Robotic Instrument Alignment

Abstract

An alignment device includes: a slender shaft; a sealing hub coupled to the proximal end of the slender shaft and configured to form a fluid-tight seal within a portion of a percutaneous access device; and an alignment structure coupled to the sealing hub and having a form configured to engage with a component of an instrument manipulator assembly of a robotic system.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 085,602, filed on September 30, 2020, entitled “ROBOTIC INSTRUMENT ALIGNMENT,” the disclosure of which is hereby incorporated by reference in its entirety. Background Art Technical Field

[0004] The present disclosure relates to the field of medical procedures and devices.

[0005] Related technologies

[0006] Various medical procedures involve the use of one or more medical devices to access a target anatomical site within a patient's body. In some cases, improper alignment of a particular device when accessing a site associated with a procedure may adversely affect the patient's health, the integrity of the medical device, and / or the efficacy of the procedure. Summary of the invention

[0007] Described herein are systems, devices, and methods that facilitate alignment of medical devices / instruments associated with specific medical procedures. Specifically, systems, devices, and methods according to one or more aspects of the present disclosure can facilitate alignment of aspiration catheter devices and / or other types of medical / surgical instruments and / or systems with percutaneous access devices / sheaths, which can advantageously reduce the risk of damaging patient anatomy and / or medical devices.

[0008] In some specific embodiments, the present disclosure relates to an alignment device, which includes: a slender shaft; a sealing hub coupled to the proximal end of the slender shaft and configured to form a fluid-tight seal within a portion of a percutaneous access device; and an alignment structure coupled to the sealing hub and having a form configured to engage with a component of an instrument manipulator assembly of a robotic system.

[0009] The elongated rod may have a blunt distal end. In some embodiments, the distal end of the elongated rod includes a flat axial face portion and a rounded circumferential edge portion. The alignment structure may have a concave proximal surface that conforms to the outer surface of the instrument manipulator assembly. For example, the alignment structure may have a vertical alignment lip that protrudes inwardly relative to the curvature of the concave proximal surface and is circumferential. The vertical alignment lip may be configured to be placed against at least one of the upward or downward surfaces of the component of the instrument manipulator assembly when the concave proximal surface is placed against the outer surface of the instrument manipulator assembly.

[0010] In some embodiments, the alignment structure includes one or more alignment marks indicating an aligned position of the alignment structure relative to at least one component of the instrument manipulator assembly.The sealing hub may have external threads configured to engage with internal threads of the percutaneous access device.

[0011] The alignment structure may be configured to be attached to the seal hub from a state separated from the seal hub. For example, the alignment structure includes a male connector protruding distally, the male connector being configured to be coupled to the seal hub. The alignment structure may be axially rotatable relative to the seal hub.

[0012] In some specific embodiments, the present disclosure relates to an alignment device, which includes: a non-invasive contact member configured to protrude from a distal portion of a sheath device; a sealing member configured to couple to a proximal portion of the sheath device and form a fluid-tight seal between the sheath device and the sealing member; and an alignment member coupled to the sealing member and configured to facilitate alignment of one or more components of the alignment device with one or more components associated with a robotic arm of a robotic system.

[0013] The non-invasive contact member may include an elongated solid rod having a blunt distal end. In some embodiments, the sealing member includes a hub structure having a tapered surface configured to be placed against a corresponding inner surface of the sheath device to form the fluid-tight seal. The alignment member may include a concave dish form.

[0014] In some specific embodiments, the present disclosure is directed to a robotic system comprising: a robotic arm; an instrument manipulator assembly associated with a distal portion of the robotic arm; a percutaneous access device comprising a slender shaft forming an access cavity; and an alignment device comprising: an elongated shaft configured to be at least partially disposed within the access cavity; and a proximal alignment member having a form configured to engage an outer surface of the instrument manipulator assembly.

[0015] In some embodiments, the instrument manipulator assembly includes an adapter component, the outer surface being associated with a rotating plate of the adapter component. For example, the adapter component may be coupled to a drape configured to provide a sterile barrier between the robotic arm and an instrument of the instrument manipulator assembly coupled to the adapter component. The robotic system may also include a catheter assembly including a catheter coupled to a catheter handle configured to be attached to the adapter component.

[0016] The alignment device may include a hub member that is fixed to the proximal end of the elongated rod. For example, the alignment member may be fixed to the alignment device on the proximal side of the hub member. In some embodiments, the alignment member has one or more alignment marks on a top surface. The robotic arm may be configured to move along an alignment path based on kinematic data related to the position of the robotic arm when the instrument manipulator assembly engages the alignment member of the alignment device.

[0017] In some implementations, the present disclosure relates to a method for aligning a robotic arm. The method includes manipulating a robotic arm of a robotic system to an alignment position in which a portion of an instrument manipulator assembly associated with a distal portion of the robotic arm engages an alignment structure of an alignment device having an elongated shaft at least partially disposed within an inner cavity of an access device; withdrawing the elongated shaft from the inner cavity; and advancing the instrument manipulator assembly along an alignment path based on the alignment position to advance an instrument coupled to the instrument manipulator assembly through the inner cavity of the access device.

[0018] The method may also include determining an alignment axis of the lumen of the access device based on the alignment position. The method may also include determining the alignment path based on kinematic robotic arm data associated with the alignment position. Advancing the instrument manipulator assembly along the alignment path may involve constraining movement of the robotic arm to the alignment path.

[0019] In some embodiments, the method further comprises: axially rotating the plate member of the instrument manipulator assembly to align one or more markings on the plate member with one or more corresponding markings associated with the alignment structure of the alignment device. The method may also comprise: after said withdrawing the elongated rod from the lumen, inserting an inner sheath member at least partially into the lumen of the access device, the inner sheath member forming a proximal seal with the access device.

[0020] The method may also include: engaging the hub of the alignment device with the proximal portion of the access device to form a fluid seal. For example, the alignment structure may be coupled to the hub. The method may also include: aspirating fluid from the anatomical site through the instrument, the instrument being a suction catheter.

[0021] In some implementations, the present disclosure relates to a percutaneous access kit comprising: a catheter coupled to a catheter handle; a percutaneous access sheath having an access lumen; and a catheter alignment device comprising an elongated shaft and a proximal alignment structure.

[0022] In some embodiments, the percutaneous access kit further comprises a tray structure comprising one or more recessed cavities configured to at least partially dispose the catheter, the catheter handle, the percutaneous access sheath, and the catheter alignment device therein. The percutaneous access kit may further comprise an inner sheath configured to at least partially dispose within the access lumen of the percutaneous access sheath and to form a proximal fluid seal between a hub of the inner sheath and a hub of the percutaneous access sheath. The percutaneous access kit may further comprise an elongated dilator form.

[0023] The catheter alignment device may also include a proximal hub configured to form a proximal fluid seal between the proximal hub and the hub of the percutaneous access sheath. In some embodiments, the elongated rod and the proximal hub are assembled together in the percutaneous access kit. In some embodiments, the alignment structure is separate from the elongated rod and the proximal hub in the percutaneous access kit.

[0024] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It will be appreciated that not necessarily all such advantages may be achieved according to any particular embodiment. Thus, the disclosed embodiments may be performed in a manner that achieves or optimizes one advantage or group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present invention in any way. In addition, the various features of the different disclosed embodiments may be combined to form additional embodiments as part of the present disclosure. Throughout the accompanying drawings, reference numerals may be reused to indicate the corresponding relationship between reference elements.

[0026] Figure 1 Embodiments of a robotic medical system including one or more percutaneous access devices are shown in accordance with one or more embodiments.

[0027] Figure 2 A robotic system arranged for diagnostic and / or therapeutic bronchoscopy is shown in accordance with one or more embodiments.

[0028] Figure 3 A table-based robotic system is shown according to one or more embodiments.

[0029] Figure 4 According to one or more embodiments, Figures 1 to 3 A medical system component implemented in any medical system.

[0030] Figure 5A and Figure 5BShown are a side view and a cross-sectional view, respectively, of a patient in a prone position with a percutaneous access device or system at least partially disposed within his / her renal anatomy, according to one or more embodiments.

[0031] Fig. 6A and Figure 6B Shown are a side view and a cross-sectional view, respectively, of a patient in a modified supine position with a percutaneous access device or system at least partially disposed within his / her renal anatomy, according to one or more embodiments.

[0032] Fig. 7A and Figure 7B An isometric view and a side view, respectively, of an inner sheath component and an outer sheath component of a percutaneous access device according to one or more embodiments are shown.

[0033] Fig. 8A and Figure 8B A perspective view and a side cross-sectional close-up view, respectively, are shown of a percutaneous access system at least partially disposed in a portion of a patient's renal anatomy, according to one or more embodiments.

[0034] Fig. 9 An exploded view of an instrument device manipulator assembly associated with a robotic arm is shown according to one or more embodiments.

[0035] Fig.10 Distal and lateral isometric views of an alignment device according to one or more embodiments are shown.

[0036] Fig.11 According to one or more embodiments, Fig.10 Proximal and lateral isometric views of the proximal portion of the alignment device.

[0037] Fig.12 A side view of an alignment device disposed in a percutaneous access device is shown according to one or more embodiments.

[0038] Fig.13 According to one or more embodiments, Fig.12 A cross-sectional view of the proximal portion of the alignment device.

[0039] Fig.14 An alignment device having an alignment structure that engages one or more surfaces and / or features of an instrument device manipulator assembly is shown according to one or more embodiments.

[0040] Fig.15 A kit for a percutaneous access system is shown according to one or more embodiments.

[0041] Figure 16-1 , Figure 16-2, Figure 16-3 , Figure 16-4 and Figure 16-5 A flow chart illustrating a process for aligning a medical device according to one or more embodiments is shown.

[0042] Figure 17-1 , Figure 17-2 , Figure 17-3 , Figure 17-4 and Figure 17-5 According to one or more embodiments, the Figure 16-1 , Figure 16-2 , Figure 16-3 , Figure 16-4 and Figure 16-5 A specific image of the various boxes, states, and / or operations associated with a process. DETAILED DESCRIPTION

[0043] The titles provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention. Although specific preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and modifications and equivalents thereof. Therefore, the scope of the claims that may appear herein is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any specific disclosed sequence. Various operations may then be described as multiple discrete operations in a manner that may help understand a specific embodiment. However, the order of description should not be interpreted as implying that these operations depend on the order. In addition, the structures, systems and / or devices described herein may be embodied as integrated components or separate components. For the purpose of comparing various embodiments, specific aspects and advantages of these embodiments are described. All such aspects or advantages may not necessarily be realized by any specific embodiment. Therefore, for example, various embodiments may be performed by realizing or optimizing an advantage or a set of advantages taught herein without necessarily realizing other aspects or advantages that may also be taught or proposed herein.

[0044] Although certain spatially relative terms, such as "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," "top," "bottom," and the like are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it should be understood that these terms are used herein for descriptive convenience to describe the positional relationship between elements / structures, as shown in the accompanying drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of elements / structures in use or operation other than the orientation depicted in the accompanying drawings. For example, an element / structure described as being "above" another element / structure may represent a position below or beside such other element / structure relative to a subject patient or an alternative orientation of the element / structure, and vice versa. It should be understood that spatially relative terms, including those listed above, may be understood relative to the corresponding illustrated orientations of the referenced drawings.

[0045] For the convenience of having devices, components, systems, features and / or modules with similar features in one or more aspects, specific reference numerals are reused in different figures of the group of figures of the present disclosure. However, with respect to any of the embodiments disclosed herein, the reuse of common reference numerals in the figures does not necessarily indicate that such features, devices, components or modules are the same or similar. On the contrary, those of ordinary skill in the art can be informed by the context that the use of common reference numerals can imply the degree of similarity between the cited themes. The use of specific reference numerals in the context of the description of a particular figure can be understood as relating to the device, component, aspect, feature, module or system identified in the particular figure, and does not necessarily relate to any device, component, aspect, feature, module or system identified by the same reference numeral in another figure. In addition, the aspects of the separate figures identified with common reference numerals can be interpreted as sharing characteristics or being completely independent of each other.

[0046] The present disclosure relates to systems, devices and methods for aligning a device / instrument of a percutaneous access system (such as a catheter or other instrument) with a particular percutaneous access device. With respect to percutaneous access devices and other medical devices related to the present disclosure, the term "device" is used according to its broad and ordinary meaning and may refer to any type of tool, instrument, assembly, system, equipment, component, etc. In some contexts herein, the term "instrument" may be used substantially interchangeably with the term "device".

[0047] Although certain aspects of the disclosure are described herein in the context of renal, urinary and / or kidney procedures (such as kidney stone removal / treatment procedures), it should be understood that such context is provided for convenience and clarity, and that the percutaneous access, device alignment, and fluid management concepts disclosed herein are applicable to any suitable medical procedure, such as robotic bronchoscopy. However, as noted, a description of the renal / urinary anatomy and associated medical problems and procedures is presented below to assist in describing the inventive concepts disclosed herein.

[0048] Kidney stone disease (also known as urolithiasis) is a medical condition that involves the formation of solid masses of material in the urinary tract, called "kidney stones," renal calculi, renal lithiasis, or nephrolithiasis, or "urinary stones." Urinary stones can form and / or be found in the kidneys, ureters, and bladder (called "bladder stones"). Such urinary stones can form due to the concentration of minerals in the urine, and can cause significant abdominal pain once such stones reach a size sufficient to block the flow of urine through the ureters or urethra. Urinary stones can be formed from calcium, magnesium, ammonia, uric acid, cysteine, and / or other compounds, or combinations thereof.

[0049] Generally, there are several approaches for treating patients with kidney stones, including observation, medical treatments (such as stone removal therapy), non-invasive treatments (such as extracorporeal shock wave lithotripsy (ESWL)), and surgical treatments (such as ureteroscopy and percutaneous nephrolithotomy ("PCNL"); see below for details). In surgical approaches (e.g., ureteroscopy and PCNL), a physician is able to access a lesion (i.e., the object to be removed; e.g., a stone), break the stone into smaller pieces or fragments, and mechanically remove relatively small stone fragments / particles from the kidney.

[0050] In some procedures, a surgeon may insert a ureteroscope through the urethra into the urinary tract to remove urinary stones from the bladder and ureters. Typically, a ureteroscope includes an endoscope at its distal end that is configured to enable visualization of the urinary tract. A ureteroscope may also include a lithotripsy device for capturing or breaking up urinary stones. During a ureteroscopy procedure, one physician / technician may control the position of the ureteroscope while another physician / technician may control the lithotripsy device.

[0051] In some procedures (such as procedures for removing relatively large stones), a physician may use a percutaneous nephrolithotomy ("PCNL") technique that involves inserting a nephroscope through the skin (i.e., percutaneously) and intervening tissue to provide access to a treatment site for breaking up and / or removing stones. A percutaneous access device (e.g., a nephroscope, sheath, sheath assembly, and / or catheter) for providing access to a target anatomical site (and / or direct access endoscope) may include one or more fluid channels for providing a flow of irrigation fluid to the target site and / or aspiration of fluid from the target site (e.g., via passive outflow and / or active aspiration). In general, the efficacy of percutaneous access to a target calyx and / or direct access to a target calyx through the urinary system may depend, at least in part, on fluid conditions within the kidney (e.g., fluid volume and / or pressure levels). Such conditions may depend, at least in part, on fluid management provided using the fluid channels, wherein such fluid management is directed, at least in part, by specific control circuitry associated with one or more devices / systems implemented in the medical procedure. During PCNL, a jet may be applied to remove stone dust, small debris, and thrombus from the treatment site as well as the field of view.

