AN ELECTROMECHANICAL DRIVER AND REMOTE SURGICAL INSTRUMENT ATTACHMENT HAVING COMPUTER ASSISTED CONTROL CAPABILITIES

Abstract: A medical tool comprising an electromechanical driver and a surgical instrument attachment for use in invasive surgery, including a handle coupled to a flexible sheath which is in turn coupled to a surgical attachment. The handle of the driver includes the electromechanical driver and at least one processor element which controls the actions of the electromechanical driver, and therefore the application elements of the surgical attachment, based on information relayed between the processor element and remotely activateable sensor assemblies in the surgical instrument attachment.

Description: AN ELECTROMECHANICAL DRIVER AND REMOTE SURGICAL INSTRUMENT ATTACHMENT HAVING COMPUTER ASSISTED CONTROL CAP ABILITIES Background of the Invention Cross-Reference to Related Application This application is a continuation-rn-part of co-pendmg application U.S.S.N. 09/324,452, entitled "An Electromechanical Dπver Device for use with Anastomosing, Stapling, and Resecting Instruments" (attorney docket no. P-101) Field of the Invention The present invention relates generally to a medical tool comprising an electromechanical driver which transmits information to and receives information from and thereby controls, a surgical instrument attachment, and more specifically to the mechanisms employed to provide such remote direction and information relaying between said electromechanical driver and said surgical instrument attachment Description of the Prior Art It shall be understood at the outset, that the present mvention has many applications within the field of surgery This disclosure shall not, therefore, be read as limiting of the scope of the invention by the specific medical or surgical applications which may be descπbed herein, as they are only used as elucidating examples of such applications in which the present invention may be employed to enhance the outcomes and/ or surgical efficiency. In particular, the present disclosure is directed to embodiments used in colon surgery, and specifically to anastomosing, resecting, and stapling instruments, however, the same mvention may be applied to other surgical applications m the fields of gynecological surgery, cardiovascular surgery, and general surgery. Upon identification of cancerous or other anomalous tissue in the gastrointestinal tract, surgical intervention is often prescribed. The field of cancer surgery, and more specifically, the surgical procedure by which a section of the gastrointestinal tract which includes cancerous or anomalous tissue is resected, includes a number of uniquely designed instruments. In combmation with a descπption of the present instrumentation and their functions, a descπption of the state of the art in this surgical procedure shall also be provided. The first question which must be answered when determining how to treat gastrointestinal cancer relates to the specific location of the cancerous tissue. This is very important insofar as the instruments which are provided m the present art have limitations relatmg to how far they may be inserted into the gastrointestinal tract. If the cancerous tissue is too far up the colon, for example, then the standard instrumentation provided is unusable, thus requiring special accommodations. These accommodations generally mcrease the πsk of contamination of the surrounding tissues with bowel contents, mcrease the length of the surgery and the correspondmg need for anesthesia, and eliminate the benefits of precise anastomosing and staplmg which comes from utilizing a mechanized device. More specifically, m the event that the cancerous tissue is located at a position in the colon which is accessible by the present mstrumentation, the patient's abdomen is initially opened to expose the bowel. The surgeon then utilizes a linear cutter and stapling device which cuts the tube of the colon on either side of the cancerous tissue, thereby creating two stapled ends of the bowel (a distal end which is directed toward the anus, and the proximal end which is closest to the small intestine) This is done in order to temporarily rrunirnize contamination. The surgeon then partially opens the proximal end and inserts the removable anvil portion of an anastomosing and stapling mstrument mto the exposed proximal end. This step, as well as those of the remainder of the surgical procedure, are related to the functioning of this surgical mstrument. More particularly, and with respect to Figure 1, the surgeon begins by taking the mstrument 30 and manually turning the dial 32 at the base of the handle 34 which causes the anvil head 36 at the opposite end to advance forward. The surgeon continues to turn the dial 32 until the anvil head 36 advances to its most extreme extended position This manual turning requires nearly thirty full rotations. Once fully extended, the anvil head of the mstrument is decoupled therefrom and is mserted mto the partial opening of the proximal end such that the coupling post extends outwardly therethrough. This partial openmg of the proximal end is then sutured closed. The extendmg shaft 38 of the anastomosing and stapling mstrument 30 is then mserted and advanced mto the lower colon, transanally, until the coupling stem 40 thereof extends through the stapled distal end. The surgeon then joins the coupling ends of the anvil and shaft together and begins to manually rotate the dial m the handle agam, this time bringing the anvil head closer to the end 42 of the shaft. Once the anvil