Medical robot system

Abstract

A robotic surgical system is configured to control the movement and actuation of a single robotic arm and the movement and actuation of a plurality of instruments carried at the distal end of the robotic arm.

Description

Technical Field

[0001] Related Application Information This application is a continuation of U.S. Patent Application No. 17 / 804,428, filed on May 27, 2022, the content of which is incorporated herein by reference.

Background Art

[0002] The present invention relates to a robotic surgical system configured to control the movement and operation of a single robotic arm and the movement and operation of a plurality of instruments in gynecological treatment.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Summary of the Invention

Means for Solving the Problems

[0004] The principles of the present disclosure relate to a medical robotic system. For example, some aspects of the techniques described herein relate to a robotic arm having a plurality of movable arm segments, an endoscopic observation assembly removably coupled to a distal segment of the robotic arm, the endoscopic observation assembly having a long endoscopic shaft extending about a longitudinal axis to a distal end carrying an image sensor, and a stabilization device removably coupled to the distal segment of the robotic arm, the stabilization device having a long instrument shaft extending about the longitudinal axis and adapted to engage tissue to stabilize a patient's cervix.

[0005] A variation of the medical robotic system may further include a motor drive configured to manipulate various tools in the medical robotic system. For example, the motor drive can rotate the long endoscopic shaft about its longitudinal axis. The motor drive can also be configured to axially move the long endoscopic shaft along its longitudinal axis.

[0006] Also, the motor drive is configured to rotate the long instrument shaft about its longitudinal axis. The motor drive can also be configured to axially move the long instrument shaft along its longitudinal axis.

[0007] In some aspects, the techniques described herein further relate to a treatment instrument removably coupled to a distal segment of the robotic arm, the treatment instrument having a treatment instrument shaft extending about a longitudinal axis to a working end and configured for introduction through a working passage of the endoscopic observation assembly.

[0008] The motor drive unit of the present robotic system can be configured to rotate the treatment instrument shaft with respect to its longitudinal axis and / or to axially move the treatment instrument shaft with respect to its longitudinal axis. Examples of such treatment instruments include, but are not limited to, resection devices, ablation devices, coagulation devices, biopsy devices, and incision devices.

[0009] In an additional variation, the treatment instrument comprises a resection device with a moving cutting member, and the system comprises a resection motor drive unit for moving the moving cutting member that moves at least rotationally or axially.

[0010] A variation of the medical robotic system comprises a cervical sealing assembly coupled to at least one of the robotic arm and the endoscopic observation assembly. In an additional variation, the distal end of the cervical sealing assembly comprises a cervical seal configured for coaxial movement with an inner portion of the elongate endoscopic shaft.

[0011] Additionally, the present robotic system can comprise a motor drive unit adapted to move the cervical seal. A variation of the system comprises a contact sensor carried by the cervical seal and adapted to sense contact with the patient's cervix and transmit a signal indicating the presence or absence of contact to a control device. In an additional variation, the medical robotic system comprises a control device configured to activate the motor drive unit to move the cervical seal in response to a signal indicating the presence of contact from the contact sensor. A variation of the system comprises a contact sensor that is any one of a pressure sensor, a capacitance sensor, an impedance sensor, and an optical sensor. Alternatively, the contact sensor can comprise a plurality of contact sensors, including combinations of those listed above.

[0012] In some aspects, the technology described herein is a method for treating tissue in a patient's uterine cavity, the method comprising providing a robotic arm in a medical robotic system having a plurality of movable arm segments with a distal arm segment carrying a plurality of motor drives for moving at least one device coupled to the distal arm segment; removably coupling an excision device to the distal arm segment, the excision device having a elongate shaft extending about a longitudinal axis to a working end carrying a cutter configured to rotate and / or reciprocate axially; introducing the working end of the excision device trans-cervically into the patient's uterine cavity; actuating the excision device to rotate and / or reciprocate the cutter; and utilizing a control device to operate at least one of the plurality of motor drives to move the working end of the excision device in a predetermined pattern to excise tissue.

[0013] The method disclosed herein can further include a control device that operates the motor drives to move the working end in an axial pattern while actuating the cutter to excise tissue. The control device can also operate the motor drives to move the working end in a rotational pattern while actuating the cutter to excise tissue.

[0014] This disclosure is related to U.S. Patent Application No. 17 / 662,182, filed by the same applicant, the entire disclosure of which is incorporated herein by reference.

[0015] Additional aspects of the invention will become apparent from the following description of the exemplary embodiments and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016]

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Best Mode for Carrying Out the Invention

[0017] FIG. 1 shows a surgical robot system 100 comprising a vertical column or tower 105 carrying a surgical robot assembly with a robotic arm 110 operable from a console 112 with a user input interface 115 and an image display device 116, adapted for use in gynecological treatment, or other treatments with similar access requirements. The user input interface 115 can comprise one or more joysticks, roller balls, and other input mechanisms known in the art. The image display device 116 can be a touch screen that can further be used to direct the movement of the arm 110 and / or to control other operating parameters of the system 100, as described below. The robotic arm 110 can move with respect to a plurality of axes as provided by a plurality of drives and actuators. In one variation, the robotic arm 110 of the system 100 can comprise as a central unit a commercially available multi-segment robotic arm manufactured by KUKA Robotics Corporation, having an office at 51870 Shelby Parkway, Shelby Township, Michigan, 48315.

[0018] Referring to FIGS. 1 and 2, the base platform 118 below the robotic arm 110 is motor-driven to move vertically in the vertical rail 125 in the tower 105 of the rolling stand 104. In a variation, the robotic arm 110 is composed of seven movable arm segments 120A - 120G, and the base rotary arm segment 120A rotates relative to the base platform 118 (FIG. 2). The arm segments 120A - 120G are adapted to rotate as indicated by the arrows A - G in FIG. 2. The distal end 126 of the sixth arm segment 120F is connected to a seventh rotary segment 120G that is motor-driven to rotate. As described below, additional motor drives and surgical instruments are adapted to be removably connected to the rotary arm segment 120G. Referring to FIG. 3, in a surgical treatment, it can be understood that the robotic arm 110 can move the distal end of the instrument in all directions, angles, pitches, and yaws, such as directions X, Y, and Z.

