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US-12622761-B2 - Fluid-driven robotic needle positioner for image-guided percutaneous interventions

US12622761B2US 12622761 B2US12622761 B2US 12622761B2US-12622761-B2

Abstract

Disclosed are systems and methods for biopsy, drainage, drug administration, electrode implantation and/or tumor ablation employing percutaneous procedures for diagnostic or therapeutic purposes, performed by inserting a needle or probe through the skin of patient towards target anatomy using a patient mounted robot.

Inventors

  • Ka Wai KWOK
  • Zhuoliang He
  • Ziyang DONG
  • Justin Di-Lang Ho
  • Ge Fang

Assignees

  • THE UNIVERSITY OF HONG KONG

Dates

Publication Date
20260512
Application Date
20210720

Claims (20)

  1. 1 . A method of performing a medical procedure, comprising: medical imaging to obtain a dataset of a region of interest; identifying a target position on or within a patient and positioning a patient on an operating table; identifying the target position relative to the robot position; determining a needle insertion path, an incision port and robot position based on the data set and the target position; non-invasive mounting of the robot on the patient at the determined incision port and robot position; coarse adjustment of the robot performed manually by a surgeon with visual feedback provided by the robot to indicate adjustment accuracy in-situ; fine adjustment of the robot after coarse adjustment for automatic needle guide positioning guided by one or both of intra-operative medical imaging or robot encoding; coarse locking of the needle guide after the coarse adjustment, wherein the coarse locking comprises use of an outer cover, wherein the outer cover partially encloses a granular jamming mechanism comprising an elastic membrane having granules enclosed therewithin, and wherein the elastic membrane encloses the needle guide, and wherein the outer cover comprises an expandable ring that is fixed in place around the needle guide, and wherein the fixing comprises installing a locking slider over a locking tab of the outer cover, thereby fixing the outer cover in a fixed shape around the needle guide; fine locking of the needle guide, after the fine adjustment, by actuating the granular jamming mechanism that provides granular jamming of the needle guide, thereby further limiting movement of the needle guide; and performing the medical procedure on the region of interest.
  2. 2 . The method according to claim 1 , wherein the medical imaging is at least one of computed tomography (CT), X-ray, ultrasound (US), or magnetic resonance imaging (MRI), and wherein the region of interest is in the human body, including the liver, kidney, lung, breast, head, neck, or shoulder.
  3. 3 . The method according to claim 1 , wherein the medical procedure is at least one of biopsy, drug administration, tumor ablation, tissue repair, drainage, or electrode implantation.
  4. 4 . The method according to claim 1 , further comprising: determining a plurality of robots, a plurality of needle insertion paths, and a plurality of incision ports.
  5. 5 . The method according to claim 1 , wherein the region of interest is a liver within the patient and the medical procedure is treating liver cancer.
  6. 6 . A patient-mounted robotic device for image-guided percutaneous procedures, comprising: a needle guide; a coarse adjustment mechanism that is manually operated by the surgeon to perform coarse adjustment; a fine adjustment mechanism that is automatically operated under intra-operative real-time imaging guidance and/or robot encoding to perform fine adjustment; a fiber-optic light that is configured to provide visual feedback to the surgeon during manual operation to indicate targeting accuracy, wherein the needle guide accommodates a needle-like surgical instrument, wherein the needle guide pose is measured with encoders and imaging fiducial markers, and wherein the fine adjustment mechanism comprises: multiple co-planar fluid-driven soft actuator chambers that act in concert to adjust the needle guide pose; a master actuation console that provides hydraulic transmission to the soft chambers, wherein both the coarse adjustment mechanism and the fine adjustment mechanisms pivot the needle guide about a remote center of motion, wherein the needle guide is lockable through a granular jamming mechanism that limits movement of the needle guide, wherein the granular jamming mechanism is coarsely jammable by latching an outer cover that partially encloses the granular jamming mechanism, and wherein the outer cover comprises a ring having an expandable central opening, wherein the latching comprises installing a locking slider over locking tabs of the outer cover, thereby reducing a size of the central opening, and a base component that allows mounting of the robotic device on the patient using noninvasive attachment to the patient.
