Surgical probe with independent energy source - Patents.com
Patent Information
- Application Number
- JP2023564145
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-04-20
- Filing Date
- 2022-04-20
- Publication Date
- 2025-04-11
AI Technical Summary
【0003】 本開示のプローブ、システム、および方法は、エネルギー源の改良された設置を提供する。いくつかの実施形態では、エネルギー源は、延在部を用いて、伸長プローブ軸からオフセットされる。エネルギー源のオフセットの量は、延在部のオフセットの量を変動させることによって、制御されることができる。エネルギー源は、ある距離だけオフセットされ、エネルギー源は、オフセット距離において、回転および並進され、組織を切除することができる。いくつかの実施形態では、プローブは、第2のエネルギー源を備える、第2の治療プローブを受容するように構成され、その中で第2のエネルギー源は、第1の治療プローブに対して回転および並進され、これは、位置正確度および安定性を改良することができる。いくつかの実施形態では、エネルギー源および延在部は、連結機構に結合され、エネルギー源をオフセットさせ、可変量のオフセットを用いて、エネルギー源を並進および回転させる。いくつかの実施形態では、第1および第2のエネルギー源は、独立して移動するように構成される。
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Abstract
Description
[Background technology]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 201,250, filed April 20, 2021, which is incorporated by reference in its entirety under 35 U.S.C. §119(e).
[0002] Previous approaches to tissue ablation involving energy sources may be sub-ideal in at least some respects. Research related to the present disclosure suggests that previous approaches may, at least in some cases, cut tissue with less accuracy and be somewhat more invasive than would be ideal. At least some of the previous approaches may position the energy source with less accuracy than would be ideal, which may lead to sub-ideal tissue ablation. Robotics approaches can provide positioning using computer control, but at least some of the previous robotics systems may not position the treatment element as accurately as would be ideal. Other factors such as tissue variability and movement may also make previous approaches sub-ideal in at least some cases. Although treatments involving more than one energy source have been proposed, previous approaches may, at least in some cases, provide sub-ideal coordination and positioning with more than one treatment probe. Summary of the Invention [Means for solving the problem]
[0003] The probes, systems, and methods of the present disclosure provide improved placement of the energy source. In some embodiments, the energy source is offset from the extended probe axis with an extension. The amount of offset of the energy source can be controlled by varying the amount of offset of the extension. The energy source is offset by a distance, and the energy source can be rotated and translated at the offset distance to ablate tissue. In some embodiments, the probe is configured to receive a second treatment probe comprising a second energy source, in which the second energy source is rotated and translated relative to the first treatment probe, which can improve positional accuracy and stability. In some embodiments, the energy source and the extension are coupled to a linkage mechanism to offset the energy source, translate and rotate the energy source with a variable amount of offset. In some embodiments, the first and second energy sources are configured to move independently.
[0004] In some embodiments, the linkage is coupled to a processor, and one or more of the energy sources are moved according to a treatment profile. In some embodiments, the probe is configured to engage multiple drive elements of the robotic arm and move one or more energy sources. In some embodiments, the robotic arm includes five or more drive elements, and the probe is configured to offset the energy source, rotate the energy source, translate the energy source, rotate a second energy source, and translate a second energy source while coupled to the five or more elements of the robotic arm.
[0005] (Incorporated by reference) All patents, applications, and publications referenced and identified in this specification are incorporated herein by reference in their entirety and shall be considered to be incorporated by reference in their entirety even if referenced elsewhere in this application. [Brief description of the drawings]
[0006] A better understanding of the features, advantages, and principles of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings.
[0007] [Figure 1] FIG. 1 shows a front view of a system for performing tissue ablation in a patient, according to some embodiments of the present disclosure.
[0008] [Diagram 2] FIG. 2 diagrammatically illustrates a system for performing tissue ablation in a patient, according to some embodiments of the present disclosure.
[0009] [Figure 3A] 3A and 3B show perspective views of a common base or mounting for supporting one or more robotic arms, according to some embodiments of the present disclosure. [Figure 3B] 3A and 3B show perspective views of a common base or mounting for supporting one or more robotic arms, according to some embodiments of the present disclosure.
[0010] [Figure 4A] 4A and 4B illustrate perspective and side views, respectively, of a system for performing tissue ablation on a patient, including a mobile base, according to some embodiments of the present disclosure. [Figure 4B] 4A and 4B illustrate perspective and side views, respectively, of a system for performing tissue resection on a patient, including a mobile base, according to some embodiments of the present disclosure.
[0011] [Figure 5A]5A and 5B show top views of the coupling between a treatment probe and a first robotic arm according to some embodiments of the present disclosure, with FIG. 5A showing the treatment probe and first robotic arm uncoupled and FIG. 5B showing the treatment probe and first robotic arm coupled. [Figure 5B] 5A and 5B show top views of the coupling between a treatment probe and a first robotic arm according to some embodiments of the present disclosure, with FIG. 5A showing the treatment probe and first robotic arm uncoupled and FIG. 5B showing the treatment probe and first robotic arm coupled.
[0012] [Figure 6A] FIG. 6A shows a drive element of a robotic arm for coupling to a surgical probe according to an embodiment of the present disclosure.
[0013] [Figure 6B] FIG. 6B illustrates a connection between the robotic arm and the treatment probe, according to some embodiments.
[0014] [Figure 7] FIG. 7 shows a probe with an energy source that is variably offset from the extension axis of the probe, according to some embodiments.
[0015] [Figure 8] FIG. 8 shows a probe as in FIG. 7 in a compact configuration with the energy source positioned toward the extension axis of the probe, according to some embodiments.
[0016] [Figure 9] FIG. 9 shows an isometric view of a probe as in FIGS. 8 and 9 in a compact configuration, according to some embodiments.
[0017] [Figure 10] FIG. 10 shows a cross-sectional view of the probe of FIGS. 7-9, according to some embodiments.
[0018] [Figure 11] FIG. 11 shows the internal drive structure of the probe of FIGS. 7-10, according to some embodiments.
[0019] [Figure 12A] 12A and 12B show top and side views, respectively, of a probe with a variable offset energy source configured for manual use, according to some embodiments. [Figure 12B] 12A and 12B show top and side views, respectively, of a probe with a variable offset energy source configured for manual use, according to some embodiments.
[0020] [Figure 13A] 13A-13C show cross-sectional views of a probe with an asymmetric internal structure to provide rotational stability, according to some embodiments. [Figure 13B] 13A-13C show cross-sectional views of a probe with an asymmetric internal structure to provide rotational stability, according to some embodiments. [Figure 13C] 13A-13C show cross-sectional views of a probe with an asymmetric internal structure to provide rotational stability, according to some embodiments.
[0021] [Figure 14A] 14A and 14B show a push / pull structure for offsetting an energy source, according to some embodiments. [Figure 14B] 14A and 14B show a push / pull structure for offsetting an energy source, according to some embodiments.
[0022] [Figure 15A] 15A-15D show a surface follower for positioning an energy source relative to depth from a tissue surface profile, according to some embodiments. [Figure 15B] 15A-15D show a surface follower for positioning an energy source relative to depth from a tissue surface profile, according to some embodiments. [Figure 15C] 15A-15D show a surface follower for positioning an energy source relative to depth from a tissue surface profile, according to some embodiments. [Figure 15D] 15A-15D show a surface follower for positioning an energy source relative to depth from a tissue surface profile, according to some embodiments.
[0023] [Figure 16A] 16A-16C show an energy source coupled to a surface follower with a pivot near the surface of the tissue follower, according to some embodiments. [Figure 16B] 16A-16C show an energy source coupled to a surface follower with a pivot near the surface of the tissue follower, according to some embodiments. [Figure 16C] 16A-16C show an energy source coupled to a surface follower with a pivot near the surface of the tissue follower, according to some embodiments.
[0024] [Figure 17A] 17A-17C show an energy source coupled to a surface follower with variable extension depth of the energy source from the follower to the tissue, according to some embodiments. [Figure 17B] 17A-17C show an energy source coupled to a surface follower with variable extension depth of the energy source from the follower to the tissue, according to some embodiments. [Figure 17C] 17A-17C show an energy source coupled to a surface follower with variable extension depth of the energy source from the follower to the tissue, according to some embodiments.
[0025] [Figure 18A]FIG. 18A illustrates deflection of a bendable link to deflect an energy source and provide rotational stability using an interlocking structure, according to some embodiments.
[0026] [Figure 18B] FIG. 18B shows a cross-sectional view of a probe as in FIG. 18A, according to some embodiments.
[0027] [Figure 18C] FIG. 18C shows a bottom view of the probe of FIGS. 18A-18B, according to some embodiments.
[0028] [Figure 18D] FIG. 18D shows deflection of the probe of FIGS. 18A-18C with a deflection angle of greater than 45 degrees from the extension axis of the probe, according to some embodiments.
[0029] [Figure 19A] 19A and 19B show side and top views, respectively, of a probe with an electrocautery wire whose cutting surface extends at an oblique angle to the bent elements, according to some embodiments. [Figure 19B] 19A and 19B show side and top views, respectively, of a probe with an electrocautery wire whose cutting surface extends at an oblique angle to the bent elements, according to some embodiments.
[0030] [Figure 20A] 20A and 20B show an energy source comprising a mechanical cutting element, according to some embodiments. [Figure 20B] 20A and 20B show an energy source comprising a mechanical cutting element, according to some embodiments.
[0031] [Figure 21A] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments. [Figure 21B] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments. [Figure 21C] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments. [Figure 21D] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments. [Figure 21E] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments. [Figure 21F] 21A-21F show a variable offset energy source comprising a variable offset water jet and a variable offset drainage lumen, according to some embodiments.
[0032] [Figure 22A] 22A and 22C show variable offset water jet and drainage lumens in a back-jet configuration, according to some embodiments. [Figure 22B] 22A and 22C show variable offset water jet and drainage lumens in a back-jet configuration, according to some embodiments. [Figure 22C] 22A and 22C show variable offset water jet and drainage lumens in a back-jet configuration, according to some embodiments.
[0033] [Figure 23] FIG. 23 illustrates a method of treating a patient, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] Detailed Description The following detailed description provides a deeper understanding of the features and advantages of the invention described in this disclosure through the embodiments disclosed herein. Although the detailed description includes many specific embodiments, these are provided only as examples and should not be construed as limiting the scope of the invention disclosed herein.
[0035] The systems and methods of the present disclosure are highly suitable for use with many probes and diagnostic and surgical procedures. Although reference is made to a probe with an energy source for prostate surgery, the present disclosure is highly suitable for use with many types of probes inserted into many types of tissues, cavities, and lumens, such as vascular cavities, nasal cavities and nares, urethral cavities, gastric cavities, airways, esophageal cavities, transesophageal, intestinal cavities, anal cavities, vaginal cavities, transabdominal, abdominal cavities, kidney surgery, ureteral surgery, kidney stone, prostate surgery, tumor surgery, cancer surgery, brain surgery, cardiac surgery, eye surgery, conjunctival surgery, liver surgery, gallbladder surgery, bladder surgery, spinal surgery, orthopedic surgery, arthroscopic surgery, liposuction, colonoscopy, intubation, minimally invasive incision, minimally invasive surgery, and others.
[0036] The systems and methods of the present disclosure are highly suitable for combination with previous probes such as imaging and therapy probes. Examples of such probes include, for example, laser therapy probes, water jet probes, RF therapy probes, radiation therapy probes, ultrasound therapy probes, ultrasound phacoemulsification probes, imaging probes, endoscopic probes, resecting endoscope probes, ultrasound imaging probes, A-scan ultrasound probes, B-scan ultrasound probes, Doppler ultrasound probes, transrectal ultrasound probes, sagittal ultrasound imaging probes, transverse ultrasound imaging probes, and transverse and sagittal ultrasound imaging probes.
[0037] The systems, methods, and devices of the present disclosure are highly suitable for combination with many previous surgical procedures, such as water jet enucleation of the prostate, transurethral resection of the prostate (TURP), holmium laser enucleation of the prostate (HOLEP), and surgical robotics systems and automated surgical procedures. The following patent applications are pending: No. PCT / US2013 / 028441, filed on February 28, 2013, entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT” and published as WO2013 / 130895; No. PCT / US2014 / 054412, filed on September 5, 2014, entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT” and published as WO2015 / 035249; No. PCT / US2014 / 054412, filed on March 9, 2020, entitled “ROBOTIC ARMS AND METHODS FOR TISSUE RESECTION AND TREATMENT” and published as WO2015 / 035249; No. PCT / US2020 / 021756, filed on November 4, 2020, entitled "SURGICAL PROBES FOR TISSUE RESECTION WITH ROBOTIC ARMS", published as WO / 2021 / 096741; No. PCT / US2020 / 058884, filed on June 23, 2021, entitled "INTEGRATION OF ROBOTIC ARMS WITH SURGICAL PROBES", published as WO / 2021 / 263276; and No. PCT / US2021 / 070760, filed on June 21, 2021, entitled "SYSTEMS AND METHODS FOR DEFINING AND MODIFYING RANGE OF MOTION OF PROBE USED IN PATIENTS" No. PCT / US2021 / 038175, entitled "IMPROVED HYPERTENSION TREATMENT" and published as WO / 2021 / 262565, the disclosure of which is incorporated by reference in its entirety, describes examples of systems, methods, probes, and procedures suitable for incorporation by the present disclosure.
[0038] In some embodiments, improved positional accuracy is provided for placement of the energy source. The energy source may comprise any suitable energy source, such as an electrode, a loop electrode, a laser source, mechanical shear, an ultrasound probe, a cavitation ultrasound probe, a water jet, e.g., a fixed pressure water jet, plasma, steam, a morcellator, a transurethral needle, photoablation, water jet evacuation, etc. The energy source can be combined with other treatments and compounds, such as photochemotherapeutic agents.
[0039] The probe, including the energy source, can be configured in many ways and may include a force sensor to detect tissue resistance and adjust one or more of the energy source deflection angle or amount of energy in response to the measured tissue resistance.
[0040] FIG. 1 illustrates an exemplary embodiment of a system 400 for performing treatment on a patient. The system 400 may include a treatment probe 450 as described herein and an imaging probe 460 as described herein. The treatment probe 450 may be coupled to a first arm 442, and the imaging probe 460 may be coupled to a second arm 444. One or both of the first arm 442 and the second arm 444 may include a robotic arm whose movement may be controlled by one or more computing devices operably coupled to the arm. The treatment probe 450 may include a device for removing target tissue from a target site within a patient. The treatment probe 450 may be configured to deliver sufficient energy from the treatment probe 450 to the target tissue to remove the target tissue. For example, the treatment probe 450 may include an electrosurgical ablation device, a laser ablation device, a transurethral needle ablation device, a water jet ablation device, or any combination thereof. The imaging probe 460 may be configured to deliver sufficient energy from the imaging probe 460 to the target tissue to image the target tissue. The imaging probe 460 may comprise, for example, an ultrasound probe, a magnetic resonance probe, an endoscope, or a fluoroscopy probe. The first arm 442 and the second arm 444 may be configured to be independently adjustable, adjustable according to a fixed relationship, adjustable according to a user-selected relationship, independently lockable, or simultaneously lockable, or any combination thereof. The first arm 442 and the second arm 444 may have multiple degrees of freedom, for example, six degrees of freedom, for manipulating the treatment probe 450 and the imaging probe 460, respectively. The treatment system 400 may be used to perform tissue ablation in a patient's organ, such as the patient's prostate. The patient may be positioned on a patient support 449, such as a bed, table, chair, or platform. The treatment probe 450 may be inserted into a target site of the patient along an entry axis that coincides with the extension axis 451 of the treatment probe.For example, the treatment probe 450 may be configured for insertion into the patient's urethra to position the energy delivery region of the treatment probe within the patient's prostate. The imaging probe 460 may be inserted into the patient along an entry axis coinciding with the imaging probe's extension axis 461 at or adjacent to the patient's target site. For example, the imaging probe 460 may comprise a transrectal ultrasound (TRUS) probe configured for insertion into the patient's rectum to view the patient's prostate and surrounding tissue. As shown in FIG. 1, the first arm 442 and the second arm 444 may be covered with a sterile drape to provide a sterile surgical environment, keep the robotic arms clean, and reduce the risk of damaging the robotic arms. Further details regarding the various components of system 400 suitable for incorporation with embodiments as disclosed herein may be found in U.S. Pat. No. 7,882,841, U.S. Pat. No. 8,814,921, U.S. Pat. No. 9,364,251, and PCT Publication No. WO2013 / 130895, the entire disclosures of which are incorporated herein by reference.
[0041] FIG. 2 diagrammatically illustrates an embodiment of a system 400 for performing tissue ablation in a patient. The system 400 may comprise a treatment probe 450 as described herein and may optionally comprise an imaging probe 460. The treatment probe 450 is coupled to a console 420 and a linkage 430. The linkage 430 may comprise one or more components of a robotic arm 442. The imaging probe 460 is coupled to an imaging console 490. The imaging probe may be coupled to a second robotic arm 444, for example. The patient treatment probe 450 and the imaging probe 460 can be coupled to a common base 440. The patient is supported using a patient support 449. The treatment probe 450 is coupled to the base 440 using a first arm 442. The imaging probe 460 is coupled to the base 440 using a second arm 444. One or both of the first arm 442 and the second arm 444 may comprise a robotic arm whose movement may be controlled by one or more computing devices operably coupled to the arm, as described in further detail herein.
[0042] Although a common base is referenced, the robotic arms can be coupled to a bedrail, a console, or any suitable support structure to support the base of the robotic arms.
[0043] In some embodiments, the system 400 comprises a user input device 496 coupled to the processor 423 for a user to manipulate a surgical instrument on the robotic arm. The user input device 496 can be located in any suitable location, for example, on a console, on a robotic arm, on a mobile base, and there may be one, two, three, four, or more user input devices used in conjunction with the system 400 to provide either redundant means of input, unique input commands, or a combination. In some embodiments, the user input device comprises a controller for moving the end of the treatment or imaging probe in response to mechanical movement of the user input device. The end of the probe can be shown on the display 425, and the user can manipulate the end of the probe. For example, the user input device may comprise a six-degree-of-freedom input controller, where the user can move the input device in six degrees of freedom, and the distal end of the probe moves in response to movement of the controller. In some embodiments, the six degrees of freedom comprise three translational degrees of freedom and three rotational degrees of freedom. The processor can be configured with instructions for probe control to be switched between automatic image-guided therapy with the energy source and therapy with the energy source, for example, with user movement of a user input device.