[0019] Referring to FIGS. 2 and 3, it can be seen that the cooperating first and second instruments are adapted for attachment to the rotary segment 120G. The first instrument is a disposable endoscopic viewing assembly 140, and the second instrument is a disposable tissue resection device 145 configured for insertion through the working passage WC in the endoscopic viewing assembly 140. In FIG. 2, the endoscopic assembly 140 and the resection device 145 are shown removed from the rotary segment 120G of the robotic arm. In FIG. 3, the endoscopic assembly 140 and the resection device 145 are fully assembled with the robotic arm 110.

[0020] FIG. 4 and FIG. 5 are enlarged views of an endoscopic observation assembly 140 including an endoscope 150 (FIG. 4) and an endoscope drive component 152 (FIG. 5). The endoscope 150 is connected to a proximal hub 154 that extends about a longitudinal axis 158 to a long shaft 155 that carries an image sensor 162 and at least one LED, shown in this variation as two LEDs 164a and 164b (FIG. 4), to a working end 160. The endoscope 150 has a working passage WC with a proximal seal 168, and the working passage extends through the long shaft 155 to the working end 160 of the endoscope. In FIG. 4, it can be seen that the working end 160 of the endoscope has an S-shape or curvature in a resting or insertion configuration, with a small cross-section that allows for non-invasive introduction through the patient's cervical canal. The working passage WC has a distal region 172 that is expandable in cross-section to receive the shaft of a component of the resection device 145, shown in FIG. 6, or the shaft of any similar instrument with a straight rigid shaft. The working end 160 of the endoscope shaft 155 of FIG. 5, other related endoscopes with expandable working passages, and the system are described in more detail in co-owned U.S. Pat. Nos. 10,433,717 and 11,259,695, and co-owned U.S. Patent Applications Nos. 15 / 975,626, 16 / 351,909, 16 / 562,069, 16 / 848,050, 17 / 447,380, and 17 / 490,643, which patents are incorporated herein by reference.

[0021] Referring to FIGS. 4 and 5, it can be seen that the hub 154 of the endoscope 150 has a proximally extending portion 174 and a rotating ring portion 175 that carries two luer fittings 176a and 176b on the lower surface 177. The luer fitting 176a is adapted to connect to a fluid inflow pipe 178a from a pipe set of the fluid management system 180 shown in FIG. 1 and further described below. The second luer fitting 176b is adapted to connect to an outflow pipe 178b of the fluid management system 180 (FIG. 1). The inflow pipe 178a communicates with an inflow passage 182 in the endoscope shaft 155 with an open end 184 at the working end 170 (FIG. 4). The working passage WC in the endoscope shaft 155 functions as a fluid outflow passage and communicates with the luer fitting 176b and the outflow pipe 178b. The arrangement of components inside the rotating ring portion 175 that allows for inflow and outflow between the rotatable endoscope shaft 155 and the rotating ring portion 175 is described in more detail in co-owned U.S. Patent No. 10,433,717, which is incorporated herein by reference.

[0022] The upper surface of the rotating ring portion 175 includes a connector 185 for connecting an electrical cable 186 to the endoscope 150 for transmitting signals from the image sensor 162 to the image processing device and for transmitting current to the LEDs 164a - 164b. The rotating ring portion 175 includes a protruding key 192 that projects into a receiving notch 194 in the housing 195 of the drive component 152, and the protruding key 192 is adapted to maintain the rotating ring portion 175 in a proper position during use when the endoscope shaft 155 is rotated (see FIG. 5). The proper position of the ring portion 175 is useful for maintaining the inflow pipe 178a, the outflow pipe 178b, and the electrical cable 186 (FIG. 1) in a proper non-rotating position when the endoscope shaft 155 is rotated.

[0023] Referring now to FIG. 5, the endoscopic drive component 152 may be adapted for single - use or multiple - use, and typically is adapted for multiple - use. In a variation, the drive component 152 is removably coupled to the arm segment 120G by a pin 196 that mates with a hole 198 in the housing 195 of the drive component 152 (see FIG. 2).

[0024] Referring again to FIG. 5, the endoscopic drive component 152 carries a rotary receiving portion 200 that is adapted to receive the proximal extending portion 174 of the hub 154 of the endoscope 150. FIG. 5 shows that the proximal extending portion 174 has a keyed surface 202 that cooperates with a keyed surface 204 of the rotary receiving portion 200, which provides for rotational locking between the endoscope 150 and the drive component 152. The rotary receiving portion 200 is operably coupled by a suitable gear mechanism to a motor drive portion 205 carried in the drive housing 195 and is adapted to rotate the rotary receiving portion 200 and the endoscope 150 in the direction of arrow R1 in FIGS. 5 and 6 when locked in place. The motor drive portion 205 can be a DC stepping motor or other type of motor and is adapted to rotate the rotary receiving portion 200 and the endoscope 150 locked at a predetermined value through 180° to 360°. The gear mechanism can be any form of conventional straight gear that converts the rotation of the motor shaft into the rotation of the receiving portion 200.

[0025] Referring now to FIGS. 7 and 8, an ablation device 145 is shown and includes a motor - driven tubular cutter 210 and an instrument drive component 212. The drive component 212 can be adapted for single - use or multiple - use, and typically is adapted for multiple - use. In a variation, the instrument drive component 212 is removably coupled to the housing 195 of the endoscopic drive component by a pin 214a that mates with a hole 214b (FIG. 5) in the endoscopic drive housing 195. The instrument drive component 212 carries a movable receiving portion 220 in the drive component 212 that receives the extending portion 222 of the proximal housing 224 of the tubular cutter 210, and (i) a first DC motor 215A for rotating and (ii) a second DC motor 215B for axially moving the tubular cutter 210.