[0052] Robotic-assisted percutaneous procedures may be implemented in conjunction with various medical procedures, such as kidney stone removal procedures, where robotic tools may enable physicians / urologists to perform endoscopic (e.g., ureteroscopy) target access as well as percutaneous access / treatment. Advantageously, aspects of the present disclosure relate to systems, devices, and methods for aligning robotically controlled catheters and / or other percutaneous access instruments / devices and / or performing fluid irrigation and / or aspiration using such instruments / devices.

[0053] In several examples described herein, object removal procedures involve the use of robotic systems and medical devices / devices for renal flushing and / or suction associated with operations for removing stones from the kidney. However, the present disclosure is not limited to kidney stone treatment. For example, the following description is also applicable to other surgical / medical operations or medical procedures for diagnosis or treatment (such as procedures involving removal of objects from the patient's body (including any objects that can be removed from the treatment site or patient cavity (e.g., esophagus, ureter, intestine, eye, etc.) or other anatomical sites via percutaneous and / or endoscopic access), such as, for example, gallbladder stone removal, lung (pulmonary / transthoracic) tumor biopsy, or cataract removal. In addition, although various aspects of the present disclosure are described herein in the context of percutaneous (e.g., nephroscope) operations for convenience, it should be understood that the inventive aspects of the present disclosure can be implemented in any suitable or desired type of medical procedures, regardless of whether it is a robot.

[0054] With respect to devices and instruments for percutaneous access to a treatment site, such as the internal calyx network of a kidney, misalignment of a catheter or other device / instrument with a percutaneous access device / sheath (through which access to internal anatomical structures is achieved) can result in internal tissue damage to the patient and / or damage to device components. Embodiments of the present disclosure relate to alignment devices comprising an elongated rod or shaft configured to be disposed within an inner cavity of a percutaneous access device and protruding / extending from a distal end of the percutaneous access device, wherein such devices may be used during an alignment procedure during which an alignment path and / or position of a catheter or other instrument relative to the percutaneous access device is determined. The rod may have a blunt distal portion that reduces the risk of tissue damage caused by sudden, sharp movement of the distal end of the percutaneous access device / sheath when the distal end of the percutaneous access device / sheath contacts the patient's internal tissue. With respect to the components of the alignment devices disclosed herein, the term "rod" is used according to its broad and ordinary meaning and may refer to any elongated rod, strut, tube, shaft, cylinder, bar, stick, handle, tube, etc., whether such structure is hollow or solid in whole or in part.

[0055] The alignment devices of the present disclosure also advantageously provide a fluid-sealing function to create a proximal fluid seal via, for example, a cone-to-cone interaction between a conical surface or component of the alignment device and a corresponding internal conical surface or component of the percutaneous access sheath. The term "sheath" is used herein in its broad and ordinary sense and may refer to any type of tube, catheter, cannula, shaft, lumen, conduit, channel, tube or other device or structure, or an assembly including at least one such device / structure, wherein such device / structure forms or includes at least one lumen or channel through which a device such as a catheter or other device may be advanced.

[0056] The alignment device of the present disclosure may also include an alignment structure that is shaped and / or otherwise configured to guide a user to align a component of a robotic instrument device manipulator assembly (also referred to herein as an "instrument manipulator assembly" or "manipulator assembly" for convenience) associated with the distal portion of the robotic arm with the alignment structure of the alignment device. For example, the alignment structure may be shaped and / or configured to engage / interface with one or more surfaces of an adapter component of the instrument device manipulator assembly. In some embodiments, for example, alignment of the instrument device manipulator assembly and / or its components with the alignment structure of the alignment device occurs when the instrument device manipulator assembly is docked on / with the alignment structure of the alignment device and an axially rotating component of the instrument device manipulator assembly is rotated to align its specific alignment features (such as alignment marks, etc.) with corresponding markings of the alignment structure of the alignment device. The blunt end of the rod of the alignment device can reduce or eliminate the risk of adverse effects to the patient in the event that axial movement is induced in some way in the sheath during the alignment process.

[0057] Medical system

[0058] Figure 1 An exemplary medical system 100 for performing various medical procedures in accordance with aspects of the present disclosure is shown. The medical system 100 may be used, for example, for percutaneous and / or endoscopic (e.g., ureteroscopy) procedures. As mentioned and described above, a particular ureteroscopy procedure involves the treatment / removal of kidney stones. In some implementations, kidney stone treatment may benefit from certain robotic techniques / devices (such as those that may be similar to Figure 1 Robotic medical solutions may provide relatively higher precision, superior control, and / or superior hand-eye coordination with respect to a particular instrument compared to fully manual procedures. For example, robotic-assisted percutaneous access to the kidney according to some procedures may advantageously enable a urologist to perform both direct access endoscopic renal access and percutaneous renal access.

[0059] In certain stone management procedures, fluid irrigation may be implemented in order to maintain desired renal distension, which may advantageously facilitate visualization and / or navigation within a target treatment site (e.g., the calyx network of the kidney). Inadequate pressurization of the kidney or other treatment site may result in a lack of effective anatomical distension for visualization, which may reduce the efficacy of the procedure and / or result in damage to internal anatomical structures. Although a human patient 7 is shown, it should be understood that the principles disclosed herein are also applicable to veterinary procedures and animal patients.

[0060] Although some embodiments of the present disclosure are presented in the context of a nephroscope (or other examples of percutaneous access devices), a ureteroscope, and / or human renal anatomy, it should be understood that the principles disclosed herein can be implemented in any type of endoscopic and / or percutaneous procedures. In addition, several examples described herein relate to object removal procedures that involve removing kidney stones from the kidney. However, the present disclosure will not be limited to kidney stone removal.

[0061] The medical system 100 includes a robotic system 10 (e.g., a mobile robotic cart) that, in some implementations, is configured to engage and / or control a medical instrument 32 (e.g., a ureteroscope) to perform a direct access procedure on a patient 7. The term "direct access" is used herein in its broad and ordinary sense and may refer to any instrumented access through a natural or artificial opening in a patient's body. For example, referring to Figure 1 , the speculum 32 can directly enter the urinary tract of the patient 7 through the urethra 65.

[0062] In the illustrated system 100, a percutaneous access device 40 is implemented to provide percutaneous access to the kidney 70. The percutaneous access device 40 may include one or more sheaths and / or shafts through which the instrument and / or fluid may enter the target anatomical structure in which the distal end of the instrument 40 is disposed. The term "percutaneous access" is used herein in accordance with its broad and ordinary meaning, and may refer to the entry of an instrument through the patient's skin and any intermediate body layers between the skin and the target anatomical location associated with the procedure (e.g., the calyx network of the kidney 70), such as by puncture and / or small incision. The term "percutaneous access device" is used herein in accordance with its broad and ordinary meaning, and may refer to a surgical tool, device, instrument, or assembly (such as a needle, scalpel, guidewire, sheath, shaft, scope, etc., and / or an assembly including one or more of these components) configured to puncture or insert through the skin and / or other tissue / anatomical structures. However, it should be understood that a percutaneous access device may refer to other types of medical devices in the context of the present disclosure. Although described as a nephroscope, a catheter, and an endoscope, respectively, in some contexts herein, it should be understood that the percutaneous access devices 40, 48 and the direct access device 32 can be any type of medical device, including an endoscope (e.g., a ureteroscope), a catheter (such as a steerable or non-steerable catheter), a nephroscope, a laparoscope, or other types of medical devices. It should be understood that references herein to percutaneous access devices can be understood to also refer to other types of access devices, regardless of whether such access devices pierce or are configured to pierce the skin of a patient. For example, such access devices may include access devices configured to enter a target anatomical structure via any patient orifice, channel, vessel, passage, etc. For example, a urethral access device is contemplated within the scope of the embodiments of the present disclosure.

[0063] The system 100 may include a catheter 48 that can access the internal renal anatomy through the percutaneous access device 40. In some embodiments, the catheter 48 can be manipulated and / or held in place by a handle-type coupling 9 coupled to an arm 12a of the robotic system 10 (such as an instrument device manipulator assembly / component). The catheter 48 can be a flexible, robotically driven instrument. In some embodiments, a passive suction outflow channel can be formed in a space between the outer wall of the catheter 48 and the inner wall / sheath of the percutaneous access device / assembly 40, wherein the catheter 48 is disposed in a channel formed by such inner wall / sheath. In some embodiments, active suction / aspiration can be performed through the lumen of the catheter 48. In the case where the catheter 48 is disposed in the percutaneous access device 40, the axis / sheath of the catheter 48 and the percutaneous access device 40 can be substantially concentric. The catheter 48 and the percutaneous access device 40 can advantageously have a substantially circular cross-sectional shape in at least a portion thereof.

[0064] The medical system 100 also includes a fluid management cart 30, which can be configured to hold one or more fluid bags / containers 33 and / or control the flow of fluid to / from them. For example, an irrigation line 35 can be coupled to one or more of the bags / containers 33 and to an irrigation port of a percutaneous access device / assembly 40. An irrigation fluid can be provided to a target anatomical structure via the irrigation line 35 and the percutaneous access device / assembly 40. The fluid management cart 30 can include specific electronic components, such as a display 36, a flow control mechanism, and / or specific associated control circuitry.

[0065] The fluid management cart 30 may include a stand-alone tower / cart and may have one or more IV bags 33 suspended on one or more sides of the fluid management cart. The cart 30 may include a pump with which aspiration fluid may be drawn into a collection container / canister via an aspiration channel / tube 31. The aspiration channel / tube 31 may be coupled to the catheter handle 9 component of the instrument device manipulator assembly 19.

[0066] The medical system 100 also includes a control system 50 configured to interface with the robotic system 10 and / or the fluid cart 30, provide information about the procedure and / or perform a variety of other operations. For example, the control system 50 may include one or more displays 56 configured to present specific information to assist the physician 5 and / or other technicians or individuals. The medical system 10 may include a table 15 configured to hold the patient 7. The system 10 may also include an electromagnetic (EM) field generator 18, which may be held by one or more of the robotic arms 12 of the robotic system 10, or may be a stand-alone device. Although various robotic arms are shown in various positions and connected to various instruments, it should be understood that such configurations are shown for convenience and illustration purposes, and such robotic arms may have different configurations over time and / or at different points during the medical procedure. In some embodiments, the arm 12a is configured to hold / control the catheter 48 only after the electromagnetic field generator 18 is removed therefrom. That is, the catheter handle 9 and field generator 18 may generally be mounted to the same robotic arm and interchanged over time.

[0067] In some implementations, the system 100 can be used to perform percutaneous procedures, such as percutaneous nephrolithotomy (PCNL). To illustrate, if the patient 7 has a kidney stone 1 that is too large to be removed / passed through the urinary tract (63, 60, 65), the physician 5 can perform a procedure to remove the kidney stone 1 through a percutaneous access point / path associated with the flank / side of the patient 7. In some embodiments, the physician 5 can interact with the control system 50 and / or the robotic system 10 to cause / control the robotic system 10 to advance and navigate the medical device 32 (e.g., a scope) from the urethra 65, through the bladder 60, up the ureter 63 into the calyx network of the kidney 70 where the stone 1 is located. The physician 5 can also interact with the control system 50 and / or the robotic system 10 to cause / control the catheter 48 to advance through the percutaneous access device 40. Control system 50 may provide information associated with medical instrument 32 and / or other instruments of system 100 via display 56, such as real-time endoscopic images captured by the medical instrument, to assist physician 5 in navigating / controlling such instrumentation.

[0068] The renal anatomy is described herein with reference to specific medical procedures relevant to aspects of the inventive concepts. Figure 1 The kidneys 70 shown in the typical anatomical position in FIG. 1 generally include two bean-shaped organs located on the left and right sides of the retroperitoneal cavity, respectively. In an adult human, the height / length of the kidney is generally about 11 cm. The kidneys receive blood from the paired renal arteries 69; the blood leaves the kidneys via the paired renal veins 67. Each kidney 70 is fluidly connected to a corresponding ureter 63, which generally includes a tube that carries secreted urine from the kidney 70 to the bladder 60.

[0069] The kidney 70 is usually located relatively high in the abdominal cavity and is located at a slight oblique angle in the retroperitoneum. The asymmetry in the abdominal cavity, generally caused by the position of the liver, usually results in the right kidney (in Figure 1 The kidney 70 is slightly lower and smaller than the left kidney (shown in detail in Figure 1), and is placed slightly more medially than the left kidney. On top of each kidney is an adrenal gland (not shown). The upper portion of the kidney 70 is partially protected by the 11th and 12th ribs (not shown). Each kidney and its adrenal gland are generally surrounded by two layers of fat: the perirenal fat present between the renal fascia and the renal capsule, and the pararenal fat above the renal fascia.

[0070] The kidneys 70 are involved in controlling the various body fluid compartments, fluid osmotic pressure, acid-base balance, various electrolyte concentrations, and the amount of toxin removal. The kidneys 70 provide a filtering function by secreting certain substances and reabsorbing other substances. Examples of substances secreted into the urine are hydrogen, ammonium, potassium, and uric acid. In addition, the kidneys also perform various other functions, such as hormone synthesis, etc.

[0071] The concave region on the concave border of the kidney 70 is the renal hilum 78, where the renal artery (not shown in the detailed view of the kidney 70) enters the kidney 70, and where the renal vein (not shown in the detailed view) and ureter 63 leave. The kidney 70 is surrounded by tough fibrous tissue, and the renal capsule 74 itself is surrounded by perirenal fat, renal fascia, and pararenal fat. The anterior (front) surface of these tissues is the peritoneum, and the posterior (back) surface is the transverse abdominal fascia.

[0072] The functional substance or parenchyma of the kidney 70 is divided into two major structures: the outer renal cortex 77 and the inner renal medulla 87. These structures are in the shape of a plurality of generally cone-shaped renal lobes, each of which contains the renal cortex surrounding a portion of the medulla called the renal pyramids 72. Between the renal pyramids 72 are cortical projections called renal columns 73. Figure 1 The urine-producing functional structures of the kidney (not shown in detail) span the cortex 77 and medulla 87. The initial filtering portion of the nephron is the corpuscle, which is located in the cortex and is followed by tubules that extend from the cortex deep into the medullary pyramids. Part of the renal cortex, the medullary rays, is a collection of tubules that drain into a single collecting duct.

[0073] The top / apex or papilla 79 of each renal pyramid empties urine into the corresponding calyx 75; the calyx 75 empties into the calyx major 76, and the calyx major 76 empties into the renal pelvis 71, which transforms into the ureter 63. The manifold-type collection of calyces minor and major may be referred to herein as the "calyx network" of the kidney. At the renal hilum 78, the ureters 63 and the renal veins leave the kidney and the renal arteries enter. Hilar fat and lymphatic tissue with lymph nodes surround these structures. The hilar fat is adjacent to a fat-filled cavity called the renal sinus. The renal sinus collectively contains the renal pelvis 71 and the renal calyx 75, 76 and separates these structures from the renal medullary tissue. The funnel-shaped / tubular anatomical structure associated with the calyx may be referred to as the infundibulum / infundibula. That is, the infundibulum generally leads to the termination of the calyx, where the papilla is exposed within the calyx.

[0074] With further reference to the medical system 100, a medical device 32 (e.g., a scope, a direct access instrument, etc.) can be advanced through the urinary tract into the kidney 70. Once at the site of the kidney stone 1 (e.g., within a target calyx 75 of the kidney 70 where the stone 1 can enter), the medical device 32 can be used to specify / identify a target location for percutaneous access to the kidney 70. In order to minimize damage to the kidney and / or surrounding anatomical structures, the physician 5 can specify a specific papilla 79 of the kidney 70 as a target location / anatomical feature for accessing the kidney 70 using a percutaneous access instrument (e.g., a needle). However, other target locations can be specified or determined. Once the percutaneous access instrument has reached the target location (e.g., calyx 75), the kidney stone 1 can be removed from the patient 7 using the utilized percutaneous access path.

