JP2019150619A - System and method for guiding instrument - Google Patents

Abstract

To provide a system and an apparatus for guiding an instrument.SOLUTION: An apparatus includes: a body; a holding member for holding an instrument, the holding member connected to the body; and one or a plurality of operation members configured to cause movement of the holding member, the movement of the holding member enabling provision of the instrument's rotary motion around a pivot point 208 outside the apparatus. Preferably, the holding member is configured to cooperate with a compliance device, the compliance device being capable of holding the instrument.SELECTED DRAWING: Figure 2(a)

Description

  The present disclosure relates generally to systems and methods for guiding an instrument.

  A minimally invasive technique / procedure to access a subject's site using current technology is desired. For example, percutaneous access to the kidney (PAK) is a minimally invasive procedure for performing kidney access in kidney stone removal. PAKs are generally punctured into a subject's skin using a hollow needle and inserted substantially accurately into the subject's renal pelvis and goblet system including a kidney stone target. A guide wire is then inserted through the hollow needle, which guides the insertion of an endoscopic surgical instrument that can disassemble and remove the calculus. In general, techniques such as the PAK process are supported using radiation imaging, such as X-rays. For example, the PAK process typically uses C-arm fluoroscopy to locate the target.

  Although minimally invasive techniques are recognized to provide advantages such as less pain, less scars, less risk of infection, and faster recovery compared to incisions, such invasive techniques are generally performed It is also recognized that this is difficult. For example, PAK is a very complex calculus removal technique to master because it generally has to learn a lot in a short period of time. The insertion process in PAK relies heavily on the surgeon's experience to manipulate and align the needle. It has been recognized that the monotonous and time consuming part of the PAK procedure is needle alignment and manipulation.

  In addition, the long procedure time while using minimally invasive techniques generally increases the risk of perioperative complications in the subject. Also, a long procedure time generally increases the health risk of the surgical team due to exposure to radiation imaging, such as X-rays. Furthermore, given that there is always a demand in the operating room, it is recognized that long procedure times place a burden on the hospital.

  In view of the challenges faced by techniques such as PAK procedures, robotic systems have been developed to facilitate such procedures. For example, a fully automated robotic system (PAKY-RCM) assisted by an image guidance system and a motorized needle insertion driver is currently under development.

  However, the inventors recognize that there are some limitations associated with robot-assisted percutaneous kidney access (PAKY). For example, one limitation is related to respiratory movements or renal movements in the retroperitoneum during subject movements. Robotic systems are generally unable to adapt to targets that are moved by, for example, respiratory motion. Another exemplary limitation relates to the various tissue interfaces that the needle generally passes before reaching the target. Robotic systems are generally unable to adapt to minute deviations in needle path due to resistance of the needle at the tissue interface, and accumulation of minute deviations is missed by the target unless surgeon intervention is incorporated It can be a cause. Furthermore, it has been found that robotic systems can cause undesirable shadowing effects on radiation imaging performed, for example, to monitor target or process progress. In addition, the cost of mounting the robot system is extremely high. Also, tactile feedback during insertion can be useful information regarding whether the target has been reached, so surgeons may prefer manual methods over robotic systems. Thus, in general, access methods under the control of the surgeon may result in lower costs and may be more preferred.

  Thus, in view of the above, there is a need for a system and apparatus for guiding an instrument that seeks to address at least one of the above problems.

According to a first aspect, an apparatus for guiding an instrument is provided, the apparatus causing a movement of the body, a gripping member connected to the body for gripping the instrument, The movement of the gripping member includes one or more actuating members configured to provide rotational movement of the instrument about a pivot point outside the device.

  The apparatus further includes that the one or more actuating members are configured to cause movement as a translational motion in a plane that is parallel to a horizontal plane relative to the body.

  Each actuation member may be provided to cause translational movement of the gripping member along a respective axis in the plane.

  The apparatus can further include an extensible member coupled to the body, the extensible member being able to position the gripping member away from the body.

  The gripping member can include at least one clamping finger that is biased toward another clamping finger.

  The at least one clamping finger can include an end on which a force is applied to release the instrument from the device.

  The apparatus can further include a locking member for engaging the clamping finger to limit movement of the at least one clamping finger.

  The gripping member can be configured to cooperate with a compliance device, and the compliance device can grip the instrument.

  The compliance device can include two or more spherical joints that allow the compliance device to follow movement along two vertical axes, and the compliance device further includes a plunger assembly for restricting instrument movement. Can be included.

  The compliance device may be capable of being individually locked to movement along each axis.

  The compliance device may be composed of a material to substantially prevent the shadowing effect of the compliance device in the imaging procedure.

  The material can be at least one selected from the group consisting of titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), and paper.

  The gripping member can include an extensible shaft.

  The gripping member can be configured to cooperate with a compliance device, and the compliance device can grip the instrument.

  The compliance device can be configured to be contacted by at least two rounded walls provided in the body of the apparatus so that the compliance device follows movement along at least one axis. Can do.

  The gripping member can further include a plug that can actuate the extendable shaft to engage the compliance device, and extending or retracting the shaft releases the compliance device in relation to the body, respectively. Or to maintain.

  The compliance device may be composed of a material to substantially prevent the shadowing effect of the compliance device in the imaging procedure.

  The material is at least one selected from the group consisting of titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), and paper.

  The apparatus can further include an attachment base disposed on the body for contacting the subject surface such that the gripping member is disposed at a distance from the subject surface.

  The mounting base can include two or more mounting segments for contacting the subject surface.

  The first actuating member may include one or more guide slots, and the second actuating member may be movable relative to the first actuating member by the guide slots.

The first actuating member may further include a travel path, allowing the above described rotational movement of the instrument about a pivot point outside the device to be within the travel path.

  A locking latch that can extend one or more locking sub-members to engage one or more walls of the travel path to limit movement of the gripping member relative to the travel path A member can further be included.

  The at least one actuating member may be provided with a predetermined weakened portion, the at least one actuating member being able to be broken to release the instrument from the gripping member.

  The one or more actuating members can include a manually operable slider mechanism.

  The apparatus can further include a rotating member coupled to the body to cause rotation of the body about a vertical axis passing through the center of the body.

  The apparatus can further include a rotational locking member for limiting the rotation of the body.

  The apparatus further includes a locking member that can limit the movement of the gripping member such that only further movement of the gripping member along a single axis is allowed.

  At least the gripping member can be made of a material for substantially preventing the shading effect of the gripping member in the imaging procedure.

The material is at least one selected from the group consisting of titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), and paper.

  According to a second aspect, a system for guiding an instrument is provided, the system comprising an imaging device having an imaging surface and a visual alignment module, wherein the visual alignment module is a visible light source. And a refractive / reflective member for receiving light from the visible light source, the refractive / reflective member being substantially transparent to the imaging device and disposed in the imaging path of the imaging device, wherein the visible light source is , Placed off the imaging path of the imaging device, so that a visible reference of being perpendicular to the imaging path and the imaging surface can be provided by the refractive / reflective member.

  The visual alignment module may be movable so that the visible light source can be adjusted in a plane parallel to the plane of the imaging surface.

  The system may further include the apparatus of the first aspect and / or described above, and the instrument may be capable of being guided according to a visual criteria.

  According to a third aspect, a method is provided for providing a visual reference for guiding an instrument, the method comprising: providing an imaging device capable of imaging a target; and a visual alignment module Wherein the visual alignment module includes a visible light source and a refractive / reflective member for receiving light from the visible light source, wherein the refractive / reflective member is substantially transparent to the imaging device. Using a refracting / reflecting member to provide a visual reference for the imaging path, wherein the visible light source is positioned off the imaging path of the imaging device, and is disposed in the imaging path of the imaging device And guiding the instrument into the imaging path based on the visual criteria.

  For guiding the instrument, the method can further include using an imaging device to image the instrument position.

  According to a fourth aspect, there is provided a method for guiding an instrument, the method comprising using the device to grip the instrument, providing a pivot point outside the device, Actuating one or more actuating members of the device to move the instrument to effect rotational movement of the instrument about the pivot point.

  For actuating the one or more actuating members to move the instrument, the method further comprises causing the instrument to move in translation in a plane parallel to a plane parallel to the body of the device. Can do.

  For actuating one or more actuating members to move the instrument, the method can further include causing the instrument to move along a respective axis of each actuating member in a plane.

  Exemplary embodiments of the present invention will be better understood and readily apparent to those skilled in the art from the following description, given by way of example only, in conjunction with the drawings.