[0026] As can be seen in FIG. 6, the shaft 225 of the tubular cutter 210 is adapted for introduction through the working passage WC of the endoscope shaft 155 of FIGS. 4 and 5. It should be understood that other treatment instruments may be used in addition to the tubular cutter, such as any type of ablation device or coagulation device, RF device, biopsy device, ultrasonic device, laser device, dissection instrument, trocar, or manipulation instrument with the tubular cutter 210 shown for purposes of illustration.

[0027] Referring to FIGS. 7 and 8, the tubular cutter 210 has a proximal housing 224 connected to a long shaft assembly 225 that extends about an axis 228 to a working end 240 (FIG. 8) adapted for tissue resection. In FIG. 8, it can be seen that the shaft assembly 225 comprises concentric inner sleeve 244 and outer sleeve 245, and the inner sleeve 244 has an inner cutting window 246 that rotates at an outer cutting window 248 of the outer sleeve 245 for tissue resection (FIG. 8). The proximal housing 224 of the tubular cutter 210 carries a motor drive 250 for rotating the inner sleeve 244 and the inner cutting window 246 at an appropriate rotational speed in the range from 1,000 RPM to 10,000 RPM or more for cutting tissue.

[0028] Referring now to FIG. 7, the tubular cutter 210 is shown partially inserted into the instrument drive component 212. The rotation receiving portion 220 of the drive component 212 is adapted to receive the extending portion 222 of the proximal housing 224 of the tubular cutter 210. FIG. 7 shows that the extending portion 222 of the housing 224 has a keyed surface 252 that cooperates with the keyed surface 254 of the rotation receiving portion 220 to provide engagement in a locked rotation of the proximal housing 224 and the receiving portion 220. As can be understood, the shaft 225 of the tubular cutter 210 is further introduced through the seal 168 into the working passage WC of the endoscope 150 when assembled with other components as in FIGS. 1-3.

[0029] In the modification, the rotation receiving portion 220 in FIG. 7 is operably connected to the first motor drive portion 215A by a gear mechanism that rotates the movable receiving portion 220, such as the toothed surfaces 262a and 262b. The first motor drive portion 215A is adapted to rotate the receiving portion 220 and the engaged cutter 210 from 180° to 360°. This is indicated by arrow R2 in FIGS. 6 and 7. The instrument drive component 212 further carries a second motor drive portion 215B that is toothed to axially move the receiving portion 220 in the housing 264 of the drive component 212. A suitable gear mechanism can consist of a worm gear 268a that engages a feature 268b on the surface of the receiving portion 220. Thus, the second motor drive portion 215B is adapted to axially move the rotation receiving portion 220 (and the engaged tubular cutter 210) in the direction of arrow AX1 in the drive housing 212 when the tubular cutter 210 is locked in place. The motor drive portions 215A and 215B can again be DC stepping motors or other suitable types of motors. As can be understood, the second motor drive portion 215B moves the working end 240 of the tubular cutter 210 axially between a fully retracted position in the working passage WC of the endoscope 150 and an extended position of the working end 240 as shown in FIG. 3 that is within the field of view FOV of the endoscope image sensor 162 during treatment. The range of extension of the working end 240 beyond the endoscope 150 is up to 15 cm maximum beyond the plane of the lens of the image sensor 162.

[0030] Referring to FIGS. 7 and 8, it can also be seen that the tubular cutter 210 is configured for use with the fluid management system 180. The fluid outflow pipe 178b of the fluid management system 180 is connected to the luer fitting 268 in the housing 224 of the tubular cutter 210. The fluid outflow and the excised tissue are aspirated through the lumen of the inner sleeve 244 of the tubular cutter 210, as is technically known. In FIGS. 7 and 8, it can further be seen that the proximal housing 224 of the tubular cutter 210 has a rotatable surface portion 275 that can rotate freely about the central portion 276. The arrangement of the components inside the proximal housing 224 that allows for outflow from the tubular cutter 210 to communicate with the luer fitting 268 at the rotatable surface portion 275 is described in more detail in co-owned U.S. Patent No. 10,433,717, which patent is incorporated herein by reference. The rotatable surface portion 275 also carries a connector 277 for connection with the electrical cable 278 to conduct current to the motor 250 in the tubular cutter 210. The correct position of the rotatable surface portion 275 is useful for maintaining the outflow pipe 178b and the electrical cable 278 (FIG. 1) in a stable non-rotating position.

[0031] Referring now to FIG. 9, it can be seen how the endoscope viewing assembly 140 and the resection device 145 can be assembled and connected to the rotary robot arm segment 120G. The first drive component 152 is vertically lifted to connect to the pin 196 in the arm segment 120G. Thereafter, the extending portion 174 of the proximal hub 154 of the endoscope is inserted into the receiving portion 200 of the endoscope drive component 152. Next, the instrument drive component 212 and its pin 214a are fitted into the receiving hole 214b in the endoscope drive housing 195. Finally, the elongated shaft 225 of the tubular cutter 210 is introduced through the working passages WC of both drive components 152, 212 and the endoscope 150. FIGS. 1 and 3 show, by way of example, both the shaft 225 and the working end 240 of the tubular cutter 210 fully extended beyond the working end 160 of the endoscope 150. However, when using the robot arm 110, as shown in FIGS. 15A-15B, it should be understood that the endoscope shaft 155 is first introduced through the patient's cervical canal CC (FIGS. 16A-16B) with the working end 240 of the tubular cutter 210 retracted into the working passage WC of the endoscope 150.