[0075] Throughout at least a portion of the procedure, the use of a fluid cart 30 and flushing lines 35 can advantageously direct fluid into the calyx network to produce the desired renal dilation for navigation and visualization. In the case of under-pressurization, where there is not enough fluid in the kidney to produce the desired or necessary dilation, the performance of laser lithotripsy can result in unintended laser damage to tissue at the treatment site due to collapse of surrounding anatomical structures caused by the under-pressurization.

[0076] Various scoposcope-type instruments disclosed herein (such as the scope 32 of system 100) can be configured to navigate within human anatomy, such as within a natural orifice or lumen of a human anatomy. The terms "scope" and "endoscope" are used herein according to their broad and ordinary meanings, and can refer to any type of elongated medical device having image generation, viewing and / or capture functionality and configured to be introduced into any type of organ, cavity, lumen, chamber, or space of the body. Scopes can include, for example, ureteroscopes (e.g., for accessing the urinary tract), laparoscopes, nephroscopes (e.g., for accessing the kidneys), bronchoscopes (e.g., for accessing airways such as bronchi), arthroscopes (e.g., for accessing joints), cystoscopes (e.g., for accessing the bladder), colonoscopes (e.g., for accessing the colon and / or rectum), borescopes, and the like. In some cases, the scope / endoscope can include a rigid or flexible tube and can be sized to pass within an outer sheath, catheter, introducer, or other lumen-type device, or can be used without such a device.

[0077] Irrigation fluid may be provided to the treatment site (e.g., kidney 70) via percutaneous access device 40, via percutaneous access catheter 48, and / or via direct access device 32. Additionally, irrigation and aspiration may or may not be provided by the same instrument. Where one or more of the instruments (32, 40, 48) provide irrigation and / or aspiration functions, one or more of the other instruments may be used for other functions, such as breaking up an object 80 to be removed.

[0078] Once the percutaneous access device 40 is positioned within the patient, it may be desirable to prevent or reduce the risk of movement of the percutaneous access device 40. For example, when the percutaneous access device 40 is initially placed within the patient to provide access to a target treatment site, such placement may be based on a position selected by a physician and may be deemed by the physician to be the optimal position. The catheter 48 may generally be advanced through the percutaneous access device 40 by advancing the instrument manipulator assembly 19 toward and / or away from the patient 7, thereby advancing the catheter 48 and / or withdrawing the catheter 48 from the access device 40. Such movement / advancement of the catheter 48 ideally does not result in undesired displacement and / or movement of the percutaneous access device 40, which may result in damage to the patient's physiology and / or result in the need for the percutaneous access device 40 to be reset by the physician. In addition, improper alignment and / or advancement of the catheter 48 may result in damage to the catheter 48, wherein one or more portions or passages of the catheter along its axial length may become at least partially bent, kinked, broken, torn, dented, and / or otherwise damaged in some manner.

[0079] In order to prevent misalignment of the catheter 48 with the access device 40 to the extent that it causes damage to the patient and / or the medical device, it may be necessary or desirable that the catheter 48 (or other device) and the percutaneous access device / sheath 40 share the same axis. As described in detail below, embodiments of the present disclosure are directed to specific alignment devices that can be used to create and / or facilitate alignment of the axis of the catheter 48 or other device manipulated by the instrument device manipulator assembly 19 with the percutaneous access sheath / device 40. In addition, such devices can be configured such that if the percutaneous access device 40 is struck during the alignment process, causing it to move undesirably, the alignment device can prevent or reduce the risk of tissue damage that may otherwise be caused by the relatively thin walls of the percutaneous access device 40. Additionally, with respect to procedures for performing device alignment while fluid flow is actively being used to produce renal dilation, the alignment device of the present disclosure can be configured to seal the percutaneous access device such that substantially no fluid flows out through the percutaneous access device (e.g., passive outflow) and the desired renal dilation is maintained.

[0080] Figure 2A cart-based robotic system 101 is shown arranged for diagnostic and / or therapeutic bronchoscopy in accordance with one or more embodiments. During bronchoscopy, the arm 12 of the robotic system 10 can be configured to deliver a medical instrument such as a steerable endoscope 52 (which can be a procedure-specific bronchoscope for bronchoscopy) to a natural orifice entry point (i.e., the mouth of the patient 7 positioned on the table 15 in this example) to deliver the diagnostic and / or therapeutic tool. As shown, the robotic system 10 (e.g., a cart) can be positioned proximate to the patient's upper torso to provide access to the entry point. Similarly, the robotic arm 12 can be actuated to position the bronchoscope 52 relative to the entry point. When performing gastrointestinal (GI) procedures using a gastroscope (a specialized endoscope used for GI procedures), the bronchoscope 52 can also be used. Figure 2 The arrangement in .

[0081] Once the robotic system 10 is properly positioned, the robotic arm 12 can insert the steerable endoscope 52 into the patient's body robotically, manually, or a combination thereof. The steerable endoscope 52 may include at least two telescopic parts, such as an inner guide portion and an outer sheath portion, each of which is coupled to a separate instrument driver from a set of instrument drivers 19, each of which is coupled to the distal end of a corresponding robotic arm 12. This linear arrangement of the instrument drivers 19 creates a "virtual track" 103 that can be repositioned in space by manipulating one or more robotic arms 12 to different angles and / or positions. The virtual tracks / paths described herein are depicted in the accompanying drawings using dashed lines that generally do not depict any physical structure of the system. Translation of one or more of the instrument drivers 19 along the virtual track 103 can advance or retract the endoscope 52 from the patient 7.

[0082] After insertion, the endoscope 52 can be guided downward to the patient's trachea and lungs using precise commands from the robotic system 10 until the target surgical site is reached. The use of a separate instrument driver 19 allows the individual parts of the endoscope / assembly 52 to be driven independently. For example, the endoscope 52 can be guided to deliver a biopsy needle to a target, such as, for example, a lesion or nodule in the patient's lung. The needle can be deployed downward along a working channel that extends the length of the endoscope to obtain a tissue sample to be analyzed by a pathologist. Depending on the pathological results, additional tools can be deployed downward along the working channel of the endoscope for additional biopsies. For example, when a nodule is identified as malignant, the endoscope 52 can be delivered through the endoscope to remove potential cancerous tissue. In some cases, diagnostic and therapeutic treatments can be delivered in separate procedures. In these cases, the endoscope 52 can also be used to deliver a benchmark to "mark" the location of the target nodule. In other cases, diagnostic and therapeutic treatments can be delivered during the same procedure.

[0083] In the system 101, the patient introducer 102 is attached to the patient 7 via a port (not shown; for example, a surgical tube). The patient introducer 102 can be fixed to the table 15 (for example, via a patient introducer holder configured to support the introducer 102 and fix the position of the patient introducer 102 relative to the table 15 or other structure). In some embodiments, the patient introducer 102 may include a proximal end, a distal end, and an introducer tube between the proximal end and the distal end. The proximal end of the patient introducer 102 can provide an opening / orifice that can be configured to receive a surgical instrument 52 (for example, a bronchoscope), and the distal end of the patient introducer 102 can provide a second opening that can be configured to guide the instrument 52 into the patient access port. The curved tube component of the introducer 102 can connect the proximal end and the distal end of the introducer and guide the instrument 52 through the introducer 102.

[0084] The curvature of the introducer 102 may enable the robotic system 10 to manipulate the instrument 52 from a position that is not directly axially aligned with the patient access port, thereby allowing for greater flexibility in the placement of the robotic system 10 within the room. Additionally, the curvature of the introducer 102 may allow the robotic arm 12 of the robotic system 10 to be substantially horizontally aligned with the patient introducer 102, which may facilitate manual movement of the robotic arm 12, if desired.

[0085] The alignment apparatus of the present disclosure may be used to provide a solution for aligning the robotic system cart 10 (e.g., the instrument device manipulator assembly 19 associated with one or more of the robotic arms 12) with the patient guide 102. For example, the alignment apparatus of the present disclosure may be coupled to the patient guide 102 during the alignment process. In some specific implementations, the robotic arms 12 of the robotic system 10 may be configured to align along a virtual track 103 having a main axis that is substantially aligned with the opening of the patient guide 102. In addition, as with other embodiments disclosed herein, the virtual track 103 may define a volume in a space in which the instrument device manipulator assembly 19 is configured to be arranged during manipulation of the instrument 52 (e.g., during a surgical procedure). Therefore, alignment of the manipulator assembly 19 with the patient guide 102 may improve operational control of the instrument 52 during the surgical procedure.

[0086] Figure 3A table-based robotic system 104 is shown in accordance with one or more embodiments of the present disclosure. By combining a robotic component 105 with a tabletop 47, the amount of capital equipment within an operating room can be reduced compared to a cart-based robotic system, which can allow for greater access to a patient 7. Much like a cart-based system, the end effector (i.e., instrument device manipulator assembly) of the robotic arm 39 of the system 104 can generally include instrument drives 42 designed to manipulate elongated medical instruments, such as a catheter 48, etc., along a virtual track or path determined during an alignment procedure.

[0087] As shown, the robotically enabled table system 104 may include a column 44 coupled to one or more brackets 41 (e.g., an annular movable structure) from which one or more robotic arms 39 may extend. The bracket 41 may translate along a vertical column interface extending along at least a portion of the length of the column 44 to provide different vantage points from which the robotic arms 39 may be positioned to reach the patient 7. In some embodiments, the bracket 41 may rotate about the column 44 using a mechanical motor positioned within the column 44 to allow the robotic arms 39 to access multiple sides of the table 104. The rotation and / or translation of the bracket 41 may allow the system 104 to align medical devices such as endoscopes and catheters into different entry points on the patient. By providing vertical adjustment, the robotic arms 39 may be advantageously configured to be compactly stored under the platform 47 of the table system 104 and then raised during a procedure.

[0088] The robotic arm 39 may be mounted on the carriage 41 via one or more arm mounts 45 that may include a series of joints that may be individually rotated and / or telescopically extended to provide additional configurability to the robotic arm 39. The column 44 provides structural support for the stage platform 47 and provides a path for vertical translation of the carriage 41. The column 44 may also transmit power and control signals to the carriage 41 and the robotic arm 39 mounted thereon.

[0089] Figure 4 The present disclosure shows that one or more embodiments of the present disclosure can be Figures 1 to 3 A medical system component implemented in any one of the medical systems of the present disclosure. Figure 1 and Figure 2 An exemplary embodiment of the control system 50 Figure 4, the control system 50 may be configured to provide various functions to assist in performing medical procedures. In some embodiments, the control system 50 may be coupled to the robotic system 10 and / or the fluid management system 30 and operate in conjunction with the robotic system and / or the fluid management system to perform medical procedures on the patient 7. For example, the control system 50 may communicate with the robotic system 10 and / or the fluid management system 30 via a wireless or wired connection (e.g., to control the robotic system 10, the fluid flow from the fluid management system 30, etc.). In addition, in some embodiments, the control system 50 may communicate with the needle and / or the nephroscope to receive position data therefrom. In addition, in some embodiments, the control system 50 may communicate with the table 15 to position the table 15 in a specific orientation or otherwise control the table 15. In some embodiments, the control system 50 may communicate with the EM field generator 18 to control the generation of the EM field in the area surrounding the patient 7.

[0090] Figure 4 Also shown is a schematic diagram of one or more embodiments of the present disclosure. Figure 1 and Figure 2 The following description relates to an exemplary embodiment of a robotic system 10. Figure 1 , Figure 2 and Figure 4 . The robotic system 10 can be configured to at least partially facilitate the performance of a medical procedure. The robotic system 10 can be configured in a variety of ways, depending on the particular procedure. The robotic system 10 may include one or more robotic arms 12 configured to engage and / or control, for example, a scope 32 and / or a percutaneous access catheter 48 to perform one or more aspects of a procedure. As shown, each robotic arm 12 may include a plurality of arm segments 23 coupled to joints 24 that may provide a plurality of degrees of movement / freedom. Figure 1 In the example of , the robotic system 10 is positioned proximate to the patient's leg, and the robotic arm 12 is actuated to engage and position the endoscope 32 for entry into an access opening, such as the urethra 65 of the patient 7. When the robotic system 10 is properly positioned, the endoscope 32 can be inserted into the patient 7 by robotic use of the robotic arm 12, manually by the physician 5, or a combination thereof. An instrument device manipulator assembly including an instrument driver base 6 can be associated with a distal portion of one of the arms 12c to facilitate robotic control / advancement of a particular medical device, such as a percutaneous access catheter 48. Any of the percutaneous medical devices 40, 48 or direct access medical devices 32 can include one or more working channels through which additional tools, such as lithotripters, basket retrieval devices, forceps, etc., can be introduced into the treatment site.

[0091] The robotic system 10 may be coupled to any component of the medical system 100, such as the control system 50, the table 15, the EM field generator 18, the scope 32, and / or any type of percutaneous access device (e.g., a needle, a catheter, a nephroscope, etc.). In some embodiments, the robotic system 10 is communicatively coupled to the control system 50. For example, the robotic system 10 may be configured to receive control signals from the control system 50 to perform operations in order to position one or more of the robotic arms 12 in a particular manner, manipulate the scope 32, manipulate the catheter 48, etc. In response, the robotic system 10 may control components of the robotic system 10 using specific control circuits 211, actuators 217, and / or other components of the robotic system 10 to perform operations. In some embodiments, the robotic system 10 and / or the control system 10 are configured to receive from the scope 32 a signal representing the internal anatomy of the patient 7 (i.e., information about the patient 7). Figure 1 images and / or image data of a specifically depicted urinary system) and / or displaying an image based thereon.

[0092] refer to Figure 4 , the robotic system 10 generally includes an elongated support structure 14 (also referred to as a "column"), a robotic system base 25, and a console 13 at the top of the column 14. The column 14 may include a support structure for supporting one or more robotic arms 12 (in Figure 1 and Figure 2 The elbow support 17 may include one or more arm supports 17 (also referred to as "brackets") that are deployed in a manner similar to that of the patient's arm 12 (three are shown in FIG). The elbow support 17 may include an individually configurable arm support that rotates along a vertical axis to adjust the base of the robotic arm 12 for better positioning relative to the patient.

[0093] The arm support 17 can be configured to translate vertically along the column 14. For example, the arm support 17 can be connected to the column 14 through slots 20 that are positioned on opposite sides of the column 14 to guide the vertical translation of the arm support 17. The slots 20 include a vertical translation interface to position and maintain the arm support 17 at various vertical heights relative to the robotic system base 25. Vertical translation of the elbow support 17 allows the robotic system 10 to adjust the range of the robotic arm 12 to meet a variety of table heights, patient body shapes, and physician preferences. Similarly, the individually configurable arm mounts on the arm support 17 can allow the robotic arm base 21 to be angled in a variety of configurations.

[0094] The robotic arm 12 may generally include a robotic arm base 21 and an end effector 22 (e.g., an instrument driver) separated by a series of links 23, the series of links being connected by a series of joints 24, each joint including one or more independent actuators 217. Each actuator may include an independently controllable motor. Each independently controllable joint 24 may provide or represent an independent degree of freedom available to the robotic arm. In some embodiments, each of the arms 12 has seven joints and thus provides seven degrees of freedom, including "redundant" degrees of freedom. The redundant degrees of freedom allow the robotic arm 12 to position its corresponding end effector 22 at a specific position, orientation, and trajectory in space using different link positions and joint angles. This allows the system to position and guide the medical device from a desired point in space while allowing the physician to move the arm joint to a clinically advantageous position away from the patient to create greater access while avoiding arm collisions.