1 is a schematic diagram illustrating a system for guiding an instrument in an exemplary embodiment. FIG. 1 is a schematic diagram of the system when viewed from arrow A, in an exemplary embodiment. FIG. FIG. 2 is a schematic diagram for generally illustrating an apparatus for guiding an instrument in an exemplary embodiment. FIG. 2 is a schematic diagram for generally illustrating an apparatus for guiding an instrument in an exemplary embodiment. FIG. 2 is a schematic diagram illustrating an instrument guide device in an exemplary embodiment. It is a figure of the enlarged display of Fig.3 (a). FIG. 6 is a schematic diagram illustrating a compliance mechanism in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating a compliance mechanism in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating a compliance mechanism in an exemplary embodiment. 6 is a schematic flowchart for illustrating a method for guiding an instrument in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating an example instrument guidance using a visual alignment module in an example embodiment. FIG. 7 is a schematic diagram illustrating the use of the visual alignment module of FIG. 6 in an exemplary embodiment. FIG. 7 is a schematic diagram illustrating the use of the visual alignment module of FIG. 6 in an exemplary embodiment. 6 is a schematic flowchart for illustrating a method for providing a visual reference for guiding an instrument in an exemplary embodiment. 4 is a schematic flowchart for illustrating a process flow for accessing a target in an exemplary embodiment. 4 is a schematic flowchart for illustrating a process flow for accessing a target in an exemplary embodiment. 1 is a schematic perspective view of an apparatus for guiding an instrument in an exemplary embodiment. FIG. 1 is an exploded view of an apparatus for guiding an instrument in an exemplary embodiment. FIG. FIG. 2 is a schematic diagram illustrating a compliance device in an exemplary embodiment. FIG. 13 is an exploded view of the compliance device of FIG. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 6 is provided to illustrate maintaining the x compliance member at different angular positions in an exemplary embodiment. FIG. 12 is an exploded view of the clamping mechanism / device of the apparatus of FIG. FIG. 6 is a schematic diagram illustrating engagement and retention / gripping of a compliance device in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating engagement and retention / gripping of a compliance device in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating engagement and retention / gripping of a compliance device in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating engagement and retention / gripping of a compliance device in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating another apparatus for guiding an instrument in an exemplary embodiment. FIG. 17 is a schematic top view of the apparatus of FIG. FIG. 6 is a schematic diagram illustrating instrument holding / gripping and release in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating instrument holding / gripping and release in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating instrument holding / gripping and release in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating instrument holding / gripping and release in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating another apparatus for guiding an instrument in an exemplary embodiment. FIG. 20 is an exploded view of the apparatus of FIG. FIG. 20 is a schematic view of the apparatus of FIG. 19 when assembled. FIG. 22 is a schematic top view depicting the apparatus of FIG. FIG. 20 is a schematic top view of the apparatus of FIG. 19 with the second actuation mechanism / member fully extended in one X-axis direction in an exemplary embodiment. FIG. 20 is a schematic top view of the apparatus of FIG. 19 with the second actuation mechanism / member fully extended in the other X-axis direction in an exemplary embodiment. FIG. 6 is a schematic view of a locking member engaged with a second actuation mechanism / member in an exemplary embodiment. 6 is a schematic cross-sectional view of a locking member engaged with a second actuation mechanism / member when viewed from arrow D in an exemplary embodiment. FIG. FIG. 20 is a schematic bottom view of the apparatus of FIG. 19 with the first actuation mechanism / member fully extended in one Y-axis direction in an exemplary embodiment. FIG. 20 is a schematic bottom view of the apparatus of FIG. 19 with the first actuation mechanism / member fully extended in the other Y-axis direction in an exemplary embodiment. FIG. 6 is a schematic diagram illustrating engagement of a locking latch member in an exemplary embodiment. FIG. 20 is a schematic top view of the apparatus of FIG. 19 for illustrating a range of motion in an exemplary embodiment. FIG. 20 is a schematic top view of the apparatus of FIG. 19 for illustrating a range of motion in an exemplary embodiment. FIG. 20 is a schematic side view of the apparatus of FIG. 19 to illustrate the release of the instrument in an exemplary embodiment. FIG. 20 is a schematic side view of the apparatus of FIG. 19 to illustrate the release of the instrument in an exemplary embodiment.

The exemplary embodiments described herein can provide a system for guiding an instrument and a system for guiding an instrument. The instrument can be, but is not limited to, a needle. The needle can be, but is not limited to, a hollow needle, for example, for introducing an instrument through the hollow needle. The system and device may be used for, but not limited to, percutaneous access to the kidney (PAK) procedure. The system and apparatus can be a passive PAK assist device (PAK-AD) for assisting a user during a surgical procedure.

  The terms “coupled” or “connected” as used in this description are intended to include both directly connected and connected via one or more intermediate means, unless otherwise specified.

  Also, when describing some embodiments, the disclosure may disclose the methods and / or processes as a particular sequence of steps. However, it will be understood that unless otherwise required, a method or process should not be limited to the specific order of steps disclosed. Other order steps may be considered. The specific order of steps disclosed herein should not be construed as an undue limitation. Unless specifically required, the methods and / or processes disclosed herein should not be limited to the steps performed in the order described. The order of the steps may vary and is still within the scope of this disclosure.

  Further, in the description herein, whenever used, the term “substantially” is understood to include, but are not limited to, “fully” or “fully”. Also, whenever used, terms such as “including”, “including”, etc., are in addition to other components not explicitly listed, as well as the elements / components listed after such terms. Are intended to be non-limiting description languages. Further, whenever used, terms such as “about”, “approximately” and the like generally refer to reasonable variations, eg, +/− 5% variation of the disclosed value, or 4% variation of the disclosed value, Or it means a 3% variation in the disclosed value, a 2% variation in the disclosed value, or a 1% variation in the disclosed value.

  Furthermore, in the description herein, some values may be disclosed in ranges. Values indicating the endpoints of the range are intended to illustrate preferred ranges. Whenever a range is stated, the range is intended to include and teach all possible subranges as well as individual numerical values within that range. That is, the end points of a range should not be interpreted as invariant limits. For example, a description in the range of 1% to 5% is a specifically stated subrange of 1% to 2%, 1% to 3%, 1% to 4%, 2% to 3%, etc., as well as individually Is intended to have values within that range, such as 1%, 2%, 3%, 4%, and 5%. The above specific disclosure intent is applicable to any depth / width of range.

  In the description herein, the “tilting” motion of the instrument and the “rotating” (ie, rotating) motion about the pivot point are used interchangeably. The instrument is moved or moved to an oblique / tilted position relative to the starting position of the instrument.

  FIG. 1 (a) is a schematic diagram illustrating a system 102 for guiding an instrument in an exemplary embodiment. In order to facilitate imaging of the subject 106, an imaging structure 104 is provided. In the exemplary embodiment, imaging structure 104 is preferably a so-called C-arm. The C-arm 104 can rotate so as to draw a substantially circle about the axis passing through the arrow A.

FIG. 1 (b) is a schematic diagram of the system 102 as viewed from arrow A in an exemplary embodiment. The C arm 104 includes an imaging device. The imaging device may be a radiation imaging device such as an X-ray imaging device, but is not limited thereto. In alternative exemplary embodiments, any other imaging device or any other imaging format may be used, such as, but not limited to, magnetic resonance tomography (MRI), computed tomography (CT) scanning. In the exemplary embodiment, the imaging device includes an x-ray transmitter 110 and an x-ray receiver 112. The plane of the transmitter, ie transmitter 110, is substantially parallel to the plane of the receiving surface, ie receiver 112.

  The system 102 further provides a guidance module 122 for guiding an instrument, such as the hollow needle 120. The guidance module 122 includes a device 124 for guiding the instrument and preferably a support arm 126. The support arm 126 is attachably coupled to the device 124, for example, to place and support the device 124 during a PAK procedure.

  In the exemplary embodiment, device 124 may be attached to support arm 126, eg, an articulated arm, for quick setup and removal. The support arm 126 takes a reference when positioning from the bed / base 128 to which the support arm 126 is attached. This, in addition to time savings for the procedure provided by the use of the alignment module 108 and / or device 124, further reduces the overall time for a PAK procedure, for example.

  In an exemplary embodiment, the device 124 can provide a fine adjustment mechanism for use in, for example, a PAK procedure, and can provide a desired correction for needle shake. In an exemplary embodiment, the adjustment can be less than about 2 mm.

  In the exemplary embodiment, device 124 is preferably constructed, in whole or in part, from materials such that the shadowing effect during imaging is substantially reduced and / or prevented. For example, for radiographic imaging, such as x-ray imaging, the device 124 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like.

  Further, in the exemplary embodiment, device 124 further includes a release mechanism (not shown) that can remove an instrument, such as needle 120, from guidance module 122. The release mechanism can facilitate removal of the guidance module 122 from the subject 106 such that the guidance module 122 does not interfere with subsequent procedure steps, for example.