[0032] Referring now to FIGS. 10 and 11, there are shown other robotic components configured for use with the system 100 of FIG. 1, comprising a tissue stabilization assembly 400 adapted to engage and hold a patient's cervix. In a typical intrauterine treatment using a transcervical approach, a physician uses a tenaculum or forceps to hold and stabilize the patient's cervix to facilitate introduction of an endoscopic shaft through the patient's cervical canal CC (FIGS. 16A-16B). In this robotic variant, the procedure is similar and the stabilization assembly 400 is a robotic assembly. FIG. 10 shows the tissue stabilization assembly 400 together with the proximal portions of the endoscopic viewing assembly 140 and the ablation device 145. The tissue stabilization assembly 400 also has a powered drive component 405 for driving an instrument or tenaculum component 410 more fully shown in FIG. 11. The tenaculum component 410 has a long shaft 415 extending about an axis 418 to a working end 420 (FIG. 11) with an openable first jaw 422a and second jaw 422b. FIGS. 10-11 show the working end 420 in the form of a conventional tenaculum, but it should be understood that suction contact working ends of gripping portions and other forms can be used to engage and stabilize a patient's cervix. In the illustrated variant, the drive component 405 of the stabilization device is similar to the instrument drive component 212 described earlier in FIG. 7 in that it also provides here two motor-driven parts for both rotation and axial movement of a receiving part 425 that receives the tenaculum component.

[0033] As can be seen in FIG. 10, the drive component 405 carries a first motor 428A and a second motor 428B configured to move the receiving part 425 in both rotation and the axial direction. The drive system can be the same as that described for the instrument drive component 212. The proximal handle or proximal housing 430 of the tenaculum 410 also includes here an extending portion 440 with a keyed surface 442 that cooperates with the keyed surface 444 in the receiving part 425. The tenaculum component 410 further carries a motor drive part 445 with a suitable gear mechanism such as a worm gear 446 for advancing and retracting the outer sleeve 448 of the shaft assembly 415 as indicated in FIG. 11 to open and close the jaws 422a and 422b. The proximal housing 430 also includes a connector 452 for connecting an electrical cable 454 to the housing 430 to send current to the motor 445. In FIG. 10, it can be seen that the drive component 405 of the stabilization device has a bracket 455 for connecting the tissue stabilization assembly 400 to the robotic arm 110, for example, with a plurality of pin arrangements of the type described previously. In one variation shown in FIG. 10, the intermediate portion of the bracket 455 of the drive component 405 of the stabilization device can include a flexible or elastic material 458 to allow bending between the drive component 405 of the stabilization device and other instruments.

[0034] FIG. 12 shows another component of the present invention comprising a cervical seal 460. Such a cervical seal 460 includes concentric sleeves 462 that slide over the shaft 155 of the endoscope 150. The cervical seal 460 can be pressed against the patient's cervix CC and optionally pushed into the cervical canal CC to prevent the inflation fluid from leaking from the uterine cavity through the cervical canal, and carries a tapered distal seal member 464 (see FIG. 16B). In this variation, the cervical seal 460 is mounted on the endoscope shaft 155 during manufacture and is manually axially moved by a locking mechanism 465 at the proximal end of the sleeve 462.

[0035] Referring now to FIGS. 13 and 14, there is shown a robotically controlled cervical seal 480 that also includes here a sleeve 482 extending over the endoscope shaft 155 by a distal tapered seal member 484 that contacts the patient's cervix. In this variation, referring to FIG. 14, there is provided a seal drive component 485 that is adapted to move the seal sleeve 482 robotically back and forth to maintain an appropriate seal. Similar to the other drive components described above, the seal drive component 485 unit has a DC motor 486 that drives a worm gear 488 that engages a protrusion feature 490 in the sleeve 482 to move the sleeve back and forth. In this variation, the drive component 485 has an open side slot 492 for receiving the sleeve 482 so that the drive component can be mounted across the endoscope 150 with its drive component 212 already assembled. In one method of use, the cervical seal sleeve 482 is manually advanced to engage the cervix and then the drive component 485 is positioned at a predetermined location to engage the seal sleeve 482 for continuous adjustment during an ablation treatment using the sensor system described below. The cervical seal sleeve 482 may require a wide range of movement and the robotic adjustment is optimized for more precise shorter axial movement when the seal member 484 is adjacent to the patient's cervix. In FIGS. 13 - 14, it can be seen that the seal drive component 485 has elongate mounting pins 495a and 495b that are adapted to couple to the housing 195 of the endoscope drive component 212 as seen in FIG. 14. In this variation, the mounting pins 495a and 495b carry electrical contacts 496a and 496b for engaging cooperating electrical contacts in the endoscope drive housing 195 to conduct current to the DC motor 486 in the seal drive component 485.

[0036] In one variation, the cervical seal 480 may have one or more sensors 498 as shown in FIG. 13 for sensing contact with the patient's cervix, and for sending a signal to the control device 500 to operate the drive component 485 to move the sealing member 484 to maintain proper engagement with the patient's cervix and prevent leakage of the inflation fluid. Such sensors 498 can be any suitable sensors, such as capacitance sensors, impedance sensors, pressure sensors, or optical sensors, with a wired connection through electrical contacts 496a and 496b to the control device 540 or the control device, or a wireless connection.

[0037] FIG. 14 shows four robot-driven components (endoscopic viewing assembly 140, resection device 145, tissue stabilization assembly 400, cervical seal 480), and the steps of assembling three of the components can be understood. During use, as described below, it can be understood that the illustration of the receiving part of the drive component may not be depicted to scale, and that the extendable dimensions of the instruments relative to each other may be significant. FIG. 15 shows the working end of the device, and it can be understood that the tenaculum shaft 415 is initially configured to extend up to a maximum of 10 cm beyond the endoscopic working end 160 to grip the patient's cervix (FIG. 16A). Thereafter, while the endoscopic shaft 155 is introduced through the patient's cervical canal CC, the tightened tenaculum working end 420 remains stationary as the drive component 152 is configured to extend the endoscopic working end 160 by a distance D1 in FIG. 15, which is up to a maximum of 15 cm beyond the tenaculum working end 420. Further, the instrument drive component 212 and the tubular cutter 210 are configured to extend the working end 240 of the tubular cutter by a distance D2 in FIG. 15, which is up to a maximum of 10 cm beyond the end of the working passage WC and the image sensor 162 (FIG. 16C). Also, the cervical seal member 484 requires a large range of axial adjustment along the endoscopic shaft 155, and both manual adjustment and robot adjustment are used as described above.