[0044] The patient is placed on the patient support 449 so that the treatment probe 450 and the ultrasound probe 460 can be inserted into the patient. The patient can be placed in one or more of a number of positions, such as, for example, prone, supine, upright, or inclined. In some embodiments, the patient is placed in a lithotomy position, for example, stirrups may be used. In some embodiments, the treatment probe 450 is inserted into the patient in a first direction on a first side of the patient, and the imaging probe is inserted into the patient in a second direction on a second side of the patient. For example, the treatment probe can be inserted into the patient's urethra from the front of the patient, and the imaging probe can be inserted transrectally into the patient's intestine from the rear of the patient. The treatment probe and the imaging probe can be placed in the patient with one or more of urethral tissue, urethral wall tissue, prostate tissue, intestinal tissue, or intestinal wall tissue extending therebetween.
[0045] The treatment probe 450 and the imaging probe 460 can be inserted into a patient in one or more of many ways. During insertion, the first and second arms, respectively, may be provided with a substantially unlocked configuration such that the treatment or imaging probe can be rotated and translated as desired to insert the probe into the patient. When the probe is inserted at a desired location, the arms can be locked. In the locked configuration, the probes can be oriented relative to one another in one or more of many ways, such as, for example, parallel, skewed, horizontal, oblique, or non-parallel. It can be useful to determine the orientation of the probe using an angle sensor as described herein to map the imaging probe image data to the treatment probe coordinate reference. Having the tissue image data mapped into the treatment probe coordinate reference space can enable precise targeting and treatment of tissue identified for treatment by an operator, such as a physician.
[0046] In some embodiments, the treatment probe 450 is coupled to the imaging probe 460 to align the treatment probe 450 based on images from the imaging probe 460. The coupling can be accomplished using a common base 440 as shown. Alternatively, or in combination, the treatment probe and / or the imaging probe may comprise magnets to hold the probe in alignment through the patient's tissue. In some embodiments, the first arm 442 is a moveable and lockable arm so that the treatment probe 450 may be positioned at a desired location within the patient. When the probe 450 is positioned at a desired location on the patient, the first arm 442 can be locked using an arm lock 427. The imaging probe can be coupled to the base 440 using a second arm 444, which can be used to adjust the alignment of the imaging probe when the treatment probe is locked in place. The second arm 444 may comprise a lockable and moveable probe, for example, under the control of the imaging system, or a console and user interface. The movable arm 444 may be finely actuated so that the imaging probe 460 may be adjusted in relation to the treatment probe 450 with movements as small as, for example, one millimeter.
[0047] In some embodiments, the therapy probe 450 and the imaging probe 460 are coupled to angle sensors such that therapy can be controlled based on the alignment of the imaging probe 460 and the therapy probe 450. The first angle sensor 495 may be coupled to the therapy probe 450 using the support 438. The second angle sensor 497 may be coupled to the imaging probe 460. The angle sensor may comprise one or more of many types of angle sensors. For example, the angle sensor may comprise a goniometer, an accelerometer, and combinations thereof. In some embodiments, the first angle sensor 495 comprises a three-dimensional accelerometer for determining the orientation of the therapy probe 450 in three dimensions. In some embodiments, the second angle sensor 497 comprises a three-dimensional accelerometer for determining the orientation of the imaging probe 460 in three dimensions. Alternatively or in combination, the first angle sensor 495 may comprise a goniometer for determining the angle of the therapy probe 450 along the extension axis 451 of the therapy probe. The second angle sensor 497 may comprise a goniometer for determining the angle of the imaging probe 460 along the extension axis 461 of the imaging probe 460. The first angle sensor 495 is coupled to the controller 424 of the treatment console 420. The second angle sensor 497 of the imaging probe is coupled to the processor 492 of the imaging console 490. Alternatively, or in combination, the second angle sensor 497 may be coupled to the controller 424 of the treatment console 420.
[0048] The console 420 includes a display 425 that is coupled to a processor system within the component used to control the treatment probe 450. The console 420 includes a processor 423 having a memory 421. A communication circuit 422 is coupled to the processor 423 and to a controller 424. The communication circuit 422 is coupled to the imaging console 490 via a communication circuit 494 of the imaging console. An arm lock 427 of the console 420 may be coupled to the first arm 442 to lock the first arm or to allow the first arm to be freely movable for inserting the probe 450 into a patient.
[0049] Optionally, the console 420 may include components of an endoscope 426 that are coupled to anchors 24 of the treatment probe 450. The endoscope 426 may include components of the console 420 and an endoscope that is insertable with the treatment probe 450 to treat a patient.
[0050] In some embodiments, the console 420 comprises impedance sensor circuitry 220 coupled to the energy source to measure the impedance of tissue being treated with energy from the energy source. In some embodiments, the energy source comprises an electrode, and the electrode comprises an impedance sensor. In some embodiments, the processor is configured with instructions to adjust the amount of energy from the energy source in response to the amount of impedance. In some embodiments, the processor is configured with instructions to adjust the amount of deflection of the extension from the extension axis and the offset of the energy source in response to the impedance.
[0051] In some embodiments, the console 420 includes force sensor circuitry 210 that is coupled to a force sensor on the treatment probe. The force sensor is coupled to the extension and can measure tissue resistance associated with, for example, deflection of the extension. In some embodiments, the force sensor is coupled to the linkage and measures tissue resistance associated with movement of the energy source away from the extension axis. In some embodiments, the force sensor is coupled to the energy source and measures tissue resistance associated with a positioning distance of the energy source from the extension axis. In some embodiments, the force sensor is configured to measure tissue resistance associated with an amount of energy delivery from the energy source.
[0052] Optionally, the console 420 may comprise one or more of modules operably coupled to the treatment probe 450 to control aspects of treatment with the treatment probe. For example, the console 420 may comprise one or more of an energy source 22 for providing energy to the treatment probe, a balloon inflation control 26 for affecting inflation of a balloon used to anchor the treatment probe at the target treatment site, an injection / irrigation control 28 for controlling injection and irrigation of the probe, an aspiration control 30 for controlling suction by the probe, an insufflation control 32 for controlling insufflation of the target treatment site (e.g., the prostate), or a light source 33, such as an infrared, visible, or ultraviolet light source, for providing light energy to the treatment probe.
[0053] The processor, controller, and control electronics and circuitry may include one or more of many suitable components, such as one or more processors, one or more field programmable gate arrays (FPGAs), and one or more memory storage devices. In some embodiments, the control electronics controls a graphic user interface (hereinafter "GUI") control panel to provide pre-procedure planning according to user-defined treatment parameters and to provide user control over the surgical procedure.
[0054] The treatment probe 450 may include an anchor 24. The anchor 24 may anchor the distal end of the probe 450 while energy is delivered to the energy delivery region 20 with the probe 450. In some embodiments, the probe includes a first energy source 250 that may be offset from the extension axis 451 of the probe with an offset 252, e.g., with deflection of the extension as described herein, which is a distance to treat tissue. The processor may be configured with instructions to perform 3D volumetric ablation of tissue with rotation, translation, and offset of the energy source 250 in response to computer control. The probe 450 may include a second energy source as described herein, such as a nozzle 200.
[0055] The treatment probe 450 may be coupled to the first arm 442 using a linkage mechanism 430. The linkage mechanism 430 may comprise components for moving the energy delivery region 20 to a desired target location on the patient, for example, based on an image of the patient. The linkage mechanism 430 may comprise a first portion 432, a second portion 434, and a third portion 436. The first portion 432 may comprise a substantially fixed tether portion. The substantially fixed tether portion 432 may be fixed to a support 438. The support 438 may comprise a reference frame for the linkage mechanism 430. The support 438 may comprise a rigid chassis or frame or housing for rigidly or rigidly coupling the first arm 442 to the treatment probe 450. The first portion 432 may remain substantially fixed, while the second portion 434 and the third portion 436 may move and direct energy from the probe 450 to the patient. The first portion 432 may be fixed at a substantially constant distance 437 to the anchor 24. The substantially fixed distance 437 between the anchor 24 and the fixed first portion 432 of the linkage allows the treatment to be precisely performed. The first portion 432 may include a linear actuator for precisely positioning the second energy source, such as the high pressure nozzle 200, within the energy delivery region 20 at a desired axial location along the extension axis 451 of the treatment probe 450. Additional actuators and linkages may also be provided and operably coupled to the processor to offset, rotate, and translate the first energy source 250 as described herein.
[0056] The extension axis 451 of the treatment probe 450 generally extends between a proximal portion of the probe 450 near the linkage 430 and a distal end having an anchor 24 attached thereto. The third portion 436 can control the rotation angle 453 about the extension axis 451. During treatment of a patient, the distance 439 between the energy delivery region 20 and the first portion 432 of the linkage can vary with reference to the anchor 24. The distance 439 can be adjusted with the translation 418 of the probe in response to computer control to set a target location along the extension axis 451 of the treatment probe. In some embodiments, the first portion of the linkage remains fixed while the second portion 434 adjusts the position of the energy delivery region 20 along the axis 451. The third portion 436 of the linkage adjusts the angle 453 about the axis in response to the controller 424 so that the distance along the axis in the angle of treatment can be very precisely controlled with reference to the anchor 24. The probe 450 may comprise a rigid member, such as a spine, extending between the support 438 and the anchor 24 such that the distance from the linkage 430 to the anchor 24 remains substantially constant during treatment. The treatment probe 450 is coupled to treatment components as described herein to enable treatment with one or more forms of energy, such as mechanical energy from a jet, electrical energy from an electrode, or light energy from a light source, such as a laser source. The light source may comprise infrared, visible, or ultraviolet light. The energy delivery region 20 can be moved under the control of the linkage 430, such as to deliver an intended form of energy to the target tissue of the patient.
[0057] The imaging console 490 may include a memory 493, a communication circuit 494, and a processor 492. The processor 492 in corresponding circuitry is coupled to the imaging probe 460. An arm controller 491 is coupled to the arm 444 for precisely positioning the imaging probe 460. The imaging console may further include a display 425.
[0058] To facilitate precise control of the treatment probe and / or imaging probe during treatment of a patient, one or more of the treatment probe or imaging probe may be coupled to a robotic computer-controllable arm. For example, with reference to the system 400 shown in FIG. 2, one or both of the first arm 442 coupled to the treatment probe 450 and the second arm 444 coupled to the imaging probe 460 as described herein may comprise a robotic computer-controllable arm. The robotic arm may be operably coupled to one or more computing devices configured to control the movement of the robotic arm. For example, the first robotic arm 442 may be operably coupled to the processor 423 of the console 420, or the second robotic arm 444 may be operably coupled to the processor 492 of the imaging console 490 and / or the processor 423 of the console 420. The one or more computing devices, such as the processors 423 and 492, may comprise computer-executable instructions for controlling the movement of the one or more robotic arms. The first and second robotic arms may be substantially similar in structure and function, or they may differ to accommodate the specific functional requirements for controlling movement of the treatment probe versus the imaging probe.
[0059] The robotic arm may include six, seven, or more joints to allow the arm to move under computer control. Suitable robotic arms are commercially available from several manufacturers, such as RoboDK Inc., Kinova Inc., and other manufacturers.
[0060] One or more computing devices operably coupled to the first and second robotic arms may be configured to automatically control the movement of the treatment probe and / or the imaging probe. For example, the robotic arm may be configured to automatically adjust the position and / or orientation of the treatment probe and / or the imaging probe during the treatment of the patient according to one or more preprogrammed parameters. The robotic arm may be configured to automatically move the treatment probe and / or the imaging probe along a preplanned or programmed treatment or scanning profile, which may be stored on the memory of the one or more computing devices. As an alternative to or in addition to automatic adjustment of the robotic arm, the one or more computing devices may be configured to control the movement of the treatment probe and / or the imaging probe in response to user input, for example, through a graphical user interface of the treatment device. As an alternative to, or in addition to, automatic adjustment of the robotic arm, the one or more computing devices may be configured to control movement of the treatment probe and / or imaging probe in response to real-time positioning information, e.g., in response to anatomical structures recognized in one or more images captured by an imaging probe or other imaging source (from which an acceptable range of motion of the treatment probe and / or imaging probe may be established), and / or position information of the treatment probe and / or imaging probe from one or more sensors coupled to the probe and / or robotic arm.
[0061] 3A and 3B show an exemplary embodiment of a common base or mount 440 for supporting one or more robotic arms of an image-guided therapy system as disclosed herein, which may include a probe 450 as described herein. FIG. 3A shows a patient support 449 including one or more rails 452. The patient support 449 may include a surgical table or platform. One or more robotic arms associated with one or more of the therapy probe or imaging probe may be mounted to the rails 452 such that the rails function as the common base 440. FIG. 3B shows the common base 440 including a floor stand 454 configured to couple to a first robotic arm connected to the therapy probe and / or a second robotic arm connected to the imaging probe. The floor stand 454 may be positioned between the patient's legs during a therapy procedure.
[0062] 4A and 4B illustrate an embodiment of a treatment system 400 as described herein that includes a mobile base 470. FIG. 4A is a front view of the treatment system 400, and FIG. 4B is a side view. The treatment system 400 may include a treatment probe 450 coupled to a first robotic arm 442 and an imaging probe 460 coupled to a second robotic arm 444. The first robotic arm 442 and the second robotic arm 444 each include a proximal end and a distal end, the distal end coupled to the treatment probe 450 and the imaging probe 460, respectively, and the proximal end coupled to a common base 440 that includes the mobile base 470. The first robotic arm 442 may include a first arm coupling structure 504 for coupling to the treatment probe 450, and the second robotic arm 444 may include a second arm coupling structure 505 for coupling to the imaging probe 460. The treatment probe 450 may be coupled to a distal end of the first robotic arm 442 via a mounting device 500, which may include a linkage configured to affect the movement (e.g., rotation, translation, pitch, etc.) of the treatment probe as described herein. The coupling of the treatment probe 450 to the first robotic arm 442 may be fixed, releasable, or user-adjustable. Similarly, the coupling of the imaging probe 460 to the second robotic arm 444 may be fixed, releasable, or user-adjustable.
[0063] The first robotic arm 442 may articulate at one or more first arm joints 443. The imaging arm 444 may articulate at one or more second arm joints 445. Each arm joint 443 or 445 may be operatively coupled to a computer-controllable actuator, such as a stepper motor, to affect movement at the joint. Each arm joint 443 or 445 may comprise one of a variety of kinematic joints, including, but not limited to, a rectangular, revolute, parallel cylinder, cylindrical, spherical, planar, edge slider, cylindrical slider, point slider, spherical slider, or cross cylinder joint, or any combination thereof. Each arm joint 443 or 445 may also comprise a linear, orthogonal, revolute, torsion, or revolute joint, or any combination thereof.
[0064] The system 400 may further comprise a console 420 as described herein, which may be supported by a mobile support 480 separate from the mobile base 470. The console 420 may be operatively coupled to the mobile base 470 via a power and communication cable 475 to enable control of a treatment probe 450 coupled to the mobile base via a first robotic arm. The treatment console 420 comprises a processor and a memory having stored thereon computer executable instructions for execution by the processor to control various modules or functions of the treatment console, such as an energy source, infusion / irrigation control, aspiration control, and other components as described herein with reference to FIG. 2. The treatment console 420 may further comprise a display 425 in communication with the processor. The display 425 may be configured to display one or more of the following: subject vital signs, such as, for example, heart rate, respiratory rate, temperature, blood pressure, oxygen saturation, or any physiological parameter, or any combination thereof; procedure status; one or more pre-taken images or sequences of images of the treatment site from one or more views; one or more real-time images or sequences of images of the treatment site from one or more views acquired by the imaging probe 460; a treatment mode, such as, but not limited to, cutting or coagulation; an intensity of treatment, a time elapsed between treatments, a time remaining between treatments, a depth of treatment, an area or volume of the treatment site that has been treated, an area or volume of the treatment site that will be treated, an area or volume of the treatment site that will not be treated; a set of treatment parameters, including location information of the treatment probe 450 or the imaging probe 460 or both; a treatment adjustment control, such as a means for adjusting the depth of treatment, the intensity of treatment, the location and / or orientation of the treatment probe 450, the depth of imaging, or the location and / or orientation of the imaging probe 460, or any combination thereof; or system configuration parameters.
[0065] The mobile base 470 may further comprise one or more computing devices for controlling the movement of the one or more robotic arms. For example, the mobile base may comprise a processor and a memory having computer-executable instructions stored thereon for execution by the one or more processors. The memory may have instructions stored thereon for operating one or more robotic arms coupled to the mobile base. The processor may be operatively coupled to the robotic arms via suitable electromechanical components to affect the movement of the robotic arms. For example, one or more joints of the robotic arms may each comprise a stepper motor, and the processor may be operatively coupled to the stepper motor at each joint to actuate the motor a prescribed increment in a prescribed direction. Alternatively, the one or more robotic arms may be operatively coupled to one or more processors of the console 420 or a separate imaging console (such as the imaging console 490 shown in FIG. 2), and the one or more console processors may be configured to execute instructions for controlling the movement of the one or more robotic arms and may communicate the instructions to the robotic arms via a communication circuit (such as the communication circuit 422 of the console 420 or the communication circuit 494 of the console 490 shown in FIG. 2). The computer executable instructions for controlling the movement of the robotic arms may be pre-programmed and stored on the memory, or may be provided by a user via one or more user inputs before or during treatment of a patient using the treatment system.
[0066] One or more computing devices operably coupled to the first and / or second robotic arms may be configured to control movement of the arms to adjust the pitch, yaw, roll, and / or linear position of the treatment probe and / or imaging probe along the target site.
[0067] The mobile base 470 may include one or more user input devices to allow a user to control the movement of the robotic arms under computer instructions. For example, as shown in FIGS. 4A and 4B, the mobile base may include a keyboard 474 and / or a foot switch 471, which is operably coupled to the mobile base via a foot switch cable 472. The keyboard 474 and foot switch 471 may be configured to control the movement of the first robotic arm 442 and / or the second robotic arm 444, independently or in combination, for example, via articulation of one or both robotic arms at one or more joints. The keyboard and foot switch may be in communication with one or more processors configured to control the movement of the robotic arms. When a user inputs commands into the keyboard and / or foot switch, the user commands can be received and converted into electrical signals by the one or more processors, which may be transmitted to one or more computer-controllable actuators operably coupled to the one or more robotic arms. The keyboard and / or footswitch may control the movement of one or both arms to or away from a treatment position, a position of interest, a predetermined location, or a user-defined location, or any combination thereof.
[0068] Optionally, the keyboard 474 and footswitch 471 may be configured to control operation of the treatment probe 450 and / or the imaging probe 460, independently or in combination. For example, the keyboard 474 and / or footswitch 471 may be configured to start, stop, pause, or resume treatment with the treatment probe. The keyboard 474 and / or footswitch 471 may be configured to begin acquiring, or to freeze, save, or display on the display 425 an image or sequence of images previously acquired or currently acquired by the imaging probe.
[0069] The mobile base 470 and mobile support 480 of the console 420 may be independently positionable around a patient supported by a patient support 449, such as a platform. For example, the mobile base 470, supporting the first and second robotic arms and the treatment and imaging probes, may be positioned between the patient's legs, while the mobile support 480 carrying the console 420 and display 425 may be positioned to the side of the patient, such as near the patient's torso. The mobile base 470 or mobile support 480 may include one or more movable elements, such as multiple wheels, that allow the base or support to move. The mobile base 470 may be covered with a sterile draping throughout the treatment procedure to prevent contamination and fluid ingress.