head and shaft are brought close together, after the surgeon has manually rotated the dial another thirty times, a gnp-style trigger 44 m the handle is manually actuated. This actuation causes a circular blade 46 to advance axially out from the tip of the shaft, and mto contact with the opposmg face 48 of the anvil 36. The blade cuts through the stapled-closed ends of the proximal and distal ends of the colon, thereby also cutting a new pair of ends of the proximal and distal portions of the colon. The tissue which has been severed is held m an mteπor volume at the end of the shaft. In lock step with the cutting, the freshly opened ends are ined together by a seπes of staples 50 which are advanced through holes m the perimeter of the tip of the shaft (being pressed against and closed by the opposmg face of the anvil). The coupled shaft and anvil are then withdrawn from the patient As with many such devices of the prior art, all of these devices are considered fully disposable, and are, m fact, thrown away after a smgle use. They are complicated devices, havmg multiple movmg parts, requiring substantial structural mtegπty and, therefore, expense m manufacturing. The fact that they are used only once, and that no part can be used again, render the use of such devices expensive and wasteful of resources. In addition to this failure, as can be readily observed from the precedmg descriptions, the pπor art devices suffer from numerous other limitations which would be desirable to overcome. These mclude the rigid and limited length shaft of the anastomosing and stapling instrument (which limits the portion of the gastrointestinal tract which may be treated by such a device), as well as the requirement that the surgeon manually actuate a number of different functions (mcludmg those associated with the dial and trigger of the anastomosing and staplmg mstrument and the multiple triggers of the cutting and staplmg mstrument). Therefore, it has been a principal object of recent inventions to provide an mstrument for cutting, anastomosing, and staplmg, for use m gastrointestinal surgery, which reduces the waste of resources by permitting the reuse of portions thereof, can extend farther mto the colon, and which are more simple to manipulate. A substantial advance m the field of colon surgery has been disclosed m U.S. Patent Application U.S.S.N. 09/324,452, entitled "An Electromechanical Dπver Device for use with Anastomosing, Stapling, and Resecting Instruments" which was invented by the same inventor as the present application, was assigned to the same assignee as the present mvention, and the specification of which is hereby incorporated fully by reference. In particular, this pπor mvention, made by the present inventor compπses an electromechanical driver assembly, mounted m a handle-shaped base unit, which couples to and motivates remote surgical attachments through a flexible shaft which may also be remotely manipulated by means of a seπes of steermg wires which are controlled withm the handle as well. First, with respect to the handle component and the flexible shaft. The handle has a pistol gπp-styled design, havmg one or more, and preferably two, finger triggers which are mdependently coupled to at least one, and preferably two separate motors which each turn separate flexible drive shafts (descπbed more fully, herembelow). The motors are each dual direction motors, and are coupled to a manual drive switch mounted to the top of the handle, by which the user can selectively alter the turning direction of each motor. In addition to the motor components, the handle further includes several other features, mcludmg: (1) an remote status mdicator; (2) a shaft steermg means; and (3) at least one additional electrical supply. The flexible shaft compπses a tubular sheath, preferably formed of a simple elastomeπc material which is tissue compatible and which is steπlizable (i.e., is sufficiently rugged to withstand an autoclave). Withm the elastomeπc sheath are a pair of smaller fixed tubes which each contam a flexible dπve shaft which is capable of rotating withm the tube. The flexible drive shaft, itself, simply must be capable of translating a torque from the motor m the handle to the distal end of the shaft, while still bemg flexible enough to be bent, angled, curved, etc. as the surgeon deems necessary to "snake" through the colon of the patient. As suggested above, m conjunction with the manually actuateable steermg means mounted to the handle, the sheath further includes at least two sets of steermg wires which are flexible, but are coupled to the inner surface of the sheath near the distal end thereof. The steering wires may be axially translated relative to one another by actuation of the steering means, which action causes the sheath to bend and curve accordingly. Referring now to one possible surgical mstrument attachment which was disclosed as a preferred embodiment m the above referenced co-pending application entitled "An Electromechanical Dπver Device for use with Anastomosing, Stapling, and Resecting Instruments", the anastomosing and stapling attachment, this attachment compπses an anvil portion, and a staple, blade and reservoir portion, which mcludes a pair of turning dπve shafts which are coupleable to the dπve components of the shaft element descπbed above, and a correspondmg pair of advancing and retracting nuts mounted to the turning dπve shafts, but which are prevented from rotatmg and therefore linearly advance and retract along the shafts when they turn. The anvil portion is bullet shaped, havmg a blunt