[0038] Referring back to FIG. 1, the fluid management system 180 is operably connected to the endoscope 150 and the tubular cutter 210, as is technically known. The fluid management system 180 includes an inflow peristaltic pump 500A and an outflow peristaltic pump 500B. The inflow pipe 178a has a proximal end connected to a fluid source 510 such as a saline bag, and the distal end of the inflow pipe 178a is connected to a luer fitting 176a on the lower surface of the endoscope handle 154. The inflow pump 500A is adapted to provide a fluid flow through the inflow pipe 178a and through the flow passage 182 in the endoscope shaft 155 to an outlet 184 at the working end 160 of the endoscope (see FIG. 4). In a variation, the outflow pipe 178b is connected to a luer fitting 176b in the endoscope 150 (FIG. 4), and a branch 515 of the outflow pipe 178b is connected to a luer fitting 268 in the tubular cutter 210 (FIG. 7). A valve or flow diverter 516 may be provided in the outflow pipe 178b to select the outflow fluid path from the endoscope 150 or the tubular cutter 210 (FIGS. 1 and 3). Thus, the fluid management system 180 enables the use of the endoscope 150 alone, and inflow and outflow occur through the endoscope shaft 155 when the cutting device does not occupy the working channel WC of the endoscope 150. When the tubular cutter 210 is positioned in the working channel WC as shown in FIG. 3, the outflow will flow through the tubular cutter 210 and through the fitting 268 in the handle 224. Thus, the outflow pump 500B is adapted to cause a fluid flow from the working space to the collection container 525. A tissue capture portion (not shown) may be provided in the outflow pipe 178b. An independent motor drive is provided to operate the first peristaltic pump 500A and the second peristaltic pump 500B, and is controlled by a control device 540 or a control device (FIG. 1) typically configured to maintain a set pressure in a working space such as a uterine cavity.

[0039] Referring now to FIGS. 16A - 16D, a schematic view in a robotic treatment for excising a uterine myoma 544 in a patient's uterus 545 is shown of the method of the present invention when using a robotic system 100 and various instruments. The uterine myoma 544 is shown on the wall of the uterine cavity 550, but it should be understood that in other variations of the method, the target tissue can be not only polyps, adhesions, endometrium, and other diseased tissues, but also fibroids or myomas. In FIG. 16A, after advancing the endoscope shaft 155 and the tenaculum shaft 415 into the patient's vagina 556, which can be opened and held by a suitable endoscope device (not shown), it can be understood that the user actuated the various segments of the robotic arm 110 to align with the external os 552 of the patient's cervix 554. FIG. 16A shows that, under the endoscope image, after the endoscope 155 and the tenaculum jaws 422a and 422b are robotically axially and rotationally maneuvered as needed, they are closed to grasp the cervix 554 to stabilize the cervix.

[0040] FIG. 16B shows a subsequent step of the method in which the user operates the robotic arm 110 to advance the endoscope working end 160 through the cervical canal CC into the uterine cavity 550 in its small cross - section or insertion profile. The fluid management system 180 is typically actuated to provide fluid inflow through the endoscope 150 to facilitate the introduction of the working end 160 through the cervical canal CC. The S - shaped end of the endoscope working end 160 may be rotated to optimally position itself relative to the tenaculum jaws for introduction into the cervical canal CC. FIG. 16B further shows the step of manually advancing the seal sleeve 482 and the seal member 484 towards the cervix 554 and the cervical canal CC.

[0041] FIG. 16C shows the seal sleeve 482 and the seal member 484 fully advanced into contact with the uterine neck 554 by either manual or drive member 485 to prevent the inflation fluid from leaking out of the cervical canal CC. FIG. 16C further shows that the user has actuated the instrument drive component 212 to advance the shaft 225 of the tubular cutter 210 through the working passage WC in the endoscope shaft 155 into the uterine cavity 550, thereby expanding the distal portion of the working passage WC as described above. FIG. 16C further shows that the robotic arm 110 has been actuated to move the distal end 160 of the endoscope 150 and the distal end 240 of the tubular cutter 210 in the direction or plane X to interact with the surface of the uterine fibroid 544.

[0042] FIG. 16D shows that the user has further actuated the robotic arm 110 to tilt the working end 240 of the tubular cutter 210 and the cutting window towards the uterine fibroid 544 to excise and remove the tissue. It should be understood that the steps of this method of excising the tissue may include axially moving and / or rotating the working end 240 of the cutter 210 slightly back and forth to excise the uterine fibroid 544. Further, the user may rotate the endoscope shaft 155 to reposition the image sensor 162 and the LED as shown in FIG. 6 to obtain the best view of the surface of the excised uterine fibroid 544. During the excision treatment, the seal drive component 485 can operate to adjust the seal 484 to maintain contact with the uterine neck and prevent fluid leakage as described above.

[0043] FIG. 16D shows steps of a method for excising uterine fibroids, but it should be further understood that the operating parameters of the tubular cutter 210 and the robotic system 100 can be controlled or automated during excision by the control device 540 of the robotic system 100 or a plurality of control devices. In a variation, for example, the fluid management system 180 can be controlled by the user from the user input interface 115 during excision, which includes adjusting any operating parameters of the fluid management system. The operating parameters of the fluid management system include (i) adjusting the set pressure in the uterine cavity, (ii) temporarily increasing the fluid inflow as a flushing mechanism to remove excised fragments or blood from the field of view, (iii) increasing the fluid pressure to a selected height over a selected time interval as a tampon insertion method, and (iv) adjusting the fluid deficiency level and warnings or system shutdowns associated with fluid deficiency. The user can also adjust the operating parameters of the endoscope 150 from the user input interface 115, including (i) adjusting the light from the LED and (ii) capturing images or videos of the treatment.

[0044] The user can also adjust the operating parameters of the tubular cutter 210 at the user input interface 115, including (i) adjusting the rotational speed of the inner cutting sleeve 144 and, in some variations, (ii) adjusting the vibration and / or translation of the inner cutting sleeve 144 within the outer sleeve during use. As is technically known, the tubular cutter can use a rotating cutting sleeve, a reciprocating cutting sleeve, or a cutting sleeve that rotates and axially translates.