[0070] 5A and 5B show an example coupling between a treatment probe 450 and a first robotic arm 442 as described herein. FIG. 5A shows the treatment probe uncoupled from the robotic arm. FIG. 5B shows the treatment probe coupled to the robotic arm. As shown, the treatment probe 450 may be coupled to the robotic arm 442 with an attachment device 500, which may include a reusable motor pack. The treatment probe 450 may be removably coupled to the attachment device 500. The attachment device may further include a connector 502 configured to couple to the robotic arm and lock the attachment device in place. The robotic arm 442 may include a coupling structure 504 disposed at a distal end of the arm configured to lock and receive the connector 502 of the attachment device 500. Once the treatment probe and the robotic arm are coupled together, movement of the treatment probe may be controlled by moving the robotic arm (e.g., by articulating one or more joints of the robotic arm under computer control).
[0071] In some embodiments, the treatment probe is coupled to the robotic arm via a quick release mechanism such that the coupling between the probe and the robotic arm can be quickly disconnected to prevent injury to the patient in the event that the robotic arm loses position or is otherwise unable to operate properly. The treatment probe and the robotic arm may be coupled to each other in a number of ways, such as mechanically (e.g., broom clips) and / or magnetically. For example, in the embodiment shown in FIGS. 5A and 5B, the coupling structure 504 may include a slot 506 having a magnet 508 disposed therein, and the connector 502 may include a ferromagnetic fastener configured to fit within the slot 506 and engage the magnet 508. The coupling structure 504 may further include a latching mechanism 510 for selectively engaging or disengaging the connector 502 with the magnet 508. For example, as shown in FIGS. 5A and 5B, the latching mechanism 510 may include a rotatable knob that can be rotated to affect engagement of the magnet 508 of the coupling structure 504 with the connector 502 of the mounting device 500. The latching mechanism may be engaged or disengaged automatically or manually by a user to respectively couple or uncouple the attachment device 500, and thus the treatment probe 450 coupled thereto, to the robotic arm 442. In some embodiments, the coupling structure 504 may be operatively coupled to one or more computing devices configured to control the robotic arm, and the one or more computing devices may comprise instructions to release the coupling of the coupling structure to the probe when an error is detected in the operation of the robotic arm.
[0072] In some embodiments, the first robotic arm 442 may be configured to automatically locate the treatment probe 450 in response to sensor location data from one or more of the attachment device 500 or coupling structure 504. The first robotic arm 442 may be operated in a "search" mode, for example, to locate the attachment device 500. In some embodiments, the probe comprises one or more reference targets and the robotic arm comprises a corresponding sensor of sufficient resolution and positioning to identify the relative position of the probe in 3D space. In some embodiments, the processor is configured with instructions to search for the treatment probe or imaging probe with a mounting structure on the robotic arm, for example, while the user holds the probe stationary when the probe is positioned within the patient.
[0073] The sensors on a robotic arm, such as the first robotic arm 442, and the sensors on a probe, such as a treatment probe, can be arranged in a number of ways, as described, for example, in PCT / US2020 / 021756, filed March 9, 2020, entitled "ROBOTIC ARMS AND METHODS FOR TISSUE RESECTION AND IMAGING," and published as WO / 2020 / 181290 (previously incorporated by reference herein).
[0074] The processor can be coupled to a sensor near the end of the robotic arm or on the probe to dynamically update the relative location during movement of the robotic arm while attempting to engage the probe on the arm. The sensor on the robotic arm may comprise multiple sensors, comprising one or more of capacitive, capacitive displacement, Doppler, inductive, magnetic, optical, radar, sonar, ultrasonic, or Hall effect sensors, to determine the relative distance between the robotic arm and the probe. In some embodiments, the probe comprises multiple targets and the sensor is configured to generate a signal in response to distance from the multiple targets. Alternatively, or in combination, the sensor can be located on the probe and on the targets on the robotic arm. In some embodiments, the sensor comprises a close-contact mechanical sensor for confirming docking of the probe on or near the robotic arm to sense the position of the probe relative to the robotic arm, for example, when the probe and arm are within a few millimeters of docking with each other. The close-contact mechanical sensor may comprise one or more of a micro-motion switch, a whisker touch sensor, or a pin-in-hole contact switch. In some embodiments, the probe and robotic arm include an integrated locking mechanism to provide a non-moving locking engagement in the final position of contact. The integrated locking mechanism may include one or more of magnetic, electromagnetic, latching, screws such as multi-turn latch screws or 11 / 4 turn latch screws, vacuum, or other mechanical means of reversible attachment as would be understood by one of ordinary skill in the art.
[0075] In some embodiments, multiple sensors are used, such as one or more sensors for close separation distances between the probe and the robotic arm, one or more sensors for intermediate separation distances, and one or more sensors for far separation distances. A coarse location sensor, e.g., a beacon, can be used to determine the approximate location of the probe. One or more sensors, e.g., a proximity sensor, can be used for fine location positioning of the probe relative to the robotic arm. In some embodiments, one or more markers on the probe are used in conjunction with a camera and machine vision detection of the one or more markers.
[0076] In some embodiments, a coarse location sensor may be provided, which may be an infrared (IR) beacon, that allows for a coarse spatial location for homing detection of the robotic arm to the probe. In some cases, a homing beacon such as an IR beacon allows for homing across longer distances compared to sensors that may rely on visual recognition as a baseline.
[0077] In some embodiments, the docking detection sensor verifies that the robotic arm is engaged with or in close proximity to the probe. As an example, a Hall effect sensor can be used in conjunction with a permanent magnet to affect the sensor output. In some embodiments, the Hall effect sensor is noise-resistant, contactless, and has a consistent detection range. Any of several different types of Hall sensors may be utilized, and in many cases the sensor functions as a simple switch and linear range measurement and detection, with the overall output voltage set by the supply voltage and varying proportionally to the strength of the magnetic field. This provides a distance measurement between the sensor and a location magnet, which may be used to measure the distance between the robotic arm and the probe and aid in docking. The sensor and beacon may be located in separate housings of the robotic arm and the probe.
[0078] In some embodiments, position sensing of the robotic arm is performed by an inertial measurement unit (IMU), which may include up to nine axes of detection. In some cases, a six-axis IMU, which may be located in a joint of the robotic arm, may be used for motion detection, vibration detection, position orientation information, redundancy, and backup of the primary encoder signal. The IMU may perform the dual function of docking with the robotic arm and probing the probe for force detection and motion compensation as described herein. The described sensors can be used in combination with any robotic arm or probe described herein.
[0079] According to some embodiments, the procedure for docking the robotic arm with the probe may include an IR beacon to provide a coarse position and spatial location for homing detection, fiducials on either the arm or the probe, optical sensors to view the fiducials that may be used to enable fine alignment of the location in the XY plane, and a Hall effect sensor to detect Z-direction proximity for docking. The IR beacon allows for longer distance seeking of the home position of the robotic arm relative to the probe. The fiducials and optical sensors may enable high speed low latency detection of the 2D location and 2D orientation of the probe by the robotic arm. A user interface, which may be located on the robotic arm, on the probe, or on the robotic arm control unit, may indicate distance, position, docked status, or other information. In some embodiments, the user interface includes one or more visual cues, such as LED indicators, to indicate the relative positions of the arm and probe and / or the docking status.
[0080] 5A and 5B are described in the context of coupling a treatment probe to a first robotic arm, a substantially similar mechanism may also be used to couple an imaging probe to a second robotic arm 444. For example, the coupling structure of the second robotic arm 444 may include a similar coupling mechanism for engaging an attachment device connected to the imaging probe.
[0081] 6A and 6B show an example coupling between a hand piece 600 and an instrument device manipulator 602. Throughout this description of various embodiments, the hand piece 600 may comprise any of a variety of instruments, such as, for example, imaging probes, treatment probes, surgical tools, catheters, energy delivery systems, implants, visualization systems, and other instruments that may be desirable to be used during diagnosis or treatment of a patient. Also, references to the hand piece 600 being coupled to a translation device may comprise any suitable probe as described herein. As used throughout this description, references to the instrument device manipulator 602 may refer to a robotic arm. The instrument device manipulator 602 may have one or more motors associated therewith, which may be carried internally or externally to the instrument device manipulator 602. In some embodiments, the instrument device manipulator 602 may carry one, two, three, four, five, six, seven, eight, or more motors. One or more of the motors may have an output shaft that is rotatably pivoted by the motor. One or more of the motors of the instrument device manipulator 602 may include a linkage (e.g., gear) on the output shaft of the motor. The linkage may include a pinion gear, a bevel gear, a spur gear, a helical gear, a worm drive gear, a planetary gear set, or some other type of linkage. The linkage may be coupled to another linkage, a chain, a belt, or some other type of linkage associated with the conversion device 610 to convert the rotational motion of the motor to motion of one or more parts of the handpiece 600. In some cases, the rotational motion of the motor is converted to rotational motion of a component of the handpiece 600, while in some cases, the rotational output of the motor is converted to linear motion of a component of the handpiece 600. The following figures provide example systems for coupling the instrument device manipulator 602 to one or more instruments, such as the handpiece 600, a probe, a scope, or other instruments.
[0082] 6A shows an example end 604 of an instrument device manipulator 602 having five linkages 606 and an electrical port 608. While the illustrated embodiment shows five linkages 606, it should be understood that the instrument device manipulator 602 may have any suitable number of linkages 606, such as two, three, four, five, six, seven, eight, nine, or more. The linkages 606 are shown as gears, but any type or combination of suitable linkages 606 may be used. Examples of linkages for rotational motion include, but are not limited to, round shafts with flats, round shafts with keyhole slots, square or rectangular shafts, splined connections, pentagonal shafts, hexagonal shafts, and the like. The linkages 606 may also provide translational motion. The electrical port 608 may provide power and communications to the handpiece 600, such as to allow signals to pass between the handpiece 600 and a computing device that may implement a treatment plan and control the operation of the instruments of the handpiece 600. In some embodiments, the handpiece includes one or more of a force sensor, force sensor circuitry, or impedance measurement circuitry coupled to the electrodes, and the electrical port 608 is configured to receive and transmit one or more of an impedance signal or a force measurement signal.
[0083] In some embodiments, each of the plurality of linkage mechanisms 606 comprises an output of the instrument device manipulator 602 that comprises an engagement structure for coupling a corresponding engagement structure of an input to a transformation device as described herein. In some embodiments, the engagement structure and the corresponding engagement structure comprise a rotatable engagement structure such as one or more of a pinion gear, a bevel gear, a spur gear, a helical gear, a worm drive gear, a gear of a planetary gear set, a formed shaft, a round shaft with flats, a round shaft with a keyhole slot, a square or rectangular shaft, a splined connection, a pentagonal shaft, a hexagonal shaft, and corresponding structures as described herein.
[0084] 6B illustrates an example coupling between the hand piece 600 and the instrument device manipulator 602. The hand piece 600 may include a treatment probe 450 to deliver energy from the first energy source 250 and the second energy source 200 as described herein. In some embodiments, the hand piece 60 and the treatment probe 450 are configured to receive a second treatment probe that includes a second energy source as described herein. The conversion device 610 couples the hand piece 600 to the instrument device manipulator 602 and transmits output from one or more motors 612, 614, etc. associated with the instrument device manipulator 602 to the hand piece 600. In some embodiments, the conversion device 610 is configured to be decoupled from the instrument device manipulator 602 and the probe, e.g., the hand piece 600, in a freestanding configuration of the conversion device 610, and the housing 611 at least partially encloses the conversion device. The translation device 610 may include deceleration or acceleration capabilities to efficiently couple between one or more motors 612 of the instrument device manipulator 602 and the R-drive, Z-drive, or both of the handpiece 600, or one or more instruments carried by the handpiece, such as, but not limited to, an imaging device, a cutting tool such as a water jet, an electrode such as an RF electrode, or other energy delivery device. In some cases, the translation device 610 can be configured to couple several configurations of handpieces 600 to the instrument device manipulator 602. For example, the translation device 610 can be configured to receive output from one or more motors 612 associated with the instrument device manipulator 602 and transmit motion to any of the various handpieces 600. In this manner, the handpiece 600 does not need to be manufactured to mate with a specific instrument device manipulator 602; rather, the conversion device 610 can be configured to mate with both, so that the handpiece 600 and its associated instrument can be manufactured regardless of the instrument device manipulator 602 to which it may ultimately be coupled.
[0085] In any of the numerous embodiments disclosed herein, the conversion device 610 may be enclosed, e.g., enclosed, at least in part, within a housing 611 that covers the internal components of the conversion device 610. The housing 611 encloses the conversion device internal functions and may comprise any suitable housing, such as a plastic housing, shown in dotted lines throughout the figures. In some cases, an output from the instrument device manipulator 602 passes through the housing and couples to an input of the conversion device 610. The output of the instrument device manipulator comprises an engagement structure and couples to a corresponding engagement structure of the input of the conversion device, which may comprise any suitable shape, generally a rotatable structure, as described herein. Similarly, an output from the conversion device 610 may extend through the housing to couple to the handpiece 600, where the output of the conversion device and the input of the handpiece comprise corresponding engagement structures, as described herein, to couple the handpiece to the conversion device.
[0086] Similarly, the input of the instrument device manipulator 602 may extend through the housing for coupling with the instrument device manipulator 602, for example, with corresponding engagement structure. Similarly, the input from the handpiece 600 may extend through the housing 611 for mechanically coupling to the conversion device 610, for example, with corresponding engagement structure.
[0087] In either case, one or more of the outputs or inputs may pass through the housing 611 to provide coupling between the instrument device manipulator 602, the conversion device 610, and / or the hand piece 600. In some cases, the instrument device manipulator 602 includes one or more outputs, which may extend through the housing. The conversion device may include one or more inputs that extend through the housing, and / or one or more outputs that may extend through the housing. Similarly, the hand piece 600 may include one or more inputs that extend through the housing of the conversion device 610.
[0088] The hand piece 600 may comprise any suitable treatment probe 616, such as, for example, a water jet 618, an RF electrode 644, or other treatment probe, and may be coupled to the instrument device manipulator 602 using an attachment device, which may comprise a reusable conversion device 610. The reusable conversion device 610 may provide advantages because mechanical and electrical precision may be built into the device with minimal impact on the cost of a single procedure. The hand piece 600 may be removably coupled to the conversion device 610, which may be removably coupled to the instrument device manipulator 602. The removable coupling promotes interchangeability of similar devices, giving the surgeon the ability to quickly and easily change between different types of instruments in response to medical needs. The hand piece 600 may comprise a position encoder 620 configured to transmit a signal associated with the position of one or more treatment probes 616, 644. The signals may correspond to the rotational angle, position, orientation, translation, or a combination of the treatment probes 616, 644. Additional encoders 620 may be provided to transmit signals associated with the position or orientation of other instruments such as imaging probes, endoscopes, catheters, lasers, microwaves, and others. Similarly, one or more encoders may be provided in conjunction with the instrument device manipulator 602 to determine the position and orientation of the instrument device manipulator 602.
[0089] The conversion device 610 may comprise a connector configured to couple to the instrument device manipulator 602 and lock the conversion device 610 in place relative to the instrument device manipulator 602. The instrument device manipulator 602 may comprise a coupling structure disposed at a distal end of an arm and configured to rigidly receive the connector of the conversion device 610. Similarly, additional coupling structure may be provided between the conversion device 610 and the handpiece 600. Once the handpiece 600 and the instrument device manipulator 602 are coupled together by the conversion device 610, movement of the handpiece 600 may be controlled by moving the instrument device manipulator 602 (e.g., by articulating one or more joints of the instrument device manipulator 602 or by actuating one or more motors of the instrument device manipulator 602, under computer control or manual control).
[0090] In some embodiments, the handpiece 600 is coupled to the conversion device 610 by a quick release mechanism such that the connection between the handpiece 600 and the conversion device 610 can be quickly disconnected to prevent injury to the patient if the instrument device manipulator 602 loses position or otherwise fails to operate properly. The quick release mechanism may also facilitate quick change of handpiece 600 and instrument during a procedure where it is desirable to attach an alternate instrument to the instrument device manipulator 602 using the conversion device 610.
[0091] Similarly, the conversion device 610 may be coupled to the instrument device manipulator 602 through a similar mechanism that may provide a quick release. The coupling of the handpiece 600 to the conversion device 610 and the conversion device 610 to the instrument device manipulator 602 may be by similar connecting structures or may be different structures. For example, the handpiece 600 may be coupled to the conversion device 610 by a magnetic coupling, while the conversion device 610 may be coupled to the instrument device manipulator 602 by a mechanical locking structure. Other coupling structures may include a slot having a magnet disposed therein, and a cooperating ferromagnetic fastener can be configured to fit within the slot. The coupling may be provided by a latching mechanism to selectively engage or disengage from the cooperating coupling member. Additionally, the coupling structure may comprise a rotating knob, a lever, cooperating bosses and pockets, hooks, latches, pins, or some other suitable type of connector to releasably secure the handpiece 600 to the conversion device 610 and the conversion device 610 to the instrument device manipulator 602.
[0092] As shown, the instrument device manipulator 602 may have two motors 612, three motors, four motors, five motors, or more. The orthogonal translation device linkage 622 shown in FIG. 6B may be geometrically preferable in some cases for the arrangement of linkages of the arms supporting the instrument device manipulator 602. The first motor 612 has an output shaft carrying a linkage, such as a bevel gear, worm gear, helical gear, or some other configuration. The first motor 612 is coupled to a cooperating linkage of a translation device 610. The translation device 610 is in turn coupled to an instrument, such as a water jet 618, to provide rotational motion of the instrument. In some embodiments, the instrument comprises a distal end, a proximal end, and a lumen extending between the distal and proximal ends. The distal end may carry an energy source, such as a nozzle, and the proximal end may be coupled to a high pressure fluid source. In some cases, the instrument is maintained in a generally straight line as it is carried by the conversion device 610. In some cases, the instrument fits into a groove formed on the exterior of the conversion device 610, facilitating rapid insertion and removal of the instrument with the conversion device 610. The instrument may be retained by a retaining structure carried by the conversion device 610, such as a clip, lever, or some other suitable structure.
[0093] The second motor 614 of the tool device manipulator 602 has an output shaft carrying a linkage, which may be a bevel gear 622, a worm drive, a helical gear, or some other suitable gear. The second motor 614 is coupled to a cooperating gear of a translation device 610. The translation device 610 is in turn coupled to a tool, such as a water jet 618, and used to provide translational linear motion of the tool. In some cases, the translation device 610 comprises an incremental translation device 610, where the rotational output of the translation device 610 is faster than the rotational input of the translation device 610. This may be accomplished, for example, by a driven gear 624 having a smaller pitch circle than the drive gear 626. In some embodiments, the driven gear 624 has a smaller number of gear teeth compared to the drive gear 626. Alternatively, the converter 610 may be a step-down converter 610, in which case the driven gear 624 has a larger pitch circle than the meshed driving gear 626. In such a case, the driven gear 624 may have more teeth than the driving gear 626, causing it to rotate slower than the driving gear 624.