  FIGS. 2 (a) and 2 (b) are schematic views for generally illustrating an apparatus for guiding an instrument in an exemplary embodiment. In the exemplary embodiment, device 202 includes a gripping member or instrument holder 204. The gripping member may be off the center of the apparatus main body, or the gripping member may be at the center of the main body. In some embodiments, the instrument holder 204 can further include a clamp or plug-shaft assembly for cooperating with the compliance device. In other embodiments, the instrument holder 204 may be an opening provided in the device 202 for holding / gripping the instrument 206.

The device 202 may include one or more actuation mechanisms for providing translational motion along one or more axes (eg, y-axis and / or x-axis) in a plane that is horizontal to the body of the device 202. Further comprising a member or device. The translational motion in the plane described above can cause / provide movement for the instrument, or rotational movement of the instrument about the pivot point 208, the pivot point being at the tip of the instrument, for example when contacting the subject. is there. Instrument movement may be in dual-planes (eg, in the YZ plane 212 and / or in the XZ plane 224). The pivot point 208 is thus outside the device 202.

For example, translation of the instrument holder 204 in the y-axis direction may cause the instrument 206 to rotate at an angle α (compare numbers 214, 216) about the outer pivot point 208 in the YZ plane 212. With translational movement of the instrument holder 204 in the x-axis method, the instrument 206 can be rotated at an angle β (compare numbers 220, 222) about the outer pivot point 208 in the XZ plane 224.

  For axial motion, to limit the movement of the gripping member (eg, along the x direction) so that only further movement of the gripping member along a single axis (eg, along the y direction) is allowed. Preferably, a locking member (not shown) can be provided.

  In the exemplary embodiment, device 202 is further rotated about an axis perpendicular to the body of device 202 (eg, the z-axis) in a plane parallel to a plane that is horizontal to the body of device 202. obtain. For example, the device 202 can be rotated with an angle theta Θ (compare numbers 226, 228) in the XY plane. A rotation locking member (not shown) may be provided to limit rotation.

  In an exemplary embodiment, for example, during the PAK process, the device 202 is brought to a second marking location, such as a pivot point 208 location, on the subject. The device 202 is rotated about the z-axis to orient to the first marking 210 on the subject. After alignment, rotation about the z-axis can be locked. The instrument 206 can then be inserted into the instrument holder 204 and contacted with the subject. The pivot point 208 may then be provided at the tip of the instrument that has contacted the subject, for example, inserted approximately 3 mm into the subject. Bi-planar movement (eg, in the XZ and YZ planes) can be caused / provided / provided by the device 202 to the instrument 206 to guide the instrument 206 to a target within the subject. It is. The instrument can then be inserted and adjustment of the instrument can still be made by translational motion.

  It will be appreciated that the pivot point 208 is not limited to being in the second marking. Rather, the pivot point 208 can be any point, for example, along the line drawn between the first marking 210 and the second marking 208, including the first and second markings themselves. .

  In an alternative exemplary embodiment, the gripping member may be in a second plane that is parallel to a horizontal plane relative to the body of the device, eg, offset a fixed distance above or below the body. The actuation mechanism / member is configured to cause movement of the gripping member as a translational motion in the second plane.

  FIG. 3 (a) is a schematic diagram illustrating an instrument guide device in an exemplary embodiment. The instrument guide device 302 is an embodiment of the device 124 of FIG. The instrument guide 302 is removably coupled or attached to a rail (not shown) of the platform 304. A subject 306 can be placed on the platform / bed 304 and the instrument guidance device 302 is positioned above or above the subject 306.

FIG. 3B is an enlarged view of FIG. Instrument 308 is shown gripped / held by instrument guide 302. The instrument 308 contacts the insertion surface of the subject 306. The tip or contact point (not shown) of the instrument 308 is the pivot point of the instrument 308 (compare 208 in FIGS. 2 (a) and (b)). Thus, the pivot point is outside the instrument guide 302. To cause / provide the instrument guide 302 to tilt the instrument 308 or to rotate the instrument 308 about the outer pivot point (compare numbers 214, 216 in FIGS. 2 (a) and (b)) An operating mechanism (not shown) is provided. For example, the actuation mechanism 310 is configured to move along the Y axis 312 as shown. In this case, the conventional Z-axis is an axis (not shown) perpendicular to the subject 306. Movement along the Y axis causes instrument 308 to pivot in the YZ plane about the pivot point. Compare arrows 314. In an exemplary embodiment, a second actuation mechanism (not shown) may be provided for X-axis motion.

  The instrument guide 302 can rotate about an axis that is perpendicular to the Z-axis, ie, the Y-axis, and perpendicular to the subject 206 (compare numbers 226, 228 in FIGS. 2 (a) and (b)). It is also preferred that it be configured.

  In another exemplary embodiment, for example, by using the second actuation mechanism 316 to further provide a translational motion in another axis (eg, the X axis) perpendicular to the axis of motion (eg, the Y axis). The needle guidance device compares the XZ plane (224 in FIGS. 2 (a) and 2 (b)) around a pivot point maintained at the needle tip (compare 208 in FIGS. 2 (a) and 2 (b)). ) Can provide / cause a rotational movement of the instrument.

  In an exemplary embodiment, X-axis (and / or Y-axis) translation motion may be provided with “fine” and “coarse” adjustments. The coarse adjustment can be a large-scale movement that slides, for example, by pulling and pushing the actuation mechanism. Fine adjustment can be made by rotating a fine screw, such as, for example, a screw pitch of less than about 2 mm. The needle guidance device is provided with a locking member / device that locks to activate coarse (or large-scale) movement, for example during needle insertion, but still allows fine (or micro-scale) adjustment. obtain. During adjustment, the pivot point is maintained at the tip of the needle so that a more accurate trajectory can be achieved during insertion. The needle guidance device is preferably configured to follow the needle tilt, for example during XZ plane motion. For example, a compliance mechanism can be provided. Compliance during insertion is advantageous when the needle encounters resistance provided by the subject's body. The needle guidance device is also configured to have a release mechanism for removing the needle from the needle guidance device. For example, release can be realized in two or fewer steps.

  4 (a), (b), and (c) are schematic diagrams illustrating different compliance mechanisms in different exemplary embodiments.

  In one exemplary embodiment, FIGS. 4 (a) (i)-(iii) show a hole / opening 402 with hemispherical walls, eg 404, 406, disposed on the sides. The opening 402 functions as a gripping member or instrument holder (compare 204 in FIGS. 2 (a) and 2 (b)). A needle 408 can be inserted into the hole / opening 402. As shown in FIGS. 4 (a) (ii), in the neutral position, the needle 408 has an outer pivot 410 at the point of contact, eg, on the surface of the subject. In the exemplary embodiment, a rotational movement of the needle 408 about the pivot point is provided / caused for translational movement of the gripping member in a direction along an axis (eg, y-axis). As illustratively shown in FIGS. 4 (a) (i), in negative y-axis motion, the needle 408 uses a hemispherical wall, eg, 404, 406, to negatively move about the pivot point 410. Rotate to angle alpha 412. As illustratively shown in FIGS. 4 (a) (iii), in positive y-axis motion, the needle 408 uses a hemispherical wall, eg, 404, 406, to positively move about the pivot point 410. Rotate to angle alpha 414. The compliance mechanisms described with reference to FIGS. 4 (a) (i) to 4 (a) (iii) are shown in FIGS. 17, 18, 19 (a) to (b), 20 (a) to (b), 22 and 24 are substantially the same as the compliance mechanism described later with reference to (a) to (b).

In one exemplary embodiment, FIGS. 4 (b) (i) through (iii) show a compliance device 416. Compliance device 416 includes a hollow shaft for receiving needle 418. The side of the compliance device 416 has a hemispherical wall, for example 4
20, 422 are arranged. As shown in FIGS. 4 (b) (ii), in the neutral position, the needle 418 has an outer pivot 424 at the point of contact, for example, on the surface of the subject. In the exemplary embodiment, rotational movement of the needle 418 about the pivot point is provided / caused for translational movement of the gripping member in a direction along an axis (eg, y-axis). As illustratively shown in FIGS. 4 (b) (i), in negative y-axis movement, the needle 418 uses a hemispherical wall, eg, 420, 422, and is negative about the pivot point 424. Rotate to angle alpha 426. As illustratively shown in FIG. 4 (b) (iii), in positive y-axis motion, the needle 418 uses a hemispherical wall, eg, 420, 422, to be positive about pivot point 424. Rotate to angle alpha 428. The compliance mechanism described with reference to FIGS. 4 (b) (i) to 4 (b) (iii) is the compliance mechanism described later with reference to FIGS. 16, 17, and 18 (a) to (d). And substantially the same.