nosed top portion, a flat cutting support surface on the bottom, and a freely rotatmg couplmg post extending axially from the bottom surface This coupling post is designed to be selectively coupleable and removable from the correspondmg nut mounted to one of the turning dπve shafts. The staple, blade, and reservoir portion (SBR portion) is cylindrical m shape, forming a housmg which has a hollow mteπor. It is this hollow mterior which forms the reservoir. On the axially outward facing surface of the cykndncal wall of the housmg are a seπes of staple ports, through which the staples of the device are discharged. A seπes of staple dπvers are mounted withm the cylindrical walls, beneath the staple ports, for dπvmg the staples therethrough. The blade is similarly cylindrical, and seats in the mside of the housmg, against the inner surface of the wall thereof. Both the blade and the staple dπver are mounted to the second nut, which is, m turn, mounted to the other turning dπve shaft. As the tuning drive shaft rotates, the nut (which is constrained against rotatmg) advances along the shaft, thus hnearly advancing the blade and staple driver. The blade and the staple dπver are, therefore, selectively advanceable axially outward from the housmg, m accordance with actuation of the appropπate trigger on the handle. In a preferred embodiment set forth m the referenced application, the anvil portion and the SBR portion further compπse an electromagnetic sensor mechanism, coupled to the LCD mdicator of the handle, which sensor is activated when the two portions have approached each other to the extent necessary for a safe staple firing, whereby the surgeon may have remote knowledge of the state of the attachment disposed withm the colon. An observed problem with prior art devices used m the anastomosing, stapling and resectmg surgical procedure described above, relates to the best mdications which the surgeon may remotely receive as to the conditions withm the patients colon. For example, it is cπtical that the surgeon know whether the tissue bemg coupled forms a contiguous and sealed rmg, such that the recoupled ends of the colon do not contain a hole through which bowel contents may leak mto the body cavity. Post surgical infection rates due to such failures are a leadmg cause of complications and are often severe and are a leadmg cause of morbidity. An associated issue of which surgeons who carry out these procedures must be cognizant relates to the ongomg viability of the tissue which has been resealed. A frequent post-surgical problem relates to the tissue necrosis which may occur if the staple rmg is too tightly compressmg the tissue, and preventmg necessary blood flow thereto. A simple light-based mechanically measured distance mdicator means is insufficient to avoid both of these problem. Pπor art devices fail to provide the means by which information regardmg the state of the tissue be g manipulated may be measured and used by the surgeon, and the instrument itself, to ensure a more positive outcome. It shall be understood that this problem, i.e., the failure of remotely controlled surgical instruments to provide for the gathering, displaying, and influencing of automatic actions, of information critical to the success of the surgical procedure simultaneously with the action of the device, is not limited to the specific instances discussed above. Rather, this failure is prevalent throughout surgical mstrumentation. It is therefore a principle object of the present mvention to provide a surgical attachment which is remotely controlled and mcludes information-gathering sensors, communication and processmg capacities, information storage capacity, and indicating means by which the user and/ or remote decision-making systems may choose to control the instrument and activate the features of the attachment m accordance with the gathered and relayed information. Other objects of the present mvention shall be recognized m accordance with the description thereof provided herembelow, and m the Detailed Descπption of Preferred Embodiments m conjunction with the remammg Figures. Summary of the Invention The precedmg objects of the mvention are provided by an electromechanical driver, a flexible shaft, and remote surgical attachment mcludmg a controller processor unit mounted m the handle which is connected via cabling m the flexible shaft to a sensor and memory unit m the remote attachment. More particularly, with respect to the bowel surgery anastomosmg, resecting, and stapling attachment descπbed above m the Description of the Prior Art, the present mvention shall be set forth with respect to the same application. Specifically, with respect to the sensor and memory unit mounted m the anastomosmg, resectmg, and stapling attachment, the sensor utilized is a pulse oximeter First, as described above, the present mvention is preferably embodied as a subsystem of a device which compπses three components, which are (1) an electromechanical driver, (2) a flexible shaft, and (3) an anastomosmg, resecting, and stapling attachment. First, with regard to the electromechanical driver, the handle has a pistol gπp- styled design, havmg at least two fmger-actuatable triggers which mdependently initiate motors which turn drive shafts mounted withm the flexible shaft. The handle further mcludes a remote status mdicator coupled to the processor unit m the handle. This mdicator provides either visual, audio, or electπcal output (to be output to a separate display device). The handle and flexible shaft further include a shaft steermg means