[0045] In another variation of the method of excising tissue, referring to FIGS. 6 and 17, the control device 540 or the control device of the robotic system 100 can automate the parameters of the excision interval in a preset "excision plan" that operates such that the actuation of the drive components of the excision device and the motors of the robotic arm 110 move the working end 160 of the tubular cutter 210 in a preset movement while efficiently excising the tissue. For example, in FIG. 6, the user can select, via the user input interface 115, an excision plan "RP1" in which the inner cutting sleeve 144 is operated at a selected RPM between 1,000 RPM and 10,000 RPM, while the drive component 212 moves the working end 160 axially back and forth (in the direction AX1 in FIG. 6) over a selected reciprocating distance from 0.1 cm to 2 cm at a selected speed from 0.1 cm / sec to 1.0 cm / sec. The excision plan RP1 can operate for a preset number of seconds, such as between 5 seconds and 30 seconds, or can be started and ended by user input. Other preset excision plans (not shown) can operate the inner cutting sleeve 244 within the RPM range described above, while actuating the drive component 212 to rotate the working end 160 of the tubular cutter 210 at a selected speed range between 10° / sec and 90° / sec at angles from 10° to 180°. Another variation can consist of a preset excision plan "RP2" as shown in FIG. 17, which combines both reciprocating and rotational movements among the parameters described above to excise tissue over any preset time interval or by start and end by the user. FIG. 17 depicts separate consecutive axial and rotational movements, but zigzag movements are possible by simultaneous axial and rotational movements. While the working end 160 of the tubular cutter 210 is being used in any preset excision plan, the user can rotate the working end 160 of the endoscope 150 to optimally view the excision of the tissue (FIGS. 6 and 17).In any of the above resection plans, the user further operates the robotic arm to move the cutting working end 240 in any direction X, Y, or Z (FIG. 3) to optimally engage the target tissue.

[0046] In FIG. 1, a console 112 with a user input interface 115 is connected by a cable 580 to a control device 540 and a connector 582 at the base of the robotic arm 110. Various instruments and drive units 140 and 145 can also be connected to the connector 582 by cables such as cables 186 and 278 to provide power transmission and electrical signal transmission among all the instruments, the console 112, and the control device 540 or between the control devices. Although electrical cables are shown, it should be understood that electrical signal transmission may be wireless.

[0047] In another variation, referring back to FIGS. 4 and 5, the extending portion 174 of the housing 154 of the endoscope 150 received by the receiving portion 200 can carry one or more load sensors 590 or force sensors around the periphery of the housing that interact with the receiving portion 200 to sense the forces applied to the working ends 160, 240 and shafts 155, 225 of the endoscope 150 and the tubular cutter 210 during ablation therapy (FIG. 16D). Signals from the force sensors 590 are received by the control device 540, and a control algorithm can continuously monitor the forces and the directions of the forces in the shafts 155 and 225 of the device. In a variation, excessive forces, such as bending forces in the shafts 155 and 240, 225, can provide an audible or visual signal that the force exceeds a preset level, or the control algorithm can stop the operation of the ablation device to reduce the forces on the shafts 155 and 225 of the endoscope 150 and the tubular cutter 210, or can automatically initiate movement of the robotic arm in an appropriate direction. In another variation, any of the above preset ablation plans (e.g., RP1 of FIG. 6, RP2 of FIG. 17) can include an ablation plan that actuates the robotic arm 110 to move the working end 240 of the cutter 210 within a preselected range of X, Y, and Z movements (see FIG. 3), and the force sensing algorithm can further automatically control and maintain a preselected pressure at the working end 240 when the working end 240 engages and ablates tissue. It should be understood that such a force sensor 590 can be positioned on any instrument housing or any cooperating drive unit, and it may also be useful to sense the force in the tenaculum 410.

[0048] Generally, the robotic system 100 of the present invention includes a surgical robotic arm 110 with a base and a plurality of arm segments that rotate or translate with respect to a plurality of axes. At least one distal segment of the robotic arm is removably coupled to a disposable endoscopic observation system 140, an excision device 145, and a tissue stabilization system 400 that can all be operated by a robotic drive mechanism to move an instrument from a remote user input interface 115.

[0049] The method of the present invention for treating a target tissue in a patient's uterine cavity includes providing a robotic arm having a plurality of arm segments to provide movement of the robotic arm with respect to a plurality of axes, wherein a distal arm segment carries a disposable endoscope on a long shaft having a working passage, and the endoscope shaft has a first insertion outer shape in an unexpanded shape and a second expanded shape by introduction of a shaft of a treatment instrument through the working passage. Thereafter, the method of the present invention includes: (i) operating the robotic arm to introduce the endoscope shaft through the patient's cervix into the uterine cavity in its first insertion outer shape; (ii) introducing the shaft of the treatment instrument through the working passage, thereby expanding the working passage to its second expanded shape, and operating the robotic arm to move the working end to its expanded working outer shape; and (iii) treating the target tissue in the uterine cavity with the working end of the treatment instrument. Also, the robotic stabilization carried by the robotic arm can be used to stabilize the patient's cervix before introducing the endoscope through the patient's cervix.

[0050] Although specific embodiments of the present invention have been described in detail above, it is understood that this description is for illustrative purposes only and that the above description of the present invention is not comprehensive. Specific features of the present invention are shown in some of the drawings and not in others, but this is for convenience only, and any feature can be combined with other features according to the present invention. Some variations and alternatives will be apparent to those skilled in the art. Such alternatives and variations are intended to be included within the scope of the claims.

[0051] The specific features presented in the dependent claims can be combined and can fall within the scope of the present invention. Also, the present invention encompasses embodiments as if the dependent claims were written in the form of a plurality of dependent claims with reference to other independent claims.

[0052] It is important to note that, where possible, aspects of the various described embodiments, or the embodiments themselves, can be combined. In that case, such combinations are intended to be within the scope of this disclosure. All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference in their entirety as if each were individually and specifically indicated to be incorporated by reference and were set forth herein in full.

Description of Reference Numerals

[0053] 100 Surgical robot system 104 Rolling stand 105 Column, tower 110 Robot arm 112 Console 115 User input interface 116 Image display device 118 Base platform 120A Movable arm segment, base rotating arm segment 120B, 120C, 120D, 120E, 120F Movable arm segments 120G movable arm segment, rotating arm segment 125 vertical rail 126 distal end of the sixth arm segment 120F 140 endoscope observation assembly, endoscope observation system 144 inner cutting sleeve 145 tissue resection device 150 endoscope 152 endoscope drive components, first drive components 154 proximal hub, endoscope handle, housing 155 elongate shaft, endoscope shaft 158 longitudinal axis 160 endoscope working end, distal end 162 image sensor, endoscope image sensor 164a, 164b LED 168 proximal seal 170 working end 172 distal region 174 proximal extending portion 175 rotating ring portion 176a, 176b luer fittings 177 bottom surface 178a inflow pipe 178b outflow pipe 180 fluid management system 182 inflow passage, flow passage 184 open end, outlet 185 connector 186 electrical cable 192 protruding key 194 receiving notch 195 housing 196 pin 198 hole 200 rotation receiving portion 202, 204 keyed surfaces 205 motor drive unit 210 motor-driven tubular cutter 212 instrument drive components, drive housing 214a pin 214b hole, receiving hole 215A First DC motor, first motor drive unit 215B Second DC motor, second motor drive unit 220 Movable receiving part, rotary receiving part 222 Extension part 224 Proximal housing 225 Long shaft assembly 228 Shaft 240 Cutter working end, distal end 244 Inner sleeve 245 Outer sleeve 246 Inner cutting window 248 Outer cutting window 250 Motor drive unit 252, 254 Keyed surface 262a, 262b Toothed surface 264 Housing 268 Luer fitting 268a Worm gear 268b Characteristic part 275 Rotatable surface part 276 Central part 277 Connector 278 Electric cable 400 Stabilization assembly, tissue stabilization system 405 Drive parts 410 Instrument, tenaculum parts 415 Long shaft, shaft assembly, tenaculum shaft 418 Shaft 420 Working end, tenaculum working end 422a First jaw part 422b Second jaw part 425 Receiving part 428A First motor 428B Second motor 430 Proximal handle, proximal housing 440 Extension part 444 Keyed surface 445 Motor drive unit 446 Worm gear 448 Outer sleeve 452 Connector 454 Electric cable 455 Bracket 458 Flexible or elastic material 460 Cervical seal 462 Sleeve 464 Tapered distal seal member 465 Locking mechanism 480 Cervical seal 482 Cervical seal sleeve 484 Distal tapered seal member, sealing member, cervical seal member 485 Seal drive component, drive member 486 DC motor 488 Worm gear 490 Protrusion feature 492 Open side slot 495a, 495b Mounting pin 496a, 496b Electrical contact 498 Sensor 500 Control device 500A Inflow peristaltic pump 500B Outflow peristaltic pump 510 Fluid supply source 515 Branch portion 516 Valve, flow bypass 525 Collection container 540 Control device 544 Uterine myoma 545 Uterus 550 Uterine cavity 552 External os of uterus 554 Cervix 556 Vagina 580 Cable 582 Connector 590 Load sensor, force sensor A Rotation of arm segment 120A AX1 Reciprocating movement of rotation receiving portion 220 B Rotation of arm segment 120B C Rotation of arm segment 120C CC Endocervical canal, cervix D Rotation of arm segment 120D Distance of extension of the working end 420 of D1 Distance of extension of the working end 240 of D2 Rotation of the arm segment 120E Rotation of the arm segment 120F FOV Field of view Rotation of the arm segment 120G Rotation of the rotation receiving part 200 and the endoscope 150 Rotation of the receiving part 220 and the cutter 210 RP1, RP2 Resection plan WC Working channel X direction, plane

Claims

1. A medical robot system for use in intrauterine treatment, comprising: A robotic arm having a plurality of movable arm segments; An endoscopic observation assembly removably coupled to the distal segment of the robotic arm, the endoscopic observation assembly having a long endoscopic shaft extending around a longitudinal axis to a distal end carrying an image sensor; A stabilization device removably coupled to the distal segment of the robotic arm, the stabilization device having a long instrument shaft extending around a longitudinal axis and adapted to engage tissue to stabilize the patient's cervix; A treatment instrument removably coupled to the distal segment of the robotic arm, the treatment instrument having a treatment instrument shaft extending around a longitudinal axis to a working end and configured for introduction through a working passage of the endoscopic observation assembly; A motor drive configured to axially move the long instrument shaft relative to its longitudinal axis, the motor drive being configured to rotate the treatment instrument shaft relative to its longitudinal axis and to axially move the treatment instrument shaft relative to its longitudinal axis; A medical robot system comprising the above components.

2. The medical robot system according to claim 1, further comprising an endoscopic motor drive configured to rotate the long endoscopic shaft relative to its longitudinal axis.

3. The medical robot system according to claim 1, further comprising an endoscopic motor drive configured to axially move the long endoscopic shaft relative to its longitudinal axis.

4. The medical robot system according to claim 1, wherein the endoscopic observation assembly carries a working passage extending therethrough.

5. The medical robot system according to claim 1, wherein the treatment instrument comprises at least one of a resection device, an ablation device, a coagulation device, a biopsy device, and an incision device.

6. The medical robot system according to claim 1, wherein the treatment instrument comprises a resection device with a movable cutting member, and the medical robot system further comprises a resection motor drive for moving the movable cutting member at least rotationally or axially.

7. The medical robot system according to claim 1, further comprising a cervical canal sealing assembly connected to at least one of the robot arm and the endoscopic observation assembly.

8. The medical robot system according to claim 7, further comprising a contact sensor carried by the cervical canal sealing assembly, the contact sensor being adapted to sense contact with the patient's cervix and transmit a signal indicating the presence or absence of the contact to a control device.

9. The medical robot system according to claim 8, wherein the control device is configured to operate the motor drive unit to move the cervical canal sealing assembly in response to the signal indicating the presence of the contact from the contact sensor.

10. The medical robot system according to claim 8, wherein the contact sensor is at least one of a pressure sensor, a capacitance sensor, an impedance sensor, and an optical sensor.

11. The medical robot system according to claim 1, further comprising a cervical canal sealing assembly connected to at least one of the robot arm and the endoscopic observation assembly.

12. A medical robot system for use in intrauterine therapy, a robot arm having a plurality of movable arm segments, an endoscopic observation assembly removably connected to the distal segment of the robot arm, the endoscopic observation assembly having a long endoscopic shaft extending around a longitudinal axis to a distal end carrying an image sensor, a stabilization device removably connected to the distal segment of the robot arm, the stabilization device having a long instrument shaft extending around a longitudinal axis and adapted to engage tissue to stabilize the patient's cervix, a cervical canal sealing assembly connected to at least one of the robot arm and the endoscopic observation assembly, the distal end of the cervical canal sealing assembly comprising a cervical seal configured for coaxial movement with an inner portion of the long endoscopic shaft, a motor drive unit adapted to move the cervical seal and comprising a medical robot system.

13. A medical robot system according to claim 12, further comprising a contact sensor carried by the cervical seal, the contact sensor being adapted to sense contact with the patient's cervix and transmit a signal indicating the presence or absence of the contact to a control device.

14. The medical robot system according to claim 13, wherein the control device is configured to operate the motor drive unit to move the cervical seal in response to the signal indicating the presence of the contact from the contact sensor.

15. The medical robot system according to claim 13, wherein the contact sensor is at least one of a pressure sensor, a capacitance sensor, an impedance sensor, and an optical sensor.

16. A medical robot system for use in intrauterine therapy, comprising a robotic arm having a plurality of movable arm segments, an endoscopic observation assembly removably coupled to a distal segment of the robotic arm, the endoscopic observation assembly having a long endoscopic shaft extending around a longitudinal axis to a distal end carrying an image sensor, and a working passage extending through the endoscopic observation assembly, and a stabilization device removably coupled to a distal segment of the robotic arm, the stabilization device having a long instrument shaft extending around a longitudinal axis and adapted to engage tissue to stabilize the patient's cervix. A medical robot system.

17. The medical robot system according to claim 16, further comprising a motor drive unit configured to rotate the long endoscopic shaft about its longitudinal axis.

18. The medical robot system according to claim 16, further comprising a motor drive unit configured to axially move the long endoscopic shaft along its longitudinal axis.

19. The medical robot system according to claim 16, further comprising a motor drive unit configured to rotate the long instrument shaft about its longitudinal axis.

20. The medical robot system according to claim 16, further comprising a motor drive unit configured to axially move the long instrument shaft along its longitudinal axis.

21. A treatment instrument removably connected to the distal segment of the robot arm, having a treatment instrument shaft that extends around the longitudinal axis to a working end and is configured for introduction through the working passage of the endoscope observation assembly, further comprising a treatment instrument, the medical robot system according to claim 20.

22. The medical robot system according to claim 21, wherein the motor drive unit is configured to rotate the treatment instrument shaft about its longitudinal axis.

23. The medical robot system according to claim 21, wherein the motor drive unit is configured to axially move the treatment instrument shaft with respect to its longitudinal axis.

24. The medical robot system according to claim 21, wherein the treatment instrument comprises at least one of a resection device, an ablation device, a coagulation device, a biopsy device, and an incision device.

25. The treatment instrument comprises a resection device with a moving cutting member, and the medical robot system comprises a resection motor drive unit for moving the moving cutting member that moves at least rotationally or axially, the medical robot system according to claim 24.

26. The medical robot system according to claim 16, further comprising a cervical canal sealing assembly connected to at least one of the robot arm and the endoscope observation assembly.

27. The medical robot system according to claim 26, wherein a distal end of the cervical canal sealing assembly comprises a cervical seal configured for coaxial movement with an inner portion of the long endoscopic shaft.

28. The medical robot system according to claim 27, further comprising a motor drive unit adapted to move the cervical seal.

29. The medical robot system according to claim 28, further comprising a contact sensor carried by the cervical seal, the contact sensor being adapted to sense contact with the patient's cervix and transmit a signal indicating the presence or absence of the contact to a control device.

30. The medical robot system according to claim 29, wherein the control device is configured to activate the motor drive unit to move the cervical seal in response to the signal indicating the presence of contact from the contact sensor.

31. The medical robot system according to claim 29, wherein the contact sensor is at least one of a pressure sensor, a capacitance sensor, an impedance sensor, and an optical sensor.

32. A method for treating tissue in a patient's uterine cavity, comprising: providing a robotic arm in a medical robot system, the robotic arm having a plurality of movable arm segments including a distal arm segment carrying a plurality of motor drives for moving at least one device coupled to the distal arm segment; removably coupling a resection device to the distal arm segment, the resection device having a long shaft extending around a longitudinal axis to a working end carrying a cutter configured to rotate and / or reciprocate axially; introducing the working end of the resection device trans-cervically into the patient's uterine cavity; actuating the resection device to rotate and / or reciprocate the cutter; utilizing a control device to operate at least one of the plurality of motor drives to move the working end of the resection device in a predetermined pattern to excise tissue. A method comprising the steps of:

33. The method according to claim 32, wherein the control device operates the motor drive to move the working end in an axial pattern while actuating the cutter to excise tissue.

34. The method according to claim 32, wherein the control device operates the motor drive to move the working end in a rotational pattern while actuating the cutter to excise tissue.

35. The method according to claim 32, wherein the control device operates at least one motor drive to move the working end in a rotational and axial pattern while actuating the cutter to excise tissue.

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