  In one exemplary embodiment, FIGS. 4 (c) (i) through (iv) show a compliance device 430. 4 (c) (iv) shows a cross-sectional view along line AA in FIG. 4 (c) (ii). Compliance device 430 includes spherical rotary joints, eg, 432, 434, for engaging corresponding sockets / holders provided on gripping member 436. Compliance device 430 also includes a shaft for receiving needle 438. As shown in FIGS. 4 (c) (ii), in the neutral position, the needle 438 has an outer pivot 440 at the point of contact, for example, on the surface of the subject. In the exemplary embodiment, rotational movement of the needle 438 about the pivot point is provided / caused for translational movement of the gripping member in a direction along an axis (eg, the y-axis). 4 (c) (i), the needle 438 interacts with a corresponding socket / holder provided on the gripping member 436 in a negative y-axis motion, as illustrated in FIGS. 4 (c) (i). , For example, 432, 434, to rotate to a negative angle alpha 442 about pivot point 440. As illustratively shown in FIGS. 4 (c) (iii), in a positive y-axis motion, the needle 438 interacts with a corresponding socket / holder provided on the gripping member 436 for a spherical rotary joint. , 432, 434, for example, to be rotated about a positive angle alpha 444 about pivot point 440. The compliance mechanisms described with reference to FIGS. 4 (c) (i) to 4 (c) (iv) are shown in FIGS. 12 (a) to (b), 13 (a) to (g), 14 and 15. This is substantially the same as the compliance mechanism described later with reference to (a) to (d).

  FIG. 5 is a schematic flowchart 500 for illustrating a method for guiding an instrument in an exemplary embodiment. In step 502, the instrument is grasped using the device. In step 504, a pivot point is provided outside the device. In step 506, one or more actuating members of the device are actuated to move the instrument to provide rotational movement of the instrument about a pivot point outside the apparatus.

  To provide a smoother pivoting movement of the instrument during the rotational movement of the instrument about the pivot point outside the device (eg as described with reference to FIGS. 4 (a) to (c)). It is preferred that a compliance device can be used.

  The method includes causing the movement of the instrument to translate in a plane that is parallel to a horizontal plane relative to the body of the device for actuating one or more actuating members to move the instrument.

  In an exemplary embodiment, the pivot point is preferably within the subject or the subject's organization.

  In an exemplary embodiment, the method can further include inserting the instrument into the subject, aligning the target within the subject, and using one or more actuating members of the device.

  This method can be used in PAK procedures.

  In another exemplary embodiment, the system 102 can be further enhanced for more accuracy by adding a visual alignment module.

  FIG. 6 is a schematic diagram illustrating an exemplary instrument guidance using a visual alignment module in an exemplary embodiment. Similar components function in substantially the same manner as the components described with reference to FIG. For ease of explanation, like numerals are used to describe like components.

  In system 602, an alignment module 604 is provided and includes a visible light source 608 and a refractive / reflective member 610. The light source 608 may be a laser pointer / light source, but is not limited thereto. The refraction / reflection member 610 may be a prism, but is not limited thereto. A gripping spine 612 is provided to hold and position the prism 610. In the exemplary embodiment, the visual reference on subject 106 is substantially perpendicular to the transmission surface or plane of transmitter 110. This can be adjusted by positioning the prism 610. Thus, the visual reference can advantageously provide a reference perpendicular to the x-ray plane.

  In the exemplary embodiment, light source 608 is positioned off the transmission path of x-ray transmitter 110. The prism 610 is disposed in the transmission / imaging path of the x-ray transmitter 110. It has been recognized that prism 610 is substantially transparent to radiation imaging. The gripping spine 612 is preferably made of a material that is transparent to radiation imaging, and the prism 610 is substantially transparent in the transmission / imaging path of the x-ray transmitter 110, so that transmission / imaging of the x-ray transmitter 110 is performed. The placement of the light source 608 off the path may therefore advantageously be such that the x-ray image acquired at the receiver 112 is substantially free of shadows.

  In the exemplary embodiment, visible alignment module 604 can increase insertion accuracy. A micromechanism or movable holder 614 may be provided connected to the laser pointer 608. The movable holder 614 can be used to perform planar motion along the receiver 112 such that a visible light reference can be projected onto the subject 106, for example. The visible light reference still remains perpendicular to the receiver imaging plane after adjustment. In the exemplary embodiment, there are two movements in the adjustment. The distance between the laser pointer 608 and the prism 610 is preferably fixed, but both components 608, 610 may be rotated along the central axis of the C-arm receiver 112 and their distance from the center The distance is adjustable. That is, the mechanism or movable holder 614 is designed to place the prism 610 at any point on the receiver plane (either radially and / or rotationally) using a polar coordinate system. Therefore, the visible light source can be adjusted in a plane parallel to the plane of the imaging surface.

FIGS. 7 (a) and (b) are schematic diagrams illustrating the use of the visual alignment module of FIG. 6 in an exemplary embodiment. In FIG. 7 (a), the laser beam is projected onto the second marking 706 on the subject 702 using the prism 610. The C-arm imaging device is tilted with respect to the first marking 704, for example, to obtain target information, eg, an image for determining depth. The laser beam is thus projected onto the second marking 706 and can guide the needle 710 to a position for accessing the target. Needle 710 contacts subject 702 with a laser beam. The guidance of the needle 710 is based on a two-plane (eg, XZ plane and YZ plane) operation, as described with reference to FIGS. 2 (a) and 2 (b). Guidance can be based on the image of the needle 710. For example, if the needle 710 is aligned with the laser beam and thus the transmission / imaging path of the x-ray imaging, the image may show the end of the needle without showing the needle trunk.

  In FIG. 7B, the laser beam is projected onto the end 712 of the needle 710. Insertion accuracy is advantageously improved by aligning the target, needle tip and center / end with the X-ray imaging plane.

  FIG. 8 is a schematic flowchart 800 for illustrating a method for providing a visual reference for guiding an instrument in an exemplary embodiment. In step 802, an imaging device capable of imaging a target is provided. In step 804, a visual alignment module is provided. The visual alignment module includes a visible light source and a refractive / reflective member for receiving light from the visible light source, wherein the refractive / reflective member is substantially transparent to the imaging device, The visible light source is disposed in the imaging path, and is disposed outside the imaging path of the imaging device. In step 806, the refractive / reflective member is used to provide a visible reference for the imaging path. In step 808, the instrument is guided to the imaging path based on the visual criteria.

  FIG. 9 is a schematic flowchart 900 for illustrating a process flow for accessing a target in an exemplary embodiment. A system and apparatus for guiding an instrument is used. In an exemplary embodiment, the instrument is a hollow needle. The imaging used is X-ray imaging. This system and apparatus is substantially the same as the system 602 described with reference to FIGS. 6, 7 (a), and 7 (b) and the apparatus described with reference to FIGS. 2 (a) and 2 (b). It is the same. Laser pointers and prisms are used for the alignment module.

  In step 902, a first marking is applied to the subject's body. This may be a marker, pen, pencil marking or the like for reference. One or more x-ray images are taken at this starting position.

In step 904, the C-arm is further rotated to take one or more x-ray images. The rotation of the C-arm may be about 20-30 degrees from the starting position. From the acquired image, target information, for example depth, is determined. A second marking is placed on the subject's body to indicate the entry point of the needle.

  In step 906, the x-ray imaging device is switched off for needle guidance. The inventors have recognized that switching off the X-ray imaging device at this stage can shorten the exposure of the user to radiation imaging that can be harmful to health.

  In step 908, the laser pointer is switched on and the laser beam is projected onto the second marking.

  In step 910, the needle guidance device is positioned on the second marking. In step 912, the needle is inserted into a guidance device that holds / holds the needle.

In step 914, the needle is inserted approximately 3 mm into the subject's body to obtain the pivot point of the needle. It will be appreciated that the pivot point may be obtained without insertion, for example on a surface in contact with the subject's body. The X-ray imaging device is then switched on.

  In step 916, the needle is guided using, for example, XZ and YZ plane motion using a guidance device so that it is aligned with the laser beam. Registration is confirmed from one or more x-ray images taken in this step. Coarse or relatively large movements can be used for alignment.

  In step 918, the needle is gradually inserted into the subject. In step 920, the needle position may be determined using x-ray imaging. This can include rotation of the C-arm.

  In step 922, needle adjustment, eg, fine adjustment of the needle, may be performed to insert the needle. This can be done because the needle is slightly displaced due to resistance by the subject's body.

  In step 924, x-ray imaging is used to determine if the needle has accessed the target. The user preferably also utilizes tactile feedback about the needle to determine whether the needle has accessed the target. If the target has not been accessed, the process loops to step 918.

  In step 926, the insertion is complete after the target is accessed. The needle guidance device or needle is released.

