Patent Publication Number: US-2023144549-A1

Title: Myringotomy tool with multiple tool heads

Description:
CROSS REFERENCE 
     This patent application is a continuation of U.S. Ser. No. 15/464,460, filed on Mar. 21, 2017, which claims priority to U.S. Provisional Patent Application 62/311,429, filed on Mar. 22, 2016, and U.S. Provisional Patent Application 62/329,223, filed on Apr. 29, 2016, the disclosures of which are incorporated by reference herein in their entireties. 
    
    
     BACKGROUND 
     Field of the Invention 
     The exemplary and non-limiting embodiments described herein relate to medical devices and, more specifically, to medical devices for myringotomy procedures. 
     Brief Description of Prior Developments 
     A myringotomy is a surgical procedure in which an incision is made in a tympanic membrane (eardrum) of a patient. The incision is typically made to relieve pressure caused by excessive fluid collection in the middle ear, generally defined by the tympanic cavity, which is the space between the eardrum and the oval window of the inner ear. In a myringotomy, a tympanostomy tube (ear tube), which is a small conduit through which fluid may pass, is inserted through the incision in the eardrum to aerate the tympanic cavity and/or to drain fluid therefrom. A patient may undergo a myringotomy procedure due to an obstructed Eustachian tube (which extends from the tympanic cavity to the nasal cavity) or one that otherwise inadequately drains or vents the tympanic cavity. Obstructions or inadequately draining or venting tympanic cavities may result from infections caused by a virus or bacteria or from an irritant or allergy in the nasal cavity. 
     A myringotomy procedure generally involves various tools. For example, the incision in the eardrum is generally made by a cutting tool. Also, the ear tube is generally inserted into the incision using a delivery tool. Furthermore, the myringotomy procedure may additionally involve a suction tool, an irrigation tool, a camera or other viewing tool, and/or an illumination tool. 
     SUMMARY 
     In accordance with one aspect of the invention, a myringotomy device comprises a housing; an elongated tube extending from the housing; and a retractable cutting tool extendable through the elongated tube, the cutting tool comprising a blade. The cutting tool is configured such that when advanced, the blade of the cutting tool extends beyond a distal end of the elongated tube. The cutting tool is also configured such that when retracted, the blade is retracted into the elongated tube and a fluid conduit is created from the distal end of the elongated tube to the housing. 
     In accordance with another aspect of the invention, a myringotomy device comprises a housing; an elongated shaft extending from the housing; an ear tube held on the outside of the elongated shaft at a chamber position that is a distance from a distal end of the elongated tube; and a movable tube configured to push or carry the ear tube over the elongated shaft to the distal end of the elongated shaft. 
     In accordance with another aspect of the invention, a myringotomy tool may comprise a housing and an extended shaft having a distal end with at least one tool located at the distal end. The extended shaft has a bend between the proximal end and the distal end of the shaft such that the straight length of shaft distal to the bend can be viewed on axis. 
     In accordance with another aspect of the invention, a myringotomy tool comprises a handpiece; an elongated tube extending from the handpiece; a blade shaft extending down the elongated tube and being extendable beyond a distal end of the elongated tube; and a knob on the handpiece, the knob being cooperably coupled to the blade shaft. The knob is configured to rotate the blade shaft when turned. 
     In accordance with another aspect of the invention, a myringotomy device may comprise a housing; a speculum coupled to the housing; two or more tools located in the housing, each of the two or more tools being coupled to a distal end of a tool carrier in the housing; and a linkage for delivering each of the two or more tools serially through the speculum. 
     In accordance with another aspect of the invention, a method of performing a myringotomy procedure comprises causing a retractable cutting tool to extend through a hollow elongated tube depending from a housing, the cutting tool comprising a blade; making an incision in an ear drum using the retractable cutting tool; retracting the retractable cutting tool; and causing an ear tube to be delivered from the elongated tube to the incision. 
     In accordance with another aspect of the invention, a method of assembling a myringotomy tool comprises providing a housing; extending an elongated shaft from the housing; providing at least a cutting tool and an ear tube delivery tool in the housing; and causing the cutting tool and the ear tube delivery tool to be serially deliverable from a distal end of the elongated shaft. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing aspects and other features of the invention are explained in the following description, taken in connection with the accompanying drawings, wherein: 
         FIG.  1    is a schematic representation of one example embodiment of a device for use in a myringotomy procedure; 
         FIG.  2    is a perspective cutaway view of one example embodiment of a myringotomy device having a cutting tool deployed; 
         FIG.  3    is a perspective cutaway view of the device of  FIG.  2    having a delivery tool deployed; 
         FIG.  4    is a perspective view of the cutting tool of the device of  FIG.  2    deployed; 
         FIGS.  5 A- 5 C  are schematic representations of the device of  FIG.  2    showing switching of the cutting and delivery tools; 
         FIGS.  6 A- 6 E  are schematic representations of various cutting operations using a myringotomy device; 
         FIGS.  7  and  8    are representations of one example embodiment of a delivery tool for use with a myringotomy device; 
         FIG.  9    is a schematic representation of another example embodiment of a delivery tool for use with a myringotomy device; 
         FIG.  10    is a schematic representation of one example embodiment of a combination cutting and delivery tool for use in a myringotomy procedure; 
         FIGS.  11 A,  11 B, and  12    are representations of other example embodiments of a combination cutting and delivery tool for use in a myringotomy procedure; 
         FIG.  13    is a schematic representation of one example embodiment of a viewing tool for use with a myringotomy device; 
         FIG.  14    is another example embodiment of a myringotomy device having spring tool deployment mechanisms; 
         FIG.  15    is another example embodiment of a myringotomy device having a thumbwheel tool deployment mechanism; 
         FIGS.  16 A- 16 C  are schematic representations of the thumbwheel tool deployment mechanism of the device of  FIG.  15   . 
