Electromechanical drive 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.

Claims

1. A surgical system, comprising: a handheld electromechanical driver, including: a handle portion supporting at least one actuation member; at least one motor supported in the handle portion and activatable by an actuation of the at least one actuation member; a power source supported in the handle portion and in communication with each motor; a processor in communication with the at least one actuation member, the at least one motor, and the power source; and an output display device supported on the handle portion and connected to the processor, wherein the output display device displays information from the processor; and a surgical attachment assembly selectively connectable to the handheld electromechanical driver, the surgical attachment assembly including a memory unit configured to store identification information of the surgical attachment assembly.

2. The surgical system according to claim 1, wherein the output display is integrally supported in the handle portion.

3. The surgical system according to claim 1, wherein the handheld electromechanical driver further includes: an elongate drive shaft portion extending from the handle portion.

4. The surgical system according to claim 3, wherein the surgical attachment assembly is selectively connectable to a distal end of the elongate drive shaft portion of the electromechanical driver, the surgical attachment assembly further includes: a first jaw; a second jaw coupled to the first jaw and being couplable to a distal end of a respective one of the elongate drive shaft portion, wherein the first and second jaws are movable relative to one another so as to staple a section of tissue disposed between the first and second jaws; and wherein the memory unit is further configured to store status information of the surgical attachment assembly and the identification information includes at least one of size, diameter, shape, length, and stapling arrangement of the surgical attachment assembly, and wherein the status information includes at least one of functionality and usage history of the surgical attachment assembly; wherein the memory unit of the surgical attachment assembly is in communication with the processor of the handheld electromechanical driver.

5. The surgical system according to claim 4, wherein at least one of the communications is wireless.

6. The surgical system according to claim 4, wherein the output display device displays at least one of identification information and status information.

7. The surgical system according to claim 6, wherein the output display device receives the at least one identification information and status information from the processor.

8. The surgical system according to claim 4, wherein the surgical attachment assembly incudes a sensor assembly capable of sensing and transmitting data corresponding to at least one of a condition of the section of tissue and an interaction between the section of tissue and the surgical attachment assembly.

9. The surgical system according to claim 8, wherein the processor of the handheld electromechanical driver is capable of receiving the data of the sensor assembly and controlling the handheld electromechanical driver in correspondence with the data of the sensor assembly.

10. The surgical system according to claim 9, wherein the sensor assembly is activated upon, and is capable of, receiving an activation signal transmitted by the processor of the handheld electromechanical driver.

11. The surgical system according to claim 10, wherein the handheld electromechanical driver further comprises an alert element in communication with the processor and capable of communicating at least one of an aspect of the data received by the processor and an aspect of the processor's control of the handheld electromechanical driver.

12. The surgical system according to claim 11, wherein communication from the alert element is communicated to and displayed by the output display device.

13. The surgical system according to claim 8, wherein the sensor assembly comprises a tissue proximity detector.

14. The surgical system according to claim 1, wherein the processor is capable of preventing activation of the handheld electromechanical driver.

15. The surgical system according to claim 3, wherein the first jaw of the surgical attachment assembly includes an anvil and the second jaw of the surgical attachment assembly includes a stapling arrangement configured to be driven by the handheld electromechanical driver.

16. The surgical system according to claim 1, wherein the power source is a battery, and wherein the battery is at least one of rechargeable and removable from the handle portion.

17. The surgical system according to claim 1, wherein the at least one actuation member is located adjacent a first surface of the handle portion, and wherein the output display device is supported on a second surface of the handle portion, wherein the second surface of the handle portion is opposite the first surface of the handle portion.

18. The surgical system according to claim 1, wherein the handle portion has a pistol grip configuration defining a lower hand grip portion and an upper body portion, wherein the output display device is supported on the upper body portion of the handle portion.

19. The surgical system according to claim 1, wherein the at least one motor is disposed distal of the power source.

20. The surgical system according to claim 3, wherein at least one torque transmitting shaft is rotatably disposed within the elongate drive shaft portion and operatively connected to a respective motor.

Description

A BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a side perspective view of an anastomosing, resecting, and stapling instrument of the prior art;

(2) FIG. 2 is a side cross-section view of a handle and flexible shaft of the present invention, wherein important internal features of the control systems are provided in detail;

(3) FIG. 3 is a side cut-away view of an anastomosing, resecting, sensing, and stapling attachment which is also an aspect of the present invention; and

(4) FIG. 4 is a flow chart illustrating the logical sequence of processor, sensor, and mechanical actions which are illustrative of features of the present invention.

A DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(5) While the present invention will be described more fully hereinafter with reference to the accompanying drawings, 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 in the art may modify the invention herein described while achieving the functions and results of this invention. Accordingly, the descriptions which follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the present invention and not as limiting of such broad scope. Like numbers refer to similar features of like elements throughout.

(6) Referring now to FIG. 2, with respect to the electromechanical driver 100, the driver has a handle portion 102 and a flexible drive shaft portion 104. The handle 102 includes a portion which is shaped in a manner which is easily gripped by the surgeon operator, for example, in the embodiment provided herein the handle comprises a pistol grip-styled portion 106. The grip portion 106 includes at least two, and in the present embodiment exactly two, independently finger-actuatable triggers 108a,108b. The finger triggers 108a,108b are independently coupled to separate motors 110,112, housed within the interior volume of the handle 100. Each motor 110,112 turns a separate flexible drive shaft (described more fully, hereinbelow).

(7) More particularly, with respect to the motors 110,112, each is a dual direction motor. In addition to being coupled to the finger-actuatable switch, the motors are also each separately coupled to a power source 114 (which is a common source in the present embodiment) and a manual drive switch 116. The manual drive 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 supplying the motors 110,112 is a single direct current supplying removable and rechargeable battery pack. It shall be understood that alternative power sources, including dual direct current sources or single remote alternating current sources (such as the alternating current provided from standard United States 120 Volt, 60 Hertz wall outlets) may be used in conjunction with alternative embodiments. In the event that the driver device should be useable with an alternating current, either a transformer can be included between the motor and the power source, or a more sophisticated intermediate gearing assembly may be provided between the motor and the extended turning drive shaft.

(8) In addition to the motors 110,112 components and the related power and drive switch elements, the handle 100 further includes a motor driven shaft steering carriage assembly, which is coupled to a manual input means, which is coupled to steering wires in the flexible shaft for selectively steering the distal tip of the flexible drive shaft 122.

(9) The handle also includes 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 electrical 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 electrical cable 144 to an input terminal 146 at the distal tip of the flexible shaft 122.

(10) More particularly, with respect to the flexible shaft 122, the shaft comprises a tubular sheath 128 which is formed of a simple, tissue compatible, elastomeric material. As this device is to be reused, it is important that the material be sterilizable (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 having ordinary skill in the art may provide an alternative embodiment having 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 include an interface between the proximal end of the shaft and the distal end of the handle which should include a coupling means for the drive components.

(11) Specifically regarding the drive components 130a,130b of the shaft 122, within the elastomeric sheath 128 are a pair of smaller fixed tubes 134a,134b which each contain a flexible drive shaft 136a,136b which is capable of rotating within the corresponding tube 134a,134b. The flexible drive shaft 122, itself, simply must be capable of translating a torque from the motor in the handle to the distal end 138a,138b of the shaft 122, while still being flexible enough to be bent, angled, curved, etc. as the surgeon deems necessary to snake through the colon of the patient. For example, the drive shafts may comprise a woven steel fiber cable, a high tensile strength polymeric material, or a sufficiently flexible unitary metal shaft.

(12) In order for the distal ends 138a,138b of the drive shafts 136a,136b to couple with an attachment, such as anastomosing, resecting, sensing, and stapling attachment, the distal tips 138a,138b of the drive shafts must have a conformation which permits the continued 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 into a hexagonal recesses in the coupling interface of the attachment. In a preferred embodiment, the attachment and the distal end of the shaft should include a collar, or other aligning means, for facilitating the fitting of the attachment onto the distal end of the shaft.

(13) In addition, the shaft includes an electrical wire 144 extending from the end coupled to the handle to the end which couples to the surgical attachment. The first end of the shaft includes the terminal inputs which are coupled to the processor unit. The second end includes a terminal 146 for coupling to the corresponding electrical input/output of the surgical attachment (described more fully hereinbelow).