comprised of steermg wires controlled by a handle mounted motor drive system mcludmg a manually actuatable steermg means for directing the steermg means, for example, a joystick or trackball, descπbed more fully m co-pendmg application U.S.S.N. , entitled "A Carnage Assembly for Controlling a Steermg Wire Steermg Mechanism withm a Flexible Shaft", which has been assigned to the same assignee as the present mvention, and which is incorporated herem fully by reference. In this embodiment of the electromechanical driver, the driver components are integrated with the controller components. It should be noted that other embodiments of the electromechanical dπver may comprise a dπver unit which is physically separate from a controller unit. That is, the driver unit may comprise the above-descπbed motors and the above-descπbed steering means, and the controller unit may compπse the above-described tπggers, the above-descπbed remote status mdicator, as well as the above-descπbed manually actuatable steermg means means. The controller unit components communicate with the driver unit components by wireless transmission, for example, through infrared, radio waves, other electromagnetic waves, or ultrasound. In such a configuration, for example, the dπver unit may be located out of the surgeon's arm's reach, while the controller unit may be selectively coupleable to that portion of the flexible shaft which is closer to the patient and closer to the surgeon. It should be further understood that additional embodiments of the electromechanical driver assembly may comprise more than two separate units, and such units may each house only one, or more than one, of the above-described separate components, all communicating by wireless means as described above For example, the remote status mdicator descπbed above could be part of a third unit which mounts to a visor wearable by the surgeon It should be further understood that all communications between these components as described herem may m such alternative embodiments take place by wireless means. Second, with respect to the flexible shaft, the shaft comprises a tubular sheath, preferably formed of a simple elastomeπc material which is tissue compatible and which is steπlizable (i.e., is sufficiently rugged to withstand an autoclave). Withm the elastomeπc sheath are a pair of smaller fixed tubes, each of which contain a flexible drive shaft which is capable of rotatmg withm the tube As suggested above, m conjunction with the steermg means mounted in the handle, the sheath further mcludes at least two steermg wires which are flexible, but are coupled to the mner surface of the sheath near the distal end thereof. In addition, the flexible shaft mcludes a least one electrical lead and correspondmg coupling terminals at each end, for coupling to the processor and controller means m the handle with the sensor and memory components m the distally mounted surgical attachment. Third, with regard to the anastomosmg, resectmg, and stapling attachment, a smgle example of the many alternative surgical attachments which may mclude aspects of the present mvention is now descπbed. This attachment comprises a selectively advanceable and retractable anvil portion, and a staple, blade, sensor, and reservoir portion. This latter element mcludes the dπve elements necessary to move the anvil forward and back, as well as the motive elements which dπve the staples and blade through the tissue. These motive elements are coupleable to the dπve components of the shaft element descπbed above. Included m the staple, blade, sensor and reservoir portion, also, are a pulse oxrmeter sensor and a tissue proximity sensor, as well as a memory unit which contains important identification information which may be retrieved by the processor unit m the handle upon connection to the flexible shaft. As stated above, when initially coupled to the flexible shaft (which shall be hereinafter taken to be permanently coupled to the handle unit), and the handle is powered up, the first mtemal act to take place is for the processor unit m the handle to query the memory unit m the attachment as to its identity and status. More particularly, as the anastomosing, resectmg, and stapling attachments may come in different diameters, shapes, lengths, and staplmg arrangement (as well as many other potential vaπations) which are readily readable by the handle mounted processor unit and displayed for the user either on a remote display panel to which the handle is coupled, or on a display screen which is integrally mcluded in the handle itself The status of the attachment shall also be queπed, for example, as to what the functionality of the attachment is, and whether or not it has been previously used, and therefore, no longer capable of firing a second time. Once this information has been gathered, and it is determined that the attachment is the appropπate one, the surgical step for which this attachment is utilized may contmue. In particular, the anvil tip is advanced via action of the drive motor and dπve elements of the handle, shaft, and attachment, until it may be manually separated from the remainder of the attachment. The appropriate openmg is made m the previously cut and stapled closed proximal end of the bowel and the anvil tip of the attachment is placed therem. The remainder of the attachment and the appropriate length of the flexible shaft is mserted through the rectum and up the bowel until the attachment coupling shaft is advanced through a small openmg m the cut and stapled closed distal end of the bowel section. After