  FIG. 10 is a schematic perspective view of an apparatus for guiding an instrument in an exemplary embodiment. The device 1002 can provide an instrument such as a hollow needle 1004 with, for example, XZ plane and YZ plane motion. Rotation / tilt angle beta β for x-axis motion about pivot point 1006 at the tip of needle 1004 and rotation / tilt angle for y-axis motion about pivot point 1006 at the tip of needle 1004 Compare alpha alpha. The pivot point is therefore outside the device 1002. An x rod 1008 is provided as an actuating member / mechanism for actuating x-axis motion. A y-rod 1010 is provided as a second actuating member / mechanism for actuating y-axis motion. A handle 1012 is provided as a third actuating member / mechanism that actuates rotation of the device 1002 about the z-axis, ie, an axis that passes perpendicularly through the center of the device 1002. Compare the angle Θ 1014. That is, the handle 1012 can function as a rotating member of the device 1002. A spring collet and slit clamp assembly (not shown) coupled to the handle 1012 can function as a rotational locking member to limit the rotation of the device 1002.

  In the exemplary embodiment, the needle insertion point, eg, pivot point 1006, is off the body 1016 of device 1002. One advantage is that detachment maximizes the user's visibility of the needle insertion point on the subject. Furthermore, by being off, for example, the possibility of projection of the device 1002 on the target of the subject during radiation imaging can be eliminated. In this regard, it is also preferred that the device 1002 be constructed in whole or in part with a material such that the shadowing effect during imaging is substantially reduced and / or prevented. For example, at least the gripping member of the device 1002 can be composed of such a material. For example, for radiographic imaging, such as x-ray imaging, the device 124 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like.

  In an exemplary embodiment, a gripping member is provided, for example in the form of a clamping device / mechanism for gripping the instrument. A clamping device / mechanism including clamping members / fingers 1018, 1020 can hold / hold the needle 1004. Clamping fingers 1018, 1020 allow the user to “fast” and easily release needle 1004 from device 1002 by applying pressure to unclamping ends 1022, 1024 of clamping fingers 1018, 1020. You can also

  In the exemplary embodiment, cam knob 1026 is provided to lock y rod 1010 after coarse or large adjustments while still allowing fine or small adjustments by rotation of y rod 1010.

  In an exemplary embodiment, a locking member is preferably provided in the x direction to limit movement in the x direction so that only further movement along a single axis (y axis) is allowed.

  Thus, the device 1002 can use the needle 1004 itself to align the needle insertion plane and the imaging plane, eg, the X-ray plane. That is, during actual use, the device 1002 grasps the needle 1004 and aligns it parallel to the line joining the first and second markings on the subject, preferably directly above. Can do. In this position, the needle 1004 may be substantially horizontal with respect to the subject's surface. The needle 1004 can then be gradually pulled by the device 1002 toward an upright or vertical position along the alignment or bond line to initiate the process for accessing the target within the subject.

  FIG. 11 is an exploded view of an apparatus for guiding an instrument in an exemplary embodiment. The device 1102 is substantially the same as the device 1002 described with reference to FIG.

  A y-rod 1104 is provided for connection to the U-shaped block 1106 via the serrated shaft 1108. In the exemplary embodiment, the U-shaped block 1106 is an extensible member that can be coupled to the body 1124, and the U-shaped block 1106 positions the clamping finger (compare 1018, 1020 in FIG. 10) with the body 1124. Can be set off from. The connecting portion is housed in the guide housing 1110. By applying a translational force, for example by pushing or pulling the y-rod 904, a y-axis motion can be realized and consequently move the coupling. It will be appreciated that such movement can provide coarse or extensive adjustments to an instrument, such as the hollow needle 1112.

  A locking / locking lever 1114 is provided on the guide housing 1110. A cam knob 1116 is provided to engage with the lock lever 1114. The cam knob 1116 can rotate around the camshaft 1118. By rotating or “reversing” the cam knob in the y-axis direction, the cam knob can engage the jaw 1120 of the lock lever 1114 and contact the serrated notch of the serrated shaft 1108. This can lock the connection in the y direction. Coarse adjustment is prevented when the lock is engaged. The y-rod 1104 still further engages the serrated shaft 1108 via fine threads (not shown) in the serrated shaft 1108 to allow fine or small adjustment of the needle 1112 in the y direction. be able to.

An x rod 1122 is provided for coupling to the guide housing 1110 via fine threads (not shown) in the body 1124 of the device 1102. An elastic member such as a spring device 1126 (compare number 1028 in FIG. 10) is provided. The spring device 1126 has an opposite end of the main body 1124 at the end stopper 11 of the guide housing 1110.
28 is slidable along the guide housing 1110 to be adjacent. This allows one degree of freedom and can provide guidance in the x direction. The x rod 1122 can be rotated clockwise or counterclockwise for forward or opposite direction, respectively, to adjust the needle 1112 in the x direction.

  The body 1124 can be placed on or resting / placed on the slit clamp 1130. As a result, the slit clamp 1130 can be attached to the spring collet 1132. This arrangement can provide theta 1102 with theta Θ angle adjustment / rotation (compare 1014 in FIG. 10). A handle 1134 having a threaded end is provided to lock the device 1102 in place after a desired rotation of approximately angle Θ. To lock the rotational movement of the device 1102, the handle 1134 is used around the spring collet 1132 to tighten the slit clamp 1130 or to make the circumference of the slit clamp smaller. Since the freedom of movement of the spring collet 1132 is limited, the rotational motion is locked or limited.

  FIG. 12 (a) is a schematic diagram illustrating a compliance device in an exemplary embodiment. Compliance device 1202 may be used with or in cooperation with apparatus 1002 or apparatus 1102 described with reference to FIGS. 10 and 11, respectively. Compliance device 1202 may be used to grasp / hold an instrument such as hollow needle 1204. Rotation / tilt angle beta β for x-axis motion about the pivot point at the tip of needle 1204 and rotation / tilt angle alpha α for y-axis motion about the pivot point at the tip of needle 1204 Is also shown.

  In some embodiments, the compliance device 1202 is preferably substantially composed of a material such that shadow effects during imaging are substantially reduced and / or prevented. For example, for radiographic imaging such as x-ray imaging, the compliance device 1202 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like.

  FIG. 12B is an exploded view of the compliance device of FIG. The compliance device 1202 includes an x compliance member 1206 and has a pair of spherical ball joints 1208, 1210 on either side of the x compliance member 1206. Compliance device 1202 also includes a y compliance member 1212. Ball joints 1208, 1210 may be placed on / in a corresponding socket / holder, eg, 1214 provided on y compliance member 1212. Thus, x compliance member 1206 can pivot / rotate relative to y compliance member 1212. The x compliance member 1206 is also provided with a groove, for example 1228, for the purpose of locking.

  In order to hold the x compliance member 1206 in place within the y compliance member 1212, a compliance cover 1216 is provided to effectively enable rotation or movement of the needle 1204 in the XZ plane. In the exemplary embodiment, the y compliance member 1212 is a corresponding socket provided on the clamping member / finger of the clamping device / mechanism (compare 1018, 1020 in FIG. 10, not shown in FIG. 12 (b)). / Includes a pair of ball joints 1218, 1220 disposed on opposite sides to engage the holder. Thus, the y compliance member 1212 can cause rotation or movement of the needle 1204 in the YZ plane.

  In the exemplary embodiment, the set of ball joints 1208, 1210, 1218, 1220 are arranged in a vertical relationship to provide compliance of the needle 1204 in all directions.

  Compliance device 1202 further includes a sleeve lock 1222, a plunger 1224, and a cam 1226. These components 1222, 1224, and 1226 can operate in combination to lock the x compliance member 1206 at different angular positions.

  FIGS. 13 (a) to (g) are provided to illustrate maintaining the x compliance member 1206 (FIG. 12 (b)) at different angular positions. For ease of explanation, like numerals are used to refer to like components from FIGS. 12 (a) and (b).

  FIG. 13A is a schematic cross-sectional view of the compliance device 1202 (FIG. 12A). The x compliance device 1206 shifts / moves the sleeve lock 1222 toward or away from the x compliance member 1206 (compare number 1302) (indicated by positions A, B, and C) 3 It can be maintained in two different engagement positions. The movement / shift of the sleeve lock 1222 can be due to the user applying force or pressure.

  FIG. 13B is a schematic side view of the compliance device 1202 for indicating the position A. FIG. FIG. 13C is a schematic cross-sectional top view taken along line AA of the compliance device 1202 at position A. FIG. By moving the sleeve lock 1222 toward the x compliance member 1206 (see position A), the ring ends 1304, 1306 of the sleeve lock 1222 are grooves in the x compliance member 1206 (compare 1228 in FIG. 12 (b)). Engage with. This locks the x compliance member 1206 in a vertical position (ie, parallel to the z-axis).

