Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/11/2024 has been entered.
Priority
The effective filing date of the claimed invention is 08-15-2019.
Applicant claims domestic benefit, and does not claim priority to a foreign application.
Information Disclosure Statement (IDS)
The IDS submitted on 08/29/2024 and 10/22/2024 are in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. Accordingly, the IDS are being considered by the Examiner.
Response to Amendment
This Action is in response to the Amendment filed 09/11/2024.
Claims 1, 9, and 15-18 are amended.
There is no new matter introduced.
Claims 1, 3-19, and 21-22 are pending.
Response to Arguments
Applicant's arguments filed 09/11/2024 have been fully considered but they are moot in view of the 35 USC 103 rejection of Zubiate et al. (US 20170100197 A1) in view of Romo et al. (US 2017/0340396 A1) directed to independent claims 1, 9, and 15.
Claim Objections
Claim 15 is objected to because of the following informalities:
In line 17 of claim 15, for the sake of consistency, “the shaft” should read as --the elongated flexible shaft--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-9, 12-15, 18-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zubiate et al. (US 2017/0100197 A1) (hereinafter “Zubiate”) in view of Romo et al. (US 2017/0340396 A1 cited previously) (hereinafter “Romo”).
Regarding claim 1, Zubiate teaches a method for a robotic medical procedure (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
Zubiate further teaches drive insertion of a flexible shaft of a medical instrument with a drive device at a first rate during a first insertion period when a distal tip of the flexible shaft is positioned within an access sheath inserted into a patient (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the probe is a flexible shaft of a medical instrument, the carriage drive segment is the drive device, and the introducer is the access sheath.).
Zubiate further teaches detecting that the distal tip of the flexible shaft is positioned beyond a distal tip of the access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
Zubiate further teaches reducing slack in the flexible shaft responsive to detecting that the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath; and transitioning to driving insertion of the flexible shaft of the medical instrument at a second rate that is slower than the first rate based at least in part on the reduced slack in the flexible shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).)
However, Zubiate does not expressly teach controlling a first robotic component to drive insertion; the first robotic component being coupled to the drive device and a second robotic component being coupled to a base of the medical instrument; detecting that the distal tip of the flexible shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component; and a flexible shaft between the first robotic component and the second robotic component.
Romo teaches methods for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo further teaches controlling a first robotic component to drive insertion, the first robotic component being coupled to the drive device and a second robotic component being coupled to a base of the medical instrument; and a flexible shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
Romo further teaches detecting the position of the distal tip of the flexible shaft is based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding claims 3-4, Zubiate in view of Romo teaches the invention of claim 1, and further teaches further comprising: driving retraction of the flexible shaft of the medical instrument with the drive device at a third rate during a first retraction period wherein the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath; and automatically transitioning to driving retraction of the flexible shaft of the medical instrument with the drive device at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the flexible shaft is positioned within the access sheath, wherein automatically transitioning to driving retraction of the flexible shaft of the medical instrument with the drive device at the fourth rate comprises detecting when the distal tip of the flexible shaft is positioned within the access sheath
(“In an embodiment, three of the bobbins 316a are configured to control the outer links, such as to steer, feed cable for articulating probe 400 advancement, retract cable for probe 400 retraction, transition probe 400 from a limp to a rigid state (e.g. to lock), and to transition probe 400 from a rigid to a limp state (e.g., to become flexible)” (Zubiate, par. [0289]). Based on par. [0289], Zubiate can perform probe retraction.
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.
“The steering module 150 comprises an integrator 151 and a steering processor 152 for executing some or all processes or computations of a steering procedure” (Zubiate, par. [0407]). Based on par. [0407], probe steering can be an automated procedure.).
Regarding claim 5, Zubiate in view of Romo teaches the invention of claim 1, as set forth above, and further teaches further comprising:
mounting the base of the medical instrument on the second robotic component (In Fig. 37D of Romo, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702);
mounting the drive device on the first robotic component (In Fig. 37D of Romo, the active drive mechanism 3713 is mounted on mechanical arm 3704); and
engaging the flexible shaft of the medical instrument with the drive device (In Fig. 37D, the active drive mechanism provides “active drive support” to the catheter 3701 (Romo, par. [0305]).