[0095] The robotic system base 25 balances the weight of the column 14, the elbow support 17, and the arm 12 on the floor. Thus, the robotic system base 25 can house certain relatively heavy components, such as electronics, motors, power supplies, and components that selectively enable the robotic system to be moved and / or fixed. For example, the robotic system base 25 includes wheel-shaped casters 28 that can allow the robotic system to be easily moved around the operating room prior to a procedure. After reaching the appropriate position, the casters 28 can be secured using wheel locks to keep the robotic system 10 in place during the procedure.

[0096] The console 13 positioned at the upper end of the column 14 can provide both a user interface for receiving user input and a display screen 16 (or a dual-purpose device, such as a touch screen, for example) that provides preoperative and / or intraoperative data to the physician / user. Potential preoperative data on the console / display 16 or display 56 may include preoperative planning, navigation and mapping data derived from a preoperative computerized tomography (CT) scan and / or a record from a preoperative patient interview. The intraoperative data on the display may include optical information provided from tools, sensors, and coordinate information from sensors, as well as important patient statistics, such as respiration, heart rate, and / or pulse. The console 13 can be positioned and tilted to allow the physician to approach the console from the side of the column 14 opposite the arm support 17. From this position, the physician can view the console 13, the robotic arm 12, and the patient while operating the console 13 from behind the robotic system 10. As shown, the console 13 may also include a handle 27 that assists in manipulating and stabilizing the robotic system 10.

[0097] The end effector 22 of each of the robotic arms 12 can serve as a driver base for an instrument device manipulator assembly, which can include an instrument handle that can be attached using an adapter. In some embodiments, the instrument handle can be removed and replaced with a different type of instrument, for example, a first type of instrument handle can manipulate an endoscope, while a second type of instrument handle can manipulate a catheter. Another type of instrument handle can be configured to hold an electromagnetic field generator 18. The adapter can include a connector for transmitting pneumatic pressure, power, electrical signals, and / or optical signals from the robotic arm 12 to the instrument handle. The instrument handle can be configured to manipulate a medical instrument (e.g., surgical tool / instrument) such as a catheter 48 using technologies including (e.g.,) direct drive, harmonic drive, gear drive, belt and pulley, magnetic drive, etc. In some embodiments, the instrument manipulator 22 can be associated with a corresponding one of the robotic arms 212, wherein the robotic arm 212 is configured to insert a corresponding coupled medical instrument into a treatment site or retract it outward from a treatment site (e.g., via a percutaneous access sheath / device).

[0098] As referenced above, Figure 1 , Figure 2 and Figure 3 The system may include specific control circuits configured to perform specific functions described herein, including control circuit 211 of robotic system 10, control circuit 231 of fluid management system 230, and / or control circuit 251 of control system 50. That is, Figure 1 and Figure 2The control circuitry of the system may be part of the robotic system 10, the fluid management system 30, the control system 50, or some combination thereof. Thus, any reference herein to a control circuit may refer to a circuit embodied in a robotic system, a fluid management system, a control system, or any other component of a medical system. The term "control circuitry" is used herein in its broad and ordinary sense and may refer to any collection of: a processor, a processing circuitry, a processing module / unit, a chip, a die (e.g., a semiconductor die including one or more active and / or passive devices and / or connectivity circuitry), a microprocessor, a microcontroller, a digital signal processor, a microcomputer, a central processing unit, a field programmable gate array, a programmable logic device, a state machine (e.g., a hardware state machine), a logic circuitry, an analog circuitry, a digital circuitry, and / or any device that manipulates signals based on hard coding of circuitry and / or operating instructions. The control circuitry referred to herein may also include one or more circuit substrates (e.g., printed circuit boards), conductive traces and through-holes and / or mounting pads, connectors, and / or components. The control circuit system mentioned herein may also include one or more storage devices, which may be embodied in a single memory device, multiple memory devices and / or an embedded circuit system of the device. Such data storage devices may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache, data storage registers and / or any device that stores digital information. It should be noted that in embodiments where the control circuit system includes a hardware and / or software state machine, an analog circuit system, a digital circuit system and / or a logic circuit system, the data storage device / register storing any associated operating instructions may be embedded in the circuit system including the state machine, the analog circuit system, the digital circuit system and / or the logic circuit system or outside the circuit system.

[0099] Control circuits 211, 231, and / or 251 may include computer-readable media that stores and / or is configured to store hard-coded and / or operational instructions corresponding to at least some of the steps and / or functions shown in one or more of the figures in the present drawings and / or described herein. In some cases, such computer-readable media may be included in a product. Control circuits 211 / 231 / 251 may be maintained / set entirely locally, or may be at least partially remotely located (e.g., indirectly communicatively coupled via a local area network and / or a wide area network). Any of control circuits 211, 231, 251 may be configured to perform any aspect of the various processes disclosed herein, including the processes shown in Figures 16 and 17 and described below.

[0100] With respect to the robotic system 10, at least a portion of the control circuit 211 may be integrated with the base 25, column 14, and / or console 13 of the robotic system 10, and / or with another system communicatively coupled to the robotic system 10. With respect to the fluid management system 30, at least a portion of the control circuit 231 may be integrated with the base 35, column 34, and / or console 38 of the fluid management system 30, and / or with another system communicatively coupled to the fluid management system 30. With respect to the control system 50, at least a portion of the control circuit 251 may be integrated with the console base 51 and / or the display unit 56 of the control system 50. It should be understood that any description of functional control circuits or related functions herein may be understood to be embodied in the robotic system 10, the fluid management system 30, the control system 50, or any combination thereof, and / or at least partially embodied in one or more other local or remote systems / devices.

[0101] Further references Figure 4 , the control system 50 may include various I / O components 258 that are configured to assist the physician 5 or others in performing medical procedures. For example, the input / output (I / O) components 258 may be configured to allow user input to control / navigate the scope 32 and / or catheter 48 within the patient 7. In some embodiments, for example, the physician 5 may provide input to the control system 50 and / or the robotic system 10, wherein in response to such input, control signals may be sent to the robotic system 10 to manipulate the scope 32 and / or catheter 48. The control system 50 may include one or more display devices 56 to provide various information about the procedure. For example, the display 56 may provide information about the scope 32 and / or catheter 48. For example, the control system 50 may receive real-time images captured by the scope 32 and display these real-time images via the display 56. Additionally or alternatively, the control system 50 may receive signals (e.g., analog signals, digital signals, electrical signals, acoustic / sound signals, pneumatic signals, tactile signals, hydraulic signals, etc.) from medical monitors and / or sensors associated with the patient 7, and the display 56 may present information about the health or environment of the patient 7. Such information may include information displayed via the medical monitors, including, for example, information related to heart rate (e.g., ECG, HRV, etc.), blood pressure / blood rate, muscle biosignals (e.g., EMG), body temperature, blood oxygen saturation (e.g., SpO2), CO2, brain waves (e.g., EEG), environment and / or local or core body temperature, etc.

[0102] To facilitate the functionality of the control system 50, the control system 50 may include various components (sometimes referred to as "subsystems"). For example, the control system 50 may include control electronics / circuitry 251, as well as one or more power supplies / interfaces 259, pneumatics, light sources, actuators, data storage devices, and / or communication interfaces 254. In some embodiments, the control system 50 is mobile, while in other embodiments, the control system 50 is a substantially stationary system. Although various functions and components are discussed as being implemented by the control system 50, any of such functions and / or components may be integrated into and / or performed by other systems and / or devices (such as the robotic system 10, the fluid management system 30, the table 15, etc.).

[0103] Further references Figure 1 and Figure 2 , the medical system 100 / 101 can provide a variety of benefits, such as providing guidance to assist a physician in performing a procedure (e.g., fluid management status / conditions, instrument tracking, instrument alignment information, etc.), enabling a physician to perform a procedure from an ergonomic position without the need for awkward arm movements and / or positions, enabling a single physician to perform a procedure with one or more medical instruments, avoiding radiation exposure (e.g., radiation exposure associated with fluoroscopy techniques), enabling procedures to be performed in a single operating environment, providing continuous aspiration for more efficient object removal (e.g., removal of kidney stones), etc. For example, the medical system 100 / 101 can provide guidance information to assist a physician in accessing a target anatomical feature using various medical instruments while minimizing bleeding and / or damage to anatomical structures (e.g., critical organs, blood vessels, etc.). In addition, the medical system 100 / 101 can provide non-radiation-based navigation and / or positioning technology to reduce radiation exposure for physicians and patients and / or reduce the number of devices in an operating room. In addition, the medical system 100 / 101 can provide functionality that is distributed between two or more of the control system 50, the fluid management system 30, and the robotic system 10, which can be independently movable. Such distribution of functionality and / or movement can enable the control system 50, the fluid management system 30, and / or the robotic system 10 to be placed in a location that is optimal for a particular medical procedure, which can maximize the working area around the patient 7 and / or provide an optimal location for the physician 5 to perform the procedure.

[0104] The various components of the system 100 / 101 may be communicatively coupled to each other via a network, which may include a wireless and / or wired network. Exemplary networks include one or more personal area networks (PANs), local area networks (LANs), wide area networks (WANs), internet area networks (IANs), cellular networks, the Internet, personal area networks (PANs), body area networks (BANs), etc. For example, Figure 2The various communication interfaces of the system 10 may be configured to communicate with one or more devices / sensors / systems, such as via wireless and / or wired network connections. In some embodiments, the various communication interfaces may implement wireless technologies such as Bluetooth, Wi-Fi, near field communication (NFC), etc. In addition, in some embodiments, the various components of the system 10 may be connected via one or more supporting cables, tubes, etc. for data communication, fluid exchange, power exchange, etc.

[0105] The control system 50, fluid management system, and / or robotic system 10 may include specific user controls 255 (e.g., controls 55), which may include any type of user input (and / or output) device or device interface, such as one or more buttons, keys, joysticks, handheld controllers (e.g., video game type controllers), computer mice, trackpads, trackballs, control pads, and / or sensors that capture hand gestures and finger postures (e.g., motion sensors or cameras), touch screens, and / or interfaces / connectors thereto. Such user controls are communicatively and / or physically coupled to respective control circuits.

[0106] In some embodiments, the user may manually manipulate the robotic arm 12 of the robotic system 10 without the use of electronic user controls. For example, during a setup in a surgical operating room, the user may manually move the robotic arm 12 and / or any other medical instrument to provide desired access to the patient 7. The robotic system 10 may rely on force feedback and inertial control from the user to determine the appropriate configuration of the robotic arm 12 and associated instruments.

[0107] The fluid management system 30 and / or the control system 50 may include one or more pumps, flow meters, valve controllers, and / or other fluid / flow control components (e.g., sensor devices, such as pressure sensors) to provide controlled flushing and / or suction / aspiration capabilities for the medical device. In some embodiments, flushing and suction capabilities may be delivered directly to / from the medical device via separate cables. In some embodiments, the control system 50 may be coupled to the robotic system 10, the table 15, and / or a medical device (such as a percutaneous access device 40 and / or a needle) or other percutaneous access device (not shown) via one or more cables or connectors (not shown). In some embodiments, the control circuit 251 of the control system 50 (or the control circuit 231 of the fluid management system 30 or the control circuit 211 of the robotic system 10) may generate and provide one or more signals to the fluid management system 30 to indicate how high (or how low) the flushing pressure level from the flushing fluid source 332 may be, wherein such signals may be converted by the fluid management system 30 into flushing outputs regarding the operation of the pump 237 and / or other flow control devices associated with the flushing fluid source 332.

[0108] According to aspects of the present disclosure, any of the control circuit 231, the control circuit 251, and the control circuit 211 can be configured to control the pump 237 and / or the vacuum 238 to provide an irrigation pressure limit. Any of the medical devices 32, 40, 48 shown in the system 100 can be attached to the pump 237, which can facilitate irrigation fluid flow. Figure 4 A pump 238 is included, but in some embodiments, irrigation fluid flow is achieved without the use of a pump, where such flow is driven primarily by gravitational potential energy. The pump 237 is attached to an irrigation source 332 that provides an irrigation fluid (e.g., saline solution) to be pumped through one or more of the medical devices 32, 40, 48 and into the treatment site. In some examples, the pump 237 is a peristaltic pump. In some embodiments, the pump 237 can be replaced with a vacuum that is configured to apply vacuum pressure to draw irrigation fluid from the irrigation fluid source 332 and out through the corresponding coupled medical device.

[0109] One or more of the percutaneous access and / or direct access devices implemented in conjunction with systems 100, 200 may be fluidly coupled / connected to a vacuum 238 configured to facilitate fluid aspiration. For example, vacuum 238 may be configured to apply negative pressure to draw fluid from the treatment site. Vacuum 238 may be connected to a collection container into which the drawn fluid is collected. In some examples, aspiration may be facilitated by one or more pumps rather than by a vacuum. Additionally, in some embodiments, aspiration is primarily passive rather than by active aspiration. Therefore, it should be understood that embodiments of the present disclosure may not include a vacuum component.

[0110] Figure 5A and Figure 5B A side view and a cross-sectional view, respectively, of a patient 7 in a prone position with a percutaneous access device 40 (e.g., a sheath assembly) at least partially disposed within his / her flank 68 and / or renal anatomy, according to one or more embodiments are shown. Figure 5B As is apparent in FIG, due to the location of the patient's flank 68 and the location / existing access path relative to other key anatomical structures 61 , the prone position may be ideal for percutaneous access to the posterior calyx of the kidney.

[0111] For PCNL procedures, such as Figure 5A and Figure 5B As shown, percutaneous access to the posterior calyx 75 of the kidney 70 can result in a percutaneous access device 40 having a sheath angle of approximately 45° above the horizontal. Thus, to achieve alignment of a catheter or other robotically controlled instrument with the access device 40, a device manipulator assembly associated with the catheter / instrument can be oriented at an angle θ1 above the horizontal. For example, the catheter can be advanced at least partially along a virtual track 501 corresponding to the axis of the sheath 42.

[0112] Fig. 6A and Figure 6B A side view and a cross-sectional view are respectively shown of a patient in a modified supine position with a percutaneous access device 40 at least partially disposed in his / her flank 68 and / or renal anatomy according to one or more embodiments. In the modified supine position, due to the generally downward orientation of the posterior calyx, the sheath angle θ2 can be generally slightly closer to horizontal than relative to a particular pitch protocol, wherein such downward trajectory is offset at least in part by tilting the patient 7 at an angle θ3 to provide greater exposure to the patient's flank 68 (e.g., using a pillow or other structure 5 to wedge / support the patient).

[0113] like Fig. 6A and Figure 6B As shown, for a percutaneous PCNL procedure in a modified supine position, percutaneous access to the posterior calyx 75 of the kidney 70 may result in the percutaneous access device 40 having a sheath angle below horizontal, such as Figure 6B 2 in . Generally speaking, in a modified supine position, a pillow 5 or similar device can be used to support the patient 7 so that the patient's flank 68 is elevated on one side. As shown in the figure, the support angle θ3 can be generally an angle between 0° and 45° above the horizontal line. Therefore, in order to achieve alignment of a catheter or other robotically controlled instrument with the access device 40, the device manipulator assembly associated with the catheter / instrument can be oriented at an angle θ2 below the horizontal line. For example, the catheter can be advanced at least partially along a virtual track 601 corresponding to the axis of the sheath 42.