  7. 7 . The patient-mounted robotic device according to claim 6 , wherein the medical imaging is at least one of computed tomography (CT), X-ray, ultrasound (US), or magnetic resonance imaging (MRI), and wherein the encoders and imaging fiducial markers are compatible with at least one of computed tomography (CT), X-ray, ultrasound (US), or magnetic resonance imaging (MRI).
  8. 8 . The patient-mounted robotic device according to claim 6 , wherein the imaging modality is MRI, the encoders are MRI-compatible, the imaging fiducial markers are MRI-based, and the master actuation console is located outside of the operating (MRI) room.
  9. 9 . The patient-mounted robotic device according to claim 6 , wherein the imaging modality is CT, X-ray, or ultrasound (US), the encoders are CT-, X-ray-, or US-compatible, and the imaging fiducial markers are CT- X-ray-, or US-based.
  10. 10 . The patient-mounted robotic device according to claim 6 , having a weight of 0.5 kg or less, wherein the patient-mounted robotic device is mountable on the patient's abdomen.
  11. 11 . The patient-mounted robotic device according to claim 6 , fit within a standard loop coil for MRI imaging.
  12. 12 . The patient-mounted robotic device according to claim 6 , wherein two or more robots, including the robot are simultaneously mounted to the patient for multiple needle insertions.
  13. 13 . The patient-mounted robotic device according to claim 6 , wherein the remote center of motion is located directly at the incision port when the device is mounted to the patient.
  14. 14 . The patient-mounted robotic device according to claim 6 , wherein the granular jamming mechanism comprises an elastic membrane having granules enclosed therewithin, wherein an actuation of the granular jamming mechanism comprises applying vacuum to the granules within the elastic membrane, and wherein the elastic membrane is at least partially enclosed within the outer cover.
  15. 15 . A method of performing a medical procedure, comprising: medical imaging to obtain a dataset of a region of interest; identifying a target position on or within a patient and positioning a patient on an operating table; identifying the target position relative to the robot position; determining a needle insertion path, an incision port and robot position based on the data set and the target position; non-invasive mounting of the robot on the patient at the determined incision port and robot position; coarse adjustment of the robot performed manually by a surgeon with visual feedback provided by the robot to indicate adjustment accuracy in-situ; fine adjustment of the robot after coarse adjustment for automatic needle guide positioning guided by one or both of intra-operative medical imaging or robot encoding; granular jamming of the needle guide, by actuating a granular jamming mechanism, thereby limiting movement of the needle guide; enclosing of the granular jamming mechanism by latching an outer cover at least partially over the granular jamming mechanism, wherein the outer cover comprises a non-continuous ring, and wherein the latching comprises installing a locking slider over locking tabs of the outer cover, thereby fixing the position of the locking tabs relative to one another; and performing the medical procedure on the region of interest.
  16. 16 . The method of claim 15 , wherein the granular jamming mechanism comprises an elastic membrane having granules enclosed therewithin, wherein actuation of the granular jamming mechanism comprises applying vacuum to the granules within the elastic membrane, and wherein the elastic membrane is partially enclosed within the outer cover.
  17. 17 . The method according to claim 1 , wherein the outer cover further encloses a flexible rotary guide, and wherein the installing the locking slider over the locking tab fixes the outer cover in a fixed shape around the rotary guide, which rotary guide thus constrains a passive holder supporting the needle guide, and thereby also friction-locking the coarse adjustment.
  18. 18 . The method according to claim 1 , wherein the coarse locking further comprises installing an inner cover over a needle guide base that fixedly supports the needle guide, and wherein the installing the outer cover comprises installing the outer cover over the inner cover and into fixed engagement with the inner cover.
  19. 19 . The method according to claim 18 , wherein the inner cover comprises first clip elements, the outer cover comprises second clip elements, and the outer cover is installed over the inner cover in a manner that fixedly engages the first clip elements and the second clip elements.