[0094] In some embodiments, the first motor 612 and the second motor 614 of the tool device manipulator 602 are coupled to a single input of the conversion device 610. For example, two or more motors of the tool device manipulator 602 may be coupled together in the conversion device 610 and combine their power into a single output shaft. In addition, the conversion device 610 may incorporate two or more motors and gearing or other leverage devices to reduce the input from the two or more motors on the output shaft, resulting in a greater combined torque, or to multiply the input from the two or more motors, resulting in a higher speed. A step-down conversion device 610 may be useful when torque is preferred over speed, such as for applying a crimping force. A step-up conversion device 610 may be useful when speed is preferred over torque, such as for ultrasonic motion, burr cutting, frictional heating, or other suitable high speed processes.
[0095] The translation device 610 may comprise a right angle translation device 610, where the output shaft of the instrument device manipulator 602 motor is orthogonal (or nearly orthogonal) to the input shaft of the handpiece 600. For convenience in describing various configurations, the handpiece 600 has a longitudinal axis, and the treatment probe 616 (e.g., water jet) extends parallel to the longitudinal axis of the handpiece 600, also referred to as the Z-direction. The XY plane is orthogonal to the Z-direction. In some embodiments, the water jet is translated in the Z-direction by a second motor, also referred to as the Z-drive 630, and rotated about its longitudinal axis by a rotational motor ("R-drive") 632. The treatment probe 616 translates longitudinally and / or rotatably oscillates under command by a computing device. The computing device sends signals to the instrument device manipulator 602 to operate one or more motors 612, which are coupled to the instrument of the handpiece 600 by a linkage. The handpiece 600 has one or more encoders 620 that transmit signals back to a computing device, such as a location, position, orientation, translation, or some other signal indicative of a parameter of the handpiece 600 or one or more instruments of the handpiece 600.
[0096] The handpiece 600 may be coupled to the translation device 610 to mechanically couple the R-drive 632 and Z-drive 630 to the instrument of the handpiece 600. For example, the translation device 610 may include a coupler 634, such as a hex shaft coupler, that receives a corresponding molded structure of the handpiece 600 such that the instrument of the handpiece 600 is drivingly engaged with the translation device 610 when the handpiece 600 is coupled to the translation device 610. Other couplers are also contemplated, including, but not limited to, round couplers with flats, round couplers with keyhole slots, square or rectangular couplers, spline couplers, pentagonal couplers, and the like. Thus, the motor of the instrument device manipulator 602 is coupled to the translation device 610, which transfers the motion of the instrument device manipulator 602 motor to the instrument of the handpiece 600. Once coupled, activation of the instrument device manipulator 602 motors results in R-drive or Z-drive movement of the instrument of the handpiece 600.
[0097] In some embodiments, input from the instrument device manipulator 602 may provide articulation of one or more instruments of the handpiece 600. For example, instruments such as probes, scopes, or other devices may be flexible, have segments, joints, or have other methods that allow for articulation of the instrument. Input from the instrument device manipulator 602 may be used to articulate the instrument, such as by manipulating wires, such as by tensioning, twisting, compression, or some other applied force. The instruments of the handpiece 600 may be rotated, translated, articulated, or a combination of movements in response to forces applied from the instrument device manipulator 602.
[0098] As an example, the hand piece 600 may carry an energy source as described herein, such as an energy delivery electrode, which in some cases may be an RF electrode 644. A third motor 646 of the instrument device manipulator 602 may be coupled to the RF electrode 644 through a translation device to linearly translate the RF electrode 644. A fourth motor 648 may be coupled to the RF electrode 644 and configured to provide rotation of the RF electrode 644. A fifth motor 650 may be coupled to the RF electrode 644 through a translation device and may be used to pivot the RF electrode 644 in a direction away from the longitudinal axis of the RF electrode. In other words, at least a portion of the RF electrode 644 may pivot, articulate, hinge, and / or bend such that the distal end of the RF electrode 644 is not coaxial with the proximal length of the shaft. Such articulation allows the distal tip of the RF electrode 644 to be moved closer to tissue spaced away from the longitudinal axis of the RF electrode 644 to ablate tissue using one or more of electrode rotation and translation, as described herein.
[0099] According to some embodiments, the RF electrode 644 is mounted on an extension 654 that is pivotally coupled to a shaft 656 at a pivot 660. In some cases, the shaft 656 is driven by one or more motors 646, 648, allowing the shaft to translate linearly and / or rotate about the shaft axis 658. The extension 654 may be coupled to the shaft 656 through any suitable connection (e.g., pivot 660) that allows the extension 654 to move away from the shaft axis 658. The extension 654 may be moved by any suitable actuator, such as a motor, a pull wire, a heat input, a gear, a shaft, or any other such suitable actuator mechanism.
[0100] The fifth motor 650 may be coupled to the RF electrode 644 through any suitable coupling 652 and may include one or more gears, wheels, drivers, push and / or pull wires, or other such structures that may be configured to articulate at least a portion of the RF electrode 644. The RF electrode 644 may be coupled to a suitable energy source, such as for providing an RF signal to the RF electrode. The source of energy may be delivered through the transducer 610, by the handpiece 600, or through some other electrical connection.
[0101] The RF electrode 644 may be coupled to the RF generator by a wire or the like that extends along or within the shaft 656. Current may be delivered to the RF electrode 644 and passed through tissue before returning to the RF generator. The current delivered by the RF electrode 644 falls off exponentially as the fourth power of the distance from the RF current source, and therefore the delivered power is absorbed in a very small volume of the tissue to be treated. According to some embodiments, the RF electrode 644 may be translated, rotated, and / or pivoted away from the axis of the shaft 656 to move the RF electrode 644 into closer proximity to the tissue to be treated.
[0102] In some embodiments, the shaft 656 carries a microwave ablation device, which may include a power delivery system, an interstitial applicator, which may be coupled to a microwave generator. The microwave ablation system may be structured and operated similarly to the RF electrode 644 as described herein.
[0103] The electrical system interface device 636 may be carried by the translation device 610 and may transmit, condition, or interpret electrical signals between the instrument device manipulator 602 and the handpiece 600. The electrical system interface device 636 may include one or more electrical connectors and may electrically couple to the handpiece 600 and the instrument device manipulator 602 when the handpiece 600 is coupled to the instrument device manipulator 602 by the translation device 610. The electrical system interface device 636 may transmit power and / or commands to the handpiece 600 from a computing system, etc., and may transmit signals from the handpiece 600 to the instrument device manipulator 602, such as signals associated with force, imaging, volume, position, direction, orientation, temperature, or some other parameter. It may also provide signal processing between the handpiece 600 and the instrument device manipulator 602, and signal passing to and from the system 400. In some embodiments, the handpiece 600 includes one or more encoders 620 to send signals to a computing system associated with parameters of the handpiece 600. Electrical energy may also be sent to one or more of the probes, such as to power lights, RF emitters, thermal ablation devices, or other devices that require power for efficient operation.
[0104] An imaging device, such as a cystoscope 642, ultrasound probe, or other type of imaging device, may be carried by the handpiece 600 and may be manually positioned by a manual position control device 640 or may be under the control of one or more motors for positioning, such as translation and / or rotation.
[0105] 7-11 show different views and configurations of the treatment probe.
[0106] FIG. 7 shows a probe with an energy source with a variable offset from the extension axis of the probe. FIG. 8 shows a probe as in FIG. 7 in a compact configuration with an energy source positioned toward the extension axis of the probe. FIG. 9 shows a perspective view of a probe as in FIGS. 8 and 9 in a compact configuration. FIG. 9 shows additional components of a probe as in FIGS. 7 and 8, in which the probe includes a digital endoscope and an active irrigation port. The probe can provide, for example, automated 3D tissue removal coupled to a computer controlled actuator, or a manual actuator, or both. In some embodiments, the movement can include automated treatment in response to an image shown on a display and sequential treatment with an energy source as described herein, such as a water jet and an electrode for cauterizing tissue.
[0107] 7-9 show a treatment probe 700 and a configuration of the treatment probe for treating tissue with a deflectable energy source. The treatment probe 700 may comprise one or more components of the treatment probe 450 and can be coupled to a robotics system or handle as described herein. The energy source 250 is configured to move away from the extension axis 451 of the probe 700 and provide an offset 252 from the axis 451. The probe 700 comprises a coupling 710 coupled to an extension 720. The extension 720 is coupled to the energy source 250 as described herein. In some embodiments, a shaft 730 is coupled to the coupling 710, and the shaft 730 is configured to rotate and translate, rotating and translating the extension 720 and the energy source 250. In some embodiments, the shaft 730 is located within a sheath 740, which allows for rotational and translational movement of the shaft 730 within the sheath 740. Shaft 730 may comprise a single or component shaft or a shaft comprising multiple shafts to provide additional movement of the energy source as described herein. In some embodiments, probe 700 comprises spine 750, e.g., to add stiffness. In some embodiments, spine 750 extends to a rounded distal tip or anchor as described herein. In some embodiments, spine 750, shaft 730, and sheath 740 are located within second sheath 742.
[0108] In some embodiments, the linkage 710 is coupled to one or more linkage mechanisms to provide the energy source 250 with an offset 252 from the axis 251. The offset 252 can be provided in a number of ways, such as with a deflection 254 of the extension 720 or a translation of the extension 720 to move the energy source 250 away from the axis 451 and back toward the axis 451. The energy source 250 can be moved with a translation 418 or a rotation 453 and combinations thereof. The extension 720 and the energy source 250 can be rotated and translated with corresponding rotational and translational movements of the shaft 730.
[0109] In some embodiments, the probe 700 is configured with a narrow profile configuration for insertion into tissue, as shown in FIG. 8. Once inserted, the extension 720 can be moved to offset the energy source 250 from the extension axis 451 such that the probe 450 has a wide profile configuration. In some embodiments, the shaft 703 is configured to move with translation 418 over a working distance 731 that is sized to enable ablation of the target tissue over a suitable distance. In some embodiments, the working distance is within a range of about 0.5 cm to about 10 cm. The offset 252 and rotation 453 can likewise be sized to enable tissue ablation over a suitable distance to provide volumetric tissue removal. In some embodiments, the extension is configured to deflect to move the energy source toward and away from the extension axis with an offset distance from the extension axis of 5 cm or less. In some embodiments, the sheath has a cross-sectional diameter within a range of 3 mm to 12 mm, optionally within a range of 4 mm to 10 mm.
[0110] The probe 700 can be configured in many ways, but in some embodiments, the coupling 710 is configured to deflect the energy source 250 from a first position near the extension axis 451 as shown in FIG. 8 toward a second position away from the extension axis 451 as shown in FIG. 7, in which the first position, the second position, and the coupling substantially define a plane that extends through the sheath 742. In some embodiments, the plane extends through a drive shaft 730 that is coupled to the energy source 250, causing the energy source to be one or more of offset, rotated, or translated relative to the shaft. In some embodiments, the probe's extension axis 451 extends along the drive shaft 730, causing the energy source to rotate about the axis of the drive shaft, which can provide improved positional accuracy of the energy source. In some embodiments, the axis of rotation of the energy source about the probe's extension axis 451 is coaxial with the axis of rotation of the drive shaft. In some embodiments, the drive shaft 730 comprises a tube, and the axis of rotation of the energy source about the probe's axis of extension 451 extends along the interior of the tube.
[0111] The probes of the present disclosure are highly suitable for use with surgical robotics and manually operated systems to provide improved placement of the energy source in relation to the extension probe with the components described herein. In some embodiments, the energy source can be offset from the extension axis 451 of the probe with a positional accuracy tolerance of 1 mm or less, optionally with a positional accuracy tolerance of 0.25 mm or less. In some embodiments, the energy source can be rotated about the extension axis of the probe with a rotational accuracy tolerance of 1 degree or less, optionally with a rotational accuracy tolerance of 0.5 degrees or less. In some embodiments, the energy source can be translated relative to the extension axis of the probe with a translational accuracy tolerance of 1 mm or less, optionally with a translational accuracy tolerance of 0.25 mm or less. The positional accuracy, rotational accuracy, and translational accuracy relate to movement of the probe near the proximal end, such as movement provided by a motor near the proximal end of the probe. In some embodiments, the positional accuracy, rotational accuracy, and translational accuracy each correspond to a limited deviation from a corresponding proximal movement, such as rotation or translation, provided by a linkage mechanism as described herein.
[0112] The components of the probe 700 can be configured in many ways to provide a suitable amount of stiffness, according to some embodiments. Research related to the present disclosure suggests that adding stiffness to one or more components of the probe can provide improved rotational stability and resistance to torsional forces. The stiffness of one or more probe components may comprise, for example, one or more of bending stiffness or torsional stiffness. The stiffness may comprise the combined stiffness of the probe or one or more components of the probe, such as the tubular drive shaft, as described herein. In some embodiments, the torsional stiffness of the probe or one or more elements of the probe is in the range of 10 Nm / radian to 125 Nm / radian. Alternatively, or in combination, the bending stiffness of the probe or one or more components of the probe is in the range of 200 to 2,000 N / m. The stiffness of the individual components and the probe can be calculated by those skilled in the art of mechanical engineering using equations or calculation methods such as finite element analysis and combinations thereof.
[0113] In some embodiments, the torsional stiffness can be determined using the following equation:
[0114] [ka] where:
[0115] G = shear modulus
[0116] D=outer diameter
[0117] d=inner diameter
[0118] L=length
[0119] Gpa = Giga Pascal
[0120] N = Newton
[0121] m = meters
[0122] mm = millimeters
[0123] While the material may comprise any suitable material, such as metal, steel, stainless steel, or plastic, in some embodiments, the shaft comprises stainless steel, such as 304 stainless steel, with a shear modulus of 200 Gpa. The dimensions of one or more components may comprise any suitable dimensions corresponding to the dimensions of the probe as described herein, such as L=300 mm, D=8 mm, and d=7 mm, which provides a torsional stiffness of, for example, about 110 Nm / radian. In another example, the dimensions of one or more probe elements have dimensions of D=6 mm, d=5.8 mm, which provides a torsional stiffness of 11 Nm / radian. Although reference is made to a component with a length of 300 mm, the length may comprise any suitable length, for example, within the range of about 100 mm to about 400 mm. A stiffness within the above range may comprise the stiffness of the probe between the energy source and a proximal linkage component coupled to the motor, such as a gear as described herein with reference to FIG. 6B.
[0124] In some embodiments, the bending stiffness can be determined using the following equation:
[0125] [ka] and
[0126] Regarding hollow tubes, [ka] and
[0127] where E=elastic modulus and I=moment of area.
[0128] One skilled in the art can determine the bending stiffness for a hollow tube with similar dimensions and parameters to those described above, in which the bending stiffness is in the range of about 200 N / m to 2,000 N / m. The combined stiffness of the probe can be determined from the stiffness of the components, for example, as described herein.
[0129] In some embodiments, the sheath 742 provides rigidity to add rigidity and stability to the energy source 250 with movement of the elongated shaft 730 and movement of the energy source relative to the sheath. In some embodiments, a spine 750 is coupled to the sheath to add rigidity to the probe. In some embodiments, the spine 750 extends distally beyond the energy source 250. The spine comprises a tube comprising one or more fluid source channels or fluid removal channels coupled to one or more openings 932 distal to the energy source to provide fluid to the energy source or remove material generated thereby. In some embodiments, the spine comprises a first side comprising a concave surface facing toward the energy source and spaced away from the energy source, and a second side comprising a convex surface facing away from the energy source to engage tissue. In some embodiments, the spine extends beyond the distal end of the sheath and one or more openings are located distally beyond the distal end of the sheath. The spine may extend to a distal tip 760, which includes a rounded end for insertion of a probe and a recess 940 in the tip to allow fluid to pass around the tip when the tip engages the wall of the lumen.
[0130] Although reference is made to a rigid sheath, in some embodiments the sheath comprises a flexible sheath.
[0131] The treatment probe 700 can be configured to receive another energy source, as shown in Figure 9. In some embodiments, the first energy source 250 is configured to deflect away from the extension axis of the probe and the second energy source 200 is configured to direct energy outward, e.g., using an end-firing configuration, emitting energy radially outward, e.g., away from or along the axis 451.
[0132] The treatment probe 700 can be configured in many ways. In some embodiments, the treatment probe includes a rigid spine 750 to maintain the probe in place, but the spine 750 may be flexible. In some embodiments, the probe 700 includes one or more joints, e.g., articulation from one or more joints is used to move the energy source away from the extension axis of the probe 451.
[0133] The probe 700 may comprise a fluid source channel 920 coupled to one or more openings 922 and a fluid removal channel 930 coupled to one or more openings. The probe 700 may comprise one or more openings 932 for removing, e.g., aspirating, tissue products, such as tissue ablation products, and one or more openings 922 for supplying fluid to the energy delivery area. The openings may remain substantially fixed while the energy source 250 moves. In some embodiments, the linkage 710 comprises an articulating joint coupled to the energy source 250 with an extension 720. In some embodiments, the energy source 250 comprises a loop electrode. Articulation of the joint can provide displacement of the energy source with a controlled deflection angle, which can provide improved accuracy of tissue, treatment, ablation, and cauterization.
[0134] In some embodiments, rotation of the extension 720 relative to the pivot at the connection 710 and rotation of the shaft 730 about the translation and extension axis 451 can provide three-dimensional (3D) volumetric ablation of tissue using the probe.
[0135] 8 and 9 show the treatment probe 700 of FIG. 7 in which a second treatment probe 950 comprising a second energy source 200, e.g., a water jet, is installed within the treatment probe 700. In some embodiments, the second treatment probe 950 is installed within the treatment probe 700 after one or more components of the treatment probe 700 are installed within the patient. In some embodiments, the first energy source (e.g., laser or electrode) is configured to rotate, translate, and offset, e.g., pivot, and the second energy source is configured to translate and rotate such that the energy source is controlled with five or more degrees of freedom, e.g., from a motor on the end of a robotic arm, as described herein.