         FIGS.  17 A- 17 F  are representations of another example embodiment of a myringotomy device having a pivot center manifold; 
         FIG.  18    is a schematic representation of an example embodiment of deploying a cutting tool from a myringotomy device; 
         FIGS.  19 A- 19 E  are representations of another example embodiment of a myringotomy device having a carousel-type tool deployment mechanism; 
         FIGS.  20 A- 20 E  are schematic representations of example operations of a myringotomy device; and 
         FIG.  21    is a perspective view of one example embodiment of a myringotomy device having a locking pawl that prevents proximal movement of a blade rod. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG.  1   , one exemplary embodiment of a myringotomy device is designated generally by the reference number  100  and is hereinafter referred to as “device  100 .” Although the features will be described with reference to the example embodiments shown in the drawings, it should be understood that features can be embodied in many alternate forms. In addition, any suitable size, shape, or type of elements or materials may be used. 
     Device  100  may be used in a myringotomy having a plurality of steps. Such steps include, but are not limited to, illuminating, viewing, cutting, delivering an ear tube, and/or suctioning. Each step may utilize or benefit from a specific tool. 
     Device  100  comprises a handpiece or handle or housing  102 , a plurality of tool heads or tools located in the housing  102 , the tools being configured to carry out the steps of a myringotomy, and a distally extending tube  110  having a distal end  112  through which the tools may be delivered and a proximal end  114  through which the tools may be controlled when the tube  110  is inserted by a surgeon into a patient&#39;s ear canal. The tools may be movable within the housing  102  on a carousel or around an axis or the like for delivery through the tube  110 . The tube  110  may be a single tubular member that is flexible and adaptable to a multitude of functions. The use of a single tubular member reduces the profile of the tools at the distal end of the tube  110 . The length of the tube  110  may be such a length so as to allow the housing  102  to be positioned out of the line of sight of the surgeon. A combination of the flexibility and the reduced tool profile further aids in the preservation of a line of sight of the surgeon. 
     Tools that may be incorporated into the device  100  include, but are not limited to, illumination tools  116  (e.g., lights), viewing tools  118  (e.g., scopes), cutting tools  120  (e.g., knives or other bladed tools), delivery tools  130  (e.g., tools that can place and/or selectively release objects), irrigation tools  134 , suction tools  138  (e.g., vacuum systems), and the like. Each tool may have an associated control. For example, the illumination tools  116  may have an illumination control  140 , the viewing tools  118  may have a viewing control  142 , the cutting tools  120  may have a cutting control  144 , the delivery tools  130  may have a delivery control  146 , the irrigation tools  134  may have an irrigation control  150 , and the suction tools  138  may have a suction control  148 . 
     Also included inside the housing  102  may be a cutting tool retraction mechanism, which may be a magnetic mechanism. In other embodiments, the cutting tool retraction mechanism may cause retraction of the cutting tool  120  using suction. Further included inside the housing  102  may be a shuttle mechanism for use with the delivery tool  130 , the cross sectional shape of which may be cylindrical to avoid contact with various surfaces and other mechanisms within the housing  102 . 
     The tube  110  may carry narrower tubes that may be used for irrigation or suction. Water, saline, or other irrigation fluid may be delivered through a first narrower tube extended through the tube  110  as needed. Additionally, a second narrower tube may be extended through the tube  110  as needed, the second narrower tube being used for suction. 
     With regard to cutting tools  120 , a rod or shaft having a tool configured to make an incision may also be selectively carried down the tube  110  as needed. A blade of the cutting tool  120  may be extended (at least initially) beyond the distal end of the tube  110 . Once the incision has been made, the surgeon may trigger the cutting tool retraction mechanism to draw the cutting tool  120  back into the tube  110 . 
     The distal end  112  of the tube  110  (which, after retraction of the cutting tool, is free from any obstruction due to the cutting tool  120 ) may then be used as a lumen for the irrigation tool  134  or the suction tool  138 . In an extended position, a shaft of the blade of the cutting tool  120  may have sealed the distal end  112  of the tube  110  so that it was fluidically obstructed and not able to function as a fluid lumen, but with the cutting tool  120  retracted fluid communication may be established. The blade shaft of the cutting tool  120  may be retracted into the tube  110  to allow for a suction or irrigation conduit to form, or the blade of the cutting tool  120  may be drawn into the tube  110  to cover the tip of the blade for safety reasons. 
     Referring now to  FIGS.  2  and  3   , one example embodiment of a housing of the device  100  is shown generally at  202 . The housing  202  itself may operate as a handle and may include a pinion  204  configured to selectively and serially drive tools out of the distal end of the housing  202  and, for example, through the tube  110  and possibly out a common speculum. Each tool may have a carrier rack  206  coupled to or integrally formed therewith, the carrier rack  206  being configured to be engaged by the pinion  204 . Each tool may be selected in the housing  202  via operation of a tool selection lever  208 , which may be a toggle switch. As shown in  FIG.  2   , upon operation of the tool selection lever  208 , the pinion  204  may be rotated in one direction to extend a first tool (e.g., the cutting tool  120 ) while simultaneously retracting a second tool (e.g., the delivery tool  130 ). As shown in  FIG.  3   , the tool selection lever  208  may then be switched to simultaneously extend the second tool (e.g., the delivery tool  130 ) and retract the first tool (e.g., the cutting tool  120 ). The first and second tools may be held at an angle from each other, although the tools may lie and actuate in a common plane. The device  100  is not limited to using a pinion  204  and carrier rack  206 , however, as any suitable mechanism may be used to serially deliver the tools through the common speculum. Also, the tools may be secured to approximately one half of the inside of the housing  202  (and/or speculum) such that suitable portions of the housing  202  (and/or speculum) are free of the support mechanism, thereby preserving a line of sight as needed. 
     Referring now to  FIGS.  2 - 4   , a cutting operation may be carried out, for example, through a cannula  200  in which the cutting tool  120  may be located and through which suction may be applied. For suction, a suction hose may attach to a sleeve seal  210  on the housing  202 . A cutting tool extension button  212  may be included on the housing  202  to selectively extend (and/or retract) the cutting tool  120  relative to the cannula  200  as needed. 