recouplmg, the anvil portion is retracted toward the stapling portion until it is mechanically determined that the two portions are withm the range which is appropπate for staple firing. At this time, the physician user is unable to simply remotely fire the staples. This lock out feature is maintained by the processor unit until such time as the surgeon causes the processor until m the handle to query the tissue proximity sensor and the pulse oximeter sensor m the attachment to determine if the tissues to be stapled together form a completely contiguous rmg so that the two tubular sections of bowel can be properly mechanically united. This measurement may be made optically, or by any other suitable means, by which the transmission of some signal which should be blocked by the intervening tissue is received by an opposmg sensor. The results of this query are then relayed back to the processor m the handle which carries out the appropπate analysis. If the proximity query results m a negative analysis outcome, an mdicator hght, audible alarm, or other suitable means of alerting the surgeon to this condition is provided. The processor will also disarm the stapling mechanism (by removing power to the dπve mechanisms, for example) to prevent an attempted override by the surgeon. If the proximity query results in a positive response, however, the next in the seπes of tests to determine if the surgeon may safely join the sections of bowel is earned out. Specifically, the processor m the handle activates the pulse oximeter sensor and queries it regarding whether the proper level of blood profusion remam m the tissue sections to be jo ed. As suggested above, if the stapling procedure has the effect of cutting off the necessary blood supply to sections of the joined tissue, a necrotic region will develop m the bowel, and future complications (which may be fatal) will arise The results of this query are also relayed to the processor in the handle. Again, if the results of the processmg of this information is negative, an indication of this state is provided by the processor. As above, if negative, the surgeon will be unable to mechanically fire the staples, as the processor will disarm the motor assembly. Additional features and aspects of the present mvention are set forth m greater detail in the description of the preferred embodiments provided herembelow A Brief Description of the Drawings: Figure 1 is a side perspective view of an anastomosing, resect g, and staplmg mstrument of the pπor art; Figure 2 is a side cross-section view of a handle and flexible shaft of the present mvention, wherem important internal features of the control systems are provided m detail; Figure 3 is a side cut-away view of an anastomosmg, resectmg, sensing, and staplmg attachment which is also an aspect of the present mvention; and Figure 4 is a flow chart illustrating the logical sequence of processor, sensor, and mechanical actions which are illustrative of features of the present mvention. A Detailed Description of the Preferred Embodiments: While the present mvention will be described more fully hereinafter with reference to the accompanymg drawmgs, in which particular embodiments are shown, and with respect to methods of surgical use, it is to be understood at the outset that persons skilled m the art may modify the mvention herein described while achievmg the functions and results of this mvention. Accordmgly, the descπptions which follow are to be understood as illustrative and exemplary of specific structures, aspects and features withm the broad scope of the present mvention and not as limiting of such broad scope. Like numbers refer to similar features of like elements throughout. Referrmg now to Figure 2, with respect to the electromechanical dπver 100, the driver has a handle portion 102 and a flexible drive shaft portion 104. The handle 102 mcludes a portion which is shaped m a manner which is easily gripped by the surgeon operator, for example, in the embodiment provided herem the handle comprises a pistol grip-styled portion 106. The grip portion 106 mcludes at least two, and m the present embodiment exactly two, mdependently finger-actuateable triggers 108a,108b. The finger tπggers 108a,108b are mdependently coupled to separate motors 110,112, housed withm the mterior volume of the handle 100. Each motor 110,112 turns a separate flexible drive shaft (described more fully, herembelow). More particularly, with respect to the motors 110,112, each is a dual direction motor. In addition to bemg coupled to the finger-actuateable switch, the motors are also each separately coupled to a power source 114 (which is a common source m the present embodiment) and a manual dπve switch 116. The manual dπve switch 116 is provided on the top of the handle 100, such that the surgeon operator can selectively alter the turning direction of each motor. In the preferred embodiment, the power source 114 supplymg the motors 110,112 is a smgle direct current supplymg removable and rechargeable battery pack. It shall be understood that alternative power sources, mcludmg dual direct current sources or smgle remote alternating current sources (such as the alternating current provided from standard United States 120 Volt, 60 Hertz wall outlets) may be used m conjunction with alternative embodiments In the event that the driver device should be useable with an alternating current, either a transformer can be mcluded between the motor and the power source, or a more sophisticated mtermediate gearing assembly may be provided between the motor and the extended