[0136] 10 and 11 show the internal and external structure of the probe as in FIG. 7-9. FIG. 10 shows a cross-sectional view of the probe of FIG. 7-9. FIG. 11 shows a perspective view of the internal drive structure of the probe of FIG. 7-10. In some embodiments, the probe comprises an outer sheath 742 of a suitable diameter, such as a 24 French ("FR") sheath. In some embodiments, a fluid removal channel 930, e.g., an aspiration channel, and a fluid source channel 920, e.g., an irrigation channel, are located within the sheath 742 and extend at least partially around components of the shaft 730. In some embodiments, the shaft 730 comprises an articulation drive tube 732 for an energy source offset and a rotation and translation drive tube 734, e.g., an RF loop drive tube. One or more of the articulation drive tube 732 or the rotation and translation drive tube 734 can be sized and shaped to receive a second treatment probe 950, e.g., a water jet probe, as described herein. The endoscope 910 may include a CMOS camera sensor, one or more lenses, and an LED light source. The endoscope 910 can be located within the probe in any suitable location, but in some embodiments, the endoscope 910 is located near the end of the drive tube and fixed relative to the sheath for viewing the energy source and extension 720 while the extension 720 moves the energy source. Alternatively, the endoscope 910 can be located on the extension 720 to place the endoscope in closer proximity to the tissue being treated with the energy source, for example.
[0137] The diameter of the outer sheath can be sized using any suitable units, such as, for example, diameter in millimeters ("mm"), or using the French scale. The French scale size can be easily converted to diameter in mm, which is about 1 / 3 of the French size. Thus, a 24FR sheath would have a diameter of about 8 mm, as would be known to one of skill in the art.
[0138] In some embodiments, the fluid source channel 920 and the fluid removal channel 930 are located within the sheath 742 to provide improved engagement and rotational stability. In some embodiments, the fluid source channel 920 comprises one or more of an air insufflation channel or an irrigation channel, and the fluid removal channel 930 comprises one or more of an exhaust channel or an aspiration channel.
[0139] In some embodiments, the fluid source channel 920 and the fluid removal channel 930 are sized and shaped to interengage within the sheath 742 with one or more of the fluid source channel 920 or the fluid removal channel 930, which are sized and shaped to receive an elongated shaft 730 coupled to the energy source 250 and allow rotation and translation of the energy source 250. In some embodiments, the fluid source channel 920 is sized and shaped to receive the elongated shaft 730 and provide a fluid source to the surgical site along the fluid source channel, the elongated shaft 730 being disposed within the fluid source channel 920. In some embodiments, the removal channel 930 is sized and shaped to receive the elongated shaft 730 and remove fluid from the surgical site along the fluid removal channel 930, the elongated shaft 730 being disposed within the fluid removal channel.
[0140] The fluid source channel 920 and the fluid removal channel 930 may comprise tubes configured to inter-engage and provide rotational stability. In some embodiments, the fluid source channel 920 comprises a first tube 924 and the fluid removal channel 930 comprises a second tube 934, where the first tube and the second tube are sized and shaped to inter-engage and provide rotational stability while the shaft 730 rotates and translates. In some embodiments, a resilient structure 1310 (as shown in FIG. 13A ) is coupled to the sheath 742, the first tube 924, and the second tube 934, urging the first tube and the second tube toward each other and providing rotational stability. In some embodiments, the first tube 924 comprises a first portion 926 and the second tube 934 comprises a second portion 936 that is sized and shaped to engage the first portion with a nested configuration. In other words, the first tube 924 may comprise a first portion 926 with a first surface profile, and the second tube 934 may comprise a second portion 936 with a second surface profile sized and shaped to engage the first surface profile. In some embodiments, the first and second surface profiles comprise curved protrusions and curved recesses that engage with each other along the axially extending lengths of the curved protrusions and curved recesses to provide translational stability. In some embodiments, the first and second portions 926 and 936 comprise a plurality of engagement structures 1010, 1020 that are sized and shaped to engage with each other and provide rotational stability. In some embodiments, the first and second portions 926 and 936 comprise a plurality of interlocking engagement structures 1320 that comprise a plurality of protrusions 1322 and a plurality of recesses 1324 that are sized and shaped to mate together in an interlocking configuration (as shown in FIG. 13C). In some embodiments, a plurality of interlocking engagement structures extend axially along the first tube and the second tube and provide torsional stability to the extension shaft.In some embodiments, the first tube 924 comprises an outer portion having a third surface profile that is sized and shaped to engage the interior of the sheath 742, and the second tube 934 comprises an outer portion having a fourth surface profile that is sized and shaped to engage the interior of the sheath 742. The sheath can be configured in many ways, but in some embodiments the interior of the sheath comprises a circular profile, the third surface profile comprises a circular profile, and the fourth surface profile comprises a circular profile.
[0141] The shaft 730 can be configured to offset, rotate, and translate the energy source 250 in a number of ways. In some embodiments, the elongated shaft 730 includes a first elongated drive tube 732 to offset the energy source 250 from the extension axis 451, e.g., by deflecting the extension 720 away from the extension axis 451. In some embodiments, the elongated shaft 730 includes a second elongated drive tube 734 to rotate and translate the energy source 250 with the energy source offset from the extension axis 451, e.g., by deflecting the extension 720 away from the extension axis.
[0142] The first and second elongate drive tubes 732 and 734 can be configured to move the energy source 250 in a number of ways. In some embodiments, the first and second elongate drive tubes 732 and 734 are configured to rotate and translate together and move the energy source 250 with the energy source offset from the axis 451, e.g., with an extension that is offset from the elongate axis. Alternatively, or in combination, the first and second elongate drive tubes 732 and 734 are configured to rotate and translate independently and move the energy source 250 with the rotation and translation. In some embodiments, the first and second elongate drive tubes 732 and 734 are arranged in a side-by-side configuration (not shown). In some embodiments, the first elongate drive tube 732 and the second elongate drive tube 734 are arranged with one drive tube over the other. The first elongate drive tube and the second elongate drive tube can be arranged, for example, in a coaxial configuration.
[0143] In some embodiments, the drive tube is sized to receive a second probe 950 comprising a second energy source. The first drive tube 732 and the second drive tube 734 are sized to receive the second probe 950 comprising a third drive tube 952 coupled to the second energy source and rotate and translate the second energy source relative to one or more of the first drive tube 732, the second drive tube 734, or the sheath 742.
[0144] The first energy 250 source may comprise any suitable energy source, such as one or more of an electrode, a loop electrode, a monopolar electrode, a bipolar electrode, a radio frequency source, a microwave source, a plasma source, a heat source, a laser source, a mechanical energy source, a mechanical shear source, a vibrational energy source, an ultrasonic energy source, a cavitational ultrasonic source, a water jet, a fixed pressure water jet, a variable pressure water jet, a water jet drainage source, a steam source, a morcellator, a photoablative energy source, an ionizing radiation energy source, a radioisotope, an ionizing plasma source, or a cryogenic energy source.
[0145] Although reference is made to a second energy source comprising nozzle 200, the second energy source may comprise any suitable energy source as described herein, such as one or more of an electrode, a loop electrode, a monopolar electrode, a bipolar electrode, a radio frequency source, a microwave source, a plasma source, a heat source, a laser source, a mechanical energy source, a mechanical shear source, a vibrational energy source, an ultrasonic energy source, a cavitational ultrasonic source, a water jet, a fixed pressure water jet, a variable pressure water jet, a water jet drainage source, a steam source, a morcellator, a photoablative energy source, an ionizing radiation energy source, a radioisotope, an ionizing plasma source, or a cryogenic energy source.
[0146] In some embodiments, the second energy source 250 comprises a water jet, as described herein. In some embodiments, the third elongated drive-tube 952 is coupled to a nozzle and generates the water jet. In some embodiments, the third elongated drive-tube 952 extends proximally from the nozzle in the first and second drive-tubes and rotates and translates the water jet relative to the first and second drive-tubes.
[0147] The endoscope 910 can be configured in any suitable manner. In some embodiments, the digital endoscope comprises a lens and a sensor array. Alternatively, the endoscope may comprise, for example, a lens and a fiber optic bundle. In some embodiments, the digital endoscope 910 is supported with an extension, and the lens and sensor array move away from the extension axis with movement of the energy source away from the extension axis.
[0148] 12A and 12B show top and side views, respectively, of a probe 700 with a variable offset energy source 250 configured for manual use with a handle 1200. In some embodiments, the probe includes a manual control for pivoting the energy source in response to movement of the manual control, as described herein. An extension shaft 730 extends proximally toward the handle 1200 and controls the angle of rotation of the energy source about the extension axis. In some embodiments, the shaft 730 is coupled to the handle and rotates the energy source with rotation of the handle. The shaft 730 may include a linkage that extends proximally toward the handle and controls the offset distance of the energy source from the extension axis 451. In some embodiments, the linkage includes a knob 1230 that controls the deflection 254 and corresponding offset distance with rotational movement 1232 of the knob. The handle 1200 may include a slider 1220 to move the energy source with translation 418 along an axis of extension 451 with corresponding proximal and distal movement of the slider 1220. Alternatively, the linkage can be configured to control the offset distance with rotational movement 1232 of the slider 1220 and knob 1230.
[0149] In some embodiments, a rigid sheath 742 extends from the handle 1200 to a proximal opening of the coupling 710 to add rigidity. The shaft 730 can be configured to move within the rigid sheath and translate the energy source 250. A coupling mechanism, including the shaft 730, extends between the coupling and the handle and offsets the energy source from the extension axis with rotation of the knob. In some embodiments, the handle 1200, shaft 730, and rigid sheath 742 are configured to move together and rotate the energy source 250 with rotation about the extension axis 451 with rotation 453.
[0150] The handle controls can be configured in many ways, but in some embodiments, a finger engagement structure 1210 is configured to engage a user's finger and the slider 1220 includes a thumb engagement structure to engage the user's thumb. The thumb engagement structure is coupled to the shaft such that translation of the thumb engagement structure relative to the shaft translates the energy source.
[0151] The extension 720 may include a fluid source channel 920 or a fluid removal channel 930 that extends to one or more openings supported with the extension. In some embodiments, the one or more openings are configured to move with the energy source 250 toward and away from the extension axis 451 as the linkage 710 deflects and straightens.
[0152] Although reference is made to manual articulation, movement of the energy source can be performed under computer control, for example, using one or more linkage mechanisms associated with the handpiece as described herein.
[0153] 13A-13C show cross-sectional views of a probe with an asymmetric internal structure to provide rotational stability.
[0154] 13A shows a probe 700 comprising a sheath 740, a fluid source channel 920 and a fluid removal channel 930. The fluid source channel 920 comprises a tube 924 and the fluid removal channel 930 comprises a tube 934 in which the tubes 924 and 934 are configured to engage with each other. The tubes may comprise an interlocking structure 1320 comprising a plurality of protrusions 1322 and a plurality of recesses 1324 to engage with each other in the interlocking configuration. In some embodiments, a compression element 1310, such as a spring, is configured to urge the tubes and the interlocking structure toward each other to add stability. The interlocking structure may extend along the probe to add rotational and translational stability.
[0155] 13B shows a probe 700 comprising a sheath 740, a fluid source channel 920 and a fluid removal channel 930. The fluid source channel 920 comprises a tube 924 and the fluid removal channel 930 comprises a tube 934, in which the tubes 924 and 934 are configured to engage with one another. One or more of the tubes are configured to receive a treatment probe as described herein. The tube 924 comprises an engagement structure 1010 configured to engage a corresponding engagement structure 1020 on the tube 934 and provide rotational stability. The tube may comprise additional engagement structure, such as a recess 1030 on the tube 934 that engages with a protrusion 1035 on the tube 924 and is shaped to provide translational stability when the tubes engage with one another. The engagement surfaces of the tubes may comprise additional structure, such as surface roughening, to provide friction between the probes.
[0156] 13C shows a probe 700 comprising a sheath 740, a fluid source channel 920, and a fluid removal channel 930. The fluid source channel 920 comprises a tube 924, and the fluid removal channel 930 comprises a tube 934, in which the tubes 924 and 934 are configured to engage with one another. One or more of the tubes are configured to receive a treatment probe, as described herein.
[0157] In some embodiments, one or more elements include an asymmetric shape, allowing the elements of the assembly to contribute to torque transmission capabilities. In some embodiments, the axially extending elements include an engagement structure, such as an interlocking structure. In some embodiments, the structure can be actuated via one or more of a screw function or a pull / push function. In some embodiments, the probe elements are configured to interact, for example, at one or more of a proximal location, a distal location, or along the assembly.
[0158] In some embodiments, the components include interlocking geometries between the parts, such as single or multiple interlocking bulges or ramps and / or 3-D interlocking features that prevent system expansion, in which movement between them causes locking.
[0159] In some embodiments, the working element provides sufficient rigidity to faithfully execute movements with reduced hysteresis.
[0160] In some embodiments, one or more components comprise a cylindrical geometry, for example an annular geometry, and engage a cylindrical wall of another component to take advantage of the available wall thickness.
[0161] In some embodiments, the outer shaft of the surgical probe 700 provides rigidity from bending to ensure accurate movement and positioning within the surgical space. The outer shaft can also prevent the inner elements from bending while allowing them to perform their functions of rotation, translation, e.g., pistoning, and offset actuation.
[0162] In some embodiments, the probe components include a reversible interlocking structure that locks the individual elements together to create a rounded torque cylinder with the inner element locked together within the sheath. In some embodiments, the cross-sectional profile of the probe elements improves torque transmission of the inner assembly due to their engagement with one another. These are just a few examples of many different geometric interlocking configurations that may be used in accordance with the present disclosure.
[0163] Although a two-dimensional cross-sectional view is shown, in some embodiments the probe elements include three-dimensional geometric interlocking features such that relative axial movement of the elements can be reduced.
[0164] 14A and 14B show a push / pull structure for offsetting the energy source.
[0165] In some embodiments, the tube within the tube comprises a push / pull configuration to cause angular bending or other action. The coupling mechanism can be configured in many ways and may comprise, for example, one or more of a pull wire or a nut drive. In some embodiments, the push / pull wire assembly is configured to provide angular deflection. The coupling mechanism may comprise, for example, a slot and pin, as desired.
[0166] In some embodiments, the push / pull coaxial tube drive shaft 1412 may be a threaded rod that is threadably coupled to the proximal end of the extension 720, which rotates and deflects the extension 720, displacing the energy source 250. In some embodiments, the coupling mechanism includes an anti-recoil feature, for example a spring-loaded nut with threads on both actuation directions.
[0167] The linkage mechanism can extend proximally of the coupling portion and the control portion, as described herein.
[0168] 14A shows a probe with a rotating coupling mechanism 1410. The coupling mechanism 1410 may include a threaded female structure 1416, similar to a nut, and a threaded drive shaft 1412. The threaded female structure 1416 is shaped to receive a threaded rod 1412. In response to rotation 1420 of the rod 1412, the extension 720 is moved toward or away from the axis of extension, depending on the direction of rotation. The coupling 710 is coupled to the threaded structure, causing the extension 720 to pivot about the coupling 710 to provide the deflection 254.
[0169] 14B shows a probe with a push / pull linkage 1450. Linkage 710 may include, for example, a pin 1460 to move the energy source with deflection 254 of the extension as described herein. The linkage may include additional pins 1462, 1464 coupled to additional extensions extending proximally from extension 720. Translational movement 1470 moves the energy source toward and away from the extension axis. In some embodiments, distal movement 1472 deflects extension 720 away from the extension probe axis and proximal movement 1474 moves extension 720 toward the extension axis.
[0170] 15A-15D show a surface follower for positioning an energy source relative to depth from a tissue surface profile.
[0171] Although these illustrations show an electrocautery wire as the energy source, any suitable energy source may be employed as described herein. In some embodiments, the surface follower is configured to slide along the surface of the tissue while the energy source extends into the tissue to one or more of a single set depth or a user-adjustable depth to achieve the depth of treatment.
[0172] 15A and 15B show an energy source coupling element that is pivoted about an axis, where the angular displacement relative to the follower provides greater ablation depth.
[0173] 15A shows a follower 1510 coupled to the extension 720 and the energy source 250, engaging and following the tissue surface 1500. When the follower is moved by the extension 720 in a direction 1504, the follower enables the energy source to ablate tissue at a depth from the tissue surface. An elongated member 1505 extends between the follower 1510 and the energy source to control the depth 1502 of tissue ablation. The member 1505 may have a substantially fixed length between the follower 1510 and the energy source 250. Alternatively, the member 1505 may have a variable length to vary the tissue ablation depth from the tissue surface 1500.
[0174] The follower 1510 can be configured in many ways, and is typically wider than the member 1505 so that the follower can slide along the tissue surface. In some embodiments, the follower 1510 comprises a support with a curved surface for sliding along the tissue surface. The tissue surface may comprise any suitable surface, such as an intact wall of a luminal tissue or an ablated tissue surface where additional ablation may be useful. Research related to the present disclosure suggests that some types of tissue, such as tissue ablated with a water jet, may comprise a fibrous surface, and that the follower may also be useful in removing fibrils by smoothing the fibrils beneath the follower 1510 and cauterizing the fibrils.
[0175] In some embodiments, the energy source 250 is coupled to a follower 1510 and varies one or more of the distance or angle between the follower and the energy source to ablate tissue to a depth 1502.
[0176] 15A, the follower 1510 is configured with a pivot 1520. The angle between the follower and the extension member 1505 corresponds to the amount of deflection of the extension from the elongated probe axis. Increasing the deflection of the extension 720 increases the angle between the follower and the energy source and the corresponding ablation depth from the tissue surface.
[0177] 15B shows a follower 1510 coupled to the energy source 250 with an extension member configured to vary the depth of ablation to a plurality of depths 1502A, 1502B, and 1502C. Tissue can be cut to that depth by varying one or more of a varying distance or angle relative to the extension surface profile of the follower 1510. The extension surface profile of the follower is indicative of the engaged tissue 1500. The extension 720 may comprise one or more of a wire, shaft, lever, extension, rod, or linkage extending along the extension and varying one or more of a distance or angle to vary the depth of ablation from the tissue surface profile.
[0178] As shown in FIG. 15B, the follower 1510 is configured to pivot the member 1505 relative to the follower 1510 and the extension 720 to vary the distance to a number of distances 1502A, 1502B, 1502C.
[0179] The pivot 1530 can vary the angle 1532 of the member 1505 relative to the follower 1510 and the extension 720. In some embodiments, the angle between the elongated surface profile and the member 1505 increases, increasing the depth to depth 1502C, and decreases, decreasing the depth to depth 1502A.
[0180] Ablation can be performed in many ways, but in some embodiments the angle between the follower and the energy source is adjusted to vary the ablation distance between the slider and the energy source while the amount of deflection of the extension remains substantially fixed.
[0181] 15C shows a follower 1510 coupled to the extension 720 with a spring 1540. The follower is configured to slide along the extension 720. The spring 1540 enables the follower 1510 to provide a variable force to the tissue surface 1500. In some embodiments, the spring 1540 includes a force-limiting feature, allowing the treatment element to vary its depth based on the reactive force during application.
[0182] 15D shows a follower coupled to an energy source using a deflectable member 1550, such as a spring, e.g., a leaf spring. The member 1550 is configured to decrease depth in response to tissue increasing tissue resistance and to increase depth in response to decreased tissue resistance. As shown in FIG. 15D, a preformed wire or spring element is configured to control the position of the treatment element, in which the length of the spring element affects the ablation depth from the follower 1510.