     When the cutting operation is carried out, the cutting tool  120  is extended from the cannula  200 . When the cutting tool extension button  212  is pressed, a spring may be compressed and a blade of the cutting tool  120  advanced out of a distal end of the cannula  200 . With the blade advanced, a weep hole  215  may be exposed, thus breaking the suction to allow the surgeon to carry out the cutting operation. When the cutting tool extension button  212  is pressed again, the blade may be retracted into the cannula  200  to cover the weep hole  215 , thus allowing the suction to resume. 
     Upon switching the tool selection lever  208  away from the side of the housing  202  in which the cannula  200  and cutting tool  120  are located, the delivery tool  130  may be actuated. In doing so, the pinion  204  may be driven to retract the cannula  200  into the tube  110  and to advance the delivery tool  130  from the tube  110 . Once the delivery tool  130  is advanced, as shown in  FIG.  3   , pushing a delivery tool button  220  may cause, for example, a mandrel to retract into the proximal direction, thereby stripping off an ear tube and leaving the ear tube in an incision in the patient&#39;s ear. The delivery tool button  220 , however, may be configured to work only when the delivery tool  130  is in a suitable operating position. The device  100  is not so limited, however, as instead of a delivery tool  130 , the housing  202  could be adapted to utilize other tools, such as, for example, an alligator forceps mechanism. 
     When the tool selection lever  208  switched, as shown in  FIG.  3   , the delivery tool  130  is retracted into the tube  110  as shown by arrow  222 . 
     Referring now to  FIGS.  5 A- 5 C , the switching of the cannula  200  and cutting tool  120  with the delivery tool  130  is shown. Both the cannula  200 /cutting tool  120  combination and the delivery tool  130  may be mounted on different axes  230 ,  232 , but they may be arranged to share the same mechanism that shuttles each tool down the tube  110 . As shown in  FIG.  5 A , both the cannula  200 /cutting tool  120  combination may be neutrally located in the housing  202 . As shown in  FIG.  5 B , rotation of the pinion  204  in a first direction  236  may cause the cannula  200 /cutting tool  120  to be deployed while the delivery tool  130  is moved in a proximal direction. As shown in  FIG.  5 C , rotation of the pinion  204  in a second direction  238  may cause the deployment of the delivery tool  130  and corresponding movement of the cannula  200 /cutting tool  120  in the proximal direction. 
     Referring now to  FIGS.  6 A- 6 E , various cutting tools are shown. In  FIG.  6 A , the cutting tool  120  in a first position  300  is moved laterally to a second position  305  such that the cutting tool  120  makes a cut in a surface of the eardrum  400 . In  FIG.  6 B , the cutting tool  120  may be used to make a scissor cut by inserting the cutting tool into the eardrum  400  and cutting from a first position  300  toward a second position  305 , then reinserting the cutting tool  120  into the eardrum  400  and cutting from the second position  305  toward the first position  300 . In  FIG.  6 C , the cutting tool  120  may be moved from a center position  310  to the first position  300 , then back to the center position  310  and subsequently to the second position  305 , thereby making an inverted scissor cut. In  FIG.  6 D , the cutting tool  120  may be used to puncture the eardrum  400  and spread the tissue thereof in outward directions. 
     In  FIG.  6 E , another embodiment of the cutting tool is shown at  620 . The cutting tool  620  comprises a rod member  622  having an offset jag  624  having a sharpened edge  626 . The offset jag  624  is used to puncture the eardrum  400 , and the rod member  622  is rotated to cause the sharpened edge  626  to cut a hole in the eardrum  400 . 
     Referring to  FIG.  7   , a delivery tool  130  that may be incorporated into the device  100  or used separately and in conjunction with other tools is shown. Once an incision is made in the eardrum  400 , the delivery tool  130  is used to deliver the ear tube, which is shown at  700 , to the incision and place the ear tube  700  such that one end of the ear tube  700  is in the outer ear and the other end of the ear tube  700  is in the middle ear, thus venting the tympanic cavity to the outer ear. The delivery tool  130  may comprises a trigger  710  mounted in the housing  202  (the housing  202  is not limited to the depicted design, as any configuration of the housing  202  may be used), with a flexible delivery tube  720  extending from the housing  202  and a sheath  725  slidably located over the delivery tube  720 . The sheath  725  is operably coupled to the trigger  710  such that movement of the trigger  710  toward the distal end causes the sheath  725  to slide over the delivery tube  720 . The ear tube  700  may be placed forward of the sheath  725 . To effect a delivery of the ear tube  700  to an incision, the surgeon directs a distal end of the delivery tube  720  to the incision and moves the trigger  710  in a forward direction, thus causing the sheath  725  to slide the ear tube  700  over the delivery tube  720  and into the incision. The delivery tube  720  may then be retracted from the incision, and the ear tube  700  caused to be captured in the incision. 
     In using the delivery tool  130  in such a manner, the ear tube  700  may be introduced into the proximity of the incision on the delivery tube  720  configured as a central shaft (tube or rod) so that the surgeon than may insert the ear tube  700  into the incision and then by withdrawing the central shaft (the delivery tube  720  or other ear tube carrier shaft) the ear tube  700  is left behind in the incision. The sheath  725  may perform as a carrier for the ear tube  700 . In this use, the delivery tube  720  may be a solid rod. For example if the delivery tube  720  is not used as a fluid lumen, then the delivery tube  720  may be a solid rod, and the distal end may also be sharp such that it functions as both a scalpel and an ear tube carrier. To improve the line of sight for the surgeon, the ear tube  700  may be carried, or chambered, a distance (possibly a considerable distance) proximal of the end of the delivery tube  720 , which may be a hollow tube or a solid rod. This distance that the ear tube  700  is chambered from the distal end of the carrier tube may be given by the geometry of the ear tube  700 . The distance may be 35-40 mm. The ear tube  700  may be chambered on the delivery tube  720  a distance from the distal end with the sheath  725  held proximal to the ear tube  700 . The surgeon may deploy the ear tube  700  into the surgical site by moving the sheath  725  distally to force the ear tube  700  to the distal end of the delivery tube  720  and then off the distal end of the delivery tube  720 . The movement of the ear tube  700  may be done in a single smooth movement, or in two discrete movements; the first to place the ear tube  700  at the very end of the delivery tube  720  and the second to push it off the end of the delivery tube  720 . In one exemplary embodiment, the ear tube  700  may be chambered directly upon the sheath  725  that surrounds the delivery tube  720 . The sheath  725  then carries the ear tube  700  thereon as the sheath  725  moves, rather than pushing the ear tube  700  along a stationary delivery tube  720 . 
     Referring to  FIG.  8   , in one example embodiment of the delivery tool  130 , the delivery tube  720  may include a suction line  800 . Furthermore, the trigger  710  may employ a spring  810  configured to indicate to the surgeon (e.g., by indicating a specified amount of force back to the surgeon) that the ear tube  700  is close to the end of the delivery tube  720 . For example, when the ear tube  700  is more proximally located along the delivery tube  720 , as indicated by distance  830 , the spring  810  provides a softer feedback of force to the surgeon, whereas when the ear tube  700  is more distally located along the delivery tube  720 , as indicated by distance  835 , the spring  810  provides a harder feedback. 
     Referring to  FIG.  9   , another example embodiment of a delivery tool is shown at  930 . Delivery tool  930  comprises a delivery tube  920  pivotally connected to a handle  940 , with any suitable mechanism  925  configured to be actuated (such as by a trigger  710 ) to shuttle the ear tube  700  down the delivery tube  920  to the incision. 
     Referring to  FIG.  10   , one example embodiment of a combination of a cutting tool  120  and a delivery tool  130  is shown at  1000  and is hereinafter referred to as “combination tool  1000 .” In the combination tool  1000 , the cutting tool  120  comprises a sharpened cannula or knife  1010 , which is used to make an opening in a surface of the eardrum  400 . The knife  1010  may be extendable from an elongated shaft in the form of a carrier tube  1020  depending from a handle  1030 . An ear tube  700  may be slidable down the carrier tube  1020  to the surface of the eardrum  400 . 
     The carrier tube  1020  may be axially fixed to the handle  1030 . The knife  1010  is located inside the carrier tube  1020  and may be deployed to a distal position such that the blade of the knife  1010  at the distal end extends out the distal end of the carrier tube  1020 . An ear tube  700  may be mounted on the outside of the carrier tube  1020  and in a position away from the distal end of the carrier tube  1020 . There may be a pusher tube or sheath  1025  proximal of the ear tube  700  and which may be in direct contact with the proximal most edge of the ear tube  700 , or there may be a gap between the sheath  1025  and the ear tube  700 . 
     In one exemplary operation of the combination tool  1000 , the surgeon may initially create an incision in a surface of the ear drum  400  using the knife  1010 . After the incision is created, the surgeon may activate a trigger, button, or similar control on the handle  1030 , and the knife  1010  may be retracted to remove the blade from the patient and to possibly also open up a fluid conduit. The surgeon may activate a trigger, button, or similar control to advance the pusher tube or sheath  1025  to drive the ear tube  700  to the distal end of the carrier tube  1020 . With the ear tube  700  at this position the surgeon may then insert the ear tube  700  into the incision. The combination tool  1000  may include two discrete controls to activate the blade retraction and to advance the sheath  1025  to insert the ear tube  700 . In the alternative, the combination tool  100  may include one control that actuations both the blade retraction and the sheath advancing mechanisms. 
     Referring now to  FIGS.  11 A,  11 B, and  12   , other example embodiments of combinations of a cutting tool  120  and a delivery tool  130  are shown at  1100  and are hereinafter referred to as “combination tool  1100 .” As shown in  FIG.  11 A , in the combination tool  1100 , the cutting tool  120  comprises a knife  1110  extendable from a carrier tube  1120  depending from a handle  1130 . Upon extending the knife  1110  from the carrier tube  1120 , an incision can be made in an eardrum. The knife  1110  may be retractable into the carrier tube  1120  using any suitable mechanism (e.g., magnetics or suction). A button  1150  or other actuator on the handle  1130  may be operated to cause the knife  1110  to retract. 
     As shown in  FIG.  11 B , the distal end  112  of the carrier tube  1120  may be flattened from a round profile to a more elongated profile so that a blade of the cutting tool  120 , which may be wider than a diameter of the main part of the tube  110  when the carrier tube  1120  has a circular cross section, can be retracted into the distal end  112  of the carrier tube  1120 . The carrier tube  1120 , when flattened on the distal end  112 , may also allow for a smaller tube to be used, without decreasing the size of the blade of the cutting tool  120 , so that the line of sight to the end of the carrier tube  1120  is improved. 
     As shown in  FIG.  12   , upon retraction of the knife  1110  into the carrier tube  1120  having either the flattened or rounded cross section, an ear tube  700  may be deployed by being shuttled down the outside surface of the carrier tube  1120  (e.g., via a sheath, pusher tube, or the like) and to a distal end of the carrier tube  1120 . Depressing the button  1150  may not only unlock the knife  1110 , as in some embodiments it may also allow the ear tube  700  to be rapidly shuttled to the distal end of the carrier tube  1120 . More specifically, the button  1150  may act as a locking pawl for the knife  1110 , and pushing the button  1150  may move the locking pawl and allow a magnetic propulsion to slide the sheath or pusher tube and the ear tube  700  farther down the carrier tube  1120  to put the ear tube  700  in close proximity to the incision (with the locking pawl out of the way, the knife  1120  can be retracted by suction and deposited into a holding area within the device). The surgeon may then control a final placement of the ear tube  700  into the incision, for example, by pushing a slide  1140  forward to push the ear tube  700  into the incision. 
     Referring now to  FIG.  13   , in any embodiment, a device  100  may have an integrated imaging system that includes the viewing tool  118 . A suitable imaging system may include, for example, a camera  1310 , a processor  1320  having software, and a display  1340 , the camera  1310 , the processor  1320 , and the display  1340  being operably coupled together and mounted in a speculum  1350  having a handle  1360  attached thereto. The camera  1310  may comprise any suitable charge-coupled device (CCD) color video camera head. Any suitable cutting tool  120  (and/or delivery tool and/or combination of cutting tools  120  and delivery tools  130 ) may also be mounted in the speculum  1350 . The illumination tool  116  may also be included in the speculum  1350 , for example, in the form of one or more light emitting diodes (LEDs). 
     Referring now to  FIG.  14   , another exemplary embodiment of a device is shown generally at  1400 . The device  1400  comprises a body portion  1410  having a speculum  1420  depending from a distal end thereof and, for example, a cutting tool  120  and a delivery tool  130  mounted in the body portion  1410 . The cutting tool  120  and/or the delivery tool  130  may be operable using springs  1440 . The body portion  1410  may include an opening  1460  extending therethrough in order to preserve a line of sight. 
     Referring now to  FIGS.  15  and  16 A- 16 C , another exemplary embodiment of a device is shown generally at  1500 . As shown in  FIG.  15   , the device  1500  may be a one-handed device (controllable by a surgeon using only one hand) and comprises a body portion  1510  in which two tool heads carrying distinct myringotomy tools (e.g., at least a cutting tool  120  and a delivery tool  130 ) may be mounted, a handle  1515  depending from the body portion  1510 , and a speculum  1520  depending from a distal end of the body portion  1510 . The cutting tool  120  and the delivery tool  130  may be coupled to and operable via a camming shuttle or thumbwheel  1550 , which may be rotatable by the surgeon. In particular, the cutting tool  120  and the delivery tool  130  may be pivotally coupled to the same rotating shuttle at outward portions of the thumbwheel  1550  such that upon rotation of the thumbwheel  1550  by the surgeon, one of the cutting tool  120  and the delivery tool  130  may be driven along a cam path and advanced through the speculum  1520  and into the patient&#39;s ear while the other of the cutting tool  120  and the delivery tool  130  may be retracted and stowed in the body portion  1510 . In the alternative, the end of each of the cutting tool  120  and the delivery tool  130  may connect to an individual shuttle. Distal to the caroming shuttle or thumbwheel  1550  there may be camming slots  1551  located forward of the cutting tool  120  and the delivery tool  130  into which locating pins  1552  on the respective cutting tool  120  and delivery tool  130  may travel. In this way, the rotation of the thumbwheel  1550  may both advance the tool and change its line of action. In particular, the line of action of one or both of the tools may be changed such that the tool is advanced along the axis of the speculum. 
     In device  1550 , suction or magnetics may be incorporated to allow for retraction of the cutting tool  120 . A push-type actuator  1560  may be used to deploy an ear tube from the delivery tool  130 . Flexible cables may be incorporated into the device  1500  and coupled to actuators located on the handle  1515  to provide control for various other tools (illumination, suction, and the like). A portion of the body portion  1510  and the speculum  1520  may be cutaway to allow a clear line of sight to be maintained by the surgeon. 
     As shown in  FIG.  16 A , the cutting tool  120  and the delivery tool  130  may be stored in a “home” position in the body portion  1510 . As shown in  FIG.  16 B , upon rotation of the thumbwheel  1550 , the cutting tool  120  (or the suction or some other tool) may be advanced along the cam path into the speculum  1520 . As shown in  FIG.  16 C , upon rotation of the thumbwheel  1550  in an opposite direction, the delivery tool  130  may be advanced along the cam path into the speculum  1520  while the cutting tool  120  is retracted. 
     Referring now to  FIGS.  17 A- 17 F , another exemplary embodiment of a device is shown generally at  1700 . In device  1700 , there may be multiple tool heads carried at the ends of flexible introducers, with each introducer having a thumb slider (sliding actuator) on a handle. The surgeon may advance any of the tools by sliding the sliding actuators in a forward direction. 
     As shown in  FIG.  17 A , the device  1700  is a manually operated knife comprising a manifold  1710  to which a handle  1720  may be pivotally mounted. A speculum  1730  may depend from a distal end of the manifold  1710 . The manifold  1710  may have a pivot center  1740  for controlling a depth and a length of an incision. The pivot center  1740 , in conjunction with the diameter of the speculum  1730 , may control an arc length for the incision. More specifically, pivoting the knife from one side of the speculum  1730  to the other may produce a cut of a known length (e.g., about 1.7 millimeters (mm)), assuming a speculum  1730  having a 4 mm diameter. There may also be a slot on a side surface of the shaft, the knife being movable in the slot to control a depth of the incision. 
     As shown in  FIG.  17 B , a rigid suction lumen or suction cannula  1750  may extend through the handle  1720  to the manifold  1710  and into the speculum  1730  and may be controllable (e.g., advanced and retracted from the speculum  1730 ) via operable connection to a first sliding actuator  1755 . The suction cannula  1750  may be coupled to a flexible tube that connects the suction cannula  1750  to a suction source. A sealing sleeve  1751  (which may be rubber) having a weep hole  1755  on an underside thereof is mounted on the suction cannula  1750  such that when the suction cannula  1750  is advanced, the suction cannula  1750  is pivoted down to the deploy position and the sealing sleeve  1751  engages a surface within the handle  1720  to block the weep hole  1775 , thereby invoking the suction. In the alternative, the suction cannula  1750  may be connected to a suction port such that when the lumen or cannula is advanced, the suction cannula  1750  connects to a fitting that is connected to the suction source, and when the suction cannula  1750  is retracted the connection with the suction source is broken (the suction is thereby not connected between the suction source and the distal tip of the suction cannula  1750 ). This may have the advantage of having the suction cannula  1750  not performing suction when the cannula  1750  is retracted. Additionally, this design may reduce the auditory shock to the patient. That is, in this design the suction source may stay connected at all times and produce a “white noise” suction sound whether the suction at the distal tip is operational or not. In this way, the patient might not be startled by a sudden sound when the suction would, otherwise, be turned on or off. 
     Ear tube insertion forceps  1760  may also extend from the handle  1720 , through the manifold  1710  and into the speculum  1730  and may be controllable via operable connection of a flexible introducer or bar linkage to a second sliding actuator  1765 . Operation of the second sliding actuator  1765  allows the forceps to move between operating and stowed positions in the handle  1720 . 
     In operation of the first sliding actuator  1755  to control the suction cannula  1750 , upon rotation to an operating position in embodiments employing the weep hole  1775 , the weep hole  1775  may be plugged to allow the suction to engage. Operation of the second sliding actuator  1765  accordingly moves another flexible introducer and deploys the forceps  1760  into the operating position. A trigger  1770  on the handle may be used to open the jaws of the forceps  1760 , thereby releasing an ear tube  700  into an incision. 
     As shown in  FIG.  17 C , the suction cannula  1750  can be rotated into an operating position. Manipulating the first sliding actuator  1755  may advance the suction cannula  1750 . When the suction cannula  1750  is in the operating position, the sealing sleeve  1751  compresses on an inner surface of the housing and the weep hole  1775  is plugged to allow the suction to engage. 
     As shown in  FIG.  17 D , the forceps  1760  can be rotated into the operating position. Manipulating the second sliding actuator  1765  may advance the forceps  1760 . Sliding the trigger  1770  on the handle  1720  accordingly opens the jaws of the forceps  1760  and releases the ear tube  700  into the incision. 
     As shown in  FIG.  17 E , a cutting tool  120  in the form of the manually operated knife is shown in the stowed position. The cutting tool  120  is shown in the operating position and prepared for making an incision. As shown in  FIG.  17 F , the cutting tool  120  includes a slot which engages a pin  1780  on the speculum  1730 . When deployed, the knife of the cutting tool  120  pivots around the pin  1780 . 
     Referring now to  FIG.  18   , one exemplary embodiment of the mounting of a cutting tool  120  is shown generally at  1800 . The cutting tool  120  may be mounted to two co-rotating wheels  1810 ,  1820  configured to, upon rotation, provide a prescribed motion to the tip of the cutting tool  120 . For example, the two wheels  1810 ,  1820  may impart a 5 degree sweep of the cutting tool  120  to provide a single-direction straight line incision while controlling the depth and width while not interfering with the positions and/or operations of other tools. As shown, the cutting tool  120  may be coupled to the each wheel  1810 ,  1820  such that at Position  1 , the cutting tool  120  is in a retracted position. When the cutting tool  120  is positioned to make an incision, a proximal end of the cutting tool  120  is in Position  2 , and a distal end (the tip) of the cutting tool is at the surface to be cut. Upon rotating the wheels  1810 ,  1820  to Position  3 , the cutting tool  120  is plunged past the surface to be cut to its maximum depth. Upon rotating the wheels  1810 ,  1820  to Position  4 , the tip of the cutting tool  120  is retracted to the surface. Upon rotating the wheels  1810 ,  1820  back to Position  1 , the cutting tool  120  is retracted. The length of an incision is determined by a trajectory of the tip of the cutting tool  120 , which is in turn determined by the dimensions of the wheels  1810 ,  1820 . This mechanism may produce incisions of highly repeatable length and depth. 
     Referring now to  FIGS.  19 A- 19 E , another exemplary embodiment of a device is shown generally at  1900 . As shown in  FIG.  19 A , device  1900  comprises a body portion having a handle  1910  depending therefrom and a speculum  1920  located at a distal end of the body portion  1930 . In the body portion  1930 , a plurality of tools may be rotatably located in a barrel or carousel  1935 . 
     As shown in  FIG.  19 B , the carousel  1935  may include four tools (e.g., a delivery tool  130 , a suction tool  138 , a cutting tool  120 , and a rosen pick  1940 ) that rotate around a common axis  1950  to deliver a desired tool to a deployment position. One quadrant may be configured to activate a selected tool and to shuttle it into a position for use. In any configuration, a line of action of a tool in the deployment position may be coaxial with the speculum, or the center axis of the carousel may be coaxial with the speculum. 
     As shown in  FIG.  19 C , a graphic showing an activation of the tools of device  1900  is shown. The device  1900  is used to sight an eardrum  400  (Step  1 ). In Step  2 , an actuator button  1960  is pressed to deploy a corresponding tool. In Step  3 , the actuator button  1910  is pressed to retract the deployed tool. In Step  4 , a trigger  1970  may be pulled to rotate the carousel to bring a second tool into position for use. In Step  5 , the suction tool may be activated. In Step  6 , an ear tube  700  may be released from the device  1900  and placed into the eardrum. 
     As shown in  FIG.  19 D , the same Steps as indicated above may be carried out using devices  1980 ,  1985  having controls as shown. 
     As shown in  FIG.  19 E , another exemplary embodiment of a device  1990  employing a carousel-type tool rotation mechanism is shown. Such a device  1990  uses a tool spin and activation knob  1992  that allows the surgeon to rotate to a specific tool and to then push it down for deployment from a body portion  1994  and through an outlet port  1998  in a speculum  1995  while keeping the device out of the line of sight. The four quadrants of the carousel  1935  allow for a cutting tool  120 , a suction tool  138 , and delivery tools  130  that may deliver two styles of eardrum tubes  700 , depending upon the preference of the surgeon. 
     Referring now to  FIGS.  20 A- 20 E , one exemplary embodiment of the operation of a device is shown generally at  2000 . In operating the device  2000 , as shown in  FIG.  20 A , the eardrum  400  is sighted (Step  1 ) for example on a display  2010 , and the suction tool and/or cutting tool  120  is moved into position (Step  2 ). The cutting tool  120  is then activated to make the incision (Step  3 ). In Step  4 , the cutting tool  120  is retracted and the suction is activated. In Step  5 , the suction and cutting tool  120  are removed, and the delivery tool  130  is maneuvered into position. In Step  6 , the ear tube  700  is released from the delivery tool  130  and inserted into the incision. 
     As shown in  FIG.  20 B , the device  2000  may be connected to house suction and Steps  3  and  4  (incision, retraction, and suction) carried out by operating a first button on a rearward facing surface of the device  2000 . Step  6  (release of the ear tube  700 ) may be carried out by operating a second button on the rearward facing surface of the device. As shown in  FIG.  20 C , the display  2010  may be flipped up and swivelled, and the movement of the cutting tool  120  and suction (Steps  2  and  5 ) may be controlled by a slider. As shown in  FIG.  20 D , upon insertion of the device  2000  into a patient&#39;s ear, a surgeon may view the inside of the patient&#39;s ear on the display  2010 . As shown in  FIG.  20 E , instead of the first and second buttons on the rearward facing surface of the device  2000  being used to carry out Steps  3 ,  4 , and  6 , buttons for controlling such functions may be located on a grip, handle, or forward facing surface of the device  2000 . 
     In any of the foregoing embodiments of cutting tools  120  and delivery tools  130 , the blade of the cutting tool  120  may be locked in a distal position against a proximally biased force generated by a potential energy field. The surgeon may control a selectively releasable stop mechanism to retract the blade into a tube. The potential energy that proximally biases the blade rod may be a compressed spring, or a magnetic field. In embodiments using a magnetic field, the magnetic field may be repulsive field that pushes the rod proximally or an attracting field that pulls the rod proximally. There may be a finger button with a pawl-type stop that prevents the proximal movement of the blade rod. When the user presses a button, the pawl is moved and the blade rod is free to move under the influence of the potential energy source. For example, as shown in  FIG.  21   , a locking pawl is shown at  2100 . by pushing the selectively releasable stop mechanism (shown as the slider button  2110 ), a cap  2120  moves forward, along with an associated blade rod  2130  that may be coupled to the knife (not shown). In doing so, a weep hole  2150  may be opened to bleed air, thus breaking suction and allowing the compressed spring  2115  to move the locking pawl  2100  and allow for the free movement (e.g., retraction) of the blade rod  2130 . 
     The mechanism that advances the ear tube  700  (the pusher tube or sheath), whether by advancing the ear tube  700  with the sheath or advancing a carrier tube carrying the ear tube  700 , may be a slider driven by the surgeon&#39;s thumb or finger. There may be a feature to provide tactile feedback as the ear tube  700  reaches its distal position. The feedback may be provided by a noiseless mechanism such as a compression spring, a compliant pad, or a repulsive magnet. 
     Also in any of the foregoing embodiments, to preserve line of sight the elongated shaft (and/or any portion of the device  100 ) may be curved or bent so that the surgeon can sight down the distal end of the device  100  without having to look past the handle. In such an embodiment, the shaft of the cutting tool  120  and/or the delivery tube  130  may be flexible in order to navigate along the curved portion of any carrier tube used to deploy the cutting tool  120  and/or the delivery tube  130 . 
     Also in any of the foregoing embodiments, shuttling the ear tube  700  down the length of the tube to the distal end may be by the use of any suitable form of potential energy. For example, the mechanism that advances the ear tube  700  may employ springs or magnets, and a catch that prevents the distal movement of the ear tube  700  until the mechanism is tripped by a finger trigger or button. Likewise, the sheath or other device used to deploy the ear tube  700  may be biased distally by a potential energy field, but prevented from moving by a pawl-type latch. Pressing a button may release the pawl and allow the sheath to move (distally) under the influence of the potential energy field. The potential energy may be provided by a spring or a magnetic field. The magnetic field may be either repulsive or attractive. 
     Additionally, the devices disclosed herein may have both a blade retraction motion and a sheath advancing motion that occurs from a single user action. In one embodiment, a device may have the blade of the cutting tool  120  biased for proximal movement and the sheath biased for distal movement, but both blocked from movement by individual pawls. The surgeon may press a button which releases one of the pawls, possibly the cutting tool retraction pawl, and then continued movement of the button releases the sheath pawl. Alternatively, the button may release the sheath pawl first. In another embodiment, the first pawl is released by movement of the actuation button allowing the movement of the first element (one of the cutting tool  120  and the sheath). As the first element moves, it trips the second pawl to allow for movement of the second element (the other of the sheath and the cutting tool  120 ). In one embodiment, the cutting tool  120  may be biased by potential energy created by the suction line. 
     However, there may be mechanisms and features for breaking or stopping the moving cutting tool  120  once it has started retracting. One type of breaking mechanism may be for the end of the blade on the cutting tool  120  to be attracted to a magnet and then to come into contact with the magnet and stick to it. The mechanical shock of the collision can be reduced with a pad of foam or other compliant material. One type of breaking mechanism may be for the cutting tool  120  to be directed towards a magnetic field that repels it. The kinetic energy of the cutting tool  120  may drive against a repulsive magnetic field such that the speed at which the cutting tool  120  is retracting is reduced or stopped. In another breaking mechanism, the cutting tool  120  may travel through a ring. The end of the cutting tool  120  may have one magnet, and the ring may have one or more magnets. The fields are configured such that the end of the cutting tool  120  is attracted to the center of the ring and once there it is held in that position. This type of mechanism may act as both the accelerating and the breaking system. 