turning dπve shaft In addition to the motors 110,112 components and the related power and dπve switch elements, the handle 100 further mcludes a motor driven shaft steermg carnage assembly, which is coupled to a manual mput means, which is coupled to steermg steermg wires m the flexible shaft for selectively steering the distal tip of the flexible drive shaft 122. The handle also mcludes a processor element 140 and output display device 142 (mounted on the exterior of the handle). The processor element 140 and the display device 142 are each electrically coupled to the power source to provide electπcal power to carry out their actions. The processor unit and display element are similarly coupled to one another to permit the processor to display the signal output generated thereby. The processor unit is also coupled via an electπcal cable 144 to an mput terminal 146 at the distal tip of the flexible shaft 122. More particularly, with respect to the flexible shaft 122, the shaft comprises a tubular sheath 128 which is formed of a simple, tissue compatible, elastomeπc material. As this device is to be reused, it is important that the material be steπlizable (i.e., is sufficiently rugged to withstand an autoclave) While the embodiment illustrated comprises a contiguous handle 100 and shaft 122, it shall be understood that one havmg ordinary skill in the art may provide an alternative embodiment havmg a separable handle and shaft, thus permitting alternative shaft lengths for alternative purposes. In such cases, the flexible shaft 122 and the handle 100 portions should mclude an interface between the proximal end of the shaft and the distal end of the handle which should mclude a coupling means for the dπve components. Specifically regarding the dπve components 130a,130b of the shaft 122, withm the elastomeric sheath 128 are a pair of smaller fixed tubes 134a,134b which each contam a flexible drive shaft 136a,136b which is capable of rotatmg withm the correspondmg tube 134a,134b. The flexible dπve shaft 122, itself, simply must be capable of translating a torque from the motor m the handle to the distal end 138a,138b of the shaft 122, while still bemg flexible enough to be bent, angled, curved, etc. as the surgeon deems necessary to "snake" through the colon of the patient. For example, the dπve shafts may comprise a woven steel fiber cable, a high tensile strength polymeric matenal, or a sufficiently flexible unitary metal shaft. In order for the distal ends 138a,138b of the dπve shafts 136a,136b to couple with an attachment, such as anastomosmg, resectmg, sensing, and staplmg attachment, the distal tips 138a,138b of the drive shafts must have a conformation which permits the contmued translation of torque. In the present embodiment, this coupling is achieved by a geometric fitting, and more precisely, the distal tips of the drive shafts are hexagonal, and thereby fit mto a hexagonal recesses m the coupling mterface of the attachment. In a preferred embodiment, the attachment and the distal end of the shaft should mclude a collar, or other aligning means, for facilitating the fitting of the attachment onto the distal end of the shaft. In addition, the shaft mcludes an electrical wire 144 extendmg from the end coupled to the handle to the end which couples to the surgical attachment. The first end of the shaft mcludes the terminal mputs which are coupled to the processor unit. The second end mcludes a terminal 146 for coupling to the correspondmg electrical mput/ output of the surgical attachment (described more fully herembelow). With reference now to Figure 3, a preferred embodiment of the anastomosmg and staplmg attachment 200 is descnbed. This attachment compπses an anvil portion 202, and a staple, blade, sensor, and reservoir (SBSR) portion 204, which mcludes a pair of turning dπve shafts 206a,206b which are coupleable to the drive components 136a,136b of the dπver component descπbed above with reference to Figure 2, and a correspondmg pair of advancing and retracting members 208a,208b mounted withm tracks and to the turning dπve shafts, which are thereby prevented from rotatmg and therefore linearly advance and retract along the shafts 206a,206b when they turn. The anvil portion mcludes a series of hght detectors. The SBSR mcludes pulse oximeter and tissue proximity sensors 150, 152 and a memory and signal transmitter and receiver member 154 which couples to the flexible shaft at the correspondmg terminal thereon by way of an electrical coupler 158 shown. The anvil portion 202 is bullet shaped, havmg a blunt nosed top portion 210, a flat cutting support surface 212 on the bottom, and a couplmg post 214 extendmg axially from the bottom surface. This coupling post 214 mounts to the first advancing and retracting member 208a which is mounted withm a linear track whereby rotation of the shaft 206a causes the member 208a and the anvil 202 coupled thereto to move axially, but not rotationally. The exterior surface of the face of the anvil which opposes the SBSR mcludes a series of hght emitting diodes 154 The staple, blade, sensor, and reservoir portion (SBSR) portion 204 is cylindrical m shape, forming a housmg which has a hollow mterior 216. It is this hollow mterior which forms the reservoir. On the axially outward facmg surface 218 of the cylindrical wall 220 of the housmg are a seπes of staple ports, through which the staples 224 of the device are discharged. A unitary blade and cylindrical staple dπver component 226 is seated withm the housmg. A circumferential pulse oximeter 150 is mounted m the housmg on