  FIG. 13D is a schematic side view of the compliance device 1202 for indicating the position B. FIG. FIG. 13E is a schematic cross-sectional top view taken along line AA of the compliance device 1202 at position B. FIG. By moving the sleeve lock 1222 to the center position (ie, position B), the ring ends 1304, 1306 of the sleeve lock 1222 are disengaged from the grooves of the x compliance member 1206 (compare 1228 in FIG. 12 (b)). To do. Accordingly, the x compliance member 1206 is allowed to rotate freely.

  FIG. 13 (f) is a schematic side view of the compliance device 1202 for indicating the position C. FIG. 13G is a schematic cross-sectional top view taken along line AA of the compliance device 1202 at position C. FIG. Shifting sleeve lock 1222 further away from x-compliance member 1206 (ie, position C) has the effect of actuating a plunger assembly, such as cam 1226 and plunger 1224. Referring to FIG. 13 (a), stop end 1308 engages cam 1226, and cam 1226 consequently rotates about camshaft 1310. The rotation of the cam 1226 causes the plunger 1224 to engage. In this engagement, the plunger 1224 is moved toward and engages the x compliance member 1206. Accordingly, a compressive force is applied to the x compliance member 1206 by the plunger 1224. This results in locking the x compliance member 1206 at the last adjusted angular position.

  The three engagement positions A, B, and C can be flexible while functioning as rotational compliance with respect to the xz plane or as a fixed guide.

Thus, for example, during a PAK procedure, a needle shaft, eg, 1312, is inserted through the hole passage of the x compliance member 1206. The needle tip is inserted into the upper surface (eg, skin surface) of the subject. When the needle tip functions as a pivot and the x compliance member 1206 functions as a needle guide, there is only a single degree of freedom that is inserted into the subject until the needle accesses the target. This advantageously reduces the possibility of errors, for example during needle insertion.

  FIG. 14 is an exploded view of the clamping mechanism / device of the apparatus of FIG. U-shaped block 1106 is slidable within or extendable from body 1124 to provide movement along the y-axis. A mounting end 1402 of the U-shaped block 1106 is provided to grip the clamping members / fingers 1404, 1406 and the compliance device 1408 (compare 1202 in FIG. 12 (a)). Thus, the U-shaped block 1106 facilitates holding / gripping and maneuvering / operation of an instrument, such as the needle 1410.

  The fingers 1404, 1406 are brought together and secured in place with pins 1412 that can pass through the U-shaped block 1106. An elastic member in the form of a leaf spring 1414 is provided, resulting in a holding force for gripping a compliance device 1408 gripped by a ball joint, for example 1416 and a corresponding socket, for example 1418. The leaf spring 1414 provides an abutment / elastic / biasing force at the ends 1420, 1422 to a corresponding slot, for example 1424, of the fingers 1404, 1406 to urge the fingers 1404, 1406 toward each other.

  Safety locks to secure fingers 1404, 1406 by locking posts / stems 1428, 1430 to prevent unintentional release of compliance device 1408 from fingers 1404, 1406, for example during a needle adjustment and / or insertion process. 1426 is provided. That is, when the safety lock 1426 is engaged, the compliance device 1408 is gripped by the fingers 1404, 1406 and prevented from substantially loosening. Therefore, the safety lock 1426 functions as a finger lock member. The safety lock 1426 includes a stem instead, such as but not limited to a lock 1426 that engages a corresponding slot provided in the fingers 1404, 1406, or a groove provided in the fingers 1404, 1406, etc. It will be appreciated that other forms may be taken. To prevent rotation of the compliance device 1408 from the last compliance position, a ball lock lever or locking lever, for example, to increase / enhance the gripping force applied to the ball joint, eg 1416, of the compliance device 1408 by the fingers 1404, 1406, eg 1432 is provided.

  15 (a)-(d) are schematic diagrams for illustrating engagement and retention / gripping of a compliance device in an exemplary embodiment. For ease of explanation, like numerals are used to refer to like components from FIG.

Referring to FIG. 15 (a), a pressing force is applied at the unclamping ends 1502, 1504 of the clamping fingers 1404, 1406 to engage the compliance device 1408. Thus, fingers 1404, 1406 are biased open and compliance device 1408 is secured / attached to the inner surface of fingers 1404, 1406 using a ball joint, eg 1416 and corresponding socket joint, eg 1418. Enable. The pressing force at the clamp release ends 1502 and 1504 is then removed.

  Referring to FIG. 15 (b), the safety lock 1426 is rotated to engage the locking posts / stems 1428, 1430. Thus, the safety lock 1426 holds / grasps the clamping fingers 1404, 1406 in place to prevent the fingers 1404, 1406 from opening out, for example, during the needle alignment and insertion process. When the safety lock 1426 is engaged, the compliance device 1408 can rotate freely about just one axis, this freedom being provided by the inner x compliance member of the compliance device 1408. Rotational motion is indicated by a solid arrow line. Locking the movement of the x-compliance member can be achieved by the plunger assembly described with reference to FIG. 13 (g).

  Referring to FIG. 15 (c), the compliance device 1408 can be rotated to various angles for alignment and insertion purposes. As shown in FIG. 15 (c), the needle 1410 is, for example, a U-shaped block 1106 (hence, to align the first and second markings on the surface with the captured X-ray image. Device). By superimposing the needle image on the target image, the insertion path can be confirmed, and therefore the user's decision regarding the entry point can be facilitated.

  Referring to FIG. 15 (d), the ball lock lever, eg 1432, is rotated inward or towards each other to increase the force pressing the socket, eg 1418, against the ball joint, eg 1416, and thus compliance. Locking the device 1408 to any desired final angle.

  In an exemplary embodiment, to release the compliance device 1408, a ball lock lever, eg, 1432, can be rotated outward or in a loosened configuration to release the safety lock 1426 and release the clamp A pressing force is applied to the parts 1502 and 1504. That is, the release of the compliance device 1408 will use the reverse order of the engagement steps described above.

  In an alternative exemplary embodiment, the clamping mechanism can be modified to have one movable clamping finger. That is, the other clamping finger can be a fixed wall or a fixed member. The movable clamping finger can be biased toward a fixed member to tighten the compliance device.

  FIG. 16 is a schematic diagram illustrating another apparatus for guiding an instrument in an exemplary embodiment. Apparatus 1602 may engage or cooperate with a compliance device 1604 for guiding an instrument such as hollow needle 1606. Device 1602 is provided as an actuating member / mechanism for actuating the y-axis motion of compliance device 1604 and as a second actuating member / mechanism for actuating the x-axis motion of compliance device 1604. X-rod 1610. Compliance device 1604 includes a body having a shaft for receiving an instrument. The compliance mechanism is substantially similar to the mechanism described with reference to FIGS. 4 (b) (i) to (iii).

  In the exemplary embodiment, the YZ plane movement of the needle 1606 is both finely and coarsely tuned. For the XZ plane operation of the needle 1606, fine tuning adjustment is performed. Fine tuning adjustments are made to adjust / change the insertion angle of the needle 1606.

  A locking mechanism / member 1612 is provided. The locking member 1612 is a screw member provided on the main body 1612 of the device 1602. To lock the movement of the x-rod 1610, the locking member 1612 is screwed in using the threads (not shown) of the body 1614 to apply a compressive force to the x-rod 1610. Thus, motion in the x direction can be limited leaving only motion in the y direction.

FIG. 17 is a schematic top view of the apparatus of FIG. A rotation mechanism / member 1702 is provided as the central ring. The rotation locking member 1704 is a screw member provided on the rotation mechanism / member 1702 of the device 1602. A rotational locking member 1704 can be used to limit the rotation of the body 1614. The body 1614 may be rotated at a rotation angle of about 360 degrees about the z axis or the axis entering the paper. Compare theta Θ. In the exemplary embodiment, device 1602 is placed over the subject during use. In this regard, device 1602 is preferably constructed in whole or in part with a material such that the shadowing effect during imaging is substantially reduced and / or prevented. For example, at least the gripping member of the device 1602 can be composed of such a material. For example, for radiographic imaging, such as x-ray imaging, the device 1602 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like. Thus, shadowing effects by the device on x-rays or radiographic images can be prevented. This will prevent shadows on the X-ray image.

  In some embodiments, the compliance device 1604 is preferably substantially composed of a material such that shadow effects during imaging are substantially reduced and / or prevented. For example, for radiographic imaging such as X-ray imaging, the compliance device 1604 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like.

  FIGS. 18 (a)-(d) are schematics for illustrating instrument holding / gripping and release in an exemplary embodiment.

  Referring to FIG. 18A, a plug 1802 is provided in the x rod 1610. FIG. 18 (a) shows the plug in the engaged position.