  20. 20 . The method according to claim 19 , wherein the locking tab comprises a second clip element of the second clip elements, and wherein installing of the locking slider over the locking tab provides a final clipping of the outer cover to the inner cover.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing dates of U.S. Provisional Application No. 63/053,798, filed on Jul. 20, 2020, the entire contents of which are incorporated by reference herein. TECHNICAL FIELD Disclosed are systems and methods for biopsy, drainage, drug administration and/or tumor ablation employing percutaneous procedures for diagnostic or therapeutic purposes, typically performed by inserting a needle or probe through the skin of patient towards target anatomy. BACKGROUND Percutaneous procedures are undertaken for diagnostic or therapeutic purposes, typically performed by inserting a needle or probe through the skin of patient towards target anatomy. Applications range from biopsy, drainage, drug administration to tumor ablation, and are applicable to numerous parts of the body including breast and kidneys, with prominence in ablation for liver cancer. As the sixth most common type of cancer, liver cancer is also one of the primary sources of cancer-related death globally. Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, with the first-line treatments by liver transplantation and resection for <20% cases. For the remaining unresectable cases, percutaneous radiofrequency (RF) ablation is considered as the standard local ablative therapy (FIG. 1a). During the procedure, an ablation needle (0D=Ø1.2-2.1 mm) is inserted through the skin into the target lesion, typically guided by ultrasound (US) (FIG. 1b), or computed tomography (CT). Multiple needle insertions may be required for completing ablation of large (>Ø3 cm) or multiple tumors. After the ablation, the completeness is typically assessed by post-operative computed tomography (CT) or sonography. Residual tumors will be treated with further ablation or adjunct therapy. However, the procedure has difficulties in treating tumors abutting vessels or organs due to inaccurate ablation margins (<1 cm), which can result in high tumor recurrence (70% at 5 years) or inadvertent organ damage. To tackle these difficulties, numerous research groups in the past have developed needle guiding devices that improve targeting accuracy and precision by either providing physical guidance for manual insertion or enabling completely automated intervention with a robotic system. Magnetic resonance image (MRI), X-ray/CT, US or a combination of these modalities could be adopted for pre-operative planning, intra-operative (intra-op) feedback/guidance, and post-operative validation. Among them, MRI has been recognized for its advantage of high soft-tissue contrast, and zero ionizing radiation (FIG. 1c). Precise, real-time temperature monitoring (resolution <1° C.) can also be achieved by intra-op MRI to enable monitoring of ablation and its heat diffusion (FIG. 1d). As an alternative to RF ablation, laser ablation provides the opportunity for zero interference with the MRI while simultaneously conducting ablation and MR thermometry. However, the success of MRI-guided ablation still depends on precise intra-tumor probe placement and skin insertion positioning for effective pull-back, both of which require highly experienced operators, and can induce inter-operator variability in ablation results. In an effort to minimize variability in probe placement, passive needle holders have been developed, such as the commercialized products SeeStar (AprioMed, Uppsala, Sweden) and Simplify (NeoRad AS, Oslo, Norway). Passive devices can assist the manual adjustment of needle orientation and retain a fixed angle for needle insertion. However, intensive manual adjustment by the surgeon is still needed to achieve precise needle placement. This requires the patient to be transferred in and out of the MRI scanner bore to perform adjustment, which will prolong the procedure time. To this end, MR safe/conditional robot-assist percutaneous systems have been extensively investigated. A CE-marked commercial robotic system Innomotion (Innomedic Inc., Herxheim, Germany) was developed for MRI- and CT-guided needle placement. It is a table-mounted system and features 5-degree-of-freedom (DoF) needle actuation driven by pneumatic cylinders. The system can achieve a mean targeting precision of <0.5 mm, and has been used for MRI-guided percutaneous interventions in 16 patients. Researchers have also developed various prototypes of table/floor-mounted robotic systems for MRI-guided needle procedure, such as the 5-DoF instrument manipulator and the MR compatible needle-guide robot actuated by pneumatic motors. A robot for MRI-guided laser ablation of the liver underwent pilot studies on two patients made use of a gantry to secure the robot over the patients and provided a large workspace (up to 90% of the liver volume) for positioning the insertion point. Other examples include a concentric tube-based needle steering robot for neurosurgical ablation and a leadscrew-based robotic system for breast biopsy that fits between a b