the outside run of the housmg, radially adjacent to the staple ports. A pulse oximeter is a simple device which shmes a specific frequency of hght through a section of tissue to measure the absorption rate of the hght Because oxygenated blood has a different color than does blood which is not fully oxygenated, the profusion of fresh blood through a tissue may be determined by this device. Therefore, the pulse oximeter comprises a seπes of hght emitting elements 154 on the anvil and hght sensors 150 mounted around the circumferential πm of the housmg member. As shown, the components of the pulse oximeter are electrically connected via wires running through the coupling post of the anvil. In addition, the attachment also mcludes a tissue proximity sensor 152, a portion of which is similarly mounted to the external πm of the housmg, radially adjacent to the pulse oximeter 150 and the staple ports. In addition, the tissue proximity detector 152 compπses a seπes of simple hght emitting elements 154 on the anvil (for example the same hght emitting elements of the pulse oximeter), and a correspondmg series of hght detectors 152 mounted around the circumferential πm of the housmg member. In the proximity sensor, if the tissue which is supposed to be disposed between the anvil and housmg is present, then the proximity sensor's hght detectors will not receive a signal (or at least below a set threshold), alternatively, if the tissue is missing, then the hght detectors will receive a stronger signal, mdicatmg that there is no tissue blocking the transmission of the hght. More particularly, the blade and staple dπver component compπses a smgle element havmg two concentric cylindrical portions. The blade portion 228 seats withm the hollow mterior 216, agamst the mteπor wall 230 thereof. The staple dπver portion 232 seats withm the wall 230 of the SBSR portion and mcludes a series of outwardly pro j ecting protuberances which push agamst staples mounted withm the staple ports. The blade 228 and staple driver portions 232 are coupled at the mteπor end thereof to a threaded member 208b which seats around turning shaft 206b. The threaded member 208b is constramed withm a linear track so that the blade and staple driver are advanced linearly upon rotation of the turning shaft 206b. In practice and with reference to the flow chart provided in Figure 4, this attachment and the associated controller features of the present mvention are utilized once the section of the colon to be removed has been resected and the two opposmg ends of the adjacent bowel have been stapled shut. The surgeon begins by coupling the anastomosmg, resect g, sensmg, and staplmg attachment 200 to the distal end of the flexible shaft. The processor m the handle unit queries the memory element m the attachment and requests identification information The attachment transmits the requested mformation, mcludmg size, status and functionality information. The processor in the handle outputs this information to the display panel, for visual mspection by the surgeon user. The processor further establishes whether the surgeon may activate the driver means m correspondence to whether the information received from the attachment was acceptable (i.e., is it unused and functional). In the event that the identification mformation received is acceptable, the surgeon then triggers the electromechanical driver to advance the anvil portion 202 to its fullest extent. The anvil head 202 is then decoupled from the first advancing and retracting member 208 and mserted mto the stapled proximal end of the bowel (which is then opened partially to receive the anvil head). The proximal end of the bowel is then sutured closed. The surgeon then advances the shaft 206a and the SBSR portion 204 of the attachment up the colon until it extends through the stapled distal end of the colon. (Alternatively, the surgeon may advance only the flexible shaft up the colon and then reattach the SBSR portion to the distal end once it emerges from the distal end of the bowel.) The surgeon then couples the anvil 202 to the advancmg and retractmg member 208a by rotation of the correspondmg drive shaft 136a. Subsequent reverse biasmg and triggering of the same motor in the handle 100 causes the anvil 202 to retract toward the SBSR portion 204. Once retracted mto the safe staple firing range, the processor disables the staple firing motor and again queries the attachment. In fact, the processor m the handle transmits an activation signal to the pulse oximeter, to sense the blood profusion through the tissue compressed between the anvil and SBSR portions. If the response received from the sensor is that the blood flow through the tissue has been compromised, the anvil portion is repositioned and the process begins anew If the response received from the sensor is that the blood flow is acceptable, then the processor activates the tissue proximity sensor. If the response is that the tissue is properly situated, then the staple driver is armed and the surgeon can fire the staples at will by manipulating the trigger on the handle. If the proximity detector response is negative, the anvil is repositioned. While there has been described and illustrated new and novel electromagnetic driver mechanisms havmg an attachment processor controller, for use with surgical attachments, it will be apparent to those skilled m the art that variations and modifications are possible without deviating from the broad spirit and prmciple of the present mvention which shall be limited solely by the scope of the claims appended hereto.

