupled to a flow control device associated with the RF control device only. This may allow a more customized aspiration profile and thereby a more customized ablation performance (such as with the Werewolf Flow Control module or similar method). Also of note, active electrode660may include a plurality of aspiration openings672, each having a different shape.

A further alternate embodiment of a blade distal portion700is shown from various angles inFIGS. 7A, 7B and 7C. Features such as the cutting windows or openings and return electrode may be similar to the previously disclosed embodiments. This embodiment includes a shield or middle tube730, in addition to inner tube720and outer tube750. Similar to previous embodiments, active electrode760is supported by spacer740coupled to outer tube750, which may provide the return path of the RF output. This device is similar to the “Orbit”-style shavers. The shield of middle tube730can be used to control suction, thereby preventing the need to set a “Window-Lock” to control suction. Shown inFIG. 7A, shield730is in an open configuration and inner tube720may rotate relative to shield730to mechanically resect tissue and aspirate the tissue debris through a lumen of inner tube. In this open configuration, there may be no aspiration available to the active electrode760, should energy be supplied, which may be preferable for some tissue treatments. Of note edges along the respectively openings of middle tube730and inner tube,720provide the tissue resection.FIG. 7Bshows the shield in a partial open configuration which may provide some aspiration through active electrode760and also through the inner tube lumen. In this partially open configuration, mechanical resection and electrosurgical tissue treatment may be used in combination or sequentially. This configuration may also be configured so control a rate of aspiration. In a third and closed configuration, shield730may be rotated to completely cover inner tube720and have an opening facing an underside of active electrode760. Aspiration may be provided to the apertures predominantly through the active electrode760.

A further alternative embodiment of a blade distal portion800may be seen inFIG. 8. This embodiment may include an axially slideable electrode860that may be removed from the immediate area around the distal tip during mechanical resection and subsequently slid over an aspiration aperture850when electrosurgical tissue treatment is desired. Multiple suction holes865are shown in this embodiment as well as others previously that may provide alternate suction paths to mitigate clogs.

The combination device may be operated in a variety of modes. For example in a first mechanical resection mode, the MDU112may rotate or move inner sleeve410so as to mechanically cut tissue, similar to other shaver devices. During this mode, resected tissue may be removed from the patient via opening420and along a lumen in the inner sleeve coupled to an aspiration source. Aspiration may be controlled by an aspiration controller220, which may for example control a speed or rotation of a peristaltic pump. Alternatively a vacuum source may be coupled to aspiration tubing and the aspiration controller may move a pinch element or selectively close a valve. Alternatively the aspiration controller may include a movable construct having a first body having one or more apertures, and a second body having one or more apertures, whereby one or more of the first and second bodies is movable relative to the other such that alignment between the first and second body apertures can be varied to change the flow rate. Aspiration may be controlled at a first flow rate during resection, and this first flow rate may be adjustable either by the user or automatically, depending on a variety of parameters such as motor speed settings, sensed electrical parameters associated with the MDU, and temperature associated with the device, as way of non-limiting examples.

In a second mode, an electrosurgical mode, the inner sleeve410may be stationary, and window420may be facing lateral opening330so as to provide an aspiration conduit during electrosurgical treatment such as ablation or coagulation, or a combination of both. During this second mode, active electrode360may be placed adjacent a target tissue and the RF generator activated, so as to electrosurgically treat tissue. Fluid, tissue and/or plasma by-products may concomitantly be removed, along a path including through an opening362in the active electrode362, through spacer opening472, through inner sleeve opening420and along inner sleeve410. Aspiration may be controlled by an aspiration control system such as a peristaltic pump or a device with controls a size of a fluid conduit or aperture in communication with the inner sleeve aspiration lumen. Aspiration control system may be in communication with RF generator. Communication may be wireless. Aspiration may be adjusted by user, or automatically set and adjusted based on operational parameters such as power settings on the RF generator, or based on sensed parameters such as electrode circuit impedance. Further description of this can be found in commonly assigned U.S. Pat. Nos. 8,192,424, 9,333,024 and 9,713,489 the complete disclosure of which is incorporated herein by reference. Aspiration may be adjusted via control of a pump speed associated with the aspiration controller, control of a valve position, or control of an orifice size as described earlier. In addition aspiration may be controlled by adjusting the position of opening420relative to opening330, which may adjust the effective aspiration through the active electrode aperture versus through the aspiration conduit. Alternatively this second mode may be a coagulation mode that includes a lower voltage output configured to coagulate tissue rather than molecularly dissociate tissue.