  FIG. 18 (b) shows the other end of the x-rod 1610 when the plug is in the engaged position. Compliance device 1604 is contacted by an elongated gripping shaft 1804 of x-rod 1610. The gripping shaft 1804 contacts the corresponding indentation / hole 1806 of the compliance device 1604 and thus locks / locks the compliance device 1604 in place. Accordingly, the gripping shaft 1804 functions as a gripping member of the device 1602 and is connected to the main body 1614 by the x rod 1610.

  Referring to FIG. 18C, for example, by pulling the plug 1802, a force is applied to the plug 1802 to move the plug 1802 to the disengagement position 1802. The gripping shaft 1804 is disengaged / retracted from the recess / hole 1806. Accordingly, the compliance device 1604 can be released from the predetermined position and moved away from the apparatus 1602 while still maintaining the needle 1810 within the shaft (not shown) of the compliance device 1604.

  Referring to FIG. 18 (d), after the compliance device 1604 reaches the subject's insertion surface, an opening 1808 is obtained around the needle 1810. The device 1602 can then be removed by, for example, releasing the locking on the device 1602 by, for example, a support arm (compare 126 in FIG. 1 (b)) and then keeping the needle 1810 in the opening 1808.

  FIG. 19 is a schematic diagram illustrating another apparatus for guiding an instrument in an exemplary embodiment. Device 1902 can engage an instrument such as hollow needle 1904.

  In some embodiments, the apparatus 1902 is preferably configured in whole or in part with a material such that the shadowing effect during imaging is substantially reduced and / or prevented. For example, at least the gripping member of the device 1902 can be composed of such a material. For example, for radiographic imaging, such as x-ray imaging, the apparatus 1902 is preferably composed of a radiolucent, radiolucent, or radiolucent material. Such materials can include, but are not limited to, titanium, glass, polystyrene, polyurethane, PVC, polyetheretherketone (PEEK), paper, and the like. Thus, shadowing effects by the device on x-rays or radiographic images can be prevented. This will prevent shadows on the X-ray image.

  In the exemplary embodiment, apparatus 1902 is a bi-plane (eg, XZ plane and YX plane) body mount apparatus without any support arms (compare 126 in FIG. 1 (b)). obtain. Device 1902 may be attached directly to the subject's body using an attachment base. In the exemplary embodiment, the mounting base includes one or more mounting segments / legs 1906, 1908 adjacent to the subject. To rotate the device 1902, a user can grip the device 1902 at the edge (eg, of the body) and rotate the device 1902 freely. For attachment, the device 1902 may be temporarily attached to the subject by an adhesive tape or gel attached to the subject or an attachment base, eg, either of the attachment segments / legs 1906, 1908. Such means of adhesive tape or gel can also function as rotational locking. Thus, the XZ and YZ plane features 1910 are raised parallel to the surface for attachment to a constant / fixed Z-axis height (compare 1912).

  Since the device 1902 can be directly attached, the device 1902 can be aligned at any angle on the surface for attachment, and thus, for example, the relative position and size of the operating table / bed Advantageously offers the flexibility of not being limited by. Further, since the device 1902 can be attached directly to the subject, the device 1902 can move, for example, to the subject's breathing pattern and frequency. Advantageously, as the device 1902 moves with the subject, the possibility of tissue and organ rupture may be minimized.

  20 is an exploded view of the device 1902 of FIG. Referring to FIG. 20, device 1902 includes a body 2002, a first actuation mechanism / member 2004, a second actuation mechanism / member 2006, and a locking member 2008. The first and second actuation mechanisms / members 2004, 2006 provide an XZ plane and a YZ plane mechanism 1910. The body 2002 includes a mounting base and, as a result, includes mounting segments / legs 1906, 1908 for attachment to a subject. The body 2002 also lifts the XZ plane and YZ plane mechanism 1910 from the attachment segments / legs 1906, 1908 to a fixed Z-axis height.

The first actuation mechanism / member 2004 may be in the form of a slider on the body 2002 to provide, for example, y-axis motion. The second actuation mechanism / member 2006 may also be in the form of a slider on the body 2002 to provide, for example, x-axis motion. The first actuation mechanism / member 2004 includes a cavity for receiving a locking latch member 2010 for locking movement or further extension in the y-axis. A locking member 2008 is provided to lock movement in the x-axis. The locking member 2008 may be a screw type member for functioning as a screw rotation lock.

  The second actuation mechanism / member 2006 further includes a travel path 2012 through which an instrument such as a needle can move freely. As shown in the figure, the main body 2002 is provided with a corresponding movement path 2014. The rotational movement of the instrument about the pivot point outside the device is preferably within the travel path 2012.

  The second actuating mechanism / member 2006 preferably further includes sawtooth portions, eg 2016, provided on the walls on both sides of the travel path 2012. The serrations function to cooperate with a flexible arm (not shown) disposed within the first actuation mechanism / member 2004, which locks movement or further extension in the y-axis when desired. In order to do this, it can be moved by a locking latch member 2010.

  An opening 2020 is provided on the first actuation mechanism / member 2004 as a gripping member for gripping / holding the instrument. The first actuation mechanism / member 2004 also includes a pre-weakened portion / line 2018.

  FIG. 21 (a) is a schematic diagram of the device 1902 when assembled. FIG. 21B is a schematic top view of the device 1902. For ease of explanation, like numerals are used to refer to like components from FIGS.

  Referring to FIG. 21 (a), the upper surface of the first actuation mechanism / member 2004 (ie, in the y direction) is provided in the same plane as the main body 2002. That is, the upper surface of the first actuation mechanism / member 2004 preferably does not protrude above the main body 2002.

  Referring to FIG. 21 (b), an instrument holder 2102 is provided for holding / gripping an instrument such as a hollow needle (compare 1904 in FIG. 19). The instrument holder 2102 is provided on the XZ plane and the YZ plane mechanism 1910. A needle can be inserted through an opening 2104 provided in the instrument holder 2102. The XZ plane and YZ plane mechanism 1910 lifted to a certain height allows the guidance of the needle tip position by positioning the pivot point at the insertion point on the subject or at the needle tip. Thus, the pivot point is outside the device 1902. The resolution of the needle tip motion is based on the height of the lift. The opening 2104 allows the needle to slide freely along the insertion plane or the subject's insertion plane. The movement of the needle is based on the XZ and YZ plane movements brought about by movement in the X and Y axes (compare explanations for FIGS. 2 (a) and (b)).

  Movement or a combination of movements in the X and Y axes can, for example, adjust / shift the needle tip position within the subject. The second actuation mechanism / member 2006 (ie, the x-axis slider) slides in a direction parallel to the body 2002, for example, by applying a pushing or pulling force in the x direction with either pad 2106, 2108. can do.

Movement in the x direction is forced by a first actuation mechanism / member 2004 (ie, a slider in the y direction) assembled on the second actuation mechanism / member 2006. That is, the second actuation mechanism / member 2006 is maintained within the end wall 2110, 2112 of the body 2002. Reference is now also made to FIGS. 22 (a) and (b). FIG. 22A shows the second operating mechanism / member 20.
FIG. 10 is a schematic top view of device 1902 with 06 fully extended in one x-axis direction (eg, + x direction). FIG. 22 (b) is a schematic top view of the device 1902 with the second actuation mechanism / member 2006 fully extended in the other x-axis direction (eg, the −x direction).

  Returning to FIG. 21 (b), the locking member 2008 can engage the second actuation mechanism / member 2006 by a thread (not shown) in the body 2002. When the locking member 2008 is engaged or screwed to engage, the locking member 2008 applies a compressive frictional force on the second actuation mechanism / member 2006 relative to the body 2002 to cause x-axis direction. Limit movement. The locking member 2008 can limit movement in the x direction so that only further movement along a single axis (y-axis) is allowed. The locking member 2008 can be a screw lock nut. Reference is now also made to FIGS. 23 (a) and (b). FIG. 23 (a) is a schematic view of the locking member 2008 engaged with the second actuation mechanism / member 2006. FIG. 23 (b) is a schematic cross-sectional view of the locking member 2008 engaged with the second actuation mechanism / member 2006 when viewed from arrow D.

  Returning to FIG. 21 (b), the first actuating mechanism / member 2004 is, for example, in the y-direction with a pad 2114 disposed on a portion of the first actuating mechanism / member 2004 that extends out of the body 2002. By applying a pushing or pulling force, it is possible to slide vertically relative to the second actuation mechanism / member 2006. The first actuation mechanism / member 2004 advances in the y-axis direction along guide slots 2116 and 2118 provided on the second actuation mechanism / member 2006. The first actuation mechanism / member 2004 can slide along the slots 2116, 2118. The slots 2116 and 2118 are closed at the ends as shown in the figure. The limit of movement of the first actuation mechanism / member 2004 is provided by the ends of the guide slots 2116, 2118. Reference is now also made to FIGS. 24 (a) and (b). FIG. 24 (a) is a schematic bottom view of the device 1902 with the first actuation mechanism / member 2004 fully extended in one y-axis direction (eg, + y direction). FIG. 24 (b) is a schematic bottom view of the device 1902 with the first actuation mechanism / member 2004 fully extended in the other y-axis direction (eg, the -y direction).