Regarding claim 6, Zubiate in view of Romo teaches the invention of claim 5, as set forth above, and further teaches wherein engaging the flexible shaft of the medical instrument with the drive device comprises engaging opposing rollers of the drive device with the flexible shaft (In Fig. 37D, “mechanical arms provide active drive support through the use of motorized rollers at the flange points of the arms” (Romo, par. [0305]).).
Regarding claim 7, Zubiate in view of Romo teaches the invention of claim 6, as set forth above, and further teaches wherein engaging the flexible shaft of the medical instrument with the drive device further comprises inserting the flexible shaft into a channel on an upper surface of the drive device (In Fig. 37D of Romo, the catheter 3701 is led between the rollers of the active drive mechanism 3713).
Regarding claims 8 and 19, Zubiate in view of Romo teaches the invention of claims 5 and 15, and further teaches further comprising:
moving the base towards the drive device with the second robotic component during insertion (In Fig. 37D of Romo, the mechanical arm 3702 leads the catheter 3701 towards mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.); and
moving the base away from the drive device with the second robotic component during retraction (In Fig. 37D of Romo, the mechanical arm 3702 pulls the catheter 3701 away from mechanical arm 3704 which has the active drive mechanism 3713 mounted to it.).
Regarding claim 9, Zubiate teaches a robotic medical system (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
Zubiate further teaches a drive device comprising a pair of rollers configured to engage a shaft of a medical instrument
(“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends” (Zubiate, par. [0292]). Based on par. [0292], the probe is a shaft of a medical instrument and the carriage drive segment is the drive device.
“In some embodiments, the mating capstans 216b and gears 316b can comprise carriage drive capstan/gear pairs for driving the inner link and outer link carriages 315a, 325b, respectively, of probe 400, which in turn advance and/or retract inner links and outer links of an inner link mechanism 420 and outer link mechanism 440, respectively” (Zubiate, par. [0349]). Based on par. [0349], carriage drive capstan(s) pair is the pair of rollers.).
Zubiate further teaches a processor (“FIG. 23 is a block diagram of a steering system 153, in accordance with the present inventive concepts. The steering system 153 includes an HID 122 and a steering module 150” (Zubiate, par. [0405]).).
Zubiate further teaches operate the rollers to drive insertion of the shaft at a first rate during a first insertion period when a distal tip of the shaft is positioned within an access sheath inserted into a patient (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the introducer is the access sheath.).
Zubiate further teaches detecting that the distal tip of the shaft is positioned beyond a distal tip of the access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
Zubiate further teaches reduce slack in the shaft responsive to detecting that the distal tip of the shaft is positioned beyond the distal tip of the access sheath; and drive insertion of the shaft at a second rate that is slower than the first rate based at least in part on the reduced slack in the shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).)
However, Zubiate does not expressly teach a first robotic component being coupled to the drive device and configured to control the drive device; a second robotic component being coupled to a base of the medical instrument; detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component; and a shaft between the first robotic component and the second robotic component.
Romo teaches systems for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo further teaches: a first robotic component coupled to the drive device and configured to control the drive device (Mechanical arm 3704 is coupled to active drive mechanism 3713. Arm 3704 controls where mechanism 3713 is positioned during a medical procedure (Romo, par. [0305]).).
Romo further teaches a second robotic component coupled to a base of the medical instrument (Mechanical arm 3702 is coupled to tool base 3709 of catheter 3701 (Romo, par. [0301]).)