[0114] Fig. 7A and Figure 7B An isometric view and a side view, respectively, of an inner sheath device / component 220 and an outer sheath device / component 200 of a percutaneous access device / assembly 40 according to one or more embodiments are shown. In the illustrated embodiment, the sheath component extends between a proximal end 202 and a distal end 204. The distal end 204 of the outer sheath component 200 can be configured to be inserted into a treatment site of a patient with or without the inner sheath component 220 assembled therewith.

[0115] In an assembled configuration, the inner sheath component 220 can be at least partially secured within the outer sheath component 200, wherein the hub 229 of the inner sheath component 220 is screwed or otherwise secured to the hub 216 of the outer sheath component 200 such that the shaft 208 of the inner sheath component 220 is disposed within and coaxial with the shaft 206 of the outer sheath component 200. In some embodiments, the distal end 204 of the outer shaft 206 is sharpened, tapered, angled, or otherwise configured such that it can form a percutaneous incision in a patient through which the outer sheath component 200 can be inserted. In some embodiments, the distal end 204 is inserted through a previously formed percutaneous incision, opening, or port.

[0116] Generally, during use of the percutaneous access device 40, the distal end 204 is positioned within the treatment site and the proximal end 202 is positioned outside the patient's body. As will be described below, the percutaneous access device 40 may provide one or more pathways, channels, or conduits from the proximal end 202 to the distal end 204 through which medical devices may be inserted to reach the treatment site. The pathways, channels, and conduits may also be used to provide flushing and aspiration of fluids through the percutaneous access sheath 200. When assembled, the outer sheath / conduit 206 and the inner sheath / conduit 208 of the percutaneous access device 40 are configured such that the distal end 204 of the inner shaft 208 is flush with or positioned proximal to the distal end 204 of the outer shaft 206.

[0117] In some embodiments, the inner sheath component 220 can be removable. For example, the inner shaft 208 can be configured to slide out of the outer shaft 206. In some embodiments, when the inner shaft 208 is positioned within the outer shaft 206, it can be secured by a valve (e.g., a rubber valve or an O-ring) to provide a seal between the proximal end 202 of the outer sheath component 200 and the proximal end of the inner sheath component 220. In some embodiments, the inner sheath component 220 can be removable from the outer sheath component 200 to allow the dilator to be assembled through the outer shaft 206. In some embodiments, the inner sheath component 220 is fixed (e.g., permanently fixed) within the outer sheath component 200 and cannot be removed.

[0118] The outer shaft 206 may include a type of tube, conduit or tube that forms an inner cavity. In some embodiments, the outer shaft 206 is rigid. For example, the outer shaft 206 may have sufficient rigidity so that it can be inserted into the patient's body through the skin. In some embodiments, the outer shaft 206 includes a hypotube. The use of a hypotube can provide a relatively thin sidewall so that the overall size / profile of the percutaneous access device 40 can be minimized while maintaining sufficient strength and rigidity. This can reduce the size of the pipeline of the percutaneous access device 40, thereby reducing potential patient complications. In some embodiments, the outer shaft 206 includes stainless steel, but other suitable materials can also be used. In the illustrated embodiment, the outer shaft 206 has a substantially circular cross-section on at least a portion of its length. The outer shaft 206 may have an outer diameter of 23Fr. (0.302 inches) and an inner diameter of 21.4Fr. (0.281 inches). These sizes are provided by way of example, and other sizes of the outer shaft 206 are possible. For example, the outer diameter of the outer shaft 206 can be about 21 Fr., about 22 Fr., about 23 Fr., about 24 Fr., or about 25 Fr., as well as other larger and smaller sizes. In addition, the inner diameter of the outer shaft 206 can be about 18 Fr., about 19 Fr., about 20 Fr., about 21 Fr., about 22 Fr., or about 23 Fr., as well as other larger and smaller sizes.

[0119] The hub 216 of the outer sheath component 200 can be positioned at the proximal end 202 of the outer shaft 206. In some embodiments, the outer shaft 206 is welded to the hub 216, but other methods for connecting the outer shaft 206 and the hub 216 are also possible. The fluid inlet 218 can be positioned on the hub 216. As will be described in more detail below, the fluid inlet 218 can be configured to be connected to an irrigation source so that irrigation can be provided and enter the treatment site through the percutaneous access device 40. In the illustrated embodiment, the fluid inlet 218 is configured as a side port. For example, the longitudinal axis of the fluid inlet can be transverse (e.g., angled or perpendicular) to the longitudinal axis of the outer shaft 206. In the illustrated embodiment, the fluid inlet 218 is configured as a Luer connector. In other embodiments, other types of connectors can be used. In addition, in some embodiments, the fluid inlet 218 can be positioned at other positions on the hub 216 and / or other parts of the outer sheath component 200.

[0120] In some embodiments, the hub 216 is made of extruded plastic, but other manufacturing methods and material types are also possible. In some embodiments, the hub 216 includes plastic (such as ABS plastic, polycarbonate or other suitable plastic) overmolded onto the outer shaft 206. In some embodiments, the percutaneous access device 40 may also include a hub 229 on the inner shaft 208. The hub 229 of the inner sheath component 220 can promote engagement and sealing between the outer sheath component 200 and the inner sheath component 220. In some embodiments, the hub 229 of the inner sheath component 220 includes plastic (such as ABS plastic, polycarbonate or other suitable plastic) overmolded onto the inner shaft 208.

[0121] The hub 216 of the outer sheath component 200 can also include a valve positioned therein. For example, when the inner shaft 208 is positioned within the outer shaft 206, the inner shaft 208 can extend through the valve of the hub 216. The valve of the hub 216 can seal the proximal end 202 of the outer shaft 206.

[0122] The inner shaft 208 may include a type of conduit, tube or pipe. In some embodiments, the inner shaft 208 is rigid. For example, the inner shaft 208 may have sufficient rigidity so that it can be inserted into the patient's body through the skin. In some embodiments, the inner shaft 208 includes a hypotube. In some embodiments, the inner shaft 208 includes stainless steel, but other materials may also be used. The inner shaft 208 may have a substantially circular cross-section over at least a portion of its length. The inner shaft 208 may have an outer diameter of 19.1Fr. (0.251 inches) and an inner diameter of 18.1Fr. (0.238 inches). In some embodiments, the inner shaft 208 has a diameter of about 16Fr., 17Fr., 18Fr., 19Fr., 20Fr., 21Fr. or 22Fr., or other larger or smaller sizes. Additionally, the inner diameter of the inner shaft 208 can be approximately 14 Fr., 15 Fr., 16 Fr., 17 Fr., 18 Fr., 19 Fr., or 20 Fr., or other larger or smaller sizes.

[0123] Fig. 8A and Figure 8B A perspective view and a side cross-sectional close-up view, respectively, are shown of a percutaneous access system deployed in a portion of a patient's renal anatomy, according to one or more embodiments. Fig. 8A and Figure 8B The system includes a percutaneous access device 40 and a robotically controlled catheter 48 aligned with an axis 801 of a sheath 42 thereof, wherein the catheter 48 is at least partially disposed within a lumen of the access device 40 .

[0124] As described above, various aspects of the present disclosure relate to systems, devices, and methods for aligning a robotically controlled catheter and / or other instrument with a percutaneous access device. Such catheters / instruments can be used to manage aspiration fluid flow to a treatment site (e.g., a kidney). Fluid irrigation and aspiration (which may be referred to herein as "jets") can represent an important component of certain medical procedures, such as percutaneous nephrolithotomy (PCNL). For example, during PCNL, a jet may be applied to clear stone dust, small debris, and thrombus from the treatment site and the field of view provided by the medical instrument. For example, with respect to Fig. 8A and Figure 8B In some embodiments, irrigation fluid 3 may be provided through a percutaneous access channel / port 218 of the device 40. Aspiration (outflow) may exit the treatment site through one or more passive and / or active outflow channels (such as through catheter 48, device handle 9, and / or port 81). In some embodiments, both irrigation and aspiration may be active.

[0125] Fig. 8A and Figure 8B The figure may represent a PCNL procedure. The renal anatomical structure shown includes an object 1 disposed in the calyx network of a kidney 70, wherein the object 1 may be any object targeted for removal, such as a kidney stone. The percutaneous access device 40 may be inserted into the kidney 70 via the skin through a flexible sheath 47. According to some specific implementations, the flexible sheath 47 may be placed by first entering the treatment site with a rigid needle and using a dilator to expand the percutaneous access path and place the sheath 47. The percutaneous access device 40 may include a working channel 44 within an inner shaft / wall 45, through which various tools (such as a catheter 48) may be inserted. In some specific implementations, a lithotripter (e.g., an ultrasonic lithotripter) may be inserted through the working channel 44 of the percutaneous access device 40. The percutaneous access device 40 may also include an optical device (not shown) configured to allow a surgeon to observe the treatment site.

[0126] The catheter 48 may be navigated within the kidney 70 by twisting the catheter 48 toward the object 1 using a specific actuator / mechanism associated with the catheter handle 9. In some implementations, the object / stone 80 may be broken up using a lithotripter (not shown) and removed in smaller fragments by percutaneous access to the catheter 48. The lithotripter may be advanced to the treatment site by percutaneous or direct access.

[0127] like Figure 8BAs shown in the arrow in, flushing (e.g., saline solution) can be applied to the treatment site (e.g., kidney 70) by percutaneous access device 40. Flushing fluid 3 can enter percutaneous access device 40 through flushing port 218 and leave through distal end 301 to enter kidney 70. Flushing can be used to remove stone powder and small fragments from the field of view of a speculum or other imaging / observation device to allow a surgeon to observe the treatment site, and to expand kidney 70 to allow access to object 1. In the illustrated example, suction is also applied from the treatment site by medical device 40. As shown in the figure, fluid can be passively removed from kidney 70 by the working channel 44 of the percutaneous access device (e.g., between the inner shaft 45 and the catheter 48 of the percutaneous access device 40). In some cases, suction is (actively) pulled through one or more outflow channels and / or is allowed to passively flow through one or more outflow channels. For example, active suction / sucking can be performed by catheter 48. In some specific implementations, the jet is applied during substantially the entire procedure. The hub 229 of the inner sheath component 220 may include specific fluid sealing features configured to prevent or reduce fluid leakage, thereby allowing desired fluid conditions to be maintained within the target anatomy.

[0128] The jets applied during the procedure can be established as Figure 8B 40. Initially, fluid may flow outward from the distal end 301 of the percutaneous access device 40 toward the subject 1. Aspiration through the catheter 48 may cause the fluid to flow back toward the percutaneous access device / sheath 40. As shown, in the region of the subject 1, flow may be directed toward and away from the subject 1 relative to the distal end 301 of the percutaneous access device 40. Without adequate aspiration of fluid, there may be a risk of overfilling the kidney.

[0129] During a ureteroscopy lithotripsy procedure, a ureteroscope may be passed through the ureter into the kidney 70, and a stone retrieval basket and / or lithotripter may be used to reposition and break up the kidney stone, respectively. For example, a lithotripter may be deployed through the working channel of a ureteroscope and used to break the stone 1 into fragments that may be aspirated through the catheter 48, the catheter handle 9, and the outflow port 81 to a collection reservoir.

[0130] Irrigation and / or suction may be administered to produce desired flow characteristics, thereby resulting in desired dilation conditions of the target organ / anatomical structure. In some embodiments, irrigation (inflow) is introduced into the treatment site through a first medical device (e.g., a percutaneous access device 40 and / or a catheter 48 disposed therein). In some embodiments, the percutaneous access device 40 and / or catheter 48 may be inserted antegrade into the treatment site of an object to be removed (e.g., a kidney stone) 80, while another medical device (e.g., an endoscope) may be inserted retrograde into the treatment site of the object 1. Although Figure 8BThe irrigation fluid 3 is shown as being provided to the treatment site percutaneously, but in some implementations, irrigation can be provided by a medical device that enters the treatment site by direct access (e.g., via the urinary tract). The suction catheter 48 can be as described above with reference to Figure 1 , Figure 2 and Figure 4 Thus, in some embodiments, aspects of the methods, devices, and systems described below may be employed robotically.

[0131] In some embodiments, the irrigation and / or aspiration rates may be adjusted to improve stone displacement or to stabilize or intentionally create turbulence so that irrigation reaches all corners of the treatment site. For example, gentle alternating cycles of irrigation and aspiration may produce an effect similar to lavage to preferentially pull large stone fragments away from the calyx and toward the aspiration site. Alternatively, short pulses of inflow and outflow may be used to create turbulence and ensure that smaller and lighter stone fragments do not settle on the floor of the treatment site, but instead remain floating in the irrigation fluid and are ultimately aspirated with the outflow.

[0132] The percutaneous access catheter 48 can be an articulated catheter introduced into the treatment site (e.g., the calyx network of the kidney 70) via percutaneous access. The catheter 48 can be configured to be able to navigate in the kidney 70. For example, the catheter 48 can be configured to be inserted and retracted into the treatment site and / or to perform articulation (e.g., bending) therein. In some embodiments, the catheter 48 may include a guide wire for controlling articulation. For example, four guide wires may be oriented in four orthogonal directions so that the catheter 48 can perform articulation. Other methods for allowing the catheter to perform articulation are also possible. The catheter 48 may include, for example, a suction lumen (or channel). The suction lumen may be fluidically coupled to a pump / vacuum device (e.g., an external pump). The pump / vacuum may generate a negative pressure that causes the catheter to flow from the treatment site into the catheter. The suction function may be able to be switched (e.g., turned on and off) and adjusted by the user or system. In some embodiments, the suction lumen may also be used for flushing.

[0133] The catheter 48 can provide various functions during the object removal procedure, such as stone stabilization during lithotripsy. For example, if the stone 1 is larger than the suction lumen of the catheter, the stone can be kept at the distal side of the suction lumen, thereby stabilizing the stone when the stone is broken into dust and smaller fragments. Active suction can hold the stone to the distal side of the catheter 48. In some cases, the stone being removed can substantially block the catheter 48, thereby causing the stone to be held by the catheter due to the pressure difference. This can provide the user with a less mobile target for lithotripsy. In addition, the catheter 48 can improve the visibility of the treatment site by removing stone dust from the kidney. This can provide the user with improved visibility (e.g., continuous sufficient visibility), for example, from an imaging device inserted into the treatment site.

[0134] The catheter 48 can remove stone dust and debris, wherein the fluid flow carries the fluid and debris into the catheter 48 for removal therethrough. Generally speaking, the debris can be removed as it is generated (i.e., when the stone is broken up). Removing debris via the catheter 48 can replace removing debris via ureteroscopic basketing, which can be relatively time consuming due to the difficulty in closing the basket around the stone and due to the need to remove and reinsert the ureteroscope during each fragment removal. Therefore, using the catheter 48 for stone removal can result in a more efficient removal procedure. Removing stone debris via the catheter can also reduce the risk of stone fragments damaging tissue compared to certain alternative stone removal methods (such as removing the stone through the ureter).

[0135] During the procedure, catheter 48 can be used in several ways. For example, catheter 48 can be mobile throughout the procedure. The catheter can be navigated around the treatment site to target a specific stone / fragment during lithotripsy in order to constrain it while also aspirating dust / debris. As another example, catheter 48 can be stationary initially during the procedure, and a scope or other device can be used to reposition the stone to catheter 48. The stone can be broken down at catheter 48. At a later time during the procedure, catheter 48 can be navigated through the treatment site to pick up remaining debris. As another example, catheter 48 can be inserted only when needed (e.g., percutaneously).