(14) With reference now to FIG. 3, a preferred embodiment of the anastomosing and stapling attachment 200 is described. This attachment comprises an anvil portion 202, and a staple, blade, sensor, and reservoir (SBSR) portion 204, which includes a pair of turning drive shafts 206a, 206b which are coupleable to the drive components 136a, 136b of the driver component described above with reference to FIG. 2, and a corresponding pair of advancing and retracting members 208a, 208b mounted within tracks and to the turning drive shafts, which are thereby prevented from rotating and therefore linearly advance and retract along the shafts 206a, 206b when they turn. The anvil portion includes a series of light detectors. The SBSR includes pulse oximeter and tissue proximity sensors 150, 152 and a memory and signal transmitter and receiver member 155 which couples to the flexible shaft at the corresponding terminal thereon by way of an electrical coupler 158 shown.

(15) The anvil portion 202 is bullet shaped, having a blunt nosed top portion 210, a flat cutting support surface 212 on the bottom, and a coupling post 214 extending axially from the bottom surface. This coupling post 214 mounts to the first advancing and retracting member 208a which is mounted within 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 includes a series of light emitting diodes 154.

(16) The staple, blade, sensor, and reservoir portion (SBSR) portion 204 is cylindrical in shape, forming a housing which has a hollow interior 216. It is this hollow interior which forms the reservoir. On the axially outward facing surface 218 of the cylindrical wall 220 of the housing are a series of staple ports, through which the staples 224 of the device are discharged. A unitary blade and cylindrical staple driver component 226 is seated within the housing. A circumferential pulse oximeter 150 is mounted in the housing on the outside rim of the housing, radially adjacent to the staple ports. A pulse oximeter is a simple device which shines a specific frequency of light through a section of tissue to measure the absorption rate of the light. 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 series of light emitting elements 154 on the anvil and light sensors 150 mounted around the circumferential rim of the housing member. As shown, the components of the pulse oximeter are electrically connected via wires running through the coupling post of the anvil.

(17) In addition, the attachment also includes a tissue proximity sensor 152, a portion of which is similarly mounted to the external rim of the housing, radially adjacent to the pulse oximeter 150 and the staple ports. In addition, the tissue proximity detector 152 comprises a series of simple light emitting elements 154 on the anvil (for example the same light emitting elements of the pulse oximeter), and a corresponding series of light detectors 152 mounted around the circumferential rim of the housing member. In the proximity sensor, if the tissue which is supposed to be disposed between the anvil and housing is present, then the proximity sensor's light detectors will not receive a signal (or at least below a set threshold), alternatively, if the tissue is missing, then the light detectors will receive a stronger signal, indicating that there is no tissue blocking the transmission of the light.

(18) More particularly, the blade and staple driver component comprises a single element having two concentric cylindrical portions. The blade portion 228 seats within the hollow interior 216, against the interior wall 230 thereof. The staple driver portion 232 seats within the wall 230 of the SBSR portion and includes a series of outwardly projecting protuberances which push against staples mounted within the staple ports.

(19) The blade 228 and staple driver portions 232 are coupled at the interior end thereof to a threaded member 208b which seats around turning shaft 206b. The threaded member 208b is constrained within a linear track so that the blade and staple driver are advanced linearly upon rotation of the turning shaft 206b.

(20) In practice and with reference to the flow chart provided in FIG. 4, this attachment and the associated controller features of the present invention are utilized once the section of the colon to be removed has been resected and the two opposing ends of the adjacent bowel have been stapled shut. The surgeon begins by coupling the anastomosing, resecting, sensing, and stapling attachment 200 to the distal end of the flexible shaft. The processor in the handle unit queries the memory element in the attachment and requests identification information. The attachment transmits the requested information, including size, status and functionality information. The processor in the handle outputs this information to the display panel, for visual inspection by the surgeon user. The processor further establishes whether the surgeon may activate the driver means in correspondence to whether the information received from the attachment was acceptable (i.e., is it unused and functional).

(21) In the event that the identification information 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 inserted into 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 advancing and retracting member 208a by rotation of the corresponding drive shaft 136a. Subsequent reverse biasing and triggering of the same motor in the handle 100 causes the anvil 202 to retract toward the SBSR portion 204.

(22) Once retracted into the safe staple firing range, the processor disables the staple firing motor and again queries the attachment. In fact, the processor in 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.

(23) While there has been described and illustrated new and novel electromagnetic driver mechanisms having an attachment processor controller, for use with surgical attachments, it will be apparent to those skilled in the art that variations and modifications are possible without deviating from the broad spirit and principle of the present invention which shall be limited solely by the scope of the claims appended hereto.