Alternatively this second mode may include some concomitant coagulation with ablation of tissue. This may be achieved by modulating the output of the RF generator. Further description of this can be found in commonly assigned Patent application No. PCT/US18/032989 the complete disclosure of which is incorporated herein by reference. Alternatively this modulation may be achieved by pulsing aspiration, either through control of the aspiration control system such as the peristaltic pump, or by continued rotation of the inner sleeve while delivering RF. Controlled rotation of the inner sleeve may modulate aspiration through the active electrode aperture362, which in turn may form and collapse plasma on the active electrode surface. Voltage supplied by the RF generator may a constant high frequency voltage level and sufficient to form plasma at the electrode surface while rotating the inner sleeve410. For example, when the inner sleeve410is oriented so as to block the aspiration through the active electrode, a plasma would be formed on active electrodes surface providing ablation of tissue. When the inner sleeve410is oriented so as to draw fluid through the active electrode aperture362, the energy supplied by the RF generator might not be sufficient to form plasma and therefore may provide a coagulation effect to the tissue. The rate at which the modulation of the aspiration rate occurs preferably is fast enough so that the tissue effect is perceived by the user as consistent, but slow enough to allow the plasma to intermittently form. The rotation of the blade could be continuous, or the blade could intermittently alternate between a number of positions that would affect the flow through the active electrode. So as to control or limit concomitant mechanical resection of tissue, the inner sleeve may preferably reciprocate so as that the cutting edge of the inner sleeve is not exposed through the outer sleeve cutting window and does not inadvertently mechanically cut tissue. Synchronized voltage modulation may also be added, between a first voltage sufficient to form a plasma and second that may aid the plasma to collapse with some communication between the inner sleeve orientation required.

During this concomitant mode a slower rotation speed than during mechanical resection may be preferable to control the frequency of plasma formation and collapse. The aspiration rate may be set at a first flowrate for a first configuration of active electrode, aspiration aperture therethrough and voltage supplied, such that when aspiration through the active electrode is at a maximum (when inner sleeve opening425directly faces the active electrode) plasma collapses and reduced aspiration (as the opening425rotates away from facing the active electrode underside) may allow plasma to reform. Alternatively aspiration flow rates may be more moderate for a second configuration of active electrode having aspiration aperture therethrough, and voltage may be supplied such that maximum moderate aspiration (when inner sleeve opening425directly faces the active electrode) aids in forming the plasma and lower aspiration rates (as the opening425rotates away from facing the active electrode underside) allows the plasma to collapse.

In a third combination mode, RF power may be supplied simultaneously while mechanically cutting tissue. The RF power may be supplied at a voltage sufficient to coagulate tissue, so as to improve visibility (reducing blood in the field). This may also reduce the need for the surgeon to stop and separately activate the RF generator when they see blood or need to ablate tissue. Alternatively if a more aggressive cutting is desired, RF power may be supplied sufficient to ablate tissue concomitantly while mechanically resecting tissue. In this third mode, should a more consistent plasma formation be desired, a separate aspiration conduit for the electrodes, distinct from the inner sleeve lumen may be preferable to maintain a more consistent fluid aspiration rate and thereby a more consistent plasma formation. Aspiration may be controlled by two aspiration controllers or at least two pumps associated with a single controller, a first pump controlled based on input from the MDU control, and second in response to input from the RF generator. Aspiration may be adjusted by user, or automatically set and adjusted based on operational parameters such as power settings on the MDU controller and/or RF generator, or based on sensed parameters such as electrode circuit impedance. Further description of this can be found in commonly assigned U.S. Pat. Nos. 8,192,424, 9,333,024 and 9,713,489 the complete disclosure of which is incorporated herein by reference.