[0136] Stabilizer 190 can be used to hold percutaneous access device 40 and to align and maintain it in the correct position once the desired position has been reached. Stabilizer 190 can be fixed to a surgical table or other structure in the surgical environment. In some cases, stabilizer 190 can be free-standing. Stabilizer 190 can advantageously be movable so that it can be brought to the correct position where percutaneous access device 40 has been placed. To this end, stabilizer 190 can include one or more joints 191 to provide the necessary degree of mobility.

[0137] Generally speaking, the catheter 48 and / or associated handle 9 can be configured to travel axially along the axis 801 of the shaft 42 of the percutaneous access device 40, which establishes a patient circuit. Therefore, proper alignment of the catheter 48 with the axis 801 of one of the percutaneous access devices 40 can be critical to facilitating such travel / advancement of the catheter 48. Misalignment between the catheter 48 and the shaft 42 can result in device damage relative to the catheter 48 and / or the percutaneous access device 40, and can also negatively impact system fluidics. For example, misalignment of the catheter 48 can result in kinks or other fluid obstructions in the catheter and / or in one or more portions of the percutaneous access device 40. Embodiments of the present disclosure provide for aligning a catheter and / or other instrument with a percutaneous access device (such as a catheter similar to the present invention). Fig. 8A and Figure 8BSuch alignment solutions can advantageously align instrument manipulator assemblies and / or components thereof (e.g., Fig. 8A Movement / advancement of the catheter handle 9) in the catheter is guided to an orientation aligned with the percutaneous access device 40.

[0138] Fig. 9 An exploded view of an instrument device manipulator assembly 19 associated with a robotic arm 12 is shown according to one or more embodiments. The instrument manipulator assembly 19 includes an instrument driver (e.g., an end effector) 6 associated with the distal end of the robotic arm 12. The instrument manipulator assembly 19 also includes an instrument handle 9 associated with a medical instrument 48. The instrument handle 9 may incorporate electromechanical components for actuating the instrument 48. For convenience, the instrument 48 is described herein as a suction catheter, but the instrument 48 can be any type of medical / surgical instrument. The descriptions herein of upward and downward facing surfaces, panels, surfaces, components and / or other features or structures may refer to Fig. 9 That is, although the instrument driver 6 may be generally configurable to face and / or be oriented in a range of directions and orientations, for convenience, the description of such components herein may be in the order of Fig. 9 The instrument drive 6 is shown in the context of a generally vertically oriented orientation.

[0139] In some embodiments, the instrument device manipulator assembly 19 also includes an adapter component 8 that is configured to provide a driver interface between the instrument driver 6 and the instrument handle 9. In some embodiments, the adapter 8 and / or the instrument handle 9 can be removable or detachable from the robotic arm 12 and can be free of any electromechanical components, such as a motor. This dichotomy may be driven by the need to sterilize medical instruments used in medical procedures and the inability to adequately sterilize expensive capital equipment due to its complex mechanical components and sensitive electronics. Therefore, the instrument handle 9 and / or the adapter 8 can be designed to be disassembled, removed, and interchanged from the instrument driver 6 (and therefore from the system) for separate sterilization or disposal. In contrast, the instrument driver 6 does not need to be changed or sterilized in some cases and can be covered for protection.

[0140] The adapter 8 may include a connector for transmitting pneumatic pressure, power, electrical signals, and / or optical signals from the robotic arm 12 and / or the instrument driver 6 to the instrument handle 9. The instrument handle 9 may be configured to manipulate the medical device 48 using one or more direct drives, harmonic drives, gear drives, belts and pulleys, magnetic drives, and / or other manipulator components or mechanisms. The robotic arm 12 may advance / insert the coupled medical device 9 into or retract it from the treatment site. In some embodiments, the instrument handle 9 may be removed and replaced with a different type of instrument handle. For example, a first type of handle may be configured to manipulate a catheter, a second type of handle may manipulate an endoscope, a third type of handle may hold an EM field generator, and the like.

[0141] The end effector (e.g., instrument driver) 6 of the robotic arm 12 may include various components / elements configured to be connected to and / or aligned with components of the adapter 8, handle 9, and / or instrument 48. For example, the end effector 6 may include a drive output 302 (e.g., a drive spline, gear, or rotatable disk) for controlling / articulating a medical device, a reader 304 for reading data from the medical device (e.g., a radio frequency identification (RFID) reader for reading a serial number from the medical device), one or more fasteners 306 for attaching the medical device 9 and / or the adapter 8 to the instrument driver 6, a marker 308 for aligning with an instrument (e.g., an access sheath) that is manually attached to a patient and / or for defining a front surface of a device manipulator assembly. In some embodiments, a portion (e.g., a plate) 315 of the adapter 8 may be configured to rotate / spin independently of one or more other components of the adapter 8 and / or the driver 6 when coupled to the driver 6.

[0142] In some configurations, a sterile drape (such as a plastic sheet or the like) may be disposed between the instrument driver 6 and the adapter 8 to provide a sterile barrier between the robotic arm 12 and the instrument 48. For example, the drape may be coupled to the adapter 8 in a manner that allows mechanical torque to be transferred from the driver 6 to the adapter 8. The adapter 8 may generally be configured to maintain a seal around its actuating components so that the adapter 8 itself provides a sterile barrier. The use of a drape coupled to the adapter 8 and / or more other components of the device manipulator assembly 19 may provide a sterile barrier between the robotic arm 12 and the surgical area, thereby allowing the use of a robotic cart associated with the arm 12 in a sterile surgical area. The driver 6 may be configured to be coupled to various types of sterile adapters that may be loaded onto and / or removed from the driver 6 of the robotic arm 12. With the arm 12 covered in plastic, physicians and / or other technicians may interact with other components of the arm 12 and / or the robotic cart (e.g., a screen) during a procedure. Covering may further prevent biohazard contamination of the equipment and / or minimize post-procedure cleanup.

[0143] although Fig. 9 The particular adapter 8 shown may be configured for coupling to a catheter handle 9 (such as an aspiration catheter handle), but adapters for use with device manipulator assemblies according to various aspects of the present disclosure may be configured for coupling to any type of surgical or medical device or instrument (such as an endoscope (e.g., a ureteroscope), a basketing device, a laser fiber driver, etc.).

[0144] Alignment devices and components

[0145] Fig.10 Distal and lateral isometric views of an alignment device 90 are shown, according to one or more embodiments of the present disclosure. Fig.11 According to one or more embodiments, Fig.10 Proximal and lateral isometric views of the proximal portion of the alignment device. Fig.12 A schematic diagram of a device disposed in a percutaneous access device 200 (eg, an outer sheath component of a percutaneous access device / assembly) is shown in accordance with one or more embodiments. Fig.10 and Fig.11 A side view of the alignment device 90 is shown. Fig.13 A cross-sectional view of a proximal portion of an alignment device 90 according to one or more embodiments is shown. The alignment device 90 is configured to facilitate alignment of a sterile adapter or other component of an instrument manipulator assembly to a desired alignment position and / or path through feature matching components. The alignment device 90 includes a blunt tip 87 for reducing the risk of tissue damage during alignment, and threaded or other features configured to facilitate secure installation of the alignment device 90 in a percutaneous access device and / or an outer sheath component thereof.

[0146] During the alignment process, the inner sheath component of the percutaneous access device (e.g., Fig. 7A and Figure 7B The inner sheath component 220 shown may not be present and / or coupled to the outer sheath component 200, such that the outer sheath component 200 may instead receive the alignment device 90 at least partially therein for implementing an alignment procedure as described in detail herein. After the correct alignment track / path and / or position of the robotic instrument manipulator assembly has been determined, the inner sheath component 220 may be coupled to the outer sheath component 200 following the alignment procedure / process.

[0147] like Fig.12 As shown, the alignment device 90 is configured to be coupled to the percutaneous access device 200 and / or at least partially disposed in some manner within at least a portion of the percutaneous access device. For example, the alignment device 90 may include an elongated rod 94 (see Fig.10), the elongated rod is configured to fit within the outer shaft of the percutaneous access device 200 so that its distal end / tip 87 protrudes a certain distance from the distal end 46 of the percutaneous access device / shaft 42.

[0148] When the percutaneous access device is placed in the patient's body in conjunction with a medical procedure (such as a kidney stone removal procedure, etc.), the elongated rod 94 can be used to provide an atraumatic contact tip 87 for the percutaneous access device. The atraumatic / blunt tip 87 may include an at least partially flat axial face 88 and / or a rounded corner / edge portion 86 to provide a blunt form that is less potentially damaging to tissue at the treatment site than the distal end of the percutaneous access device 200 alone. The length L1 of the elongated rod 94 can be used to place its distal tip 87 distal to the distal opening 46 of the percutaneous access device 200 and / or its outer shaft 42. In some embodiments, the elongated rod 94 has a length of approximately 7.1 inches to 7.2 inches. The length L1 can be advantageously determined relative to the length of the tube portion of the percutaneous access device, in which the elongated rod 94 is configured to be disposed. For example, the length L1 can be advantageously greater than such a tube length by an amount between 0 mm and 5 mm. For example, the length L1 can be greater than the tube length of the percutaneous access device by a distance between 3 mm and 5 mm.

[0149] It may be desirable to limit the protrusion distance / length d1 of the elongated rod 94 from the shaft 42 to prevent undesired contact and / or movement of the patient's anatomy by the distal end 87 of the rod 94. For example, in some embodiments, the protrusion distance d1 of the rod 94 beyond the distal end 204 of the outer sheath component 200 may be approximately 5 mm or less. With such a short protrusion distance d1, the edge of the distal end 46 of the shaft 42 may substantially blend and / or smoothly transition with the end 87 (e.g., the side 86) of the rod 94. That is, the distal end 46 of the shaft 42 may have at least partially rounded or tapered edges that may transition relative to the rounded or tapered side 86 of the distal end 87 of the rod 94. The presence of the blunt tip 87 distal to the distal end 46 of the shaft 42 reduces impact / damage caused by direct axial contact with the contour of the tubular shaft 42, wherein the flat contact surface 88 is less potentially traumatic to biological tissue than an alternative annular interface of the shaft 42 that might exist in the absence of the rod 94 of the alignment device 90.

[0150] The alignment device 90 can also be configured to provide a proximal fluid seal with the outer sheath component 200, which can be achieved using a proximal hub portion 95 (also referred to herein as a hub structure, hub component and / or hub member), which in some respects can be similar to similar hub components of specific inner sheath components of percutaneous access devices according to various aspects of the present disclosure.

[0151] The alignment device 90 also includes an alignment structure / member 92, which may include a specific structure or form having a shape and / or configuration designed to engage or interface with a component of a robotic instrument manipulator assembly to facilitate / guide engagement and alignment of one or more components of the instrument manipulator assembly with the alignment structure / member 92, thereby determining an alignment axis or path associated with a percutaneous access device in which the alignment device 90 is disposed, and / or thereby determining an aligned position and / or axis or path of movement of the instrument manipulator assembly. In some embodiments, the alignment structure / member 92 may have a concave, dished shape / form.

[0152] As described above, the rod 94 has a blunt tip 87 that can reduce or eliminate the risk of tissue damage caused by sudden sharp movement of the distal end of the percutaneous access device, and the rod is configured to be disposed in the percutaneous access device when it contacts the tissue. The non-invasive shape / form of the distal tip 87 of the rod 94 can prevent trauma to biological tissue during the alignment process to displace and / or manipulate the percutaneous access device. For example, the percutaneous access device or its outer sheath component can include a relatively thin wall. For example, such a wall can have a thickness of about 10 / 1000 of an inch or other similarly thin dimensions. Generally speaking, when trying to align the robotic instrument manipulator assembly with the percutaneous access device, the robotic arm (e.g., the instrument manipulator assembly or other parts of the instrument manipulator assembly) may collide with the access device, which may cause a sharp movement of the distal end and / or other parts of the percutaneous access device and / or the impact of the distal end and / or other parts of the percutaneous access device on the biological tissue of the patient. Therefore, the rod 94 and / or its distal end 87 can mitigate and / or reduce any tissue cutting or damage caused by the thin wall thickness of the access device / sheath. That is to say, Fig.12 As shown, by having the blunt end portion 87 extend / protrude from the access device / sheath by a relatively minimal amount, if the distal end 46 of the percutaneous access device 200 moves during the alignment process, contact with any biological tissue, at least initially, will be primarily with the end 87 of the slender shaft 94 rather than the distal end 46 of the sheath 42, which can prevent and / or reduce potential damage to the biological tissue.

[0153] The alignment device 90 is configured to be disposed in an outer sheath component (e.g., outer sheath component 200) of a percutaneous access device, wherein the alignment device 90 may include a sealing hub 95 configured to mate with a sealing method of an inner sheath component of the percutaneous access device such that insertion of the sealing hub 95 and engagement with the proximal hub portion 216 of the percutaneous access device 200 may be achieved to form a proximal fluid seal between the hub 95 of the alignment device 90 and the proximal hub 216 of the percutaneous access device. For example, the hub 95 may have specific conical contact features 93 that are configured to create a seal via a conical-conical interaction with a corresponding surface / feature of an interior of the hub 216 of the percutaneous access device. Although shown as conical features 93, in some embodiments, the sealing surface / feature may be an axially flat / blunt surface that provides a sealing seat against which a corresponding flat / blunt surface of the hub 216 may be pressed / placed to provide a fluid seal.

[0154] The alignment structure 92 may be shaped or formed to facilitate and / or guide the user to align the sterile adapter surface or other components of the instrument manipulator assembly to the desired contact with the alignment structure 92. For example, when the manipulator assembly (e.g., its circumferential surface) docks with the alignment structure 92 of the alignment device 90 and rotates to align the specific alignment mark or structure of the manipulator assembly (e.g., its adapter component) with the visual and / or tactile mark 97 associated with the alignment structure 92, the shape of the alignment structure 92 and / or the engaging lip 96 associated therewith may facilitate or ensure that the correct alignment of the robotic instrument manipulator assembly occurs. For example, such alignment marks may be visible, set, printed and / or otherwise present on the upper surface 98 of the alignment structure 92. In some embodiments, the upper surface 98 may be substantially flat over its length. The lip 96 may protrude inwardly relative to the curvature of the proximal surface 91 of the alignment structure 92 and be circumferential, as shown.

[0155] In the case where the elongated rod 94 is disposed within the outer shaft 42, there may be a certain amount of clearance between the outer surface of the rod 94 and the inner surface of the outer shaft 42, through which the flushing fluid may be provided to the treatment site via the port 218 of the outer sheath component 200. However, it may be desirable to prevent fluid from leaking from the proximal end of the hub 216, such as when the fluid is being flushed to the treatment site (e.g., kidney) or the fluid condition of the treatment site will be maintained with little or no passive outflow. For example, with respect to a renal procedure, the outflow of fluid from the kidney through the proximal end of the hub 216 may cause the kidney to at least partially collapse due to fluid loss and / or the desired expansion of the kidney may be lost or reduced. Therefore, the sealing contact surface 93 of the hub 95 may be used to prevent such undesirable fluid leakage. The hub 95 may also include a specific thread feature 89 and / or a manually rotating feature / fin 99 to help couple the sealing hub 95 to the hub 216 of the percutaneous access device. For example, the thread 89 may engage with a corresponding thread inside the hub component 216 of the percutaneous access device. The user can manually manipulate and rotate the hub member 95 to couple and seal the alignment device 90 to the outer sheath member 200. In some embodiments, the distal end portion 46 of the outer shaft 42 includes a marker band or other feature 44 (e.g., a laser marker band) that can be used to detect when the shaft 42 has entered a certain distance into a target cavity, vessel, or other treatment site. For example, the marker band 44 can become visible on an endoscopic image, indicating the distance that the shaft 42 has been advanced into the treatment site (e.g., the target calyx of the kidney).