[0183] 16A-16C show an energy source 250 coupled to a surface follower 1510 with a pivot 1530 near the surface of the tissue follower. An extension 720 includes one or more push / pull extensions 1610 coupled to the energy source 250. One or more wires 1610 extend from the extension 720 within one or more tubes 1630 to pivot the energy source 250 relative to the tissue follower 1510 about a pivot axis 1531 and along a path 1532. Translational motion 1620 of the wires 1610 within the extension 720 can be used to adjust the pivot angle. The pivot angle can be adjusted to ablate tissue to a first depth 1502A as shown in FIG. 16B or a second depth 1502B as shown in FIG. 16C.
[0184] 17A-17C show an energy source 250 coupled to a surface follower 1510 with a variable extension depth of the energy source 250 from the follower 1510 to the tissue. The variable extension depth can be controlled using one or more push / pull extensions 1610, such as wires, tubes, or shafts, that can be used to vary the depth. In some embodiments, retraction of the extension 1610 between the follower and the energy source decreases the distance to a first distance 1502A and advancement of the extension 1610 increases the distance to a second distance 1502B.
[0185] The coupling 710 can be configured in a number of ways to offset the energy source 250 from the extension axis 451. In some embodiments, the coupling comprises, for example, one or more of a pivot, a hinge, a bendable coupling, multiple slits in the tube, or multiple non-planar slits in the tube.
[0186] FIG 18A shows deflection of linkage 710, which includes a bendable linkage for deflecting the energy source with a complementary structure, e.g., an interlocking structure, to provide rotational stability. FIG 18B shows a cross-sectional view of the probe as in FIG 18A. FIG 18C shows a bottom view of the probe of FIG 18A-18B. FIG 18D shows deflection of the probe of FIG 18A-18C with a deflection angle of more than 45 degrees from the extension axis of the probe.
[0187] The bendable joint can be configured in many ways and may be an internally actuated tension or expansion feature to add rigidity to the distal end. In some embodiments, the slit interlocking elements interlock in three dimensions, such as radially, using, for example, a wedge feature. In some embodiments, the slit is fabricated by laser cutting the tubing using a laser angle to create a conical shape, in which a male cone fits, for example, into a female cone. In some embodiments, the cut tubing includes an interlocking slit piece to improve rotational stability.
[0188] In some embodiments, the angle of deflection 254 can be controlled by the distance the link element extends beyond the distal opening 1850 of the sheath 740. The rotational and translational position of the link 710 can be controlled by, for example, the shaft 730. In some embodiments, the link 710 comprises a plurality of slits 1800 defining a plurality of gaps 1810. One or more of the plurality of distances across the plurality of gaps 1810 are configured to decrease to deflect the extension 720 and move the energy source 250 away from the extension axis. The plurality of slits 1800 extend through a first side of the tube and only partially through a second side of the tube, allowing the tube to fold along the second side as the plurality of distances along the first side decrease. In some embodiments, the plurality of slots 1800 are configured to at least partially close along one or more of the plurality of slots to deflect the extension and move the energy source away from the axis, in some embodiments, the angle of deflection is related to the number of closed slots 1820.
[0189] The slits can be configured with appropriate structures to provide improved stiffness and resistance to torsional deflection. In some embodiments, the plurality of slits comprises non-planar slits 1860, e.g., V-shaped slits. The non-planar slits comprise corresponding opposing engagement structures that interengage with each other with at least partial closure of the plurality of slits.
[0190] In some embodiments, the sheath 740 includes a retaining sheath over the multiple slits, and controls the deflection angle of the extension by exposing one or more of the multiple slits from the sheath. The angle of deflection 254 is related to the number of slits exposed from the sheath and thereby the distance one or more of the multiple slits extend beyond the distal end 1850 of the sheath. As shown in Figures 18A-18D, the angle of deflection 254 can gradually increase with the exposure of the slits, as shown with deflections 254A, 254B, and 254C, respectively.
[0191] In some embodiments, a coupling mechanism is coupled to the sheath or one or more of the slits to move one or more of the slits or shafts to expose and cover the slits with the shaft and to control the deflection angle. The coupling mechanism may comprise any suitable coupling mechanism as described herein, for example, one or more of a threaded connection, a preloaded spring, a pull wire, a gear, or a rod coupled to a proximal portion of the probe.
[0192] The sheath can be configured to hold the gaps open in any suitable manner when retained within the sheath 740. In some embodiments, the sheath 740 comprises sufficient rigidity to move the extension and energy source toward the extension axis after the extension is deflected away from the extension axis. In some embodiments, the sheath comprises sufficient rigidity to open one or more of the multiple gaps after the distance across one or more of the multiple gaps is reduced to move the energy source and extension toward the extension axis.
[0193] 19A and 19B show side and top views, respectively, of a probe with an energy source, such as an electrocautery wire, cut to extend at an oblique angle relative to the bent element. In some embodiments, the cutting edge of the electrode is at an oblique angle, e.g., 45°, relative to the shaft, allowing the cutting action to occur in a direction 1950 with both rotational 1954 and translational 1952 motion, e.g., axial motion. In some embodiments, this oblique angle increases the tissue ratio with axial and rotational motion, e.g., when the direction of movement of the electrode is approximately perpendicular to the tissue receiving the region of the electrode.
[0194] As shown in FIG. 19B, the extension 720 away from the shaft and the deflection 254 of the electrode can be aligned with the extension axis such that the deflection 254 remains aligned with the extension axis, which can improve rotational accuracy and reduce errors associated with eccentric movement of the energy source 250.
[0195] The energy source 250 may include an electrode that is shaped to define a region 1920 through which ablated tissue may pass as the electrode ablates the tissue as the electrode moves. In some embodiments, the region 1920 defined by the electrode extends in an oblique direction 1956 relative to the shaft extension axis 451 and a plane perpendicular to the shaft extension axis.
[0196] Region 1920 can be configured in many ways, but in some embodiments, the region comprises an area defined by the non-linear shape of a cutting edge 1910 of an electrode. The area defined by edge 1910 extends in an oblique direction 1956 relative to the elongation axis of the shaft and a plane 1957 perpendicular to the elongation axis 451. The non-linear shape may comprise a portion of a loop such that a portion of the loop defines the area of region 1920. In other words, the region is defined by a curved electrode, which extends in an oblique direction relative to the elongation axis of the shaft and a plane perpendicular to the elongation axis.
[0197] The oblique angle can be configured in many ways, but in some embodiments, the direction 1956 extends in a plane 1957 at an angle relative to the axis of extension 451, within a range of about 15 degrees to about 75 degrees, and optionally, within a range of about 30 degrees to about 60 degrees.
[0198] The diagonal configuration of the electrode is well suited for processor-controlled tissue cutting with rotational and translational movements as described herein. The processor is operably coupled to a linkage comprising a shaft for rotating and translating the electrode with an extension biased away from the extension axis. The processor can be configured with instructions to offset the electrode from the extension axis, rotate and translate the shaft, and move the electrode with rotational movement 1954 and translational movement 1952 to pass tissue through a region 1920 defined by the nonlinear shape of the cutting edge 1910 of the electrode. In some embodiments, the cutting edge 1910 of the electrode extends in a direction 1956, and the processor is configured with instructions to move the electrode transversely to the direction along which the cutting edge extends to facilitate movement of the resected tissue through the region 1920. In some embodiments, the processor is configured to reduce (e.g., limit) movement of the electrode to the direction 1956 along which the cutting edge extends.
[0199] The probe can be configured to move the electrodes in many ways, but in some embodiments the direction of movement of the electrodes corresponds to synchronous rotational 1954 and translational 1052 movement of the electrodes.
[0200] 20A and 20B show an energy source 250 that includes a mechanical energy source such as a cutting element. In some embodiments, the energy source provides mechanical cutting shear force to resect tissue. The cutting element includes a movable cutting edge and a movable cutting edge 2030.
[0201] 20A shows a fixed outer tube with cutting edges 2020 on one or two surfaces (distal, proximal, or both) that interacts with a reciprocating inner element 2010 with edges 2012 to shear tissue. The inner element 2010 comprises a tubular central region and removes the sheared tissue. The inner element 2010 moves back and forth, for example, in either a single physician-controlled motion or by a motorized reciprocating motion. In some embodiments, the central lumen of the assembly can be used under vacuum suction, for example, to remove the cut tissue.
[0202] Although reference is made to movement of the inner element with the outer element fixed, the movement can also be reversed.
[0203] 20B illustrates tissue shearing using a rotational motion. The inner element 2010 includes a cutting edge 2012. The stationary element includes an edge 2020. The stationary element may comprise a grooved end of the outer tube. The inner element may include a fitted central tube, which rotates or reciprocates 2050 to provide tissue resection.
[0204] In some embodiments, the outer tube defines one or more openings and has a partially closed end that receives tissue, and the internal rotating cutting element shears the tissue as it is drawn into the one or more openings. A suction element, such as a tube, can be configured to draw tissue into the one or more openings and cut the tissue upon engagement with the internal rotating element.
[0205] The stationary element may comprise a stabilizing structure for receiving tissue and a cutting edge for engaging the tissue against the stabilizing structure and using a shearing force to resect the tissue upon engagement with the edge 2012 of the moving element. The cutting edge may be moved using one or more of a translational or rotational motion to shear the tissue. The tissue stabilizing structure comprises a recess or opening 2060 to receive the tissue 2070.
[0206] In some embodiments, the mechanical energy source comprises one or more elements of a vitrectomy device, as would be known to one skilled in the art of ophthalmic surgery.
[0207] The mechanical source of energy 250 can be powered using one or more elongated structures that extend along the extension 720 with the extension deflected away from the axis and transmit energy to the energy source 250, as described herein.
[0208] 21A-21F show a variable offset energy source 250 with a variable offset water jet coupled to a variable offset evacuation lumen. These embodiments show the jet lumen where the jet enters the receiving or evacuation lumen, which together form an eductor pump, creating a localized vacuum that can draw loose tissue into the jet area, allowing the jet force to act on tissue, cutting and ablating it as it is driven down the evacuation lumen and out of the surgical space.
[0209] These configurations can provide tissue ablation by drawing tissue into the water jet with entrainment. The tissue drawn with entrainment may comprise any suitable tissue, such as naturally occurring tissue or collagenous tissue following tissue ablation with the water jet.
[0210] In some embodiments, one of the lumens includes an electrically exposed surface to cauterize tissue and facilitate hemostasis and tissue ablation.
[0211] 21A and 21B show a probe 700 with a variable offset energy source 250. The probe 700 may comprise one or more components of the probe 450 as described herein. The probe 700 may comprise components as described herein, such as a link 710, an extension 720, a shaft 730, a spine 750, and a tip 760. The link 710 can be configured to offset the energy source 250 with a deflection 254 of the extension 720 as described herein. The extension 720 comprises a water jet supply tube 2110 coupled to a nozzle 2150 of the water jet, and a fluid removal channel 2120. The fluid removal channel 2120 extends to an opening 2122 to remove material generated with an energy source, such as a water jet 2140. The water jet 2140 is directed toward the opening 2122. The nozzle is coupled to the jet supply tube 2110 and generates the water jet 2140. The nozzle 2150 of the water jet 2140 is oriented in a direction towards the opening 2122 to direct the excised tissue towards the opening. In other words, the nozzle 2150 faces the opening 2122.
[0212] In some embodiments, the nozzle 2150 and the opening 2122 are separated by a gap 2130, which defines a distance 2132 between the nozzle and the opening. The gap 2130 is sized to entrain the tissue towards the water jet 2140 for ablation. In some embodiments, the opening 2122, the nozzle 2150, and the gap 2130 are arranged in an eductor pump configuration to draw the tissue into the gap. The distance may comprise any suitable distance and can be in the range of about 0.1 mm to about 5 mm, optionally in the range of about 0.25 mm to about 2.5 mm.
[0213] In some embodiments, the extension 720 comprises an injection supply tube 2110 and a drainage tube 2120. The drainage tube 2120 comprises a fluid removal channel, and the injection supply tube and the drainage tube are configured to move together and to move the gap 2130 using deflection of the extension 703, as described herein.
[0214] In some embodiments, the jet supply tube 2110 and the drain tube 2120 are arranged in a side-by-side configuration. The jet supply tube and the drain tube can be arranged in an above-and-below configuration, for example.
[0215] 21A, the nozzle is oriented transversely to the elongation axis 451 toward the opening, and the opening 2122 is oriented transversely to the elongation axis. In some embodiments, the nozzle and opening are oriented approximately perpendicular to the elongation axis. Using these transverse configurations, the gap 2130 is placed in close proximity to the tissue 2100, facilitating tissue removal. Research related to this configuration suggests that other configurations may be useful depending on the type of tissue being removed.
[0216] In some embodiments, the water jet supply tube 2110 and the drainage tube 2120 are arranged in a side-by-side configuration relative to the extension axis 451, which can facilitate pivoting at the connection 710, for example.
[0217] 21C and 21D show a nozzle oriented in a direction toward the extension axis 451 near the tip 760 of the probe 700 toward the opening, and an opening 2122 oriented away from the probe and the extension axis. In some embodiments, the water jet supply tube 2110 and the drainage tube 2120 are arranged in an up-down configuration, for example, with respect to the extension axis 451. The water jet supply tube 2110 can be located below the drainage tube 2120, for example.
[0218] 21E and 21F show the nozzle oriented away from the probe and extension axis 451 and the opening 2122 oriented toward the extension axis 451 near the tip 760. The water jet supply tube 2110 and the drainage tube 2120 are arranged in an up-down configuration with respect to the extension axis 451. The water jet supply tube 2110 is located above the drainage tube 2120.
[0219] 22A-22C show a probe 700 with variable offset water jets and a drainage lumen in a reverse water jet configuration. As shown, the probe 700 has similar components and movements as the probe shown in FIGS.
[0220] With these reverse water jet configurations, the water jets are directed towards the coupling 710 and axis 451. As shown in Fig. 22A, the jet supply tube 2110 and drainage tube are arranged in a side-by-side configuration with respect to the extension axis 451. The water jets 2140 are directed towards the extension axis of the elongated drainage tube 2120, which can aid in retraction of tissue and fluid with entrainment.
[0221] 22C shows the water jet supply tube 2110 and drainage tube arranged in a top-bottom configuration relative to the extension axis 451. The water jet supply tube 2110 is shown above the drainage tube 2120. The water jet 2140 is oriented toward the extension axis of the elongated drainage tube 2120 to aid in retraction of tissue and fluids with entrainment.
[0222] FIG. 23 illustrates a method 2300 of treating a patient.
[0223] In step 2310, the processor receives user input, such as a treatment profile or movement commands, from a user control, which is coupled to the linkage, as described herein.
[0224] In step 2320, a processor receives input corresponding to a shape of an energy source, such as an electrode. The processor can be configured to rotate and translate the electrode with the extension biased away from the extension shaft. In some embodiments, the processor is configured with instructions to rotate and translate the extension shaft to move the electrode and pass tissue through a region defined by the electrode.
[0225] In step 2330, the processor determines a direction of movement to facilitate tissue advancement through the region of the energy source, such as an electrode. In some embodiments, the cutting edge of the electrode extends in a direction, and the processor is configured with instructions to move the electrode transversely to the direction along which the cutting edge extends to facilitate movement of the resected tissue through the region. In some embodiments, the processor is configured with instructions to restrict movement of the electrode to the direction along which the cutting edge extends.
[0226] In step 2340, the processor determines a movement of the electrode corresponding to the synchronous offset, rotation, and translation movement of the energy source, such as an electrode. For example, the processor can be configured to move the electrode with one or more of an offset, a rotation about an extension axis, or a translation along an extension axis, simultaneously, as described herein.
[0227] At step 2350, the processor receives as an input a tissue ablation profile. In some embodiments, the processor is configured to determine a plurality of offsets of the energy source corresponding to the tissue ablation profile.
[0228] The tissue ablation profile may correspond to a three-dimensional tissue ablation profile, and the processor is configured with instructions for determining a plurality of offsets, translations, and rotations about an elongation axis of the energy source and positioning the energy source at a plurality of locations corresponding to the three-dimensional tissue ablation profile. Examples of suitable three-dimensional tissue ablation profiles are described in PCT / US2014 / 054412, filed September 5, 2014, entitled "AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT," and published as WO2015 / 035249, the entire disclosure of which has been previously incorporated by reference herein.
[0229] In step 2360, the processor determines multiple locations of the tissue ablation profile relative to the extension axis of the probe.
[0230] In step 2370, the processor determines a plurality of corresponding offsets, rotations, and translations of the energy source relative to the extension axis. The processor determines a corresponding offset, corresponding rotation, and corresponding translation location of the energy source relative to the extension axis for each of a plurality of locations of the tissue ablation profile. In some embodiments, the offset comprises a deflection of the energy source away from the extension axis of the probe, and the processor is configured with instructions for determining a translation of a shaft coupled to the energy source in response to the angle of deflection of the energy source relative to the extension axis and the translation location of the three-dimensional profile.
[0231] In step 2380, the processor adjusts the amount of energy from the energy source in response to the amount of impedance of the energy source.
[0232] At step 2385, the processor adjusts the offset of the energy source from the extension axis in response to the amount of impedance. In some embodiments, the processor is configured with instructions for adjusting the amount of deflection of the extension and offset of the energy source from the extension axis in response to the amount of impedance.
[0233] In step 2390, the processor adjusts the offset of the energy source from the axis of extension in response to the amount of force measured with the force sensor.
[0234] In step 2395, the processor adjusts the amount of energy from the energy source in response to the amount of force measured with the force sensor.
[0235] 23 illustrates a method of treating a patient according to some embodiments, although one of ordinary skill in the art would recognize many adaptations and variations. For example, the steps can be performed in any suitable order. Some of the steps can be omitted and some of the steps can be repeated. Furthermore, some of the steps may include sub-steps of other steps. Also, a computing device such as a processor as described herein can be configured to perform one or more steps of method 2300.
[0236] As described herein, the computing devices and systems described and / or illustrated herein broadly represent any type or form of computing device or system capable of executing computer-readable instructions such as those contained within the modules described herein. In their most basic configurations, these computing devices may each include at least one memory device and at least one physical processor.
[0237] The term "memory" or "memory device" as used herein generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one embodiment, a memory device may store, load, and / or maintain one or more of the modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, any variation or combination of one or more thereof, or any other suitable storage memory.
[0238] Additionally, the term "processor" or "physical processor" as used herein generally refers to any type or form of hardware-implemented processing unit capable of interpreting and / or executing computer-readable instructions. In one embodiment, the physical processor may access and / or modify one or more modules stored in the memory device described above. Examples of physical processors include, but are not limited to, a microprocessor, a microcontroller, a central processing unit (CPU), a field programmable gate array (FPGA) implementing a soft-core processor, an application specific integrated circuit (ASIC), a portion of one or more of them, a variation or combination of one or more of them, or any other suitable physical processor. The processor may comprise a distributed processor system, e.g., parallel-running processors, or remote processors such as servers, and combinations thereof.