Romo further teaches a shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
Romo further teaches detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding claims 12 and 18, Zubiate in view of Romo teaches the invention of claims 9 and 15, and further teaches
wherein the processor is further configured to: operate the rollers to drive retraction of the shaft of the medical instrument at a third rate during a first retraction period when the distal tip of the shaft is positioned beyond the distal tip of the access sheath; and operate the rollers to drive retraction of the shaft of the medical instrument at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the shaft is positioned within the access sheath;
wherein the processor is further configured to: drive retraction of the elongated flexible shaft of the medical instrument at a third rate during a first retraction period when the distal tip of the elongated flexible shaft is positioned beyond the distal tip of the elongated flexible access sheath; and transition to driving retraction of the elongated flexible shaft of the medical instrument at a fourth rate that is faster than the third rate during a second retraction period when the distal tip of the elongated flexible shaft is positioned within the elongated flexible access sheath
(“In an embodiment, three of the bobbins 316a are configured to control the outer links, such as to steer, feed cable for articulating probe 400 advancement, retract cable for probe 400 retraction, transition probe 400 from a limp to a rigid state (e.g. to lock), and to transition probe 400 from a rigid to a limp state (e.g., to become flexible)” (Zubiate, par. [0289]). Based on par. [0289], Zubiate can perform probe retraction.
Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0289] and [0292], during the retraction, probe 400 initially moves in a controlled fine motion, but once it has been detected that the probe has entered introducer 480, the probe 400 rapidly moves.).
Regarding claim 13, Zubiate in view of Romo teaches the invention of claim 9, as set forth above, and further teaches further comprising: wherein the first robotic component is a first robotic arm (In Fig. 37D, mechanical arm 3704) and the second robotic component is a second robotic arm (In Fig. 37D, mechanical arm 3702).
Regarding claim 14, Zubiate in view of Romo teaches the invention of claim 13, as set forth above, and teaches further comprising: the second robotic arm is configured to move the base of the medical instrument towards the drive device during insertion (In Fig. 37D of Romo, the mechanical arm 3702 can lead the catheter 3701 towards mechanical arm 3704, which has the active drive mechanism 3713 mounted to it.); and the first robotic arm is configured to move the base of the medical instrument away from the drive device during retraction (In Fig. 37D of Romo, the mechanical arm 3704, which has the active drive mechanism 3713 mounted to it, can pull away from tool base 3709 of the catheter 3701.).
Regarding claim 15, Zubiate teaches a robotic medical system (“articulating probe assemblies, systems and methods incorporating the same, and systems and methods for performing a surgical procedure” (Zubiate, par. [0043])).
Zubiate further teaches an elongated flexible access sheath (“The introducer 480 can be constructed and arranged to slidingly receive an articulating probe such as the articulating probe 400, and support, stabilize, and/or guide the articulating probe to a region of interest. The region of interest may be a lumen of a body of a patient (P), such as a cavity at the patient's head (H), e.g., a nose or mouth, or an opening formed by an incision” (Zubiate, par. [0275]). Based on par. [0275], the introducer can accommodate different orifice configurations of a patient.).
Zubiate further teaches a medical instrument comprising an elongated flexible shaft configured to be received in a drive device (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], the probe is an elongated flexible shaft of a medical instrument and the carriage drive segment is the drive device.).
Zubiate further teaches a processor (“FIG. 23 is a block diagram of a steering system 153, in accordance with the present inventive concepts. The steering system 153 includes an HID 122 and a steering module 150” (Zubiate, par. [0405]).).
Zubiate further teaches drive insertion of the elongated flexible shaft with the drive device at a first rate during a first insertion period when a distal tip of the elongated flexible shaft is positioned within the elongated flexible access sheath (“A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]).).
Zubiate further teaches detect that the distal tip of the elongate flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath “A carriage drive segment 310 is attached distally to a reinforced introducer 480, through which probe 400 extends. Introducer 480 can be used for guiding the probe 400′s initial path through or toward a target area such as, for example, when introducer 480 comprises an outer surface similar to a body cavity shape found in a majority of patients. Probe 400 can be configured to rapidly advance through introducer 480, prior to fine motion control used after probe 400 exits introducer 480, for example, when performing a medical procedure on a patient using the probe 400” (Zubiate, par. [0292]). Based on par. [0292], it is implied that there is detection of when the probe 400 exits the introducer 480, so as to change control of probe movement from rapidly advancing to fine motion control.).