[0156] Alignment structure 92 may have a dished form that is concave proximally to conform to the convex curvature of a surface of a component of an instrument manipulator assembly. For example, concave form 92 may be sized / shaped to interface against an outwardly radiused / convex surface of an adapter component of an instrument manipulator assembly as described herein.

[0157] In some embodiments, the alignment structure 92 also includes a lip feature 96 that protrudes radially inward relative to the axis of curvature of the alignment structure 92. Although the lip feature 96 is shown as extending along the bottom portion of the alignment structure 92, it should be understood that the lip features according to aspects of the present disclosure can be provided and / or positioned at or along the bottom portion or side, the top portion or side, and / or any other portion or side of the alignment structure 92. The lip feature 96 can be configured to provide a seat surface against which the underside of a component of the instrument manipulator assembly can be placed or rested to provide vertical alignment with the alignment device 90.

[0158] Feature 92 may have a disc or sheet-type form as shown, or may have any other shape or configuration designed to mechanically / physically engage or interface with a component of an instrument manipulator assembly of a robotic system. With respect to the configuration shown, the concave surface of alignment structure 92 provides mechanical engagement with one or more components of an instrument manipulator assembly (e.g., a sterile adapter component). However, it should be understood that some embodiments may incorporate other types of engagement features, such as one or more magnets, lasers or other optical devices / sensors, and / or other types of features that may facilitate and / or guide alignment of the proximal portion of alignment device 90 with a component of an instrument manipulator assembly.

[0159] The top surface 98 of the alignment structure 92 can be printed or otherwise marked to aid alignment with the top surface of a corresponding component of the instrument manipulator assembly of the robotic system (e.g., the top surface of the rotating plate portion of the adapter component of the instrument manipulator assembly). The hub 95 can include a partial tapered feature 93 that is configured to maintain a fluid seal when attached to the outer sheath component 200.

[0160] In some embodiments, the alignment structure 92 can be a separate component from the hub 95 and / or rod 94 of the alignment device / assembly 90. For example, the alignment structure 92 can be removable from the hub 95. In some implementations, the elongated rod 94 can be coupled to the hub component 95 and inserted into the outer sheath component 200 together as a combined assembly, wherein the alignment structure 92 can be attached to the hub 95 after being placed in the outer sheath component 200 with the desired alignment. In some embodiments, the rod 94 can be cured to the hub 95 in some manner, such as by ultraviolet radiation, etc.

[0161] The alignment structure 92 may include a male connector 106 that may protrude axially distally relative to the rod and hub and is configured to be received by a corresponding recessed cavity of the hub 95. The projection 106 may allow the alignment structure 92 to be disengaged from the rest of the alignment device (e.g., the assembly of the hub 95 and the rod 94). The projection 106 may be a snap-fit ​​type connector / projection and may have a length such that when received in the hub 95 (e.g., in its female receptacle), it may lock in place without contacting the proximal end of the rod 94, as shown in FIG. Fig.13 For example, before the connector 106 contacts the rod 94, the distal side 107 of the alignment structure 92 may be lowered to the lowest point on the proximal side 108 of the hub 95. Fig.13 With the connection shown, in some embodiments, the alignment structure 92 may have some freedom to rotate axially within the hub 95. However, it may be desirable to limit the ability of the alignment structure 92 to rotate to avoid undesired rotation when the instrument device manipulator assembly approaches and engages the alignment structure 92.

[0162] Fig.14 An alignment device 90 having an alignment structure 92 that engages one or more surfaces and / or features of an instrument manipulator assembly 19 is shown in accordance with one or more embodiments of the present disclosure. Fig.14 , the alignment structure 92 is engaged / interfaced with the rotating plate component 315 of the instrument device manipulator assembly 19, which may include the instrument driver 6 and the adapter 8, at a stage in the process associated with the alignment of the manipulator assembly 19 with the alignment device 90. At this stage, the instrument handle / base (e.g., catheter handle) may not be coupled to the assembly 19. As with other embodiments of the present disclosure, although the adapter component 8 is shown as being coupled to the instrument driver 6, it should be understood that the engagement / interfacing of the alignment device 90 with the instrument manipulator assembly 19 may be relative to any component of the assembly.

[0163] Once the rotating plate 315 or other component of the manipulator assembly 19 is in mating contact with the alignment structure 92, such as by positioning the outer surface 316 of the rotating plate 315 against the concave proximal surface 91 of the alignment structure 92 so that the lower surface of the rotating plate 315 is seated on the vertical alignment lip 96, the rotating plate 315 can be axially rotated to align one or more alignment marks / features 311 associated with the manipulator assembly 19 (e.g., on the upper surface 312 of the rotating plate 315) into an axial alignment as indicated by one or more marks or indicators 97 associated with the alignment structure 92. For example, such a feature 97 may be on or associated with the upper surface 98 of the alignment structure 92. Although Fig.14 Other figures and / or embodiments shown and / or described herein relate to bottom lip features 96 configured to seat / place the underside of a component of an instrument device manipulator assembly 19 thereon, but it should be understood that such lip features may be implemented as upper lip features, wherein such features may be associated with the top side / top portion of the alignment structure 92 and configured to allow the alignment structure 92 to be placed or rest on an upper surface of a component of the manipulator assembly 19 (e.g., the upper surface 312 of the rotating plate 315). That is, in such embodiments, the instrument manipulator assembly 19 may be lifted against one or more upper lip features of the alignment structure 92.

[0164] The rotation of the rotating plate 315 may be substantially independent of the rotation of portions of the instrument driver 6. For example, axially rotating the rotating plate 315 of the adapter 8 may not result in a commensurate rotation of the housing of the driver 6. However, the rotation of the rotating plate 315 may result in the rotation of certain other features of the adapter 8 and / or assembly 19 (such as the driver / gear 309 and / or other components) and certain corresponding interface components of the driver 6.

[0165] Fig.15A kit 150 for a percutaneous access system is shown according to one or more embodiments. The kit 150 can advantageously be sterilized for surgical use. In some embodiments, a shrink wrap or other sanitary covering can enclose the kit 150 prior to its use. In some embodiments, such a covering can be gas and / or fluid impermeable.

[0166] The kit 150 may include a component retaining form or structure 155, which is referred to herein as a "tray", such term being used according to its broad and ordinary meaning. The tray 155 may be implemented as a single unitary form, and / or may be composed of multiple parts or components that are integrated together to form the retaining tray 155. For example, the tray 155 may include one or more grooves, cavities, channels, cavities, openings, recesses, indentations, etc. configured and / or shaped to receive and / or place one or more portions of various components retained in the retaining form / structure 155. In addition, the tray 155 may include specific pressure-type, tension-type and / or friction-type fittings / features that are configured to retain various components and reduce the tendency of such components / parts to disengage or separate from the tray 155. That is, in some embodiments, it may be necessary to apply a certain amount of force to extract one or more of the components or portions thereof from the tray 155 so that such components / parts are at least partially fixed in their corresponding positions / cavities in the kit 150.

[0167] The kit 150 may include one or more of the catheter 48, the catheter handle 9, the outer sheath component 200, the inner sheath component 220, the dilator 3, the alignment device 90, and / or the dilator and sheath assembly 2, as shown. However, it should be understood that the kit 150 may include Fig.15 Additional components not shown and / or may be omitted in some embodiments Fig.15 One or more of the components shown. Fig.15As shown, in some embodiments, the catheter 48 can be stored / retained in a retaining tray 155, at least partially within the lumen of the inner sheath component 220. It should be understood that the inner sheath component 220 and the outer sheath component 200 can be components of a percutaneous access device assembly as described in detail herein. In addition, in some embodiments, the dilator 3 can be fixed in the retaining tray 155, at least partially within the lumen of the outer sheath component 200, as shown. In some embodiments, the alignment device 90 can be configured in a separate configuration in the kit 150, wherein the alignment structure 92 is separately provided from the assembled slender rod 94 and hub 95 components, which can be coupled together or separated in the kit 150. For example, the rod 94 can be connected to the hub 95 with a cured adhesive (such as an ultraviolet radiation cured adhesive). In some embodiments, the alignment device 90 is provided in an assembled configuration in the retaining structure / form 155, wherein the alignment structure 92 is mechanically coupled to one or more of the hub component 95 and the slender rod component 94. As Fig.15 As shown, in an embodiment where the alignment structure 92 and the remainder of the alignment device 90 are separately disposed in the tray 155 , such components may be retained in a common cavity or portion of the tray 155 .

[0168] Alignment process

[0169] Figure 16-1 , Figure 16-2 , Figure 16-3 , Figure 16-4 and Figure 16-5 A flow chart illustrating a process 1600 for aligning a medical device and / or instrument manipulator assembly according to one or more embodiments is shown. Figure 17-1 , Figure 17-2 , Figure 17-3 , Figure 17-4 and Figure 17-5 Specific images corresponding to various blocks, states, and / or operations associated with process 1600 are shown in accordance with one or more embodiments of the present disclosure.

[0170] Prior to performing process 1600, certain preliminary processes and / or operations may be performed. For example, prior to the operations associated with block 1602, process 1600 may involve entering a percutaneous access kit, which may be similar in some respects to the Fig.15The kit 150 shown. The preliminary procedure / operation may also involve percutaneous access to the target treatment site, such as the internal anatomy of the patient's kidney, and expansion of the access path to the target treatment site. For example, a needle may first be used to puncture the skin and tissue leading to the treatment site (e.g., through the target nipple to enter the target calyx of the kidney), after which a guide wire may be passed through and / or along the needle. A dilator may be passed over the guide wire to expand the percutaneous path to the treatment site. After entry and expansion, the outer sheath component 200 of the percutaneous access device assembly may be inserted so that its distal end 46 is at least partially disposed within the treatment site. After placement of the outer sheath component 200, a stabilizer structure 190 may be used to secure such a device / component to its desired placement.

[0171] At block 1602, process 1600 involves inserting an alignment device into a percutaneous access device / sheath. For example, the percutaneous access device may include an outer sheath component 200 of a percutaneous access device assembly according to a particular embodiment of the present disclosure. Insertion of alignment device 90 may involve advancing an elongated shaft portion 94 of alignment device 90 through the lumen of shaft 42 of outer sheath component 200. Alignment device 90 may be inserted in an assembled form in which elongated shaft 94, hub 95, and alignment structure 92 are coupled together, or may be inserted in a configuration in which elongated shaft and hub 95 are coupled together and inserted as an integrated assembly, while alignment structure 92 is clipped or otherwise secured to hub 95 after hub 95 and shaft 94 assembly is placed and secured in / into outer sheath component 200 and / or hub 216 thereof. The alignment device 90 and / or its hub component 95 can be mechanically fixed / coupled to the outer sheath component 200, such as by inserting the rod 94 at least partially into the component 200 and screwing the hub 95 into the outer sheath hub 216 to tighten and seal the hub 95 against one or more inner surfaces of the outer sheath hub 216. In some specific implementations, once the hub 95 has been firmly coupled to the sheath hub 216, the alignment structure 92 can be rotated so that it is ground approximately parallel relative to its top surface and / or bottom surface. In some specific implementations, this rotation step is not implemented. For example, this rotation may not be necessary because the instrument device manipulator assembly 19 can force this rotational alignment of the alignment structure 92 to match the plane of the instrument manipulator assembly 19 and / or one or more components thereof to manually force the alignment structure 92 to align with the manipulator assembly 19.

[0172] At block 1604, the process 1600 involves coupling or otherwise mating or engaging one or more components of the robotic instrument manipulator assembly 19 with the alignment structure 92 of the alignment device 90. Such an operation may involve manually positioning the robotic arm 12 so that the manipulator assembly 19 interfaces, mates, or otherwise engages with the alignment structure 92. For example, the protruding lip feature 96 of the alignment structure 92 may engage with a corresponding bottom surface of a component of the instrument manipulator assembly 19, such as an adapter plate component thereof. For example, a rotatable top plate component of the adapter 8 may physically interface with the alignment member 92 in the manner described.

[0173] According to some specific implementations, the operations associated with box 1604 may involve placing the robotic system 10 in an arm alignment posture / configuration. For example, a clutch-type mechanism may be engaged to allow manual repositioning of one or more portions of the arm 12 in a relatively free manner. In some embodiments, this alignment mode of the robotic system 10 may be caused / initiated substantially automatically and / or in response to one or more triggering events associated with a relevant procedure / process. In some embodiments, the manual manipulation mode of the arm 12 may be initiated using one or more inputs on the arm (e.g., buttons, touch sensors, etc.) and / or applying a force exceeding a threshold to the arm.

[0174] With respect to the image 1703 associated with the engagement of the instrument device manipulator assembly 19 with the alignment structure 92, such engagement may involve manually articulating, moving, and / or arranging the robotic arm 12 in any suitable or desired manner. Such an arrangement / configuration of the various components of the robotic arm 12 may be indicative of and / or based on specific kinematic information / data associated with the robotic arm. For example, the kinematic information / data on which the position and / or alignment configuration of the robotic arm 12 may be based may include actuator position data when engaged with the alignment structure / member 92, actuator velocity data, actuator sequencing information, and / or other data associated with a specific configuration of the robotic arm 12.

[0175] In a particular embodiment, the robotic arm 12 may have seven joints 24 and thus provide seven degrees of freedom. However, any number of joints may be implemented with any number of degrees of freedom. In general, multiple arm joints may generate multiple degrees of freedom, thereby allowing "redundant" degrees of freedom. The redundant degrees of freedom allow the robotic arm 12 to position the instrument driver 6 at a specific position, orientation, and / or trajectory in space using different link positions and / or joint angles (specific exemplary arm angles are shown in image 1703). In some embodiments, the instrument driver 6 may be configured to engage and / or control medical devices, devices, objects, etc. The degrees of freedom of movement of the arm 12 may allow the robotic system 10 to position and / or guide a medical device (e.g., a catheter) from a desired point in space, and / or allow a physician to move the arm 12 into a configuration that cooperates with the alignment device 90 and thereby aligns with the axis of the shaft 42 of the percutaneous access device 200.

[0176] The various arm segments 23 and / or associated actuators may be moved / adjusted to achieve the mating position shown in image 1703, wherein the manipulator assembly 19 is aligned with the sheath angle θ5 of the percutaneous access device 200. For example, due to variability in the user's alignment about the axis 42, the sheath angle θ5 may vary during the procedure. To align with the sheath angle θ5, the distal arm segment 23d may be moved to a corresponding angle θ4. The height offset H1 of the arm support 17 within the track 20 may be further adjusted to achieve the desired position of the manipulator assembly 19.

[0177] At block 1606, process 1600 involves rotating rotatable component 315 of instrument device manipulator assembly 19 to align one or more indicia or other visual indicators 311 associated therewith with corresponding alignment marks associated with alignment structure 92 (e.g., on its top surface, such as Figure 17-2 In some embodiments, the operations associated with block 1606 involve matching the pad print on the top surface of the alignment tool 92 with a corresponding mark of the rotating component 315 of the manipulator assembly 19. The rotating component 315 may include a top plate of an adapter component 8 that is coupled to an instrument driver 6 associated with the distal end of the robotic arm 12. Rotating the top plate of the adapter component (or other rotatable component of the adapter 8 and / or manipulator assembly 19) may be implemented to align the mark 311 with the mark 97.