Claims: What is claimed is: 1. An electromechanical dπver, flexible shaft, and surgical attachment assembly, compπsmg: a) a flexible shaft mcludmg a flexible sheath havmg a first end and a second end, and havmg disposed therem at least one flexible torque translatmg member and at least one electπcal connection wire; b) said at least one flexible torque translatmg member bemg coupleable to a surgical attachment at said first end of said sheath, and to a driver element at said second end; c) said surgical attachment mcludmg I) at least one selectively moveable element, said moveable element bemg coupled to said torque translatmg member such that said moveable element may be selectively moved m correspondence with the provision of a torque along said torque translatmg member, u) at least one selectively activateable sensor mechanism for sensmg and providmg data concerning at least one feature of the environment surrounding said attachment when selectively activated by an activating signal, m) said attachment further mcludmg at least one transmitter and receiver mechanism coupled to the sensor mechanism and the at least one electrical connection wire for receiving said activating signal, and transmittmg said sensor data along said connection wire; and d) said driver element mcludmg l) a torque generating mechanism coupled to said torque translatmg member, and u) a processor element coupled to said at least one electπcal connection wire for sendmg an activating signal, receivmg said sensor data, analyzing same, and controlling the application of said torque by said torque generatmg mechanism m accordance with said analysis. 2. The electromechanical driver assembly as set forth m claim 1, wherem the surgical attachment comprises an anastomosmg, resectmg, and stapling instrument. 3. The electromechanical driver assembly as set forth in claim 1, wherem the activatable sensor comprises a pulse oximeter. 4 The electromechanical driver assembly as set forth m claim 1, wherem the activatable sensor comprises a tissue proximity detector. 5 The electromechanical driver assembly as set forth in claim 1, wherem the processor element of the dπver element is coupled to a display means. 6 A medical tool, compπsmg: a) an electromechanical dπver, b) a sensor assembly capable of sensmg and transmitting data regarding at least one of a feature of the environment surrounding at least a portion of said tool and a feature of the tool, c) a processor element capable of receivmg said data and controlling said electromechanical driver m coπespondence with said data, d) an application element driven by said electromechanical dπver. 7. The medical tool as set forth m claim 6, wherem said sensor assembly is activated upon, and is capable of, receivmg an activation signal transmitted by said processor element. 8. The medical tool as set forth m claim 6, wherem said electromechanical dnver comprises a torque generating mechanism and said application element is a selectively movable element which is m mechanical communication with said torque generating mechanism. 9. The medical tool as set forth m claim 6, wherem at least one of said electromechanical driver, said sensor assembly, said processor element, and said application element is housed m an attachment portion, and the remamder of said electromechanical driver, said sensor assembly, said processor element, and said application element are housed m a main portion to which said attachment portion can be attached and detached, wherem when said attachment portion is attached to said mam portion, said transmission of data, said receipt of data, said control, and said driving is possible. 10. The medical tool as set forth m claim 9, wherem said electromechanical dπver and said processor element are housed m said mam portion, and said sensor assembly and said application element are housed m said attachment portion. 11. The medical tool as set forth m claim 6, further comprismg an alert element coupled to said processor element and capable of communicating at least one of an aspect of the data received by said processor element and an aspect of the processor element's control of the electromechanical driver. 12. The medical tool as set forth m claim 6, wherem said sensor assembly compπses a pulse oximeter. 13. The medical tool as set forth m claim 6, wherem said sensor assembly compπses a tissue proximity detector. 14. The medical tool as set forth m claim 6, wherem, said processor element is capable of preventmg activation of said electromechanical dπver.

Inventors: WHITMAN MICHAEL P, WHITMAN, MICHAEL, P.
Applicants: POWERMED INC, POWERMED, INC.
Application year: 2001
Main classification: A61B17
IPC codes: A61B17, A61B19