  Returning to FIG. 21 (b), the y-axis motion can be locked by pulling or extending the locking latch member 2010 from within the cavity of the first actuation mechanism / member 2004.

  FIG. 25 is a schematic diagram illustrating engagement of a locking latch member in an exemplary embodiment. The locking latch member 2010 is attached to a flexible member, such as 2502, 2504, disposed within the first actuation mechanism / member 2004. When the locking latch member 2010 is extended from within the cavity of the first actuating mechanism / member (not shown) (compare 2506), the ends 2508, 2510 of the locking latch member 2010 are used as a locking submember of the flexible member. It functions to push or extend portions, eg, 2502, 2504, outward. Flexible arms, e.g., 2502, 2504, or extended portions 2512, 2514 of the locking sub-member, are provided on the wall of the path of travel of the second actuation mechanism / member (not shown) (compare 2012 in FIG. 20). Can engage a sawtooth or gear tooth, eg, 2016. Engagement can therefore limit movement along the y-axis direction.

  FIGS. 26 (a) and (b) are schematic top views of apparatus 1902 to illustrate the range of motion in an exemplary embodiment. FIG. 26 (a) shows the device 1902 fully extended in the -x and + y directions. FIG. 26 (b) shows the device 1902 fully extended in the + x and −y directions.

Referring to FIG. 20, a pre-weakened portion / line 2018 may be provided across the first actuation mechanism / member 2004. It will be appreciated that the pre-weakened portion could alternatively be provided on any component of the device 1902, such as on the body and / or the second actuation mechanism / member.

  FIGS. 27 (a) and (b) are schematic side views of an apparatus 1902 for illustrating device release in an exemplary embodiment. FIG. 27 (a) shows the final position of the device for guiding the instrument, for example after inserting the needle into the subject.

  Referring to FIG. 27 (b), the first actuation mechanism / member 2004 folds the first actuation mechanism / member 2004 along a pre-weakened portion / line (compare 2018 in FIG. 20). (Compare 2702). After folding, a cavity or free path for the inserted needle is created. The attached device (compare 1902 in FIG. 19) can be removed from the needle. For example, the body and the second actuation mechanism / member may be removed in the direction indicated by numeral 2704. Thus, instrument release can occur without any component contacting the inserted instrument. In the exemplary embodiment, folding makes the device non-reusable and destructive.

  Thus, in the exemplary embodiment described, a device may be provided for translating an instrument, or a portion of the needle, so that the needle can tilt at an angle. The tilt / rotation angle can be centered on a pivot point maintained at the needle tip, for example. The device may cause the needle to translate in a single plane so that the needle moves in two planes (eg, the XZ plane and the YZ plane) and tilts / rotates the needle at two angles within each plane. it can. The apparatus can perform fine and coarse adjustments for XZ and YZ plane operations. In the exemplary embodiment, the range of XZ plane and YZ plane motion / adjustment is in the range of 0 to about 200 mm. Needle gripping can be a toggle (eg, using a plug) or a clipping (using a clamping mechanism). In exemplary embodiments, it may be preferred that the material used to construct the device is a rigid plastic such as polycarbonate (PC), PEEK, titanium, and / or acrylonitrile butadiene styrene (ABS). Furthermore, it may be preferred that the material used to construct the device is a radiolucent or translucent material to minimize or prevent shading in the x-ray image.

  In some exemplary embodiments, a laser source may be attached to the C-arm receiver away from the x-ray imaging. The laser beam (by the prism) can be perpendicular to the C-arm receiver plane. The laser can be directed at the subject using a prism. The visible reference or point of the laser may be adjustable using a movable mechanism attached to the C-arm receiver.

In the described exemplary embodiment, a pivot point can be provided outside the device for guiding the instrument to provide certainty that allows free rotation of the instrument throughout the other device, for example, The point of rotation may be within the body of such a device. It has been recognized that too much freedom of rotation or movement can lead to errors during the procedure. Furthermore, the apparatus in the exemplary embodiment may be relatively cheaper and easier to use compared to robotic devices. The device in the exemplary embodiment may also allow a user to obtain direct contact feedback during instrument insertion. Also, if there is any deviation due to subject movement, eg, respiration, the instrument can be guided to the original path using the device in the exemplary embodiment. Further, because the x-rays can be switched off during needle guidance / insertion, the systems and devices in the exemplary embodiments can reduce exposure to x-rays during the procedure. It has also been recognized that the apparatus in the exemplary embodiment can simplify the technique so that the learning curve of the procedure can be shortened for new users. It has also been recognized that shorter procedure times can be obtained with easier guidance and reference.

  Thus, the exemplary embodiment advantageously provides a passive PAK assist device (PAK-AD) that can combine precision adjustment and guidance techniques with user skills and dexterity to manage the needle alignment and insertion process. Can be provided. The device in the exemplary embodiment can provide that the needle is referenced for adjustment in one plane without affecting alignment in other planes. The device in the exemplary embodiment allows the needle to be physically locked in place and can allow only one DOF for insertion of the needle into the subject. The exemplary embodiment also provides an articulated support arm coupled with several guidance and locking modules to help achieve high alignment accuracy of the needle with respect to the target while simultaneously positioning the needle on the target. The user can still be given full control to adjust and insert.

  Although the exemplary embodiments described have been described with respect to the x-axis and the y-axis, it will be understood that the exemplary embodiments are not so limited. For example, the x and y axes are arbitrary and may be interchangeable. Also other axes, even non-vertical axes can be used. Similarly, although the XZ and YZ planes have been described, other planes can be used.

  Also, in the exemplary embodiment described, an instrument such as a needle is described for ease of illustration. It will be appreciated that the apparatus and system may be provided independently of the instrument.

  Furthermore, it will be appreciated that the XZ and YZ plane motions that result in tilt / rotation motions about pivot points outside the apparatus of the exemplary embodiment are not limited to being used only in PAK procedures. The devices of the exemplary embodiments can be used for a variety of biological systems and other procedures, such as kidney stone removal procedures, procedures for the colon, stomach, and lungs. The apparatus of the exemplary embodiment can also be used for cosmetic procedures. The apparatus of the exemplary embodiment can also be used for non-surgical procedures that utilize instrument guidance to an implanted target, preferably with the aid of an imaging system such as X-ray imaging.

  Further, it will be appreciated that the described exemplary embodiment having a compliance device that cooperates with a gripping member is not so limited. That is, these exemplary embodiments can be modified so that the gripping member holds / holds the instrument directly, ie without a separate compliance device.

  In the exemplary embodiment described, the subject may be a human or animal subject. The target can be a tissue, tumor, stone, or the like.

  Further, it will be appreciated that the exemplary embodiments can be modified so that the imaging and / or alignment steps can be performed or supported by an automated system. That is, the exemplary embodiments can be modified to provide a partially passive PAK support device, and such exemplary embodiments are not limited to totally passive PAK support devices. .

  Those skilled in the art will appreciate that other variations and / or modifications can be made to the specific embodiments without departing from the scope of the invention as broadly described. This embodiment is therefore to be considered in all respects only as illustrative and not restrictive.

Claims (6)

A method for guiding an instrument by a device, comprising:
Gripping the instrument using the device;
Providing a pivot point outside the device;
Actuating one or more actuating members of the device to move the instrument as one or more translational motions limited in a single plane parallel to a horizontal plane relative to the body of the device; Said instrument moving in the same direction as said one or more translational movements and said instrument in one or more planes perpendicular to said plane parallel to a plane parallel to said body Actuating, wherein the rotational motion is about the pivot point outside the device.   For the step of actuating one or more actuating members to move the instrument, the method is along a respective axis of each actuating member in the plane that is parallel to a plane parallel to the body. The method of claim 1, further comprising causing the translational motion of the instrument.   Providing a rotating thread member as the one or more actuating members; and causing the one or more translational movements of the gripping member by rotating the rotating thread member. The method according to 1 or 2.   3. The method according to claim 1, further comprising: providing a mounting base disposed on the body; and contacting the object surface such that the device is disposed at a fixed distance parallel to the object surface. The method described.   The method of claim 4, wherein the mounting base includes two or more mounting segments for contacting the object surface.   A step of providing a manually operable slider mechanism as the one or more actuating members; and a rotating operation of the manually operable slider mechanism to cause the one or more translational operations of the gripping member by hand. The method according to claim 4 or 5, further comprising: