The present invention relates to manual and robotic surgical cautery and cutting tools, and methods for minimally invasive surgery using same.
Minimally invasive surgery is any technique involved in surgery that does not need a large incision. Robotic surgery may be associated with each of open surgery and minimally invasive surgery. Robotic surgery, also called robot-assisted surgery, allows medical practitioners to perform complex procedures with more precision, flexibility and control than is possible using conventional surgical techniques. An “open” surgery means the cutting of skin and tissues so that the surgeon has a full view of the structures or organs involved.
Various types of minimally invasive procedures include laparoscopic, endoscopic, arthroscopic, bronchoscopic, thoracoscopic, cystoscopic, gastroscopic, hysteroscopic, laryngoscopic, sigmoidoscopic, and colonoscopic procedures.
Laparoscopic surgery is conducted via the peritoneal cavity by percutaneous insertion of appropriate instruments through the abdominal wall. By manipulation of the instruments while viewing the surgical site through a laparoscope, surgery may be performed on the gallbladder, the kidneys, liver and large bowel, for instance.
Endoscopic surgery in general, and laparoscopic surgery in particular are recognized to have considerable advantages over open surgery because of the avoidance of large incisions and the discomfort, long and expensive hospital stay, and extended period of incapacity required by such incisions. Endoscopic procedures instead employ a few small penetrations of the body, which lessen the patient's discomfort, and reduce the time and expense of the hospital stay and the patient's period of incapacity.
Open and minimally invasive procedures often involve cutting and connecting bodily tissue including organic materials, musculature, connective tissue and vascular conduits. Bodily tissue typically is cut during a surgical procedure. As bodily tissue is highly vascularized there tends to be bleeding. Surgeons have long sought surgical instruments and methods that slow or reduce bleeding during surgical procedures.
Medical practitioners use electrocauterization to control bleeding from small blood vessels, remove diseased tissue, destroy abnormal tissue, prevent uncontrolled bleeding, and remove small skin growths and areas of damaged skin. Electrocautery is one form of electrosurgery. Electrocautery and electrocauterization as used herein are distinguished from AC-type (alternating current type) electrosurgery. AC-type electrosurgery is the surgical application of high-frequency electricity to cause the thermal tissue effects of vaporization, desiccation, coagulation and fulguration. It is not synonymous with electrocautery as used herein. AC-type electrosurgery includes monopolar electrocaurery (having a passive return electrode at the patient), and bipolar electrocautery (having a return path at the device tip.)
Electrocautery is a form of direct transference of heat to the tissue. Instead of passing electrical current through the tissue, low-voltage, high-amperage, direct or alternating current is used to heat a resistive element, which is applied to the tissue. The resulting effect depends on the tissue. Direct application to tumor leads to destruction of tumor cells, whereas application to vessels results in hemostasis. Electrocautery is most commonly used when high-frequency electrosurgery is contraindicated.
An electrocautery device can deliver heat at a single temperature or range of temperatures, between 100° C. and 1200° C. Surgeons consider the histologic properties of the tissue to be treated, the area and depth of destruction desired, possible complications, and capabilities of the different electrocautery tools. A common principle of all electrosurgical procedures is to use the least amount of power possible to achieve the desired effect, limiting damage to the adjacent tissue.
Electrosurgical instruments are available that use electrical energy to perform electrocautery. Typically, electrosurgical instruments are hand instruments. One or more electrodes are configured to be supplied with electrical energy from an electrosurgical unit including a power supply. The electrical energy can be used to coagulate, fuse, or cut tissue to which it is applied. Advantageously, application of electrical energy to tissue tends to stop bleeding of the tissue. A shortcoming of using electrosurgical waveforms for “cutting”, however, is a poor ability to transect tissue. This is intentional as many surgeons need much more coagulation capability.
Some medical procedures require cauterization of certain vessels in order to permanently prevent the passage of blood or other substances through those vessels. In gallbladder surgery, isolation of the gallbladder often requires cauterization of the cystic artery, the artery which carries blood to the gallbladder. Cauterization of the vessels in the mesentery, the fold attaching the bowel to the body wall, is needed during bowel resection to provide surgical access to the bowel. Cauterization is also frequently used to seal the vas deferens in vasectomy, and in tubal ligation to seal the fallopian tubes to block the passage of sperm and egg, respectively. Cauterization is also frequently used for inguinal or ventral and incisional hernia procedures.
The surgical instrument of the present invention combines a cautery tool and a knife tool allowing the surgeon to perform diverse operative actions on blood and tissue, including blood coagulation and tissue destruction, dissection, and transection. The instrument is particularly adapted for minimally invasive surgery, although it may be used in open surgery. The surgical instrument includes an elongated body extending longitudinally in an axial direction and having a first channel extending in the longitudinal direction to a distal end of the elongated body. The knife tool includes a shaft and a distal portion having a blade. The knife tool is situated in the first channel and is movable along the first channel. In a specific embodiment the first channel is a through channel extending longitudinally in an axial direction. A blade is adapted for performing a cutting action consisting of mechanically cutting by applying physical stress. The blade has a cutting edge with a physical sharpness adapted for performing the cutting action against tissue.
The cautery tool including a conductor and a cautery tip electrically coupled to the conductor. The conductor is embedded in the elongated body. In some embodiments the elongated body includes a second channel in which the conductor is situated. The conductor is insulated in the elongated body so as to be electrically isolated from the knife tool. The cautery tip is positioned at the distal end of the elongated body and electrically coupled to the conductor. The conductor and cautery tip has a cautery-off state and a cautery-active state. During the cautery-active state, the cautery tip is energized to provide heat for performing any one or more of a cauterizing, coagulating, and dissecting action.
The knife tool is movable within the first channel between a retracted position and a fully extended position. The cautery tip has a through opening aligned with the first channel of the elongated body. The cutting edge of the knife tool is unexposed when the knife tool is in the retracted position. Preferably, the distal tip of the knife tool is proximal to the distal end of the first channel when the knife tool is n the retracted position. In other embodiments, the distal tip of the knife tool is in the through opening, but proximal to the distal end of the through opening, when the knife tool is on the retracted position. The distal portion of the knife tool, including the cutting edge, travels through the through opening to be exposed distal to the through opening when the knife tool is moved from the retracted position to the fully extended position. Specifically, the cutting edge of the knife tool is exposed distal to the distal end of the cautery tip when the knife tool is in the fully extended position.
In some embodiments the surgical instrument includes a proximal base. In various embodiments the proximal base is formed as a hand grip, one or more finger grips, or a robotic arm.
There are various preferred embodiments of a knife position-setting structure, which determines the position of the knife tool along the first channel of the elongated body. The knife tool is advanced and retracted in the axial direction along the first channel. The knife position-setting structure is embodied by the elongated body, the knife tool, and the proximal base in various embodiments. For example, an access structure which can be grasped by the surgeon, is accessible at the proximal end of the knife tool or the proximal end of a sled coupled to the knife tool. A groove or track is formed at the proximal end of the elongated body or at the proximal base. The access structure is moved forward or backward along the axial direction of the groove to move the knife tool. In some embodiments, the groove has multiple notches to lock the knife tool into position at the retracted position, the fully extended position, or at an intermediate extended position.
In another preferred embodiment, the knife position-setting structure includes a ratchet gear and pawl at the proximal base. A first trigger is pulled to rotate the ratchet gear and advance the knife tool along the first channel. The pawl locks the ratchet gear in position with the knife advanced. A second trigger releases the pawl. The ratchet gear is spring biased to return the knife tool to the retracted position. An advantage for this embodiment for a hand-held instrument is that one hand can grip and operate the instrument. More specifically a single finger can be used to pull the first or the second trigger to advance or retract the knife tool relative to the first channel and through opening.
In various embodiments the cautery tip is configured as a spatula, ball, L-hook, J-hook, or other shape. For a hook embodiment the cautery tip through opening extends through a ledge portion. For the spatula and ball tips the through opening in the cautery tip is continuous with the first channel of the elongated body. For the hook-shaped tip embodiments there is an open space region between a distal end of the first channel of the elongated body and the through opening at the ledge portion. Accordingly for the hook embodiments, the distal tip of the knife tool travels through the open space region as the knife tool travels from the retracted position to the fully extended position. The surgical instrument is configured so the knife tool's cutting edge is unexposed within the first channel while the knife tool is in the retracted position. The surgical instrument is configured so the knife tool's cutting edge is exposed in the open space region while the knife tool is in an intermediate extended position. The surgical instrument is configured so the knife tool's cutting edge is exposed distal to the distal side of the ledge portion while the knife tool is in the fully extended position.
The surgical instrument in accordance with embodiments of the present invention is useful, for example, in incarcerated inguinal hernia procedures and abdominal wall hernia procedures, in which the ring of the defect needs to be cut to enlarge the defect so the surgeon can reduce the incarcerated contents. The instrument also is useful as an alternative to the scissor in dividing adhesions very close to the intestines. The instrument also is useful for any procedures where an incision is needed (without heat/energy) followed by the need for cauterization. In a gallbladder procedure, the surgical instrument is useful for example after clipping the cystic duct and cystic artery. The surgeon can use the hook tip and knife tool's cutting edge to cut the cystic duct and the cystic artery and then continue with a hook cautery dissection. This has an advantage over the multiple step procedure of inserting and removing tools from the laparoscopic incision. For example, when using scissors, the surgeon needs to removery the cautery tool, then get and insert the scissors, then cut with the scissors, then remove the scissors, then re-inert the cautery tool. The present invention eliminates an exchange of instruments through the incision. This is particularly advantageous for a robotic surgical procedure where a knife is needed, such as for choledochotomie, pyloromyotomy, or an excision biopsy of a solid tumor, to avoid a cautery artifact.
In the following description, for purposes of explanation and not limitation, specific details may be set forth to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details. Detailed descriptions of well-known components are omitted so as not to obscure the description of the present invention.
Referring to
The knife tool 20 includes a shaft 22 and a distal portion 24. In some embodiments the knife tool 20 extends a partial length of the elongated member 14. In other embodiments the knife tool 20 extends to a proximal end of the elongated member 14 when the knife tool is retracted. Is still other embodiments, the knife tool extends proximal to the proximal end of the elongated body 14 into the proximal base 16. The distal portion 24 of the knife tool has a cutting edge 25. The knife tool 20 is situated in the channel 16, and is movable between a retracted position and a fully extended position. In an exemplary embodiment the cutting edge 25 can have a standard #11 blade shape or a standard #15 blade shape. In an exemplary embodiment channel 16 has a diameter of 5 mm or less and the shaft 22 has a cross sectional diameter of 2-3 mm. In another exemplary embodiment the channel 16 has a diameter of less than 10 mm and the shaft 22 has a cross sectional diameter of 8 mm. The specific diameter of the channel 16 and knife shaft 22 can differ according to different embodiments and surgical needs. The diameter of the cautery tip 18 through hole 19 preferably is the same as the diameter of the channel 16. In other embodiments the cross-sectional shape of the through hole 19 has the shape of the cross section of the distal portion 24, or a cutting edge portion of the knife tool 20. For example, the cross-sectional shape of the through hole 19 may differ from the cross sectional shape of the shaft 22. In such embodiment, the distal portion 24 may extend into the through opening 19 and the cutting edge 25 extend beyond the distal end of the through opening 19. In effect the differing cross-sectional shape of the through hole 19 limits the potential fully extended position of the knife tool 20.
The surgical instrument 10 includes the proximal base 26 to which the elongated body 14 is removably attached by a connector 28. A power interface 30 is situated at the proximal base 26, connector 28, or elongated body 14. A power source 32 is coupled to the power interface 30 to drive the cautery tool 12 into an active state, in which the cautery tip 18 is heated for performing a cauterizing action, such as to provide coagulation of a blood vessel, dissection of tissue, or destruction of tissue. In some embodiments the power source is coupled to the power interface by a wire and adapter. A switch 31 at the power source turns power on or off to use the instrument 10 in the cautery-off state or cautery-on state. In other embodiments the power source includes batteries situated in the proximal base 26. The switch 31 is situated at the proximal base 26 and turns power on or off to use the instrument 10 in the cautery-off state or cautery-on state. In various embodiments the switch 31 is located at the power supply 32, proximal base 26, or elongated body 14. In various embodiments the switch 31 is wired to be between the power source 32 and power interface 30, between the power interface 30 and the connector 28, or between connector 28 and the conductor 15.
The surgical instrument 10 also includes a knife position-setting structure 34. The knife position-setting structure 34 is manipulated to move the knife tool 20 along the channel 16 between the retracted position and a fully extended position. In some embodiments, the knife position-setting structure 34 is integrally formed toward or at a proximal end of the knife tool 20. In other embodiments, the knife position-setting structure 34 includes a separate member axially located at least partially within the channel 16 and aligned with the shaft 22 of the knife tool 20. The knife tool 20 preferably is locked in the retracted position or fully extended position. In some embodiments, the knife position-setting structure 34 also can lock the knife tool 20 in an intermediary position between the retracted position and the fully extended position. In the retracted position the knife tool 20 is unexposed-meaning that the distal end 23 of the knife tool remains proximal to the distal end 21 of the through opening 19 of the cautery tip, or for some embodiments meaning that the distal end 23 of the knife tool 20 remains proximal to the distal end 17 of the channel 16 of the elongated body 14. In the fully extended position distal tip 23 of the knife tool 20 extends distal to the distal end 21 of the through opening 19 of the cautery tip 18. In particular, the cutting edge 25 is exposed beyond the distal end 21 of the through opening 19, so as to allow for a cutting action in the space beyond the distal end 21 of the cautery tip 18.
The surgical instrument 10 may be embodied in various cautery tip 18 configurations. The spatula 18″ is electrically resistive so as to heat up during the cautery-on state.
The surgical instrument 110 includes a proximal base 126 to which the elongated body 114 is removably attached by a connector 128. The proximal base 126 may serve as a handle for holding the surgical instrument 110 or be an adapter for coupling the surgical instrument 110 to a robotic arm. For example, the proximal base 126 may be a longitudinally-oriented hand grip generally aligned with the axis of the elongated body 14. Alternatively, the proximal base 126 may have one or more finger grips (such as of the shape used for scissors.) A power interface 130 is situated at the proximal base 126. A power source 32 is coupled to the power interface 130 to drive the cautery tool 12 into an active state, in which the cautery tip 18 is heated for performing a cauterizing action, such as to provide coagulation of a blood vessel, dissection of tissue, or destruction of tissue. A switch (not shown) at the power source turns power on or off to use the instrument 110 in the cautery-off state or cautery-on state. In some embodiments the power source includes batteries situated in the proximal base 26. A switch (not shown) is situated at the proximal base 26 and turns power on or off to use the instrument 110 in the cautery-off state or cautery-on state.
The knife position-setting structure 34 (
As shown in
To lock the knife tool 20 in the retracted position (see
To move the knife tool 20 out of the retracted position, the surgeon grabs the access portion 161 and rotates the sled 134 circumferentially to move the radial arm 164 out of the notch 170A into the longitudinally extending portion of the groove 166. To move the knife tool 20 to the fully extended position (see
For the ball 18′ and spatula 18″ embodiments of the surgical instrument 110 the notch 170B may be omitted. In such embodiments, the knife tool 20 is moved between a retracted position and a fully extended position. (See
The proximal base 226 may serve as a handle for holding the surgical instrument 210 or be an adapter for coupling the surgical instrument 210 to a robotic arm. For example, the proximal base 226 may be a longitudinally-oriented hand grip generally aligned with the axis of the elongated body 14. Alternatively, as shown in
As shown in
The elongated body 14 is removably attached to the proximal base 226 by the connector 228. A power interface 230 is situated at the proximal base 226 and extends through the connector 228 to be in electrical communication with the elongated body 14. A power source 32 (
The knife position-setting structure 34 (
The channel 277 is axially aligned with the channel 16 of the elongated body 14 and the through opening 19 of the cautery tip 18. The proximal end of the sled 234 is situated in the channel 277. The body portion groove 269 is of similar shape as the groove 166 in the elongated body 114 of the surgical instrument 110 embodiment. The body portion groove 269 extends in the axial direction at the periphery of the body portion 265, and is in radial communication with the channel 277. In the illustrated embodiment a plurality of circumferentially extending notches 270 are formed at respective locations along the body portion groove 269.
Movement of the knife tool 20 between the retracted position and fully extended position is the same as described above for the surgical instrument embodiment 110. In particular, the action between the access portion 261 and body portion groove 269 and notches 270 of
For the ball 18′ and spatula 18″ embodiments of the surgical instrument 210 the notch 270B may be omitted. In such embodiments, the knife tool 20 is moved between a retracted position and a fully extended position. (See
In an alternative embodiment, the body portion groove 269 does not have any notches, and the access portion 261 is not rotated circumferentially. Instead, the body portion 265 also includes a notched lid member (not shown) which covers all or portion(s) of the body portion groove 269. The lid member is rotated in a circumferential direction (or hinged to lift off the groove 269) to expose the entire length of the body portion groove 269. The sled 234 is moved along the body portion groove 269 forward or backward in the axial direction to position the radial arm 264 into circumferential alignment with a notch in the lid member. The lid member then is rotated in the reverse circumferential direction (or hinged to return onto the groove 269) to cover the body portion groove 269. As covered, at least a portion of the groove 269 proximal to and distal to the notch 270 is covered. In some embodiments only the groove 269 portions aligned with the notched portions of the lid member are exposed, but with the radial arm 264 extending radially through one of the notches. Accordingly, the knife tool 20 is locked into a position corresponding to the aligned notch. Each notch corresponds to a given retracted or extended position of the knife tool 20.
The proximal base 326 may serve as a handle for holding the surgical instrument 310. For example, the proximal base 326 may be a longitudinally-oriented hand grip generally aligned with the axis of the elongated body 14. Alternatively, as shown in
As shown in
The cautery tool 12 is removably attached to the proximal base 326 by the connector 328. In particular the elongated body 14 is coupled to the connector 328. A power interface 330 is situated at the proximal base 326 and extends through the connector 328 to be in electrical communication with the elongated body 14. A power source 32 (
The knife position-setting structure 34 (
The sled 334 includes a rigid, longitudinal portion 367 that extends through the connector 328 into the channel 16 of the elongated body 14 to the knife tool's shaft 22. The longitudinal portion 367 and the knife tool 20 have a loose fit within the channel 16 allowing the sled 334 to move the knife tool 20 along the channel 16 forward or backward in an axial direction. The sled 334 has an access knob 361 attached or integral to the proximal end of the longitudinal portion 367. In one embodiment the sled 334 and knife tool 20 are a unitary structure formed as a single member.
Referring to
The ratchet, pawl and trigger mechanism 335, as shown in
One of the link member(s) 381 is coupled to a wheel 390 that runs along the track 379. The coupling member 371 is coupled to the wheel 390, so that as the wheel 390 moves along the track 379, the coupling member 371 moves the sled 334 in a corresponding axial movement.
Referring to
The position of the first trigger 375 defines the axial position of distal tip 23 of the knife tool 20. When the trigger 375 is pulled in direction 400 the ratchet gear 377 is rotated directly or via one or more gears 384 in a direction opposite direction 388. As per ratchet and pawl design, the ratchet gear 377 is able to be moved in the direction opposite direction 388 without being restricted by the pawl 393. Accordingly, the surgeon pulls the first trigger 375 to rotate the ratchet gear 377 into a position corresponding to an intermediate extended position (see
When the first trigger 375 is pulled, the ratchet gear 377 rotates forcing the link member(s) 381 to move the wheel 390 along the track 379 forward in the axial direction 382. While the first trigger 375 is not forced by the surgeon, and the second trigger 395 is pulled in direction 399, the ratchet gear 377 rotates in direction 388 forcing the link member(s) 381 to move the wheel 390 along the track 379 backward in the axial direction 382. Forward motion corresponds to advancement of the sled 334 and knife tool 20 distally. Backward motion corresponds to retraction of the sled 334 and knife tool 20 proximally.
The surgical instrument embodiments described above are for use by a medical practitioner performing a medical procedure. The instrument is particularly adapted for minimally invasive surgery, including robotic-assisted surgery. For embodiments intended for multiple procedures, the instruments described herein are designed for easy assembly and disassembly, for sterilization, and for stability during use. The instruments can be sterilized using any medically acceptable method. In some instances, the entire instrument is sterilized. In other instances, after the surgical procedure, the proximal base components and knife position-setting structure can be sterilized and re-used, while the elongated body, cautery tool and knife tool are discarded. In still other instances, only the cautery tip and/or knife tool are discarded and the rest sterilized and re-used.
As shown in
In preferred embodiments the elongated body is made from an electrically insulative material, such as a medical grade polymer having sufficient properties to carry out the functions described herein. If the surgical instrument is reusable, then the elongated body is constructed from a medical grade polymer that can be appropriately sterilized.
In preferred embodiments the conductor is made of a conductive metal or alloy satisfying physiological requirements. In preferred embodiments the cautery tip is made of silver, tungsten steel, or other stable metal or alloy satisfying physiological requirements and possessing the desired ohmic resistance, so that the tip may directly constitute an electric heating or resistance element. In some embodiment the cautery tip includes a coating formed of platinum, palladium or another suitable metal or alloy.
In an alternative embodiment as shown in
In some embodiments, the knife tool 20 and sled 34, 134, 234, 334 are made of steel or another metal or alloy satisfying physiological requirements. The knife tool 20 and sled 34, 134, 234, 334 also include a PTFE coating or other insulative coating. Preferably only the cutting edge of the knife tool 20 is left uncoated, so as to provide an effective cutting edge. In other embodiments, the sled 34, 134, 234, 334 is made of a rigid insulative material, satisfying physiological requirements. In other embodiments the knife tool 20 and/or sled 34, 134, 234, 334 is made from a polymer or other electrically insulative material capable of maintaining a sharp cutting edge under exposure to cautery tip heating temperatures, while also satisfying physiological and thermal requirements.
In preferred embodiments, the cutting capability of the knife tool is limited to (consists of) one cutting member which cuts using a mechanical action to apply physical stresses. The knife tool is distinguished from an electrical cutting edge, which applies electrical current or heat to cut. The knife tool is distinguished from surgical scissors. Surgical scissors consist of two members arranged so that at least one member, coupled to the other at a pivot point, moves relative to the other to achieve a cutting action. A pin provided as the pivot point couples the two members. For scissors respective blades may slide across each other. For surgical scissors, one member may move relative to the second member with one member having a cutting edge, and the second member serving an anvil, flat edge, or a second cutting edge. In contrast, the knife tool embodiments illustrated herein lack a second member coupled to the shaft or distal portion at a pivot point. There is no second member coupled to and pivotally movable relative to the shaft, distal portion, or the cutting edge, which acts together with the cutting edge to perform a cutting action. The knife tool has no pivot point along the shaft or distal portion shared by a crossing blade, a second cutting edge member, flat edge member, or anvil member. In a preferred embodiment there is no capability for pivotally moving the cutting edge relative to the shaft or distal portion of the knife tool In the illustrated surgical tool embodiment the knife tool is limited to axial motion (i.e., forward and backward motion along the axis) and rotational motion (i.e., about the axis), referenced to the axis of the channel in which the knife tool is situated. In the illustrated surgical tool embodiment there is no capability for an off-axis motion of any portion of the knife tool relative to the axis of the channel in which the knife tool is situated. The cutting edge is sharp enough to cut through tissue without a being referenced to or butting against a second surgical cutting edge member, a surgical flat edge member, or a surgical anvil member. In some embodiments, the distal portion has multiple cutting edges on one member such as in a spear shaped distal portion.
The invention is intended to extend to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims. Those skilled in the art, having the benefit of the teachings of this specification, may affect numerous modifications thereto and changes may be made in form and details without departing from the scope and spirit of the invention.