     If the cutting tool  120  is being drawn proximally up a suction line, it may be beneficial to stop the cutting tool  120  within the handle and before it enters the suction line, without interfering with continuous application of suction. One mechanism for stopping or breaking a moving cutting tool  120  is to drive the cutting tool  120  into a widened section of the tube within which it is traveling. Once inside the wider section, the cutting tool  120  is directed to one side of the tube, possibly by gravity or magnets, so that the cutting tool  120  does not pass into the downstream suction conduit. A device may have magnets on the side of a chamber to hold the blade of the cutting tool  120  so that it does not rattle once it is in the chamber. Alternately, the downstream suction conduit may be on a lateral side of the chamber, rather than at the axial end of the chamber, or the chamber may be curved so that a straight section of the blade of the cutting tool  120  is not able to navigate to enter into the suction line. 
     Furthermore, devices described herein may have a handle and an elongated blade of a cutting tool  120  with a linear blade at the distal end. The handle may have a rotating knob that rotates the proximal end of the blade shaft to reorient the blade relative to the handle. In this way the orientation of the incision can be changed without the surgeon having to twist or rotate the handle. The knob may have a tab that rides in a slot in the proximal end of the blade shaft of the cutting tool. 
     In one example, a myringotomy device comprises a housing; an elongated tube extending from the housing; and a retractable cutting tool extendable through the elongated tube, the cutting tool comprising a blade. The cutting tool is configured such that when advanced, the blade of the cutting tool extends beyond a distal end of the elongated tube. The cutting tool is also configured such that when retracted, the blade is retracted into the elongated tube and a fluid conduit is created from the distal end of the elongated tube to the housing. 
     The myringotomy device may further comprise a pinion in the housing and a carrier rack on the retractable cutting tool, the pinion and the carrier rack being configured to cooperably cause the extension and retraction of the cutting tool. The myringotomy device may further comprise a suction hose attached to the housing, the suction hose being configured to provide suction when the fluid conduit is created. The myringotomy device may further comprise a cutting tool extension button on the housing, the cutting tool extension button being configured to selectively extend or retract the cutting tool relative to the elongated tube. When the cutting tool is retracted, a weep hole in the elongated tube may be configured to be covered to cause the fluid conduit to be created. The myringotomy device may further comprise an ear tube delivery tool extendable through the elongated tube. The elongated tube may be flexible to allow the housing to be positioned out of a line of sight of a user. 
     In another example, a myringotomy device comprises a housing; an elongated shaft extending from the housing; an ear tube held on the outside of the elongated shaft at a chamber position that is a distance from a distal end of the elongated tube; and a movable tube configured to push or carry the ear tube over the elongated shaft to the distal end of the elongated shaft. 
     The movable tube configured to push or carry the ear tube may be actuatable via a trigger on the housing. The myringotomy device may further comprise a spring coupled to the trigger, the spring being configured to indicate an amount of force back to a user as feedback to determine a distance from the ear tube to the distal end of the elongated tube. The elongated shaft may comprise a hollow tube operable as a fluid conduit. The elongated shaft may comprise a solid rod. 
     In another example, a myringotomy tool may comprise a housing and an extended shaft having a distal end with at least one tool located at the distal end. The extended shaft has a bend between the proximal end and the distal end of the shaft such that the straight length of shaft distal to the bend can be viewed on axis. 
     The at least one tool may comprise one or more of a cutting tool, an ear tube delivery tool, a suction tool, an irrigation tool, and a viewing tool. The extended shaft may be hollow and the at least one tool may be retractable into the extended shaft. The extended shaft may be solid and an ear tube delivery tool may be extendable over the solid extended shaft. 
     In another example, a myringotomy tool comprises a handpiece; an elongated tube extending from the handpiece; a blade shaft extending down the elongated tube and being extendable beyond a distal end of the elongated tube; and a knob on the handpiece, the knob being cooperably coupled to the blade shaft. The knob is configured to rotate the blade shaft when turned. The blade shaft may be retractable into the elongated tube. 
     In another example, a myringotomy device may comprise a housing; a speculum coupled to the housing; two or more tools located in the housing, each of the two or more tools being coupled to a distal end of a tool carrier in the housing; and a linkage for delivering each of the two or more tools serially through the speculum. 
     The two or more tools may comprise at least a cutting tool and an ear tube delivery tool. The two or more tools may further comprise at least one of a suction tool and an imaging tool. The linkage may be coupled to a sliding actuator. 
     In another example, a method of performing a myringotomy procedure comprises causing a retractable cutting tool to extend through a hollow elongated tube depending from a housing, the cutting tool comprising a blade; making an incision in an ear drum using the retractable cutting tool; retracting the retractable cutting tool; and causing an ear tube to be delivered from the elongated tube to the incision. 
     The method may further comprise causing suction to be formed in the elongated tube and suctioning the ear drum before delivery of the ear tube. Causing an ear tube to be delivered from the elongated tube to the incision may comprise one of pushing the ear tube from a distal end of the elongated tube and into the incision and carrying the ear tube over the elongated tube to the incision and pushing the ear tube into the incision. 
     In another example, a method of assembling a myringotomy tool comprises providing a housing; extending an elongated shaft from the housing; providing at least a cutting tool and an ear tube delivery tool in the housing; and causing the cutting tool and the ear tube delivery tool to be serially deliverable from a distal end of the elongated shaft. 
     Causing the cutting tool and the ear tube delivery tool to be serially deliverable may comprise causing the cutting tool and the ear tube delivery tool to be movable using a pinion and a carrier rack. Causing the cutting tool and the ear tube delivery tool to be serially deliverable may comprise causing the cutting tool and the ear tube delivery tool to be movable using slider mechanisms. 
     It should be understood that the foregoing description is only illustrative. Various alternatives and modifications can be devised by those skilled in the art. For example, features recited in the various dependent claims could be combined with each other in any suitable combination(s). In addition, features from different embodiments described above could be selectively combined into a new embodiment. Accordingly, the description is intended to embrace all such alternatives, modifications, and variances which fall within the scope of the appended claims.