Now referring toFIGS. 9A and 9B, showing an embodiment that includes a blade portion114including a disposable handswitch900, with buttons and controls905for use with a combination surgical device. Like components are given like numbering to previous figures. Since the reusable handle112may be alternatively used with non-combination devices that provide powered resection alone, a combination device including a second modality may require a control means that is not available via the reusable handle112. One option, described heretoforth is the use of a footswitch. An alternate option, sometimes preferred by users is the provision for a handswitch option900, that may be attached to the handle of a reusable device (shown inFIG. 9B) such as the combination surgical device for control of (RF) radiofrequency treatment. This may be in the form of RF generator control buttons905electrically coupled to the RF generator (140) via the RF generator cable116. On opening the disposable package including the blade portion114with a handswitch900, the user may couple the blade portion112to the handle112and then place the disposable handswitch900on a desired portion of the reusable handle112. Disposable handswitch900may be removeably fixed to the MDU112using coupling means such as adhesive, or a clip that at least partially surrounds the MDU112for example. Coupling means may be operable to prevent unintentional relative movement between the handswitch900and reusable handle112. Once the procedure is complete, the disposable handswitch900may be removed along with the blade portion114for disposal.

In one example embodiment, the inventor envisions a single strip of buttons905overmolded or placed within a rubber or elastomeric mat. Buttons905are operable to close an electric circuit or a pair of contacts upon activation of said button905to allow electrical energy to be delivered between the electrodes of the blade portion114. A cord910or more preferably an extension of the overmolded rubber mat may physically couple the disposable blade114with the buttons905. Cord910may house wiring for selective electrical communication between the blade114and generator cable116and may also electrically insulates the wires. Handswitch900may be couple to any portion of the blade portion114and the cord910may be long enough or extendable, allowing the handswitch900to attach to the reusable handle112. The handswitch900may attach to the reusable handle112using an adhesive or sticky strip, which may be covered while packaged, covered by an easy to peel adhesive cover915. Removal of this easy peel cover may then expose the adhesive to then attach the handswitch mat900to the handle112.

The blade portion114is shown coupled to the reusable handle inFIG. 9B, the adhesive cover is removed and the handswitch strip attached to a desired location of the reusable handle112. It may be preferable to attach the handswitch900to a side perpendicular to the side of the reusable permanent buttons950and951may be best. The inventor also envisions a ‘Y” shaped strip allowing buttons to be placed on 2 opposing sides of the permanent buttons951, giving the surgeon more options. The disposable handswitch900strip should be shaped to fit easily on an existing surface of the reusable handle112, but does not need to be rectangular as shown. The disposable handswitch900strip is configured to attach to apportion of the device that is easy accessible by the user. The buttons910may include a first button to activate ablation, a second to activate coagulation, and maybe a third to cycle through power settings or different modes, such as a vacuum mode described in more detailed in commonly assigned U.S. Pat. Nos. 8,192,424, 9,333,024 and 9,713,489 the complete disclosure of which is incorporated herein by reference. The adhesive should allow strong attachment to the reusable MDU handle112and also provide for easy release at the end of the procedure. The adhesive is therefore configured to have a degree of water resistance to prevent peeling off during operating procedures.

In alternative embodiments, handswitch900may include a clip for selectively or temporarily fixing the handswitch900to the reusable handle112. Clip may partially encircle the reusable handle112. Clip may have an inner circumferential surface configured to engage an outer surface of the reusable handle112, and may have an internal diameter slightly smaller than an outer diameter of the reusable handle112, so as to better secure the handswitch900. Alternatively or in addition to, inner surface of the clip may have gripping features, such as teeth or high friction surfaces to again improve engagement between the handswitch900and handle112. Handswitch900may include2clips, one at either end of the handswitch900to better stabilize the handswitch900with the reusable handle112.

In further alternative embodiments, handswitch900may include thin sleeve that may slide onto reusable handle, the sleeve having openings for access to the reusable controls950and951. Alternatively, the handswitch900may include a thin wrapping element that is configured to wrap around a portion of the reusable handle and may include openings to expose the reusable controlled950and950. The example wrap may completely wrap around the handle112and couple to itself using friction, Velcro or adhesive for example. The thin wrapping element may be partially stretchable to improve securement with the reusable handle.