[0178] At block 608, process 1600 involves determining a virtual track and / or alignment path associated with percutaneous access device 200 based at least in part on the position, orientation, and / or configuration of a robotic arm and / or instrument device manipulator assembly 19 interfaced with alignment device 90. Such a track 170 and / or access path may advantageously take into account a vertical offset (relative to the vertical offset) between an interface location 171 of manipulator assembly 19 relative to a location / axis of catheter 48. Figure 17-2 1 ), the catheter will (or in some embodiments is) coupled to the adapter 8 and / or other components of the manipulator assembly 19. The rotating component 315 can rotate / rotatable clockwise and / or counterclockwise, depending on the embodiment or specific implementation.

[0179] In some implementations, once the robotic arm 12 and instrument manipulator assembly 19 are in proper alignment, a snapshot may be taken regarding the position of the arm 12 and / or manipulator 19 to determine and / or record their position in space. Such position determination / measurement may be performed using any position sensing / determination scheme, including electromagnetic position sensing, or based on robotic arm position data.

[0180] The alignment of the instrument manipulator 19 with the alignment device 90 via the use of the alignment member 92 can be geometrically defined by the six degrees of freedom of movement of the subject in three-dimensional space. That is, if the alignment device 90 is considered to be a fixed point in space, the alignment of the manipulator assembly 19 with the alignment device 90 can be specified by providing values ​​for the six degrees of freedom of movement of the manipulator assembly 19 relative to the alignment device 90. These degrees of freedom may include the position of the manipulator assembly 19 (e.g., forward / backward (X-axis), left / right (Y-axis), up / down (Z-axis), as shown in image 1703) and / or orientation (e.g., pitch (rotation around the Y-axis), yaw (rotation around the Z-axis), and roll (rotation around the X-axis)). Although the position axes (X-axis, Y-axis, and Z-axis) can be defined, positioned, and / or oriented in a variety of different ways, the present disclosure may generally refer to these axes shown in image 1703 in some contexts herein.

[0181] Various aspects of the present disclosure relate to methods and techniques for placing the manipulator assembly 19 into an alignment position / orientation relative to the alignment device 90 to align the manipulator assembly 19 with the alignment device 90. The surgical robotic system 10 may record the spatial position and / or orientation of the manipulator assembly 19 during alignment so that the surgical robotic system 10 is aware of the spatial position and / or orientation of the percutaneous access device 200 during the surgical procedure.

[0182] The alignment of the manipulator assembly 19 with the alignment device 90 can also be defined by the alignment of one or more axes of the manipulator assembly 19 with one or more axes of the percutaneous access device 200, as indicated by engagement with the alignment device 90. For example, the percutaneous access device 200 can define an axis (which can be referred to herein as a receiving axis) along which the percutaneous access device is configured to receive a surgical instrument 48 (e.g., a suction catheter). In some implementations, the determined track / path 170 can be or correspond to the axis of the access / outer sheath component 200. Additionally or alternatively, the determined alignment path can indicate and / or guide the non-linear path of the robotic arm to a desired alignment with the percutaneous access device 200.

[0183] The determination of the alignment path 170 (eg, a "virtual track") may be based on kinematic information associated with the robotic arm when engaged with the alignment structure / member 92. Figure 17-1 Any of the angles, aspects, positions, and / or configurations shown in connection with the image 1703 of the robotic cart / system 10 in FIG. 1 may be associated with specific configuration data that can be used to determine an alignment path.

[0184] At block 1610, the process 1600 involves retracting the robotic arm 12 and / or the instrument device manipulator assembly 19 away from the sheath component 200 and / or the alignment device 90 and alignment structure 92. Such retraction of the robotic arm may allow for reconfiguration of the percutaneous access sheath 200 and may be associated with the end of the alignment phase of the process 1600. That is, the operations associated with block 1610 may be triggered and / or initiated after recording / registering the alignment position, trajectory, and / or path 170 associated with block 1608 and in accordance with the alignment process. When or after the robotic arm 12 is retracted from the sheath component 200 and / or the alignment device 90, the rotatable component 315 of the instrument device manipulator assembly 19 (e.g., a component of the adapter 8) may be rotated a certain amount to align one or more components thereof with the sheath component 200. For example, in some implementations, when the catheter handle 9 is attached to the adapter 8, the rotatable component may be rotated 90° to align with the catheter hub / handle 9 so that its catheter 48 is aligned with the sheath 200.

[0185] At block 1611, the process 1600 involves removing the alignment device 90 from the outer sheath component 200 and inserting the inner sheath component 220 into the outer sheath component 200 to form the percutaneous access device / assembly 40, wherein the space between the inner shaft of the inner sheath component and the outer shaft of the outer sheath component can be used to provide irrigation fluid to the treatment site. The inner sheath component 220 can engage the hub 216 of the outer sheath component 200 in a manner that forms a proximal fluid seal, which can be similar to the seal formed between the hub 95 of the alignment device 95 and the sheath hub 216 as described above. It may be desirable to relatively quickly exchange the alignment device 90 with the inner sheath component 220 in order to reduce any proximal fluid leakage from / through the proximal end of the hub 216 during the time when no inner hub is fluid-sealed therein.

[0186] At box 1612, process 1600 involves inserting an aspiration catheter 48 or other device into the percutaneous access device 40. In some implementations, such insertion may be performed manually without the assistance of the robotic system 10. The catheter 48 may be coupled to and / or associated with a handle component 9, which may be configured to be physically coupled to an adapter 8 or other components of the instrument device manipulator assembly 19, as described herein. Insertion of the catheter 48 or other instrument into the percutaneous access device 40 should generally be performed in a careful manner so as to avoid interfering with the access device 40 in a manner that may cause physical harm to the patient and / or obstruction or damage to the catheter 48. In some implementations, the insertion of the catheter 48 in conjunction with box 1612 may be performed using a robotic arm 12, wherein the handle 9 is coupled to the instrument device manipulator assembly 19 when the catheter 48 is inserted. Such insertion and / or advancement may be at least partially substantially colinear with the determined track / path 170.

[0187] At box 1614, process 1600 involves coupling the catheter handle 9 or other device to the instrument device manipulator assembly 19. For example, advancement of the manipulator assembly 19 and / or associated robotic arm to the coupled position may be via a determined alignment path based at least in part on the registered alignment position / track.

[0188] At box 1615, process 1600 involves using the robotic arm 12 to advance the catheter 48 along the determined virtual track / path 170. For example, the robotic system can be configured to move the manipulator assembly 19 along the determined track / path 170 as determined in conjunction with box 1608 of process 1600. Process 1600 can also involve preparing tubing for flushing and / or aspiration and / or priming such fluid lines on a fluidics tower or system. Process 1600 can also involve passing the flushing line to the port 218 of the outer sheath component 200 for providing irrigation to the treatment site. The aspiration line 82 can also be coupled to the aspiration port 81 associated with the handle 9. Such operations can be performed at any stage in process 1600. The operations associated with box 1615 can involve robotically controlling or constraining the movement of the arm 12 along the alignment path, which can be determined based on specific kinematic information / data associated with the engagement position of the instrument manipulator assembly 19 and the alignment device 90 as described above.

[0189] At block 1616, process 1600 involves aspirating the treatment site within the patient using catheter 48. For example, fluid may be drawn through catheter 48 using one or more pumps or vacuums that may draw fluid through ports 81 associated with catheter handle 9. Such ports 81 may be coupled to tubing that is fluidically coupled to one or more components of the fluidic tower / system.

[0190] Additional Implementation

[0191] Depending on the implementation, specific actions, events or functions of any one of the processes or algorithms described herein may be performed in a different order, added, merged or completely ignored. Therefore, in certain implementations, not all described actions or events are necessary for the practice of the process.

[0192] Unless otherwise specifically stated or understood in the context of use, conditional language used herein, such as "may", "can", "might", "could", "for example", etc., refers to its ordinary meaning and is generally intended to convey that a particular embodiment includes and other embodiments do not include specific features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that one or more embodiments require features, elements and / or steps in any way, or that one or more embodiments must include logic for determining whether these features, elements and / or steps are included in any particular embodiment or whether they will be performed in any particular embodiment with or without author input or prompting. The terms "include", "comprise", "have", etc. are synonymous and are used in their ordinary sense and are used inclusively in an open-ended manner and do not exclude additional elements, features, actions, operations, etc. Moreover, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that when used, for example, to connect a series of elements, the term "or" refers to one, some, or all of the elements in the series. Unless specifically stated otherwise, conjunctive language such as the phrase "at least one of X, Y, and Z" is understood in the context of general usage to convey that an item, term, element, etc. can be X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z each be present.

[0193] It should be understood that in the above description of the embodiments, in order to simplify the present disclosure and assist in understanding one or more of the various inventive aspects, various features are sometimes grouped together in a single embodiment, figure, or description thereof. However, this method of the present disclosure should not be understood to reflect the following intention: any claim requires more features than the features explicitly described in that claim. In addition, any component, feature, or step illustrated and / or described in the specific embodiments herein may be applied to any other embodiment or used with any other embodiment. In addition, for each embodiment, no component, feature, step, or group of components, features, or steps is necessary or indispensable. Therefore, it is expected that the scope of the present invention disclosed herein and claimed below is not limited to the specific embodiments described above, but should only be determined by a fair reading of the appended claims.

[0194] It should be understood that specific ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc. do not necessarily indicate the priority or order of the element relative to any other element, but may generally distinguish the element from another element with a similar or identical name (but used to use the ordinal term). In addition, as used herein, indefinite articles ("a" and "an") may indicate "one or more" rather than "one." In addition, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events that are not explicitly stated.

[0195] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments belong. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and not interpreted in an idealized or overly formal sense, unless expressly defined as such herein.

[0196] For ease of description, the spatially relative terms "external," "internal," "upper," "lower," "below," "above," "vertical," "horizontal," and similar terms may be used herein to describe the relationship between one element or component and another element or component depicted in the drawings. It should be understood that the spatially relative terms are intended to cover different orientations of the device in use or operation other than the orientation depicted in the drawings. For example, where the device shown in the drawings is flipped, a device that is "below" or "under" another device may be placed "above" the other device. Thus, the illustrative term "below" may include both a lower position and an upper position. The device may also be oriented in another direction, and thus the spatially relative terms may be interpreted differently depending on the orientation.

[0197] Unless otherwise expressly stated, comparative and / or quantitative terms such as "less", "more", "greater", etc., are intended to encompass equivalent concepts. For example, "less" may mean not only "less" in the strictest mathematical sense, but also "less than or equal to".

Claims

1. An alignment device, comprising: Slender rod; a sealing hub coupled to the proximal end of the elongated shaft and configured to form a fluid-tight seal within a portion of the percutaneous access device; as well as an alignment structure coupled to the sealing hub and having a form configured to engage a component of an instrument manipulator assembly of a robotic system; wherein the alignment structure comprises one or more alignment marks indicating an aligned position of the alignment structure relative to at least one component of the instrument manipulator assembly; Wherein the alignment structure is axially rotatable relative to the sealing hub.

2. The alignment device of claim 1, wherein the elongated rod has a blunt distal end.

3. The alignment device of claim 1, wherein the distal end of the elongated shaft includes a flat axial face portion and a rounded circumferential edge portion.

4. The alignment device of claim 1, wherein the alignment structure has a concave proximal surface that conforms to an outer surface of the instrument manipulator assembly.

5. The alignment device of claim 4, wherein the alignment structure has a vertical alignment lip that projects inwardly relative to the curvature of the concave proximal surface and is circumferential.

6. An alignment device according to claim 5, wherein the vertical alignment lip is configured to be placed against at least one of the upward surface or the downward surface of the component of the instrument manipulator assembly when the concave proximal surface is placed against the outer surface of the instrument manipulator assembly.

7. The alignment device of claim 1, wherein the sealing hub has external threads configured to engage with internal threads of the percutaneous access device.

8. The alignment device of claim 1, wherein the alignment structure is configured to be attached to the sealing hub from a state separated from the sealing hub.

9. The alignment device of claim 8, wherein the alignment structure comprises a distally projecting male connector configured to couple to the sealing hub.

10. An alignment device comprising: a non-invasive contact member configured to protrude from a distal portion of the sheath device; a sealing member configured to couple to a proximal portion of the sheath device and to form a fluid-tight seal between the sheath device and the sealing member; as well as an alignment member coupled to the sealing member and configured to facilitate alignment of one or more components of the alignment device with one or more components associated with a robotic arm of a robotic system; wherein the alignment member includes one or more alignment marks indicating an aligned position of the alignment member relative to at least one component of an instrument manipulator assembly of the robotic system; Wherein the alignment structure is axially rotatable relative to the sealing member.

11. The alignment device of claim 10, wherein the non-invasive contact member comprises an elongated solid rod having a blunt distal end.

12. The alignment device of claim 10, wherein the sealing member comprises a hub structure having a tapered surface configured to be placed against a corresponding inner surface of the sheath device to form the fluid-tight seal.

13. The alignment device of claim 10, wherein the alignment member comprises a concave dish form.

14. A robot system comprising: Robotic arm; an instrument manipulator assembly associated with a distal portion of the robotic arm; a percutaneous access device comprising an elongated shaft defining an access lumen; as well as The alignment device according to any one of claims 1 to 9, comprising: an elongated rod configured to be at least partially disposed within the access lumen; and a proximal alignment member having a form configured to engage an outer surface of the instrument manipulator assembly.

15. The robotic system of claim 14, wherein the instrument manipulator assembly includes an adapter component, the outer surface being associated with a rotating plate of the adapter component.

16. The robotic system of claim 15, wherein the adapter component is coupled to a drape configured to provide a sterile barrier between the robotic arm and an instrument of the instrument manipulator assembly coupled to the adapter component.

17. The robotic system according to claim 15, further comprising: A catheter assembly includes a catheter coupled to a catheter handle configured to attach to the adapter component.

18. The robotic system of claim 14, wherein the alignment device comprises a hub member secured to a proximal end of the elongated shaft.

19. The robotic system of claim 18, wherein the alignment member is secured to the alignment device on a proximal side of the hub member.

20. The robotic system of claim 14, wherein the alignment member has one or more alignment marks on a top surface thereof.

21. The robotic system of claim 14, wherein the robotic arm is configured to move along an alignment path based on kinematic data associated with a position of the robotic arm when the instrument manipulator assembly engages the alignment member of the alignment device.

22. A percutaneous access kit comprising: a catheter coupled to the catheter handle; a percutaneous access sheath having an access lumen; as well as The alignment device according to any one of claims 1-9, wherein the alignment device is used to align the catheter.

23. The percutaneous access kit of claim 22, further comprising: A tray structure includes one or more recessed cavities configured to have the catheter, the catheter handle, the percutaneous access sheath, and the alignment device at least partially disposed therein.

24. The percutaneous access kit of claim 22, further comprising: An inner sheath is configured to be at least partially disposed within the access lumen of the percutaneous access sheath and to form a proximal fluid seal between a hub of the inner sheath and a hub of the percutaneous access sheath.

25. The percutaneous access kit of claim 22, further comprising: Slender dilator form.

26. The percutaneous access kit of claim 22, wherein the alignment device further comprises a proximal hub configured to form a proximal fluid seal between the proximal hub and a hub of the percutaneous access sheath.

27. The percutaneous access kit of claim 26, wherein the elongated shaft and the proximal hub are assembled together in the percutaneous access kit.

28. The percutaneous access kit of claim 26, wherein the alignment structure is separate from the elongated shaft and the proximal hub in the percutaneous access kit.

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