Zubiate further teaches reduce slack in the elongated flexible shaft responsive to detecting that the distal tip of the elongated flexible shaft is positioned beyond the distal tip of the elongated flexible access sheath; and transition to driving insertion of the shaft at a second rate that is slower than the first rate based at least in part on the reduced slack in the elongated flexible shaft (“The method of FIG. 27 actively manages a cable payout offset that is applied to the two or more (e.g. three) outer mechanism 440 tensioning cables such that 1) when steering “quickly” (as determined by a velocity or acceleration assessment, such as when beginning or in the middle of a steering maneuver, and/or by assessing the amount of steering called for by the user (e.g. the offset of the HID from the neutral position)), the outer links 441 are loosely tensioned with a larger cable payout offset, and 2) when steering “slowly” (e.g. at the end of a steering maneuver, and/or when the offset of the HID from the neutral position is small or minimal), the outer links 441 are more tightly tensioned with a smaller cable payout offset. Thus, the method of FIG. 27 provides for the constant monitoring of the steering input from the user and, in response to steering motion values generated from the monitoring, smoothly varies the tension of one or more cables to anticipate the end of a steering move by tightening the tensioning cables as the steering command slows. Once the steering command ends (i.e. the user is no longer directing the probe to steer via the HID or other input mechanism), articulating probe 400 is already in a partially locked state—because the cables are tensioned thus reducing the additional tension that is required to fully lock articulating probe 400 (e.g. reducing unwanted motion caused by applying tension to cables). The method of FIG. 27 can smoothly ramp cable payout from low to high tension based on the assessment performed in step 2702 (e.g. slower payout when less aggressive steering detected)” (Zubiate, par. [0433]).).
However, Zubiate does not expressly teach a drive device that is coupled to a first robotic component, the medical instrument further comprising an instrument handle configured to couple to a second robotic component; detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on a position of the second robotic component relative to a position of the first robotic component; and the elongated flexible shaft between the first robotic component and the second robotic component.
Romo teaches systems for moving or manipulating robotic arms (Romo, Abstract). Field of the present application pertains to medical devices (Romo, par. [0003]). Romo further teaches a medical instrument comprising an elongated flexible shaft configured to be received in a drive device that is coupled to a first robotic component (In Fig. 37D, catheter 3701 is received by active drive mechanism 3713, which is coupled to mechanical arm 3704 (Romo, par. [0305]).).
Romo further teaches the medical instrument further comprising an instrument handle configured to couple to a second robotic component (Mechanical arm 3702 is coupled to tool base 3709 of catheter 3701 (Romo, par. [0301]).).
Romo further teaches a shaft between the first robotic component and the second robotic component (In Fig. 37D, catheter 3701 is mounted to tool base 3709 of mechanical arm 3702, and the active drive mechanism 3713 is mounted on mechanical arm 3704. Active drive mechanism 3713 controls insertion of catheter 3701 through the use of motorized rollers (Romo, par. [0305]).).
Romo further teaches detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on a position of the second robotic component relative to a position of the first robotic component (See Fig. 2A of Romo. Proximal end 222 of leader 212 is mounted to tool base 208 of second arm 204, and tool base 206 (which can provide mechanical actuation (e.g., motor driven axels) (Romo, par. [0124])) is mounted to first arm 202. Here, robotic arms are arranged to form a “virtual rail” (Romo, par. [0121]) and can move leader 212 deeper into the patient. Detection of arm positions can occur by using registration targets (Romo, par. [0131]). Based on the positioning of the arms, the positioning of the distal end 220 of the leader 212 can be deduced.).
It would have been obvious to one of ordinary skill in the art to include the catheter and active drive mechanism supported by robotic arms of Romo in the invention of Zubiate in order to “support intuitive control and management of flexible and/or steerable elongate devices, such as steerable catheters, that are suitable for use during minimally invasive medical techniques” (Romo, par. [0004]).