[0239] Although illustrated as separate elements, the method steps described and / or illustrated herein may represent parts of a single application. Additionally, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, may cause the computing device to perform one or more tasks, such as method steps.
[0240] In addition, one or more of the devices described herein may transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more of the modules listed herein may transform a processor, volatile memory, non-volatile memory, and / or any other portion of a physical computing device from one form of computing device to another form of computing device by executing on the computing device, storing data on the computing device, and / or otherwise interacting with the computing device.
[0241] The term "computer-readable medium" as used herein generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transmission-type media, such as carrier waves, and non-transitory-type media, such as magnetic storage media (e.g., hard disk drives, tape drives, and floppy disks), optical storage media (e.g., compact discs (CDs), digital video discs (DVDs), and BLU-RAY discs), electronic storage media (e.g., solid-state drives and flash media), and other distribution systems.
[0242] Those skilled in the art will recognize that any process or method disclosed herein may be modified in many ways. The process parameters and sequences of steps described and / or illustrated herein are given as examples only and can be varied as desired. For example, although the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily have to be performed in the order shown or discussed.
[0243] The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or comprise additional steps in addition to those disclosed. Furthermore, the steps of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.
[0244] A processor as described herein may be configured to perform one or more steps of any of the methods disclosed herein. Alternatively, or in combination, a processor may be configured to combine one or more steps of one or more methods as disclosed herein.
[0245] Unless otherwise stated, the terms "connected to" and "coupled to" (and their derivatives) as used in this specification and the claims shall be interpreted as allowing both direct and indirect (i.e., via other elements or components) connections. Additionally, the terms "a" or "an" as used in this specification and the claims shall be interpreted as meaning "at least one of." Finally, for ease of use, the terms "including" and "having" (and their derivatives) as used in this specification and the claims shall be synonymous with and have the same meaning as the word "comprising."
[0246] A processor as disclosed herein may be configured with instructions to perform any one or more steps of any method as disclosed herein.
[0247] It should be understood that the terms "first," "second," "third," etc. may be used herein to describe various layers, elements, components, regions, or sections without reference to any particular order or sequence of events. These terms are merely used to distinguish one layer, element, component, region, or section from another layer, element, component, region, or section. A first layer, element, component, region, or section as described herein could be referred to as a second layer, element, component, region, or section without departing from the teachings of the present disclosure.
[0248] As used herein, the term "or" is used inclusively to refer to items as alternatives and in combination.
[0249] As used herein, letters such as numbers refer to similar elements.
[0250] This disclosure includes the following numbered appendices:
[0251] Appendix 1. A probe for treating a subject comprising: an energy source; an extension shaft having an extension axis; and an extension portion coupled to the extension shaft with a coupling portion, such that movement of the extension portion away from the extension axis moves the energy source away from the extension axis, offsetting the energy source from the extension axis.
[0252] Clause 2. The probe of clause 1, wherein the energy source comprises one or more of an electrode, a loop electrode, a monopolar electrode, a bipolar electrode, a radio frequency source, a microwave source, a plasma source, a heat source, a laser source, a mechanical energy source, a mechanical shear source, a vibrational energy source, an ultrasonic energy source, a cavitational ultrasonic source, a water jet, a fixed pressure water jet, a variable pressure water jet, a water jet drainage source, an eductor pump, a steam source, a morcellator, a photoablative energy source, an ionizing radiation energy source, a radioisotope, an ionizing plasma source, or a cryogenic energy source.
[0253] Appendix 3. The probe of Appendix 1, further comprising a sheath, the elongated shaft being positioned within the sheath and enabling rotation and translation of the energy source relative to the sheath as the extension is deflected away from the elongated shaft.
[0254] Appendix 4. The probe of Appendix 3, further comprising a fluid source channel and a fluid removal channel within the sheath, optionally, the fluid source channel comprises one or more of an air insufflation channel or an irrigation channel, and the fluid removal channel comprises one or more of an exhaust channel or an aspiration channel.
[0255] Appendix 5. The probe of Appendix 4, wherein the fluid source channel and the fluid removal channel are sized and shaped to interengage within the sheath, and one or more of the fluid source channel or fluid removal channel are sized and shaped to receive an elongate shaft coupled to the energy source and to allow rotation and translation of the energy source as the energy source is deflected away from the elongate shaft.
[0256] Appendix 6. The probe of Appendix 5, wherein the fluid source channel is sized and shaped to receive the elongate shaft and provide a fluid source along the fluid source channel to the surgical site, and the elongate shaft is positioned within the fluid source channel.
[0257] Clause 7. The probe of clause 5, wherein the fluid removal channel is sized and shaped to receive the elongated shaft and remove fluid from the surgical site along the fluid removal channel, the elongated shaft being positioned within the fluid removal channel.
[0258] Clause 8. The probe of clause 5, wherein the fluid source channel comprises a first tube and the fluid removal channel comprises a second tube, the first tube and the second tube being interengaged with each other and sized and shaped to provide rotational stability during rotation and translation of the extension shaft.
[0259] Clause 9. The probe of clause 8, further comprising a resilient structure coupled to the sheath, the first tube, and the second tube to urge the first tube and the second tube toward each other and provide rotational stability.
[0260] Clause 10. The probe of clause 8, wherein the first tube comprises a first portion and the second tube comprises a second portion sized and shaped to engage the first portion using a nested configuration.
[0261] Clause 11. The probe of clause 8, wherein the first tube includes a first portion with a first surface profile and the second tube includes a second portion with a second surface profile sized and shaped to engage the first surface profile.
[0262] Addendum 12. The probe of Addendum 11, wherein the first surface profile and the second surface profile comprise a curved protrusion and a curved recess, and engage with each other along the axially extending lengths of the curved protrusion and the curved recess.
[0263] Clause 13. The probe of clause 11, wherein the first and second portions include a plurality of engagement structures sized and shaped to engage with each other.
[0264] Clause 14. The probe of clause 13, wherein the plurality of engagement structures comprises a plurality of protrusions and a plurality of recesses sized and shaped to mate together in an interlocking configuration.
[0265] Clause 15. The probe of clause 14, wherein the plurality of engagement structures extend axially along the first tube and the second tube and provide torsional stability to the extension shaft.
[0266] Clause 16. The probe of clause 11, wherein the first tube has a third surface profile sized and shaped to engage an interior of the sheath, the second tube has a fourth surface profile sized and shaped to engage an interior of the sheath, and optionally, the interior of the sheath has a circular profile, the third surface profile has a circular profile, and the fourth surface profile has a circular profile.
[0267] Addendum 17. The probe of Addendum 3, wherein the sheath provides stiffness, adds rigidity, and stabilizes the energy source with movement of the elongate shaft and movement of the energy source relative to the sheath.
[0268] Clause 18. The probe of clause 3, further comprising a spine coupled to the sheath to add rigidity to the probe.
[0269] Clause 19. The probe of clause 18, wherein the spine extends distally beyond the energy source.
[0270] Addendum 20. The probe of Addendum 19, wherein the spine comprises a tube coupled to one or more openings distal to the energy source and comprising one or more fluid-filling or fluid-removing channels for providing fluid to the energy source or removing material generated thereby.
[0271] Addendum 21. The probe of Addendum 20, wherein the spine has a first side having a concave surface facing toward and away from the energy source, and a second side having a convex surface facing away from the energy source and engaging tissue.
[0272] Clause 22. The probe of clause 20, wherein the spine extends beyond a distal end of the sheath and the one or more openings are located distally beyond the distal end of the sheath.
[0273] Addendum 23. The probe of Addendum 18, wherein the spine extends to a distal tip having a rounded end for insertion of the probe and a recess in the distal tip that allows fluid to pass around the distal tip when the distal tip engages the wall of the lumen.
[0274] Clause 24. The probe of clause 3, wherein the sheath comprises a flexible sheath.
[0275] Clause 25. The probe of clause 3, wherein the sheath has a cross-sectional diameter in the range of 3 mm to 12 mm, optionally in the range of 6 mm to 10 mm.
[0276] Addendum 26. The probe of Addendum 3, wherein the coupling portion is configured to deflect the energy source from a first position near the elongation axis toward a second position away from the elongation axis, and the first position, the second position, and the coupling portion substantially define a plane extending through the sheath.
[0277] Addendum 27. The probe of Addendum 26, wherein the plane extends through a drive shaft coupled to the energy source and offsets, rotates, or translates the energy source relative to the shaft or more.
[0278] Addendum 28. The probe of Addendum 27, wherein the probe's extension axis extends along the drive shaft and rotates the energy source about the axis of the drive shaft.
[0279] Addendum 29. The probe of Addendum 28, wherein the axis of rotation of the energy source about the extension axis of the probe is coaxial with the axis of rotation of the drive shaft.
[0280] Addendum 30. The probe of Addendum 28, wherein the drive shaft comprises a tube and the axis of rotation of the energy source about the extension axis of the probe extends along the interior of the tube.
[0281] Addendum 31. The probe of Addendum 1, wherein the energy source is configured to advance and retract using translational motion over a distance in the range of about 0.5 cm to about 10 cm.
[0282] Addendum 32. The probe of Addendum 1, wherein the extension is configured to deflect to move the energy source toward and away from the extension axis with an offset distance from the extension axis of 5 cm or less.
[0283] Addendum 33. The probe of Addendum 1, wherein the probe is configured to offset the energy source relative to corresponding proximal movement of the linkage with an accuracy of a tolerance of 1 mm or less, optionally 0.25 mm or less.
[0284] Addendum 34. The probe of Addendum 1, wherein the probe is configured to rotate the energy source relative to a corresponding proximal movement of the linkage with a rotational accuracy tolerance of 1 degree or less, optionally 0.5 degrees or less.
[0285] Addendum 35. The probe of Addendum 1, wherein the probe is configured to translate the energy source relative to a corresponding proximal movement of the linkage with a translational accuracy tolerance of 1 mm or less, optionally 0.25 mm or less.
[0286] Addendum 36. The probe of Addendum 1, wherein the probe has a torsional stiffness between the energy source and a proximal drive component coupled to the motor in the range of about 10 Nm / radian to about 125 Nm / radian, and optionally the probe has a length in the range of 100 mm to about 400 mm.
[0287] Addendum 37. The probe of Addendum 1, wherein one or more components of the probe have a torsional stiffness in the range of about 10 Nm / radian to about 125 Nm / radian, and optionally, one or more components have a length in the range of 100 mm to about 400 mm.
[0288] Addendum 38. The probe of Addendum 1, wherein the probe has a bending stiffness in the range of about 200 N / m to about 2,000 N / m between the energy source and a proximal drive component coupled to the motor, and optionally the probe has a length in the range of 100 mm to about 400 mm.
[0289] Addendum 39. The probe of Addendum 1, wherein one or more components of the probe have a bending stiffness in the range of about 200 N / m to about 2,000 N / m, and optionally, one or more components have a length in the range of 100 mm to about 400 mm.
[0290] Addendum 40. The probe of Addendum 1, further comprising a digital endoscope comprising a lens and a sensor array.
[0291] Addendum 41. The probe of Addendum 40, wherein the digital endoscope is supported using an extension, and the lens and sensor array move away from the extension axis with movement of the energy source away from the extension axis.
[0292] Addendum 42. The probe of Addendum 40, wherein the fluid source channel or fluid removal channel extends to one or more openings supported with an extension portion, and the one or more openings are configured to move toward and away from the extension axis along with the energy source upon deflection and straightening of the coupling portion.
[0293] Clause 43. The probe of clause 1, wherein the elongated shaft includes a first elongated drive tube to deflect the extension away from the elongated axis.
[0294] Clause 44. The probe of clause 43, wherein the elongated shaft includes a second elongated drive tube for rotating and translating the energy source as the extension is deflected from the elongated axis.
[0295] Addendum 45. The probe of claim 44, wherein the first elongate drive tube and the second elongate drive tube are configured to rotate and translate together as the extension is deflected from the elongate axis, and to use the rotation and translation to move the energy source.
[0296] Clause 46. The probe of clause 44, wherein the first elongate drive tube and the second elongate drive tube are configured to rotate and translate independently and to use the rotation and translation to move the energy source.
[0297] Clause 47. The probe of clause 44, wherein the first elongate drive tube and the second elongate drive tube are arranged in a side-by-side configuration.
[0298] Clause 48. The probe of clause 44, wherein the first elongate drive tube and the second elongate drive tube are arranged with one drive tube spanning the other drive tube.
[0299] Clause 49. The probe of clause 48, wherein the first elongate drive tube and the second elongate drive tube are arranged in a coaxial configuration.
[0300] Clause 50. The probe of clause 48, further comprising a sheath, the elongate shaft being positioned within the sheath and enabling rotation and translation of the energy source relative to the sheath as the extension is deflected away from the elongate shaft, the first elongate drive tube and the second elongate drive tube being sized to receive a third drive tube coupled to the second energy source and rotate and translate the second energy source relative to the sheath.
[0301] Clause 51. The probe of clause 50, wherein the second energy source comprises one or more of an electrode, a loop electrode, a monopolar electrode, a bipolar electrode, a radio frequency source, a microwave source, a plasma source, a heat source, a laser source, a mechanical energy source, a mechanical shear source, a vibrational energy source, an ultrasonic energy source, a cavitational ultrasonic source, a water jet, a fixed pressure water jet, a variable pressure water jet, a water jet drainage source, an eductor pump, a steam source, a morcellator, a photoablative energy source, an ionizing radiation energy source, a radioisotope, an ionizing plasma source, or a cryogenic energy source.
[0302] Clause 52. The probe of clause 51, wherein the second energy source comprises a water jet.
[0303] Clause 53. The probe of clause 52, wherein the third elongate drive tube is coupled to a nozzle to generate the water jet.
[0304] Clause 54. The probe of clause 53, wherein a third elongate drive tube extends proximally from nozzles in the first and second elongate drive tubes and rotates and translates the water jet relative to the first and second elongate drive tubes.
[0305] Addendum 55. The probe of Addendum 1, wherein the energy source comprises an electrode shaped to define a region through which ablated tissue may pass while the electrode ablates tissue as the electrode moves.
[0306] Addendum 56. The probe of Addendum 55, wherein the area defined by the electrodes extends obliquely relative to the extension axis of the elongation shaft and a plane perpendicular to the extension axis of the elongation shaft.
[0307] Addendum 57. The probe of Addendum 55, wherein the region comprises an area defined by a nonlinear shape of the electrode, the area extending in an oblique direction relative to the extension axis of the extension shaft and a plane perpendicular to the extension axis, and optionally, the nonlinear shape forms part of a loop, the part of the loop defining the area.
[0308] Addendum 58. The probe of Addendum 55, wherein the region is defined by a curved electrode, the curved electrode extending obliquely relative to the extension axis of the extension shaft and a plane perpendicular to the extension axis.
[0309] Addendum 59. The probe of Addendum 58, wherein the direction extends at an angle relative to the elongation axis and plane, the angle being within the range of about 15 degrees to about 75 degrees, and optionally within the range of about 30 degrees to about 60 degrees.
[0310] Clause 60. The probe of clause 1, further comprising an impedance sensor coupled to the energy source to measure the impedance of tissue being treated with energy from the energy source.
[0311] Clause 61. The probe of clause 60, wherein the energy source comprises an electrode, the electrode comprising an impedance sensor.
[0312] Addendum 62. The probe of Addendum 1, further comprising a force sensor coupled to the extension to measure tissue resistance associated with deflection of the extension.
[0313] Addendum 63. The probe of Addendum 62, wherein the force sensor is coupled to the linkage and measures tissue resistance associated with movement of the energy source away from the extension axis.
[0314] Addendum 64. The probe of Addendum 1, further comprising a force sensor coupled to the energy source to measure tissue resistance related to a positioning distance of the energy source from the extension axis.
[0315] Addendum 65. The probe of Addendum 64, wherein the force sensor is configured to measure tissue resistance related to an amount of energy delivery from the energy source.
[0316] Addendum 66. The probe of Addendum 1, further comprising a coupling mechanism coupled to the coupling portion for controlling an amount of offset of the extension portion away from the extension axis, the coupling mechanism comprising one or more of a threaded connection, a preloaded spring, a pull wire, a tube, or a rod coupled to a proximal portion of the probe, and optionally, the offset corresponds to an amount of deflection of the extension portion.
[0317] Addendum 67. The probe of Addendum 1, wherein the connection portion comprises one or more of a pivot portion, a hinge, a bendable connection, multiple slits in the tube, or multiple non-planar slits in the tube.
[0318] Addendum 68. The probe of Addendum 67, wherein the coupling portion comprises a plurality of slits defining a plurality of gaps, and wherein one or more of a plurality of distances across the plurality of gaps are configured to decrease to deflect the extension portion and move the energy source away from the extension axis.
[0319] Clause 69. The probe of clause 68, wherein the plurality of slits extend through a first side of the tube and only partially through a second side of the tube, enabling the tube to fold along the second side with a plurality of decreasing distances along the first side.
[0320] Addendum 70. The probe of Addendum 68, wherein the plurality of slits are configured to at least partially close along one or more of the plurality of slits to deflect the extension and move the energy source away from the extension axis.
[0321] Addendum 71. The probe of Addendum 68, wherein the plurality of slits comprises non-planar slits, the non-planar slits comprising corresponding opposing engagement structures that engage with one another upon at least partial closure of the plurality of slits.
[0322] Addendum 72. The probe of Addendum 68, further comprising a retaining sheath across the multiple slits to control a deflection angle of the extension portion to expose one or more of the multiple slits from the retaining sheath.
[0323] Addendum 73. The probe of Addendum 72, wherein the deflection angle is related to the number of slits exposed from the retaining sheath.
[0324] Clause 74. The probe of clause 72, wherein the deflection angle is related to the distance by which one or more of the plurality of slits extend beyond the distal end of the retaining sheath.
[0325] Addendum 75. The probe of Addendum 74, further comprising a coupling mechanism coupled to the retaining sheath or one or more of the plurality of slits to move one or more of the slits or the elongated shaft to expose and cover the plurality of slits with the elongated shaft and to control the deflection angle.
[0326] Addendum 76. The probe of Addendum 75, wherein the coupling mechanism comprises one or more of a threaded connection, a preloaded spring, a pull wire, or a rod coupled to a proximal portion of the probe.
[0327] Addendum 77. The probe of Addendum 72, wherein the retaining sheath has sufficient rigidity to move the extension and energy source toward the extension axis after the extension is deflected away from the extension axis.
[0328] Addendum 78. The probe of Addendum 77, wherein the retaining sheath has sufficient rigidity to open one or more of the plurality of gaps after a distance across one or more of the plurality of gaps is reduced to move the energy source and extension portion toward the extension axis.