Regarding claim 22, Zubiate in view of Romo teaches the invention of claim 1, as set forth above, and further teaches wherein the detecting that the distal tip of the flexible shaft is positioned beyond the distal tip of the access sheath is based on driver data associated with driving the drive device (See Fig. 17A of Romo. The instrument device manipulator (IDM) 1703 uses angular motion transmitted via output shafts in order to control the robotic catheter 1704 (Romo, par. [0188]).).
Claims 10-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zubiate (US 20170100197 A1) in view of Romo (US 2017/0340396 A1), as applied to claims 9 and 15, and further in view of Diolaiti (US 2009/0326552 A1 cited previously).
Regarding claims 10-11 and 16-17, Zubiate in view of Romo teaches the invention of claims 9 and 15, but does not expressly teach lines 3-4 of claim 10, line 3 of claim 11, lines 3-4 of claim 16, and lines 3-4 of claim 17.
Diolaiti discloses a method for manipulating a medical robotic system in par. [0006] - [0008]. Diolaiti further teaches
wherein the processor is configured to detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on geometric information indicating at least one of a length of the shaft;
wherein the processor is configured to detect that the distal tip of the shaft is positioned beyond a distal tip of the access sheath based on image information obtained with the medical instrument
wherein the processor is configured to detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on geometric information associated with the elongated flexible access sheath and the elongated flexible shaft,
wherein the processor is configured to detect that the distal tip of the elongated flexible shaft is positioned beyond a distal tip of the elongated flexible access sheath based on image information obtained with the medical instrument
(“[D]etermining a length that the tip of the articulatable instrument extends beyond the distal end of the entry guide” (Diolaiti, claim 7), and “determine lengths that distal tips of the plurality of articulatable instruments extend beyond the distal end of the entry guide” (Diolaiti, claim 25). Furthermore, in applying the method [of Fig. 8], images of the articulatable instrument tip and entry guide tip reference are collected by camera 211 (Diolaiti, par. [0068]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the device component position detection of Diolaiti in the invention of Zubiate, as modified thus far, in order to properly guide instruments and maneuver them about a work site within a patient (Diolaiti, par. [0004]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Zubiate (US 20170100197 A1) in view of Romo (US 2017/0340396 A1), as applied to claim 1 above, and further in view of Shelton IV et al. (US 2020/0405403 A1 filed 06/27/2019 and cited previously) (hereinafter “Shelton IV”).
Regarding claim 21, Zubiate in view of Romo teaches the invention of claim 1, as set forth above, but does not expressly teach lines 2-5 of claim 21.
Shelton IV teaches a method of using a surgical modular robotic assembly (Shelton IV, Abstract). Shelton IV further teaches further comprising: using kinematics data to determine a distance between a distal end of the first robotic component and a distal end of the second robotic component; and determining the position of the second robotic component relative to the first robotic component based on the distance (“Based on the position or proximity signals, the base unit control circuit can determine the pose of each robotic arm, including the position and orientation of each arm, as well as the positional relationships between various arms such as a distance between a first robotic arm and a second robotic arm of the robotic arms 9002a-9002e” (Shelton IV, par. [0873]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the distance between a first robotic arm and second robotic arm of Shelton IV in the invention of Zubiate, as modified thus far, in order to “aggregate data to compile a more complete view of the surgical site and/or the surgical procedure in order to determine the best possible course of action” (Shelton IV, par. [0464]).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Darisse et al. (US 2014/0012288 A1) (hereinafter “Darisse”) teaches the following:
“[T]he feeding mechanism 16 is the feeding mechanism shown in Figs. 5A and 5B and described above, and used to independently cause both an inner core 12 and outer sleeve 14 of probe 10 to transition from rigid to flexible states; as well as independently advance and retract the inner core 12 and outer sleeve 14” (par. [0205]).
“Outer sleeve 14 may be advanced through introduction device 330 at an accelerated rate, such as a rate faster than is used during surgical or other high-precision manipulations” (par. [0206]).
“The accelerated rate may be achieved by increasing the speed of cable tensioning (inner core and outer sleeve transitioning from flexible to rigid states)” (par. [0207]).
Conclusion
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/P.M./Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792
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