[0329] Addendum 79. The probe of Addendum 1, wherein the elongated shaft extends proximally toward the handle and controls the angle of rotation of the energy source about the elongated axis.
[0330] Addendum 80. The probe of Addendum 79, wherein the elongated shaft is coupled to the handle and rotates the energy source upon rotation of the handle.
[0331] Addendum 81. The probe of Addendum 79, further comprising a linkage mechanism extending proximally toward the handle to control the offset distance of the energy source from the extension axis.
[0332] Addendum 82. The probe of Addendum 81, wherein the coupling mechanism includes a knob that controls the offset distance as the knob is rotated.
[0333] Clause 83. The probe of clause 81, further comprising a slider for translating the energy source along the extension axis.
[0334] Addendum 84. The probe of Addendum 81, wherein the linkage mechanism includes a slider and controls the offset distance with proximal and distal movement of the slider.
[0335] Addendum 85. The probe of Addendum 79, further comprising a rigid sheath extending from the handle to the proximal opening of the coupling for adding rigidity, the elongate shaft configured to move with the rigid sheath and translate the energy source, a coupling mechanism extending between the coupling and the handle for offsetting the energy source from the elongate axis with rotation of the knob, and the handle and rigid sheath moving together to rotate the energy source about the elongate axis with rotation of the elongate shaft and coupling mechanism.
[0336] Addendum 86. The probe of Addendum 85, further comprising a finger engagement structure for engaging a user's finger and a thumb engagement structure for engaging a user's thumb, the thumb engagement structure coupled to the elongation shaft and causing the energy source to translate upon translation of the thumb engagement structure relative to the elongation shaft.
[0337] Addendum 87. The probe of Addendum 1, further comprising a follower coupled to the extension and the energy source, adapted to engage the tissue surface and, when moved by the extension, to follow the tissue surface and ablate tissue at a depth from the tissue surface.
[0338] Addendum 88. The probe of Addendum 87, wherein the follower comprises a support with a curved surface for sliding along the tissue surface.
[0339] Addendum 89. The probe of Addendum 87, wherein the energy source is coupled to the follower and varies one or more of the distance or angle between the follower and the energy source to ablate tissue to a depth.
[0340] Addendum 90. The probe of Addendum 89, wherein the follower has an elongated surface profile and engages and slides along the tissue surface, and one or more of a distance or angle is varied relative to the elongated surface profile to vary the depth.
[0341] Addendum 91. The probe of Addendum 90, wherein the follower is configured to follow the tissue surface profile and ablate tissue to a depth, and optionally, the depth from the tissue surface profile remains substantially constant as the distance from the tissue surface profile to the extension axis of the probe varies.
[0342] Clause 92. The probe of clause 90, further comprising one or more of a wire, shaft, lever, extension, rod, or linkage extending along the extension to vary one or more of the distance or angle to vary the depth of ablation from the tissue surface.
[0343] Addendum 93. The probe of Addendum 90, wherein the follower is configured to pivot relative to the extension to vary the distance.
[0344] Clause 94. The probe of clause 93, wherein the angle between the elongated surface profile and the extension increases for increasing depth and decreases for decreasing depth.
[0345] Addendum 95. The probe of Addendum 94, wherein the angle corresponds to an amount of deflection of the extension from the extension axis, and increasing the deflection increases the angle between the follower and the energy source and the depth from the tissue surface.
[0346] Addendum 96. The probe of Addendum 90, wherein the angle between the follower and the energy source is adjusted to vary the ablation distance between the follower and the energy source while the amount of deflection of the extension remains substantially fixed.
[0347] Addendum 97. The probe of Addendum 96, wherein advancement of the elongated structure between the follower and the energy source increases the distance and retraction of the elongated structure decreases the distance, optionally wherein the elongated structure comprises a wire.
[0348] Clause 98. The probe of clause 90, wherein the follower is coupled to the extension, the follower using a spring to provide a variable force associated with the follower on the tissue surface.
[0349] Addendum 99. The probe of Addendum 90, wherein the follower is coupled to the energy source using a deflectable member and decreases depth in response to tissue increasing tissue resistance and increases depth in response to decreased tissue resistance.
[0350] Addendum 100. The probe of Addendum 1, wherein the energy source comprises a mechanical energy source configured to ablate tissue using shear.
[0351] Addendum 101. The probe of Addendum 100, wherein the mechanical energy source comprises a tissue stabilization structure for receiving tissue and a cutting edge for engaging the tissue against the tissue stabilization structure and cutting the tissue using shearing.
[0352] Clause 102. The probe of clause 101, wherein the cutting edge is moved using one or more of a translational or rotational motion to shear the tissue.
[0353] Clause 103. The probe of clause 101, wherein the tissue stabilization structure comprises a recess for receiving tissue.
[0354] Clause 104. The probe of clause 100, wherein the mechanical energy source comprises a vitrectomy device.
[0355] Clause 105. The probe of claim 100, wherein one or more elongated structures extend along the extension and transmit energy to the energy source as the extension is deflected away from the extension axis.
[0356] Addendum 106. The probe of Addendum 1, further comprising a fluid removal channel coupled to the extension and moving with the extension, the fluid removal channel extending to the opening and removing material generated using the energy source.
[0357] Clause 107. The probe of clause 106, wherein the energy source is directed toward the opening.
[0358] Addendum 108. The probe of Addendum 107, wherein the energy source is coupled to the jet supply tube and includes a nozzle for generating a water jet, the nozzle of the water jet being oriented in a direction toward the opening to direct the excised tissue toward the opening, and optionally the nozzle faces the opening.
[0359] Clause 109. The probe of clause 108, wherein the nozzle and the opening are separated by a gap that defines a distance between the nozzle and the opening.
[0360] Addendum 110. The probe of Addendum 109, wherein the gap is sized to entrain tissue toward the water jet for ablation.
[0361] Addendum 111. The probe of Addendum 109, wherein the opening, nozzle, and gap are arranged in an eductor pump configuration to draw tissue into the gap.
[0362] Clause 112. The probe of clause 109, wherein the distance is in the range of about 0.1 mm to about 5 mm, optionally in the range of about 0.25 mm to about 2.5 mm.
[0363] Addendum 113. The probe of Addendum 109, wherein the extension portion comprises a jet supply tube and a drainage tube, the drainage tube comprising a fluid removal channel, and the jet supply tube and the drainage tube are configured to move together and move the gap upon deflection of the extension portion.
[0364] Clause 114. The probe of clause 113, wherein the injection supply tube and the drainage tube are arranged in a side-by-side configuration.
[0365] Addendum 115. The probe of Addendum 113, wherein the injection supply tube and the drainage tube are arranged in an up-down configuration.
[0366] Addendum 116. The probe of Addendum 108, wherein the nozzle is oriented toward the opening transversely to the elongation axis, and the opening is oriented transversely to the elongation axis, and optionally, the nozzle and opening are oriented approximately perpendicular to the elongation axis.
[0367] Clause 117. The probe of clause 108, wherein the nozzle is oriented toward the opening in a direction toward the elongation axis and the opening is oriented away from the elongation axis.
[0368] Clause 118. The probe of clause 108, wherein the nozzle is oriented away from the elongation axis and the opening is oriented toward the elongation axis.
[0369] Clause 119. The probe of clause 1, further comprising a lumen for delivering one or more of a therapeutic compound, a photochemotherapeutic agent, a chemotherapeutic agent, or a hemostatic agent.
[0370] Addendum 120. The probe of Addendum 1, further comprising a plurality of drive coupling mechanisms for offsetting the energy source, translating the energy source, and rotating the energy source.
[0371] Addendum 121. The probe of Addendum 120, wherein the plurality of drive coupling mechanisms comprises a drive coupling mechanism for rotating the second energy source and for translating the second energy source.
[0372] Addendum 122. The probe of Addendum 120, wherein the multiple drive couplings include five or more drive couplings for the multiple drive couplings to offset the energy source, translate the energy source, rotate the energy source, rotate the second energy source, and translate the second energy source.
[0373] Addendum 123. The probe of Addendum 120, further comprising a first plurality of movable engagement structures coupled to a plurality of drive coupling mechanisms configured to engage a second plurality of engagement structures on the robotic arm and drive the plurality of drive coupling mechanisms, optionally wherein the first plurality of movable engagement structures and the second plurality of engagement structures comprise rotatable engagement structures.
[0374] Addendum 124. The probe of Addendum 123, wherein the first plurality of movable engagement structures comprises five or more engagement structures, the five or more engagement structures configured to drive five or more linkages to offset the energy source, translate the energy source, rotate the energy source, rotate the second energy source, and translate the second energy source.
[0375] Addendum 125. A system comprising a processor operatively coupled to the probe of any one of the preceding appendices and configured to move an energy source.
[0376] Addendum 126. The system of Addendum 125, wherein the processor is coupled to the elongation shaft and rotates and translates the electrode as the extension is deflected away from the elongation shaft, the processor being configured with instructions for rotating and translating the elongation shaft to move the electrode and pass tissue through an area defined by the electrode.
[0377] Addendum 127. The system of Addendum 126, wherein the cutting edge of the electrode extends in a direction, and the processor is configured with instructions to move the electrode transversely to the direction along which the cutting edge extends to facilitate movement of the resected tissue through the region, and optionally, to limit movement of the electrode to the direction along which the cutting edge extends.
[0378] Addendum 128. The system of Addendum 126, wherein the movement of the electrodes corresponds to synchronous rotational and translational movement of the electrodes.
[0379] Addendum 129. The system of Addendum 125, wherein the processor is configured to receive as an input a tissue ablation profile, and the processor is configured to determine a plurality of offsets of the energy source corresponding to the tissue ablation profile.
[0380] Addendum 130. The system of Addendum 129, wherein the tissue ablation profile corresponds to a three-dimensional tissue ablation profile, and the processor is configured with instructions for determining multiple offsets, translations, and rotations of the energy source about the extension axis to position the energy source at multiple locations corresponding to the three-dimensional tissue ablation profile.
[0381] Addendum 131. The system of Addendum 129, wherein the processor is configured to determine multiple locations of the tissue ablation profile relative to the extension axis of the probe, and the processor is configured to determine multiple corresponding offsets, rotations, and translations of the energy source relative to the extension axis.
[0382] Addendum 132. The system of Addendum 131, wherein the processor is configured with instructions for determining, for each of a plurality of locations of the tissue ablation profile, a corresponding offset, a corresponding rotation, and a corresponding location of the energy source relative to the elongation axis.
[0383] Addendum 133. The system of Addendum 129, wherein the offset comprises a deflection of the energy source away from an extension axis of the probe, and the processor is configured with instructions for determining a translation of a shaft coupled to the energy source in response to an angle of deflection of the energy source relative to the extension axis and a translation location of the three-dimensional profile.
[0384] Addendum 134. The system of Addendum 125, wherein the processor is configured with instructions for adjusting an amount of energy from the energy source in response to an amount of impedance of the energy source.
[0385] Addendum 135. The system of Addendum 125, wherein the processor is configured with instructions for adjusting an offset of the energy source from the extension axis in response to an amount of impedance.
[0386] Addendum 136. The system of Addendum 125, wherein the processor is configured with instructions for adjusting an amount of deflection of the extension from the extension axis and an offset of the energy source in response to an amount of impedance.
[0387] Addendum 137. The system of Addendum 125, wherein the processor is configured with instructions for adjusting the offset of the energy source from the extension axis in response to an amount of force measured using the force sensor.
[0388] Addendum 138. The system of Addendum 125, wherein the processor is configured with instructions for adjusting an amount of energy from the energy source in response to an amount of force measured using the force sensor.
[0389] Addendum 139. A method of treating tissue, the method including: inserting a probe into a patient; offsetting an energy source away from an extension axis of the probe; and rotating and translating the energy source about the extension axis of the probe as the energy source is offset from the extension axis.
[0390] Clause 140. The method of clause 139, wherein the probe comprises a probe according to any one of the preceding clauses.
[0391] The embodiments of the present disclosure are shown and described herein and are provided only as examples. Those skilled in the art will recognize numerous adaptations, changes, modifications, and substitutions without departing from the scope of the present disclosure. Several alternatives and combinations of the embodiments disclosed herein may be utilized without departing from the scope of the present disclosure and the invention disclosed herein. Therefore, the scope of the invention of the present disclosure is to be defined only by the scope of the appended claims and their equivalents.
Claims
1. 1. A probe for treating a subject, comprising: An energy source; an extension shaft having an extension axis; an extension coupled to the extension shaft with a linkage, wherein movement of the extension away from the extension axis moves the energy source away from the extension axis, offsetting the energy source from the extension axis; The probe comprises:
2. 10. The probe of claim 1, wherein the energy source comprises one or more of an electrode, a loop electrode, a monopolar electrode, a bipolar electrode, a radio frequency source, a microwave source, a plasma source, a heat source, a laser source, a mechanical energy source, a mechanical shear source, a vibrational energy source, an ultrasonic energy source, a cavitational ultrasonic source, a water jet, a fixed pressure water jet, a variable pressure water jet, a water jet drainage source, an eductor pump, a steam source, a morcellator, a photoablative energy source, an ionizing radiation energy source, a radioisotope, an ionizing plasma source, or a cryogenic energy source.
3. 10. The probe of claim 1, further comprising a sheath, the elongated shaft being positioned within the sheath to allow rotation and translation of the energy source relative to the sheath as the extension is deflected away from the elongated shaft.
4. 4. The probe of claim 3, further comprising a fluid source channel and a fluid removal channel within the sheath, optionally the fluid source channel comprising one or more of an air insufflation channel or an irrigation channel, and the fluid removal channel comprising one or more of an exhaust channel or an aspiration channel.
5. 5. The probe of claim 4, wherein the fluid supply channel and the fluid removal channel are sized and shaped to interengage within the sheath, and one or more of the fluid supply channel or the fluid removal channel are sized and shaped to receive the elongate shaft coupled to the energy source and to allow rotation and translation of the energy source as the energy source is deflected away from the elongate shaft.
6. The probe of claim 5 , wherein the fluid source channel is sized and shaped to receive the elongated shaft and provide a fluid supply along the fluid source channel to a surgical site, the elongated shaft being positioned within the fluid source channel.
7. The probe of claim 5 , wherein the fluid removal channel is sized and shaped to receive the elongated shaft and remove fluid from a surgical site along the fluid removal channel, and the elongated shaft is positioned within the fluid removal channel.
8. 6. The probe of claim 5, wherein the fluid source channel comprises a first tube and the fluid removal channel comprises a second tube, the first tube and the second tube engaging each other and sized and shaped to provide rotational stability during rotation and translation of the elongate shaft.
9. 9. The probe of claim 8, further comprising a resilient structure coupled to the sheath, the first tube, and the second tube to urge the first tube and the second tube toward each other and provide rotational stability.
10. 9. The probe of claim 8, wherein the first tube comprises a first portion and the second tube comprises a second portion sized and shaped to engage the first portion using a nested configuration.
11. 9. The probe of claim 8, wherein the first tube comprises a first portion with a first surface profile and the second tube comprises a second portion with a second surface profile sized and shaped to engage the first surface profile.
12. The probe of claim 11 , wherein the first and second surface profiles comprise curved protrusions and curved recesses that interengage along axially extending lengths of the curved protrusions and curved recesses.
13. The probe of claim 11 , wherein the first and second portions include a plurality of engagement structures sized and shaped to engage with one another.
14. The probe of claim 13 , wherein the plurality of engagement structures comprises a plurality of protrusions and a plurality of recesses sized and shaped to mate together in an interlocking configuration.
15. The probe of claim 14 , wherein the plurality of engagement structures extend axially along the first and second tubes and provide torsional stability to the elongation shaft.
16. 12. The probe of claim 11, wherein the first tube comprises a third surface profile sized and shaped to engage an interior of the sheath, and the second tube comprises a fourth surface profile sized and shaped to engage an interior of the sheath, optionally wherein the interior of the sheath comprises a circular profile, the third surface profile comprises a circular profile, and the fourth surface profile comprises a circular profile.
17. The probe of claim 3 , wherein the sheath provides stiffness and adds rigidity to stabilize the energy source with movement of the elongate shaft and movement of the energy source relative to the sheath.
18. The probe of claim 3 , further comprising a spine coupled to the sheath to add stiffness to the probe.
19. The probe of claim 18 , wherein the spine extends distally beyond the energy source.
20. 20. The probe of claim 19, wherein the spine comprises a tube coupled to one or more openings distal to the energy source and comprising one or more fluid-filling or fluid-removal channels for providing fluid to the energy source or removing material generated thereby.
21. 2. The probe of claim 1, further comprising a coupling mechanism coupled to the coupling portion that controls an amount of offset of the extension portion away from the axis of extension, the coupling mechanism comprising one or more of a threaded connection, a preloaded spring, a pull wire, a tube, or a rod coupled to a proximal portion of the probe, and optionally the offset corresponds to an amount of deflection of the extension portion.
22. The probe of claim 1 , further comprising a plurality of drive linkages for offsetting the energy source, translating the energy source, and rotating the energy source.
23. 23. The probe of claim 22, wherein the multiple drive linkages comprise five or more drive linkages for a multiple drive linkage to offset the energy source, translate the energy source, rotate the energy source, rotate a second energy source, and translate the second energy source.
24. 23. The probe of claim 22, further comprising a first plurality of movable engagement structures coupled to a second plurality of engagement structures on a robotic arm configured to engage the second plurality of drive coupling mechanisms and drive the second plurality of drive coupling mechanisms, optionally the first plurality of movable engagement structures and the second plurality of engagement structures comprise rotatable engagement structures.
25. 25. The probe of claim 24, wherein the first plurality of movable engagement structures comprises five or more engagement structures configured to drive five or more linkages to offset the energy source, translate the energy source, rotate the energy source, rotate a second energy source, and translate the second energy source.
26. 1. A system comprising: A processor operatively coupled to the probe of claim 1 for moving the energy source. A system comprising:
27. 27. The system of claim 26, wherein the processor is configured to receive as an input a tissue ablation profile, the processor being configured to determine a plurality of offsets of the energy source corresponding to the tissue ablation profile.
28. 28. The system of claim 27, wherein the tissue ablation profile corresponds to a three-dimensional tissue ablation profile, and the processor is configured with instructions for determining multiple offsets, translations, and rotations of the energy source about the elongation axis to position the energy source at multiple locations corresponding to the three-dimensional tissue ablation profile.
29. 28. The system of claim 27, wherein the processor is configured to determine a plurality of locations of the tissue ablation profile relative to an extension axis of the probe, the processor being configured to determine a plurality of corresponding offsets, rotations, and translations of the energy source relative to the extension axis.
30. 30. The system of claim 29, wherein the processor is configured with instructions to determine, for each of a plurality of locations of the tissue ablation profile, a corresponding offset, a corresponding rotation, and a corresponding location of the energy source relative to the elongation axis.